Food Labeling; Serving Sizes; Reference Amount and Serving Size Declaration for Hard Candies, Breath Mints

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94P-0168]

Food Labeling; Serving Sizes; Reference Amount and Serving Size

Declaration for Hard Candies, Breath Mints

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 label serving size for

the product category ``Hard candies, breath mints'' to one unit. This

action is in response to a petition to provide a serving size for

breath mints that more accurately reflects the amount customarily

consumed per eating occasion. In a related issue, FDA is proposing to

allow the declaration of caloric amounts of less than 5 calories in the

nutrition label.

DATES: Submit written comments by March 16, 1998. Submit written

comments on the information collection provisions by January 29, 1998.

See Section V of this document for the proposed effective date of a

final rule based on this document.

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 provisions to

the Office of Information and Regulatory Affairs, Office of Management

and Budget (OMB), New Executive Office Bldg., 725 17th St. NW., rm.

10235, Washington, DC 20503, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Center for Food

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 response to the Nutrition Labeling and Education Act

(hereinafter referred to as ``the 1990 amendments''), FDA, among other

actions, issued a proposal on serving sizes (56 FR 60394, November 27,

1991). FDA proposed a reference amount customarily consumed per eating

occasion (hereinafter referred to as ``reference amount'') of 15 grams

(g) for ``Baking candies * * * and hard candies'' but no separate

reference amount for breath mints (56 FR 60394 at 60419).

The agency received several comments from hard candy manufacturers

opposing the uniform 15-g reference amount for hard candies (58 FR 2229

at 2266, January 6, 1993). The comments stated that the 15-g reference

amount would result in the serving size of breath mints being the

entire package, and that, therefore, breath mints should have a

separate smaller reference amount. Most comments recommended a

reference amount of one piece. One comment disagreed, however, arguing

that several pieces may be consumed during one eating occasion. None of

the comments that requested a reference amount based on pieces included

any data to support their request.

One comment submitted data from a home use mail survey that

supported 2 g as the customarily consumed amount for large breath

mints. FDA carefully examined the data from this survey and noted that

it only tested the manufacturer's own brands of candies and breath

mints. However, in the final rule for serving sizes, because these data

were the only breath mint data available to FDA, the agency created a

separate product category for ``Hard candies, breath mints'' with a

reference amount of ``2 g'' (58 FR 2229 at 2297). The 2 g reflected the

weight of one breath mint (Ref. 1).

II. The Petition and Other Communications

FDA received a petition dated April 20, 1994 (Docket No. 94P-0168),

from Ferrero USA, Inc., requesting that the agency amend the product

category for ``Sugars and Sweets: Hard candies, breath mints'' to

create a separate product category with a 0.5-g reference amount for

small breath mints (weighing 0.5 g or less) that fulfill the same

breath-freshening function as a larger mint. The manufacturer submitted

study data not only on small breath mints but also on five large breath

mint products. The manufacturer asserted that the data establish that

their small breath mints (0.38 g each) are consumed one mint at a time,

and that the majority of consumers never eat 2 g of small breath mints,

equivalent to five mints, during an entire day.

The company also stated that consumers chose the small breath mints

for their breath freshening ability and lower caloric content. The

manufacturer stated that their trademarked slogan has been ``The 1 1/2

calorie breath mint,'' based on a serving size of ``1 mint,'' and that

changing this slogan would result in an economic hardship. The

petitioner concluded that the serving size for small breath mints

should be ``1 mint'' and requested that FDA create a separate product

category for small breath mints with a reference amount of 0.5 g.

The agency received correspondence opposed to, and in support of,

this petition. The opposing comments (Docket No. 94P-0168, comments 1

and 2) stated: (1) That the facts presented in the petition did not

support the 0.5 g (one mint) reference amount because nearly half of

the users surveyed consumed two or more mints per occasion; (2) that

the attempt to establish such an extremely narrow reference category to

accommodate a single product runs counter to one of the principal

objectives of the 1990 amendments, to provide consistency in labeled

serving sizes among comparable and interchangeable products; (3) that

``breath-freshening function'' is not the

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statutory standard for the reference amount category and would

inappropriately require FDA to apply subjective criteria to determine

the correct product category for small breath mints; (4) that basing

the reference amount on breath-freshening function would be a dangerous

precedent for the agency because, unlike artificial sugar and salt

substitutes, there is no established methodology for determining

breath-freshening function; (5) that granting the petition could result

in the agency being inundated by requests for new or alternate serving

sizes for products purporting to have a functional property; and (6)

that the petitioner was making a mockery of FDA's petition process by

already using an illegal ``1 mint'' serving size.

In rebuttal (Docket No. 94P-0168, amendment 1 and comment 3), the

petitioner argued: (1) That the change recommended in the petition

would make it easier for breath mint consumers to compare the

nutritional composition of competing breath mint products, regardless

of size, on a per mint basis; (2) that comparison on a mint-to-mint

basis is in keeping with the intent of the 1990 amendments because it

would accurately reflect the customarily consumed amounts of small

breath mints that are comparable to large mints in terms of breath

freshening; (3) that the functional utility of breath mints is a

necessary element of the product category definition because the

consumption behavior of consumers is directly related to this

functional utility, analogous to other functional food products such as

artificial sweeteners and salt substitutes; (4) that the burden of

determining breath-freshening ability would be on the manufacturer and

not on FDA; (5) that there is a well-established and accepted

scientific methodology for testing breath malodor (included in the

petition); (6) that the underlying concept in reference amount issues

is the amount customarily consumed; and (7) that the data conclusively

establish that, for the specific product researched, the majority of

consumers eat one mint per eating occasion to attain the same breath-

freshening benefit they would attain by consuming one larger breath

mint.

In addition, the agency received letters from two other

manufacturers of breath mint products requesting a ``1 mint'' serving

size. FDA received one letter and spoke with a manufacturer of breath

mints that are even smaller (0.13 g each) than those discussed in the

petition (Refs. 2 and 3). The letter indicated that under current

regulations, the serving size for the company's product would need to

be expressed as ``15 pieces (2 g).'' The manufacturer stated that the

tablets are promoted as breath mints, that they have been specially

formulated to be extremely potent, and that it is the manufacturer's

intent that the consumer need only use one tablet per occasion to

achieve fresh breath. The manufacturer objected to the 2-g reference

amount because it felt it would be subject to unlimited liability if

the serving size remains 15 tablets for its ``extremely potent'' breath

mint product. The company requested that it be permitted to express the

serving size as one piece. No data were submitted with the request.

The agency received another letter from a manufacturer of breath

mints that are larger (0.67 g each) than those discussed in the

petition (Ref. 4). This letter stated that, in accordance with current

regulations, the serving size for the company's product is expressed as

``3 pieces (2 g).'' The manufacturer stated that the mints are

characterized by strong flavor and are typically consumed one at a

time. The manufacturer objected to being required to list their serving

size as three mints if larger and smaller mints would be permitted to

use a one mint serving size. The manufacturer stated that it would

support a proposal to establish a one mint serving size for breath

mints. No data were submitted in this letter.

III. Basis for the Proposed Action on Serving Size

A. Evaluation of the Appropriateness of the Current Serving Size

Declaration on the Label of Small Breath Mints

As discussed in section I of this document, in the final rule for

serving sizes (58 FR 2229 at 2297), data on large breath mints were

used to establish the 2-g reference amount for the ``Hard candies,

breath mints'' product category.

FDA has carefully reviewed the evidence (e.g., study design,

results, conclusions) supporting the petitioner's request that FDA

create a product category for small breath mints with a reference

amount of 0.5 g (Refs. 5, 6, and 7). The analysis submitted with the

petition was based on ``the number of pieces put into the mouth at one

time.'' However, reference amounts are based on ``amounts customarily

consumed per eating occasion.'' Therefore, FDA reanalyzed the data to

estimate the number of mints customarily consumed at a single eating

occasion. The number of pieces put into the mouth at one time may not

always represent the number of pieces customarily consumed at a single

eating occasion. For example, a person may eat 10 jelly beans within a

few minutes but may only put one piece in his or her mouth at a time

and finish each one before eating another. This situation would still

represent 10 jelly beans eaten during a single eating occasion.

Based on the agency's reanalysis of the data, FDA determined that,

when compared with larger breath mints, people typically eat more small

breath mints at a single eating occasion. The agency calculated that

the mean, median, and modal intakes in the petitioner's survey round to

two mints customarily consumed per eating occasion. This is greater

than the one mint reported by the petitioner, but much less than the

serving size declaration of five breath mints currently required on the

label. Therefore, the data suggest that serving sizes near 2 g are too

large for small breath mint products.

B. Consideration of a Different Reference Amount for Breath Mints

Many of the issues raised by the petitioner and in comments

objecting to the petition (e.g., marketing position, trademarked

slogan, and established serving size declarations) are irrelevant with

regard to determining the reference amount customarily consumed per

eating occasion.

``Breath-freshening'' functionality is important in selecting the

appropriate product category (e.g., ``Hard candies, breath mints'' as

opposed to ``Hard candies, other''). However, neither the petition nor

the comments demonstrated that ``breath freshening efficacy'' and

``breath malodor elimination'' are related to consumption. Therefore,

the extent of breath freshening of these various products is immaterial

in terms of establishing an appropriate reference amount for the

product category ``Hard candies, breath mints.''

Based on the current reference amount of 2 g for the ``Hard

candies, breath mints'' product category, the various breath mint

products discussed with the agency would have the following serving

sizes:

Table 1.--Serving Sizes for Breath Mints

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Large breath mints.................................... 1 mint (2 g)

Medium breath mints................................... 3 mints (2 g)

Small breath mints.................................... 5 mints (2 g)

Very small breath mints............................... 15 mints (2 g)

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In response to the petition, FDA has considered various options for

the breath mint product category and the

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advantages and disadvantages of the various approaches. The agency

searched for a rationale that is applicable to all breath mint products

and that would not penalize small manufacturers who cannot easily

obtain supportive data.

Because consumption is the basis for establishing a reference

amount, the objection in the opposing comments that nearly half of the

users surveyed consumed two or more mints per occasion remains a valid

concern. As stated earlier, FDA's reanalysis of the data on small

breath mints suggests that the consumption per eating occasion is, in

fact, closer to two mints than to one mint (Ref. 5).

However, FDA is not convinced that creating a separate category for

small breath mints in Table 2 of Sec. 101.12 (b) (21 CFR 101.12(b)), as

suggested by the petitioner, is the most reasonable option for

achieving appropriate serving sizes for labeling all of the different

breath mint products on the market. The agency is reluctant to create a

0.5 g-reference amount for small breath mints (as requested by the

petitioner) or a reference amount equivalent to ``2 pieces'' (as

supported by the data). These options may not be appropriate for other

breath mint products and could result in a proliferation of requests

for additional product categories for other breath mints. This action

could evolve into reference amounts that are brand dependent (e.g.,

separate reference amounts for each size or brand of breath mints) and

would require each manufacturer to obtain independent data to

demonstrate how their particular product is used.

The agency is not convinced by the data presented that there is

justification for revising the current reference amount of 2 g because

the majority of breath mint packages sold to consumers contain breath

mints whose weight is closer to 2 g (the weight of large breath mints)

than to any other value (Ref. 8). Furthermore, as discussed in section

III.A of this document, the data available to the agency indicate that

some people may consume more small breath mints than large breath mints

at a single eating occasion, resulting in an amount consumed that is

greater than the weight of an individual small breath mint.

Accordingly, FDA tentatively concludes that there is not a sufficient

basis for revising the current reference amount of ``2 g.''

However, the agency is concerned about the apparent

inappropriateness of the resulting serving sizes on the labels of small

and very small breath mints (e.g., 5 small breath mints or 15 very

small breath mints per serving). The comments that the agency has

received from manufacturers, as well as the limited consumption data

available to FDA, all suggest that the products were designed to be

consumed singly or in small numbers, and that consumers do, in fact,

limit their consumption to such amounts.

Therefore, the agency is persuaded that it is worthwhile to

consider requiring the serving size on the label of all breath mints to

be declared as one mint to more accurately reflect consumption across

the broad spectrum of breath mint sizes, rather than declaring the

serving size in terms of the number of mints closest to the 2-g

reference amount, an amount reflective of products at only one end of

the spectrum. A way to accomplish this approach would be to revise

Footnote 9 to Table 2 in Sec. 101.12 to require the serving size

declaration on the label of breath mints to be expressed as ``1 piece

(____ g)'' similar to the current declaration of ice cream cones, eggs,

and chewing gum but to keep 2 g as the reference amount.

This action would allow comparison of breath mints on a mint-to-

mint basis and would more accurately reflect consumption of this type

of product. A serving size declaration of ``1 mint (2 g)'' would

continue to reflect the consumption data for the large breath mints

that were the basis for the current reference amount. In addition, for

the petitioner's small breath mints, a serving size declaration of ``1

mint (0.4 g)'' is closer to the amount consumed (i.e., 2 mints based on

FDA's reanalysis) than a declaration of ``5 mints (2 g).''

Accordingly, while proposing to maintain a fixed value (2 g) as the

reference amount, FDA is proposing to revise Sec. 101.12, Table 2,

Footnote 9 to state ``Label serving sizes for ice cream cones, eggs,

and breath mints of all sizes will be 1 unit.'' Such action will allow

for efficient enforcement of the act by maintaining one subcategory in

Table 2 for all breath mints, yet it will prevent consumer confusion

that could result from inappropriately high numbers of pieces specified

for a serving on the nutrition label.

At the same time, by maintaining a fixed value (2 g) as the

reference amount, this action provides for a consistent basis for

nutrient content and health claims, although in all likelihood the

reference amount will have little impact on most claims. For example,

because the reference amount is small (i.e., 30 g or less or 2

tablespoons or less), products making ``low'' claims (e.g., ``low

calorie'') must meet the claim criteria based not only on the amount of

the nutrient per reference amount but also per 50 g of product. The per

50-g criterion will be the most difficult for breath mints to meet and

will, therefore, be the determining factor. For ``free'' claims,

products must meet the claim criteria based on the amount of the

nutrient per serving size (one piece) and per reference amount (2 g).

Thus, a ``calorie free'' claim would only be permitted on products

containing less than 5 calories per breath mint and per 2 g of breath

mints (e.g., in the case of small breath mints, the product would have

to have less than 5 calories per five pieces, so a small breath mint

with 1 1/2 calories per mint would not be ``calorie free'').

IV. Basis for the Proposed Action on Declaration of Calories

FDA's regulations permit a claim about the amount of a nutrient in

a product (e.g., ``1 tablet has 5 calories'') provided that: (1) It is

a factual statement that is not false or misleading; and (2) it does

not in any way implicitly characterize the level of the nutrient as

being high or low (Sec. 101.13(i)(3)). In addition, the amount claimed

must be accompanied by a referral statement (e.g., ``See back panel for

nutrition information'') (Sec. 101.13(g)). These claims may be based on

the amount of the nutrient in a serving or unit of the product. To not

be misleading, claims based on the amount of nutrient in a unit (e.g.,

one mint) must identify the unit if the serving size declared on the

label is not one unit.

Under the agency's nutrition labeling regulations, products

containing less than 5 calories per serving must either declare the

calories to the nearest 5-calorie increment, i.e., as ``5 calories,''

or as ``0'' (Sec. 101.9(c)(1)). Accordingly, calorie values of 2.49 or

less per serving would always be declared in the nutrition label as

``0,'' while values of 2.5 to 4.99 calories could be declared as ``0''

or rounded to ``5.'' FDA set the rounding rules because it concluded

that the caloric contribution of foods could not be determined with

sufficient accuracy to justify smaller increments (55 FR 29487 at

29503, July 19, 1990). In addition, FDA concluded that amounts of less

than 5 calories per serving are trivial and of no physiological

significance (56 FR at 60421 at 60438, November 27, 1991).

The agency is aware, however, that amount claims are being made

under Sec. 101.13(i)(3) on labels of breath mints stating that the

mints have 1 1/2 calories, a specific amount that is not allowed to be

declared on the nutrition label.

While the regulations do not specifically state that the

quantitative

[[Page 67778]]

amount specified in an amount claim must be consistent with the amount

declared on the nutrition label, the agency has stated its belief in

the importance of consistency between nutrient content claims and

information in the nutrition label to prevent consumer confusion

(technical amendments published on August 18, 1993 (58 FR 44020 at

44024)). This expectation of consistency appears to have been shared by

at least one comment who suggested that ``FDA should permit the use of

amount and percentage statements to convey information regarding the

calorie content per serving of food, consistent with the number of

calories that appear on the nutrition panel'' (58 FR 2302 at 2309).

FDA still considers the difference between 0 and 5 calories to be

insignificant. However, the agency does not consider it likely that

consumers would be misled by a calorie declaration of less than 5

calories. Results of an FDA nutrition label format study found that

consumers respond to the absolute size of numbers used to describe

nutrient amounts. Subjects estimated the significance of all small

numbers as small (Refs. 9 and 10).

Therefore, the agency tentatively concludes that consumers will

interpret any specific calorie declaration of less than 5 calories as

implying that the food has an insignificant amount of calories. To

resolve the discrepancy of declaring 0 calories on the nutrition label

and amounts such as 1, 1.5, or 2 calories in an amount claim elsewhere

on the label and to allow manufacturers more flexibility in label

statements, FDA is proposing to modify Sec. 101.9(c)(1) to state that,

if a manufacturer provides a claim about the amount of calories in a

food for which a serving of a product contains less than 5 calories per

serving, e.g., ``1 calorie per mint,'' the number of calories declared

in the nutrition label shall be consistent with the amount declared in

the claim. FDA is also proposing to amend Sec. 101.9(c)(1) to allow the

nutrition label on any product with less than 5 calories per serving to

optionally declare the exact amount of calories in lieu of zero

calories. This added flexibility will allow any products with less than

5 calories per serving to declare the exact amount of calories rather

than just those products that make amount claims on the label.

V. Effective Date

The agency periodically establishes by final rule in the Federal

Register uniform effective dates for compliance with food labeling

requirements (see, e.g., the Federal Register of December 27, 1996 (61

FR 68145)). FDA proposes that any final rule that may issue based upon

this proposal become effective in accordance with a uniform effective

date for compliance with food labeling requirements, which is

established by final rule in the Federal Register and which is not

sooner than 1 year following publication of any final rule based upon

this proposal. The final rule would apply to affected products

initially introduced or initially delivered for introduction into

interstate commerce on or after its effective date. However, FDA notes

that it generally encourages industry to comply with new labeling

regulations as quickly as feasible. Thus, when industry members

voluntarily change their labels, it is appropriate that they respond to

any new requirements that have been published as final regulations up

to that time. On the other hand, if any industry members can foresee

that the proposed effective date will create particular problems, they

should bring these problems to the agency's attention in comments on

this proposal.

VI. Environmental Impact

The agency has determined under 21 CFR 25.32(p) 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. Executive Order 12866 Analysis

FDA has examined the economic implications of the proposed rule as

required by Executive Order 12866. 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 which 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. FDA

finds that this proposed rule is not a significant rule as defined by

Executive Order 12866.

This proposed rule will cause the labels of small breath mints to

be revised. FDA estimates that there are 18 brands and 125 labels of

breath mints of all sizes. Of those breath mints for which FDA has

information regarding the size of the product, there are 4 firms

producing 5 brands of small breath mints, or 30 distinct small breath

mint labels. For breath mint products, the average administrative,

redesign, and inventory disposal costs for a labeling change of this

type, with a 1-year compliance period are $500 per label, or a total of

$15,000.

The benefit of this proposed regulation is that manufacturers can

provide a serving size that is more appropriate for small breath mints

providing more accurate information to consumers.

VIII. Small Entity Analysis

FDA has examined the economic implications of the proposed rule as

required by the Regulatory Flexibility Act (5 U.S.C. 601-612). 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. Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the

agency certifies that this proposed rule will not have a significant

impact on a substantial number of small entities.

According to the Regulatory Flexibility Act, the definition of a

small entity is a business independently owned and operated and not

dominant in its field. The Small Business Administration has set size

standards for most business categories through use of four-digit

Standard Industrial Classification codes. FDA estimates that three of

the firms producing small breath mints are small (under 500 employees).

One of these small entities is the petitioner. FDA has received

information from the other two small entities stating that they are in

favor of granting the petition. Because FDA is providing these small

entities with exactly what they requested, the agency concludes that

this rule will not result in a significant impact on a substantial

number of small entities.

IX. The Paperwork Reduction Act of 1995

This proposed rule contains information collection requirements

that are subject to review by the Office of Management and Budget (OMB)

under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-

3520). The title, description, and respondent description of the

information collection requirements are shown below with an estimate of

the annual reporting burden. Included in the estimate is the time for

reviewing instructions, searching existing data sources, gathering and

maintaining the data needed, and

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completing and reviewing each collection of information.

FDA invites comments on: (1) Whether the proposed collection of

information is necessary for the proper performance of FDA's functions,

including whether the information will have practical utility; (2) the

accuracy of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

Title: Nutrition Labeling; Declaration of Caloric Amounts and

Serving Sizes for Breath Mints.

Description: Section 403(q) of the act requires that the label or

labeling of a food bear nutrition information, including information on

the number of calories present in the product and the serving size and

number of servings per container. FDA has issued regulations in

Sec. 101.9(c)(1) that require that the nutrition facts panel of the

food label disclose the number of calories in the food. FDA has issued

regulations in Sec. 101.9(d)(3) that require that the nutrition facts

panel disclose the serving size of the food product and the number of

servings in each package.

The regulations set forth in this proposed rule would modify the

rounding rules for calories in Sec. 101.9(c)(1) to allow the voluntary

declaration of caloric amounts of less than 5 in the nutrition label.

The regulations would also require that the number of calories declared

on the nutrition label of a food product be consistent with any claims

about caloric content that are made in its labeling. As a result of

this proposed rule, manufacturers and other producers of products that

make claims that their products contain between 1 and 5 calories would

be required to change the declaration of the amount of calories on the

nutrition label. Finally, as a result of the proposed rule,

manufacturers of small breath mints would be required, under

Sec. 101.9(b), to change the serving size disclosed on the labels of

their products and, under Sec. 101.9(c) and (d), the amounts and daily

values for nutrients listed in the nutrition label for their products.

Description of Respondents: Persons and businesses, including small

businesses.

Table 2.--Estimated Additional Reporting Burden1

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Total

21 CFR Section No. of Total No. of Hours per Total Hours Operating

Respondents Responses Response Costs

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101.9(b) and (c)(1) 4 30 1 30 $15,000

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\1\ There are no capital or maintenance costs associated with this collection of information.

The proposed modification of the rules for the declaration of the

amount of calories and the proposed change of the label serving size on

the nutrition facts panel would result in a one-time burden created by

the need for firms to revise their labels. In addition to changing the

statement of calories and the serving sizes, firms would have to

recalculate the number of servings per container and any nutrient

amounts and Daily Values affected by the change in serving size. As

noted in section VII of this document, Executive Order 12866 Analysis,

FDA is aware of only four firms that currently market small breath

mints. These are the only firms that would be affected by this proposed

rule. FDA estimates that there are approximately 30 labels for products

marketed by these firms that would require revision because of this

proposed rule. FDA estimates that these firms would require an average

of 1 hour per label to comply with the requirements of a final rule

based on this proposal. Further, as discussed in section VII of this

document, Executive Order 12866 Analysis, the proposed rule would

result in a one-time operating cost of $500 per label or a total

estimated operating cost of $15,000.

In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)),

the agency has submitted the information collection requirements of the

proposed rule to OMB for review. Interested persons are requested to

send comments regarding information collection by January 29, 1998, to

the Office of Information and Regulatory Affairs, OMB (address above),

ATTN: Desk Officer for FDA.

X. Comments

Interested persons may, on or before March 16, 1998, 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.

XI. 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. Memorandum to file, from Lori A. LeGault and Ellen M.

Anderson, Center for Food Safety and Nutrition (CFSAN), FDA, August

28, 1997.

2. Letter to F. Edward Scarbrough, CFSAN, FDA, from Richard J.

Litner, Nutrinfo Corp., August 24, 1994.

3. Memorandum of telephone conversation between Ellen M.

Anderson, CFSAN, FDA, and Richard J. Litner and David Kiernan,

Nutrinfo Corp., November 4, 1994.

4. Letter to F. Edward Scarbrough, CFSAN, FDA, from Sheryl A.

Marcouiller, Kraft Foods, June 28, 1996.

5. Memorandum from Sara Fein, CFSAN, FDA, to Lynn McFerron,

CFSAN, FDA, September 9, 1994.

6. Memorandum from Sara Fein, CFSAN, FDA, to Lori LeGault,

CFSAN, FDA, February 5, 1996.

7. Memorandum to file from Lori A. LeGault and Ellen M.

Anderson, CFSAN, FDA, August 28, 1997.

8. Memorandum to file from Thomas B. O'Brien, Mary M. Bender,

and Ellen M. Anderson, CFAN, FDA, August 28, 1997.

9. Memorandum from Sara B. Fein, CFSAN, FDA, to Virginia

Wilkening, CFSAN, FDA, May 13, 1997.

10. Levy, Alan S., Sara B. Fein, and Raymond E. Schucker,

``Performance Characteristics of Seven Nutrition Label Formats,''

Journal of Public Policy and Marketing, 15 (1)(Spring 1996): 1-15.

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:

[[Page 67780]]

PART 101--FOOD LABELING

1. The authority citation for 21 CFR part 101 continues to read as

follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,

343, 348, 371.

2. Section 101.9 is amended by revising paragraph (c)(1)

introductory text to read as follows:

Sec. 101.9 Nutrition labeling of food.

* * * * *

(c) * * *

(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A

statement of the caloric content per serving, expressed to the nearest

5-calorie increment, up to and including 50 calories, and 10-calorie

increment above 50 calories, except that amounts less than 5 calories

may be expressed either as zero or as the exact amount. However, if a

manufacturer provides a claim under Sec. 101.13(i) about the amount of

calories in a serving of a product containing less than 5 calories

(e.g., ``1 calorie per mint''), the number of calories declared in the

nutrition label shall be consistent with that declared in the amount

claim (e.g., ``1''). Energy content per serving may also be expressed

in kilojoule units, added in parentheses immediately following the

statement of the caloric content.

* * * * *

3. Section 101.12 is amended in paragraph (b), Table 2, under the

``Sugars and Sweets'' category by revising the entry for ``Hard

candies, breath mints'' and Footnote 9 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 Supply 1 2 3 4

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

Product category Reference amount Label Statement 5

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

* * * * * *

*

Sugars and Sweets:

* * * * * *

*

Hard candies, breath mints 9 2 g ____ piece(s) (____ g)

* * * * * *

*

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

\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; 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\ Manufactures 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).

\6\ Includes cakes that weigh 10 g or more per cubic inch.

\7\ Includes cakes that weigh 4 g or more per cubic inch but less than 10 g per cubic inch.

\8\ Includes cakes that weigh less than 4 g per cubic inch.

\9\ Label serving size for ice cream cones, eggs, and breath mints of all sizes will be 1 unit. Label serving

size of all chewing gums that weigh more than the reference amount that can reasonably be consumed at a single-

eating occasion will be 1 unit.

* * * * *

Dated: December 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-33926 Filed 12-29-97; 8:45 am]

BILLING CODE 4160-01-F