[Federal Register Volume 60, Number 1 (Tuesday, January 3, 1995)]
[Rules and Regulations]
[Pages 174-217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32105]
[[Page 173]]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Parts 317 and 381
Nutrition Labeling of Meat and Poultry Products; Final Rule
Federal Register / Vol. 60, No. 1 / Tuesday, January 3, 1995 / Rules
and Regulations
[[Page 174]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. 94-029F]
Nutrition Labeling of Meat and Poultry Products; Codification
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its
final nutrition labeling regulations to provide codified language for
provisions that previously cross-referenced those requirements
contained in the final nutrition labeling regulations of the Food and
Drug Administration (FDA) that FSIS adopted. FSIS is taking this action
to provide complete codified language for the nutrition labeling of
meat and poultry products in the regulations under 9 CFR parts 317 and
381. Full codification of the final FSIS nutrition labeling regulations
will facilitate their use by improving their clarity and accessibility.
EFFECTIVE DATE: January 3, 1995, except that the amendments to
Secs. 317.363 and 381.463 are effective on November 10, 1995. The
incorporation by reference of Agriculture Handbook No. 74 (Slightly
revised February 1973), pages 2, 3, 9-11, and 25, and the ``Report of
the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,''
Rome, 1990, sections 5.4.1, 7.2.1, and 8, contained in these
regulations, is approved by the Director of the Office of the Federal
Register as of January 3, 1995.
FOR FURTHER INFORMATION CONTACT: Charles Edwards, Director, Product
Assessment Division, Regulatory Programs, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250, (202)
254-2565.
SUPPLEMENTARY INFORMATION:
Background
FSIS published its final nutrition labeling regulations in the
Federal Register on January 6, 1993 (58 FR 632). Corrections and
technical amendments to this final rule were published on August 18,
1993 (58 FR 43787), and September 10, 1993 (58 FR 47624), respectively.
The technical amendments, which were issued as an interim final rule,
were confirmed as final on March 16, 1994 (59 FR 12157). FSIS also
published a final rule on placement of nutrition labeling on meat and
poultry products on August 8, 1994 (59 FR 40209), and a final rule with
additional technical amendments to the nutrition labeling regulations
on September 1, 1994 (59 FR 45189). Most of the changes FSIS made in
the final rules pertaining to technical amendments and the placement of
nutrition labeling on meat and poultry products were designed to
parallel similar changes that FDA made to its nutrition labeling
regulations. FSIS adopted certain changes made by FDA in cross-
referenced provisions, in addition to amending certain of its own
provisions to be consistent with those changes.
The codified portion of FSIS's final regulations published on
January 6, 1993, cross-referenced provisions of FDA's regulations where
the requirements are identical, and, for the most part, provided
codified language only for those provisions where there are variations
from FDA because of the different products that FSIS regulates. FSIS
used cross-references in order to issue its final nutrition labeling
regulations simultaneously with FDA on January 6, 1993. In the preamble
to its final rule of January 6, 1993, FSIS said that it had received
many comments which suggested that the Agency include all of the
codified language for the nutrition labeling of meat and poultry
products in the regulations under 9 CFR parts 317 and 381. The
commenters stated that it is very difficult to go back and forth
between FDA and FSIS regulations to look up different provisions for
the nutrition labeling regulations. FSIS agreed with these comments and
said it planned to publish the codified language in its entirety, while
noting that future codification did not postpone the implementation
date of the nutrition labeling regulations.
The Amendments
This document sets forth in entirety the codified language for
previously cross-referenced nutrition labeling provisions. It includes
all changes in the above-mentioned final rules as they apply to the
cross-referenced provisions. Sections that contain cross-referenced
provisions include those pertaining to the nutrition label content
(serving sizes; mandatory and voluntary nutrients; and format
requirements for the standard display, dual column display, and
simplified format); Reference Amounts Customarily Consumed per eating
occasion; general principles for nutrient content claims; nutrient
content claims (claims for ``good source,'' ``high,'' and ``more'';
``light'' or ``lite''; calorie content; sodium content; and fat, fatty
acids, and cholesterol content); and label statements for reducing or
maintaining body weight.
In incorporating the previously cross-referenced provisions
contained in 21 CFR, FSIS has made an effort to order the paragraphs
and subdivisions, to the extent possible, in the same sequence as the
comparable paragraphs and subdivisions in FDA's nutrition labeling
regulations in 21 CFR. Accordingly, some existing paragraphs have been
redesignated. FSIS believes that such consistency of presentation will
be useful to interested parties who compare the FSIS and FDA
provisions, and to those manufacturers producing both FSIS- and FDA-
regulated products who refer to both agencies' regulations for
nutrition labeling requirements.
FSIS is also making several amendments to sections of the nutrition
labeling regulations (9 CFR part 317, subpart B, and part 381, subpart
Y) that do not contain cross-referenced provisions to correct
typographical errors, make minor editorial changes for clarity and
accuracy, and reorder information in several paragraphs to improve
clarity and readability. For example, in part 317, the terminology for
``meat products'' is changed, in most cases, to ``meat or meat food
products,'' which mirrors the statutory language contained in the
Federal Meat Inspection Act. The term ``product component'' is changed
to ``food component'' when it refers to a constituent of food whose
declaration on product labeling is mandatory or voluntary under the
regulations, and ingredients with specific food factors for calorie
calculations. Cross-references within paragraphs in various sections of
the nutrition labeling provisions are changed to conform with any
redesignated paragraph that is the subject of the cross-reference.
Units of measure and weights are, for the most part, abbreviated after
their first appearance within a section.
FSIS provided provisions at 9 CFR 317.309(e)(2)(i) and
381.409(e)(2)(i) for use of an aggregate display of nutrition
information on the outer label or labeling of products that contain two
or more products in the same package. However, in 9 CFR
317.309(e)(2)(ii) and 381.409(e)(2)(ii) that specify the format
requirements for the aggregate display, FSIS inadvertently provided
that the identity of each food shall be specified immediately under the
``Nutrition Facts'' title. In fact, the identity of the food is placed
to the right of the ``Nutrition Facts'' title as illustrated by a
sample label for the aggregate display at 21 CFR 101.9(d)(13)(ii). FSIS
is correcting this oversight in paragraphs 9 [[Page 175]] CFR
317.309(e)(2)(ii) and 381.409(e)(2)(ii), which are redesignated as 9
CFR 317.309(d)(13)(ii) and 381.409(d)(13)(ii), respectively.
FSIS is revising the language of 9 CFR 317.309(g) and 381.409(g) to
clarify the identity of nutrients that shall be included in a
simplified format and those that may be included voluntarily. Sections
317.309(g)(2) and 381.409(g)(2) (9 CFR 317.309(g)(2) and 381.409(g)(2))
specify that the simplified format shall include serving size, number
of servings per container, calories, total fat, total carbohydrate,
protein, and sodium. The provisions do not provide specifically that
calories from fat, saturated fat, cholesterol, dietary fiber, sugars,
vitamin A, vitamin C, calcium, and iron also must be declared in the
simplified format when any are present in more than insignificant
amounts, as must any added vitamins and minerals for which Reference
Daily Intakes (RDI) are established if their addition were to be
allowed. Those provisions also do not indicate that other nutrients for
which nutrition labeling is voluntary (e.g., sugar alcohol or thiamin)
may also be declared in the simplified format. FSIS is redesignating
sections 317.309(g) and 381.409(g) as 317.309(f) and 381.409(f),
respectively, revising the newly designated paragraphs, and adding a
paragraph to specify the requirements completely. This action provides
codified language that is consistent with comparable FDA provisions at
21 CFR 101.9(f) and prevents misinterpretation of the simplified format
provisions.
FSIS is amending 9 CFR 317.313(q)(4) and 381.414(q)(4) pertaining
to exemptions from the general principles for nutrient content claims
by correcting the terminology for the products that are not subject to
the provisions in the sections. Accordingly, the term ``products for
special dietary use'' is changed to read ``infant formulas and medical
foods,'' which is the terminology employed by FDA in the comparable
provision in 21 CFR at 101.13(q)(4). Products for special dietary use,
as described in 21 CFR part 105, include products such as
hypoallergenic products, products designed for weight reduction or
weight maintenance, products for use in diets of diabetics, and
products used to regulate sodium intake, all of which are subject to
the provisions of 9 CFR 317.313 and 381.413. To leave the terminology
uncorrected creates an apparent conflict with provisions in the
sections of the nutrition labeling regulations pertaining to nutrient
content claims about calorie content (9 CFR 317.360 and 381.460) and
sodium content (9 CFR 313.361 and 381.461), and label or labeling
statements relating to usefulness in reducing or maintaining body
weight (9 CFR 317.380 and 381.480).
At 9 CFR 317.345(a)(2) and 381.445(a)(2), FSIS set forth guidelines
for voluntary nutrition labeling of single-ingredient, raw products
that specify that point-of-purchase materials are not subject to any
format requirements if only nutrition information, and not a nutrition
claim, is supplied on point-of-purchase materials. FSIS specifically
mentioned that listing of Daily Reference Values, which is a footnote,
is voluntary but did not specify that the listing of percent of Daily
Value is also a format requirement. FSIS is making minor editorial
changes in 9 CFR 317.345(a)(2) and 381.445(a)(2) to clarify this point
and is reordering some of the information to improve readability.
In addition, at 9 CFR 317.362(f)(1) and 381.462(f)(2), FSIS used
the following statements as examples of declarations of quantitative
information for claims of cholesterol free, low cholesterol, or reduced
cholesterol that compare the level of cholesterol in an individual food
product with that of a reference food: (e.g., ``contains no cholesterol
compared with 30 mg in one serving of `reference food'; contains 11 g
of fat per serving'' or ``cholesterol lowered from 30 mg to 5 mg per
serving; contains 13 g of fat per serving''). FSIS is not including in
these amendments those portions of the statements that disclose fat
contents, that is, ``contains 11 grams of fat per serving'' and
``contains 13 g of fat per serving,'' because FSIS does not require
such disclosure but, rather, permits disclosure on an optional basis.
Executive Order 12866
This final rule has been determined to be not significant for
purposes of Executive Order 12866 and therefore has not been reviewed
by the Office of Management and Budget.
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking, labeling, packaging,
or ingredient requirement on federally inspected meat and poultry
products that are in addition to, or different than, those imposed
under the FMIA or PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat and poultry products that
are outside official establishments for the purpose of preventing the
distribution of meat and poultry products that are misbranded or
adulterated under the FMIA or PPIA, or, in the case of imported
articles, which are not at such an establishment, after their entry
into the United States. Under the FMIA and PPIA, States that maintain
meat and poultry inspection programs must impose requirements that are
at least equal to those required under the FMIA and PPIA. The States
may, however, impose more stringent requirements on such State
inspected products and establishments.
No retroactive effect will be given to this final rule. The
administrative procedures specified in 9 CFR 306.5 and 381.35 must be
exhausted prior to any judicial challenge of the application of the
provisions of this final rule, if the challenge involves any decision
of an inspector relating to inspection services provided under the FMIA
or PPIA. The administrative procedures specified in 9 CFR parts 335 and
381, subpart W, must be exhausted prior to any judicial challenge of
the application of the provisions of this final rule with respect to
labeling decisions.
Effect on Small Entities
The Administrator, FSIS, has made a determination that this final
rule will not have a significant economic impact on a substantial
number of small entities. This final rule simply codifies into 9 CFR
the 21 CFR provisions that were previously cross-referenced in 9 CFR
317 and 381 pertaining to nutrition labeling. In addition, small
entities are exempt from nutrition labeling regulations, provided their
products do not make nutrition claims or nutrition information.
List of Subjects
9 CFR Part 317
Food labeling, Food packaging, Incorporation by reference, Meat
inspection.
9 CFR Part 381
Food labeling, Incorporation by reference, Poultry and poultry
products.
Final Rule
For the reasons discussed in the preamble, FSIS is amending 9 CFR
parts 317 and 381 of the Federal meat and poultry products inspection
regulations as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for part 317 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
[[Page 176]] 2. Section 317.300 is amended by revising the section
heading, paragraph (a) and the first sentence of paragraph (b) to read
as follows:
Sec. 317.300 Nutrition labeling of meat or meat food products.
(a) Nutrition labeling shall be provided for all meat or meat food
products intended for human consumption and offered for sale, except
single-ingredient, raw products, in accordance with the requirements of
Sec. 317.309; except as exempted under Sec. 317.400 of this subpart.
(b) Nutrition labeling may be provided for single-ingredient, raw
meat or meat food products in accordance with the requirements of
Secs. 317.309 and 317.345. * * *
3. Section 317.302 is amended by adding the words ``or meat food''
after the words ``packaged meat'' in paragraph (a) and after the word
``Meat'' in the first sentence of paragraph (c).
4. Section 317.308 is amended by adding the words ``or meat food''
after the word ``meat'' in the section title and after the word
``meat'' in the text.
5. Section 317.309 is amended by changing the section reference in
the fifth sentence of paragraph (h)(2) from ``317.309(b)'' to
``317.309(c)'' and revising paragraphs (a) through (g) to read as
follows:
Sec. 317.309 Nutrition label content.
(a) All nutrient and food component quantities shall be declared in
relation to a serving as defined in this section.
(b)(1) The term ``serving'' or ``serving size'' means an amount of
food customarily consumed per eating occasion by persons 4 years of age
or older, which is expressed in a common household measure that is
appropriate to the product. When the product is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14)
of this section and for products that are intended for weight control
and are available only through a weight-control or weight-maintenance
program, serving size declared on a product label shall be determined
from the ``Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply'' (Reference Amount(s)) that appear in
Sec. 317.312(b) using the procedures described in this paragraph (b).
For products that are both intended for weight control and available
only through a weight-control program, a manufacturer may determine the
serving size that is consistent with the meal plan of the program. Such
products must bear a statement, ``for sale only through the ______
program'' (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal
display panel. However, the Reference Amounts in Sec. 317.312(b) shall
be used for purposes of evaluating whether weight-control products that
are available only through a weight-control program qualify for
nutrition claims.
(3) The declaration of nutrient and food component content shall be
on the basis of the product ``as packaged'' for all products, except
that single-ingredient, raw products may be declared on the basis of
the product ``as consumed'' as set forth in Sec. 317.345(a)(1). In
addition to the required declaration on the basis of ``as packaged''
for products other than single-ingredient, raw products, the
declaration may also be made on the basis of ``as consumed,'' provided
that preparation and cooking instructions are clearly stated.
(4) For products in discrete units (e.g., hot dogs, and
individually packaged products within a multi-serving package), and for
products which consist of two or more foods packaged and presented to
be consumed together where the ingredient represented as the main
ingredient is in discrete units (e.g., beef fritters and barbecue
sauce), the serving size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount,
the serving size shall be the number of whole units that most closely
approximates the Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent
of the Reference Amount, the manufacturer may declare one unit or two
units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent
of the Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or
milliliter) or larger and are individual units within a multi-serving
package, if a unit contains more than 150 percent but less than 200
percent of the Reference Amount, the manufacturer may decide whether to
declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., beef fritters and
barbecue sauce), the serving size may be the number of discrete units
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product as
determined in Sec. 317.312(c).
(vii) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving
containers), the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided
for consumption (e.g., pizza), for unprepared products where the entire
contents of the package is used to prepare large discrete units that
are usually divided for consumption (e.g. pizza kit), and for products
which consist of two or more foods packaged and presented to be
consumed together where the ingredient represented as the main
ingredient is a large discrete unit usually divided for consumption,
the serving size shall be the fractional slice of the ready-to-eat
product (e.g., \1/8\ quiche, \1/4\ pizza) that most closely
approximates the Reference Amount for the product category. The serving
size may be the fraction of the package used to make the Reference
Amount for the unprepared product determined in Sec. 317.312(d) or the
fraction of the large discrete unit represented as the main ingredient
plus proportioned minor ingredients used to make the Reference Amount
of the combined product determined in Sec. 317.312(c). In expressing
the fractional slice, manufacturers shall use \1/2\, \1/3\, \1/4\, \1/
5\, \1/6\, or smaller fractions that can be generated by further
division by 2 or 3.
(6) For nondiscrete bulk products (e.g., whole roast beef,
marinated beef tenderloin, large can of chili), and for products which
consist of two or more foods packaged and presented to be consumed
together where the ingredient represented as the main ingredient is a
bulk product (e.g., roast beef and gravy), the serving size shall be
the amount in household measure that most closely approximates the
Reference Amount for the product category and may be the amount of the
bulk product represented as the main ingredient plus proportioned minor
ingredients used to [[Page 177]] make the Reference Amount for the
combined product determined in Sec. 317.312(c).
(7) For labeling purposes, the term ``common household measure'' or
``common household unit'' means cup, tablespoon, teaspoon, piece,
slice, fraction (e.g., \1/4\ pizza), ounce (oz), or other common
household equipment used to package food products (e.g., jar or tray).
In expressing serving size in household measures, except as specified
in paragraphs (b)(7)(iv), (v), and (vi) of this section, the following
rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup
increments, tablespoons in whole number of tablespoons for quantities
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp),
1, 1\1/3\, 1\1/2\, or 1 \2/3\ tbsp for quantities less than 2 tbsp but
greater than or equal to 1 tbsp, and teaspoons in whole number of
teaspoons for quantities less than 1 tbsp but greater than or equal to
1 teaspoon (tsp), and in \1/4\-tsp increments for quantities less than
1 tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If cups, tablespoons and teaspoons, or units such as piece,
slice, tray, jar, or fraction are not applicable, ounces may be used.
Ounce measurements shall be expressed in 0.5-ounce increments most
closely approximating the Reference Amount with rounding indicated by
the use of the term ``about'' (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be
used for single-serving containers and meal-type products and for
individually packaged products within multi-serving containers (e.g.,
can, box, package, meal, or dinner). A description of the individual
unit shall be used for other products in discrete units (e.g., chop,
slice, link, or patty).
(v) For unprepared products where the entire contents of the
package is used to prepare large discrete units that are usually
divided for consumption (e.g., pizza kit), the fraction or portion of
the package may be used.
(vi) For products that consist of two or more distinct ingredients
or components packaged and presented to be consumed together (e.g., ham
with a glaze packet), the nutrition information may be declared for
each component or as a composite. The serving size may be provided in
accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6)
of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1
oz in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in
Sec. 317.312(b) and the procedures described in this section, falls
exactly half way between two serving sizes (e.g., 2.5 tbsp),
manufacturers shall round the serving size up to the next incremental
size.
(8) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable Reference Amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving, except for products
that have Reference Amounts of 100 g (or mL) or larger, manufacturers
may decide whether a package that contains more than 150 percent but
less than 200 percent of the Reference Amount is 1 or 2 servings.
Packages sold individually that contain 200 percent or more of the
applicable Reference Amount may be labeled as a single-serving if the
entire content of the package can reasonably be consumed at a single-
eating occasion.
(9) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs
(b)(2) through (b)(8) of this section and shall be followed by the
equivalent metric quantity in parenthesis (fluids in milliliters and
all other foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement
on the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to
paragraph (b)(11) of this section. However, if a manufacturer
voluntarily provides the metric quantity on products that can be sold
as single-servings, then the numerical value provided as part of the
serving size declaration must be identical to the metric quantity
declaration provided as part of the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between
2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g
(mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce, in
parenthesis, following the metric measure separated by a slash where
other common household measures are used as the primary unit for
serving size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce
quantity equivalent to the metric quantity should be expressed in 0.1-
oz increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, and oz for ounce.
(10) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term ``about'' (e.g., about 2 servings;
about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size (e.g., pickled pigs feet), the manufacturer may
state the typical number of servings per container (e.g., usually 5
servings).
(iii) For random weight products, a manufacturer may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the Reference Amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the ``varied'' statement (e.g., varied
(approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving
containers), the number of servings shall be the number of individual
packages within the total package.
(v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by
multiplying the number of individual multi-serving units in the total
package by the number of servings in each individual unit.
(11) The declaration of nutrient and food component content shall
be on the basis of product as packaged or purchased with the exception
of [[Page 178]] products that are packed or canned in water, brine, or
oil but whose liquid packing medium is not customarily consumed.
Declaration of the nutrient and food component content of products that
are packed in liquid which is not customarily consumed shall be based
on the drained solids.
(12) Serving size for meal-type products as defined in
Sec. 317.313(l) shall be the entire content (edible portion only) of
the package.
(13) Another column of figures may be used to declare the nutrient
and food component information in the same format as required by
Sec. 317.309(e),
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as
packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete
units in a multi-serving container is more than one unit.
(14) If a product consists of assortments of meat or meat food
products (e.g., variety packs) in the same package, nutrient content
shall be expressed on the entire package contents or on each individual
product.
(15) If a product is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare the nutrient contents on the basis of the product as
consumed for the product alone (e.g., a cream soup mix may be labeled
with one set of Daily Values for the dry mix (per serving), and another
set for the serving of the final soup when prepared (e.g., per serving
of cream soup mix and 1 cup of vitamin D fortified whole milk)):
Provided, That the type and quantity of the other ingredients to be
added to the product by the user and the specific method of cooking and
other preparation shall be specified prominently on the label.
(c) The declaration of nutrition information on the label or in
labeling of a meat or meat food product shall contain information about
the level of the following nutrients, except for those nutrients whose
inclusion, and the declaration of amounts, is voluntary as set forth in
this paragraph. No nutrients or food components other than those listed
in this paragraph as either mandatory or voluntary may be included
within the nutrition label. Except as provided for in paragraph (f) or
(g) of this section, nutrient information shall be presented using the
nutrient names specified and in the following order in the formats
specified in paragraph (d) or (e) of this section.
(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parenthesis immediately
following the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i.e., the Atwater method) given
in Table 13, page 25, ``Energy Value of Foods--Basis and Derivation,''
by A. L. Merrill and B. K. Watt, United States Department of
Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised
February 1973), which is incorporated by reference. Table 13 of the
``Energy Value of Foods--Basis and Derivation,'' Agriculture Handbook
No. 74 is incorporated as it exists on the date of approval. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is
available for inspection at the Office of the Federal Register, suite
700, 800 North Capitol Street, NW., Washington, DC, or at the office of
the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence
Avenue, SW., Washington, DC. Copies of the incorporation by reference
are available from the Product Assessment Division, Regulatory
Programs, Food Safety and Inspection Service, U.S. Department of
Agriculture, Room 329, West End Court Building, Washington, DC 20250-
3700;
(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973),
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture
Handbook No. 74 is incorporated as it exists on the date of approval.
This incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(The availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section.);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA's Agriculture
Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. (The availability of this incorporation by reference is given
in paragraph (c)(1)(i)(A) of this section.); or
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of 21 CFR, or by other means, as
appropriate.
(ii) ``Calories from fat'': A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section
per serving, expressed to the nearest 5-calorie increment, up to and
including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of ``calories from fat'' is not
required on products that contain less than 0.5 gram of fat per serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section.
(iii) ``Calories from saturated fat'' or ``Calories from
saturated'' (VOLUNTARY): A statement of the caloric content derived
from saturated fat as defined in paragraph (c)(2)(i) of this section
per serving may be declared voluntarily, expressed to the nearest 5-
calorie increment, up to and including 50 calories, and the nearest 10-
calorie increment above 50 calories, except that amounts less than 5
calories may be expressed as zero. This statement shall be indented
under the statement of calories from fat as provided in paragraph
(d)(5) of this section.
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat per serving defined as total lipid fatty acids and
expressed as triglycerides. Amounts shall be expressed to the nearest
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram,
the content shall be expressed as zero.
(i) ``Saturated fat'' or ``Saturated'': A statement of the number
of grams of saturated fat per serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat per serving if no claims are
made about fat or cholesterol content, and if ``calories from saturated
fat'' is not declared. Saturated fat content shall be indented and
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram
increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 [[Page 179]] gram, the
content shall be expressed as zero.
(A) ``Stearic Acid'' (VOLUNTARY): A statement of the number of
grams of stearic acid per serving may be declared voluntarily, except
that when a claim is made about stearic acid, label declaration shall
be required. Stearic acid content shall be indented under saturated fat
and expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams
and the nearest gram increment above 5 grams. If the serving contains
less than 0.5 gram, the content shall be expressed as zero.
(B) [Reserved]
(ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat per serving
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids
may be declared voluntarily, except that when monounsaturated fat is
declared, or when a claim about fatty acids or cholesterol is made on
the label or in labeling of a product other than one that meets the
criteria in Sec. 317.362(b)(1) for a claim for ``fat free,'' label
declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest
gram increment above 5 grams. If the serving contains less than 0.5
gram, the content shall be expressed as zero.
(iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat per serving
defined as cis-monounsaturated fatty acids may be declared voluntarily,
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a
product other than one that meets the criteria in Sec. 317.362(b)(1)
for a claim for ``fat free,'' label declaration of monounsaturated fat
is required. Monounsaturated fat content shall be indented and
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram
increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(3) ``Cholesterol'': A statement of the cholesterol content per
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not
required for products that contain less than 2 milligrams of
cholesterol per serving and make no claim about fat, fatty acids, or
cholesterol content, or such products may state the cholesterol content
as zero. If the product contains 2 to 5 milligrams of cholesterol per
serving, the content may be stated as ``less than 5 milligrams.''
(4) ``Sodium'': A statement of the number of milligrams of sodium
per serving expressed as zero when the serving contains less than 5
milligrams of sodium, to the nearest 5-milligram increment when the
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140
milligrams.
(5) ``Potassium'' (VOLUNTARY): A statement of the number of
milligrams of potassium per serving may be declared voluntarily, except
that when a claim is made about potassium content, label declaration
shall be required. Potassium content shall be expressed as zero when
the serving contains less than 5 milligrams of potassium, to the
nearest 5-milligram increment when the serving contains 5 to 140
milligrams of potassium, and to the nearest 10-milligram increment when
the serving contains greater than 140 milligrams.
(6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement
of the number of grams of total carbohydrate per serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, or, if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the product. This
calculation method is described in USDA's Agriculture Handbook No. 74
(Slightly revised February 1973), pages 2 and 3, which is incorporated
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is
incorporated as it exists on the date of approval. This incorporation
by reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of
this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section.)
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber per serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required, or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5 gram, the content may be
expressed as zero.
(A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the
content may be expressed as zero.
(B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber per serving may be declared
voluntarily except when a claim is made on the label or in labeling
about insoluble fiber, label declaration shall be required. Insoluble
fiber content shall be indented under dietary fiber and expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, and if the serving contains less than 0.5
gram, the content may be expressed as zero.
(ii) ``Sugars'': A statement of the number of grams of sugars per
serving, except that label declaration of sugars content is not
required for products that contain less than 1 gram of sugars per
serving if no claims are made about sweeteners, sugars, or sugar
alcohol content. Sugars shall be defined as the sum of all free mono-
and disaccharides (such as glucose, fructose, lactose, and sucrose).
Sugars content shall be indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the
content may be expressed as zero.
(iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of
grams of sugar alcohols per serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
product, sugar alcohol content shall be declared. For nutrition
labeling purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu
of the term ``sugar alcohol,'' the name of the specific sugar alcohol
(e.g., ``xylitol'') present in the product may be used in the nutrition
label, provided [[Page 180]] that only one sugar alcohol is present in
the product. Sugar alcohol content shall be indented and expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less then 1 gram'' or ``less than 1 gram'' may
be used as an alternative, and if the serving contains less than 0.5
gram, the content may be expressed as zero.
(iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number
of grams of other carbohydrate per serving may be declared voluntarily.
Other carbohydrate shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it
shall be defined as the difference between total carbohydrate and the
sum of dietary fiber and sugars. Other carbohydrate content shall be
indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(7) ``Protein'': A statement of the number of grams of protein per
serving expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero. When the protein in products represented or purported to be for
adults and children 4 or more years of age has a protein quality value
that is a protein digestibility-corrected amino acid score of less than
20 expressed as a percent, or when the protein in a product represented
or purported to be for children greater than 1 but less than 4 years of
age has a protein quality value that is a protein digestibility-
corrected amino acid score of less than 40 expressed as a percent,
either of the following shall be placed adjacent to the declaration of
protein content by weight: The statement ``not a significant source of
protein,'' or a listing aligned under the column headed ``Percent Daily
Value'' of the corrected amount of protein per serving, as determined
in paragraph (c)(7)(ii) of this section, calculated as a percentage of
the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as
appropriate, for protein and expressed as percent of Daily Value. When
the protein quality in a product as measured by the Protein Efficiency
Ratio (PER) is less than 40 percent of the reference standard (casein)
for a product represented or purported to be for infants, the statement
``not a significant source of protein'' shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on
the basis of the factor of 6.25 times the nitrogen content of the food
as determined by appropriate methods of analysis in accordance with
Sec. 317.309(h), except when the procedure for a specific food requires
another factor.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for infants or
children under 4 years of age. When such a declaration is provided, it
shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column headed ``Percent Daily Value,''
and expressed to the nearest whole percent. However, the percentage of
the RDI for protein shall not be declared if the product is represented
or purported to be for infants and the protein quality value is less
than 40 percent of the reference standard.
(ii) The corrected amount of protein (grams) per serving for
products represented or purported to be for adults and children 1 or
more years of age is equal to the actual amount of protein (grams) per
serving multiplied by the amino acid score corrected for protein
digestibility. If the corrected score is above 1.00, then it shall be
set at 1.00. The protein digestibility-corrected amino acid score shall
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert
Consultation on Protein Quality Evaluation,'' Rome, 1990, which is
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the ``Report
of the Joint FAO/WHO Expert Consultation on Protein Quality
Evaluation,'' as published by the Food and Agriculture Organization of
the United Nations/World Health Organization, is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the
Office of the Federal Register, suite 700, 800 North Capitol Street,
NW., Washington, DC, or at the office of the FSIS Docket Clerk, Room
3171, South Building, 14th and Independence Avenue, SW., Washington,
DC. Copies of the incorporation by reference are available from the
Product Assessment Division, Regulatory Programs, Food Safety and
Inspection Service, U.S. Department of Agriculture, Room 329, West End
Court Building, Washington, DC 20250-3700. For products represented or
purported to be for infants, the corrected amount of protein (grams)
per serving is equal to the actual amount of protein (grams) per
serving multiplied by the relative protein quality value. The relative
protein quality value shall be determined by dividing the subject
product's protein PER value by the PER value for casein. If the
relative protein value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI,
a value of 50 grams of protein shall be the DRV for adults and children
4 or more years of age, and the RDI for protein for children less than
4 years of age, infants, pregnant women, and lactating women shall be
16 grams, 14 grams, 60 grams, and 65 grams, respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d) through (g) of this section, products
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For products represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the
RDI values for infants from birth to 12 months of age and for children
under 4 years of age. Similarly, the percent of Daily Value based on
both the RDI values for pregnant women and for lactating women shall be
declared separately on products represented or purported to be for use
by both pregnant and lactating women. When such dual declaration is
used on any label, it shall be included in all labeling, and equal
prominence shall be given to both values in all such labeling. All
other products shall use the RDI for adults and children 4 or more
years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall [[Page 181]] include any of the other vitamins and
minerals listed in paragraph (c)(8)(iv) of this section when they are
added, or when a claim is made about them. Other vitamins and minerals
need not be declared if neither the nutrient nor the component is
otherwise referred to on the label or in labeling or advertising and
the vitamins and minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another product; or
(B) Included in a product solely for technological purposes and
declared only in the ingredients statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and minerals shall be listed in the order
established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and including the 10-percent
level, the nearest 5-percent increment above 10 percent and up to and
including the 50-percent level, and the nearest 10-percent increment
above the 50-percent level. Amounts of vitamins and minerals present at
less than 2 percent of the RDI are not required to be declared in
nutrition labeling but may be declared by a zero or by the use of an
asterisk (or other symbol) that refers to another asterisk (or symbol)
that is placed at the bottom of the table and that is followed by the
statement ``Contains less than 2 percent of the Daily Value of this
(these) nutrient (nutrients).'' Alternatively, if vitamin A, vitamin C,
calcium, or iron is present in amounts less than 2 percent of the RDI,
label declaration of the nutrient(s) is not required if the statement
``Not a significant source of ______ (listing the vitamins or minerals
omitted)'' is placed at the bottom of the table of nutrient values.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams
(v) The following synonyms may be added in parenthesis immediately
following the name of the nutrient or dietary component:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent of
Daily Value of vitamin A in the product (e.g., ``Percent Daily Value:
Vitamin A 50 (90 percent as beta-carotene)''). When declared, the
percentages shall be expressed in the same increments as are provided
for vitamins and minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Food component Unit of measurement DRV
------------------------------------------------------------------------
Fat............................ grams (g)...................... 65
Saturated fatty acids.......... do............................. 20
Cholesterol.................... milligrams (mg)................ 300
Total carbohydrate............. grams (g)...................... 300
Fiber.......................... do............................. 25
Sodium......................... milligrams (mg)................ 2,400
Potassium...................... do............................. 3,500
Protein........................ grams (g)...................... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on products in the following format, except
on products on which dual columns of nutrition information are declared
as provided for in paragraph (e) of this section, on those products on
which the simplified format is permitted to be used as provided for in
paragraph (f) of this section, on products for infants and children
less than 4 years of age as provided for in Sec. 317.400(c), and on
products in packages that have a total surface area available to bear
labeling of 40 or less square inches as provided for in paragraph (g)
of this section.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for
the information required by paragraphs (d)(7) and (d)(8) of this
section, and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7),
and (d)(8) of this section shall be in type size no smaller than 8
point. Except for the heading ``Nutrition Facts,'' the information
required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and
all other information contained within the nutrition label shall be in
type size no smaller than 6 point. When provided, the information
described in paragraph (d)(10) of this section shall also be in type no
smaller than 6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and
``% Daily Value*''), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
Calories, Total fat, Cholesterol, Sodium, Potassium, Total
carbohydrate, and Protein), and the percentage amounts required by
paragraph (d)(7)(ii) of this section shall be highlighted by bold or
extra bold type or other highlighting (reverse printing is not
permitted as a form of highlighting) that prominently distinguishes it
from other information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text
shall separate ``Amount Per Serving'' from the calorie statements
required in paragraph (d)(5) of this section and shall separate each
nutrient and its corresponding percent of Daily Value required in
paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient
and percent of Daily Value above and below it.
(2) The information shall be presented under the identifying
heading of ``Nutrition Facts'' which shall be set in a type size larger
than all other print size in the nutrition label and, except for labels
presented according to the format provided for in paragraph (d)(11) of
this section, unless impractical, shall be set the full width of the
information [[Page 182]] provided under paragraph (d)(7) of this
section.
(3) Information on serving size shall immediately follow the
heading. Such information shall include:
(i) ``Serving Size'': A statement of the serving size as specified
in paragraph (b)(9) of this section.
(ii) ``Servings Per Container'': The number of servings per
container, except that this statement is not required on single-serving
containers as defined in paragraph (b)(8) of this section.
(4) A subheading ``Amount Per Serving'' shall be separated from
serving size information by a bar.
(5) Information on calories shall immediately follow the heading
``Amount Per Serving'' and shall be declared in one line, leaving
sufficient space between the declaration of ``Calories'' and ``Calories
from fat'' to allow clear differentiation, or, if ``Calories from
saturated fat'' is declared, in a column with total ``Calories'' at the
top, followed by ``Calories from fat'' (indented), and ``Calories from
saturated fat'' (indented).
(6) The column heading ``% Daily Value,'' followed by an asterisk
(e.g., ``% Daily Value*''), shall be separated from information on
calories by a bar. The position of this column heading shall allow for
a list of nutrient names and amounts as described in paragraph (d)(7)
of this section to be to the left of, and below, this column heading.
The column headings ``Percent Daily Value,'' ``Percent DV,'' or ``%
DV'' may be substituted for ``% Daily Value.''
(7) Except as provided for in paragraph (g) of this section, and
except as permitted by Sec. 317.400(d)(2), nutrient information for
both mandatory and any voluntary nutrients listed in paragraph (c) of
this section that are to be declared in the nutrition label, except
vitamins and minerals, shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of
this section, shall be given in a column and followed immediately by
the quantitative amount by weight for that nutrient appended with a
``g'' for grams or ``mg'' for milligrams.
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% Daily Value'' established in
paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column
described in paragraph (d)(7)(i) of this section for which a DRV has
been established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns, except that when more than
four vitamins and minerals are declared, they may be declared
vertically with percentages listed under the column headed ``% Daily
Value.''
(9) A footnote, preceded by an asterisk, shall be placed beneath
the list of vitamins and minerals and shall be separated from that list
by a hairline.
(i) The footnote shall state: Percent Daily Values are based on a
2,000 calorie diet. Your daily values may be higher or lower depending
on your calorie needs.
------------------------------------------------------------------------
Calories: 2,000 2,500
------------------------------------------------------------------------
Total fat........ Less than........ 65 g............ 80 g
Saturated fat.... Less than........ 20 g............ 25 g
Cholesterol...... Less than........ 300 mg.......... 300 mg
Sodium........... Less than........ 2,400 mg........ 2,400 mg
Total ................. 300 g........... 375 g
carbohydrate.
Dietary fiber.... ................. 25 g............ 30 g
------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
``2,000'' and value of 65 g in the column headed ``2,500.''
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (g)(2) of this
section may be used within the footnote.
(10) Caloric conversion information on a per-gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9), separated from that information by a
hairline. This information may be presented horizontally (i.e.,
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent of Daily Value information. The
caloric conversion information provided for in paragraph (d)(10) of
this section may be presented beneath either side or along the full
length of the nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set
off by a line that distinguishes it and sets it apart from the percent
of Daily Value information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 inches) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of iron,
the nutrition label may be presented in a tabular display in which the
footnote required by paragraph (d)(9) of the section is given to the
far right of the label, and additional vitamins and minerals beyond the
four that are required (i.e., vitamin A, vitamin C, calcium, and iron)
are [[Page 183]] arrayed horizontally following declarations of the
required vitamins and minerals.
(12) The following sample label illustrates the provisions of
paragraph (d) of this section:
BILLING CODE 3410-DM-P
[GRAPHIC][TIFF OMITTED]TR03JA95.000
BILLING CODE 3410-DM-C
(13)(i) Nutrition labeling on the outer label of packages of meat
or meat food products that contain two or more products in the same
packages (e.g., variety packs) or of packages that are used
interchangeably for the same type of food (e.g., meat salad containers)
may use an aggregate display.
(ii) Aggregate displays shall comply with format requirements of
paragraph [[Page 184]] (d) of this section to the maximum extent
possible, except that the identity of each food shall be specified to
the right of the ``Nutrition Facts'' title, and both the quantitative
amount by weight (i.e., g/mg amounts) and the percent Daily Value for
each nutrient shall be listed in separate columns under the name of
each food.
(14) When nutrition labeling appears in a second language, the
nutrition information may be presented in a separate nutrition label
for each language or in one nutrition label with the information in the
second language following that in English. Numeric characters that are
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both
languages.
(e) Nutrition information may be presented for two or more forms of
the same product (e.g., both ``raw'' and ``cooked'') or for common
combinations of foods as provided for in paragraph (b) of this section,
or for different units (e.g., per 100 grams) as provided for in
paragraph (b) of this section, or for two or more groups for which
RDI's are established (e.g., both infants and children less than 4
years of age) as provided for in paragraph (c)(8)(i) of this section.
When such dual labeling is provided, equal prominence shall be given to
both sets of values. Information shall be presented in a format
consistent with paragraph (d) of this section, except that:
(1) Following the subheading of ``Amount Per Serving,'' there shall
be two or more column headings accurately describing the forms of the
same product (e.g., ``raw'' and ``roasted''), the combinations of
foods, the units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the Reference Amount in Sec. 317.312(b) shall be to the
left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of
the same product, for combinations of foods, or for different units,
total calories and calories from fat (and calories from saturated fat,
when declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the
product as packaged and according to the label serving size based on
the Reference Amount in Sec. 317.312(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the Reference Amount in Sec. 317.312(b) or as a footnote.
(A) If such additional quantitative information is given
immediately adjacent to the required quantitative information, it shall
be declared for all nutrients listed and placed immediately following
and differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'')
referring to another asterisk (or symbol) at the bottom of the
nutrition label identifying the form(s) of the product for which
quantitative information is presented.
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of
this section shall be presented under the subheading ``% DAILY VALUE''
and in columns directly under the column headings set forth in
paragraph (e)(1) of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
BILLING CODE 3410-DM-P
[[Page 185]]
[GRAPHIC][TIFF OMITTED]TR03JA95.001
BILLING CODE 3410-DM-C
(f)(1) Nutrition information may be presented in a simplified
format as set forth herein when any required nutrients, other than the
core nutrients (i.e., calories, total fat, sodium, total carbohydrate,
and protein), are present in insignificant amounts. An insignificant
amount shall be defined as that amount that may be rounded to zero in
nutrition labeling, except that for total carbohydrate, dietary fiber,
sugars and protein, it shall be an amount less than 1 gram.
(2) The simplified format shall include information on the
following nutrients:
(i) Total calories, total fat, total carbohydrate, sodium, and
protein;
(ii) Any of the following that are present in more than
insignificant amounts: Calories from fat, saturated fat, cholesterol,
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in
more than insignificant amounts may be [[Page 186]] voluntarily
declared as part of the simplified format.
(4) Any required nutrient, other than a core nutrient, that is
present in an insignificant amount may be omitted from the tabular
listing, provided that the following statement is included at the
bottom of the nutrition label, ``Not a significant source of
________.'' The blank shall be filled in with the appropriate nutrient
or food component. Alternatively, amounts of vitamins and minerals
present in insignificant amounts may be declared by the use of an
asterisk (or symbol) that is placed at the bottom of the table of
nutrient values and that is followed by the statement ``Contains less
than 2 percent of the Daily Value of this (these) nutrient
(nutrients).''
(5) Except as provided for in paragraph (g) of this section and in
Sec. 317.400(c) and (d), nutrient information declared in the
simplified format shall be presented in the same manner as specified in
paragraphs (d) or (e) of this section, except that the footnote
required in paragraph (d)(9) of this section is not required. When the
footnote is omitted, an asterisk shall be placed at the bottom of the
label followed by the statement ``Percent Daily Values are based on a
2,000 calorie diet'' and, if the term ``Daily Value'' is not spelled
out in the heading, a statement that ``DV'' represents ``Daily Value.''
(g) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements
of paragraphs (c) through (f) of this section and Sec. 317.302(a) by
one or more of the following means:
(1)(i) Presenting the required nutrition information in a tabular
or linear (i.e., string) fashion, rather than in vertical columns if
the product has a total surface area available to bear labeling of less
than 12 square inches, or if the product has a total surface area
available to bear labeling of 40 or less square inches and the package
shape or size cannot accommodate a standard vertical column or tabular
display on any label panel. Nutrition information may be given in a
linear fashion only if the package shape or size will not accommodate a
tabular display.
(ii) When nutrition information is given in a linear display, the
nutrition information shall be set off in a box by the use of a
hairline. The percent Daily Value is separated from the quantitative
amount declaration by the use of parenthesis, and all nutrients, both
principal components and subcomponents, are treated similarly. Bolding
is required only on the title ``Nutrition Facts'' and is allowed for
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,''
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
(2) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(3) Omitting the footnote required in paragraph (d)(9) of this
section and placing another asterisk at the bottom of the label
followed by the statement ``Percent Daily Values are based on a 2,000
calorie diet'' and, if the term ``Daily Value'' is not spelled out in
the heading, a statement that ``DV'' represents ``Daily Value.''
(4) Presenting the required nutrition information on any other
label panel.
* * * * *
6. Section 317.312 is amended by redesignating paragraph (d) as
(g), correcting the spelling of the word ``Nationwide'' in footnote 1
of Table 2 in paragraph (b), revising paragraph (a), and adding new
paragraphs (d), (e), and (f) to read as follows:
Sec. 317.312 Reference amounts customarily consumed per eating
occasion.
(a) The general principles followed in arriving at the reference
amounts customarily consumed per eating occasion (Reference Amount(s)),
as set forth in paragraph (b) of this section, are:
(1) The Reference Amounts are calculated for persons 4 years of age
or older to reflect the amount of food customarily consumed per eating
occasion by persons in this population group. These Reference Amounts
are based on data set forth in appropriate national food consumption
surveys.
(2) The Reference Amounts are calculated for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants up to 12 months of age or by children 1
through 3 years of age, respectively. These Reference Amounts are based
on data set forth in appropriate national food consumption surveys.
Such Reference Amounts are to be used only when the product is
specially formulated or processed for use by an infant or by a child
under 4 years of age.
(3) An appropriate national food consumption survey includes a
large sample size representative of the demographic and socioeconomic
characteristics of the relevant population group and must be based on
consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating
occasion, the mean, median, and mode of the consumed amount per eating
occasion were considered.
(5) When survey data were insufficient, FSIS took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
Reference Amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The Reference Amount is based on the major intended use of the
product (e.g., a mixed dish measurable with a cup as a main dish and
not as a side dish).
(8) The Reference Amounts for products that are consumed as an
ingredient of other products, but that may also be consumed in the form
in which they are purchased (e.g., ground beef), are based on use in
the form purchased.
(9) FSIS sought to ensure that foods that have similar dietary
usage, product characteristics, and customarily consumed amounts have a
uniform Reference Amount.
* * * * *
(d) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a Reference Amount for the product in the prepared
form, then the Reference Amount for the unprepared product shall be
determined using the following rules:
(1) Except as provided for in paragraph (d)(2) of this section, the
Reference Amount for the unprepared product shall be the amount of the
[[Page 187]] unprepared product required to make the Reference Amount
for the prepared product as established in paragraph (b) of this
section.
(2) For products where the entire contents of the package is used
to prepare one large discrete unit usually divided for consumption, the
Reference Amount for the unprepared product shall be the amount of the
unprepared product required to make the fraction of the large discrete
unit closest to the Reference Amount for the prepared product as
established in paragraph (b) of this section.
(e) The Reference Amount for an imitation or substitute product or
altered product as defined in Sec. 317.313(d), such as a ``low
calorie'' version, shall be the same as for the product for which it is
offered as a substitute.
(f) The Reference Amounts set forth in paragraphs (b) through (e)
of this section shall be used in determining whether a product meets
the criteria for nutritional claims. If the serving size declared on
the product label differs from the Reference Amount, and the product
meets the criteria for the claim only on the basis of the Reference
Amount, the claim shall be followed by a statement that sets forth the
basis on which the claim is made. That statement shall include the
Reference Amount as it appears in paragraph (b) of this section
followed, in parentheses, by the amount in common household measure if
the Reference Amount is expressed in measures other than common
household measures.
* * * * *
7. Section 317.313 is amended by revising paragraphs (a), (b), (g),
(i), (j), (k), (p), and (q)(4) and adding new paragraphs (c), (d), (e),
and (f) to read as follows:
Sec. 317.313 Nutrient content claims; general principles.
(a) This section applies to meat or meat food products that are
intended for human consumption and that are offered for sale.
(b) A claim which, expressly or by implication, characterizes the
level of a nutrient (nutrient content claim) of the type required in
nutrition labeling pursuant to Sec. 317.309, may not be made on a label
or in labeling of that product unless the claim is made in accordance
with the applicable provisions in this subpart.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the product, e.g., ``low
sodium'' or ``contains 100 calories.''
(2) An implied nutrient content claim is any claim that:
(i) Describes the product or an ingredient therein in a manner that
suggests that a nutrient is absent or present in a certain amount
(e.g., ``high in oat bran''); or
(ii) Suggests that the product, because of its nutrient content,
may be useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient (e.g.,
``healthy, contains 3 grams (g) of fat'').
(3) Except for claims regarding vitamins and minerals described in
paragraph (q)(3) of this section, no nutrient content claims may be
made on products intended specifically for use by infants and children
less than 2 years of age unless the claim is specifically provided for
in subpart B of this part.
(4) Reasonable variations in the spelling of the terms defined in
applicable provisions in this subpart and their synonyms are permitted
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
(c) Information that is required or permitted by Sec. 317.309 to be
declared in nutrition labeling, and that appears as part of the
nutrition label, is not a nutrient content claim and is not subject to
the requirements of this section. If such information is declared
elsewhere on the label or in labeling, it is a nutrient content claim
and is subject to the requirements for nutrient content claims.
(d) A ``substitute'' product is one that may be used
interchangeably with another product that it resembles, i.e., that it
is organoleptically, physically, and functionally (including shelf
life) similar to, and that it is not nutritionally inferior to unless
it is labeled as an ``imitation.''
(1) If there is a difference in performance characteristics that
materially limits the use of the product, the product may still be
considered a substitute if the label includes a disclaimer adjacent to
the most prominent claim as defined in paragraph (j)(2)(iii) of this
section, informing the consumer of such difference (e.g., ``not
recommended for frying'').
(2) This disclaimer shall be in easily legible print or type and in
a size no less than that required by Sec. 317.2(h) for the net quantity
of contents statement, except where the size of the claim is less than
two times the required size of the net quantity of contents statement,
in which case the disclaimer statement shall be no less than one-half
the size of the claim but no smaller than \1/16\-inch minimum height,
except as permitted by Sec. 317.400(d)(2).
(e)(1) Because the use of a ``free'' or ``low'' claim before the
name of a product implies that the product differs from other products
of the same type by virtue of its having a lower amount of the
nutrient, only products that have been specially processed, altered,
formulated, or reformulated so as to lower the amount of the nutrient
in the product, remove the nutrient from the product, or not include
the nutrient in the product, may bear such a claim (e.g., ``low sodium
beef noodle soup'').
(2) Any claim for the absence of a nutrient in a product, or that a
product is low in a nutrient when the product has not been specially
processed, altered, formulated, or reformulated to qualify for that
claim shall indicate that the product inherently meets the criteria and
shall clearly refer to all products of that type and not merely to the
particular brand to which the labeling attaches (e.g., ``lard, a sodium
free food'').
(f) A nutrient content claim shall be in type size and style no
larger than two times that of the statement of identity and shall not
be unduly prominent in type style compared to the statement of
identity.
(g) Labeling information required in Secs. 317.313, 317.354,
317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not
otherwise specified, is required to be in letters and/or numbers no
less than \1/16\ inch in height, except as permitted by
Sec. 317.400(d)(2).
(h) [Reserved]
(i) Except as provided in Sec. 317.309 or in paragraph (q)(3) of
this section, the label or labeling of a product may contain a
statement about the amount or percentage of a nutrient if:
(1) The use of the statement on the product implicitly
characterizes the level of the nutrient in the product and is
consistent with a definition for a claim, as provided in subpart B of
this part, for the nutrient that the label addresses. Such a claim
might be, ``less than 10 g of fat per serving;''
(2) The use of the statement on the product implicitly
characterizes the level of the nutrient in the product and is not
consistent with such a definition, but the label carries a disclaimer
adjacent to the statement that the product is not ``low'' in or a
``good source'' of the nutrient, such as ``only 200 milligrams (mg)
sodium per serving, not a low sodium product.'' The disclaimer must be
in easily legible print or type and in a size no less than required by
Sec. 317.2(h) for the net quantity of contents, except where the size
of the claim is less than two times [[Page 188]] the required size of
the net quantity of contents statement, in which case the disclaimer
statement shall be no less than one-half the size of the claim but no
smaller than \1/16\-inch minimum height, except as permitted by
Sec. 317.400(d)(2);
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the product and it is not false or misleading
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which
case no disclaimer is required.
(4) ``Percent fat free'' claims are not authorized by this
paragraph. Such claims shall comply with Sec. 317.362(b)(6).
(j) A product may bear a statement that compares the level of a
nutrient in the product with the level of a nutrient in a reference
product. These statements shall be known as ``relative claims'' and
include ``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more''
claims.
(1) To bear a relative claim about the level of a nutrient, the
amount of that nutrient in the product must be compared to an amount of
nutrient in an appropriate reference product as specified in this
paragraph (j).
(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the
reference product may be a dissimilar product within a product category
that can generally be substituted for one another in the diet or a
similar product.
(B) For ``light,'' ``reduced,'' and ``added'' claims, the reference
product shall be a similar product, and
(ii)(A) For ``light'' claims, the reference product shall be
representative of the type of product that includes the product that
bears the claim. The nutrient value for the reference product shall be
representative of a broad base of products of that type; e.g., a value
in a representative, valid data base; an average value determined from
the top three national (or regional) brands, a market basket norm; or,
where its nutrient value is representative of the product type, a
market leader. Firms using such a reference nutrient value as a basis
for a claim, are required to provide specific information upon which
the nutrient value was derived, on request, to consumers and
appropriate regulatory officials.
(B) For relative claims other than ``light,'' including ``less''
and ``more'' claims, the reference product may be the same as that
provided for ``light'' in paragraph (j)(1)(ii)(A) of this section or it
may be the manufacturer's regular product, or that of another
manufacturer, that has been offered for sale to the public on a regular
basis for a substantial period of time in the same geographic area by
the same business entity or by one entitled to use its trade name,
provided the name of the competitor is not used on the labeling of the
product. The nutrient values used to determine the claim when comparing
a single manufacturer's product to the labeled product shall be either
the values declared in nutrition labeling or the actual nutrient
values, provided that the resulting labeling is internally consistent
(i.e., that the values stated in the nutrition information, the
nutrient values in the accompanying information, and the declaration of
the percentage of nutrient by which the product has been modified are
consistent and will not cause consumer confusion when compared), and
that the actual modification is at least equal to the percentage
specified in the definition of the claim.
(2) For products bearing relative claims:
(i) The label or labeling must state the identity of the reference
product and the percent (or fraction) of the amount of the nutrient in
the reference product by which the nutrient has been modified, (e.g.,
``50 percent less fat than `reference product''' or ``\1/3\ fewer
calories than `reference product'''); and
(ii) This information shall be immediately adjacent to the most
prominent claim in easily legible boldface print or type, in distinct
contrast to other printed or graphic matter, that is no less than that
required by Sec. 317.2(h) for net quantity of contents, except where
the size of the claim is less than two times the required size of the
net quantity of contents statement, in which case the referral
statement shall be no less than one-half the size of the claim, but no
smaller than \1/16\-inch minimum height, except as permitted by
Sec. 317.400(d)(2).
(iii) The determination of which use of the claim is in the most
prominent location on the label or labeling will be made based on the
following factors, considered in order:
(A) A claim on the principal display panel adjacent to the
statement of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount
of the subject nutrient in the product per labeled serving size with
that in the reference product; and
(B) This statement shall appear adjacent to the most prominent
claim or to the nutrition information.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a product if the nutrient content
of the reference product meets the requirement for a ``low'' claim for
that nutrient.
(k) The term ``modified'' may be used in the statement of identity
of a product that bears a relative claim that complies with the
requirements of this part, followed immediately by the name of the
nutrient whose content has been altered (e.g., ``modified fat
`product'''). This statement of identity must be immediately followed
by the comparative statement such as ``contains 35 percent less fat
than `reference product'.'' The label or labeling must also bear the
information required by paragraph (j)(2) of this section in the manner
prescribed.
* * * * *
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 317.312(b) through (e) shall be used in
determining whether a product meets the criteria for a nutrient content
claim. If the serving size declared on the product label differs from
the reference amount customarily consumed, and the amount of the
nutrient contained in the labeled serving does not meet the maximum or
minimum amount criterion in the definition for the descriptor for that
nutrient, the claim shall be followed by the criteria for the claim as
required by Sec. 317.312(f) (e.g., ``very low sodium, 35 mg or less per
55 grams'').
(2) The criteria for the claim shall be immediately adjacent to the
most prominent claim in easily legible print or type and in a size that
is no less than that required by Sec. 317.2(h) for net quantity of
contents, except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the criteria statement shall be no less than one-half the size of the
claim but no smaller than \1/16\-inch minimum height, except as
permitted by Sec. 317.400(d)(2).
(q) * * *
(4) The requirements of this section do not apply to infant
formulas and medical foods, as described in 21 CFR 101.13(q)(4).
* * * * *
8. Section 317.345 is amended by revising the section reference in
paragraph (c) from ``Sec. 317.309(g)'' to ``Sec. 317.309(f)'' and
revising paragraphs (a)(2) introductory text, (a)(2)(ii) and
(a)(2)(iii) to read as follows: [[Page 189]]
Sec. 317.345 Guidelines for voluntary nutrition labeling of single-
ingredient, raw products.
(a) * * *
(2) A retailer may choose to provide nutrition information at the
point-of-purchase, such as by posting a sign, or by making the
information readily available in brochures, notebooks, or leaflet form
in close proximity to the food. The nutrition labeling information may
also be supplemented by a video, live demonstration, or other media. If
a nutrition claim is made on point-of-purchase materials all of the
requirements of the mandatory nutrition labeling program apply.
However, if only nutrition information--and not a nutrition claim--is
supplied on point-of-purchase materials:
(i) * * *
(ii) The listing of percent of Daily Value for the nutrients
(except vitamins and minerals specified in Sec. 317.309(c)(8)) and
footnote required by Sec. 317.309(d)(9) may be omitted; and
(iii) The point-of-purchase materials are not subject to any of the
format requirements.
* * * * *
9. Section 317.354 is revised to read as follows:
Sec. 317.354 Nutrient content claims for ``good source,'' ``high,''
and ``more.''
(a) General requirements. Except as provided in paragraph (e) of
this section, a claim about the level of a nutrient in a product in
relation to the Reference Daily Intake (RDI) or Daily Reference Value
(DRV) established for that nutrient (excluding total carbohydrate) in
Sec. 317.309(c), may only be made on the label or in labeling of the
product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 317.309.
(b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or
``excellent source of'' may be used on the label or in labeling of
products, except meal-type products as defined in Sec. 317.313(l),
provided that the product contains 20 percent or more of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains a food that meets the definition of
``high'' in paragraph (b)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., ``the serving of broccoli in this meal is
high in vitamin C'').
(c) ``Good Source'' claims. (1) The terms ``good source,''
``contains,'' or ``provides'' may be used on the label or in labeling
of products, except meal-type products as described in Sec. 317.313(l),
provided that the product contains 10 to 19 percent of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains a food that meets the definition of ``good
source'' in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., ``the serving of sweet potatoes in this
meal is a good source of fiber'').
(d) Fiber claims. (1) If a nutrient content claim is made with
respect to the level of dietary fiber, i.e., that the product is high
in fiber, a good source of fiber, or that the product contains ``more''
fiber, and the product is not ``low'' in total fat as defined in
Sec. 317.362(b)(2) or, in the case of a meal-type product, is not
``low'' in total fat as defined in Sec. 317.362(b)(3), then the
labeling shall disclose the level of total fat per labeled serving size
(e.g., ``contains 12 grams (g) of fat per serving''); and
(2) The disclosure shall appear in immediate proximity to such
claim and be in a type size no less than one-half the size of the
claim.
(e) ``More'' claims. (1) A relative claim using the terms ``more''
and ``added'' may be used on the label or in labeling to describe the
level of protein, vitamins, minerals, dietary fiber, or potassium in a
product, except meal-type products as defined in Sec. 317.313(l),
provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per reference amount
customarily consumed than an appropriate reference product as described
in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber than `reference
product'''); and
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``fiber content of `reference product'
is 1 g per serving; `this product' contains 4 g per serving'').
(2) A relative claim using the terms ``more'' and ``added'' may be
used on the label or in labeling to describe the level of protein,
vitamins, minerals, dietary fiber, or potassium in meal-type products
as defined in Sec. 317.313(l), provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per 100 g of product than
an appropriate reference product as described in Sec. 317.313(j)(1);
and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber per 3 ounces
(oz) than does `reference product'''), and
(B) Quantitative information comparing the level of the nutrient in
the meal-type product per specified weight with that of the reference
product that it replaces is declared adjacent to the most prominent
claim or to the nutrition information (e.g., ``fiber content of
`reference product' is 2 g per 3 oz; `this product' contains 5 g per 3
oz'').
10. Section 317.356 is revised to read as follows:
Sec. 317.356 Nutrient content claims for ``light'' or ``lite.''
(a) General requirements. A claim using the terms ``light'' or
``lite'' to describe a product may only be made on the label or in
labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 317.309.
(b) ``Light'' claims. The terms ``light'' or ``lite'' may be used
on the label or in [[Page 190]] labeling of products, except meal-type
products as defined in Sec. 317.313(l), without further qualification,
provided that:
(1) If the product derives 50 percent or more of its calories from
fat, its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to an appropriate reference
product as described in Sec. 317.313(j)(1); or
(2) If the product derives less than 50 percent of its calories
from fat:
(i) The number of calories is reduced by at least one-third (33\1/
3\ percent) per reference amount customarily consumed compared to an
appropriate reference product as described in Sec. 317.313(j)(1); or
(ii) Its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to the appropriate reference
product as described in Sec. 317.313(j)(1); and
(3) As required in Sec. 317.313(j)(2) for relative claims:
(i) The identity of the reference product and the percent (or
fraction) that the calories and the fat were reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``\1/3\
fewer calories and 50 percent less fat than the market leader''); and
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference product that it replaces is declared adjacent to the most
prominent claim or to the nutrition information (e.g., ``lite `this
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
(iii) If the labeled product contains less than 40 calories or less
than 3 g fat per reference amount customarily consumed, the percentage
reduction for that nutrient need not be declared.
(4) A ``light'' claim may not be made on a product for which the
reference product meets the definition of ``low fat'' and ``low
calorie.''
(c)(1)(i) A product for which the reference product contains 40
calories or less and 3 g fat or less per reference amount customarily
consumed may use the terms ``light'' or ``lite'' without further
qualification if it is reduced by 50 percent or more in sodium content
compared to the reference product; and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``50 percent less
sodium than the market leader''); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., ``lite `this product'--500 milligrams (mg) sodium
per serving; regular `reference product'--1,000 mg sodium per
serving'').
(2)(i) A product for which the reference product contains more than
40 calories or more than 3 g fat per reference amount customarily
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if
it is reduced by 50 percent or more in sodium content compared to the
reference product, provided that ``light'' or ``lite'' is presented in
immediate proximity with ``in sodium'' and the entire term is presented
in uniform type size, style, color, and prominence; and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``50 percent less
sodium than the market leader''); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., or ``lite `this product'--170 mg sodium per serving;
regular `reference product'--350 mg per serving'').
(3) Except for meal-type products as defined in Sec. 317.313(l), a
``light in sodium'' claim may not be made on a product for which the
reference product meets the definition of ``low in sodium.''
(d)(1) The terms ``light'' or ``lite'' may be used on the label or
in labeling of a meal-type product as defined in Sec. 317.313(l),
provided that:
(i) The product meets the definition of:
(A) ``Low in calories'' as defined in Sec. 317.360(b)(3); or
(B) ``Low in fat'' as defined in Sec. 317.362(b)(3); and
(ii)(A) A statement appears on the principal display panel that
explains whether ``light'' is used to mean ``low fat,'' ``low
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
(B) The accompanying statement is no less than one-half the type
size of the ``light'' or ``lite'' claim.
(2)(i) The terms ``light in sodium'' or ``lite in sodium'' may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that the product meets the definition of
``low in sodium'' as defined in Sec. 317.361(b)(5)(i); and
(ii) ``Light'' or ``lite'' and ``in sodium'' are presented in
uniform type size, style, color, and prominence.
(3) The term ``light'' or ``lite'' may be used in the brand name of
a product to describe the sodium content, provided that:
(i) The product is reduced by 50 percent or more in sodium content
compared to the reference product;
(ii) A statement specifically stating that the product is ``light
in sodium'' or ``lite in sodium'' appears:
(A) Contiguous to the brand name; and
(B) In uniform type size, style, color, and prominence as the
product name; and
(iii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim; and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information.
(e) Except as provided in paragraphs (b) through (d) of this
section, the terms ``light'' or ``lite'' may not be used to refer to a
product that is not reduced in fat by 50 percent, or, if applicable, in
calories by \1/3\ or, when properly qualified, in sodium by 50 percent
unless:
(1) It describes some physical or organoleptic attribute of the
product such as texture or color and the information (e.g., ``light in
color'' or ``light in texture'') so stated, clearly conveys the nature
of the product; and
(2) The attribute (e.g., ``color'' or ``texture'') is in the same
style, color, and at least one-half the type size as the word ``light''
and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word ``light'' has
been associated, through common use, with a particular product to
reflect a physical or organoleptic attribute to the point where it has
become part of the statement of identity, such use of the term
``light'' shall not be considered a nutrient content claim subject to
the requirements in this part.
(g) The term ``lightly salted'' may be used on a product to which
has been added 50 percent less sodium than is normally added to the
reference product [[Page 191]] as described in Sec. 317.313(j)(1)(i)(B)
and (j)(1)(ii)(B), provided that if the product is not ``low in
sodium'' as defined in Sec. 317.361(b)(4), the statement ``not a low
sodium food,'' shall appear adjacent to the nutrition information and
the information required to accompany a relative claim shall appear on
the label or labeling as specified in Sec. 317.313(j)(2).
11. Section 317.360 is revised to read as follows:
Sec. 317.360 Nutrient content claims for calorie content.
(a) General requirements. A claim about the calorie or sugar
content of a product may only be made on the label or in labeling of
the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 317.309.
(b) Calorie content claims. (1) The terms ``calorie free,'' ``free
of calories,'' ``no calories,'' ``zero calories,'' ``without
calories,'' ``trivial source of calories,'' ``negligible source of
calories,'' or ``dietarily insignificant source of calories'' may be
used on the label or in labeling of products, provided that:
(i) The product contains less than 5 calories per reference amount
customarily consumed and per labeled serving size; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms ``low calorie,'' ``few calories,'' ``contains a small
amount of calories,'' ``low source of calories,'' or ``low in
calories'' may be used on the label or in labeling of products, except
meal-type products as defined in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does
not provide more than 40 calories per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and does not provide more than 40 calories
per reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 120 calories or less per 100 g of product;
and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the calorie content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches.
(4) The terms ``reduced calorie,'' ``reduced in calories,''
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower
in calories'' may be used on the label or in labeling of products,
except meal-type products as defined in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent fewer calories per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
lower calorie `product'--``33\1/3\ percent fewer calories than our
regular `product'''); and
(B) Quantitative information comparing the level of calories in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``calorie content has been reduced
from 150 to 100 calories per serving'').
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of products if the reference
product meets the definition for ``low calorie.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent fewer calories per 100
g of product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``calorie reduced `product', 25% less calories per ounce (oz) (or 3 oz)
than our regular `product'''); and
(B) Quantitative information comparing the level of calories in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., ``calorie content has been reduced from
110 calories per 3 oz to 80 calories per 3 oz'').
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of products if the reference
product meets the definition for ``low calorie.''
(c) Sugar content claims. (1) Terms such as ``sugar free,'' ``free
of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,''
``sugarless,'' ``trivial source of sugar,'' ``negligible source of
sugar,'' or ``dietarily insignificant source of sugar'' may reasonably
be expected to be regarded by consumers as terms that represent that
the product contains no sugars or sweeteners, e.g., ``sugar free,'' or
``no sugar,'' as indicating a product which is low in calories or
significantly reduced in calories. Consequently, except as provided in
paragraph (c)(2) of this section, a product may not be labeled with
such terms unless:
(i) The product contains less than 0.5 g of sugars, as defined in
Sec. 317.309(c)(6)(ii), per reference amount customarily consumed and
per labeled serving size or, in the case of a meal-type product, less
than 0.5 g of sugars per labeled serving size;
(ii) The product contains no ingredient that is a sugar or that is
generally understood by consumers to contain sugars unless the listing
of the ingredient in the ingredients statement is followed by an
asterisk that refers to the statement below the list of ingredients,
which states: ``Adds a trivial amount of sugar,'' ``adds a negligible
amount of sugar,'' or ``adds a dietarily insignificant amount of
sugar;'' and
(iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or
bears a relative claim of special dietary usefulness
[[Page 192]] labeled in compliance with paragraphs (b)(2), (b)(3),
(b)(4), or (b)(5) of this section; or
(B) Such term is immediately accompanied, each time it is used, by
either the statement ``not a reduced calorie product,'' ``not a low
calorie product,'' or ``not for weight control.''
(2) The terms ``no added sugar,'' ``without added sugar,'' or ``no
sugar added'' may be used only if:
(i) No amount of sugars, as defined in Sec. 317.309(c)(6)(ii), or
any other ingredient that contains sugars that functionally substitute
for added sugars is added during processing or packaging;
(ii) The product does not contain an ingredient containing added
sugars such as jam, jelly, or concentrated fruit juice;
(iii) The sugars content has not been increased above the amount
present in the ingredients by some means such as the use of enzymes,
except where the intended functional effect of the process is not to
increase the sugars content of a product, and a functionally
insignificant increase in sugars results;
(iv) The product that it resembles and for which it substitutes
normally contains added sugars; and
(v) The product bears a statement that the product is not ``low
calorie'' or ``calorie reduced'' (unless the product meets the
requirements for a ``low'' or ``reduced calorie'' product) and that
directs consumers' attention to the nutrition panel for further
information on sugar and calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual
statement that a product, including products intended specifically for
infants and children less than 2 years of age, is unsweetened or
contains no added sweeteners in the case of a product that contains
apparent substantial inherent sugar content, e.g., juices.
(4) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar
reduced,'' ``less sugar,'' ``lower sugar,'' or ``lower in sugar'' may
be used on the label or in labeling of products, except meal-type
products as defined in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sugars per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., ``this
product contains 25 percent less sugar than our regular product''); and
(B) Quantitative information comparing the level of the sugar in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sugar content has been lowered from
8 g to 6 g per serving'').
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sugars per 100 g
of product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sugar `product'--25% less sugar than our regular
`product'''); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sugar content has been reduced from
17 g per 3 oz to 13 g per 3 oz'').
12. Section 317.361 is revised to read as follows:
Sec. 317.361 Nutrient content claims for the sodium content.
(a) General requirements. A claim about the level of sodium in a
product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 317.309.
(b) Sodium content claims. (1) The terms ``sodium free,'' ``free of
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial
source of sodium,'' ``negligible source of sodium,'' or ``dietarily
insignificant source of sodium'' may be used on the label or in
labeling of products, provided that:
(i) The product contains less than 5 milligrams (mg) of sodium per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product, less than 5 mg of sodium per
labeled serving size;
(ii) The product contains no ingredient that is sodium chloride or
is generally understood by consumers to contain sodium unless the
listing of the ingredient in the ingredients statement is followed by
an asterisk that refers to the statement below the list of ingredients,
which states: ``Adds a trivial amount of sodium,'' ``adds a negligible
amount of sodium'' or ``adds a dietarily insignificant amount of
sodium''; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms ``very low sodium'' or ``very low in sodium'' may be
used on the label or in labeling of products, except meal-type products
as defined in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and
contains 35 mg or less sodium per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 35 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form);
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 35 mg or less of sodium per 100 g of
product; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely [[Page 193]] to the particular brand to which
the label attaches.
(4) The terms ``low sodium,'' ``low in sodium,'' ``little sodium,''
``contains a small amount of sodium,'' or ``low source of sodium'' may
be used on the label and in labeling of products, except meal-type
products as defined in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp and contains 140 mg or less
sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 140 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form);
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 140 mg or less sodium per 100 g of
product; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium''
may be used on the label or in labeling of products, except meal-type
products as defined in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sodium per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sodium `product', 50 percent less sodium than regular
`product'''); and
(B) Quantitative information comparing the level of sodium in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sodium content has been lowered from
300 to 150 mg per serving'').
(iii) Claims described in paragraph (b)(6) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
sodium.''
(7) The terms defined in paragraph (b)(6) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sodium per 100 g
of product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sodium `product'--30% less sodium per 3 oz than our `regular
product'''); and
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., ``sodium content has been reduced from 220
mg per 3 oz to 150 mg per 3 oz'').
(iii) Claims described in paragraph (b)(7) of this section may not
be made on the label or in labeling of products if the nutrient content
of the reference product meets the definition for ``low sodium.''
(c) The term ``salt'' is not synonymous with ``sodium.'' Salt
refers to sodium chloride. However, references to salt content such as
``unsalted,'' ``no salt,'' ``no salt added'' are potentially
misleading.
(1) The term ``salt free'' may be used on the label or in labeling
of products only if the product is ``sodium free'' as defined in
paragraph (b)(1) of this section.
(2) The terms ``unsalted,'' ``without added salt,'' and ``no salt
added'' may be used on the label or in labeling of products only if:
(i) No salt is added during processing;
(ii) The product that it resembles and for which it substitutes is
normally processed with salt; and
(iii) If the product is not sodium free, the statement, ``not a
sodium free product'' or ``not for control of sodium in the diet''
appears adjacent to the nutrition information of the product bearing
the claim.
(3) Paragraph (c)(2) of this section shall not apply to a factual
statement that a product intended specifically for infants and children
less than 2 years of age is unsalted, provided such statement refers to
the taste of the product and is not false or otherwise misleading.
13. Section 317.362 is revised to read as follows:
Sec. 317.362 Nutrient content claims for fat, fatty acids, and
cholesterol content.
(a) General requirements. A claim about the level of fat, fatty
acid, and cholesterol in a product may only be made on the label or in
labeling of products if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 317.309.
(b) Fat content claims. (1) The terms ``fat free,'' ``free of
fat,'' ``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial
source of fat,'' ``negligible source of fat,'' or ``dietarily
insignificant source of fat'' may be used on the label or in labeling
of products, provided that:
(i) The product contains less than 0.5 gram (g) of fat per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product, less than 0.5 g of fat per labeled
serving size;
(ii) The product contains no added ingredient that is a fat or is
generally understood by consumers to contain fat unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of fat,'' ``adds a negligible amount of
fat,'' or ``adds a dietarily insignificant amount of fat''; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the [[Page 194]] particular brand to which the
label attaches.
(2) The terms ``low fat,'' ``low in fat,'' ``contains a small
amount of fat,'' ``low source of fat,'' or ``little fat'' may be used
on the label and in labeling of products, except meal-type products as
defined in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g
or less of fat per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 3 g or less of fat per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 3 g or less of total fat per 100 g of
product and not more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,''
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the
label or in labeling of products, except meal-type products as defined
in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less fat per reference
amount customarily consumed than an appropriate reference product as
described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., ``reduced
fat--50 percent less fat than our regular `product'''); and
(B) Quantitative information comparing the level of fat in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``fat content has been reduced from 8
g to 4 g per serving'').
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low fat.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less fat per 100 g of
product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., ``reduced
fat `product', 33 percent less fat per 3 oz than our regular
`product'''); and
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent such claim or to
the nutrition information (e.g., ``fat content has been reduced from 8
g per 3 oz to 5 g per 3 oz'').
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low fat.''
(6) The term ``______ percent fat free'' may be used on the label
or in labeling of products, provided that:
(i) The product meets the criteria for ``low fat'' in paragraph
(b)(2) or (b)(3) of this section;
(ii) The percent declared and the words ``fat free'' are in uniform
type size; and
(iii) A ``100 percent fat free'' claim may be made only on products
that meet the criteria for ``fat free'' in paragraph (b)(1) of this
section, that contain less than 0.5 g of fat per 100 g, and that
contain no added fat.
(iv) A synonym for ``______ percent fat free'' is ``______ percent
lean.''
(c) Fatty acid content claims. (1) The terms ``saturated fat
free,'' ``free of saturated fat,'' ``no saturated fat,'' ``zero
saturated fat,'' ``without saturated fat,'' ``trivial source of
saturated fat,'' ``negligible source of saturated fat,'' or ``dietarily
insignificant source of saturated fat'' may be used on the label or in
labeling of products, provided that:
(i) The product contains less than 0.5 g of saturated fat and less
than 0.5 g trans fatty acids per reference amount customarily consumed
and per labeled serving size or, in the case of a meal-type product,
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids
per labeled serving size;
(ii) The product contains no ingredient that is generally
understood by consumers to contain saturated fat unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of saturated fat,'' ``adds a negligible
amount of saturated fat,'' or ``adds a dietarily insignificant amount
of saturated fat;'' and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products
of its type and not merely to the particular brand to which the label
attaches.
(2) The terms ``low in saturated fat,'' ``low saturated fat,''
``contains a small amount of saturated fat,'' ``low source of saturated
fat,'' or ``a little saturated fat'' may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 317.313(l), provided that:
(i) The product contains 1 g or less of saturated fat per reference
amount customarily consumed and not more than 15 percent of calories
from saturated fat; and
(ii) If the product meets these conditions without benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products
of its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (c)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 1 g or less of saturated fat per 100 g and
less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat [[Page 195]] content, it is labeled to clearly refer to
all products of its type and not merely to the particular brand to
which the label attaches.
(4) The terms ``reduced saturated fat,'' ``reduced in saturated
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower
saturated fat,'' or ``lower in saturated fat'' may be used on the label
or in labeling of products, except meal-type products as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``reduced saturated fat `product', contains 50 percent less saturated
fat than the national average for `product'''); and
(B) Quantitative information comparing the level of saturated fat
in the product per labeled serving size with that of the reference
product that it replaces is declared adjacent to the most prominent
claim or to the nutrition information (e.g., ``saturated fat reduced
from 3 g to 1.5 g per serving'').
(iii) Claims described in paragraph (c)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
saturated fat.''
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
100 g of product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``reduced saturated fat `product','' ``50 percent less saturated fat
than our regular `product'''); and
(B) Quantitative information comparing the level of saturated fat
in the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``saturated fat content has been
reduced from 2.5 g per 3 oz to 1.5 g per 3 oz'').
(iii) Claims described in paragraph (c)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
saturated fat.''
(d) Cholesterol content claims. (1) The terms ``cholesterol free,''
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,''
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible
source of cholesterol,'' or ``dietarily insignificant source of
cholesterol'' may be used on the label or in labeling of products,
provided that:
(i) The product contains less than 2 milligrams (mg) of cholesterol
per reference amount customarily consumed and per labeled serving size
or, in the case of a meal-type product as defined in Sec. 317.313(l),
less than 2 mg of cholesterol per labeled serving size;
(ii) The product contains no ingredient that is generally
understood by consumers to contain cholesterol, unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of cholesterol,'' ``adds a negligible
amount of cholesterol,'' or ``adds a dietarily insignificant amount of
cholesterol'';
(iii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed or, in the case of a meal-type
product as defined in Sec. 317.313(l), 2 g or less of saturated fat per
labeled serving size; and
(iv) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches;
or
(v) If the product meets these conditions only as a result of
special processing, alteration, formulation, or reformulation, the
amount of cholesterol is reduced by 25 percent or more from the
reference product it replaces as described in Sec. 317.313(j)(1) and
for which it substitutes as described in Sec. 317.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``cholesterol free
`product', contains 100 percent less cholesterol than `reference
product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``contains no cholesterol compared
with 30 mg in one serving of `reference product''').
(2) The terms ``low in cholesterol,'' ``low cholesterol,''
``contains a small amount of cholesterol,'' ``low source of
cholesterol,'' or ``little cholesterol'' may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 317.313(l), provided that:
(i)(A) If the product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed; and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed; or
(B) If the product has a reference amount customarily consumed of
30 g or less or 2 tbsp or less:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form);
and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed.
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches; or
(iii) If the product contains 20 mg or less of cholesterol only as
a result of special processing, alteration, formulation, or
reformulation, the amount of cholesterol is reduced by 25 percent or
more from the reference product it replaces as described in
Sec. 317.313(j)(1) and for which it substitutes as described in
Sec. 317.313(d) that has a significant (e.g., 5 percent or more of a
national or regional market) market share. As required in
Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced [[Page 196]] are
declared in immediate proximity to the most prominent such claim (e.g.,
``low cholesterol `product', contains 85 percent less cholesterol than
our regular `product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5
mg per serving'').
(3) The terms defined in paragraph (d)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 20 mg or less of cholesterol per 100 g of
product;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,''
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,''
or ``lower in cholesterol'' may be used on the label or in labeling of
products or products that substitute for those products as specified in
Sec. 317.313(d), excluding meal-type products as defined in
Sec. 317.313(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 317.313(j)(1) and
for which it substitutes as described in Sec. 317.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed; and
(iii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``25
percent less cholesterol than `reference product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30
mg per serving'').
(iv) Claims described in paragraph (d)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
cholesterol.''
(5) The terms defined in paragraph (d)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 317.313(j)(1) and
for which it substitutes as described in Sec. 317.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``25% less
cholesterol than `reference product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol content has been reduced
from 35 mg per 3 oz to 25 mg per 3 oz).
(iv) Claims described in paragraph (d)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
cholesterol.''
(e) ``Lean'' and ``Extra Lean'' claims. (1) The term ``lean'' may
be used on the label or in labeling of a product, provided that the
product contains less than 10 g of fat, 4.5 g or less of saturated fat,
and less than 95 mg of cholesterol per 100 g of product and per
reference amount customarily consumed for individual foods, and per 100
g of product and per labeled serving size for meal-type products as
defined in Sec. 317.313(l).
(2) The term ``extra lean'' may be used on the label or in labeling
of a product, provided that the product contains less than 5 g of fat,
less than 2 g of saturated fat, and less than 95 mg of cholesterol per
100 g of product and per reference amount customarily consumed for
individual foods, and per 100 g of product and per labeled serving size
for meal-type products as defined in Sec. 317.313(l).
Sec. 317.363 [Amended]
14. Section 317.363 is amended by revising the section reference in
paragraphs (b)(2) introductory text and (b)(3) introductory text from
``Sec. 317.309(g)(1)'' to ``Sec. 317.309(f)(1).''
Sec. 317.369 [Amended]
15. Section 317.369 is amended by adding the word ``meat'' before
the words ``food products'' in the last sentence of paragraph (k)(5)
introductory text; by replacing the word ``preceding'' in paragraph
(k)(5)(i)(A) with the word ``proceeding''; and by replacing the word
``application'' in the second sentence of paragraph (k)(5)(i)(B) with
the word ``applicant''.
16. Section 317.380 is amended by revising paragraphs (e) and (f)
to read as follows:
Sec. 317.380 Label statements relating to usefulness in reducing or
maintaining body weight.
* * * * *
(e) ``Label terms suggesting usefulness as low calorie or reduced
calorie foods''. (1) Except as provided in paragraphs (e)(2) and (e)(3)
of this section, a product may be labeled with terms such as ``diet,''
``dietetic,'' ``artificially sweetened,'' or ``sweetened with
nonnutritive sweetener'' only if the claim is not false or misleading,
and the product is labeled ``low calorie'' or ``reduced calorie'' or
bears another comparative calorie claim in compliance with the
applicable provisions in this subpart.
(2) Paragraph (e)(1) of this section shall not apply to any use of
such terms that is specifically authorized by regulation governing a
particular food, or, unless otherwise restricted by regulation, to any
use of the term ``diet'' that clearly shows that the product is offered
solely for a dietary use other than regulating body weight, e.g., ``for
low sodium diets.''
(3) Paragraph (e)(1) of this section shall not apply to any use of
such terms on a formulated meal replacement or other product that is
represented to be of special dietary use as a whole meal, pending the
issuance of a regulation governing the use of such terms on foods.
(f) ``Sugar free'' and ``no added sugar''. Criteria for the use of
the terms ``sugar free'' and ``no added sugar'' are provided for in
Sec. 317.360(c).
Sec. 317.400 [Amended]
17. Section 317.400 is amended by adding the words ``meat or''
before the words ``meat food products'' in paragraph (a) introductory
text; by revising the section reference in [[Page 197]] paragraph
(c)(2)(iii) from ``Sec. 317.309(e)'' to ``Sec. 317.309(d)(6)''; and by
revising the words ``at 21 CFR 101.9(d)(9)'' in paragraph (c)(2)(v) to
the words ``in Sec. 317.309(d)(9).''
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
18. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR
2.17, 2.55.
Sec. 381.400 [Amended]
19. Section 381.400 is amended by adding the words ``intended for
human consumption and offered for sale'' after the words ``poultry
products'' in paragraph (a).
20. Section 381.409 is amended by revising the section reference in
the fifth sentence of paragraph (h)(2) from ``Sec. 381.409(b)'' to
``Sec. 381.409(c)'' and revising paragraphs (a) through (g) to read as
follows:
Sec. 381.409 Nutrition label content.
(a) All nutrient and food component quantities shall be declared in
relation to a serving as defined in this section.
(b)(1) The term ``serving'' or ``serving size'' means an amount of
food customarily consumed per eating occasion by persons 4 years of age
or older, which is expressed in a common household measure that is
appropriate to the product. When the product is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14)
of this section and for products that are intended for weight control
and are available only through a weight-control or weight-maintenance
program, the serving size declared on a product label shall be
determined from the ``Reference Amounts Customarily Consumed Per Eating
Occasion--General Food Supply'' (Reference Amount(s)) that appear in
Sec. 381.412(b) using the procedures described in this paragraph (b).
For products that are both intended for weight control and available
only through a weight-control program, a manufacturer may determine the
serving size that is consistent with the meal plan of the program. Such
products must bear a statement, ``for sale only through the ______
program'' (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal
display panel. However, the Reference Amounts in Sec. 381.412(b) shall
be used for purposes of evaluating whether weight-control products that
are available only through a weight-control program qualify for
nutrition claims.
(3) The declaration of nutrient and food component content shall be
on the basis of the product ``as packaged'' for all products, except
that single-ingredient, raw products may be declared on the basis of
the product ``as consumed'' as set forth in Sec. 381.445(a)(1). In
addition to the required declaration on the basis of ``as packaged''
for products other than single ingredient, raw products, the
declaration may also be made on the basis of ``as consumed,'' provided
that preparation and cooking instructions are clearly stated.
(4) For products in discrete units (e.g., chicken wings, and
individually packaged products within a multi-serving package), and for
products which consist of two or more foods packaged and presented to
be consumed together where the ingredient represented as the main
ingredient is in discrete units (e.g., chicken wings and barbecue
sauce), the serving size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount,
the serving size shall be the number of whole units that most closely
approximates the Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent
of the Reference Amount, the manufacturer may declare one unit or two
units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent
of the Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or
milliliter) or larger and are individual units within a multi-serving
package, if a unit contains more than 150 percent but less than 200
percent of the Reference Amount, the manufacturer may decide whether to
declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., chicken wings and
barbecue sauce), the serving size may be the number of discrete units
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product as
determined in Sec. 381.412(c).
(vii) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving
containers), the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided
for consumption (e.g., pizza, pan of poultry lasagna), for unprepared
products where the entire contents of the package is used to prepare
large discrete units that are usually divided for consumption (e.g.,
pizza kit), and for products which consist of two or more foods
packaged and presented to be consumed together where the ingredient
represented as the main ingredient is a large discrete unit usually
divided for consumption, the serving size shall be the fractional slice
of the ready-to-eat product (e.g., \1/8\ quiche, \1/4\ pizza) that most
closely approximates the Reference Amount for the product category. The
serving size may be the fraction of the package used to make the
Reference Amount for the unprepared product determined in
Sec. 381.412(d) or the fraction of the large discrete unit represented
as the main ingredient plus proportioned minor ingredients used to make
the Reference Amount of the combined product determined in
Sec. 381.412(c). In expressing the fractional slice, manufacturers
shall use \1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller fractions that
can be generated by further division by 2 or 3.
(6) For nondiscrete bulk products (e.g., whole turkey, turkey
breast, ground poultry), and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is a bulk product (e.g.,
turkey breast and gravy), the serving size shall be the amount in
household measure that most closely approximates the Reference Amount
for the product category and may be the amount of the bulk product
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product determined
in Sec. 381.412(c).
(7) For labeling purposes, the term ``common household measure'' or
``common household unit'' means cup, tablespoon, teaspoon, piece,
slice, fraction (e.g., \1/4\ pizza), ounce (oz), or other common
household equipment used to package food products (e.g., jar
[[Page 198]] or tray). In expressing serving size in household
measures, except as specified in paragraphs (b)(7)(iv), (v), and (vi)
of this section, the following rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup
increments, tablespoons in whole number of tablespoons for quantities
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp),
1, 1\1/3\, 1\1/2\, or 1\2/3\ tbsp for quantities less than 2 tbsp but
greater than or equal to 1 tbsp, and teaspoons in whole number of
teaspoons for quantities less than 1 tbsp but greater than or equal to
1 teaspoon (tsp), and in \1/4\-tsp increments for quantities less than
1 tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If cups, tablespoons and teaspoons, or units such as piece,
slice, tray, jar, or fraction are not applicable, ounces may be used.
Ounce measurements shall be expressed in 0.5-ounce increments most
closely approximating the Reference Amount with rounding indicated by
the use of the term ``about'' (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be
used for single-serving containers and meal-type products and for
individually packaged products within multi-serving containers (e.g.,
can, box, package, meal, or dinner). A description of the individual
unit shall be used for other products in discrete units (e.g., wing,
slice, link, or patty).
(v) For unprepared products where the entire contents of the
package is used to prepare large discrete units that are usually
divided for consumption (e.g., pizza kit), the fraction or portion of
the package may be used.
(vi) For products that consist of two or more distinct ingredients
or components packaged and presented to be consumed together (e.g.,
chicken wings with a glaze packet), the nutrition information may be
declared for each component or as a composite. The serving size may be
provided in accordance with the provisions of paragraphs (b)(4),
(b)(5), and (b)(6) of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1
oz in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in
Sec. 381.412(b) and the procedures described in this section, falls
exactly half way between two serving sizes (e.g., 2.5 tbsp),
manufacturers shall round the serving size up to the next incremental
size.
(8) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable Reference Amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving, except for products
that have Reference Amounts of 100 g (or mL) or larger, manufacturers
may decide whether a package that contains more than 150 percent but
less than 200 percent of the Reference Amount is 1 or 2 servings.
Packages sold individually that contain 200 percent or more of the
applicable Reference Amount may be labeled as a single-serving if the
entire content of the package can reasonably be consumed at a single-
eating occasion.
(9) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs
(b)(2) through (b)(8) of this section and shall be followed by the
equivalent metric quantity in parenthesis (fluids in milliliters and
all other foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement
on the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to
paragraph (b)(11) of this section. However, if a manufacturer
voluntarily provides the metric quantity on products that can be sold
as single servings, then the numerical value provided as part of the
serving size declaration must be identical to the metric quantity
declaration provided as part of the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between
2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g
(mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce, in
parenthesis, following the metric measure separated by a slash where
other common household measures are used as the primary unit for
serving size, e.g., 1 slice (28 g/1 oz) for sliced chicken roll. The
ounce quantity equivalent to the metric quantity should be expressed in
0.1-oz increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, and oz for ounce.
(10) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term ``about'' (e.g., about 2 servings;
about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size, the manufacturer may state the typical number
of servings per container (e.g., usually 5 servings).
(iii) For random weight products, a manufacturer may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the Reference Amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the ``varied'' statement (e.g., varied
(approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving
containers), the number of servings shall be the number of individual
packages within the total package.
(v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by
multiplying the number of individual multi-serving units in the total
package by the number of servings in each individual unit.
(11) The declaration of nutrient and food component content shall
be on the basis of product as packaged or purchased with the exception
of products that are packed or canned in water, brine, or oil but whose
liquid packing medium is not customarily consumed. Declaration of the
nutrient and food component content of products that are packed in
liquid which is not customarily consumed shall be based on the drained
solids.
(12) Serving size for meal-type products as defined in
Sec. 381.413(l) shall [[Page 199]] be the entire content (edible
portion only) of the package.
(13) Another column of figures may be used to declare the nutrient
and food component information in the same format as required by
Sec. 381.409(e),
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as
packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete
units in a multi-serving container is more than one unit.
(14) If a product consists of assortments of poultry products
(e.g., variety packs) in the same package, nutrient content shall be
expressed on the entire package contents or on each individual product.
(15) If a product is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare the nutrient contents on the basis of the product as
consumed for the product alone (e.g., a cream soup mix may be labeled
with one set of Daily Values for the dry mix (per serving), and another
set for the serving of the final soup when prepared (e.g., per serving
of cream soup mix and 1 cup of vitamin D fortified whole milk)):
Provided, that the type and quantity of the other ingredients to be
added to the product by the user and the specific method of cooking and
other preparation shall be specified prominently on the label.
(c) The declaration of nutrition information on the label or in
labeling of a poultry product shall contain information about the level
of the following nutrients, except for those nutrients whose inclusion,
and the declaration of amounts, is voluntary as set forth in this
paragraph. No nutrients or food components other than those listed in
this paragraph as either mandatory or voluntary may be included within
the nutrition label. Except as provided for in paragraph (f) or (g) of
this section, nutrient information shall be presented using the
nutrient names specified and in the following order in the formats
specified in paragraph (d) or (e) of this section.
(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parenthesis immediately
following the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i.e., the Atwater method) given
in Table 13, page 25, ``Energy Value of Foods--Basis and Derivation,''
by A. L. Merrill and B. K. Watt, United States Department of
Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised
February 1973), which is incorporated by reference. Table 13 of the
``Energy Value of Foods--Basis and Derivation,'' Agriculture Handbook
No. 74 is incorporated as it exists on the date of approval. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is
available for inspection at the Office of the Federal Register, suite
700, 800 North Capitol Street, NW., Washington, DC, or at the office of
the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence
Avenue, SW., Washington, DC. Copies of the incorporation by reference
are available from the Product Assessment Division, Regulatory
Programs, Food Safety and Inspection Service, U.S. Department of
Agriculture, Room 329, West End Court Building, Washington, DC 20250-
3700;
(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973),
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture
Handbook No. 74 is incorporated as it exists on the date of approval.
This incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(The availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section.);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA's Agriculture
Handbook No. 74 (Slightly revised February 1973), pages 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. (The availability of this incorporation by reference is given
in paragraph (c)(1)(i)(A) of this section.); or
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of 21 CFR, or by other means, as
appropriate.
(ii) ``Calories from fat'': A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section
per serving, expressed to the nearest 5-calorie increment, up to and
including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of ``calories from fat'' is not
required on products that contain less than 0.5 gram of fat per serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section.
(iii) ``Calories from saturated fat'' or ``Calories from
saturated'' (VOLUNTARY): A statement of the caloric content derived
from saturated fat as defined in paragraph (c)(2)(i) of this section
per serving may be declared voluntarily, expressed to the nearest 5-
calorie increment, up to and including 50 calories, and the nearest 10-
calorie increment above 50 calories, except that amounts less than 5
calories may be expressed as zero. This statement shall be indented
under the statement of calories from fat as provided in paragraph
(d)(5) of this section.
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat per serving defined as total lipid fatty acids and
expressed as triglycerides. Amounts shall be expressed to the nearest
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram,
the content shall be expressed as zero.
(i) ``Saturated fat'' or ``Saturated'': A statement of the number
of grams of saturated fat per serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat per serving if no claims are
made about fat or cholesterol content, and if ``calories from saturated
fat'' is not declared. Saturated fat content shall be indented and
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram
increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(A) ``Stearic Acid'' (VOLUNTARY): A statement of the number of
grams of stearic acid per serving may be declared voluntarily, except
that when a claim is made about stearic acid, label declaration shall
be required. Stearic acid content shall be indented under saturated fat
and expressed to the [[Page 200]] nearest 0.5 (\1/2\)-gram increment
below 5 grams and the nearest gram increment above 5 grams. If the
serving contains less than 0.5 gram, the content shall be expressed as
zero.
(B) [Reserved]
(ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat per serving
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids
may be declared voluntarily, except that when monounsaturated fat is
declared, or when a claim about fatty acids or cholesterol is made on
the label or in labeling of a product other than one that meets the
criteria in Sec. 381.462(b)(1) for a claim for ``fat free,'' label
declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest
gram increment above 5 grams. If the serving contains less than 0.5
gram, the content shall be expressed as zero.
(iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat per serving
defined as cis-monounsaturated fatty acids may be declared voluntarily,
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a
product other than one that meets the criteria in Sec. 381.462(b)(1)
for a claim for ``fat free,'' label declaration of monounsaturated fat
is required. Monounsaturated fat content shall be indented and
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram
increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(3) ``Cholesterol'': A statement of the cholesterol content per
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not
required for products that contain less than 2 milligrams of
cholesterol per serving and make no claim about fat, fatty acids, or
cholesterol content, or such products may state the cholesterol content
as zero. If the product contains 2 to 5 milligrams of cholesterol per
serving, the content may be stated as ``less than 5 milligrams.''
(4) ``Sodium'': A statement of the number of milligrams of sodium
per serving expressed as zero when the serving contains less than 5
milligrams of sodium, to the nearest 5-milligram increment when the
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140
milligrams.
(5) ``Potassium'' (VOLUNTARY): A statement of the number of
milligrams of potassium per serving may be declared voluntarily, except
that when a claim is made about potassium content, label declaration
shall be required. Potassium content shall be expressed as zero when
the serving contains less than 5 milligrams of potassium, to the
nearest 5-milligram increment when the serving contains 5 to 140
milligrams of potassium, and to the nearest 10-milligram increment when
the serving contains greater than 140 milligrams.
(6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement
of the number of grams of total carbohydrate per serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, or, if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the product. This
calculation method is described in USDA's Agriculture Handbook No. 74
(Slightly revised February 1973), pages 2 and 3, which is incorporated
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is
incorporated as it exists on the date of approval. This incorporation
by reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of
this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section.).
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber per serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required, or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5 gram, the content may be
expressed as zero.
(A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the
content may be expressed as zero.
(B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber per serving may be declared
voluntarily except when a claim is made on the label or in labeling
about insoluble fiber, label declaration shall be required. Insoluble
fiber content shall be indented under dietary fiber and expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, and if the serving contains less than 0.5
gram, the content may be expressed as zero.
(ii) ``Sugars'': A statement of the number of grams of sugars per
serving, except that label declaration of sugars content is not
required for products that contain less than 1 gram of sugars per
serving if no claims are made about sweeteners, sugars, or sugar
alcohol content. Sugars shall be defined as the sum of all free mono-
and disaccharides (such as glucose, fructose, lactose, and sucrose).
Sugars content shall be indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the
content may be expressed as zero.
(iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of
grams of sugar alcohols per serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
product, sugar alcohol content shall be declared. For nutrition
labeling purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu
of the term ``sugar alcohol,'' the name of the specific sugar alcohol
(e.g., ``xylitol'') present in the product may be used in the nutrition
label, provided that only one sugar alcohol is present in the product.
Sugar alcohol content shall be indented and expressed to the nearest
gram, except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the
content may be expressed as zero. [[Page 201]]
(iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number
of grams of other carbohydrate per serving may be declared voluntarily.
Other carbohydrate shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it
shall be defined as the difference between total carbohydrate and the
sum of dietary fiber and sugars. Other carbohydrate content shall be
indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(7) ``Protein'': A statement of the number of grams of protein per
serving expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero. When the protein in products represented or purported to be for
adults and children 4 or more years of age has a protein quality value
that is a protein digestibility-corrected amino acid score of less than
20 expressed as a percent, or when the protein in a product represented
or purported to be for children greater than 1 but less than 4 years of
age has a protein quality value that is a protein digestibility-
corrected amino acid score of less than 40 expressed as a percent,
either of the following shall be placed adjacent to the declaration of
protein content by weight: The statement ``not a significant source of
protein,'' or a listing aligned under the column headed ``Percent Daily
Value'' of the corrected amount of protein per serving, as determined
in paragraph (c)(7)(ii) of this section, calculated as a percentage of
the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as
appropriate, for protein and expressed as percent of Daily Value. When
the protein quality in a product as measured by the Protein Efficiency
Ratio (PER) is less than 40 percent of the reference standard (casein)
for a product represented or purported to be for infants, the statement
``not a significant source of protein'' shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on
the basis of the factor of 6.25 times the nitrogen content of the food
as determined by appropriate methods of analysis in accordance with
Sec. 381.409(h), except when the procedure for a specific food requires
another factor.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for infants or
children under 4 years of age. When such a declaration is provided, it
shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column headed ``Percent Daily Value,''
and expressed to the nearest whole percent. However, the percentage of
the RDI for protein shall not be declared if the product is represented
or purported to be for infants and the protein quality value is less
than 40 percent of the reference standard.
(ii) The corrected amount of protein (grams) per serving for
products represented or purported to be for adults and children 1 or
more years of age is equal to the actual amount of protein (grams) per
serving multiplied by the amino acid score corrected for protein
digestibility. If the corrected score is above 1.00, then it shall be
set at 1.00. The protein digestibility-corrected amino acid score shall
be determined by methods given in sections 5.4.1, 7.2.1, and 8 in
``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert
Consultation on Protein Quality Evaluation,'' Rome, 1990, which is
incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the ``Report
of the Joint FAO/WHO Expert Consultation on Protein Quality
Evaluation,'' as published by the Food and Agriculture Organization of
the United Nations/World Health Organization, is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the
Office of the Federal Register, suite 700, 800 North Capitol Street,
NW., Washington, DC, or at the office of the FSIS Docket Clerk, Room
3171, South Building, 14th and Independence Avenue, SW., Washington,
DC. Copies of the incorporation by reference are available from the
Product Assessment Division, Regulatory Programs, Food Safety and
Inspection Service, U.S. Department of Agriculture, Room 329, West End
Court Building, Washington, DC 20250-3700. For products represented or
purported to be for infants, the corrected amount of protein (grams)
per serving is equal to the actual amount of protein (grams) per
serving multiplied by the relative protein quality value. The relative
protein quality value shall be determined by dividing the subject
product's protein PER value by the PER value for casein. If the
relative protein value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI,
a value of 50 grams of protein shall be the DRV for adults and children
4 or more years of age, and the RDI for protein for children less than
4 years of age, infants, pregnant women, and lactating women shall be
16 grams, 14 grams, 60 grams, and 65 grams, respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d) through (g) of this section, products
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For products represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the
RDI values for infants from birth to 12 months of age and for children
under 4 years of age. Similarly, the percent of Daily Value based on
both the RDI values for pregnant women and for lactating women shall be
declared separately on products represented or purported to be for use
by both pregnant and lactating women. When such dual declaration is
used on any label, it shall be included in all labeling, and equal
prominence shall be given to both values in all such labeling. All
other products shall use the RDI for adults and children 4 or more
years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall include any of the other vitamins and minerals listed
in paragraph (c)(8)(iv) of this section when they are added, or when a
claim is made about them. Other vitamins and minerals need not be
declared if neither the nutrient nor the component is otherwise
referred to on the label or in labeling or advertising and the vitamins
and minerals are: [[Page 202]]
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another product; or
(B) Included in a product solely for technological purposes and
declared only in the ingredients statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and minerals shall be listed in the order
established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and including the 10-percent
level, the nearest 5-percent increment above 10 percent and up to and
including the 50-percent level, and the nearest 10-percent increment
above the 50-percent level. Amounts of vitamins and minerals present at
less than 2 percent of the RDI are not required to be declared in
nutrition labeling but may be declared by a zero or by the use of an
asterisk (or other symbol) that refers to another asterisk (or symbol)
that is placed at the bottom of the table and that is followed by the
statement ``Contains less than 2 percent of the Daily Value of this
(these) nutrient (nutrients).'' Alternatively, if vitamin A, vitamin C,
calcium, or iron is present in amounts less than 2 percent of the RDI,
label declaration of the nutrient(s) is not required if the statement
``Not a significant source of ________ (listing the vitamins or
minerals omitted)'' is placed at the bottom of the table of nutrient
values.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams
(v) The following synonyms may be added in parenthesis immediately
following the name of the nutrient or dietary component:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent of
Daily Value of vitamin A in the product (e.g., ``Percent Daily Value:
Vitamin A 50 (90 percent as beta-carotene)''). When declared, the
percentages shall be expressed in the same increments as are provided
for vitamins and minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Food component Unit of measurement DRV
------------------------------------------------------------------------
Fat............................ grams (g)...................... 65
Saturated fatty acids.......... ......do....................... 20
Cholesterol.................... milligrams (mg)................ 300
Total carbohydrate............. grams (g)...................... 300
Fiber.......................... ......do....................... 25
Sodium......................... milligrams (mg)................ 2400
Potassium...................... ......do....................... 3500
Protein........................ grams (g)...................... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on products in the following format, except
on products on which dual columns of nutrition information are declared
as provided for in paragraph (e) of this section, on those products on
which the simplified format is permitted to be used as provided for in
paragraph (f) of this section, on products for infants and children
less than 4 years of age as provided for in Sec. 381.500(c), and on
products in packages that have a total surface area available to bear
labeling of 40 or less square inches as provided for in paragraph (g)
of this section.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for
the information required by paragraphs (d)(7) and (d)(8) of this
section, and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7),
and (d)(8) of this section shall be in type size no smaller than 8
point. Except for the heading ``Nutrition Facts,'' the information
required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and
all other information contained within the nutrition label shall be in
type size no smaller than 6 point. When provided, the information
described in paragraph (d)(10) of this section shall also be in type no
smaller than 6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., ``Nutrition Facts,'' ``Amount Per Serving,'' and
``% Daily Value*''), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
Calories, Total fat, Cholesterol, Sodium, Potassium, Total
carbohydrate, and Protein), and the percentage amounts required by
paragraph (d)(7)(ii) of this section shall be highlighted by bold or
extra bold type or other highlighting (reverse printing is not
permitted as a form of highlighting) that prominently distinguishes it
from other information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text
shall separate ``Amount Per Serving'' from the calorie statements
required in paragraph (d)(5) of this section and shall separate each
nutrient and its corresponding percent of Daily Value required in
paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient
and percent of Daily Value above and below it.
(2) The information shall be presented under the identifying
heading of ``Nutrition Facts'' which shall be set in a type size larger
than all other print size in the nutrition label and, except for labels
presented according to the format provided for in paragraph (d)(11) of
this section, unless impractical, shall be set the full width of the
information provided under paragraph (d)(7) of this section.
(3) Information on serving size shall immediately follow the
heading. Such information shall include:
(i) ``Serving Size'': A statement of the serving size as specified
in paragraph (b)(9) of this section. [[Page 203]]
(ii) ``Servings Per Container'': The number of servings per
container, except that this statement is not required on single-serving
containers as defined in paragraph (b)(8) of this section.
(4) A subheading ``Amount Per Serving'' shall be separated from
serving size information by a bar.
(5) Information on calories shall immediately follow the heading
``Amount Per Serving'' and shall be declared in one line, leaving
sufficient space between the declaration of ``Calories'' and ``Calories
from fat'' to allow clear differentiation, or, if ``Calories from
saturated fat'' is declared, in a column with total ``Calories'' at the
top, followed by ``Calories from fat'' (indented), and ``Calories from
saturated fat'' (indented).
(6) The column heading ``% Daily Value,'' followed by an asterisk
(e.g., ``% Daily Value*''), shall be separated from information on
calories by a bar. The position of this column heading shall allow for
a list of nutrient names and amounts as described in paragraph (d)(7)
of this section to be to the left of, and below, this column heading.
The column heading ``Percent Daily Value,'' ``Percent DV,'' or ``% DV''
may be substituted for ``% Daily Value.''
(7) Except as provided for in paragraph (g) of this section, and
except as permitted by Sec. 381.500(d)(2), nutrient information for
both mandatory and any voluntary nutrients listed in paragraph (c) of
this section that are to be declared in the nutrition label, except
vitamins and minerals, shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of
this section, shall be given in a column and followed immediately by
the quantitative amount by weight for that nutrient appended with a
``g'' for grams or ``mg'' for milligrams.
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% Daily Value'' established in
paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column
described in paragraph (d)(7)(i) of this section for which a DRV has
been established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns, except that when more than
four vitamins and minerals are declared, they may be declared
vertically with percentages listed under the column headed ``% Daily
Value.''
(9) A footnote, preceded by an asterisk, shall be placed beneath
the list of vitamins and minerals and shall be separated from that list
by a hairline.
(i) The footnote shall state: Percent Daily Values are based on a
2,000 calorie diet. Your daily values may be higher or lower depending
on your calorie needs.
------------------------------------------------------------------------
Calories 2,000 2,500
------------------------------------------------------------------------
Total fat........................ Less than.... 65 g 80 g
Saturated fat.................... Less than.... 20 g 25 g
Cholesterol...................... Less than.... 300 mg 300 mg
Sodium........................... Less than.... 2400 mg 2400 mg
Total carbohydrate............... ............. 300 g 375 g
Dietary fiber.................... ............. 25 g 30 g
------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
``2,000'' and value of 65 g in the column headed ``2,500.''
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (g)(2) of this
section may be used within the footnote.
(10) Caloric conversion information on a per-gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9), separated from that information by a
hairline. This information may be presented horizontally (i.e.,
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent of Daily Value information. The
caloric conversion information provided for in paragraph (d)(10) of
this section may be presented beneath either side or along the full
length of the nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set
off by a line that distinguishes it and sets it apart from the percent
of Daily Value information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 inches) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of iron,
the nutrition label may be presented in a tabular display in which the
footnote required by paragraph (d)(9) of the section is given to the
far right of the label, and additional vitamins and minerals beyond the
four that are required (i.e., vitamin A, vitamin C, calcium, and iron)
are arrayed horizontally following declarations of the required
vitamins and minerals.
(12) The following sample label illustrates the provisions of
paragraph (d) of this section:
BILLING CODE 3410-DM-P
[[Page 204]]
[GRAPHIC][TIFF OMITTED]TR03JA95.002
BILLING CODE 3410-DM-C
[[Page 205]]
(13)(i) Nutrition labeling on the outer label of packages of
poultry products that contain two or more products in the same packages
(e.g., variety packs) or of packages that are used interchangeably for
the same type of food (e.g., poultry salad containers) may use an
aggregate display.
(ii) Aggregate displays shall comply with format requirements of
paragraph (d) of this section to the maximum extent possible, except
that the identity of each food shall be specified to the right of the
``Nutrition Facts'' title, and both the quantitative amount by weight
(i.e., g/mg amounts) and the percent Daily Value for each nutrient
shall be listed in separate columns under the name of each food.
(14) When nutrition labeling appears in a second language, the
nutrition information may be presented in a separate nutrition label
for each language or in one nutrition label with the information in the
second language following that in English. Numeric characters that are
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both
languages.
(e) Nutrition information may be presented for two or more forms of
the same product (e.g., both ``raw'' and ``cooked'') or for common
combinations of foods as provided for in paragraph (b) of this section,
or for different units (e.g., per 100 grams) as provided for in
paragraph (b) of this section, or for two or more groups for which
RDI's are established (e.g., both infants and children less than 4
years of age) as provided for in paragraph (c)(8)(i) of this section.
When such dual labeling is provided, equal prominence shall be given to
both sets of values. Information shall be presented in a format
consistent with paragraph (d) of this section, except that:
(1) Following the subheading of ``Amount Per Serving,'' there shall
be two or more column headings accurately describing the forms of the
same product (e.g., ``raw'' and ``roasted''), the combinations of
foods, the units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the Reference Amount in Sec. 381.412(b) shall be to the
left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of
the same product, for combinations of foods, or for different units,
total calories and calories from fat (and calories from saturated fat,
when declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the
product as packaged and according to the label serving size based on
the Reference Amount in Sec. 381.412(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the Reference Amount in Sec. 381.412(b) or as a footnote.
(A) If such additional quantitative information is given
immediately adjacent to the required quantitative information, it shall
be declared for all nutrients listed and placed immediately following
and differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'')
referring to another asterisk (or symbol) at the bottom of the
nutrition label identifying the form(s) of the product for which
quantitative information is presented.
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of
this section shall be presented under the subheading ``% DAILY VALUE''
and in columns directly under the column headings set forth in
paragraph (e)(1) of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
BILLING CODE 3410-DM-P
[[Page 206]]
[GRAPHIC][TIFF OMITTED]TR03JA95.003
BILLING CODE 3410-DM-C
(f)(1) Nutrition information may be presented in a simplified
format as set forth herein when any required nutrients, other than the
core nutrients (i.e., calories, total fat, sodium, total carbohydrate,
and protein), are present in insignificant amounts. An insignificant
amount shall be defined as that amount that may be rounded to zero in
nutrition labeling, except that for total carbohydrate, dietary fiber,
sugars and protein, it shall be an amount less than 1 gram.
(2) The simplified format shall include information on the
following nutrients:
(i) Total calories, total fat, total carbohydrate, sodium, and
protein;
(ii) Any of the following that are present in more than
insignificant amounts: Calories from fat, saturated fat, cholesterol,
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in
more than insignificant amounts may be voluntarily declared as part of
the simplified format.
(4) Any required nutrient, other than a core nutrient, that is
present in an insignificant amount may be omitted from the tabular
listing, provided that the following statement is included at the
bottom of the nutrition label, ``Not a significant source of
________.'' The [[Page 207]] blank shall be filled in with the
appropriate nutrient or food component. Alternatively, amounts of
vitamins and minerals present in insignificant amounts may be declared
by the use of an asterisk (or symbol) that is placed at the bottom of
the table of nutrient values and that is followed by the statement
``Contains less than 2 percent of the Daily Value of this (these)
nutrient (nutrients).''
(5) Except as provided for in paragraph (g) of this section and in
Sec. 381.500(c) and (d), nutrient information declared in the
simplified format shall be presented in the same manner as specified in
paragraphs (d) or (e) of this section, except that the footnote
required in paragraph (d)(9) of this section is not required. When the
footnote is omitted, an asterisk shall be placed at the bottom of the
label followed by the statement ``Percent Daily Values are based on a
2,000 calorie diet'' and, if the term ``Daily Value'' is not spelled
out in the heading, a statement that ``DV'' represents ``Daily Value.''
(g) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements
of paragraphs (c) through (f) of this section and Sec. 381.402(a) by
one or more of the following means:
(1)(i) Presenting the required nutrition information in a tabular
or linear (i.e., string) fashion, rather than in vertical columns if
the product has a total surface area available to bear labeling of less
than 12 square inches, or if the product has a total surface area
available to bear labeling of 40 or less square inches and the package
shape or size cannot accommodate a standard vertical column or tabular
display on any label panel. Nutrition information may be given in a
linear fashion only if the package shape or size will not accommodate a
tabular display.
(ii) When nutrition information is given in a linear display, the
nutrition information shall be set off in a box by the use of a
hairline. The percent Daily Value is separated from the quantitative
amount declaration by the use of parenthesis, and all nutrients, both
principal components and subcomponents, are treated similarly. Bolding
is required only on the title ``Nutrition Facts'' and is allowed for
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,''
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
(2) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(3) Omitting the footnote required in paragraph (d)(9) of this
section and placing another asterisk at the bottom of the label
followed by the statement ``Percent Daily Values are based on a 2,000
calorie diet'' and, if the term ``Daily Value'' is not spelled out in
the heading, a statement that ``DV'' represents ``Daily Value.''
* * * * *
21. Section 381.412 is amended by redesignating paragraph (d) as
(g), revising paragraph (a), and adding new paragraphs (d), (e), and
(f) to read as follows: Sec. 381.412 Reference amounts customarily
consumed per eating occasion.
(a) The general principles followed in arriving at the reference
amounts customarily consumed per eating occasion (Reference Amount(s)),
as set forth in paragraph (b) of this section, are:
(1) The Reference Amounts are calculated for persons 4 years of
age or older to reflect the amount of food customarily consumed per
eating occasion by persons in this population group. These Reference
Amounts are based on data set forth in appropriate national food
consumption surveys.
(2) The Reference Amounts are calculated for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants up to 12 months of age or by children 1
through 3 years of age, respectively. These Reference Amounts are based
on data set forth in appropriate national food consumption surveys.
Such Reference Amounts are to be used only when the product is
specially formulated or processed for use by an infant or by a child
under 4 years of age.
(3) An appropriate national food consumption survey includes a
large sample size representative of the demographic and socioeconomic
characteristics of the relevant population group and must be based on
consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per
eating occasion, the mean, median, and mode of the consumed amount per
eating occasion were considered.
(5) When survey data were insufficient, FSIS took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
Reference Amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The Reference Amount is based on the major intended use of the
product (e.g., a mixed dish measurable with a cup as a main dish and
not as a side dish).
(8) The Reference Amounts for products that are consumed as an
ingredient of other products, but that may also be consumed in the form
in which they are purchased (e.g., ground poultry), are based on use in
the form purchased.
(9) FSIS sought to ensure that foods that have similar dietary
usage, product characteristics, and customarily consumed amounts have a
uniform Reference Amount.
* * * * *
(d) If a product requires further preparation, e.g., cooking or
the addition of water or other ingredients, and if paragraph (b) of
this section provides a Reference Amount for the product in the
prepared form, then the Reference Amount for the unprepared product
shall be determined using the following rules:
(1) Except as provided for in paragraph (d)(2) of this section, the
Reference Amount for the unprepared product shall be the amount of the
unprepared product required to make the Reference Amount for the
prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used
to prepare one large discrete unit usually divided for consumption, the
Reference Amount for the unprepared product shall be the amount of the
unprepared product required to make the fraction of the large discrete
unit closest to the Reference Amount for the prepared product as
established in paragraph (b) of this section. [[Page 208]]
(e) The Reference Amount for an imitation or substitute product or
altered product as defined in Sec. 381.413(d), such as a ``low
calorie'' version, shall be the same as for the product for which it is
offered as a substitute.
(f) The Reference Amounts set forth in paragraphs (b) through (e)
of this section shall be used in determining whether a product meets
the criteria for nutritional claims. If the serving size declared on
the product label differs from the Reference Amount, and the product
meets the criteria for the claim only on the basis of the Reference
Amount, the claim shall be followed by a statement that sets forth the
basis on which the claim is made. That statement shall include the
Reference Amount as it appears in paragraph (b) of this section
followed, in parenthesis, by the amount in common household measure if
the Reference Amount is expressed in measures other than common
household measures.
* * * * *
22. Section 381.413 is amended by revising paragraphs (b), (g),
(i), (j), (k), (p), and (q)(4) and adding new paragraphs (c), (d), (e),
and (f) to read as follows:
Sec. 381.413 Nutrient content claims; general principles.
* * * * *
(b) A claim which, expressly or by implication, characterizes the
level of a nutrient (nutrient content claim) of the type required in
nutrition labeling pursuant to Sec. 381.409, may not be made on a label
or in labeling of that product unless the claim is made in accordance
with the applicable provisions in this subpart.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the product, e.g., ``low
sodium'' or ``contains 100 calories.''
(2) An implied nutrient content claim is any claim that:
(i) Describes the product or an ingredient therein in a manner that
suggests that a nutrient is absent or present in a certain amount
(e.g., ``high in oat bran''); or
(ii) Suggests that the product, because of its nutrient content,
may be useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient (e.g.,
``healthy, contains 3 grams (g) of fat'').
(3) Except for claims regarding vitamins and minerals described in
paragraph (q)(3) of this section, no nutrient content claims may be
made on products intended specifically for use by infants and children
less than 2 years of age unless the claim is specifically provided for
in subpart Y of this part.
(4) Reasonable variations in the spelling of the terms defined in
applicable provisions in this subpart and their synonyms are permitted
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
(c) Information that is required or permitted by Sec. 381.409 to be
declared in nutrition labeling, and that appears as part of the
nutrition label, is not a nutrient content claim and is not subject to
the requirements of this section. If such information is declared
elsewhere on the label or in labeling, it is a nutrient content claim
and is subject to the requirements for nutrient content claims.
(d) A ``substitute'' product is one that may be used
interchangeably with another product that it resembles, i.e., that it
is organoleptically, physically, and functionally (including shelf
life) similar to, and that it is not nutritionally inferior to unless
it is labeled as an ``imitation.''
(1) If there is a difference in performance characteristics that
materially limits the use of the product, the product may still be
considered a substitute if the label includes a disclaimer adjacent to
the most prominent claim as defined in paragraph (j)(2)(iii) of this
section, informing the consumer of such difference (e.g., ``not
recommended for frying'').
(2) This disclaimer shall be in easily legible print or type and in
a size no less than that required by Sec. 381.121(c) for the net
quantity of contents statement, except where the size of the claim is
less than two times the required size of the net quantity of contents
statement, in which case the disclaimer statement shall be no less than
one-half the size of the claim but no smaller than \1/16\-inch minimum
height, except as permitted by Sec. 381.500(d)(2).
(e)(1) Because the use of a ``free'' or ``low'' claim before the
name of a product implies that the product differs from other products
of the same type by virtue of its having a lower amount of the
nutrient, only products that have been specially processed, altered,
formulated, or reformulated so as to lower the amount of the nutrient
in the product, remove the nutrient from the product, or not include
the nutrient in the product, may bear such a claim (e.g., ``low sodium
chicken noodle soup'').
(2) Any claim for the absence of a nutrient in a product, or that a
product is low in a nutrient when the product has not been specially
processed, altered, formulated, or reformulated to qualify for that
claim shall indicate that the product inherently meets the criteria and
shall clearly refer to all products of that type and not merely to the
particular brand to which the labeling attaches (e.g., ``chicken breast
meat, a low sodium food'').
(f) A nutrient content claim shall be in type size and style no
larger than two times that of the statement of identity and shall not
be unduly prominent in type style compared to the statement of
identity.
(g) Labeling information required in Secs. 381.413, 381.454,
381.456, 381.460, 381.461, 381.462, and 381.480, whose type size is not
otherwise specified, is required to be in letters and/or numbers no
less than \1/16\ inch in height, except as permitted by
Sec. 381.500(d)(2).
(h) [Reserved]
(i) Except as provided in Sec. 381.409 or in paragraph (q)(3) of
this section, the label or labeling of a product may contain a
statement about the amount or percentage of a nutrient if:
(1) The use of the statement on the product implicitly
characterizes the level of the nutrient in the product and is
consistent with a definition for a claim, as provided in subpart Y of
this part, for the nutrient that the label addresses. Such a claim
might be, ``less than 10 g of fat per serving;''
(2) The use of the statement on the product implicitly
characterizes the level of the nutrient in the product and is not
consistent with such a definition, but the label carries a disclaimer
adjacent to the statement that the product is not ``low'' in or a
``good source'' of the nutrient, such as ``only 200 milligrams (mg)
sodium per serving, not a low sodium product.'' The disclaimer must be
in easily legible print or type and in a size no less than required by
Sec. 381.121(c) for the net quantity of contents, except where the size
of the claim is less than two times the required size of the net
quantity of contents statement, in which case the disclaimer statement
shall be no less than one-half the size of the claim but no smaller
than \1/16\-inch minimum height, except as permitted by
Sec. 381.500(d)(2);
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the product and it is not false or misleading
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which
case no disclaimer is required.
(4) ``Percent fat free'' claims are not authorized by this
paragraph. Such claims shall comply with Sec. 381.462(b)(6).
(j) A product may bear a statement that compares the level of a
nutrient in the product with the level of a nutrient [[Page 209]] in a
reference product. These statements shall be known as ``relative
claims'' and include ``light,'' ``reduced,'' ``less'' (or ``fewer''),
and ``more'' claims.
(1) To bear a relative claim about the level of a nutrient, the
amount of that nutrient in the product must be compared to an amount of
nutrient in an appropriate reference product as specified in this
paragraph (j).
(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the
reference product may be a dissimilar product within a product category
that can generally be substituted for one another in the diet or a
similar product.
(B) For ``light,'' ``reduced,'' and ``added'' claims, the reference
product shall be a similar product, and
(ii)(A) For ``light'' claims, the reference product shall be
representative of the type of product that includes the product that
bears the claim. The nutrient value for the reference product shall be
representative of a broad base of products of that type; e.g., a value
in a representative, valid data base; an average value determined from
the top three national (or regional) brands, a market basket norm; or,
where its nutrient value is representative of the product type, a
market leader. Firms using such a reference nutrient value as a basis
for a claim, are required to provide specific information upon which
the nutrient value was derived, on request, to consumers and
appropriate regulatory officials.
(B) For relative claims other than ``light,'' including ``less''
and ``more'' claims, the reference product may be the same as that
provided for ``light'' in paragraph (j)(1)(ii)(A) of this section or it
may be the manufacturer's regular product, or that of another
manufacturer, that has been offered for sale to the public on a regular
basis for a substantial period of time in the same geographic area by
the same business entity or by one entitled to use its trade name,
provided the name of the competitor is not used on the labeling of the
product. The nutrient values used to determine the claim when comparing
a single manufacturer's product to the labeled product shall be either
the values declared in nutrition labeling or the actual nutrient
values, provided that the resulting labeling is internally consistent
(i.e., that the values stated in the nutrition information, the
nutrient values in the accompanying information, and the declaration of
the percentage of nutrient by which the product has been modified are
consistent and will not cause consumer confusion when compared), and
that the actual modification is at least equal to the percentage
specified in the definition of the claim.
(2) For products bearing relative claims:
(i) The label or labeling must state the identity of the reference
product and the percent (or fraction) of the amount of the nutrient in
the reference product by which the nutrient has been modified, (e.g.,
``50 percent less fat than `reference product''' or ``\1/3\ fewer
calories than `reference product'''); and
(ii) This information shall be immediately adjacent to the most
prominent claim in easily legible boldface print or type, in distinct
contrast to other printed or graphic matter, that is no less than that
required by Sec. 381.121(c) for net quantity of contents, except where
the size of the claim is less than two times the required size of the
net quantity of contents statement, in which case the referral
statement shall be no less than one-half the size of the claim, but no
smaller than \1/16\-inch minimum height, except as permitted by
Sec. 381.500(d)(2).
(iii) The determination of which use of the claim is in the most
prominent location on the label or labeling will be made based on the
following factors, considered in order:
(A) A claim on the principal display panel adjacent to the
statement of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount
of the subject nutrient in the product per labeled serving size with
that in the reference product; and
(B) This statement shall appear adjacent to the most prominent
claim or to the nutrition information.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a product if the nutrient content
of the reference product meets the requirement for a ``low'' claim for
that nutrient.
(k) The term ``modified'' may be used in the statement of identity
of a product that bears a relative claim that complies with the
requirements of this part, followed immediately by the name of the
nutrient whose content has been altered (e.g., ``modified fat
`product'''). This statement of identity must be immediately followed
by the comparative statement such as ``contains 35 percent less fat
than `reference product'.'' The label or labeling must also bear the
information required by paragraph (j)(2) of this section in the manner
prescribed.
* * * * *
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 381.412(b) through (e) shall be used in
determining whether a product meets the criteria for a nutrient content
claim. If the serving size declared on the product label differs from
the reference amount customarily consumed, and the amount of the
nutrient contained in the labeled serving does not meet the maximum or
minimum amount criterion in the definition for the descriptor for that
nutrient, the claim shall be followed by the criteria for the claim as
required by Sec. 381.412(f) (e.g., ``very low sodium, 35 mg or less per
55 grams'').
(2) The criteria for the claim shall be immediately adjacent to the
most prominent claim in easily legible print or type and in a size that
is no less than that required by Sec. 381.121(c) for net quantity of
contents, except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the criteria statement shall be no less than one-half the size of the
claim but no smaller than 1/16-inch minimum height, except as permitted
by Sec. 381.500(d)(2).
(q) * * *
(4) The requirements of this section do not apply to infant
formulas and medical foods, as described in 21 CFR 101.13(q)(4).
* * * * *
22. Section 381.445 is amended by revising the section reference in
paragraph (c) from ``Sec. 381.409(g)'' to ``Sec. 381.409(f)'' and by
revising paragraph (a)(2) introductory text, (a)(2)(ii) and (a)(2)(iii)
to read as follows: Sec. 381.445 Guidelines for voluntary nutrition
labeling of single-ingredient, raw products.
(a) * * *
(2) A retailer may choose to provide nutrition information at the
point-of-purchase, such as by posting a sign, or by making the
information readily available in brochures, notebooks, or leaflet form
in close proximity to the food. The nutrition labeling information may
also be supplemented by a video, live demonstration, or other media. If
a nutrition claim is made on point-of-purchase materials all of the
requirements of the mandatory nutrition labeling program apply.
However, if only nutrition information--and not a nutrition claim--is
supplied on point-of-purchase materials:
(i) * * * [[Page 210]]
(ii) The listing of percent of Daily Value for the nutrients
(except vitamins and minerals specified in Sec. 381.409(c)(8)) and
footnote required by Sec. 381.409(d)(9) may be omitted; and
(iii) The point-of-purchase materials are not subject to any of the
format requirements.
* * * * *
23. Section 381.454 is revised to read as follows:
Sec. 381.454 Nutrient content claims for ``good source,'' ``high,''
and ``more.''
(a) General requirements. Except as provided in paragraph (e) of
this section, a claim about the level of a nutrient in a product in
relation to the Reference Daily Intake (RDI) or Daily Reference Value
(DRV), established for that nutrient (excluding total carbohydrate) in
Sec. 381.409(c), may only be made on the label or in labeling of the
product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 381.409.
(b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or
``excellent source of'' may be used on the label or in labeling of
products, except meal-type products as defined in Sec. 381.413(l),
provided that the product contains 20 percent or more of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains a food that meets the definition of
``high'' in paragraph (b)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., ``the serving of broccoli in this meal is
high in vitamin C'').
(c) ``Good Source'' claims. (1) The terms ``good source,''
``contains,'' or ``provides'' may be used on the label or in labeling
of products, except meal-type products as described in Sec. 381.413(l),
provided that the product contains 10 to 19 percent of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains a food that meets the definition of ``good
source'' in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., ``the serving of sweet potatoes in this
meal is a good source of fiber'').
(d) Fiber claims. (1) If a nutrient content claim is made with
respect to the level of dietary fiber, i.e., that the product is high
in fiber, a good source of fiber, or that the product contains ``more''
fiber, and the product is not ``low'' in total fat as defined in
Sec. 381.462(b)(2) or, in the case of a meal-type product, is not
``low'' in total fat as defined in Sec. 381.462(b)(3), then the
labeling shall disclose the level of total fat per labeled serving size
(e.g., ``contains 12 grams (g) of fat per serving''); and
(2) The disclosure shall appear in immediate proximity to such
claim and be in a type size no less than one-half the size of the
claim.
(e) ``More'' claims. (1) A relative claim using the terms ``more''
and ``added'' may be used on the label or in labeling to describe the
level of protein, vitamins, minerals, dietary fiber, or potassium in a
product, except meal-type products as defined in Sec. 381.413(l),
provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per reference amount
customarily consumed than an appropriate reference product as described
in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber than `reference
product'''); and
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``fiber content of `reference product'
is 1 g per serving; `this product' contains 4 g per serving'').
(2) A relative claim using the terms ``more'' and ``added'' may be
used on the label or in labeling to describe the level of protein,
vitamins, minerals, dietary fiber, or potassium in meal-type products
as defined in Sec. 381.413(l), provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per 100 g of product than
an appropriate reference product as described in Sec. 381.413(j)(1);
and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber per 3 ounces
(oz) than does `reference product'''), and
(B) Quantitative information comparing the level of the nutrient in
the meal-type product per specified weight with that of the reference
product that it replaces is declared adjacent to the most prominent
claim or to the nutrition information (e.g., ``fiber content of
`reference product' is 2 g per 3 oz; `this product' contains 5 g per 3
oz'').
24. Section 381.456 is revised to read as follows:
Sec. 381.456 Nutrient content claims for ``light'' or ``lite.''
(a) General requirements. A claim using the terms ``light'' or
``lite'' to describe a product may only be made on the label or in
labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 381.409.
(b) ``Light'' claims. The terms ``light'' or ``lite'' may be used
on the label or in labeling of products, except meal-type products as
defined in Sec. 381.413(l), without further qualification, provided
that:
(1) If the product derives 50 percent or more of its calories from
fat, its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to an appropriate reference
product as described in Sec. 381.413(j)(1); or
(2) If the product derives less than 50 percent of its calories
from fat:
(i) The number of calories is reduced by at least one-third (33\1/
3\ percent) per reference amount customarily consumed compared to an
appropriate reference product as described in Sec. 381.413(j)(1); or
[[Page 211]]
(ii) Its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to the appropriate reference
product as described in Sec. 381.413(j)(1); and
(3) As required in Sec. 381.413(j)(2) for relative claims:
(i) The identity of the reference product and the percent (or
fraction) that the calories and the fat were reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``\1/3\
fewer calories and 50 percent less fat than the market leader''); and
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference product that it replaces is declared adjacent to the most
prominent claim or to the nutrition information (e.g., ``lite `this
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
(iii) If the labeled product contains less than 40 calories or less
than 3 g fat per reference amount customarily consumed, the percentage
reduction for that nutrient need not be declared.
(4) A ``light'' claim may not be made on a product for which the
reference product meets the definition of ``low fat'' and ``low
calorie.''
(c)(1)(i) A product for which the reference product contains 40
calories or less and 3 g fat or less per reference amount customarily
consumed may use the terms ``light'' or ``lite'' without further
qualification if it is reduced by 50 percent or more in sodium content
compared to the reference product; and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``50 percent less
sodium than the market leader''); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., ``lite `this product'--500 milligrams (mg) sodium
per serving; regular `reference product'--1,000 mg sodium per
serving'').
(2)(i) A product for which the reference product contains more than
40 calories or more than 3 g fat per reference amount customarily
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if
it is reduced by 50 percent or more in sodium content compared to the
reference product, provided that ``light'' or ``lite'' is presented in
immediate proximity with ``in sodium'' and the entire term is presented
in uniform type size, style, color, and prominence; and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``50 percent less
sodium than the market leader''); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., or ``lite `this product'--170 mg sodium per serving;
regular `reference product'--350 mg per serving'').
(3) Except for meal-type products as defined in Sec. 381.413(l), a
``light in sodium'' claim may not be made on a product for which the
reference product meets the definition of ``low in sodium.''
(d)(1) The terms ``light'' or ``lite'' may be used on the label or
in labeling of a meal-type product as defined in Sec. 381.413(l),
provided that:
(i) The product meets the definition of:
(A) ``Low in calories'' as defined in Sec. 381.460(b)(3); or
(B) ``Low in fat'' as defined in Sec. 381.462(b)(3); and
(ii)(A) A statement appears on the principal display panel that
explains whether ``light'' is used to mean ``low fat,'' ``low
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
(B) The accompanying statement is no less than one-half the type
size of the ``light'' or ``lite'' claim.
(2)(i) The terms ``light in sodium'' or ``lite in sodium'' may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that the product meets the definition of
``low in sodium'' as defined in Sec. 381.461(b)(5)(i); and
(ii) ``Light'' or ``lite'' and ``in sodium'' are presented in
uniform type size, style, color, and prominence.
(3) The terms ``light'' or ``lite'' may be used in the brand name
of a product to describe the sodium content, provided that:
(i) The product is reduced by 50 percent or more in sodium content
compared to the reference product;
(ii) A statement specifically stating that the product is ``light
in sodium'' or ``lite in sodium'' appears:
(A) Contiguous to the brand name; and
(B) In uniform type size, style, color, and prominence as the
product name; and
(iii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim; and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information.
(e) Except as provided in paragraphs (b) through (d) of this
section, the terms ``light'' or ``lite'' may not be used to refer to a
product that is not reduced in fat by 50 percent, or, if applicable, in
calories by \1/3\ or, when properly qualified, in sodium by 50 percent
unless:
(1) It describes some physical or organoleptic attribute of the
product such as texture or color and the information (e.g., ``light in
color'' or ``light in texture'') so stated, clearly conveys the nature
of the product; and
(2) The attribute (e.g., ``color'' or ``texture'') is in the same
style, color, and at least one-half the type size as the word ``light''
and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word ``light'' has
been associated, through common use, with a particular product to
reflect a physical or organoleptic attribute to the point where it has
become part of the statement of identity, such use of the term
``light'' shall not be considered a nutrient content claim subject to
the requirements in this part.
(g) The term ``lightly salted'' may be used on a product to which
has been added 50 percent less sodium than is normally added to the
reference product as described in Sec. 381.413(j)(1)(i)(B) and
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as
defined in Sec. 381.461(b)(4), the statement ``not a low sodium food,''
shall appear adjacent to the nutrition information and the information
required to accompany a relative claim shall appear on the label or
labeling as specified in Sec. 381.413(j)(2).
25. Section 381.460 is revised to read as follows:
Sec. 381.460 Nutrient content claims for calorie content.
(a) General requirements. A claim about the calorie or sugar
content of a product may only be made on the label or in labeling of
the product if:
[[Page 212]]
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 381.409.
(b) Calorie content claims. (1) The terms ``calorie free,'' ``free
of calories,'' ``no calories,'' ``zero calories,'' ``without
calories,'' ``trivial source of calories,'' ``negligible source of
calories,'' or ``dietarily insignificant source of calories'' may be
used on the label or in labeling of products, provided that:
(i) The product contains less than 5 calories per reference amount
customarily consumed and per labeled serving size; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms ``low calorie,'' ``few calories,'' ``contains a small
amount of calories,'' ``low source of calories,'' or ``low in
calories'' may be used on the label or in labeling of products, except
meal-type products as defined in Sec. 381.413(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does
not provide more than 40 calories per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and does not provide more than 40 calories
per reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 120 calories or less per 100 g of product;
and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the calorie content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches.
(4) The terms ``reduced calorie,'' ``reduced in calories,''
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower
in calories'' may be used on the label or in labeling of products,
except meal-type products as defined in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent fewer calories per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
lower calorie `product'--``33 \1/3\ percent fewer calories than our
regular `product'''); and
(B) Quantitative information comparing the level of calories in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``calorie content has been reduced
from 150 to 100 calories per serving'').
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of products if the reference
product meets the definition for ``low calorie.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent fewer calories per 100
g of product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``calorie reduced `product', 25% less calories per ounce (oz) (or 3 oz)
than our regular `product'''); and
(B) Quantitative information comparing the level of calories in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., ``calorie content has been reduced from
110 calories per 3 oz to 80 calories per 3 oz'').
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of products if the reference
product meets the definition for ``low calorie.''
(c) Sugar content claims. (1) Terms such as ``sugar free,'' ``free
of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,''
``sugarless,'' ``trivial source of sugar,'' ``negligible source of
sugar,'' or ``dietarily insignificant source of sugar'' may reasonably
be expected to be regarded by consumers as terms that represent that
the product contains no sugars or sweeteners, e.g., ``sugar free,'' or
``no sugar,'' as indicating a product which is low in calories or
significantly reduced in calories. Consequently, except as provided in
paragraph (c)(2) of this section, a product may not be labeled with
such terms unless:
(i) The product contains less than 0.5 g of sugars, as defined in
Sec. 381.409(c)(6)(ii), per reference amount customarily consumed and
per labeled serving size or, in the case of a meal-type product, less
than 0.5 g of sugars per labeled serving size;
(ii) The product contains no ingredient that is a sugar or that is
generally understood by consumers to contain sugars unless the listing
of the ingredient in the ingredients statement is followed by an
asterisk that refers to the statement below the list of ingredients,
which states: ``Adds a trivial amount of sugar,'' ``adds a negligible
amount of sugar,'' or ``adds a dietarily insignificant amount of
sugar;'' and
(iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or
bears a relative claim of special dietary usefulness labeled in
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this
section; or
(B) Such term is immediately accompanied, each time it is used, by
either the statement ``not a reduced calorie product,'' ``not a low
calorie product,'' or ``not for weight control.''
(2) The terms ``no added sugar,'' ``without added sugar,'' or ``no
sugar added'' may be used only if:
(i) No amount of sugars, as defined in Sec. 381.409(c)(6)(ii), or
any other ingredient that contains sugars that functionally substitute
for added sugars is added during processing or packaging; [[Page 213]]
(ii) The product does not contain an ingredient containing added
sugars such as jam, jelly, or concentrated fruit juice;
(iii) The sugars content has not been increased above the amount
present in the ingredients by some means such as the use of enzymes,
except where the intended functional effect of the process is not to
increase the sugars content of a product, and a functionally
insignificant increase in sugars results;
(iv) The product that it resembles and for which it substitutes
normally contains added sugars; and
(v) The product bears a statement that the product is not ``low
calorie'' or ``calorie reduced'' (unless the product meets the
requirements for a ``low'' or ``reduced calorie'' product) and that
directs consumers' attention to the nutrition panel for further
information on sugar and calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual
statement that a product, including products intended specifically for
infants and children less than 2 years of age, is unsweetened or
contains no added sweeteners in the case of a product that contains
apparent substantial inherent sugar content, e.g., juices.
(4) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar
reduced,'' ``less sugar,'' ``lower sugar,'' or ``lower in sugar'' may
be used on the label or in labeling of products, except meal-type
products as defined in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sugars per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., ``this
product contains 25 percent less sugar than our regular product''); and
(B) Quantitative information comparing the level of the sugar in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sugar content has been lowered from
8 g to 6 g per serving'').
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sugars per 100 g
of product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sugar `product'--25% less sugar than our regular
`product'''); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sugar content has been reduced from
17 g per 3 oz to 13 g per 3 oz'').
26. Section 381.461 is revised to read as follows:
Sec. 381.461 Nutrient content claims for the sodium content.
(a) General requirements. A claim about the level of sodium in a
product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 381.409.
(b) Sodium content claims. (1) The terms ``sodium free,'' ``free of
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial
source of sodium,'' ``negligible source of sodium,'' or ``dietarily
insignificant source of sodium'' may be used on the label or in
labeling of products, provided that:
(i) The product contains less than 5 milligrams (mg) of sodium per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product, less than 5 mg of sodium per
labeled serving size;
(ii) The product contains no ingredient that is sodium chloride or
is generally understood by consumers to contain sodium unless the
listing of the ingredient in the ingredients statement is followed by
an asterisk that refers to the statement below the list of ingredients,
which states: ``Adds a trivial amount of sodium,'' ``adds a negligible
amount of sodium'' or ``adds a dietarily insignificant amount of
sodium;'' and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms ``very low sodium'' or ``very low in sodium'' may be
used on the label or in labeling of products, except meal-type products
as defined in Sec. 381.413(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and
contains 35 mg or less sodium per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 35 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form);
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 140 mg or less sodium per 100 g of
product; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium''
may be used on the label or in labeling of products, except meal-type
products as defined in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sodium per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(l); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) [[Page 214]] that the sodium differs between the two products
are declared in immediate proximity to the most prominent such claim
(e.g., ``reduced sodium `product', 50 percent less sodium than regular
`product'''); and
(B) Quantitative information comparing the level of sodium in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sodium content has been lowered from
300 to 150 mg per serving'').
(iii) Claims described in paragraph (b)(6) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
sodium.''
(7) The terms defined in paragraph (b)(6) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less sodium per 100 g
of product than an appropriate reference product as described in
Sec. 381.413(j)(l); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sodium `product'--30% less sodium per 3 oz than our `regular
product'''); and
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., ``sodium content has been reduced from 220
mg per 3 oz to 150 mg per 3 oz'').
(iii) Claims described in paragraph (b)(7) of this section may not
be made on the label or in labeling of products if the nutrient content
of the reference product meets the definition for ``low sodium.''
(c) The term ``salt'' is not synonymous with ``sodium.'' Salt
refers to sodium chloride. However, references to salt content such as
``unsalted,'' ``no salt,'' ``no salt added'' are potentially
misleading.
(1) The term ``salt free'' may be used on the label or in labeling
of products only if the product is ``sodium free'' as defined in
paragraph (b)(1) of this section.
(2) The terms ``unsalted,'' ``without added salt,'' and ``no salt
added'' may be used on the label or in labeling of products only if:
(i) No salt is added during processing;
(ii) The product that it resembles and for which it substitutes is
normally processed with salt; and
(iii) If the product is not sodium free, the statement ``not a
sodium free product'' or ``not for control of sodium in the diet''
appears adjacent to the nutrition information of the product bearing
the claim.
(3) Paragraph (c)(2) of this section shall not apply to a factual
statement that a product intended specifically for infants and children
less than 2 years of age is unsalted, provided such statement refers to
the taste of the product and is not false or otherwise misleading.
27. Section 381.462 is revised to read as follows:
Sec. 381.462 Nutrient content claims for fat, fatty acids, and
cholesterol content. '
(a) General requirements. A claim about the level of fat, fatty
acid, and cholesterol in a product may only be made on the label or in
labeling of products if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 381.413; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 381.409.
(b) Fat content claims. (1) The terms ``fat free,'' ``free of
fat,'' ``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial
source of fat,'' ``negligible source of fat,'' or ``dietarily
insignificant source of fat'' may be used on the label or in labeling
of products, provided that:
(i) The product contains less than 0.5 gram (g) of fat per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product, less than 0.5 g of fat per labeled
serving size;
(ii) The product contains no added ingredient that is a fat or is
generally understood by consumers to contain fat unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of fat,'' ``adds a negligible amount of
fat,'' or ``adds a dietarily insignificant amount of fat''; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label
attaches.
(2) The terms ``low fat,'' ``low in fat,'' ``contains a small
amount of fat,'' ``low source of fat,'' or ``little fat'' may be used
on the label and in labeling of products, except meal-type products as
defined in Sec. 381.413(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g
or less of fat per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 3 g or less of fat per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 3 g or less of total fat per 100 g of
product and not more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,''
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the
label or in labeling of products, except meal-type products as defined
in Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less fat per reference
amount customarily consumed than an appropriate reference product as
described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two [[Page 215]] products
are declared in immediate proximity to the most prominent such claim
(e.g., ``reduced fat--50 percent less fat than our regular
`product'''); and
(B) Quantitative information comparing the level of fat in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``fat content has been reduced from 8
g to 4 g per serving'').
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low fat.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less fat per 100 g of
product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., ``reduced
fat `product', 33 percent less fat per 3 oz than our regular
`product'''); and
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent such claim or to
the nutrition information (e.g., ``fat content has been reduced from 8
g per 3 oz to 5 g per 3 oz'').
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low fat.''
(6) The term ``____________ percent fat free'' may be used on the
label or in labeling of products, provided that:
(i) The product meets the criteria for ``low fat'' in paragraph
(b)(2) or (b)(3) of this section;
(ii) The percent declared and the words ``fat free'' are in uniform
type size; and
(iii) A ``100 percent fat free'' claim may be made only on products
that meet the criteria for ``fat free'' in paragraph (b)(1) of this
section, that contain less than 0.5 g of fat per 100 g, and that
contain no added fat.
(iv) A synonym for ``______ percent fat free'' is ``______ percent
lean.''
(c) Fatty acid content claims. (1) The terms ``saturated fat
free,'' ``free of saturated fat,'' ``no saturated fat,'' ``zero
saturated fat,'' ``without saturated fat,'' ``trivial source of
saturated fat,'' ``negligible source of saturated fat,'' or ``dietarily
insignificant source of saturated fat'' may be used on the label or in
labeling of products, provided that:
(i) The product contains less than 0.5 g of saturated fat and less
than 0.5 g trans fatty acids per reference amount customarily consumed
and per labeled serving size or, in the case of a meal-type product,
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids
per labeled serving size;
(ii) The product contains no ingredient that is generally
understood by consumers to contain saturated fat unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of saturated fat,'' ``adds a negligible
amount of saturated fat,'' or ``adds a dietarily insignificant amount
of saturated fat;'' and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products
of its type and not merely to the particular brand to which the label
attaches.
(2) The terms ``low in saturated fat,'' ``low saturated fat,''
``contains a small amount of saturated fat,'' ``low source of saturated
fat,'' or ``a little saturated fat'' may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 381.413(l), provided that:
(i) The product contains 1 g or less of saturated fat per reference
amount customarily consumed and not more than 15 percent of calories
from saturated fat; and
(ii) If the product meets these conditions without benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products
of its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (c)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 1 g or less of saturated fat per 100 g and
less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products
of its type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced saturated fat,'' ``reduced in saturated
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower
saturated fat,'' or ``lower in saturated fat'' may be used on the label
or in labeling of products, except meal-type products as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``reduced saturated fat `product', contains 50 percent less saturated
fat than the national average for `product'''); and
(B) Quantitative information comparing the level of saturated fat
in the product per labeled serving size with that of the reference
product that it replaces is declared adjacent to the most prominent
claim or to the nutrition information (e.g., ``saturated fat reduced
from 3 g to 1.5 g per serving'').
(iii) Claims described in paragraph (c)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
saturated fat.''
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
100 g of product than an appropriate reference product as described in
Sec. 381.413(j)(1); and
(ii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``reduced saturated fat `product', 50 percent less saturated fat than
our regular `product'''); and
(B) Quantitative information comparing the level of saturated fat
in the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``saturated fat content
[[Page 216]] has been reduced from 2.5 g per 3 oz to 1.5 g per 3 oz'').
(iii) Claims described in paragraph (c)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
saturated fat.''
(d) Cholesterol content claims. (1) The terms ``cholesterol free,''
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,''
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible
source of cholesterol,'' or ``dietarily insignificant source of
cholesterol'' may be used on the label or in labeling of products,
provided that:
(i) The product contains less than 2 milligrams (mg) of cholesterol
per reference amount customarily consumed and per labeled serving size
or, in the case of a meal-type product as defined in Sec. 381.413(l),
less than 2 mg of cholesterol per labeled serving size;
(ii) The product contains no ingredient that is generally
understood by consumers to contain cholesterol, unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of cholesterol,'' ``adds a negligible
amount of cholesterol,'' or ``adds a dietarily insignificant amount of
cholesterol'';
(iii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed or, in the case of a meal-type
product as defined in Sec. 381.413(l), 2 g or less of saturated fat per
labeled serving size; and
(iv) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches;
or
(v) If the product meets these conditions only as a result of
special processing, alteration, formulation, or reformulation, the
amount of cholesterol is reduced by 25 percent or more from the
reference product it replaces as described in Sec. 381.413(j)(1) and
for which it substitutes as described in Sec. 381.413(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``cholesterol free
`product', contains 100 percent less cholesterol than `reference
product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``contains no cholesterol compared
with 30 mg in one serving of `reference product''').
(2) The terms ``low in cholesterol,'' ``low cholesterol,''
``contains a small amount of cholesterol,'' ``low source of
cholesterol,'' or ``little cholesterol'' may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 381.413(l), provided that:
(i)(A) If the product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed; and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed; or
(B) If the product has a reference amount customarily consumed of
30 g or less or 2 tbsp or less:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in
Sec. 381.409(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form);
and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed.
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches; or
(iii) If the product contains 20 mg or less of cholesterol only as
a result of special processing, alteration, formulation, or
reformulation, the amount of cholesterol is reduced by 25 percent or
more from the reference product it replaces as described in
Sec. 381.413(j)(1) and for which it substitutes as described in
Sec. 381.413(d) that has a significant (e.g., 5 percent or more of a
national or regional market) market share. As required in
Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``low
cholesterol `product', contains 85 percent less cholesterol than our
regular `product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5
mg per serving'').
(3) The terms defined in paragraph (d)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product contains 20 mg or less of cholesterol per 100 g of
product;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,''
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,''
or ``lower in cholesterol'' may be used on the label or in labeling of
products or products that substitute for those products as specified in
Sec. 381.413(d), excluding meal-type products as defined in
Sec. 381.413(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 381.413(j)(1) and
for which it substitutes as described in Sec. 381.413(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed; and
(iii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``25
percent less cholesterol than `reference product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30
mg per serving''). [[Page 217]]
(iv) Claims described in paragraph (d)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
cholesterol.''
(5) The terms defined in paragraph (d)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 381.413(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 381.413(j)(1) and
for which it substitutes as described in Sec. 381.413(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) As required in Sec. 381.413(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``25% less
cholesterol than `reference product'''); and
(B) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol content has been reduced
from 35 mg per 3 oz to 25 mg per 3 oz).
(iv) Claims described in paragraph (d)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
cholesterol.''
(e) ``Lean'' and ``Extra Lean'' claims. (1) The term ``lean'' may
be used on the label or in labeling of a product, provided that the
product contains less than 10 g of fat, 4.5 g or less of saturated fat,
and less than 95 mg of cholesterol per 100 g of product and per
reference amount customarily consumed for individual foods, and per 100
g of product and per labeled serving size for meal-type products as
defined in Sec. 381.413(l).
(2) The term ``extra lean'' may be used on the label or in labeling
of a product, provided that the product contains less than 5 g of fat,
less than 2 g of saturated fat, and less than 95 mg of cholesterol per
100 g of product and per reference amount customarily consumed for
individual foods, and per 100 g of product and per labeled serving size
for meal-type products as defined in Sec. 381.413(l).
28. Section 381.463 is amended by revising the section reference in
paragraphs (b)(2) and (b)(3) from ``Sec. 381.409(g)(1)'' to
``Sec. 381.409(f)(1).''
29. Section 381.469 is amended by removing the word ``rule'' from
the third sentence of paragraph (m)(5).
30. Section 381.480 is amended by revising paragraphs (e) and (f)
to read as follows:
Sec. 381.480 Label statements relating to usefulness in reducing or
maintaining body weight.
* * * * *
(e) ``Label terms suggesting usefulness as low calorie or reduced
calorie foods''. (1) Except as provided in paragraphs (e)(2) and (e)(3)
of this section, a product may be labeled with terms such as ``diet,''
``dietetic,'' ``artificially sweetened,'' or ``sweetened with
nonnutritive sweetener'' only if the claim is not false or misleading,
and the product is labeled ``low calorie'' or ``reduced calorie'' or
bears another comparative calorie claim in compliance with the
applicable provisions in this subpart.
(2) Paragraph (e)(1) of this section shall not apply to any use of
such terms that is specifically authorized by regulation governing a
particular food, or, unless otherwise restricted by regulation, to any
use of the term ``diet'' that clearly shows that the product is offered
solely for a dietary use other than regulating body weight, e.g., ``for
low sodium diets.''
(3) Paragraph (e)(1) of this section shall not apply to any use of
such terms on a formulated meal replacement or other product that is
represented to be of special dietary use as a whole meal, pending the
issuance of a regulation governing the use of such terms on foods.
(f) ``Sugar free'' and ``no added sugar''. Criteria for the use of
the terms ``sugar free'' and ``no added sugar'' are provided for in
Sec. 381.460(c).
31. Section 381.500 is amended by removing the word ``food'' after
the word ``poultry'' in paragraph (a) introductory text; by revising
the words ``Products produced'' in paragraph (a)(1) introductory text
to the words ``Food products produced''; by revising the section
reference in paragraph (c)(2)(iii) from ``Sec. 381.409(e)'' to
``Sec. 381.409(d)(6)''; and by revising the words ``at 21 CFR
101.9(d)(9)'' in paragraph (c)(2)(v) to the words ``in
Sec. 381.409(d)(9)''.
Done at Washington, DC, on December 22, 1994.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 94-32105 Filed 12-30-94; 8:45 am]
BILLING CODE 3410-DM-P
