Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67775

between 9 a.m. and 4 p.m., Monday

through Friday.

1. DHHS, Public Health Service (PHS),

‘‘The Surgeon General’s Report on Nutrition

and Health,’’ U.S. Government Printing

Office, Washington, DC, pp. 139 to 143, 157

to 161, 165, and 167 to 174, 1988.

2. FNB/NAS, Diet and Health, National

Academy Press, Washington, DC, pp. 355 to

356, 549 to 553 and 556 to 561, 1989.

3. Joint National Committee on Detection,

Evaluation, and Treatment of High Blood

Pressure, ‘‘The Fifth Report of the Joint

National Committee on Detection,

Evaluation, and Treatment of High Blood

Pressure,’’ Archives of Internal Medicine,

153:154 to 183, 1993.

4. Nutrition Committee, American Heart

Association, ‘‘Dietary Guidelines for Healthy

American Adults—A Statement for Health

Professionals from the Nutrition Committee,

American Heart Association,’’ Circulation,

94:1795 to 1800, 1996.

5. LSRO, ‘‘Evaluation of Publicly Available

Scientific Evidence Regarding Certain

Nutrient-Disease Relationships, 4. Sodium

and Hypertension,’’ Bethesda, MD, December

1991.

6. FNB, National Research Council,

‘‘Recommended Dietary Allowances,’’ 10th

ed., National Academy Press, Washington,

DC, pp. 247–261, 1989.

7. USDA, DHHS, ‘‘Report of the Dietary

Guidelines Advisory Committee on the

Dietary Guidelines for Americans,’’ USDA,

Washington, DC, 1995.

8. USDA, DHHS, ‘‘Nutrition and Your

Health: Dietary Guidelines for Americans,’’

4th ed., Home and Garden Bulletin No. 232,

1995.

Dated: December 10, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–33921 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–01–F

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.

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
67776 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

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

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)

In response to the petition, FDA has

considered various options for the

breath mint product category and the
Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67777

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 § 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 greference 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 § 101.12 to require the

serving size declaration on the label of

breath mints to be expressed as ‘‘1 piece

(ll 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 § 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 (§ 101.13(i)(3)). In

addition, the amount claimed must be

accompanied by a referral statement

(e.g., ‘‘See back panel for nutrition

information’’) (§ 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’’ (§ 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

§ 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
67778 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

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 § 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 § 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
Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67779

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

§ 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

§ 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

§ 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 § 101.9(b), to change the serving

size disclosed on the labels of their

products and, under § 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

21 CFR Section No. of

Respondents

Total No. of ResponsesHours per

Response Total Hours Total OperatingCosts

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

1There 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:
67780 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

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:

§ 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 § 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:

§ 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 ll piece(s) (ll g)

* * * * * * *

1These 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. 5The 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 § 101.9(b) using the reference amount determined according to § 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

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[REG–209463–82]

RIN 1545–AV82

Required Distributions From Qualified

Plans and Individual Retirement Plans

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Notice of proposed rulemaking.

SUMMARY: This document contains

amendments to the existing proposed

regulations under section 401(a)(9) that

make changes to the rules that apply if

a trust is named as a beneficiary of an

employee’s benefit under a retirement

plan. These proposed regulations will

affect administrators of, participants in,

and beneficiaries of qualified plans,

institutions which sponsor and

individuals who administer individual

retirement plans, individuals who use

individual retirement plans, simplified

employee pensions and SIMPLE Savings

Plans for retirement income and

beneficiaries of individual retirement

plans; and employees for whom

amounts are contributed to section

403(b) annuity contracts, custodial

accounts, or retirement income accounts

and beneficiaries of such contracts and

accounts.

DATES: Written comments and requests

for a public hearing must be received by

March 30, 1998.

ADDRESSES: Send submissions to

CC:DOM:CORP:R (REG–209463–82),