[Federal Register Volume 61, Number 246 (Friday, December 20, 1996)]
[Proposed Rules]
[Pages 67243-67260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32124]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 61, No. 246 / Friday, December 20, 1996 /
Proposed Rules
[[Page 67243]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 96N-0421 and 94P-0453/CP1]
Food Labeling: Nutrient Content Claims Pertaining to the
Available Fat Content of Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its food labeling regulations to provide for the use of nutrient
content claims on the food label or in labeling based on the reduced
availability of fat to the body from the food because of the use of a
fat substitute ingredient in the food. This proposal responds, in part,
to a citizen petition on the use of digestibility coefficients in
determining the quantity of fat declared on a food label. FDA is
undertaking this action to encourage innovation on the part of food
manufacturers and to foster a situation that will provide increased
product choices for consumers in achieving dietary goals.
DATES: Submit written comments by April 21, 1997. Submit written
comments on the information collection requirements by January 21,
1997. The agency is proposing that any final rule that may issue based
upon this proposed rule become effective 30 days after its date of
publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Submit written comments on the information
collection requirements to the Office of Information and Regulatory
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Washington,
DC 20503, ATTN: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Virginia L. Wilkening, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5763.
SUPPLEMENTARY INFORMATION:
I. Background
A. The 1990 Amendments and Implementing Regulations
The Nutrition Labeling and Education Act of 1990 (the 1990
amendments) and the final regulations that implement the 1990
amendments (58 FR 2066, January 6, 1993, as modified at 58 FR 44020,
August 18, 1993) provided for a number of fundamental changes in how
food is labeled, including requiring that nutrition labeling appear on
most foods and establishing that terms that characterize the level of a
nutrient in a food may not be used in food labeling unless defined by
FDA.
The 1990 amendments added section 403(q) to the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 343(q)), which requires that most
food bear nutrition labeling. In response to this provision, in the
January 6, 1993, final rule on nutrition labeling (entitled ``Food
Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content
Revision, Format for Nutrition Label,'' (the nutrition labeling final
rule (58 FR 2079)), FDA prescribed how nutrition labeling is to be
provided on the foods that are regulated by the agency. Among other
things, the agency required that the nutrition label include
information on total calories and calories from fat and on the
quantitative amounts of specified nutrients (e.g., total fat, saturated
fat, total carbohydrate, and dietary fiber) per serving.
In the nutrition labeling final rule (58 FR 2079 at 2110), FDA
recognized that many food ingredients have caloric values substantially
different from the general factors of 4, 4, and 9 calories per gram (g)
for protein, carbohydrate, and fat, respectively. Therefore, the agency
provided a number of options for calculating the energy value of foods.
For example, FDA stated that calories may be calculated, under
Sec. 101.9(c)(1)(i)(A) (21 CFR 101.9(c)(1)(i)(A)), by using specific
Atwater factors given in Table 13 ``Energy Value of Foods-Basis and
Derivation,'' U.S. Department of Agriculture (USDA) Handbook No. 74;
under Sec. 101.9(c)(1)(i)(C), by multiplying the general factor of 4
calories per g by the amount of total carbohydrate less the amount of
insoluble dietary fiber; under Sec. 101.9(c)(1)(i)(D), by using data
for specific energy factors for particular foods or ingredients
approved by FDA through the food additive or generally recognized as
safe (GRAS) petition processes in parts 170 and 171 (21 CFR parts 170
and 171) and provided in parts 172 or 184 (21 CFR parts 172 or 184); or
under Sec. 101.9(c)(1)(i)(E), by using bomb calorimetry data.
FDA also defined the basic nutrients that are to be declared as
part of the nutrition label (58 FR 2079 at 2086). In particular, FDA
defined ``total fat'' as total lipid fatty acids expressed as
triglycerides (Sec. 101.9(c)(2)) and ``saturated fat'' as the sum of
all fatty acids containing no double bonds (Sec. 101.9(c)(2)(i) (58 FR
2079 at 2089)).
In addition to adding section 403(q) on nutrition labeling to the
act, the 1990 amendments added section 403(r) on nutrient-related
claims and, in particular, section 403(r)(1)(A) of the act, which
states that a food is misbranded if it bears a claim in its label or
labeling that expressly or implicitly characterizes the level of any
nutrient of the type required to be declared in nutrition labeling
unless the claim is made in accordance with section 403(r)(2) of the
act. Section 403(r)(2)(A)(i) of the act states that a claim may be made
only if the characterization of the level made in the claim uses terms
that are defined in regulations of the Secretary of the Department of
Health and Human Services.
In the Federal Register of January 6, 1993 (58 FR 2302), FDA
published a final rule (entitled ``Food Labeling: Nutrient Content
Claims, General Principles, Petitions, Definitions of Terms;
Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and
Cholesterol Content of Food,'' hereinafter referred to as ``the
nutrient content claims final rule'') that implemented the nutrient
content claims provisions of the act by establishing general rules for
how such claims are to be made and defining various terms (e.g.,
``high,'' ``low,'' ``free,'' and ``reduced'') that could be used to
characterize the level of various nutrients in the food.
[[Page 67244]]
FDA noted that its approach to developing a system of nutrient
content claims emphasized three objectives: (1) Consistency among
definitions, (2) claims that are consistent with public health goals,
and (3) claims that will help consumers to maintain healthy dietary
practices (58 FR 2302 at 2319). The agency stated that it is important
for effective consumer education to establish consistent definitions
for descriptive terms whenever possible to limit the possibility of
consumer confusion (58 FR 2302 at 2319).
B. Citizen Petition
Nabisco Group (Nabisco) (hereinafter ``the petitioner'') submitted
a citizen petition (filed December 21, 1994, Docket No. 94P-0453/CP1)
requesting that FDA amend its food labeling regulations to permit the
use of a ``digestibility coefficient'' or ``food factor'' in
determining the quantity of fat to be declared on the nutrition label
and to permit nutrient content claims to be based on the quantity of
fat declared. According to the petitioner, this action would permit
claims on a class of products that contain significantly less available
fat compared to an appropriate reference food but that may not qualify
to bear a calorie claim or a fat claim based on the total analytically-
determined amount of fat in the food. The petitioner asserted that the
nutritional benefit of foods with reduced available fat is similar to
that of foods with reduced total fat, and that providing for claims on
foods that contain significantly less available fat would further FDA's
goal of promoting healthier diets by encouraging product innovation.
The petitioner noted that the costs of development and reformulation
for the use of manufactured fat substitutes, such as salatrim, make
them much more expensive to use than fats from traditional sources. The
petitioner maintained that, unless manufacturers are able to promote
the beneficial aspects of products containing these ingredients, they
would have no incentive to develop or use them. Thus, the petitioner
continued, it is imperative that manufacturers be able to make claims
for foods containing fat substitutes with reduced availability.
Specifically, the petitioner requested that FDA
amendSec. 101.9(c)(2) by inserting the following language at the end of
the first paragraph in that section:
Fat content may be calculated by applying a food factor to the
actual amount of fat present per serving, using specific food
factors for particular foods or ingredients approved by FDA and
provided in parts 172 or 184 of this chapter, or by other means as
appropriate.
The requested change would allow the amount of total fat present per
serving to be multiplied by a specific factor approved by FDA, to yield
the quantity of fat that is to be declared in nutrition labeling, even
though the declared value may be less than the actual amount of fat in
the food. The approach suggested by the petitioner, that the factor
used to calculate available fat content be approved by FDA, is similar
to the approach taken by FDA in Sec. 101.9(c)(1)(i)(D), which provides
that specific food factors may be used to calculate total caloric
content declared in nutrition labeling if they have been approved by
FDA and provided for in part 172, part 184, or by other means as
appropriate. The petitioner also suggested that the agency could permit
self-determination of a food factor for calculating nutrient
availability by a manufacturer, pending agency review of a GRAS
petition for the ingredient to which the factor applies.
The petitioner noted, for example, that it had filed a GRAS
petition for salatrim (GRASP 4G0404) that proposed a food factor of 5/9
for this ingredient.\1\ The petitioner maintained that the amount of
available (i.e., absorbed/digestible) fat in an ingredient should be
reflected in the ``food factor'' or ``digestibility coefficient'' for
that ingredient. The petitioner went on to suggest that manufacturers
be permitted to make fat reduction claims for products that claim the
amount of available fat as opposed to the chemically analyzed quantity
of fat in the food.
---------------------------------------------------------------------------
\1\ Dietary fats consist of one, two, or three fatty acid
molecules attached to a glycerol backbone (i.e., mono-, di-, or
triglycerides). Salatrim is a manufactured fat substitute in which
the manufacturer controls the fatty acid composition of the
triglyceride. Salatrim is the trade name for a family of
triglycerides that contain one or two long chain fatty acids,
primarily stearic acid (C18:0, 50 to 60 percent by weight), and one
or two short chain fatty acids, primarily acetic acid (C2:0) and
propionic acid (C3:0), randomly attached to the glycerol backbone.
The stearic acid component is incompletely absorbed, as addressed in
the current petition. The short chain fatty acids are fully
absorbed, but they have a lower energy value than long chain fatty
acids that comprise dietary fats. Thus, the reduction in energy from
salatrim compared to conventional dietary fats is derived in part
from the incomplete absorption of stearic acid and, in part, from
the low energy value of the short chain fatty acids. In combination,
these two factors have been estimated by the petitioner to result in
a caloric value that is approximately 55 percent (5/9) of the energy
value of conventional fats (i.e., a food factor of 55 percent,
according to the definition of terms in section II.A. of this
document). The digestibility coefficient, which addresses only the
availability of fat, would consider only the incomplete absorption
of stearic acid from this ingredient.
---------------------------------------------------------------------------
Additionally, the petitioner requested that FDA amend
Sec. 101.9(c)(2) to provide that a food factor be used to calculate the
quantity of all fatty acids (i.e., saturated fat, polyunsaturated fat,
and monounsaturated fat) declared on the nutrition label.
II. Agency Response
A. Definition of Terms
To understand the issues raised by the petition, and the agency's
response to those issues, it is important to distinguish among three
terms, ``bioavailability'' or ``availability,'' ``food factor,'' and
``digestibility coefficient.'' These terms are often used
interchangeably but have substantially different meanings. The agency's
approach to how energy and nutrient values are declared in nutrition
labeling is determined by the differences among these terms.
FDA notes that bioavailability is the result of a series of complex
events, i.e., digestion, absorption, and metabolism (Ref. 1). Digestion
refers to the chemical and physical breakdown of food and its
macromolecular components in the gastrointestinal tract (e.g., the
breakdown of triglycerides (fats) into fatty acids and glycerol).
Absorption refers to the intestinal absorption of the component
molecules (e.g., fatty acids). The mechanisms of reduced availability
of a fat substitute may vary for different ingredients. Some products
are less available because they are resistant to chemical (e.g.,
enzymatic) digestion (e.g., olestra). Other products exploit less
efficient absorption of certain compounds, such as long chain and very
long chain fatty acids (e.g., salatrim and caprenin).
FDA will use the term ``available'' to refer to the portion of a
fat substitute that is physiologically available from a food, i.e.,
that portion that is digested, absorbed, and metabolized, or, more
simply, the proportion of the consumed fat substitute that can be
utilized. The prefix ``bio'' in ``bioavailable'' denotes that a
biological attribute is being discussed as opposed to, some other type
of availability, e.g., availability within the marketplace. However,
based on the context in which the agency expects the term to be used
(i.e., fat availability), FDA does not anticipate that the term
``availability'' will be confused with other forms of availability.
Thus, for the purposes of this rulemaking, and consistent with current
scientific literature, the term ``available'' will be used as a synonym
to the term ``bioavailable'' to describe the effects of different
mechanisms in
[[Page 67245]]
reducing the digestion and absorption of fat substitutes.
The term ``food factor'' will be used to refer to those factors
(i.e., Atwater factor, general food factor, and specific food factor)
that are used to calculate energy value (total caloric content) of a
food or ingredient (Sec. 101.9(c)(1)(i)) or to calculate the amount of
calories in a food that it derives from the fat component of the food
(Sec. 101.9(c)(1)(ii)). It is important to note that energy values vary
for different classes of nutrients or ingredients and for ingredients
within a class (e.g., different fats). The general factors of 4, 4, and
9 calories per g for carbohydrates, protein, and fat, respectively, are
general factors (i.e., a rule of thumb) that may be used to approximate
the energy content of foods containing common dietary carbohydrates,
protein, and fats. The use of more specific factors to calculate the
energy value of a food increases the accuracy of the value (Ref. 2).
The term ``digestibility coefficient'' is used extensively in
scientific literature to refer to the multiplicand used to calculate
the amount of a nutrient that is physiologically available (Refs. 3 and
4). In this document, FDA will use the term ``digestibility
coefficient'' to represent the factor used to calculate fat
availability.
Food factors and digestibility coefficients do not necessarily
refer to the same thing. As noted above, when food factors for specific
ingredients are available that are more accurate than the general
factors, their use increases the accuracy of the calculation of the
total energy value for the food. Specific food factors reflect the
different parameters, including but not limited to availability, that
affect the amount of energy that may be derived from a particular food
or ingredient. It may be possible, under certain circumstances (e.g.,
when a 50 percent reduction in availability of a fat substitute results
in a proportionate reduction in the energy value of the ingredient), to
use the same number to calculate both energy value and fat availability
for a food or an ingredient. However, the energy values of different
food components may vary because of parameters unrelated to reduced
availability, such as differences in molecular weight and heat of
combustion.
Reduced availability will reduce the amount of calories that derive
from a particular food component because only part of the component can
be absorbed. However, different nutrients (e.g., fat, carbohydrate, and
protein) and different food components within a class (e.g., fats
composed of different fatty acids) may be essentially 100 percent
available and still have different energy values. Very short chain
fatty acids, for example, are at the lower end of the energy value
range compared to longer chain fatty acids. In fact, a reduced calorie
fat ingredient can be made by combining fat components that have a
lower energy value because of reduced availability with components that
are naturally lower in energy but that are fully available (as is the
case with salatrim). Therefore, when the energy value and the nutrient
availability of a fat substitute are reduced, but not proportionately
(such as when the fat substitute depends on two different mechanisms to
achieve a lower energy value compared to the average value for fat, but
only one of the mechanisms relates to the availability of the
nutrient), the food factor used to calculate available calories would
be expected to differ from the digestibility coefficient used to
calculate the availability of the fat.
Comments are requested on these definitions of terms and the
tentative conclusions resulting from their use.
B. Current Position
In its discussion of total fat in the nutrition labeling final rule
(58 FR 2079 at 2087), FDA responded to a number of comments that
requested that fat be defined to exclude various types of long chain
fatty acids because of their poor availability. These comments asserted
that ``total fat'' should be defined as ``total digestible fat'' to
allow for the use of fat-type ingredients that have reduced
digestibility and, therefore, provide fewer calories per g than the
fats that they replace.
In response to these comments, FDA acknowledged the effect that the
use of fats that contain very long chain (longer than 18 carbons) fatty
acids with reduced digestibility have on the available fat and calorie
content of foods. FDA stated that, in an effort to encourage innovation
in the creation of products that provide lower fat and calorie
contents, it was willing to consider the digestibility of novel fat
compounds (58 FR 2079 at 2087). In fact, as stated above,
Sec. 101.9(c)(1)(i)(D) provides for calculating the caloric content of
foods and ingredients, including fat substitutes, using a specific food
factor approved by FDA. However, FDA concluded that, because of the
diversity of possible products, it was not appropriate to modify the
definition of ``total fat'' in Sec. 101.9(c)(2) (58 FR 2079 at 2087).
That definition, i.e., ``total lipid fatty acids expressed as
triglycerides,'' represents all fatty acids obtainable from a total
lipid extraction (58 FR 2079 at 2087), and, by maintaining this
definition, FDA not only included all sources of fatty acids that
provide energy in the amount of fat to be declared in nutrition
labeling but the nondigestible fatty acids as well.
Rather than modifying the definition, the agency stated that it
would address the digestibility of novel fat compounds on a case-by-
case basis. Because the digestibility of a substance is one of the
identifying characteristics of the substance, the agency requested that
manufacturers who wish to declare adjusted values of total fat based on
reduced digestibility include information on the digestibility of the
compound, analytical assay procedures for the compound, and data on
interference with required methods of analysis, in food additive
petitions (part 171) on such substances or in petitions for affirmation
that the use of such substances is GRAS (Sec. 170.35) (58 FR 2079 at
2087).
The agency anticipated including the specific digestibility
coefficients that could be used in determining the quantitative
declaration of fats and the caloric contribution from fats as part of
the statement of identity for the substances in the listing regulations
for them in part 172 or in the GRAS affirmation regulations in part 184
for those whose use is affirmed as GRAS. However, FDA also recognized
that mechanisms other than food additive or GRAS petitions may be
appropriate to bring issues involving the digestibility of a substance
to the attention of the agency. Thus, it suggested the mechanism in
Sec. 101.9(g)(9) as a possible means of requesting the use of specific
digestibility coefficients (58 FR 2079 at 2087).
The agency also responded to a number of comments that stated that
fatty acids with carbon chains longer than 18 (i.e., C20-C24) should
not be categorized together with those having chain lengths of 12 to 18
carbons as saturated fatty acids because very long chain fatty acids
are poorly absorbed and have little or no physiological effect, e.g.,
they will not contribute to raising serum cholesterol. After reviewing
all the comments, FDA was not persuaded to exclude any fatty acids from
the definition of saturated fat on the basis of their physiologic
effects. Rather, FDA defined saturated fat as ``the sum of all fatty
acids containing no double bonds'' (58 FR 2079 at 2089). FDA did not
address the issue of digestibility or availability of individual fatty
acids in its discussion, but the agency noted that an inclusive
chemical definition avoids controversy about which saturated fatty
acids are associated with increases in blood
[[Page 67246]]
cholesterol, is consistent with general dietary guidelines recommending
reduced saturated fat consumption, avoids under-reporting of saturated
fat, and is more consistent with international definitions (58 FR 2079
at 2089).
Thus, while FDA's final regulations provide for the use of food
factors and other options to calculate more accurately the total energy
value of a food (Sec. 101.9(c)(1)), they do not provide for the use of
a mechanism to calculate available fat or available saturated fat for
nutrition labeling. The regulations require that nutrition labeling and
claims reflect the total amount of fat and saturated fat in a food
(i.e., ``all fatty acids obtainable from a total lipid extraction'' (58
FR 2079 at 2087)). The only exceptions to this general requirement are
provided in: (1) The voluntary nutrition labeling final rule for raw
fruit, vegetables, and fish (61 FR 42742, August 16, 1996) with respect
to total fat in orange roughy and (2) the olestra final rule in
Sec. 172.867(e)(5).
In regard to orange roughy, FDA notes that this fish is one of the
few foods that contains wax esters (i.e., single fatty acids esterified
to long chain alcohols). Because wax esters are extracted along with
lipids during analysis, under Sec. 101.9(c)(2), nutrition labeling for
orange roughy should reflect these wax esters in the total fat
declaration. However, the value for fat in cooked orange roughy in
Agricultural Handbook 8-15 (1990 Supplement), upon which FDA relied in
developing the interim nutrition labeling values for this food, does
not include the wax esters in the value of total fat because, as stated
in the Handbook, the wax esters do not provide a metabolizable source
of energy for humans (Ref. 5). In the Federal Register of July 18, 1994
(59 FR 36379), FDA proposed to revise its guidelines for the voluntary
nutrition labeling of raw fruit, vegetables, and fish, stating its
intention to revise the total fat value for orange roughy to include
the wax esters should it receive acceptable information in comments on
its proposal. While such a revision would have made the orange roughy
declaration of total fat consistent with declarations for other foods,
FDA did not receive any information that would enable it to change the
value of fat for orange roughy to include the wax esters. Accordingly,
the nutrient values for orange roughy in part 101 (21 CFR part 101),
appendix D continue to exclude the wax esters (61 FR 42742).
With regard to olestra, FDA recently published a final rule
establishing conditions of safe use for this substance as a replacement
for fats and oils (hereinafter referred to as the ``olestra final
rule'' (61 FR 3118, January 30, 1996)). FDA specified that olestra, a
sucrose polyester composed of six to eight fatty acids bound to sucrose
by ester bonds, need not be considered as a source of fat or calories
for purposes of nutrition labeling or nutrient content claims
(Sec. 172.867(e)(5)). This holding was based on the fact that nearly
all ingested olestra remains intact and is not absorbed, but is
excreted intact in the feces (61 FR 3118 at 3126). Because the fatty
acids in olestra are not absorbed and, therefore, are unavailable to
the body, FDA decided not to require that the fatty acids be included
in the declaration of total fat.
C. Proposal to Allow Nutrient Content Claims Based on Fat Availability
Having carefully considered the Nabisco petition, FDA tentatively
concludes that there is merit in providing a generic means of allowing
for the digestibility of fat substitutes, rather than in addressing
this issue on a case-by-case basis as stated in the nutrition labeling
final rule (58 FR 2079 at 2087) and as implemented in the olestra final
rule (61 FR 3118).
As noted in the nutrition labeling and nutrient content claims
final rules, dietary guidance given in various reports, such as the
Surgeon General's ``Report on Nutrition and Health'' (Ref. 6), the
National Academy of Sciences' ``Diet and Health: Implications for
Reducing Chronic Disease Risk'' (Ref. 7), the National Cholesterol
Education Program's ``Report of the Expert Panel on Population
Strategies for Blood Cholesterol Reduction'' (Ref. 8), and the
``Dietary Guidelines for Americans'' (Ref. 9), recommends reducing the
consumption of fat (especially saturated fat) and cholesterol by
choosing foods that are relatively low in fat and high in
carbohydrates. These recommendations have been carried forward in the
recent publication of the fourth edition of the ``Dietary Guidelines
for Americans'' (Ref. 10). Read together, these dietary guidance
reports make clear that reducing the fat content of the American diet
is an important public health goal.
The issue presented by the petitioner thus becomes whether fat-
based fat substitutes with reduced availability will play a useful role
in helping consumers to construct a healthy diet, and, if so, whether
it is appropriate to authorize nutrient content claims based on the
amount of available fat from such ingredients. To answer these
questions, it is useful to understand the physiological functions of
dietary fats and the metabolic processes necessary to achieve these
functions. The physiological functions of fats include transporting fat
soluble vitamins within the body, serving as structural components in
cell membranes, serving as a source of essential fatty acids, and
acting as precursors of certain hormones, prostaglandins, and other
active substances. While dietary fats are insoluble in water, the
digestion processes convert them into free fatty acids and
monoglycerides, in which forms they are absorbed from the digestive
tract. Products of digestion are absorbed from the intestinal lumen
into the enterocytes (i.e., intestinal cells). The form of transport
and ultimate fate of fatty acids depends to a large extent on chain
length and extent of unsaturation (Refs. 11 and 12).
Long chain fatty acids (>C12) are formed into new triglycerides and
transported, bound to protein (i.e., lipoproteins), into intercellular
spaces and thus into the lymphatic system. To pass through the
capillaries of the organs in which they will ultimately be used or
stored (e.g., adipose tissue, heart, skeletal muscle, or mammary
gland), triglycerides must be hydrolyzed into fatty acids and glycerol.
Shorter chain fatty acids (C18) fatty acids in place of common
dietary fatty acids (C12-C18)? (5) Are there any safety concerns
associated with such a shift?
Additionally, if the proposed action does not become a final rule
because of objections to the principle of providing for claims and
nutrition labeling based on availability, are there other, more
appropriate ways to inform consumers of the amount of available fat in
a food product? Comments are requested on these issues.
FDA has, on a number of occasions, raised the issue of nutrient
availability. For example, in the Federal Register of August 29, 1978
(43 FR 38575 at 38576), the agency stated that it intended to publish a
proposal on availability requirements of iron sources used to fortify
foods. At the time, however, FDA did not have sufficient information on
[[Page 67255]]
availability of iron from different sources or on how to best measure
iron availability in foods. Consequently, the agency did not publish a
proposal. Since that time, significant research has been done to
evaluate availability of different nutrients and food components.
Basing fat claims on amounts of available fat could set a precedent for
doing so with other nutrients, such as iron and calcium. Is there
sufficient data to consider labeling issues based on the availability
of nutrients other than fat, and, if so, how might consumers be
affected?
III. Analysis of Impacts
FDA has examined the economic implications of the proposed rule as
required by Executive Order 12866 and the Regulatory Flexibility Act (5
U.S.C. 601-612). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select the regulatory approach that
maximizes net benefits (including potential economic, environmental,
public health and safety effects; distributive impacts; and equity).
Executive Order 12866 classifies a rule as significant if it meets any
one of a number of specified conditions, including having an annual
effect on the economy of $100 million or adversely affecting in a
material way a sector of the economy, competition, or jobs, or if it
raises novel legal or policy issues. If a rule has a significant impact
on a substantial number of small entities, the Regulatory Flexibility
Act requires agencies to analyze options that would minimize the
economic impact of that rule on small entities. FDA finds that this
proposed rule is not a significant rule as defined by Executive Order
12866. Similarly, it has been determined that this rule is not a major
rule for the purpose of congressional review (Pub. L. 104-121).
FDA is proposing to allow the declaration of available amounts of
fat and fatty acids in nutrition labeling when fat-based fat
substitutes are used. FDA also is providing for definitions for claims
based on amounts of available fat and fatty acids in a food. Currently
available fat-based fat substitutes include such substances as
salatrim, caprenin, and olestra. This rule will not result in any
changes for manufacturers of products containing olestra because, in
the food additive approval, FDA determined that olestra will not be
counted as a fat.
A. Benefits
If finalized, the proposal to provide an expanded definition of fat
claims based on available fat would give manufacturers a way to promote
products containing novel fat ingredients, thereby encouraging
innovation and increasing consumers' product choices in planning
healthy diets.
B. Costs
There are two different ways in which the rule imposes costs: (1)
Revising existing labels to reflect the new regulations; and (2) data
gathering and premarket notification.
Any food manufacturer currently using claims based on available fat
for foods containing fat-based fat substitutes may have to change their
labels to reflect the new regulations. Such labels may be changed to
reflect proper wording of the claim as allowed by FDA. To continue to
use the claims, manufacturers will have to alter the nutrition facts
panel on their products so that the amount of fat that is reported
reflects the amount that is available. FDA is aware of very few
products containing fat-based fat substitutes on the market. FDA is
aware of two manufacturers marketing products containing a fat-based
fat substitute (other than olestra) for which claims are made. However,
because of recent emphasis on reducing intakes of fat, FDA expects that
many products containing fat-based fat substitutes will be marketed in
the future. Because of the small number of such products currently in
existence, few if any labels will be modified as a result of this
proposed regulation if made final. Therefore, the label revision costs
of this proposed regulation will be minimal.
The second way in which the rule imposes costs is in the premarket
notification requirements for the digestibility coefficient. If this
proposal is adopted, producers of fat substitutes will be required to
notify FDA of their intent to market fat substitutes that could provide
the basis for nutrient content claims based on availability and to
provide the agency with data supporting a digestibility coefficient.
Thus, the fat substitute will be tested to determine the digestibility
coefficient. FDA estimates that the cost of testing a fat substitute to
determine digestibility will be in excess of $100,000 and perhaps as
high as $1 million. It is not clear that the costs of the initial
notification will be significantly more than the current cost of FDA
approval of a substitute. However, FDA is also proposing to require the
notifier to continue to submit any information related to the
availability of the fat substitute of which it becomes aware to FDA as
long as the ingredient is marketed. Therefore, producers will continue
to bear the costs of informing FDA of any new information pertaining to
the digestibility of the fat substitute that becomes available. FDA is
not proposing to require that firms continue to generate or actively
seek out new data, only that they provide FDA with any data of which
they become aware. Therefore, although not zero, the costs will not be
significant.
C. Regulatory Options
1. Approval of the Nutrient Content Claim
One option available to FDA is to deny the petition for nutrient
content claims based on the availability of fat. Because the
marketability of fat-based fat substitutes depends on the manufacturers
ability to market the food containing them as lower in fat, if FDA were
to select this option, firms would not have any reason to develop fat
substitutes that are less bioavailable. Therefore, FDA would be
stifling innovation. Also, if FDA were to deny the petition, consumers
would not benefit from the availability of lower available fat foods.
2. Premarket Approval
As an alternative to premarket notification, FDA considered the
options of premarket approval of the digestibility coefficient and
postmarket notification. A premarket approval of the digestibility
coefficient would result in the manufacturer not being able to market a
food containing a fat-based substitute until FDA has published in the
Federal Register its approval of the coefficient. This option could
result in great delays in marketing a product and would be more costly
to all parties involved--the firms, the consumer, and the government.
However, this option would provide all parties with greater certainty
about the information provided on the label.
3. Postmarket Notification
In contrast to a premarket notification, under a postmarket
notification requirement the manufacturer can market the food prior to
notifying FDA. However, although a postmarket notification clearly does
not cause a delay in placing the product in the marketplace, it is not
clear that a premarket notification requirement would cause any delay
in marketing the food because manufacturers would account for the FDA
review period in their timeframes. FDA requests comments on whether the
options of postmarket notification and premarket notification are
significantly different
[[Page 67256]]
with respect to delays in marketing foods.
A postmarket notification might result in greater uncertainty about
the nutritional content of the food. Also, if FDA were to determine
that the digestibility coefficient is inaccurate or inappropriate after
the product is marketed, then the manufacturer will incur significant
costs to remove the product from the market, reanalyze the
digestibility, revise the labeling, and try again to market the
product. Similarly, if the digestibility coefficient is wrong, then
consumers could be harmed if the foods they believe are low fat are not
in fact low fat.
4. Sunset Provision
Another regulatory option available to FDA would be to limit the
length of the time for which the notifier is required to continually
submit information to FDA. This option would reduce costs by reducing
the amount of information that must be provided to FDA. Although
significant information may be generated with experience in marketing
the product, at some point in time, the marginal cost of that
information may exceed the marginal benefit. FDA requests comments on
this option, including how long the manufacturer should be required to
update the notification.
5. Multiple Digestibility Coefficients
FDA is raising questions about whether it is appropriate to
establish one digestibility coefficient for fat and its fatty acid
subcomponents for all approved uses of a fat substitute, or whether
different digestibility coefficients should be established for each
fatty acid subcomponent and for different uses. If different food
components and different processing methods significantly affect the
digestibility of fat, then different coefficients may be appropriate
for different foods or different conditions of use. If one
digestibility coefficient is appropriate for all approved uses, then
the necessary tests will be conducted once as a part of the initial
development and approval of the fat substitute.
The ability to make a nutrient content claim based on the
availability of the fat then will apply to all producers of foods that
include the fat substitute. However, if FDA determines that one
digestibility coefficient for all uses is not appropriate, then the
digestibility of the fat substitute will need to be tested, and a new
notification submitted, as appropriate when the fat substitute is used
under conditions that would change its digestibility. Because there are
no official methods for determining the digestibility of a fat
substitute, FDA cannot estimate the costs of performing new tests for
each use. The agency is aware however that, animal tests are relatively
costly, in excess of $100,000 per test and perhaps as high as $1
million. The digestibility of the fat substitute is likely to be tested
only for those uses for which the expected revenues will exceed the
costs of the tests and premarket notification. Because testing is a
high fixed cost, digestibility coefficients would only be determined
for products with a sufficiently high volume.
D. Regulatory Flexibility
FDA has also considered the impact of the premarket notification on
small entities. None of the firms currently marketing fat-based fat
substitutes, or the foods that contain them, are small. Therefore, the
only potential for impact on small entities would be if this rule
creates barriers to entry into markets for either fat-based fat
substitutes or the products that contain them. The incremental cost of
developing digestibility data and submitting it to FDA is not expected
to be large relative to the cost of seeking approval for fat
substitutes. In fact, because fat-based fat substitutes are developed
specifically because of their reduced digestibility, digestibility
testing for the initial intended uses may be a part of the development
of the fat substitute. FDA requests comments on whether the incremental
costs of the notification requirements themselves are likely to create
barriers for the ability of small firms to develop or manufacture fat-
based fat substitutes.
However, whether or not the notification requirements will create
barriers for the ability of small entities to develop or manufacture
foods that contain fat-based fat substitutes depends on whether or not
one digestibility coefficient is determined to be appropriate for all
approved food uses. If one coefficient is appropriate, then this rule
is not expected to create any significant difficulties for small firms.
However, if a separate digestibility coefficient is required for each
approved use of a fat substitute, then this rule may create barriers to
entry for small firms. As stated previously, the cost of testing the
fat-based fat substitute for a particular use and submitting a
notification will be prohibitive if the potential use is of
sufficiently low volume. This situation will primarily occur in niche
markets, which are dominated by small firms. Certain small firms might
not be able to take advantage of the opportunity to market their
product based on the amount of available fat. FDA cannot predict how
many small firms, if any, might be prevented from using nutrient
content claims based on available fat should different digestibility
coefficients be required for each approved use of a fat substitute.
However, given recent interest in reducing intakes of fat, it is likely
that many small firms will have a desire to use fat-based fat
substitutes and make claims based on available fat.
FDA requests comments, especially from small firms, on the economic
implications of this proposal, specifically with respect to barriers to
entry that might be created by a provision for different coefficients
for each approved use.
Because of concerns regarding potential barriers to entry, if
different digestibility coefficients are necessary for different uses
of a fat-based fat substitute, it may cause a significant impact on
small entities.
IV. The Paperwork Reduction Act of 1995
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3506 and 3507). Therefore, in accordance with 5 CFR part
1320, a description of the information collection requirement is given
below with an estimate of the annual collection of information burden.
Included in the estimate is the time for reviewing instructions,
gathering necessary information, and completion and submission of the
notice. Also included is the time necessary for retaining records and
making them available to appropriate regulatory officials.
FDA is soliciting comments to: (1) Evaluate whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (2) evaluate the accuracy of the agency's
estimate of the burden of the proposed collection of information; (3)
evaluate the quality, utility, and clarity of the information to be
collected; and (4) minimize the burden of the collection of information
on those who are to respond, including through the use of automated
collection techniques or other forms of information technology, when
appropriate.
Title: Notification of fat substitute digestibility coefficient.
Description: Section 403(r) of the act requires that food bearing
nutrient content claims be labeled in compliance with regulations
issued by FDA. FDA
[[Page 67257]]
has issued regulations in Sec. 101.62(b) and (c) for nutrient content
claims that may be used to characterize the level of fat and fatty
acids in food products. Among other things, Sec. 101.62(b) and (c)
define specific levels of fat that may not be exceeded for a food
product to bear specific nutrient content claims concerning fat or
fatty acids.
The regulations set forth in this proposed rule provide that the
digestibility of fat or fatty acids can be used as a basis for
determining whether a food complies with the level requirements
established in Sec. 101.62(b) and (c) for nutrient content claims for
fat or fatty acids. The proposed rule requires that manufacturers that
intend to market a fat-based substitute whose reduced availability can
be relied upon as the basis for nutrient content claims for fat or
fatty acids notify FDA at least 120 days before marketing the
substance. Such notification shall include data and other appropriate
information to establish the appropriateness of the digestibility
coefficients to be used for the substance and a certification that all
data of which the firm is aware that pertains to the digestibility of
the fat-based fat substitute is being submitted, with assurances that
any new data will also be promptly submitted as it becomes available.
Firms that use the substance in their food products may proceed to use
claims based on the digestibility coefficient for the substance if FDA
does not object to the digestibility coefficient within the 120-day
review period. The proposed rule also requires that manufacturers of
food products whose labeling bears nutrient content claims based in
part or whole on digestibility of a fat-based fat substitute retain the
all records that support the quantitative declaration of fat and any
fatty acid components declared for as long as the product is marketed.
The manufacturer of such a food product would be required to make those
records available for review and copying by appropriate regulatory
officials upon request.
Descriptions of Respondents: Persons and businesses, including
small businesses.
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
101.63(c) 2 1 2 100 200
101.9(g)(10) 25 1 25 1 25
Total 225
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection.
FDA believes that the information that would be submitted in a
notification would be that information that a prudent business would
obtain as a normal part of doing business.
The agency has submitted copies of the proposed rule to OMB for its
review of these requirements. Interested persons are requested to
submit written comments regarding information collection requirements
by January 21, 1997, to the Office of Information and Regulatory
Affairs, OMB (address above), ATTN: Desk Officer for FDA.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(b)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Comments
Interested persons may by April 21, 1997, submit to the Dockets
Management Branch (address above) written comments regarding this
proposal and may by January 21, 1997, submit comments on the
information collection requirements. Two copies of any comments are to
be submitted, except that individuals may submit one copy. Comments are
to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
VII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Bender, A. E., ``Nutritional Significance of
Bioavailability,'' in Nutrient Availability: Chemical & Biological
Aspects, edited by D. Southgate, I. Johnson, and G. R. Fenwick, The
Royal Society of Chemistry, Thomas Graham House, Cambridge, England,
pp. 3 to 9, 1989.
2. Merrill, A. L., and B. K. Watt, ``Energy Value of Foods--
Basis and Derivation,'' U.S. Department of Agriculture, Agriculture
Handbook No. 74, U.S. Government Printing Office, Washington, DC,
revised February 1973.
3. Allison, R. G., and F. R. Senti, ``A Perspective on the
Application of the Atwater System of Food Energy Assessment,'' Life
Sciences Research Office, FASEB, Bethesda, MD, 1983.
4. Apgar, J. L., C. A. Shively, and S. M. Tarka, ``Digestibility
of Cocoa Butter and Corn Oil and Their Influence on Fatty Acid
Distribution in Rats,'' Journal of Nutrition, 117:660-665, 1987.
5. U.S. Department of Agriculture, ``Composition of Foods:
Finfish and Shellfish Products,'' Agriculture Handbook Number 8-15,
Human Nutrition Information Service, USDA, page 91, 1987.
6. U.S. Department of Health and Human Services, The Surgeon
General's Report on Nutrition and Health, DHHS (Public Health
Service) Publication No. 88-50210 (Government Printing Office Stock
N. 017-001-00465-1), U.S. Government Printing Office, Washington,
DC, 1988.
7. National Research Council, Diet and Health--Implications for
Reducing Chronic Disease Risk, National Academy Press, Washington,
DC, pp. 206-210, 654-656, 669-672, 1989.
8. National Heart, Lung, and Blood Institute, ``Report of the
Expert Panel on Population Strategies for Blood Cholesterol
Reduction,'' NCEP, PHS, National Institutes of Health, DHHS,
Washington, DC; NIH Publication No. 90-3046, 1990.
9. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, ``Nutrition and Your Health, Dietary Guidelines
for Americans,'' Washington, DC, Home and Garden Bulletin No. 232,
3d edition, U.S. Government Printing Office, 1990.
10. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, ``Nutrition and Your Health, Dietary Guidelines
for Americans,'' Washington, DC, Home and Garden Bulletin No. 232,
4th edition, U.S. Government Printing Office, 1995.
11. Brindley, D. N., ``Absorption and Metabolism of Fats,'' in
Health Effects of Dietary Fatty Acids, edited by G. L. Nelson, The
American Oil Chemists' Society, Champaign, IL, pp. 35-47, 1991.
12. Carey, M. C., D. M. Small, and C. M. Bliss, ``Lipid
Digestion and Absorption,'' Annual Review of Physiology, 45:651-677,
1983.
13. Vanderveen, J. E., N. D. Heidelbaugh, and M. J. O'Hara,
``Study of Man During a 56-day Exposure to an Oxygen-Helium
[[Page 67258]]
Atmosphere at 258 mm. Hg Total Pressure IX. Nutritional Evaluation
of Feeding Bite-size Foods,'' Aerospace Medicine, 37:591-594, 1966.
14. Emken, E. A., R. O. Adolf, W. K. Rohwedder, and R. M.
Gulley, ``Influence of Linoleic Acid on Desaturation and Uptake of
Deuterium-labeled Palmitic and Stearic Acids in Humans,'' Biochimica
et Biophysica Acta, 1170:173-181, 1993.
15. Chen, I. S., S. Subramaniam, G. V. Vahouny, M. M. Cassidy,
I. Ikeda, and D. Kritchevsky, ``A Comparison of the Digestion and
Absorption of Cocoa Butter and Palm Kernel Oil and Their Effects on
Cholesterol Absorption in Rats,'' Journal of Nutrition, 1569-1573,
1989.
16. Erdman, J. W., C. L. Poor, and J. M. Dietz, ``Factors
Affecting the Bioavailability of Vitamin A, Carotenoids, and Vitamin
E,'' Journal of Food Technology, 42(10):214-221, 1988.
17. Letter from Stephen A. Brown to Dr. F. Edward Scarborough,
Office of Food Labeling, FDA, May 29, 1996.
18. Memo from John Wallingford, Office of Special Nutritionals
to the Director, Office of Food Labeling, FDA, September 30, 1996.
19. Labels of Hershey's Reduced Fat Baking Chips and Snackwell's
Fudge Dipped Granola Bars.
20. The American Dietetic Association, ``1995 Nutrition Trends
Survey, Executive Summary,'' Chicago, IL, 1995.
21. Food and Agriculture Organization of the United Nations and
the World Health Organization, ``Fats and Oils in Human Nutrition,
Report of a Joint Expert Consultation,'' FAO Food & Nutrition Paper
57, Rome, October 19 to 26, 1993.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.9 is amended by revising paragraph (c)(2), and by
adding new paragraphs (d)(15) and (g)(10) to read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(c) * * *
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat in a serving defined as total lipid fatty acids and
expressed as triglycerides, except that, for a food that bears a claim
that is made in compliance with Sec. 101.63, a statement of the grams
of available fat may be declared instead in accordance with paragraph
(d)(15) of this section. Amounts shall be expressed to the nearest 0.5-
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 in a serving defined as the sum of all fatty
acids containing no double bonds, except that, for a food that bears a
claim that is made in compliance with Sec. 101.63, a statement of the
grams of available saturated fat may be declared instead in accordance
with paragraph (d)(15) of this section. However, a label declaration of
saturated fat content is not required for products that contain less
than 0.5 gram of total fat in a serving if no claims are made about fat
or cholesterol content, and if ``calories from saturated fat'' is not
declared. Except as provided for in paragraph (f) of this section, if a
statement of the saturated fat content is not required and, as a
result, not declared, the statement ``Not a significant source of
saturated fat'' shall be placed at the bottom of the table of nutrient
values in the same type size. Saturated fat content shall be indented
and expressed as grams per serving to the nearest 0.5-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.
(ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat in a 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 is made on the label or in labeling about
fatty acids or cholesterol, label declaration of polyunsaturated fat is
required. When a food bears a claim that is made in compliance with
Sec. 101.63, the grams of available polyunsaturated fat may be
declared, in accordance with paragraph (d)(15) of this section, as the
amount of polyunsaturated fat. Polyunsaturated fat content shall be
indented and expressed as grams per serving to the nearest 0.5-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 in a serving
defined as cis-monounsaturated fatty acids may be declared voluntarily
except that when polyunsaturated fat is declared or when a claim is
made on the label or in labeling about fatty acids or cholesterol,
label declaration of monounsaturated fat is required. When a food bears
a claim that is made in compliance with Sec. 101.63, the grams of
available monounsaturated fat may be declared, in accordance with
paragraph (d)(15) of this section, as the amount of monounsaturated
fat. Monounsaturated fat content shall be indented and expressed as
grams per serving to the nearest 0.5-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.
* * * * *
(d) * * *
(15) For food products that bear a claim that is made in compliance
with Sec. 101.63, and that contain an ingredient for which a
digestibility coefficient is used to calculate the number of grams of
total fat or fatty acids that are available from the ingredient, there
shall be, in the nutrition label, following the quantitative
declaration of fat (and saturated fat, polyunsaturated fat, or
monounsaturated fat, if declared) and again immediately preceding the
footnote required by paragraph (d)(9) of this section, an asterisk (*)
or other similar cross-reference symbol. The asterisk or other symbol
shall be followed by a statement that the declared amount of ``total
fat'' has been adjusted to reflect reduced digestibility of the
ingredient (e.g., ``*Total fat content adjusted for reduced
availability of fat from [name of ingredient]''). The footnote required
by paragraph (d)(9) of this section shall be separated by a hairline
from the footnote required under this paragraph.
* * * * *
(g) * * *
(10) Each person responsible for the labeling of a food that bears
a claim that is made in compliance with Sec. 101.63, and for which
available fat is declared in accordance with paragraph (d)(15) of this
section, shall retain, for as long as the food is marketed, all records
that support the quantitative declaration of fat and any fatty acid
subcomponents declared. Such records shall be made available for
authorized inspection and copying by appropriate regulatory officials
and shall be submitted to those regulatory officials upon request.
* * * * *
3. Section 101.13 is amended by revising paragraph (o) to read as
follows:
[[Page 67259]]
Sec. 101.13 Nutrient content claims--general principles.
* * * * *
(o) Except as provided in Secs. 101.10 and 101.63, compliance with
requirements for nutrient content claims in this section and in the
regulations in subpart D of this part will be determined using the
analytical methodology prescribed for determining compliance with
nutrition labeling in Sec. 101.9.
* * * * *
4. Section 101.62 is amended by revising paragraphs (b)(1)(i),
(b)(2)(i)(A), (b)(2)(i)(B), (b)(3)(i), (b)(4)(i), (b)(5)(i), (c)(1)(i),
(c)(2)(i), (c)(3)(i), (c)(4)(i), and (c)(5)(i) to read as follows:
Sec. 101.62 Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.
* * * * *
(b) * * *
(1) * * *
(i) The food contains less than 0.5 g of total fat or, as provided
in Sec. 101.63, available fat per reference amount customarily consumed
and per labeled serving or; in the case of a meal product or main dish
product, less than 0.5 g total fat, or as provided in Sec. 101.63,
available fat per labeled serving; and
* * * * *
(2) * * *
(i)(A) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and contains 3 g or less of
total fat or, as provided in Sec. 101.63, available fat per reference
amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less, or 2 tablespoons or less, and contains 3 g or less of total fat
or, as provided in Sec. 101.63, available fat per reference amount
customarily consumed and per 50-g of food (for dehydrated foods that
must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in
Sec. 101.9(f)(1), of all nutrients per reference amount customarily
consumed, the per 50-g criterion refers to the ``as prepared'' form);
and
* * * * *
(3) * * *
(i) The product contains 3 g or less of total fat or, as provided
in Sec. 101.63, available fat per 100 g and not more than 30 percent of
calories from fat; and
* * * * *
(4) * * *
(i) The food contains at least 25 percent less total fat or, as
provided in Sec. 101.63, available fat per reference amount customarily
consumed than an appropriate reference food as described in
Sec. 101.13(j)(1); and
* * * * *
(5) * * *
(i) The food contains at least 25 percent less total fat or, as
provided in Sec. 101.63, available fat per 100 g of food than an
appropriate reference food as described in Sec. 101.13(j)(1); and
* * * * *
(c) * * *
(1) * * *
(i) The food contains less than 0.5 g of saturated fat or, as
provided in Sec. 101.63, available saturated fat and less than 0.5 g
trans fatty acid per reference amount customarily consumed and per
labeled serving, or in the case of a meal product or main dish product,
less than 0.5 g of saturated fat or, as provided in Sec. 101.63,
available saturated fat and less than 0.5 g trans fatty acid per
labeled serving; and
* * * * *
(2) * * *
(i) The food contains 1 g or less of saturated fat or, as provided
in Sec. 101.63, available saturated fat per reference amount
customarily consumed and not more than 15 percent of calories from
saturated fat; and
* * * * *
(3) * * *
(i) The food contains 1 g or less of saturated fat or, as provided
in Sec. 101.63, available saturated fat per 100 g and less than 10
percent of calories from saturated fat; and
* * * * *
(4) * * *
(i) The food contains at least 25 percent less saturated fat or, as
provided in Sec. 101.63, available saturated fat per reference amount
customarily consumed than an appropriate reference food as described in
Sec. 101.13(j)(1); and
* * * * *
(5) * * *
(i) The food contains at least 25 percent less saturated fat or, as
provided in Sec. 101.63, available saturated fat per 100 g of food than
an appropriate reference food as described in Sec. 101.13(j)(1); and
* * * * *
5. New Sec. 101.63 is added to subpart D to read as follows:
Sec. 101.63 Nutrient content claims for fat and fatty acids based on
use of ingredients formulated to reduce amount of available fat.
(a) Coverage. This regulation defines the circumstances in which
nutrient content claims for fat and fatty acids can be made for foods
that contain manufactured fat-based fat substitutes that have been
formulated to provide functional characteristics of fat but to limit or
eliminate absorption and digestion of the fat from the substance by the
body, thereby restricting the availability of the fat to the body.
(b) Claims. The terms defined in Sec. 101.62 may be used on the
label or in the labeling of foods that contain an ingredient that is
covered under this paragraph, provided that:
(1) There has been compliance with the notification provisions of
paragraph (c) of this section, and FDA has not objected (see paragraph
(d) of this section);
(2) The level of available fat or available saturated fat in the
food meets the applicable level in Sec. 101.62; and
(3) The food is nutrition labeled in accordance with paragraph (e)
of this section.
(c) Notification. The manufacturer of an ingredient covered under
paragraph (a) of this section shall notify FDA at least 120 days before
such ingredient is introduced into or delivered for introduction into
interstate commerce. Such notification shall be signed by a responsible
person and shall include:
(1) The name and address of the manufacturer and a contact person;
(2) The common or usual name of the fat substitute that is the
subject of the claim (i.e., the notified substance);
(3) Descriptive information that characterizes the substance,
including its chemical structure and physical characteristics, its
purity and homogeneity, and a detailed description of the analytical
methodology for determining the amount of the substance present in a
food or a statement that refers the agency to where this analytical
methodology can be found in its records (e.g., in a filed food additive
petition or in a petition for affirmation that use of a substance is
generally recognized as safe). Where the substance is part of a family
of similar structured fats, information should be submitted on the
applicability of the digestibility coefficient to other forms of the
substance;
(4) The digestibility coefficient that is expected to be used to
adjust the amount of total fat or of fatty acids contributed by such an
ingredient to reflect the amount of fat and fatty acids available from
the finished food product;
(5) Data that establish the appropriateness of the digestibility
coefficient to be used including, but not limited to:
(i) Evidence demonstrating the reduced absorption of the substance
or its components, such as:
[[Page 67260]]
(A) An estimate of the biologic variability in the availability of
the substance in humans and in the relationship between the amount of
the substance ingested and the rate of absorption (i.e., dose-
response);
(B) A statement of the relevance, and limit to relevance to the
human, of any animal model used to estimate human digestion and
absorption of the substance; and
(C) For any clinical studies that are relied on to demonstrate
reduced absorption or digestion, information on the characteristics of
the subjects studied and the manner in which they are representative of
the population for whom the substance is intended. For example:
(1) An accounting of subjects enrolled in the study including those
who did not complete the study, reasons for any noncompletion, and an
assessment of the effect that noncompletion of subjects had on the
results of the study; and
(2) A description of any adverse events that occurred during the
study, and a comparison of the frequency and type of effects as a
function of the feeding of the substance;
(ii) Information about foods or diets that may affect the
digestibility coefficient, such as:
(A) Interactions of the substance with other components of foods or
the diet that could significantly affect the digestibility coefficient;
(B) Steps in processing of the types of foods expected to contain
the fat substitute that could affect the digestibility coefficient;
(C) The amount of the substance used in feeding studies, the
relationship of that amount to expected levels of intake, and the dose-
response relationship between the amount of the substance and the
digestibility coefficient; and
(D) The duration of feeding studies and changes in the
digestibility coefficient with continued exposure;
(6) A certification that all data of which the firm is aware that
pertain to the digestibility of the fat substitute have been submitted,
and that any new data will be promptly submitted as it becomes
available for as long as the ingredient is marketed; and
(7) Such notification shall be submitted to the Office of Food
Labeling (HFS-150), Food and Drug Administration, 200 C St., SW.,
Washington, DC 20204.
(d) FDA review. Upon receipt, FDA will notify the submitting firm
that it has received the notification and will commence its review. If
firms do not receive written objections from FDA within 120 days of
FDA's receipt of the notification, nutrient content claims based on the
digestibility coefficient submitted may be used.
(e) Nutrition labeling. When a claim is made for fat or saturated
fat under this section, the nutrition label shall declare the amount of
available fat or saturated fat in accordance with Sec. 101.9(d)(15).
(f) Misbranding. Any food product containing ingredients that are
covered under paragraph (a) of this section that bears a claim based on
available levels of fat for which supporting data have not been
provided to FDA in accordance with this section or to which FDA has
objected in response to the notification filed in accordance with
paragraph (c) of this section will be deemed to be misbranded under
section 403(a) and (r)(1)(A) of the Federal Food, Drug, and Cosmetic
Act.
Dated: December 11, 1996.
William B. Schultz,
Deputy Commissioner for Policy
[FR Doc. 96-32124 Filed 12-19-96; 8:45 am]
BILLING CODE 4160-01-F
