Food Labeling: Nutrient Content Claims, Definition of Term: Healthy

8.

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

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

Sec. 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 Sec

ese foods

would have to meet the lower sodium qualifying levels to bear the claim

``healthy'' (59 FR 24232 at 24241 and 24245 and see

Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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.

aid 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.

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''

elines. 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 Sec. 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 Sec. 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

second-tier

sodium levels in Sec. 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 Sec. 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)

nies 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

Sec. 101.65(d)(2)(ii) and (d)(4)(ii), and likewise for

Sec. 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

Sec. 101.65(d)(2)(ii) and (d)(4)(ii), and likewise for

Sec. 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

Sec. 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

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

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

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)

ef.

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)

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 Sec. 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

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 second-tier 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

d 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

reduce the amount of sodium in foods labeled ``healthy.'' It is

important that consumers seeking to eat a health-promoting 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 Sec. 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

Sec. 101.65(d)(2)(ii) and (d)(4)(ii) as requested in the petition, and,

at the same time, propose to amend Sec. 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 Sec. 101.65(d)(2)(ii)(C)(1) and (d)(2)(ii)(C)(2),

propose to amend the definition of ``healthy'' in

Sec. 101.65(d)(2)(ii) and (d)(4)(ii) as requested in the petition, and,

at the same time, propose to amend Sec. 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 Sec. 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

Sec. 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

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.

on 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

posed 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

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

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.

l 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