Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67771

Interested persons may, on or before

February 13, 1998, submit written

comments on the data developed under

Study B to the Dockets Management

Branch (address above). 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 and labeled ‘‘ATTN: Study B,

OTC Drug Labeling Data Collection.’’

The data, frequency tabulations, and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday. An electronic

format of the data are available on the

internet at: www.fda.gov/CDER/ or can

be obtained in electronic form from the

Dockets Management Branch at the

address listed above.

Dated: December 19, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33803 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 Nos. 91N–384H and 96P–0500]

RIN 0910–AA19

Food Labeling: Nutrient Content

Claims, Definition of Term: Healthy

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is considering whether to

institute rulemaking to reevaluate and

possibly amend certain provisions of the

nutrient content claims regulations

pertaining to the use of the term

‘‘healthy.’’ This action is in response to

a citizen petition from ConAgra, Inc., to

amend the definition of this term. The

petitioner has raised important issues

regarding both the technological

feasibility of reductions in sodium

levels in foods that currently meet

FDA’s definition for the term ‘‘healthy’’

and the safety of at least some of these

foods if there are reductions in their

sodium levels. The agency is requesting

that data be submitted relative to these

issues. In addition, FDA is responding

to comments that it received in response

to a stay of certain provisions pertaining

to the use of the term ‘‘healthy.’’

DATES: Written comments by March 16,

1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Joyce J. Saltsman, Center for Food Safety

and Applied Nutrition (HFS–165), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5483.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 10,

1994 (59 FR 24232), FDA published a

final rule to establish a definition of the

term ‘‘healthy’’ under section 403(r) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 343(r)). In that

final rule, FDA stated that the

fundamental purpose of a ‘‘healthy’’

claim is to highlight those foods that,

based on their nutrient levels, are

particularly useful in constructing a diet

that conforms to current dietary

guidelines (59 FR 24232 at 24233). In its

consideration of comments relative to

the proposed qualifying level of sodium

to be incorporated into the definition of

the term ‘‘healthy,’’ the agency rejected

comments that suggested that the food

should meet the requirements for ‘‘low

sodium’’ (59 FR 24232 at 24239). The

agency stated that such a definition was

too restrictive, and that many foods that

would otherwise meet the definition of

‘‘healthy’’ would be disqualified by a

‘‘low sodium’’ requirement. The agency

stated that for the claim to be useful,

foods that are able to bear the term

should be of a sufficient number and

variety to help consumers achieve a

total diet that is consistent with current

dietary recommendations (59 FR 24232

at 24239).

The agency explained that sodium

plays an important role in consumer

acceptance of a product, and that many

products that qualify to bear a claim for

‘‘healthy’’ may lose their appeal to

consumers because of an unacceptable

flavor profile if, in addition to being low

in fat and saturated fat, the foods were

low in sodium. FDA stated that, if

consumers abandon products or add salt

to taste at the table, foods bearing the

term would lose their usefulness in

assisting consumers to achieve dietary

recommendations with respect to

sodium intake (59 FR 24232 at 24239).

Based on the comments to the

proposed rule for ‘‘healthy’’ relative to

specific sodium levels, the agency

adopted qualifying criteria of 360

milligrams (mg) of sodium per reference

amount customarily consumed (RACC)

in individual foods and 480 mg sodium

per RACC in main dish and meal

products (59 FR 24232 at 24240). In

addition, the agency established a

transition period to allow time for

industry to reformulate products to meet

the new qualifying sodium levels. The

agency determined that levels of 480 mg

of sodium in individual foods, single

ingredient seafood, and game meat, and

of 600 mg of sodium in main dishes and

meal products, were appropriate levels

during the transition period, but that

after January 1, 1998 (essentially 3-1/2

years from the date of publication of the

final rule), these foods would have to

meet the lower sodium qualifying levels

to bear the claim ‘‘healthy’’ (59 FR

24232 at 24241 and 24245 and see

§ 101.65(d)(2)(ii), (d)(3)(ii), and (d)(4)(ii)

(21 CFR 101.65(d)(2)(ii), (d)(3)(ii), and

(d)(4)(ii))).

On December 13, 1996, FDA received

a petition from ConAgra, Inc. (the

petitioner), 888 17th St. NW., suite 300,

Washington, DC 20006, requesting that

§ 101.65(d) be amended to ‘‘eliminate

the sliding scale sodium requirement for

foods labeled ‘healthy’ by eliminating

the entire second tier levels of 360 mg

sodium for individual foods and 480 mg

sodium for meals and main dishes’’

(Docket 96P–0500, CP–1, p. 1).

Alternatively, the petitioner requested

that the effective date of January 1,

1998, in § 101.65(d)(2) through (d)(4) be

delayed until such time as food

technology catches up with FDA’s goals

to reduce the sodium content of foods,

and until there is a better understanding

of the relationship between sodium and

hypertension.

The agency was persuaded by the

petition that it is in the public interest

to stay the effect of the lower standards

for sodium in the definition of

‘‘healthy’’ in § 101.65 while the agency

endeavors to resolve the issues raised by

the petition. Therefore, in the Federal

Register of April 1, 1997 (62 FR 15390),

FDA published a final rule that stayed,

until January 1, 2000, the effective date

of January 1, 1998, in § 101.65(d)(2)(ii)

and (d)(4)(ii) for when foods must

achieve the lower sodium levels (the

‘‘second tier levels’’) to qualify to bear

the term ‘‘healthy.’’ The agency said that

it was issuing the stay to allow itself

time to reevaluate the standard, and to

evaluate the data contained in the

petition and any additional data that it

may receive; to conduct any subsequent

notice-and-comment rulemaking that it

finds is necessary; and to allow ample

time for implementation of the rule or

of any changes in the rule that may

result from the agency’s reevaluation.
67772 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

Accordingly, FDA announced that

interested persons may submit

comments regarding the appropriateness

of the basis for the stay and the

feasibility of further lowering the

sodium level in foods while maintaining

consumer acceptability.

FDA is issuing this advance notice of

proposed rulemaking (ANPRM) to

respond to the comments that it

received in response to the stay and to

solicit comments and additional

information on whether it should

propose to amend the definition of the

term ‘‘healthy’’ relative to the sodium

requirements. Those interested persons

that believe that the agency should

amend the ‘‘healthy’’ definition should

address what the amended regulation

should require to ensure that the term

can appear on a significant number of

foods but is not so broadly defined as

to lose its value in highlighting foods

that are useful in constructing a diet that

is consistent with dietary guidelines.

Those who believe that the current

definition is appropriate and should not

be changed should provide data that

demonstrate that the definition, with the

sodium levels that were scheduled to

take effect in January of 1998, is not so

restrictive as to effectively preclude use

of the term.

II. FDA’s Response to Comments on the

Stay of Certain Provisions in the

Definition of ‘‘Healthy’’

FDA received eight comments in

response to the stay of the sodium

provisions in § 101.65(d)(2)(ii) and

(d)(4)(ii) from industry, trade

associations, a health care association,

and a Federal Government agency. Most

of the comments agreed with the

agency’s decision to stay these

provisions until January 1, 2000, to

allow the agency time to reevaluate the

standard on the basis of available data,

including the data contained in the

petition and any additional data that the

agency may receive.

Three comments disagreed with the

agency’s decision to stay the

regulations. Two of the comments

asserted that to stay the sodium level is

a disadvantage to those companies that

are ready to produce products that

qualify to bear the term ‘‘healthy’’ under

the stayed provisions. One comment

stated that the consumer benefits if

companies are prepared and allowed to

respond to the opportunity to be one of

a few or of several to offer and label

foods as ‘‘healthy.’’ The other comment

stated that many companies have

demonstrated their ability and

willingness to manufacture products

that meet the lower second-tier sodium

levels in § 101.65(d)(2)(ii) and (d)(4)(ii).

The comment stated that reducing

sodium intake is one component of a

comprehensive nutritional approach to

blood pressure lowering that would

benefit many Americans.

One comment stated that FDA’s

decision to stay the lower sodium

requirements conflicts with the agency’s

findings in adopting the ‘‘healthy’’ final

rule in 1994. The comment noted that,

in the final ‘‘healthy’’ regulation, FDA

arrived at the final sodium criteria based

on four key findings: (1) The levels will

assist consumers in constructing a diet

consistent with dietary guidelines; (2)

they provide for a reasonable amount of

sodium that enables a wide variety of

foods to use the ‘‘healthy’’ claim

without compromising the appeal of the

food; (3) the levels are not so restrictive

that they are likely to disqualify many

foods that are recommended to be

included in a healthy diet; and (4) the

level ensures consistency with the U.S.

Department of Agriculture (USDA). The

comment stated that FDA seems willing

to ignore its stated public health goals

out of concern that certain foods may

not be commercially viable at the levels

of sodium determined by FDA to be

appropriate.

FDA recognizes that some companies

will have reformulated their products to

meet the second tier sodium levels in

§ 101.65(d)(2)(ii) and (d)(4)(ii) by 1998,

but it disagrees with the comments that

stated that the stay will put these

companies at a disadvantage. These

companies will be able to make

comparative claims that highlight their

achievement (e.g., ‘‘25 percent less

sodium than Brand X’’). As stated in the

final rule of April 1, 1997, FDA

encourages manufacturers who can meet

the lower sodium levels for particular

foods to do so even as the agency

reevaluates the issues discussed in the

petition (62 FR 15390 at 15391).

The agency also disagrees that it is

ignoring the basis on which it

established the sodium criteria out of

concern that certain foods may not be

commercially viable at the second-tier

sodium levels. The petitioner raised

significant questions, based on work

that it did after publication of the

‘‘healthy’’ final rule, relative to the

second of the four key findings noted

previously; namely, whether there will

be a wide variety of foods that will

qualify to use the term ‘‘healthy’’ at the

second-tier sodium levels that are also

acceptable to consumers. Given this

fact, but given that the scientific

evidence indicates further reductions in

fat and sodium intakes will result in

meaningful public health gains (62 FR

15390), the agency is staying the second

tier levels until it resolves this issue.

The agency is concerned that if the

technology does not yet exist that

permits manufacturers to produce, by

January 1, 1998, certain types of

reduced sodium foods that are

acceptable to consumers, the possibility

exits that the term ‘‘healthy’’ will

disappear from the market. FDA will

evaluate the data that it receives on

whether the technological barriers to

reducing the sodium content to the

lower levels required in

§ 101.65(d)(2)(ii) and (d)(4)(ii), and

likewise for § 101.65(d)(3)(ii), are

insurmountable or not. The burden is on

interested persons to provide

convincing evidence to show why the

lower sodium levels are not attainable.

If they fail to do so, the lower sodium

levels will become effective on January

1, 2000.

III. Petition to Amend the Definition of

‘‘Healthy’’ and the Agency Response

A. The Petition

The petitioner cited as grounds to

amend the definition of ‘‘healthy’’: (1) A

lack of scientific basis supporting the

Daily Reference Value for sodium and

the allowable levels of sodium in

§ 101.65(d); (2) a lack of consumer

acceptance of products containing low

sodium levels; (3) a lack of acceptable

sodium substitutes and the difficulties

in manufacturing whole lines of food

products at low sodium levels; and (4)

FDA’s failure to provide notice and

comment on the second tier sodium

levels in the ‘‘healthy’’ definition, to

follow directives of the Nutrition

Labeling and Education Act of 1990 (the

1990 amendments), and to consider

recent scientific studies that raise

concerns if too little sodium is

consumed (Docket 96P–0500, CP–1, p.

3).–

Relative to the efforts of industry to

lower the sodium level of foods, the

petitioner stated that the technology

does not yet exist to manufacture certain

low fat products that both contain the

levels of sodium necessary to satisfy the

second tier requirements in the

‘‘healthy’’ definition and are acceptable

to consumers (Docket 96P–0500, CP–1,

p. 24). The petitioner argued that there

is no adequate substitute for sodium

chloride as a provider of a salty taste

(Docket 96P–0500, CP–1, p. 36). In

addition, the petitioner stated that salt

enhances or modifies all flavors of food,

and that flavors are dulled or become

harsh when salt is reduced.

The petitioner submitted the results of

a consumer survey that examined

consumer acceptance of three products

(hot dogs, macaroni and cheese, and

chicken soup) with different sodium
Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67773

levels (600 mg, 480 mg, and 360 mg

sodium per serving) (Docket 96P–0500,

CP–1, pp. 25 to 28 and exhibit 161).

While the results of the survey show

reductions in consumer acceptance at

levels of 480 mg sodium, a much

greater, i.e., a statistically significant,

reduction occurred at levels of 360 mg

sodium per serving. As stated by the

petitioner, ‘‘If the sodium is so low in

a product as to render the product

tasteless or even bad tasting, consumers

will not eat the product or will reach for

the table salt. This is counter productive

to the intent of the 1990 amendments

and will not result in the goal Congress

envisioned; i.e., to improve the eating

habits of the American public, but

instead could result in even more salt

intake—not less’’ (Docket 96P–0500,

CP–1, p.28).

The petitioner also delineated several

technological concerns associated with

lowering the sodium levels in foods

related to the functional role of salt. For

example, the petitioner described the

effects of such reductions on the

microbial stability of perishable

products, on product texture and water

binding capacity, on the flavor

characteristics of certain ingredients,

and on total electrolyte levels, which,

the petitioner asserted, play a critical

role in product safety (Docket 96P–0500,

CP–1, pp. 28 to 30).

The petitioner explained that a

number of novel, proprietary, and

known technological approaches to

replace or potentiate sodium have been

evaluated, but that, to date, none have

been found to have suitable consumer

acceptance. The petitioner stated that

potassium chloride, often cited as

capable of increasing salty taste, is also

known for leaving a bitter aftertaste and

has not gained widespread, satisfactory

consumer acceptance (Docket 96P–0500,

CP–1, p. 41). The petitioner suggested

that to achieve the second-tier sodium

levels as defined for ‘‘healthy’’ will

require the ‘‘invention, development,

and commercialization of ingredients or

components that do not exist today’’

(Docket 96P–0500, CP–1, p. 41).

B. The Agency Response

FDA finds that some of the issues

raised in the petition regarding the

second tier sodium levels appear to

have merit. Others do not.

The agency does not find merit in the

petition’s questions regarding the lack of

scientific basis for the usefulness of

lowered sodium levels in the diet of the

general population. There is significant

scientific agreement that lower dietary

sodium levels reduce the risk of

hypertension (Refs. 1 to 7). The

overwhelming majority of experts and of

authoritative bodies still favors making

recommendations for the general public

to moderate sodium intake. This

consensus is reflected in the Dietary

Guidelines for Americans (Ref. 8).

FDA also finds the petitioner’s

argument that the agency failed to

provide notice and comment on the

second tier sodium levels in the

‘‘healthy’’ definition to be without

merit. The revisions in the sodium

requirements for individual foods and

main dishes and meal products that

were adopted in the ‘‘healthy’’ final rule

were a logical outgrowth of the proposal

(59 FR 24232 at 24241). In the proposal,

the agency asked for comments for

evaluating whether the definition of

‘‘healthy’’ that it had proposed (i.e.,

foods that do not exceed the disclosure

level for sodium or cholesterol and are

‘‘low’’ in fat and saturated fat) was

appropriate (58 FR 2944 at 2947). FDA

acknowledged that its proposed

definition of the term ‘‘healthy’’ differed

from the definition for ‘‘healthy’’ that

was proposed by USDA (i.e., meat or

poultry that contain less than 10 grams

(g) of fat, less than 4 g of saturated fat,

less than 95 mg of cholesterol, and less

than 480 mg of sodium per 100 g and

per reference amount customarily

consumed for individual foods, and per

100 g and labeled serving for meal-type

products) (58 FR 688); and FDA asked

for comments on whether it was

necessary that FDA and USDA provide

uniform criteria for use of this term, or

whether different definitions would be

appropriate (58 FR 2944 at 2948). As

stated previously, the agency received

comments that argued that FDA should

adopt levels both lower and higher than

those that it proposed and those that it

adopted (see 59 FR 24232 at 24238 and

24239). FDA considered the information

submitted in the comments in arriving

at the final levels (see 59 FR 24232 at

24239 to 24241). Thus, the agency

provided full and adequate notice of its

intent to adopt sodium levels, and the

levels that it adopted were the logical

outgrowth of the proposal. See Small

Refiner Lead Phase-Down Task Force v.

USEPA, 70S F.2d 506, 548–550 (D.C.

Cir. 1983).

However, the agency does find that

the issues relative to technological and

safety concerns of reduced sodium

foods present important questions that

merit further consideration.

FDA has defined the term ‘‘healthy’’

to serve as a means to help consumers

to identify food products that will help

them meet the guidelines for a healthy

diet. Consumers understand the

significance of this term, and thus many

make purchasing decisions based on its

presence on a food label. Because of this

fact, manufacturers have an incentive to

produce foods that qualify to bear this

term. If the petitioner is correct that the

technology does not yet exist that will

permit manufacturers, by January 1,

1998, to produce certain types of low fat

foods at the lower levels of sodium

required in § 101.65(d) that are still

acceptable to, and safe for, consumers,

then the possibility exists that ‘‘healthy’’

will disappear from the market for such

foods. This result would force

consumers who are interested in foods

with restricted fat and sodium levels to

choose among foods in which an effort

has been made to lower the level of one

or the other of these nutrients but not

necessarily both. If this situation comes

to pass, FDA will have squandered a

significant opportunity. Therefore, the

agency has decided that, before allowing

the new sodium levels for ‘‘healthy’’ to

go into effect, it needs to explore

whether it has created an unattainable

standard for many types of foods.

Accordingly, FDA is considering

whether to institute rulemaking to

resolve the issues raised by the petition

and to reevaluate the sodium provisions

of the nutrient content claims

regulations pertaining to the use of the

term ‘‘healthy.’’ In this notice, the

agency is asking for data or evidence on

what will happen to the use of the term

‘‘healthy’’ in the market if the secondtier sodium levels were in effect. How

many products that bear the term

‘‘healthy’’ would be eliminated? Would

there be other impacts on the number of

consumer choices?

The agency is also asking for: (1) Data

regarding the technological feasibility of

reducing the sodium content of

individual foods (including single

ingredient seafood and game meats) to

360 mg per RACC and of reducing the

sodium content of meals and main

dishes to 480 mg sodium per labeled

serving, and (2) additional information

or views on consumer acceptance of

foods with such sodium levels.

With regard to technological

feasibility, the agency is asking for

information about the availability or

lack of availability of acceptable sodium

substitutes, the difficulties in

manufacturing different lines of food

products with lowered sodium levels,

and the impact of these sodium levels

on the shelf-life stability and the safety

of the food. Are there certain types of

foods for which it is not possible to

reach the second tier levels of sodium?

If so, what are these foods? Should FDA

make special exemptions for them, or

should FDA exclude them from bearing

the term ‘‘healthy?’’

The agency is also asking for

comments on other approaches to
67774 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

reduce the amount of sodium in foods

labeled ‘‘healthy.’’ It is important that

consumers seeking to eat a healthpromoting diet have food choices

available that enable them to reduce the

amount of sodium in their diet.

If the comments reveal that agreement

exists that there are technological

hurdles that cannot be overcome at this

time for all foods, or certain types of

food, the agency is interested in

exploring options for maximizing the

public health gains that would come

from reducing dietary sodium levels. To

this end, the agency has identified the

following four options that seem to

represent the available alternatives.

One, the agency may make no changes

to the stayed rule, and the second tier

sodium levels in § 101.65(d)(2)(ii) and

(d)(4)(ii) will become effective on

January 1, 2000. This is the default

option should the industry fail to

provide evidence, data, or arguments

that support amendment of these

sections. Adequate support for these

levels existed at the time FDA published

the May 10, 1994, final rule; and the

agency will not hesitate to reconfirm

them in the event that the industry fails

to provide evidence to persuade FDA to

do otherwise.

Two, FDA can propose to amend the

definition of ‘‘healthy’’ in

§ 101.65(d)(2)(ii) and (d)(4)(ii) as

requested in the petition, and, at the

same time, propose to amend

§ 101.65(d)(3)(ii), to make the current

sodium levels for individual foods,

single ingredient seafood and game

meats, main dishes, and meal products

the qualifying levels and to delete

§ 101.65(d)(2)(ii)(C)(1) and

(d)(2)(ii)(C)(2), (d)(3)(ii)(C)(1) and

(d)(3)(ii)(C)(2), and (d)(4)(ii)(B) in their

entirety. FDA is likely to propose this

option should the evidence submitted in

response to this ANPRM demonstrate

that it is technologically impossible to

find salt substitutes for use in any type

of food that would satisfactorily meet

the requirements for taste, texture,

safety, and consumer acceptance.

However, persons who support this

course would have to provide evidence

on the efforts that they or others have

made to comply with the second tier

sodium levels, and they would have to

provide a persuasive explanation as to

why these reductions in sodium levels

are not attainable.

Three, if data and information

submitted in response to this ANPRM

suggest that technological advancements

could be made but would require more

time than provided in the stay of the

effective date for the tier two sodium

reductions (i.e., January 1, 2000, see 62

FR 15390), the agency would consider

continuing the stay of the effective date

of § 101.65(d)(2) and (d)(4) for an

appropriate period of time. To support

this option, FDA would expect to

receive information demonstrating that

progress is being made in the

reformulation of ‘‘healthy’’ products, as

well as information that provides an

estimate of how much additional time is

needed and that establishes the

reasonableness of this estimate.–

Four, the agency could reconsider the

sodium levels that it has established as

the second tier of the ‘‘healthy’’

definition. For example, one possibility

might be that an individual food would

have to contain 360 mg sodium or less

per RACC, or at least 25 percent less

sodium per RACC than a market basket

norm, so long as the final sodium level

does not exceed 480 mg per RACC. For

both main dish and meal products, the

agency might consider the use of a

percent reduction from the disclosure

level for main dishes (720 mg sodium)

or a percent reduction from the market

basket norm. If a 25 percent reduction

from the disclosure level of 720 mg were

applied, the sodium level per labeled

serving for main dishes and meals

would be 540 mg (720 mg times 0.25

equals 180, and 720 mg minus 180 mg

equals 540 mg).

If the definition is set at the

reasonably achievable level of a 25

percent reduction from the disclosure

level or from the market basket norm,

more foods are likely to be available,

and consumers will be able to select

from more and different foods to meet

dietary guidelines. Furthermore, market

competition may spur some

manufacturers to exceed this minimal

reduction, thereby resulting in foods

with even greater reductions. On the

other hand, the question that must be

considered is whether a 25 percent

reduction from the disclosure level or

market basket norm is of adequate

dietary significance to warrant use of

the term ‘‘healthy.’’

Based on the foregoing, the agency

requests comments on whether it should

institute rulemaking to reevaluate the

sodium provisions of the nutrient

content claims regulations pertaining to

the use of the term ‘‘healthy’’ and on the

other issues raised by the petition.

IV. Executive Order 12866 Analysis

If any rulemaking is proposed as a

result of comments received to this

ANPRM, FDA will examine the

economic implications of the proposed

rule as required by Executive Order

12866, which directs agencies to assess

all costs and benefits of available

regulatory alternatives. Executive Order

12866 classifies a rule as significant if

it meets any one of a number of

specified conditions, including having

an annual effect on the economy of $100

million or adversely affecting in a

material way a sector of the economy,

competition, or jobs, or if it raises novel

legal or policy issues.

If FDA institutes rulemaking, the

agency will examine the potential costs

of the proposed rule, including but not

limited to label redesign costs, product

reformulation costs, and potential loss

of product or product name. FDA will

also examine potential benefits

including improved access to

information regarding the health effects

of particular foods. FDA requests

information that would aid the agency

in responding to the Executive Order.

V. Regulatory Flexibility Analysis

If a rule has a significant impact on a

substantial number of small entities, the

Regulatory Flexibility Act (5 U.S.C.

601–612) requires agencies to analyze

options that would minimize the

economic impact of that rule on 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 (SBA) has set size

standards for most business categories

through use of four-digit Standard

Industrial Classification codes. For most

processed foods, SBA considers any

entity with fewer than 500 employees to

be small. FDA requests information on

the number of small entities that use the

term ‘‘healthy’’ in the labeling of their

products. FDA also requests information

regarding the impact on small entities of

the four options which FDA has

identified and described in section III.B

of this document. Specifically, FDA is

interested in how each option may

impact on a small entity’s viability.

VI. Comments

Interested persons may, on or before

March 16, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

ANPRM. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

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

Monday through Friday.

VII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons
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