Food Labeling; Requirements for Nutrient Content Claims for Dietary Supplements of Vitamins, Minerals, Herbs, and Other Similar Nutritionnal Substances

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 91N-384D]

RIN 0905-AD96

Food Labeling; Requirements for Nutrient Content Claims for

Dietary Supplements of Vitamins, Minerals, Herbs, and Other Similar

Nutritionnal Substances

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its

regulations to: (1) Include dietary supplements of vitamins, minerals,

herbs, and other similar nutritional substances (hereinafter referred

to as ``dietary supplements'') under the coverage of the general

principles for nutrient content claims; (2) provide for the use of

expressed and implied nutrient content claims on labels or in labeling

of dietary supplements; and (3) provide for petitions for nutrient

content claims for dietary supplements. This final rule is in response

to the Nutrition Labeling and Education Act of 1990 and to the Dietary

Supplement Act of 1992.

EFFECTIVE DATE: July 1, 1995.

FOR FURTHER INFORMATION CONTACT: Camille E. Brewer, 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. Regulatory History

On November 8, 1990, President Bush signed into law the Nutrition

Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-

535). The 1990 amendments revised the Federal Food, Drug, and Cosmetic

Act (the act) in a number of important ways. One of the most notable

aspects of the 1990 amendments is that they establish FDA's authority

to regulate nutrient content claims on food labels and in food

labeling. Section 403(r)(1)(A) of the act, which was added by the 1990

amendments, provides that a product is misbranded if it bears a claim

in its label or labeling that either expressly or implicitly

characterizes the level of any nutrient of the type required to be

declared as part of nutrition labeling, unless such claim has been

specifically defined (or otherwise exempted) by regulation. The 1990

amendments also direct the Secretary and, by delegation, FDA to

promulgate regulations to define specific nutrient content claims

including ``free,'' ``low,'' ``light'' or ``lite,'' ``reduced,''

``less,'' and ``high'' (section 3(b)(1)(A)(iii) of the 1990

amendments).

In the Federal Register of November 27, 1991 (56 FR 60421 and 56 FR

60478), FDA published two documents in which it proposed, among other

things, to define nutrient content claims, to provide for their use on

foods labels, and to establish procedures for the submission and review

of petitions regarding the use of specific nutrient content claims.

These proposals applied to dietary supplements as well as foods in

conventional food form.

On October 6, 1992, the President signed the Dietary Supplement Act

of 1992, Title II of Pub. L. 102-571 (the DS act). Section 202(a)(1) of

the DS act established a moratorium on the implementation of the 1990

amendments with respect to dietary supplements until December 15, 1993.

Section 202(a)(2)(A) required the Secretary, and by delegation FDA, to

issue proposed regulations on nutrient content claims for dietary

supplements no later than June 15, 1993.

FDA issued final regulations that implemented the 1990 amendments

with respect to nutrient content claims on foods in conventional food

form on January 6, 1993 (hereinafter referred to as the ``final rule on

nutrient content claims'') (58 FR 2302). FDA modified these final

regulations slightly in a document that made technical corrections to

them (58 FR 44020, August 18, 1993) (hereinafter referred to as ``the

technical corrections document''). In response to the requirements of

the DS act, FDA published in the Federal Register of June 18, 1993 (58

FR 33731) a proposal to: (1) Include dietary supplements under the

coverage of the general principles for nutrient content claims; (2)

provide for the use of expressed and implied nutrient content claims on

labels or in labeling of dietary supplements; and (3) provide for

petitions for nutrient content claims for dietary supplements

(hereinafter referred to as the ``proposal on nutrient content claims

for dietary supplements'').

FDA received approximately 500 letters in response to its June 18,

1993, proposal on nutrient content claims for dietary supplements. Each

letter contained one or more comments. The letters were from a wide

range of sources, including consumers; consumer organizations;

professional associations; Federal, State, and local government

agencies; industry; and industry trade associations. Many comments

generally supported the proposal or various provisions of the proposal.

Other comments addressed issues outside the scope of the proposal

(e.g., freedom of choice, access to health care, access to dietary

supplements) and will not be discussed here. Many comments suggested

modifications, revisions, or revocations of various aspects of the

proposal. A summary of the comments, the agency's responses to the

comments, and a complete discussion of the agency's conclusions with

respect to nutrient content claims for dietary supplements follows.

II. Nutrient Content Claims for Dietary Supplements--FDA Authority

1. A couple of comments contended that FDA lacks the statutory

authority to prohibit claims for substances for which no reference

value (i.e., Reference Daily Intake (RDI) or Daily Reference Value

(DRV)) has been established. The comments also stated that the agency

lacks legal authority to promulgate regulations governing products

bearing a nutrient content claim for a nutrient or other substance not

explicitly named in section 403(q)(1) or (q)(2) of the 1990 amendments.

The comments said that the references to section 403(q)(1) or (q)(2) of

the act are references to those nutrients that the 1990 amendments

require to be listed (``mandatory nutrients'') on the nutrition label.

The comments argued that under these provisions, a food may be subject

to a misbranding charge under section 403(r)(1) of the act only if it

characterizes, either explicitly or implicitly, the level of a

mandatory nutrient in the food.

The comments also stated that the 1990 amendments did not provide

FDA with misbranding authority over products that bear a claim

characterizing the level of a nutrient or other substance that is not

listed in section 403(q)(1) or (q)(2) of the act. The comments

maintained that, regardless of whether a RDI or DRV has been

established, no special requirements should apply if a manufacturer of

a substance not covered by section 403(q)(1) or (q)(2), such as garlic,

wished to claim that his product was ``high in garlic'' or a ``good

source of garlic.'' The comments argued that while FDA maintains its

general misbranding authority over products bearing claims that

characterize the level of a nonmandatory substance, FDA still must meet

its burden of proving that any such claims are actually ``false or

misleading in any particular'' under the general misbranding provision,

section 403(a)(1) of the act.

Section 403(r)(1)(A) of the act states that a food intended for

human consumption is misbranded if it bears a claim that expressly or

by implication ``characterizes the level of any nutrient which is of

the type required by paragraph (q)(1) or (q)(2) to be in the label or

labeling of the food * * *.'' The statute uses the same language in

section 403(r)(1)(B) to describe the substances that could be the

subject of a health claim. A health claim is a claim that

``characterizes the relationship of any nutrient which is of the type

required by paragraph (q)(1) or (q)(2) to be in the label or labeling

of the food to a disease or a health-related condition * * *.''

Under section 403(r)(1)(B), a health claim may be made in accordance

with section 403(r)(5)(D) as well as section 403(r)(3). Thus, because a

statute must be read as a whole, the language in section 403(r)(1)(A)

and (r)(1)(B) of the act that describes the substances that may be the

subject of a nutrient content or of a health claim must be read in

conjunction with section 403(r)(5)(D), which addresses health claims

for vitamins, minerals, herbs, or other similar nutritional substances

that are components of dietary supplements. Thus, the ``nutrients of

the type required by paragraph (q)(1) or (q)(2)'' that are the subject

of sections 403(r)(1)(A) and (r)(1)(B) of the act include vitamins,

minerals, herbs, and other similar nutritional substances.

The legislative history of ``other nutritional substances'' reveals

that its coverage is broad and could, in appropriate circumstances,

include garlic. See 136 Cong. Record S16609 (daily ed. October 24,

1990) (discussion between Senators Metzenbaum and Symms). Therefore,

while a label claim that a food contains garlic that is intended to

describe the taste of the food would not be subject to section

403(r)(1)(A) of the act, a claim that describes the garlic content in a

way that reveals that garlic is being referred to as a nutritional

substance would be subject to that section. Under section 403(r)(1)(A)

of the act, the latter claim would misbrand the food unless its use has

been authorized by FDA under section 403(r)(2). Thus, FDA rejects the

comments that disagreed with the proposed coverage of the nutrient

content claim provisions.

FDA has relied on the RDI's and DRV's in defining nutrient content

claims under section 403(r)(2) of the act because it has concluded that

if the characterization of the level of a nutrient is to have any

meaning, there must be a level that can be used as a reference in

determining whether the characterization is valid and appropriate. The

RDI's and DRV's provide such levels. Thus, in Sec. 101.54(a) (21 CFR

101.54(a)), FDA has limited the use of ``good source,'' ``high,'' and

``more'' claims to use with nutrients for which an RDI or DRV has been

established. FDA is not aware of any other alternative standards.

If interested persons are aware of other standards that can be used

as reference values to establish the validity of content claims for

substances for which RDI's and DRV's have not been established, those

persons should make FDA aware of those standards through Sec. 101.69

(21 CFR 101.69) or other appropriate means. FDA will carefully consider

using such standards as the basis for content claims for the substances

involved.

III. Basis for Nutrient Content Claims For Dietary Supplements

A. Relationship to January 6, 1993 Final Rules, Consistency with

Established Nutrient Content Claims, Scope

2. Many comments supported consistency in definitions for nutrient

content claims between foods in conventional food form and dietary

supplements. However, one comment stated that consistency in

definitions for nutrient content claims for dietary supplements and

foods in conventional food form is inappropriate. The comment argued

that FDA has chosen to define nutrient content claims that are not

meaningful to the supplement industry and to consumers.

Many comments pointed out that dietary supplements are intended to

contribute, with foods in conventional food form, to consumers' daily

nutrient intake. Thus, the comments argued that it is important that

the terms used to describe the levels of nutrients in both dietary

supplements and foods in conventional food form be consistent. These

comments maintained that consumers would be confused if claims were to

be allowed on dietary supplements that were not defined in the same

manner as those for foods in conventional food form.

FDA disagrees with the comments that said that consistency with

established nutrient content claims is inappropriate as a basic

principle for defining nutrient content claims for dietary supplements.

There is much about dietary supplements that suggests that the

principles that guide FDA in defining nutrient content claims for

dietary supplements should be the same as the principles that guide the

agency in defining nutrient content claims on foods in conventional

food form. Dietary supplements that are not intended for use as drugs

have traditionally been regulated as foods and, as such, must be

evaluated within the context of the total daily diet. In addition,

nutrients from dietary supplements serve the same physiological

function as nutrients from foods in conventional food form. While some

consumers seek to ensure that the nutrient content of their diet is

adequate through foods in conventional food form, other consumers seek

to ensure nutritional adequacy by making dietary supplements part of

their diets (Ref. 1). Consistent use of terms on dietary supplements

and on foods in conventional food form will thus help consumers to

construct a nutritionally adequate total daily diet by allowing

consumers to make meaningful comparisons among these products. It will

also facilitate use of these terms by consumers.

Over the years, FDA has stressed the importance of consistent

definitions and descriptive terms as a necessary requirement for

effective education and for preventing misleading labeling (Ref. 2). If

terms were given different definitions depending on whether they were

to be used to describe foods in conventional food form or dietary

supplements, it would make it much more difficult for the public to

understand what these terms are intended to convey about a particular

food. Moreover, a single definition for a particular term eliminates

any possibility that ambiguities could be created by the use of that

term. Therefore, the agency concludes that for nutrient content claims,

the definition of a particular term should be the same regardless of

the type of food that it is being used to describe.

Additionally, FDA has been criticized for treating dietary

supplements differently than other foods. FDA has no desire to

discriminate in any way against supplements. Thus, by having a single

definition for a particular nutrient content claim, FDA is providing

the basis for dietary supplements to make the same claims as other

foods and to be factored into the diet like other foods.

Nonetheless, as discussed in the proposal on nutrient content

claims for dietary supplements (58 FR 33731), FDA recognizes that

dietary supplements differ in at least two respects from foods in

conventional food form. First, dietary supplements are likely to

contain much higher levels of nutrients than foods in conventional food

form. Thus, additional nutrient content claims that are specific for

dietary supplements may be appropriate. As discussed later in this

document, the agency intends in the near future to initiate a separate

rulemaking to establish such claims for dietary supplements. Second,

dietary supplements generally do not contain several nutrients (e.g.,

fat, cholesterol) found in foods in conventional food form. Therefore,

in this document, FDA is limiting the use of certain claims that are

useful for describing foods in conventional food form but that do not

meaningfully describe dietary supplements.

B. General Principles

1. Substitute Foods

3. One comment objected to the requirement to use the word

``imitation'' on dietary supplements that are nutritionally inferior to

other products of the same type. The comment argued that FDA was never

given the authority to decide on formulations of dietary supplements,

and that setting such formulations is the exclusive role of the

manufacturer. Further, the comment stated that there is nothing

``imitation'' about ``less'' in the supplement industry, and that a

requirement that a supplement be labeled ``imitation'' if it is

nutritionally inferior to another product forces manufacturers to

increase potencies in order that their products will not have to be

labeled ``imitation.''

Under section 403(r)(2)(A)(ii) of the act, for a food to be labeled

as ``[nutrient] free,'' the nutrient must usually be present in the

food or in a food for which it substitutes, as that term is defined by

the Secretary (and by delegation, FDA) for the food. Accordingly, the

agency defined ``substitute foods'' in Sec. 101.13(d) (21 CFR 101.3(d))

in the final rule on nutrient content claims (58 FR 2302 at 2411) for

the purpose of identifying the characteristics that substitute foods

must have if they are to bear nutrient content claims that highlight

differences between them and the foods for which they substitute. The

definition states that a substitute food is one that may be used

interchangeably with another food that it resembles, i.e., to which it

is organoleptically, physically, and functionally (including shelf

life) similar and to which it is not nutritionally inferior, unless it

is labeled as an ``imitation.'' Additionally, Sec. 101.3(e)(1) (21 CFR

101.3(e)(l)) states that a food shall be deemed to be an imitation, and

thus subject to the requirements of section 403(c) of the act, if it is

a substitute for or resembles another food but is nutritionally

inferior to that food. Thus, the issue that the agency must consider is

whether dietary supplements that are foods should be subject to these

provisions on substitute foods as any other foods are.

The agency has no evidence that manufacturers will increase the

potencies for their products to avoid the use of this term and

disagrees that this provision will interfere with a manufacturer's

right to decide on product formulations. It is extremely unlikely that

the term ``imitation'' will ever be used on dietary supplements,

particularly dietary supplements of vitamins and minerals. The issue of

whether a supplement would be an ``imitation'' would arise only when a

manufacturer chooses to make a ``free'' or ``low'' claim for sugar or

sodium on a dietary supplement (see comment 4). In such circumstances,

under section 403(r)(2)(A)(ii) of the act, the manufacturer must

identify a product on the market with which its product can be used

interchangeably, to which the manufacturers product is not

nutritionally inferior, and that contains sodium or sugar. Such a

product may include the version of the manufacturer's product that

contains sodium or sugar. As long as such a product exists, the

manufacturer's product need not be labeled as an imitation. Moreover,

if because of the way the manufacturer has formulated its product,

there is no product with which it is used interchangeably, the product

can be called ``------------, a sodium-free food.'' Only in the rare

situations in which neither of the conditions apply would the product

have to be called ``imitation'' for it to bear a ``free'' or ``low''

sodium or sugar claim.

Sections 101.13(d)(1) and (d)(2) are designed to ensure that

material differences between the substitute food and the reference food

are conspicuously stated on the label or labeling of the food, so that

consumers can make fully informed judgments about the value of the

substitute food and its usefulness in maintaining healthy dietary

practices. If a product has substantially less of a nutrient than the

reference food, and to that extent is materially different and inferior

in nutrient content, then ``imitation'' is an entirely appropriate

term. For this reason, the agency concludes that there is no reason to

apply the substitute food provisions any differently to dietary

supplements than to other foods.

2. Requirements for ``Low'' and ``Free'' Claims

4. Several comments from dietary supplement manufacturers and trade

associations questioned the need to allow ``low'' and ``free'' claims

for nutrients such as fat and cholesterol that are not typically found

in dietary supplements. One comment suggested that ``free,'' ``low,''

and ``reduced'' claims for calories, fat, and cholesterol on dietary

supplements should be permitted only on dietary supplements that are a

significant source of calories, such as protein supplements. The

comment argued that consumers do not expect most dietary supplements to

contain significant amounts of calories, and that it is nonsensical and

confusing to permit dietary supplements that are not a significant

source of calories to make a claim about reduced amounts of calories,

fat, and cholesterol contained therein. Another comment stated that

Americans who consume dietary supplements do not do so because the

products are ``low in fat,'' ``cholesterol free,'' or ``low calorie,''

and that consumers are not interested in the fat content of dietary

supplements. The comment argued that consumers care about the

substances in the products and the benefits that those products can

have for their health.

In the proposal on nutrient content claims for dietary supplements,

the agency requested comment on the need for extending ``free,''

``low,'' and ``reduced'' claims to dietary supplements (58 FR 33731 at

33745). The agency has reviewed the comments that it received and is

persuaded by them that it not meaningful to allow claims about the

calorie, fat (including saturated fat), or cholesterol content of most

dietary supplements. Most of these products do not contain those

nutrients, and most consumers do not expect that they do. Thus,

consumers would not generally look to these products in making dietary

choices that are designed to control the amount of calories, fat,

saturated fat, and cholesterol in the foods they eat. In fact, claims

about these nutrients in most dietary supplements would only serve to

confuse consumers. While it is true that FDA is requiring information

about these nutrients in the nutrition label of supplements of herbs

and of other similar nutritional substances, this requirement derives

mainly from the limitation on the exemption in section 403(q)(5)(F) of

the act (formerly section 403(q)(5)(E)). See the final rule on general

requirements for nutrition labeling for dietary supplements published

elsewhere in this issue of the Federal Register.

However, the agency recognizes that there are some dietary

supplements, such as protein supplements, in which the amount of

calories in the product is significant to consumers. On these products,

the source of the calories, particularly whether they are from fat, is

relevant and useful information.

Therefore, FDA has decided, based on the comments that it received

to only allow calorie, fat, saturated fat, and cholesterol claims on

those dietary supplements in which the amount of calories is important

to consumers. In attempting to define what this level of calories

should be, the agency looked first to Sec. 101.9(f)(1) and (j)(4),

which said that a food has ``insignificant'' calories for the purposes

of nutrition labeling if it has an amount of calories that can be

rounded to zero. Section 101.9(c)(1) states that ``less than 5

calories'' per serving may be expressed as zero, the same amount that

is defined as ``calorie free.''

While FDA does not have information on the caloric content of

dietary supplements, it would not be unreasonable to expect that many

dietary supplements contain more than 5 calories (cal) per serving,

particularly children's chewable vitamin and mineral supplements,

supplements that contain herbal extracts, and supplements that contain

caloric binders and fillers. Thus, to tie the use of ``free,'' ``low,''

and ``reduced'' calorie, fat, and cholesterol claims on labels of

dietary supplements to the presence of more than an ``insignificant

amount'' of calories in the food would be over-inclusive and would

allow many products in which the amount of calories is not significant

to consumers to bear such claims.

FDA next looked at the definition of ``low calorie'' in

Sec. 101.60(b)(2) (21 CFR 101.60(b)(2)) for use in determining which

dietary supplements should be allowed to bear ``free,'' ``low,'' and

``reduced'' claims. Section 101.60(b)(2) defines a ``low calorie'' food

as a food that contains 40 cal or less per reference amount customarily

consumed (hereinafter referred to as reference amount) and per 50 grams

(g) if the reference amount is small. FDA believes that 40 cal per

reference amount represents a reasonable level for demarcating a

dietetically relevant source of calories for dietary supplements. In a

product that contains this amount of calories, the source of the

calories (e.g., fat) is of significance to consumers.

Accordingly, the agency is revising Sec. 101.62(a) (21 CFR

101.62(a)) by adding paragraph (a)(4) to state that ``free,'' ``low,''

and ``reduced'' claims for fat, saturated fat, and cholesterol may not

be made for dietary supplements that meet the criteria in

Sec. 101.60(b)(1) and (b)(2) for ``calorie free'' and ``low calorie''

claims. FDA is also revising Sec. 101.13(b) by adding new paragraph

(b)(5) to reflect these provisions. As a consequence, claims that

identify all products of that class of being ``low'' or ``free'' of a

nutrient (e.g., ``vitamin C supplement, a fat-free supplement'') will

also be prohibited.

However, to use the same criteria (i.e., that a product may not be

``calorie free'' or ``low calorie'') as a basis for when a calorie

claim may be made, has the effect of prohibiting the very claims that

the criterion seeks to permit, namely ``calorie free'' and ``low

calorie'' claims. Such a criterion would permit only relative calorie

claims (e.g. ``reduced'') on dietary supplements. Therefore, a slightly

different scheme for permitting calorie claims on certain dietary

supplements, such as protein supplements, must be derived.

While, as stated above, the agency believes that calorie claims

should not be permitted on most dietary supplements, it does believe

that ``calorie free'' and ``low calorie'' claims may be appropriate if

an equivalent amount of a similar food (i.e., another protein

supplement) that the labeled food resembles and for which it

substitutes would normally contain an appreciable amount of calories.

Such a claim would highlight that the labeled food had a different

calorie profile than would be expected in the similar product. It would

also serve to direct a consumer to a product that had a lower amount of

calories. Because the food would meet the criteria for ``low calorie''

and would be so labeled, it would not be necessary to highlight any

comparative differences between the labeled and the similar food as

would be required for a relative claim.

Therefore, the agency is revising Sec. 101.62(a) by adding new

paragraph (a)(4) to state that claims for calories may not be made on

labels of dietary supplements that meet the criteria in

Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' and ``low calorie''

except when an equivalent amount of a similar dietary supplement (e.g.,

another protein supplement) that the labeled food resembles and for

which it substitutes normally exceeds the definition for ``low

calorie'' in Sec. 101.60(b)(2). It is including similar language in

Sec. 101.13(b)(5).

The comments specifically objected to claims for calories, fat, and

cholesterol. Claims for sodium and sugar content were not mentioned.

Since the sugar and sodium levels in dietary supplements can vary

substantially, the agency finds that claims about the sugar and sodium

content of dietary supplements may be useful in helping consumers to

make purchasing decisions that will assist them in maintaining healthy

dietary practices. Thus, extending the definitions of ``low,''

``free,'' and ``reduced'' for sugar and sodium to dietary supplements

is appropriate irrespective of the calorie level of the dietary

supplement. Therefore, FDA concludes that there is no need to place

limitations on claims for sugar and sodium content other than those in

Secs. 101.60(c) and 101.61, respectively. As explained below, FDA is

amending these provisions to reflect their application to dietary

supplements.

3. Labeling Mechanics

a. Type size

5. In discussing type size for nutrient content claims, one comment

stated that every new statement that is required on dietary supplement

labels will create a problem for manufacturers, particularly if they

are constrained by minimum-type size requirements.

The agency acknowledges that dietary supplements are frequently

packaged in small containers, and for this reason, FDA specifically

asked for information on the impact of the type size proposal on

dietary supplements that are packaged in small containers (58 FR 33731

at 33734). No suggestions or examples were presented to assist the

agency in deciding how to address this problem. Therefore, the agency

has made no special provision for dietary supplements in the type size

requirements for nutrient content claims. FDA discusses the type size

requirements for the nutrition labeling of dietary supplements in the

final rule on nutrition labeling of dietary supplements published

elsewhere in this issue of the Federal Register.

FDA stated in the technical corrections document (58 FR 44020 at

44020 and 44021) that there was a need to specify the minimum type size

for labeling information (e.g., accompanying information) required

under the nutrient content claims regulation. As a result, the agency

modified Sec. 101.2(b) to include Secs. 101.13, 101.54, 101.56, 101.60,

101.61, 101.62, and 101.65 in the list of sections set out in

Sec. 101.2(b) for which a minimum type size for required label

information is specified. For consistency, the agency also modified

Sec. 101.2(f) to include Secs. 101.13, 101.54, 101.56, 101.60, 101.61,

101.62, and 101.65.The effect of these revisions for dietary

supplements is that label information required by the nutrient content

claims regulations, but whose type size is not otherwise specified,

will be required to be in letters or numbers no less than one-sixteenth

of an inch in height unless otherwise specified by Sec. 101.2(c). FDA

believes that making nutrient content claims on dietary supplements

subject to this requirement is appropriate because this requirement is

the logical outgrowth of the proposal. In the proposal on nutrient

content claims for dietary supplements, FDA raised the issue of how to

make nutrient content claims on dietary supplements. The question of

how to ensure the legibility of the referral statement, which is

required by section 403(r)(2)(B) of the act, is one that is at least

implicitly raised by this issue. Thus, the agency's decision to

explicitly address the question of the type size of the referral

statement in this final rule represents the logical outgrowth of issues

that were raised in the proposal.

The agency pointed out in the technical corrections document that

if there are circumstances in which the product is not able to comply

with type size requirements, manufacturers may request an alternative

means of compliance (e.g., permission to use a reduced type size) in

accordance with Sec. 101.9(g)(9). Section 101.9(g)(9) states that when

it is not technologically feasible, or some other circumstance makes it

impracticable, for firms to comply with nutrition labeling

requirements, they may write to the Office of Food Labeling, Food and

Drug Administration, and request an alternative means of compliance.

For the reasons explained above, dietary supplements of herbs and other

similar nutritional substances are appropriately subject to this

provision even though it was not specifically set out in the proposal

on nutrient content claims for dietary supplements. A similar provision

is included in Sec. 101.36(d)(2) of the final regulation for nutrition

labeling for dietary supplements of vitamins and minerals, in a

companion document in this issue of the Federal Register. These

provisions allow flexibility to ensure that there will be either

sufficient space to make nutrient content claims on the labels of

dietary supplements, or that manufacturers will have recourse to

request relief.

b. Disclosure levels

6. One comment stated that there are a certain number of products,

such as chewable tablets containing sodium ascorbate, for which

information on sodium might be useful to consumers in maintaining

healthy diets. The comment suggested that the agency urge supplement

manufacturers to include information on sodium content, even though the

sodium level might not reach the threshold levels established in

Sec. 101.13(h)(1) that would trigger a required statement.

The agency disagrees that there is a sufficient basis for requiring

either the declaration of total sodium content on the principal display

panel of a dietary supplement or for requiring a referral statement

directing the consumer to the nutrition label for information about

sodium content on all dietary supplements. Section 101.13(h)(1)

specifies that the referral statement (i.e., ``See [appropriate panel]

for information about [nutrient requiring disclosure] and other

nutrients'') is required only when the sodium (or fat, saturated fat,

or cholesterol) content of a product exceeds the disclosure level. FDA

finds that there is no reason to provide a different rule for dietary

supplements.

To the extent, as the comment suggests, that information on sodium

content would be useful, it will be provided on the nutrition label as

long as it is present at more than an insignificant level. Section

101.36(b)(3), which lists the nutrients that must be included in the

nutrition label of a dietary supplement of a vitamin or mineral,

provides that all nutrients listed in Sec. 101.9(c), including sodium,

must be declared on the nutrition label of a dietary supplement of

vitamins and minerals, except that nutrients present at levels that

would be declared as zero shall not be declared. (For sodium, the

amount that is declared as zero is less than 5 milligrams (mg) per

serving.) Section 101.9(c) itself requires that sodium be listed on the

nutrition label of other dietary supplements. Consumers thus will be

able to readily find the amount of sodium in a product by examining the

nutrition label. Because the comment provided no basis for its

suggestion other than usefulness, FDA is not making any special

provision for the declaration of sodium on dietary supplements.

4. Relative Claims, Reference Foods, ``Modified''

7. One comment requested that the agency clarify in Sec. 101.13(j)

that for dietary supplements, the reference food may be a source of the

nutrient in either a dissimilar food within a product category or a

similar food. The comment stated that the most helpful information to a

consumer purchasing a dietary supplement often may be a comparison of

the vitamin or mineral content to a recognized source of the nutrient,

e.g., ``contains more vitamin C than two 8 oz glasses of orange

juice.'' In addition, the comment maintained that the examples used in

the proposed rule on nutrient content claims for dietary supplements

(58 FR 33731 at 33737) for comparing dissimilar foods within the same

product category (e.g., potato chips as a reference for pretzels)

generally does not apply to dietary supplements.

The agency agrees that a clarification is warranted to reinforce

that Sec. 101.13(j) applies to dietary supplements as well as to foods

in conventional food form. Section 101.13(j)(1)(i)(A) states that for

``less'' (or ``fewer'') and ``more'' claims, the reference food may be

a dissimilar food within a product category that can generally be

substituted for one another in the diet (e.g., potato chips as

reference for pretzels) or a similar food (e.g., potato chips as

reference for potato chips).

The agency agrees that adding examples that are specific for

dietary supplements will clarify that for ``less'' (or ``fewer'') and

``more'' claims, the reference food may be a dissimilar food within a

product category for which the labeled food can generally be

substituted (e.g., orange juice as a reference for vitamin C tablet) or

a similar food (e.g., one brand of multivitamin as a reference for

another brand of multivitamin). Accordingly, the agency is revising

Sec. 101.13(j)(1)(i)(A) to include these examples.

Additionally, to clarify Sec. 101.13(j)(1)(i)(B) for ``light,''

``reduced,'' ``added,'' ``fortified,'' and ``enriched'' claims, the

agency is revising this regulation to include an example of a reference

food that is a similar food (e.g., one brand of multivitamin for

another brand of multivitamin).

8. One comment agreed that the term ``modified'' would rarely be a

useful term for vitamin/mineral supplements but stated that this term

might be useful for certain dietary supplements that contain ``other

similar nutritional substances.'' The comment stated that there are

techniques for concentrating certain fish oils that are high in omega-3

fatty acids. The comment suggested that the use of the term

``modified'' might serve to distinguish products containing the

concentrated fish oils from other fish oil products that would have to

be taken several times a day to provide the same amount of fish oil and

thus result in the consumption of significantly more calories. The

comment argued that use of the term ``modified'' on dietary supplements

should be authorized to maintain the principle of consistency between

foods in conventional food form and dietary supplements.

The agency agrees. FDA has defined ``modified'' for use as part of

the statement of identity on foods to reflect the fact that a change

has been made in a food (56 FR 60421 at 60454). The term is not to be

used alone, nor is the term to be used to describe products that have

not been altered (58 FR 2302 at 2367 and 2412). Based on the comment,

the agency concludes that this term may have some limited usefulness

for dietary supplements, and thus this term may be used on such

products when they meet the conditions of Sec. 101.13(k). FDA finds,

however, that no change in Sec. 101.13(k) is necessary to authorize

this use of the term.

5. Reference Amounts

9. One comment stated that if comparative claims (e.g., ``reduced

sodium'') were to be made for dietary supplements, there need to be

reference amounts (i.e., reference amounts customarily consumed)

established so that one product recommending consumption of, for

example, one tablespoon (tbsp) per day is not compared to a product

recommending five tbsp per day. The comment argued that the proposal

allows very flexible reference amounts for supplements (i.e., whatever

the manufacturer is recommending for consumption) and suggests that

reference amounts of reference foods (as established in Sec. 101.13(j))

be specified in more concrete terms.

The agency is not persuaded by the comment that more concrete terms

are needed for reference amounts at this time. The agency has

established in the final rule on general requirements for nutrition

labeling for dietary supplements published elsewhere in this issue of

the Federal Register a definition for the reference amount customarily

consumed for dietary supplements in Sec. 101.12(b) as ``the maximum

amount recommended on the label for consumption per eating occasion or,

in the absence of recommendations, 1 tablet, capsule, packet, or

teaspoonful, as appropriate.'' This definition is based on comments

received on the proposal for mandatory nutrition labeling for dietary

supplements.

Section 101.13(p)(1), which FDA proposed to apply to dietary

supplements, states that unless otherwise specified, the reference

amount customarily consumed set forth in Sec. 101.12(b) through (f)

shall be used in determining whether a product meets the criteria for a

nutrient content claim. The comment did not suggest an alternative to

the reference amount that could be used as the basis for comparative

claims for dietary supplements. Therefore, given the fact, as the

agency said in the proposal on nutrient content claims for dietary

supplements (58 FR 33731 at 33732), that a consistent approach to

nutrient content claims on dietary supplements and on foods in

conventional food form will increase consumers' ability to use and

understand such claims, FDA is not adopting a different approach to

comparative claims for dietary supplements than the one that it adopted

for foods in conventional food form.

The agency acknowledges that there is a potential for unfair

marketing and misleading claims if the serving size is manipulated

upwards or downwards to enable a product to make a nutrient content

claim. The agency retains the authority to regulate any such misleading

claims under section 403(a) of the act. Issues concerning serving size

are further discussed in the companion document on nutrition labeling

for dietary supplements, published elsewhere in this issue of the

Federal Register.

IV. Definitions for Specific Nutrient Content Claim Terms

A. Use of RDI's and DRV's in Formulating Definitions

10. Many comments stated that limiting nutrient content claims to

those nutrients with RDI's or DRV's was unnecessarily restrictive.

Several comments suggested that content claims should be authorized

with respect to a nutrient as long as it has either an RDI or DRV as

established by FDA in Sec. 101.9(c) or a Recommended Dietary Allowance

(RDA) as established by the National Academy of Sciences (NAS) (Ref.

4). Other comments also stated that nutrient content claims should be

authorized for nutrients for which NAS has established Estimated Safe

and Adequate Daily Dietary Intakes (ESADDI's). Other comments suggested

that FDA should expand the number of vitamins and minerals with RDI's

when it publishes the final RDI/DRV rule following the expiration of

the DS act moratorium.

FDA agrees that the current list of RDI's does not represent the

entire list of nutrients for which dietary recommendations have been

established. The agency had proposed to establish RDI's for all

nutrients for which RDA's or ESADDI's were provided in the 1989 edition

of the NAS RDA's (56 FR 60366). However, under the DS act, the agency

was constrained to retain the label reference values established in

Sec. 101.9(c)(8)(iv) until at least November 8, 1993. These values were

based on the 1968 RDA's. The 1968 RDA's did not contain recommended

dietary values for a number of nutrients for which NAS has subsequently

provided RDA's or ESADDI's. RDA's for vitamin K and selenium were

established subsequent to 1968 and are listed in the 1989 edition of

the NAS RDA's (Ref. 4). Furthermore, the 1980 and 1989 editions of the

NAS RDA's provided ESADDI's for chloride, manganese, fluoride,

chromium, and molybdenum. Now that the moratorium established by the DS

act has expired, the agency is proposing elsewhere in this issue of the

Federal Register to establish RDI's for all nutrients for which RDA's

or ESADDI's are provided in the 1980 and 1989 editions of the NAS's

Recommended Dietary Allowances but for which RDI's or DRV's have not

been established by FDA. Once RDI's are established for these

additional seven nutrients, nutrient content claims may be made for

them.

FDA intends to consider revising all of the RDI's to conform to the

most recent levels established by NAS. However, FDA is aware that NAS

is in the process of reevaluating the basis on which RDA's are

determined. It is considering the issue of whether values should be

selected to prevent deficiencies or to promote optimal wellness. The

agency believes that its action should await completion of the NAS

process. FDA is committed to working with NAS to help resolve this

issue.

Accordingly, as stated in response to comment number 1 above, FDA

has concluded that it is not possible to define nutrient content claims

for nutrients for which no reliable reference standards such as the

RDI's and DRV's have been established. The agency believes that

authorization for nutrient content claims for nutrients for which no

RDI or DRV exists (e.g., vitamin K) needs to be deferred until RDI's or

DRV's are adopted. In the interim, quantitative nutrient information

may be listed in the nutrition label as discussed in the final rule on

general requirements for nutrition labeling for dietary supplements

published elsewhere in this issue of the Federal Register.

Also, manufacturers may provide amount or percentage statements as

described in Sec. 101.13(i)(3) for those nutrients that do not have

RDI's or DRV's. For example, while there is no RDI for fluoride, under

this provision, manufacturers may declare the amount of the nutrient

present (e.g., 2 mg fluoride) on any panel outside of the Nutrition

Facts box.

11. One comment stated that claims should be permitted for beta-

carotene.The agency believes that claims regarding beta-carotene (e.g.,

``contains beta-carotene'') are claims about an ingredient that make

implied representations about the level of vitamin A that is present in

the food as beta-carotene. This conclusion is consistent with section

403(r)(1)(A) of the act, which states that a food can be misbranded by

a statement that expressly or by implication characterizes the level of

a nutrient in a food. The agency considers that the claim ``contains

beta-carotene'' implies that there is enough beta-carotene in the food

to constitute a ``good source'' of vitamin A (i.e., it contains 10

percent or more of the DV for vitamin A from beta-carotene). Such a

claim is provided for in Sec. 101.65(c).

12. One comment advocated defining nutrient content claims for

ultratrace nutrients including boron, silicon, vanadium, arsenic, and

tin. The comment stated that claims about these ultratrace elements

should be permitted on the basis of the RDA, ESADDI, or the amounts

found in the average well-balanced diet. Additionally, this comment

argued that reference values should be available for ultratrace

nutrients once reputable scientific evidence is established that such

nutrients serve important metabolic or physiological functions in the

body. The comment also suggested that label information be permitted

for choline and inositol.

The agency disagrees. The trace elements arsenic, nickel, silicon,

boron, cadmium, lead, lithium, tin, vanadium, and cobalt, as well as

choline and inositol, have not been shown to be essential in humans. No

RDA's or ESADDI's for these substances have been established by NAS.

NAS states that several of these substances ``naturally present in

foods are known to be required in the diets of various animal or

microbial species, but there is little or no evidence of their dietary

essentiality for humans'' (Ref. 4). While NAS acknowledges that some of

these classes of substances may ``one day be candidates for RDA's,'' it

states that there is currently no evidence that these substances are

essential in humans (Ref. 4).

As stated in the ``Summary'' section of the 10th edition of the NAS

RDA publication (Ref. 4), the NAS RDA's are based not only on data from

nutrient intake measurements but also on information from nutrient

balance studies, experimental intake studies, biochemical measurements,

epidemiological observations of nutrient status, and extrapolation of

data from animal experiments. FDA does not agree with the comments that

it is desirable to base label reference values for nutrient content

claims solely on individual scientific research publications, no matter

how current, or solely on data on amounts of the trace element found in

well-balanced diets. The existence of such data does not mean that

there is scientific agreement on the essentiality of the nutrient or on

the recommended level in the diet. Should agreement on the essentiality

of additional nutrients be reached, timely and appropriate changes to

the label reference values can be made through FDA's rulemaking

procedures.

However, as stated above, manufacturers are free to declare the

amount of the trace elements, or choline or inositol, on the product

label outside of the ``Nutrition Facts'' panel in accordance with

Sec. 101.13(i)(3). Such a statement of amount is not considered to

characterize the level of the nutrient in the food, as would claims

such as ``high'' or ``more.''

13. One comment stated that although no RDI's have been established

for certain vitamins and minerals, nutrient content claims could be

based on reference foods that are recognized sources of those

nutrients. For example, the label could state that ``Brand X provides

more vitamin K than two servings of cabbage,'' based on the vitamin K

content of the reference amount for vegetables without sauce listed in

Sec. 101.12, Table 2.

The agency disagrees. Until a reference standard is established

there is no basis for confidence that cabbage is a good source of

vitamin K. There is also no basis for confidence that the amount of

vitamin K in the food that is to be the subject of the claim is

nutritionally significant. Elsewhere in this issue of the Federal

Register, the agency has proposed to expand the list of nutrients with

RDI's, including vitamin K. At this time, however, FDA concludes that

it would be premature to authorize such claims.

B. Specific Requirements for Nutrient Content Claims (21 CFR 101,

Subpart D)--Applicability to Dietary Supplements

1. Sec. 101.54 Nutrient Content Claims for ``Good Source,'' ``high,''

and ``More''

a. ``Good source'' and ``high''

14. One comment encouraged the agency to maintain the proposed

definitions for ``good source'' and ``high'' for dietary supplements.

The comment argued that a higher level (e.g., 40 percent of the RDI)

would suggest to consumers that daily nutrient intakes could be

achieved by consuming only a few foods, which is inconsistent with

dietary guidelines. The comment maintained that if a new higher claim

level was adopted for supplements, it would likely also apply to foods

in conventional food form based on the logic of the proposal for

nutrient content claims for dietary supplements (i.e., consistency in

definitions). The comment stated that users of dietary supplements are

well aware of the elevated nutrient levels in these products, and that

a new paradigm is not needed to inform consumers of these levels.

On the other hand, several comments did not support the proposal to

use the same definitions for ``good source'' and ``high'' claims as

those used for foods in conventional food form. The comments argued

that the terms ``good source'' and ``high'' should not carry the same

meaning for supplements as for foods in conventional food form, that

most supplements contain at least 100 percent of the Daily Value for

most of the nutrients they provide, and that consumers expect most of

these products to contain at least 100 percent of the Daily Value. The

comments maintained that allowing any product with as little as 10 or

20 percent of the RDI to carry ``good source'' and ``high'' claims

would confuse and mislead consumers.

One comment questioned whether it is appropriate to permit the use

of these nutrient content claims on vitamins and mineral supplements

since it implies that supplements are comparable to, and acceptable

substitutes for, foods in conventional food form. The comment also

noted that nutrition educators feel strongly that supplements can

enhance the nutrient intake from foods in conventional food form but

can never replace them since foods in conventional food form provides

other important components. On the other hand, many comments supported

the proposal to extend the same definitions for ``good source'' and

``high'' for foods in conventional food form to dietary supplements.

These comments emphasized the importance of consistency in definitions

to assist consumer education.

One comment requested clarification on whether the terms ``good

source'' and ``contains'' will be permitted for dietary supplements.

The comment maintained that such claims provide consumers with

important information regarding the precise content of various

nutrients and should not be subject to discriminatory treatment solely

on the basis of whether such claims are made for a nutrient in a

dietary supplement as opposed to one in a conventional food.

The agency has reviewed these comments and is not persuaded that

the definition of the terms ``good source'' and ``high'' should be

different for dietary supplements than for foods in conventional food

form. The agency finds that the definitions for foods in conventional

food form and dietary supplements should be consistent. As directed by

the 1990 amendments (section 3(b)(1)(A)(iii)(VI)), FDA defined the term

``high,'' and the synonyms ``rich in'' and ``excellent source of,'' for

use on labels and in labeling in Sec. 101.54 (58 FR 2302 at 2344). In

Sec. 101.54(c)(1) of final rule on nutrient content claims, the agency

stated that the term ``good source'' may be used to describe a food

when a serving of the food contains 10 to 19 percent of the RDI or the

DRV for a nutrient. Likewise, the agency stated that the term ``high''

may be used to describe a food when a serving contains 20 percent or

more of the RDI or the DRV. FDA concluded that the use of these terms

would permit a sufficient number of food items to bear ``good source''

and ``high'' claims to allow consumers to use the claims in selecting

foods that are better sources of nutrients (58 FR 2344).

While FDA recognizes that under the present definitions, most, if

not all, dietary supplements of vitamins, minerals, potassium, and

fiber would qualify for ``good source'' or ``high'' claims, the agency

does not agree with those comments that argued that the definitions, as

proposed, would be confusing or misleading to consumers. As suggested

by the IOM report on nutrition labeling (Ref. 6), the use of consistent

and targeted content claims increases consumers' confidence in the

validity of the claim. FDA is aware of no evidence to support an

alternate conclusion. The basic principle of consistency in definitions

of nutrient content claims is discussed in detail in comment 2 of this

document.

Furthermore, the agency recognizes that consumers expect dietary

supplements to be concentrated sources of nutrients. Consumer studies

support this conclusion (Refs. 1 and 5). FDA acknowledges that the

terms ``good source'' and ``high'' might be of limited utility in

comparing nutrient content among dietary supplements of vitamins and

minerals because virtually the entire class of products would qualify

for such claims. However, these terms may be useful for some single

source dietary supplements of calcium, biotin, or fiber or for

multinutrient preparations containing these nutrients. These nutrients

are generally found in dietary supplements at levels below the Daily

Value.

Additionally, FDA believes that these terms would be useful in

highlighting the nutrient content of some herbs and other similar

nutritional substances that have nutrients at levels high enough to

qualify for the definition of one of the above terms. For these

reasons, the agency is not persuaded to preclude the use of these terms

for dietary supplements.

The agency agrees with the comment that stated that dietary

supplements cannot replace foods in conventional food form in all

respects because the latter foods supply other important components.

However, FDA recognizes that dietary supplements can be a useful part

of the diet for those who wish to make sure that they consume at least

the RDI amount for all vitamins and minerals or for those who wish to

increase their daily intake of a particular substance above those

levels that are ordinarily available from conventional foods. Thus, FDA

finds that use of these terms on dietary supplements is appropriate.

FDA is convinced that consistency in definitions of nutrient

content claims across the food supply is necessary. Consistency

facilitates consumer education by limiting the number of terms that the

public must learn and interpret. Moreover, different definitions for

the same terms for dietary supplements and foods in conventional food

form would be confusing to consumers because of the difficulties

inherent in learning alternate definitions for the same term. There is

a greater chance of error and misinterpretation when several

definitions must be learned for the same term. Thus, different

definitions would likely do more harm than good. Accordingly, the

agency concludes that the proposed definitions for ``good source'' and

``high'' are appropriate, and that there is no reason to define the

terms differently for dietary supplements.

The agency would like to clarify that ``good source'' and

``contains'' as defined Sec. 101.54(c)(1) are nutrient content claims

that can be used for foods in conventional food form as well as for

dietary supplements. There is nothing in this final rule that states

that the use of these terms would not be allowed for dietary

supplements.

15. One comment stated that under FDA's proposal, consumers who

want truly high levels--that is, levels that exceed the RDI--would have

no means of identifying those products, other than reading the fine

print on the back of each supplement label.

The comment acknowledged that consumers might also be confused if

``high'' had one meaning when the claim appears on labels of dietary

supplements and a different meaning when the claim appears on labels of

foods in conventional food form. To avoid that inconsistency, the

comment urged FDA to prohibit the claims ``good source'' and ``high''

on supplements. Further, the comment suggested that the agency should

define the term ``high potency'' and allow it to be used only on

supplements.

FDA disagrees that the terms ``good source'' and ``high'' should be

prohibited on the labels of dietary supplements. The agency recognizes

that a claim of ``high'' will not specifically identify those products

that have levels of nutrients that exceed the RDI. However, the

quantitative amount of a nutrient in a dietary supplement is often a

part of the statement of identity for the product, and additional

quantitative information regarding the level of a nutrient may also be

found in amount or percentage statements on the principal display

panel. In addition, as a result of the agency's new format

requirements, the nutrition label for dietary supplements of vitamins

and minerals provides quantitative information on the levels of

specific nutrients as well as the percent DV for each nutrient in a

more legible format. Consequently, consumers will have easy access to

information regarding the levels of specific nutrients and may adjust

their levels of intake accordingly.

Further, as discussed in the previous comment, while the terms

``good source'' and ``high'' may be of limited utility for dietary

supplements of vitamins and minerals, these terms may be useful in

highlighting the nutritional content of single nutrients, such as

biotin and calcium, that are generally found in products at levels well

below the RDI, as well as of dietary supplements of herbs and other

similar nutritional products. Therefore, FDA concludes that precluding

the use of these terms on dietary supplements is unjustified.

However, FDA believes that there is a sufficient basis to consider

defining the term ``high potency'' or some similar term as a nutrient

content claim. FDA's tentative view is that this term, or a similar

term when defined, could provide a way for manufacturers to describe

the higher levels of nutrients in dietary supplements. (See comment 25

for further discussion of this matter.)

b. ``More''

16. One comment stated that consumers could be misled if

comparative claims are made among high potency vitamin/mineral

supplements. The comment stated that if, for example, one brand of 300-

mg vitamin B6 tablets claimed that it contained ``more'' than a

competitive 250-mg product, then the consumer may get the misleading

impression that the former product is better. The comment maintained

that as customers shop for supplements, they will be able to readily

observe whether one product is more potent than another without label

claims suggesting superiority of one over another. If such a claim

resulted in better sales, then a ``horsepower race'' would ensue. The

comment recommended that ``more'' claims for vitamins and minerals not

be allowed if the nutrient potency of the reference product already

meets or exceeds 100 percent of the Daily Value.

The agency acknowledges that there is the possibility that some

manufacturers may choose to increase potencies in order to make a

``more'' claim in comparison to another brand, but the agency disagrees

that the limitation suggested by the comment is warranted at this time.

The agency points out that ``more'' claims for nutrients with an RDI or

DRV, including those products with nutrients in megadoses, such as

those in the example cited by the comment, must include the following

information: The percentage (or fraction) that the nutrient was

increased relative to the RDI or DRV, the identity of the reference

food, and the quantitative amount of the nutrient present (e.g.,

contains ``20 percent more of the DV for vitamin B6 per tablet than

product `x'. The vitamin B6 content of product `x' is 250 mg. This

product contains 300 mg vitamin B6.'') The nutrition label of a product

containing 300 mg of vitamin B6 must state that the product contains

1,500 percent of the Daily Value. The agency acknowledges that the

amount of information required to make a ``more'' claim is

considerable, but such information is necessary to allow consumers to

readily see how the amount of a nutrient for which a ``more'' claim is

made fits into the total daily diet.

Furthermore, FDA believes that the concern regarding ``horsepower

races'' in dietary supplements stems from concerns of possible unfair

marketing among manufacturers as well as from safety concerns inherent

in the addition of very high levels of nutrients to supplements.

Similar concerns with foods in conventional food form led to the

establishment of FDA's fortification policy in 1980. This policy, while

published in Sec. 104.20, does not have the force of a regulation.

However, the agency has not found evidence of widespread ``horsepower

races'' with such foods. The agency urges industry, particularly

industry associations, to develop standards regarding nutrient levels

and to monitor compliance with those standards to minimize any safety

problems.

c. Restrictions on label or labeling claims based on section

411(b)(2)(B) of the act

17. One comment from a trade association stated that the literal

reading of section 411(b)(2)(B) of the act prohibits giving prominence

on the label of dietary supplements of vitamins or minerals to

ingredients that are not vitamins or minerals. The comment argued that

these prohibitions result in the withholding of information that is of

interest to consumers, and that it is increasingly common for

manufacturers to market products that offer a combination of vitamins,

minerals, herbs, and other dietary substances. The comment stated that

the principal reason for the purchase of these products is not their

vitamin and mineral content but the other ingredients. The comment

invited FDA to join the supplement industry in seeking an amendment to

section 411 of the act that will remedy this problem.

Another comment disagreed with FDA's interpretation of section

411(b)(2)(B) of the act and suggested that this section merely

prohibits giving prominence or emphasis to such ingredients. The

comment argued that nutrients other than vitamins and minerals or

sources of vitamins and minerals should be permitted to appear outside

or immediately following the nutrition label, providing that such

information is not emphasized by, for example, being presented in type

size greater than that used in the nutrition label. The comment stated

that such limited declarations would not conflict with current

provisions of the act and would be fair and reasonable means of

communicating about the presence of ingredients that provide added

value to many dietary supplement products.

The agency is persuaded by these comments that a clarification of

those sections of the proposal relating to section 411(b)(2)(B) of the

act is needed. Section 411(b)(2)(B) of the act states that the labeling

and advertising for dietary supplements of vitamins and minerals may

not give prominence to or emphasize ingredients that are not vitamins,

minerals, or represented as a source of vitamins or minerals. Because

of this provision, nutrient content claims about ingredients that are

not vitamins or minerals (e.g., ``more fiber,'' ``high protein'') may

not be made on dietary supplements of vitamins or minerals.

It must be emphasized that this provision pertains only to dietary

supplements of vitamins and minerals. If, for example, an herbal

extract includes vitamins and minerals but is labeled as an herbal

extract, in compliance with Sec. 101.9 and other applicable provisions,

and is advertised as such, section 411(b)(2)(B) of the act would not

apply. The same is true for a product that is primarily a protein

supplement. A protein supplement with added vitamins and minerals that

is labeled and advertised as a protein supplement could declare that it

is high in fiber. Such claims are permissible as long as they are made

in accordance with section 403(r) of the act, and they are not false or

misleading in any particular.

However, section 411(b)(2)(B) of the act makes clear that in the

labeling and advertising of dietary supplements of vitamins and

minerals, ingredients other than vitamins or minerals cannot be

emphasized or given prominence. FDA interprets prominence not solely as

a function of type size. Declaring an ingredient outside or immediately

following the nutrition label is another means of giving prominence.

For example, a statement such as ``5 g psyllium,'' except in extremely

limited circumstances, cannot be made on the principal display panel,

outside the nutrition label, or immediately following the nutrition

label of a dietary supplement of vitamins and minerals because such

placements give prominence to that ingredient. However, the declaration

of psyllium in the ingredient list would not be construed as giving

prominence to that ingredient. On the other hand, ``5 g psyllium''

could be declared in an amount statement on the principal display

panel, outside, or immediately following the nutrition label on protein

supplements, on dietary supplements of herbal extracts, and on dietary

supplements of other similar nutritional substances so long as these

dietary supplements are not subject to section 411 of the act.

FDA advises that if a sugar is an ingredient in a dietary

supplement of vitamins or minerals, claims about the amount of sugar

actually in the product would have to be restricted. However, ``sugar-

free'' and ``no added sugar'' are absence claims that assert that sugar

is not an ingredient. The agency concludes that the use of these terms

is acceptable on dietary supplements of vitamins or minerals, as well

as on other types of dietary supplements.

In view of this clarification, the agency believes that section

411(b)(2)(B) of the act, as written, is sufficiently flexible to

accommodate claims on products that are not dietary supplements of

vitamins or minerals. FDA believes that it is therefore unnecessary to

amend section 411 of the act.

2. Nutrient Content Claims for Sugar Content

18. One comment questioned the appropriateness of allowing ``sugar-

free'' claims for a dietary supplement containing less than 0.5 g of

sugars. The comment stated that many supplements come in capsules or

tablets that weigh slightly less or not much more than 0.5 g, and

therefore, supplements that are mostly sugars could use the term

``sugar-free.'' The comment suggested that the term ``sugar free'' on a

dietary supplement should mean a much lower amount of sugars, or that

the product should be totally devoid of sugars.

The comment also argued that terms such as ``negligible source of

sugar,'' ``dietarily insignificant source of sugar,'' and ``trivial

source of sugar'' are not synonymous with ``sugar-free'' because such

terms connote the presence of some sugar content.

FDA is not persuaded by the comment that 0.5 g or less of sugars

per serving is an inappropriate definition of insignificance for sugars

for dietary supplements. Section 101.60(c)(1) provides that for a food

in conventional food form to make a ``sugar free'' claim, the food must

contain less than 0.5 g of sugars per reference amount. Less than 0.5 g

of sugars per reference amount is an amount that is consistent with the

agency's policy of defining ``free'' claims at or near the reliable

limit of detection and in an amount that is dietetically

inconsequential (56 FR 60421 at 60432). As a result, even frequent

consumption of a food bearing a ``sugar free'' claim would not result

in an intake of sugars that would affect the overall diet in any

meaningful way.

FDA acknowledges that there may be situations in which a dietary

supplement may contain a significant proportion of sugars on a weight

basis and be able to make the claim ``sugar free.'' The agency

believes, however, that even in such instances, if the total amount of

sugars in a serving of the product is less than 0.5 g, its net

contribution to the total daily diet would be inconsequential.

Additionally, FDA considers it important that nutrient content

claims correspond with the nutrition label, which serves as a source of

specific information for consumers concerning the nutritional value of

the food. The nutrition labeling regulations allow foods containing

less than 0.5 g sugars per labeled serving to declare 0 g of sugars

(Secs. 101.9(c)(6)(ii) and 101.36(b)(3)).

FDA rejects the suggestion that it permit use of the term ``sugar

free'' only where there is an absolute absence of sugars. FDA believes

that it is appropriate to apply the term ``free'' to a nutrient when a

food contains that nutrient in a dietetically trivial or

physiologically inconsequential amount, even though the nutrient is

present at a level at or near its reliable limit of quantitation,

because with modern analytical methods, the level at which the presence

of a nutrient may be quantified is becoming increasingly smaller (58 FR

2302 at 2320). The agency believes that it is appropriate to focus on

dietary insignificance, and very trivial amounts have no impact on the

diet for the purpose of defining ``sugar free.''

The agency also disagrees that the terms ``negligible source of

sugar,'' ``dietarily insignificant source of sugar'', and ``trivial

source of sugar'' are inappropriate synonyms for ``sugar free.''

Section 403(r)(2)(A)(i) of the act states that a nutrient content claim

must be defined by regulation. In addition, section (3)(b)(1)(A)(ix) of

the 1990 amendments provides that those regulations may include similar

terms commonly understood to have the same meaning. The agency is not

aware of any reason why the above terms are inappropriate synonyms for

``sugar free.'' Although these synonyms do not convey the absolute

absence of sugar, they reflect that the amounts are dietetically

trivial and of no dietary significance. Therefore, the agency rejects

this comment.

19. One comment stated that the term ``no added sugar'' can be used

only when a product is expected to contain sugar, but that consumers do

not know when supplements are expected to contain sugars. The comments

suggested that FDA should not preclude the use of the term ``no added

sugars'' as this term would be useful to consumers in identifying those

products without sugar.

The agency is persuaded that a review of the conditions for the use

of the term ``no added sugar'' is warranted. FDA did not propose to

preclude the use of the term ``no added sugar'' on all dietary

supplements. The agency finds that this term is appropriate for some

dietary supplements, such as children's chewable vitamins, that are

frequently sweetened. Section 101.60(c)(2) states that the terms ``no

added sugar,'' ``without added sugar,'' or ``no sugar added'' may be

used only if: (1) No amount of sugars, as defined in

Sec. 101.9(c)(6)(ii), or any ingredient that contains sugars, or that

functionally substitutes for added sugars is added during processing or

packaging, (2) the product does not contain an ingredient containing

added sugars, (3) the sugars content has not been increased above the

amount present in the ingredients by some means such as the use of

enzymes, (4) the food that it resembles and for which it substitutes

normally is formulated with sugars, and (5) the product bears a

statement that the food is not ``low calorie'' or ``calorie reduced''

(unless the food meets the requirements for a ``low'' or ``reduced

calorie'' food) and that directs consumers' attention to the nutrition

label for further information on sugar and calorie content.

As is the case for foods in conventional food form, the agency

believes that to avoid misleading consumers, the term ``no added

sugar'' should be limited to dietary supplements that would be expected

to contain added sugars. The agency advises that the purpose of a ``no

added sugar'' claim is to identify a food that differs from a similar

food because it does not contain the added sugars that would normally

be present in the similar food. For this provision to be of practical

benefit to consumers, it must preclude the use of the claim on a food

where the sugars that are normally added are replaced with an

ingredient that contains sugars that functionally substitute for the

added sugars. Thus, the agency concludes that the use of any ingredient

that contains sugars that would normally be added to a food precludes

the use of the ``no added sugar'' nutrient content claim. The agency

believes that claims concerning the absence of added sugars on products

that would not normally contain added sugar (e.g., dietary supplements

of vitamins and minerals for adults) are likely to mislead consumers

into thinking that a particular brand may be more desirable when

compared to other brands of the same product.

FDA acknowledges that consumers may not know every type of product

that could be expected to contain sugar. However, the final rule on

nutrition labeling for dietary supplements published elsewhere in this

issue of the Federal Register specifies that sugars will be listed in

the ingredient label and must be declared in the nutrition label if

present in more than insignificant amounts. Through these provisions

the consumer can readily ascertain which products contain sugars.

C. Implied Nutrient Content Claims

1. Claims That are not Nutrient Content Claims

Section 101.65(b)(1) of the final rule on nutrient content claims

provides that statements that declare the absence of food components or

ingredients that are not nutrients of the type required to be declared

on the nutrition label, and that are intended to facilitate avoidance

for such reasons as food intolerance (e.g., lactose free), religious

beliefs, dietary practices such as vegetarianism or other nonnutrition

related reason, (e.g., ``100 percent milk free''), are not nutrient

content claims. In the proposal on nutrient content claims for dietary

supplements, the agency tentatively concluded that this paragraph is

applicable to dietary supplements and requested comment on other

examples that are appropriate for dietary supplements.

20. Comments suggested that other examples of terms in this

category include the following: gluten free, wheat free, corn free,

yeast free, starch free, milk free, egg free, soy free, no artificial

ingredients, nonirradiated, and no synthetic ingredients. The comments

requested that FDA confirm that these statements are allowed on the

label.

None of the terms that were submitted in the comments other than

``egg free'' would constitute nutrient content claims. The term ``egg

free'' can be interpreted as an implied claim about cholesterol.

The agency points out that it does not currently have a definition

for ``artificial'' except as that term applies to flavors and colors.

Similarly, it has no definition for ``synthetic'' except as that term

applies to flavors and colors. Although these terms have not been

defined by FDA, the agency believes that they are not nutrient content

claims unless they are used in a context in which they explicitly or

implicitly describe the level of a nutrient. However, even if these

terms are not nutrient content claims, manufacturers who use them must

make sure that their use is not false or misleading.

21. FDA proposed to include dietary supplements in the coverage of

Sec. 101.65(b)(4). This section states that when an ingredient

constitutes essentially 100 percent of a food, so that the name of the

ingredient is the statement of identity, the name of the ingredient

generally does not constitute an implied nutrient content claim unless

it is used in a context to suggest that a nutrient is absent or present

in a certain amount. FDA used a statement of identity for a dietary

supplement in which an ingredient constitutes essentially 100 percent

of a supplement (e.g. ``60 mg--vitamin C'') as an example. One comment

pointed out that 60 mg vitamin C tablets contain excipients (fillers,

binders, lubricants, disintegrants) other than vitamin C. The comment

requested clarification as to whether, in the example of vitamin C

tablets, Sec. 101.65(b)(4) requires that the amount claimed in the

statement of identity constitute 100 percent of the claimed amount of a

food in Sec. 101.65(b)(4).

In the example added to Sec. 101.65(b)(4), the amount refers to the

claimed nutrient. A tablet stating ``60 mg--vitamin C tablets'' should

contain 60 mg of that nutrient. The agency recognizes that a nutrient

will not constitute precisely 100 percent of some dietary supplements,

such as vitamin tablets or capsules, and advises that small amounts of

excipients, binders, lubricants, or disintegrants added for

technological purposes are allowable in addition to the stated nutrient

content.

Additionally, FDA points out that under Sec. 101.3(c), if a food is

marketed in various optional forms, the particular form is a necessary

part of the statement of identity. Because vitamin C is marketed in

tablet, capsule, and liquid form, the form is part of the name.

Therefore, this food should be called ``60 mg-vitamin C tablets.'' The

agency acknowledges an error in this regard in the proposal and is

revising Sec. 101.65(b)(4) to make the correction.

22. One comment stated that it is not unusual for a dietary

supplement to contain several nutrients of one type and a single

nutrient of another type, such as ``multiple-vitamins with iron.'' The

comment requested confirmation that ``with iron'' would not represent

an implied nutrient content claim.

The agency advises that a term such as ``with iron,'' when used on

the statement of identity of a supplement, is intended to describe the

nature of the food. When a statement of identity simply states ``with

iron'' or specifies the amount of iron in a product (e.g.,

``multivitamin with 15 mg iron''), the statement is not a nutrient

content claim. Such statements fall under Sec. 101.65(b)(5).

However, as the agency stated in Sec. 101.65(b)(5), there may be

cases in which other statements on the label or labeling would have the

effect of making the statement into a nutrient content claim. For

example, if the labeling of a multivitamin with iron includes a

discussion of the importance of iron in the diet, FDA believes the

statement ``with iron'' would be an implied claim that the multivitamin

is a good source of iron. If the labeling is devoid of such

information, FDA would be unlikely to consider the name to be an

implied nutrient content claim. The agency will evaluate such claims on

a case-by-case basis in the context of the entire label and labeling to

determine whether they are nutrient content claims.

23. One comment maintained that FDA failed to address whether the

currently used claim of ``high in antioxidants'' was within the scope

of the proposed regulation.

While the term ``high in antioxidants'' was not explicitly

discussed in the proposed regulations for nutrient content claims for

dietary supplements, the agency considers it to be an implied nutrient

content claim that would come under Sec. 101.65. FDA's view is that

this claim implies that the food on which it appears contains a

``high'' amount (i.e., at least 20 percent of the RDI, see

Sec. 101.54(b)(1)) of each antioxidant. One problem with this claim,

however, is that there is no established definition of

``antioxidants.''

FDA believes that a logical place to start in defining this term is

section 3(b)(1)(A)(x) of the 1990 amendments. That provision directed

FDA to determine whether a health claim on antioxidant vitamins and

cancer, could be authorized under the standard that it established for

dietary supplements under section 403(r)(5)(D) of the act. In its

proposed regulations to implement the 1990 amendments, in response to

this provision, FDA considered the effects of vitamin C, vitamin E, and

beta-carotene on cancer because these nutrients are the vitamins or

provitamins that function as antioxidants (56 FR 60624, November 27,

1991). In the final rule on antioxidant vitamins and cancer, FDA

concluded that its selection of these nutrients was appropriate (58 FR

2622, January 6, 1993). Thus, the agency has determined that the

direct-acting antioxidant vitamins or provitamins include vitamin C,

vitamin E, and beta-carotene. Based on its review of the information

presented at a recent conference entitled ``Antioxidant Vitamins and

Cancer and Cardiovascular Disease,'' which was initiated by FDA, the

agency is not aware of any basis to expand this list because the

biological role of other vitamins as direct antioxidants has not been

confirmed (Ref. 3).

While it is arguable that FDA could authorize ``high in

antioxidants'' as an implied claim pertaining to antioxidant vitamins

as a logical outgrowth of the proposal, because the claim applies to

foods in conventional food form as well as to dietary supplements, the

agency believes that the better course is to propose to authorize such

a claim. In addition, the definition of ``antioxidants'' is not free

from controversy. The agency is aware, based on its review of dietary

supplements whose labeling currently includes a ``high in antioxidant''

claim, that some manufacturers view this term as including certain

minerals. Antioxidant minerals have not been addressed by the agency,

and, therefore, final rules implementing the 1990 amendments do not

provide for claims about them. Thus, FDA finds that a rulemaking on the

definition of ``antioxidants'' will provide an opportunity to establish

the precise meaning of this term.

Consequently, FDA intends to address this issue as quickly as

possible in a forthcoming proposal. Given that, elsewhere in this issue

of the Federal Register, the agency is establishing a date of

applicability of July 5, 1995, for this regulation, FDA anticipates

that there is sufficient time to take final action on such a proposal

before that date.

2. ``Healthier''

24. One comment from a manufacturer observed that FDA proposed a

regulation concerning use of the term ``healthy'' (proposed

Sec. 101.65(d)(2) (58 FR 2949)) in the January 6, 1993 Federal Register

(58 FR 2944 at 2949). The comment notes that ``healthy'' and similar

terms are used in a variety of contexts. For example, one of the

manufacturer's dietary supplements is labeled as ``the way to

a healthier life.'' The comment suggested that this claim should not be

deemed to be subject to the ``healthy'' definition.

FDA advises that it is in the process of finalizing regulations on

the January 6, 1993, proposal for the claim ``healthy.'' The use of

terms such as ``healthy,'' ``healthier,'' ``healthiest'' will be

addressed in that final rule.

In its final rule on nutrient content claims, FDA concluded that a

claim that a food, because of its nutrient content, may be useful in

maintaining healthy dietary practices is a claim that characterizes the

level of a nutrient in that food (58 FR 2302 at 2375). Accordingly, the

agency provided in Sec. 101.65(d)(1) that such statements are implied

nutrient content claims and are subject to the requirements of section

403(r) of the act.

However, the agency also stated that when a term such as

``healthy,'' ``wholesome,'' or ``nutritious'' appears on a food label

in a context that does not render it an implied nutrient content claim,

it is not subject to the requirements of section 403(r) of the act (58

FR 2302 at 2375). Under such conditions, the use of the term is subject

to section 403(a) of the act, and FDA will consider whether it is

misleading on a case-by-case basis. The agency intends to give more

specific guidance in the final rule on ``healthy.''

1. General Nutrition Claims Such as ``High Potency,'' ``High

Absorption,'' and ``Balanced''

a. General issues

In the proposal on nutrient content claims for dietary supplements,

FDA requested comment on terms, ``high potency,'' ``high absorption,''

and ``balanced,'' which are often encountered on labels or in labeling

of dietary supplements and which seem to imply that the dietary

supplement will contribute to good health (58 FR 33731 at 33748). The

agency requested comment on whether there are established meanings for

these terms, and, if so, whether they characterize the level of the

nutrients in the food. FDA stated that if comments demonstrate that

there are accepted definitions used in the dietary supplement industry

for these terms that characterize the level of nutrients, and that if

it determines that these definitions will assist consumers in

maintaining healthy dietary practices, FDA will proceed with further

rulemaking to adopt the definitions or to propose new ones.

FDA also stated that if the agency agrees that such terms are

nutrient content claims, under the provisions of the statute, such

claims would be prohibited after the effective date for final rules,

until such time as they are defined by FDA by regulation. Further, FDA

stated that if comments demonstrate that there are accepted definitions

for these terms, and they do not characterize the level of nutrients,

in accordance with Sec. 101.65(d)(1) such terms would not be subject to

section 403(r) of the act unless used in a nutritional context in

association with an explicit or implicit claim or statement

characterizing the nutrient content of the food.

25. Several comments maintained that the terms ``high potency,''

``high absorption,'' and ``balanced'' are implied nutrient content

claims and urged the agency to define or prohibit these terms. The

comments stated that it is inappropriate and fraught with possibilities

for deception to allow each manufacturer to define such claims. One

comment stated that although these terms imply features of nutrient

content to consumers, they do not have any established or useful

meaning with regard to dietary supplements. The comment argued that

these terms seem to be more specific to dietary supplements than to

other food, so that their applicability in helping consumers make

appropriate nutritional choices from the variety of foods available

seems limited.

On the other hand, several comments stated that these terms do not

inherently refer to the level of nutrients, are not nutrient content

claims, and therefore should not be defined. These comments maintained

that such terms are formulation descriptions, which properly and

truthfully describe the nature and type of the product. These comments

contended that these terms have been used for many years, and that

consumers have come to understand that products so described provide an

amount of the primary nutrients in the formulation that is at least

equal to the RDA's for those nutrients.

One comment argued that FDA precedent exists for excluding such

terms from regulation as nutrient content claims. The comment stated

that as formulation descriptions, these terms are useful to consumers

in helping them to make product choices, and manufacturers should be

allowed to continue to use these terms in a manner that is consistent

with FDA's policy on claims such as ``maximum strength'' for internal

analgesics in the over-the-counter drug review (i.e., kept outside the

scope of this rulemaking).

The agency agrees that these terms seem to have more direct

application to dietary supplements than to foods in conventional food

form. Furthermore, these terms may have some utility in helping

consumers select among dietary supplements. However, while these terms

have apparently been used for years to imply superiority, the agency is

uncertain what they mean to consumers.

The agency disagrees that these terms should be regulated in the

same manner as terms such as ``maximum strength,'' which are used on

the labels of over-the-counter drug products. The over-the-counter drug

regulations include maximum amount limitations. Section 411(a)(1)(A) of

the act prohibits limits on the potency of dietary supplements of

vitamins or minerals except on the basis of safety. Therefore, the

situations are not analogous.

The agency believes that each of these terms should be evaluated

individually because they do not seem to be synonymous. ``High

potency'' seems to focus on nutrient level or content, but

``balanced,'' as one comment suggested, seems to be a formulation

claim. ``High absorption'' seems to focus on how the body responds to

the nutrient. The agency will address each of these terms in more

detail in the comments that follow.

b. Definition for ``high potency''

26. The majority of comments stated that the term ``high potency''

or ``full potency'' is an implied nutrient content claim and should be

defined. Several definitions were offered for this term. A few comments

stated that multivitamins and minerals are termed ``high potency'' when

the majority of nutrients with established RDA's are present at the

levels equal to or in excess of the RDA.

Similarly, another comment stated that the term should be

restricted to formulations that contain micronutrients at levels of at

least twice the applicable RDI or DRV because a multivitamin at 100

percent of the DV might be ``high potency'' compared to a food in

conventional food form but not ``high potency'' when compared to other

dietary supplements.

Another comment suggested that FDA should require a ``high

potency'' single-ingredient supplement to contain at least twice the

RDI, and that the front of the label should disclose what multiple of

the RDI the supplement contains. The comment acknowledged that under

this scheme, some nutrients, such as calcium and selenium, would not

qualify to carry a ``high potency'' claim, because they are rarely sold

at double the RDI. The comment suggested that if the supplement

industry begins to market those supplements at higher doses in order to

make ``high potency'' claims, then FDA could establish a lower minimum

level, such as 50 percent more than the RDI for selenium or 50 percent

of the RDI for calcium. Those minimum levels would apply to those

nutrients only. The comment also suggested that FDA should allow ``high

potency'' claims on multinutrient supplements when more than one-third

of the nutrients that they contain meet the minimum level required for

a high potency claim, and the label discloses which nutrients are

present at high levels. For example, the label of a ``high potency''

multivitamin could carry an asterisk next to the claim, with the

following disclosure: ``contains high levels of [number] vitamins.''

Further, the comment stated that it is not reasonable to require

that all of the nutrients in a multinutrient supplement be present at

levels that are necessary for high potency claims because many

nutrients are not--and should not--be sold in such high doses. For

example, the comment suggested that ``high potency'' claims should be

allowed on a multivitamin-and-mineral supplement that contains at least

double the RDI of vitamins A, C, E, B6, B12, thiamin, riboflavin, and

niacin but smaller amounts of vitamin D, iron, calcium, magnesium,

zinc, and copper. The comment stated that the latter nutrients are

typically sold at doses lower than double the RDI and may pose a risk

at high levels.

FDA has reviewed the comments and is persuaded that ``high

potency'' is a claim that characterizes the level of a nutrient and

therefore meets the definition in Sec. 101.13(b) of a nutrient content

claim. FDA also is persuaded by the comments that this is a term that

FDA should define in order to ensure that it will be useful to

consumers in maintaining healthy dietary practices. However, given the

range and diversity of the suggested definitions, the agency is not

prepared to offer a definition of ``high potency'' at this time. FDA

intends to review the suggestions it received on this issue and based

on information received in comments, issue a proposed rule on an

appropriate definition of ``high potency.''

FDA recognizes that there is a need to provide this definition as

quickly as possible. Therefore, FDA intends to act on this matter as

expeditiously as its resources allow.

c. Definitions for ``high absorption''

27. A couple of comments stated that the term ``high absorption''

does not refer to the level of nutrients but rather to bioavailability

or how efficiently the nutrients are released from the product and

absorbed into the bloodstream. One comment stated that ``high

absorption'' means that the product meets the definition for ``high,''

and that a ``high amount'' is digested and assimilated.

Another comment stated that from a biological viewpoint, the extent

to which nutrients are absorbed from food or supplements depends not

only on the chemical form of the nutrient itself but on the chemical

environment presented by the carrier food in which it is contained and

on the physiological state of nutrient need of the individual consumer.

Given these factors, the comment stated that it is difficult to provide

a meaningful definition of absorbability.

One comment requested that the label should disclose information

about the bioavailability of the product. Another comment suggested

that FDA should allow labels to make ``high absorption'' or similar

claims only when the manufacturer supplies bioavailability data showing

that the product is better absorbed than a standard supplement. The

comment stated that the agency should not allow this claim on

supplements that simply meet or exceed the United States Pharmacopeial

Convention's (USP's) (or other) standards for disintegration or

dissolution, because meeting those standards does not ensure that the

product is well absorbed.

The agency agrees that the term ``high absorption'' generally

refers to how well a nutrient is absorbed into the system. A product

can be well absorbed irrespective of the quantitative amount found in

the product. Accordingly, FDA finds that ``high absorption'' is not a

nutrient content claim and thus will not define this term. The use of

this term is subject to section 201(n) and 403(a) of the act, however.

The agency expects that any product bearing a ``high absorption'' claim

will contain the nutrients that are the subject of the claim in a form

than can be readily assimilated by the body. In addition, manufacturers

who make a ``high absorption'' claim should have data available to

support the claim and should be prepared to make such data available to

regulatory officials on request. Failure to do so could lead the agency

to conclude that there is no basis for the claim, and thus that it is

false or misleading.

d. Definitions for ``balanced''

28. A few comments stated that ``balanced'' is not a nutrient

content claim. One comment suggested that ``balanced'' refers to the

ratio of nutrients, not the level, and that the term can apply equally

to products containing low or high quantities of nutrients. Another

comment stated that there is little need for FDA to define ``balanced''

because most multinutrient supplements that are currently on the market

do not contain nutrients in proportions that would impair the

absorption or utilization of other nutrients. The comment suggested

that until researchers gain further information on the most favorable

proportions of nutrients in supplements, the agency should leave this

term undefined and therefore prohibited. Another comment suggested that

``balanced'' be defined as any supplement containing from 50 to 150

percent of the RDI for each vitamin and mineral component of the

product for which an RDI has been established.

The agency is persuaded by the comments that the term ``balanced''

does not typically characterize the level of nutrients, but rather that

it is a formulation claim that addresses the ratio of nutrients. The

term ``balanced'' may be used in different ways, each of which relates

to the formulation of a product. For example, the term ``balanced'' may

refer to the assortment of nutrients that are present in a product, or

it may reflect interactions between the nutrients present, such as

sparing effects or impairment or enhancement of absorption.

Accordingly, this term does not meet the definition for a nutrient

content claim in Sec. 101.13(b). Therefore, the use of the term

``balanced'' is subject to sections 403(a) and 201(n) of the act and

not section 403(r) of the act. The agency will determine whether the

use of this term is misleading on a case-by-case basis.

e. Temporary suspension of the use of terms

29. One comment stated that use of the terms ``high potency,''

``high absorption,'' and ``balanced'' should not be suspended

temporarily during the rulemaking process because such a suspension

would result in unnecessary labeling costs. Another comment requested

additional time to comment on the definition of ``high potency'' and

suggested that until FDA defines this term, the agency should permit

dietary supplement manufacturers to continue to use this term as it is

currently being used. The comment suggested that as an executive

agency, FDA has inherent authority to refrain from enforcing a

statutory provision in circumstances in which the enforcement would do

more harm than good. The comment argued that to the extent that ``high

potency'' is being used as part of a brand name (and was being used

before October 25, 1989), the 1990 amendments permit its continued use

in the brand name until FDA has defined the term (section 403(r)(2)(C)

of the act).

The comment argued that there is no reason for FDA to prohibit the

use of a nutrient content claim while a definition is being developed.

Further, the comment noted that an enforcement moratorium would avoid

the relabeling problem that would arise if FDA disapproves and then

reapproves use of the term within a short period of time. The comment

stated that FDA will continue to have authority to prohibit use of the

term when such use is false or misleading.

FDA advises that it intends to define ``high potency'' as a

nutrient content claim in a separate rulemaking as quickly as possible.

The agency is postponing the date that it will apply this final rule on

nutrient content claims on dietary supplements until July 1, 1995. This

postponement is discussed in detail in the document on the date of

application for the nutrition labeling and nutrient content claim

requirements for dietary supplements found elsewhere in this issue of

the Federal Register. FDA intends to complete its rulemaking on ``high

potency'' in sufficient time to assure implementation by the time that

dietary supplement manufacturers will be required to comply with the

nutrient content claim provisions.

The agency also advises that the term ``high potency,'' when used

as part of a brand name, would fall under section 403(r)(2)(C) of the

act, if as the comment stated, it was used as part of the brand name

before October 25, 1989. However, once this term is defined by the

Secretary, it will have to be used in a manner that complies with that

definition. In addition, use of the term in the brand name is subject

to section 403(a) of the act, which prohibits the use of false and

misleading labeling irrespective of whether the use of the term in the

brand name is exempt under section 403(r)(2)(C) of the act.

As discussed previously, the comments did not demonstrate that

there are accepted definitions for any of these terms. However, the

comments have convinced the agency that the terms ``high absorption''

and ``balanced'' do not generally characterize the level of nutrients.

Accordingly, the agency concludes that these terms are not subject to

section 403(r) of the act.

4. Age Specific Claims

30. One comment stated that there are products with brand names

that imply that the product is especially useful for a particular

segment of the population. The comment argued that it would therefore

be appropriate for FDA to require that these special formulas comply

with clearly defined requirements (e.g., that they contain high amounts

of particular vitamins and minerals that are needed by the relevant

group). Another comment maintained that such names mislead consumers

because they provide no explanation for those special population

claims, and that in many cases, the supplements do not contain levels

of nutrients that are appropriate for the special population named in

the claim. The comment suggested that FDA should, at the very least,

require labels to provide an explanation for these claims. For example,

an explanation for a product with a brand name implying that it is

useful for women might state that ``this product is especially suited

for young women because it contains 100 percent of the RDI for folic

acid and iron and 30 percent of the RDI for calcium.''

FDA agrees that products marketed for special population groups may

include claims or brand names that can be misleading. These claims and

brand names seem to imply a particular benefit for certain subgroups of

the population and often do not disclose how or why they meet the needs

of that particular subgroup. Disclosure of such facts would help to

protect a product from being misbranded under section 403(a) of the act

because its labeling would reveal material facts about the product's

claimed special usefulness.

However, such claims about the usefulness of a product for

particular population groups generally fall under section 403(j) of the

act to the extent that they represent the product to be for special

dietary use. As special dietary use claims, they are outside the scope

of this rulemaking. Among other things, Sec. 105.3 defines ``special

dietary uses'' as ``uses for supplying particular dietary needs which

exist by reason of a physical, physiological, pathological or other

condition, including but not limited to the conditions of disease,

convalescence, pregnancy, lactation, allergic hypersensitivity to food,

underweight, and overweight; [and] [u]ses for supplying particular

dietary needs which exist by reason of age, including but not limited

to the ages of infancy and childhood'' (Sec. 105.3(a)(1)(i) and

(a)(l)(ii)). The agency intends to consider proposing regulations for

such products. However, because of resource constraints and other

agency priorities, any such proposal will not be available in the

immediate future. In the interim, such claims will continue to be

subject to the general misbranding provisions of sections 201(n) and

403(a) of the act.

5. ``Natural''

31. Several comments suggested that FDA define the term ``natural''

for dietary supplements because that term is widely used in the

labeling of dietary supplements even though there is no established

definition of that term, and it is misleading as it is now used. For

example, one comment stated that studies indicate that natural vitamin

E (d-alpha tocopherol) is better utilized than synthetic vitamin E (dl-

alpha and other tocopherols), but that ``natural'' claims now appear on

products containing synthetic vitamin E, misleading consumers who think

they are getting a better utilized product. The comment stated that in

other instances, companies use the term ``natural'' to mean that the

product contains no artificial ingredients.

One comment acknowledged that FDA has struggled with how to define

this term for foods in conventional food form. This comment suggested

that the agency need not resolve the dilemma at this time, but that it

should simply establish a supplement-specific definition, just as FDA

has established a special definition for ``natural flavor'' in

Sec. 101.22. Another comment suggested that FDA should allow

``natural'' claims on products containing only the naturally occurring

form of a vitamin. The comment suggested that FDA could request

comments about whether to limit ``natural'' claims to nutrients, such

as vitamin E, that appear to offer some advantage when consumed in a

natural form. The comment also stated that many consumers will want the

option of purchasing other nutrients in the natural form as well.

FDA is not persuaded by the comments that the term ``natural''

should be defined at this time. As one comment acknowledged, the agency

has recently expended its resources exploring the use of this term, and

it was unable to arrive at an acceptable definition (58 FR 2302 at

2407). FDA currently lacks sufficient resources to thoroughly explore

and develop proposed regulations for the use of this term on dietary

supplements.

In the final rule on nutrient content claims, the agency determined

that it would maintain its current policy (as discussed in the general

principles proposal (56 FR 60421 at 60466) of interpreting this term to

mean that nothing artificial or synthetic (including all color

additives regardless of source) has been included in, or has been added

to, a food (Ref. 7). FDA also decided that it would continue to

distinguish between natural and artificial flavors as outlined in

Sec. 101.22. The agency concludes that, for the reasons cited above, it

is appropriate to apply this policy to dietary supplements.

In this regard, FDA also points out that Sec. 101.9(k)(6) states

that a food labeled under the provisions of this section shall be

deemed to be misbranded under sections 201(n) and 403(a) of the act if

its label or labeling represents, suggests, or implies, ``that a

natural vitamin in a food is superior to an added or synthetic vitamin

or to differentiate in any way between vitamins naturally present from

those added.''

V. Other Provisions

FDA did not receive any comments that dealt specifically with the

other provisions of the proposal. In the absence of any basis for doing

otherwise, FDA is adopting those provisions as proposed.

VI. Economic Impact

In its dietary supplement labeling proposals of June 18, 1993, FDA

stated that the proposed rules on the labeling of dietary supplements,

taken as a whole, would have associated costs of approximately $20

million. Thus, the agency concluded that the proposed rules would not

constitute a major rule as defined by Executive Order 12291. In

accordance with the Regulatory Flexibility Act (Pub. L. 96-354), FDA

explored whether the proposed rules may have a significant impact on

small businesses and tentatively concluded that they do not.

FDA has evaluated the many comments that it received in response to

its economic impact analysis. Because the issues raised in the comments

relate to all three proposals, FDA has combined its discussion of these

comments and presented them in the final rule regarding the date of

application published elsewhere in this issue of the Federal Register.

FDA has examined the economic implications of the final rules

amending 21 CFR as required by Executive Order 12866 and the Regulatory

Flexibility Act. Executive Order 12866 directs agencies to assess all

costs and benefits of available regulatory alternatives and, when

regulation is necessary, to select regulatory approaches that maximize

net benefits (including potential economic, environmental, public

health and safety effects; distributive impacts; and equity). The

Regulatory Flexibility Act requires the agency to analyze options for

regulatory relief for small businesses. FDA has concluded, based on its

review of the available data and comments, that these final rules are

not significant as defined by Executive Order 12866. Further, in

accordance with the Regulatory Flexibility Act, the agency certifies

that these final rules will not have a significant impact on a

substantial number of small businesses.

VII. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(11) that this

action is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VIII. Paperwork Reduction Act

In the June 18, 1993, proposal on nutrient content claims for

dietary supplements (58 FR 33731 at 33749), FDA announced that the

agency had submitted to the Office of Management and Budget (OMB) for

its review the collection of information requirements contained in

proposed Sec. 101.69, for petitions regarding the use of nutrient

content claims in conjunction with food labeling on dietary

supplements. Also in that document, FDA published its estimated annual

collection of information burden for this provision.

None of the more than 500 comments received in response to the

dietary supplement proposal addressed the content of petitions under

the proposed nutrient content claim petition requirements. Thus, the

agency's estimated annual reporting and recordkeeping burden from the

health claim petition requirements contained in this final rule remains

unchanged from that announced in June.

FDA has submitted copies of the final rule to OMB for its review of

these reporting requirements.

IX. References

The following references have been placed on file 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. Moss, A. J., A. S. Levy, I. Kim, Y. Park, ``Use of Vitamin

and Mineral Supplements in the United States, Current Users, Types

of Products and Nutrients,'' Advance Data from Vital and Health

Statistics of the National Center for Health Statistics, No. 174,

July 18, 1989.

2. Pennington, J. A. T., V. L. Wilkening, J. E. Vanderveen,

``Descriptive Terms for Food Labeling,'' Journal of Nutrition

Education, p. 51, June 1990.

3. Transcript to Docket N-289 for FDA-Initiated Public

Conference: Antioxidant Vitamins and Cancer and Cardiovascular

Disease, November 1993.

4. Subcommittee on the 10th Edition of the Recommended Dietary

Allowances, Food and Nutrition Board, Commission on Life Sciences,

National Research Council, ``Recommended Dietary Allowances, 10th

Ed.,'' Washington, DC, National Academy Press, 1989.

5. Committee on Diet and Health, Food and Nutrition Board,

Commission on Life Sciences, National Research Council, National

Academy of Sciences, ``Diet and Health, Implications for Reducing

Chronic Disease Risk,'' National Academy Press, Washington, DC,

1989.

6. Committee on the Nutrition Components of Food Labeling, Food

and Nutrition Board, Institute of Medicine, National Academy of

Sciences, ``Nutrition Labeling, Issues and Directions for the

1990's,'' Washington, DC, National Academy Press, 1990.

7. Newberry, R., letter to Clinton K. Davies, September 29,

1988.

List of Subjects in 21 CFR Part 101

Food labeling, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

101 is amended as follows:

PART 101--FOOD LABELING

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

follows:

Authority: Secs. 4, 5, 6, of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 371).

2. Section 101.13, effective May 8, 1994, is amended by revising

paragraph (a), by adding paragraph (b)(5), by revising the first

sentence in paragraph (c), introductory text of paragraph (i),

(j)(1)(i)(A) and (j)(l)(i)(B), and (n) to read as follows:

Sec. 101.13 Nutrient content claims--general principles.

(a) This section and the regulations in subpart D of this part

apply to foods that are intended for human consumption and that are

offered for sale, including foods in conventional food form and dietary

supplements of vitamins, minerals, herbs, and other similar nutritional

substances (dietary supplements).

(b) * * *

(5) For dietary supplements, claims for calories, fat, saturated

fat, and cholesterol may not be made on products that meet the criteria

in Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''

claims, except, in the case of calorie claims, when an equivalent

amount of a similar dietary supplement (e.g., another protein

supplement) that the labeled food resembles and for which it

substitutes, normally exceeds the definition for ``low calorie'' in

Sec. 101.60(b)(2).

(c) Information that is required or permitted by Sec. 101.9 or

Sec. 101.36, as applicable, to be declared in nutrition labeling, and

that appears as part of the nutrition label, is not a nutrient content

claim and is not subject to the requirements of this section. * * *

* * * * *

(i) Except as provided in Sec. 101.9 or Sec. 101.36, as applicable,

or in paragraph (q)(3) of this section, the label or labeling of a

product may contain a statement about the amount or percentage of a

nutrient if:

* * * * *

(j) * * *

(1) * * *

(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the

reference food may be a dissimilar food within a product category that

can generally be substituted for one another in the diet (e.g., potato

chips as reference for pretzels, orange juice as a reference for

vitamin C tablets) or a similar food (e.g., potato chips as reference

for potato chips, one brand of multivitamin as reference for another

brand of multivitamin).

(B) For ``light,'' ``reduced,'' ``added,'' ``fortified,'' and

``enriched'' claims, the reference food shall be a similar food (e.g.,

potato chips as a reference for potato chips, one brand of multivitamin

for another brand of multivitamin).

* * * * *

(n) Nutrition labeling in accordance with Sec. 101.9, Sec. 101.10,

or Sec. 101.36, as applicable, shall be provided for any food for which

a nutrient content claim is made.

* * * * *

3. Section 101.54, effective May 8, 1994, is amended by revising

paragraph (a)(3), (b)(1), (c)(1) and the introductory text of paragraph

(e)(1) to read as follows:

Sec. 101.54 Nutrient content claims for ``good source,'' ``high,'' and

``more.''

(a) * * *

(3) The food for which the claim is made is labeled in accordance

with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.

(b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or

``excellent source of'' may be used on the label and in the labeling of

foods except meal products as defined in Sec. 101.13(l), main dish

products as defined in Sec. 101.13(m), and dietary supplements of

vitamins or minerals to characterize the level of any substance that is

not a vitamin or mineral, provided that the food contains 20 percent or

more of the RDI or the DRV per reference amount customarily consumed.

* * * * *

(c) ``Good Source'' claims. (1) The terms ``good source,''

``contains,'' or ``provides'' may be used on the label or in labeling

of foods except meal products as described in Sec. 101.13(l) main dish

products as described in Sec. 101.13(m), and dietary supplements of

vitamins or minerals to characterize the level of any substance that is

not a vitamin or mineral, provided that the food contains 10 to 19

percent of the RDI or the DRV per reference amount customarily

consumed.

* * * * *

(e) ``More'' claims. (1) A relative claim using the terms ``more,''

``fortified,'' ``enriched,'' and ``added'' may be used on the label or

in labeling of foods to describe the level of protein, vitamins,

minerals, dietary fiber, or potassium except as limited by

Sec. 101.13(j)(1)(i) and except meal products as defined in

Sec. 101.13(l), main dish products as defined in Sec. 101.13(m), and

dietary supplements of vitamins or minerals to characterize the level

of any substance that is not a vitamin or mineral, provided that:

* * * * *

4. Section 101.60 is amended by revising paragraphs (a)(2) and

(a)(3), by adding new paragraph (a)(4), by redesignating paragraphs

(c)(4) and (c)(5) as paragraphs (c)(5) and (c)(6), and adding a new

paragraph (c)(4), and by revising the introductory text of newly

redesignated paragraph (c)(5) to read as follows:

Sec. 101.60 Nutrient content claims for the calorie content of foods.

(a) * * *

(2) The claim is made in accordance with the general requirements

for nutrient content claims in Sec. 101.13;

(3) The food for which the claim is made is labeled in accordance

with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and

(4) For dietary supplements, claims regarding calories may not be

made on products that meet the criteria in Sec. 101.60(b)(1) or (b)(2)

for ``calorie free'' or ``low calorie'' claims except when an

equivalent amount of a similar dietary supplement (e.g., another

protein supplement) that the labeled food resembles and for which it

substitutes, normally exceeds the definition for ``low calorie'' in

Sec. 101.60(b)(2).

* * * * *

(c) * * *

(4) The claims provided for in paragraph (c)(1) and (c)(2) of this

section may be used on labels or in labeling of dietary supplements of

vitamins or minerals that are intended specifically for use by infants

and children less than 2 years of age.

(5) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar

reduced,'' ``less sugar,'' ``lower sugar'' or ``lower in sugar'' may be

used on the label or in labeling of foods, except meal products as

defined in Sec. 101.13(l), main dish products as defined in

Sec. 101.13(m), and dietary supplements of vitamins or minerals,

provided that:

* * * * *

6. Section 101.61 is amended by revising paragraph (a)(3) to read

as follows:

Sec. 101.61 Nutrient content claims for the sodium content of foods.

(a) * * *

(3) The food for which the claim is made is labeled in accordance

with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.

* * * * *

7. Section 101.62 is amended by revising paragraphs (a)(2) and

(a)(3) and by adding paragraph (a)(4) to read as follows:

Sec. 101.62 Nutrient content claims for fat, fatty acid, and

cholesterol content of foods.

(a) * * *

(2) The claim is made in accordance with the general requirements

for nutrient content claims in Sec. 101.13;

(3) The food for which the claim is made is labeled in accordance

with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and

(4) For dietary supplements, claims for fat, saturated fat, and

cholesterol may not be made on products that meet the criteria in

Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''

claims.

* * * * *

8. Section 101.65 is amended by revising paragraphs (a)(3), (b)(3)

and (b)(4) to read as follows:

Sec. 101.65 Implied nutrient content claims and related label

statements.

(a) * * *

(3) The food for which the claim is made is labeled in accordance

with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.

(b) * * *

(3) A claim about the presence of an ingredient that is perceived

to add value to the product, e.g., ``made with real butter,'' ``made

with whole fruit,'' or ``contains honey,'' except that claims about the

presence of ingredients other than vitamins or minerals or that are

represented as a source of vitamins and minerals are not allowed on

labels or in labeling of dietary supplements of vitamins and minerals

that are not in conventional food form.

(4) A statement of identity for a food in which an ingredient

constitutes essentially 100 percent of a food (e.g., ``corn oil,''

``oat bran,'' ``vitamin C 60 mg tablet'').

* * * * *

Dated: December 23, 1993

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 93-31814 Filed 12-29-93; 8:45 am]

BILLING CODE 4160-01-F