Food Labeling; Serving Sizes; Reference Amount for ``Salt, Salt Substitutes, Seasoning Salts (e.g., Garlic Salt)''

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.

-----------------------------------------------------------------------

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