[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Proposed Rules]
[Pages 37616-37620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17919]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 101
[Docket No. 93P-0448]
Food Labeling; Serving Sizes; Reference Amount for ``Salt, Salt
Substitutes, Seasoning Salts (e.g., Garlic Salt)''
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the nutrition labeling regulations to change the reference amount
customarily consumed per eating occasion for the food category ``salt,
salt substitutes, seasoning salts (e.g., garlic salt)'' from a weight-
based reference amount of 1 gram (g) to a volume-based reference amount
of 1/4 teaspoon (tsp). This action is necessary to provide consistency
with the agency's criteria for determining volumetric versus weight-
based reference amounts for all product categories.
DATES: Written comments by October 4, 1995.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Center for Food
[[Page 37617]]
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5662.
SUPPLEMENTARY INFORMATION:
I. Background-
In the Federal Register of July 19, 1990 (55 FR 29517 at 29532), as
part of its effort to make the food label more useful and
understandable to consumers, FDA proposed standard serving sizes for
159 food product categories based on the amount of food commonly
consumed per eating occasion by persons 4 years of age or older. For
the category ``salt, seasoning salt (e.g., garlic salt),'' the agency
proposed a serving size of 1 g.
On November 8, 1990, however, before FDA could issue a final rule
in the serving size rulemaking, Congress passed the Nutrition Labeling
and Education Act of 1990 (the 1990 amendments). This statute amended
the Federal Food, Drug, and Cosmetic Act (the act) to require that
virtually all foods bear nutrition information that is based on a
serving size that reflects the amount of food that is customarily
consumed and that is expressed in a common household measure that is
appropriate to the food (section 403(q)(1)(A)(i) of the act (21 U.S.C.
343(q)(1)(A)(i))). The new law also directed FDA to adopt regulations
that establish standards to define serving sizes (section 2(b)(1)(B) of
the 1990 amendments (21 U.S.C. 343 note)).
In response to the new law, FDA, among other actions, issued a
reproposal on serving sizes (56 FR 60394, November 27, 1991). In that
reproposal, FDA carried forward the 1-g value for salt, although it
called this amount the ``reference amount customarily consumed'' to
reflect the requirements of the new law. FDA chose this amount based in
part on its tentative determination to use weight-based amounts except
in those instances in which it was demonstrably inappropriate to do so.
The agency also included salt substitutes in the food category for salt
and seasoning salts.
FDA received three comments on the proposed reference amount for
salt (58 FR 2229 at 2260, January 6, 1993). One comment agreed with the
proposed 1-g reference amount. The second comment also agreed with this
amount, but it requested a voluntary declaration based on 1/4 tsp. The
third comment argued that a weight-based reference amount was
inappropriate for salt and requested that a volume-based reference
amount be established. However, this comment did not include any data
to support its assertions. Thus, in its final rule on serving sizes,
FDA concluded that, in the absence of evidence to support a different
reference amount, 1 g was the appropriate reference amount for ``salt,
salt substitutes, seasoning salts (e.g., garlic salt)'' (58 FR 2229 at
2297).
II. The Petition
On November 19, 1993, FDA received a petition from Akzo Salt, Inc.,
that requested that FDA change the reference amount for salt from 1 g
to a density-adjusted reference amount to be listed as ``x g-1/4 tsp.''
In support of its petition, the petitioner submitted the results of a
consumer study of consumption patterns for salt and low-density salt
and analytical data comparing the physical properties (including
density) of salt and low-density salt. The company stated that the low-
density salt product contains 33 percent less sodium by volume than
regular table salt, that the consumer data demonstrate that equivalent
volumes of low-density salt and regular salt are consumed, and that,
therefore, consumers who use similar volumes of low-density and regular
salt would consume 33 percent less sodium by using the low-density salt
product rather than regular table salt. The company concluded that it
should be permitted to communicate the benefits of its low-density salt
product to consumers in a truthful manner, including making claims that
would be prohibited under regulations established in response to the
1990 amendments.
On May 24, 1994, the petitioner amended its petition by submitting
supplemental materials consisting of detailed information regarding the
protocol, data tabulation, and results of the consumer study. The
supplemental materials also included an independent evaluation of the
results and conclusions of the consumer study.
On February 2, 1994, FDA received a comment that requested that the
agency reject the petition and take no further action with regard to
salt and salt products. The comment stated that amending the reference
amount as requested by the petitioner would permit a comparative claim
that would be contrary to the letter and intent of the 1990 amendments,
which the comment claimed was to provide for comparison of two distinct
foods and not two versions of the same food. The comment also argued
that the proposed change would undermine the overall structure of FDA's
regulation of nutrient content claims by acting as an incentive for
manufacturers to extend their products with air or other nonnutritive
substances in order to make claims. Finally, the comment asserted that
the consumer study data submitted in the petition were incorrect and
insufficient. On April 14, 1994, FDA received a response by the
petitioner to the various arguments made in this comment.
FDA has carefully considered the information in this petition, the
supplemental submission, and the comments. Based on its review, FDA
finds that the petitioner has made a prima-facie case that a volume-
based reference amount of 1/4 tsp for salt is more appropriate than the
reference amount that FDA adopted in 1993 (Ref. 1). Therefore, in
accordance with 21 CFR 10.30(e)(2)(i), FDA is granting the petition and
proposing to change the reference amount for ``salt, salt substitutes,
seasoning salts (e.g., garlic salt)'' from 1 g to 1/4 tsp. A discussion
of the basis for the agency's action on the petition and for the
proposed change in the reference amount follows.
III. Basis for the Proposed Action
A. The Appropriateness of a Weight-Based Reference Amount
As stated above, in the final rule on serving sizes, FDA adopted a
weight-based reference amount of 1 g for ``salt, salt substitutes,
seasoning salts (e.g., garlic salt)'' based on the agency's
determination to use weight-based reference amounts unless such amounts
were shown to be demonstrably inappropriate (58 FR 2229 at 2238) and on
the lack of data showing that a weight-based reference amount was
inappropriate for salt.
In the final rule on serving sizes, however, FDA outlined the
circumstances in which a weight-based reference amount would not
adequately reflect the amount of food customarily consumed per eating
occasion (see comment 20 in 58 FR 2229 at 2238). The agency stated that
weight-based reference amounts are inappropriate when foods within a
product category vary considerably in density, that is, there is a
density difference of 25 percent or more among the products in the
category (see Sec. 101.12(e) (21 CFR 101.12(e))), and the customarily
consumed amounts for different products are more uniform when expressed
in volume than in weight. As an example, the agency explained that,
although the reference amount for the category ``Mixed Dishes:
Measurable with cup, * * *'' is 1 cup, the g weights of different types
of products within the category differ widely from about 160 g for
seafood with vegetables without sauce to about 250 g for seafood stew.
The use of a weight-based reference amount for this product category
would result in serving sizes too large for some
[[Page 37618]]
products and too small for others. However, FDA found, based on
consumption and usage data, that the volume amounts customarily
consumed are similar for all products within this category. Thus, the
agency concluded that a volume-based reference amount, rather than a
weight-based reference amount, was appropriate for this class of foods.
Similarly, FDA changed the reference amount for peanut butter from
``30 g'' in the proposal to a volume-based amount of ``2 tbsp'' in the
final rule in response to data demonstrating that there is a density
variation of greater than 25 percent among peanut butters (whipped
peanut butter is approximately 33 percent less dense than regular
peanut butter), and that common cookbook usage of peanut butter is
expressed by volume (e.g., tablespoon and cup) demonstrating that the
amount customarily consumed in recipes that include peanut butter is
measured by volume and not by weight (see comment 108 in the final rule
for serving sizes, 58 FR 2229 at 2263). FDA concluded that the volume-
based amount more accurately reflected the amount customarily consumed
of the various types of peanut butter.
The agency does not agree with the comment that it received on the
petition that a comparative claim between two versions of the same food
(i.e., salt and low-density salt) would be contrary to the letter and
intent of the 1990 amendments and would undermine FDA's regulation of
nutrient content claims by encouraging the use of nonnutritive
substances in order to make claims. In addition to providing for claims
that compare similar kinds of foods (e.g., potato chips can serve as a
reference food for potato chips) (see 21 CFR 101.13(j)), FDA provided
procedures in Sec. 101.12(e) to define reference amounts for aerated
products to permit comparison of equal volumes of the aerated and
nonaerated versions.
One purpose of the 1990 amendments was to help consumers maintain
healthy dietary practices (see e.g., sections 403(q)(1) and
(r)(2)(A)(ii)(II) of the act). In comment 138, in the final rule for
serving sizes (58 FR 2229 at 2271), FDA specifically stated:
In light of the current dietary guidelines for reducing fat and
calorie intakes * * *, FDA acknowledges that it is desirable to have
a wide selection of low fat and low calorie foods available to
consumers. Some consumers may benefit from having such aerated foods
if they consume an equivalent volume of aerated food as they would
have the regular food, e.g., two instead of three aerated waffles.
Similarly, given the dietary guidelines recommending that people use
salt and sodium in moderation (Refs. 3 through 5), if consumers consume
equivalent volumes of low-density salt and regular salt, then it would
be beneficial for consumers to have a variety of products available
that are permitted to compare the sodium content of different types of
salt and salt substitute products.
FDA has reviewed the materials in the petition and in the
supplemental submission and comments. Based on this review, the agency
concludes that the petitioner has made a prima-facie showing that a
weight-based reference amount is not appropriate for salt. First, the
density difference between low-density salt and conventional table salt
is reported in the petition to be 33 percent, which supports that the
densities of the foods in the salt products category vary considerably.
Second, the consumer research data included in the supplemental
submission provide evidence that similar volumes, rather than similar
weights, of low- and high-density salt products are customarily
consumed. For these reasons, FDA has tentatively determined that a
weight-based reference amount is not appropriate for salt products.
Therefore, FDA is proposing to make a change in the reference amount
for salt.
B. Relief Requested of a Density-Adjusted Reference Amount
The petition requested a density-adjusted reference amount for the
product category ``salt, salt substitutes, seasoning salts (e.g.,
garlic salt).'' However, there are several difficulties with using a
density-adjusted reference amount for this product category.
FDA discussed density-adjusted reference amounts in the context of
aerated products, specifically waffles, in comment 138 in the final
rule on serving sizes (58 FR 2229 at 2271). In response to requests for
a volumetric reference amount for waffles, the agency noted that the
wide variability in size and shape of discrete products like waffles
makes it difficult to establish a volume for the aerated version that
would be equivalent to the reference amount of the regular counterpart.
Consequently, FDA permitted manufacturers to use density-adjusted
reference amounts for aerated products in discrete units that vary
widely in size and shape. The manufacturer adjusts for the difference
in density of the aerated food relative to the regular product. For
example, if the density of the aerated food is 30 percent lower than
the density of the regular product, the density-adjusted reference
amount for the aerated food would be 30 percent less than the reference
amount of the regular counterpart.
FDA tentatively finds that a density-adjusted reference amount
would not be appropriate for salt products for three reasons. First,
unlike waffles, which are sold and consumed in discrete units, salt
products are bulk products that are measured by volume. An aerated
reference amount (i.e., density adjusted) is not appropriate, because
there are no discrete units such that the regular and the aerated
versions are ``the same in size, shape, and volume'' (see
Sec. 101.12(e)(1)).
Second, applying the rounding specifications for aerated reference
amounts leads to an absurdity for products with small reference amounts
like salt. Section 101.12(e) of FDA's regulations specifies that the
reference amount for an aerated food ``shall be rounded to the nearest
5-g increment.'' The current reference amount for salt is 1 g. Thus, if
a density-adjusted reference amount were calculated for a low-density
salt product, it would be 0.67 g. Rounding 0.67 g to the nearest 5-g
increment gives 0 g which is an illogical and nonsensical result.
Finally, Sec. 101.12(e) requires that the product bear a
descriptive term indicating that air has been incorporated (e.g.,
whipped, aerated). Describing the product as ``whipped salt'' or
``aerated salt'' is apt to be confusing to consumers given that the
appearance and the consistency of the two salts are very similar. For
these reasons, the concept of a density-adjusted reference amount for
salt products is not appropriate.
C. Consideration of a Volumetric Reference Amount
The petition and supplemental submission support a volumetric
reference amount for salt and salt products. As noted in the petition,
in the proposed and final serving sizes regulations (56 FR 60394 and 58
FR 2229), FDA discussed its approach to products like salt that can
easily be measured volumetrically. As discussed above, the agency
considers volumetric reference amounts appropriate when three criteria
are met: (1) The product can easily be measured volumetrically, (2) the
densities vary widely, and (3) the amount customarily consumed is more
uniform when expressed as a volume rather than a weight.
First, in order for a volumetric reference amount to be
appropriate, the product must be a bulk product that can be measured
volumetrically, such as peanut butter or fluids (final rule for serving
sizes, comment 20, 58 FR 2229 at 2238 and comment 108, at 2263). Salt
[[Page 37619]]
and salt products can be measured volumetrically.
Second, there must be a significant difference in the densities
(i.e., 25 percent or more) of the different forms of the product such
that a range of densities are represented within the product category
(see discussions on aerated products in Sec. 101.12(e) and peanut
butter (58 FR 2229 at 2263)). FDA considers the 33-percent density
difference reported for low-density salt relative to conventional table
salt to be significant and to justify a finding that the densities of
different products within the category vary widely.
Third, the amount customarily consumed must be more uniform when
expressed volumetrically than when expressed gravimetrically (56 FR
60394 at 60406 and 58 FR 2229 at 2238). There must be some indication
or likelihood that similar volumes, rather than similar weights, of
both low- and high-density products within the same product category
are customarily consumed. The evidence must show that the amount that
people consume is more consistent when expressed in volumetric terms
than when expressed in terms of weight.
In the final serving sizes regulation (58 FR 2229 at 2260), FDA
rejected a request for a volume-based reference amount for salt
products, even though salt products are measured volumetrically. The
agency observed that ``[t]he comment did not submit any data to support
that regular salt and the low-density salt are consumed equally on a
volume basis.'' FDA noted that like sugar, salt is used as a flavoring
agent to attain a given level of saltiness. Thus, the agency stated,
the reference amount for a salt substitute, such as a low-density salt
product, should be the amount necessary to provide a salty taste
equivalent to one reference amount of salt.
In reconsidering whether the amounts consumed of the various
products within the salt category are more similar when expressed in
terms of volume than in terms of weight, FDA looked at the quality of
the supporting evidence submitted, including the study design, the
results, and the conclusions. The agency evaluated the data provided in
the supplementary submission and determined: (1) That the consumer
research conducted on behalf of the petitioner is a reasonably well
controlled experiment that meets scientific standards for testing
household salt consumption differences due to two types of salt; and
(2) that the result supports, but does not prove, the hypothesis that
salt is used on a volumetric rather than on a weight basis (Ref. 2).
Thus, FDA has tentatively concluded that the data provide evidence that
similar volumes, rather than similar weights, of low- and high-density
products are customarily consumed.
Section 101.12(e), which applies to discrete products like waffles,
requires that the aerated version bear a descriptive term indicating
that air has been incorporated (e.g., whipped, aerated). Some product
categories that have volumetric reference amounts contain products
whose common or usual names clearly indicate that air has been
incorporated into the product (e.g., whipped peanut butter, whipped
dessert topping). Some products in other product categories with
volumetric reference amounts do not bear such descriptive terms (e.g.,
pudding, ice cream). Given these differences, FDA is requesting
comments on whether low-density salt products should be required to
clearly identify that they contain more air than conventional salt
products. It is the agency's opinion that terms such as ``whipped
salt'' or ``aerated salt'' are apt to be confusing to consumers.
Therefore, FDA is also requesting comments on what kind of descriptive
terms would be clear and nonmisleading for consumers.
IV. Conclusion
FDA has determined that volumetric reference amounts are
appropriate when: (1) Products are bulk products that can be measured
volumetrically; (2) there are significant differences in densities
among the products within a product category such that a range of
densities are represented within the particular product category; and
(3) the amount customarily consumed is more uniform when expressed
volumetrically, that is, there is some indication or likelihood that
similar volumes, rather than similar weights, of both low- and high-
density products within the same product category are customarily
consumed.
The petition and supplemental submission contain information that
evidences that similar volumes rather than similar weights of low- and
high-density salt products are customarily consumed. Because the
products within the category can be measured volumetrically, and the
density difference among products within the same product category
appear to be significant, FDA has concluded that the petitioner has
made a prima facie showing that it is appropriate for the reference
amount for salt and salt products to be expressed on a volumetric
rather than a gravimetric (i.e., weight) basis.
FDA is proposing to change the reference amount for salt andsalt
products from 1 g to 1/4 tsp and to solicit public comment on the
proposed change. The agency selected 1/4 tsp because it is the
volumetric amount that most closely reflects the amount customarily
consumed. It is the smallest volumetric amount permitted in the
regulations (21 CFR 101.9(b)(5)(i)). In addition, the 1/4 tsp reference
amount will permit comparison with herbs and spices which also have a
reference amount of 1/4 tsp.
V. Comments
Interested persons may, on or before October 4, 1995, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. 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.
VI. Environmental Impact-
The agency has determined under 21 CFR 25.24(a)(11) 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.
VII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because there is no cost to industry, the agency
certifies that the proposed rule will not have a significant
[[Page 37620]]
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
VIII. 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) Letter from Dykstra, Gary, to Wayne H. Matelski, dated July
11, 1995.
(2) Brenda Derby, Consumer Studies Branch, Division of Market
Studies, memo to file, June 20, 1994.
(3) U.S. Department of Agriculture and Department of Health and
Human Services (DHHS), ``Nutrition and Your Health: Dietary
Guidelines for Americans,'' 3d ed., U.S. Government Printing Office,
Washington, DC, 1990.
(4) DHHS, ``The Surgeon General's Report on Nutrition and
Health,'' U.S. Government Printing Office, Washington, DC, 1988.
(5) National Research Council, ``Diet and Health. Implications
for Reducing Chronic Disease Risk,'' National Academy Press,
Washington, DC, 1989.
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 101.12 is amended in paragraph (b), Table 2, under the
``Miscellaneous category'' by revising the entry for ``Salt, salt
substitutes, seasoning salts (e.g., garlic salt)'' under the headings
``Reference amount'' and ``Label statement'' to read as follows:
Sec. 101.12 Reference amounts customarily consumed per eating
occasion.
* * * * *
(b) * * *
Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply1, 2, 3, 4
----------------------------------------------------------------------------------------------------------------
Product category Reference amount Label statement5
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Miscellaneous category:
* * * * * *
*
Salt, salt substitutes, 1/4 tsp 1/4 tsp (------g);
seasoning salts (e.g., garlic ------ piece(s) (--
salt). ----g) for
discrete pieces
(e.g.,
individually
packaged products)
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the
U.S. Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or
almost ready-to-serve form of the product (i.e., heat and serve, brown and serve). If not listed separately,
the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; dry, fresh, and
frozen pasta) is the amount required to make the reference amount of the prepared form. Prepared means
prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the label serving size in a household measure
most appropriate to their specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington,
DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers on the presentation of serving size
information on the label, but they are not required. The term ``piece'' is used as a generic description of a
discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific
product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided
is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not
apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless
specifically stated in the product category, reference amount, or label statement column that it is for these
forms of the product. For products that require further preparation, manufacturers must determine the label
statement following the rules in Sec. 101.9(b) using the reference amount determined according to Sec.
101.12(c).
* * * * *
Dated: June 26, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-17919 Filed 7-20-95; 8:45 am]
BILLING CODE 4160-01-F
