Law Library


Federal Register: September 23, 1997 (Volume 62, Number 184)

Rules and Regulations

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Page 49859

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

 

21 CFR Part 101

 

Docket No. 95N-0282

 

 

Food Labeling; Requirements for Nutrient Content Claims, Health

Claims, and Statements of Nutritional Support for Dietary Supplements

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION: Final rule.

 

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

nutrient content claims regulations to change the terminology used to

describe dietary supplements; provide for the use of statements that

characterize the percentage level of dietary ingredients that do not

have Reference Daily Intakes (RDI's) or Daily Reference Values (DRV's);

and withdraw the provision that dietary supplements of vitamins and

minerals may not give prominence to any ingredient that is not a

vitamin or a mineral on its label or in labeling. The agency is also

amending its regulations to specify how (i.e., text, placement, and

type size) the disclaimer that must be contained in statements made in

accordance with the Federal Food, Drug, and Cosmetic Act (the act) is

to be presented. Additionally, FDA is removing the definition of

``dietary supplements,'' and revising the terminology used to describe

these products in the regulations on health claims for food products.

FDA is taking this action to implement, in part, the Dietary Supplement

Health and Education Act of 1994 (the DSHEA).

 

EFFECTIVE DATE: March 23, 1999.

 

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. Background

 

    On October 25, 1994, the President signed into law the DSHEA (Pub.

L. 103-417). The DSHEA, among other things, defined ``dietary

supplement'' by adding section 201(ff) to the act (21 U.S.C. 321(ff));

made provision for statements that characterize the percentage level of

dietary ingredients that do not have RDI's or DRV's by adding section

403(r)(2)(F) to the act (21 U.S.C. 343(r)(2)(F)); and amended sections

411(b)(2) and (c)(1) of the act (21 U.S.C. 350(b)(2) and (c)(1)) on the

labeling of products that contain vitamins and minerals. In addition,

the DSHEA added section 403(r)(6) to the act, which states that

statements may be made for dietary supplements if:

    the statement claims a benefit related to a classical nutrient

deficiency disease and discloses the prevalence of such disease in

the United States, describes the role of a nutrient or dietary

ingredient intended to affect the structure or function in humans,

characterizes the documented mechanism by which a nutrient or

dietary ingredient acts to maintain such structure or function, or

describes general well-being from consumption of a nutrient or

dietary ingredient * * *

(section 403(r)(6)(A) of the act), and if certain other conditions are

met. The manufacturer of the dietary supplement must have

substantiation that the statement is truthful and not misleading

(section 403(r)(6)(B)), and the statement must prominently contain the

following:

    This statement has not been evaluated by the Food and Drug

Administration. This product is not intended to diagnose, treat,

cure, or prevent any disease.

Section 403(r)(6)(C) of the act.

    In the Federal Register of December 28, 1995, FDA published a

proposed rule entitled ``Food Labeling; Requirements for Nutrient

Content Claims, Health Claims, and Statements of Nutritional Support

for Dietary Supplements'' (60 FR 67176)(hereinafter referred to as

``the dietary supplement proposal''), in which the agency proposed to

conform its regulations on nutrient content claims and health claims to

the DSHEA. The proposed rule addressed how the statements provided for

in section 403(r)(6) of the act (referred to as ``statements of

nutritional support'' in the dietary supplement proposal) are to be

presented on the label or in labeling of a dietary supplement. In

addition, the proposal sought to provide for the use of statements that

characterize the percentage level of dietary ingredients that do not

have RDI's or DRV's on the labels and in the labeling of dietary

supplements.

    The agency received approximately 30 letters in response to the

proposed rule. Each letter contained one or more comments. Several

comments supported the proposal generally or supported aspects of the

proposal. Other comments addressed issues outside the scope of the

proposal (e.g., monitoring of adverse events, definition of fiber) and

will not be discussed here. Several comments suggested modifications or

revisions of various aspects of the proposal. A summary of these

comments, and a discussion of the agency's conclusions, follow.

 

II. Revised Regulations

 

A. Coverage

 

    1. A couple of comments maintained that there is no statutory basis

for the issuance of FDA's dietary supplement proposal. These comments

argued that the Nutrition Labeling and Education Act of 1990

(hereinafter referred to as ``the 1990 amendments'') limits the reach

of ``nutrient content claims'' to claims regarding nutrients of the

type required under section 403(q)(1) and (q)(2) of the act, that is,

according to these comments, the nutrients that are to be declared in

nutrition labeling. One comment maintained that the existence of the

alternative language in section 403(r)(5)(D) of the act suggests that

Congress was aware of the difference between ``nutrients'' and ``other

similar nutritional substances,'' and that it intentionally utilized

different language for nutrient content claims and health claims.

Similarly, another comment stated that there is no justification for

FDA to conclude that the phrase ``other similar nutritional

substances'' is applicable to nutrient content claims.

    The agency has addressed the question of the application of the

nutrient content claims provisions to nutrients without RDI's or DRV's

(59 FR 378, January 4, 1994; and 60 FR 67176, December 28, 1995). In

the dietary supplement proposal (60 FR 67176), the agency stated:

    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

both sections 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 agency also noted in the dietary supplement proposal (60 FR

67176) that the legislative history of ``other

 

Page 49860

 

nutritional substances'' reveals that its coverage is broad and could,

in appropriate circumstances, include dietary ingredients without RDI's

or DRV's (136 Congressional Record S16609 (October 24, 1990)). In a

discussion between Senators Metzenbaum and Symms before the passage of

the 1990 amendments, Senator Symms stated:

    * * * What follows is a list of a few of the items and foods

that I believe would fall under the ``other similar nutritional

substances'' category established by this bill:

    Primrose oil, black currant seed oil, coldpressed flax seed oil,

``Barleygreen'' and similar nutritional powdered drink mixes,

Coenzyme Q 10, enzymes such as bromelain and quercetin, amino acids,

pollens, propolis, royal jelly, garlic, orotates, calcium-EAP

(colamine phosphate), glandulars, hydrogen peroxide

(H2O2), nutritional antioxidants such a

superoxide dismutase (SOD), and herbal tinctures.

Based on this colloquy, the agency interprets the list of dietary

ingredients that fall under the definition of ``dietary supplement'' in

section 201(ff) of the act as an explication of ``other similar

nutritional substances.'' The comments to this rulemaking ignored the

identity of language between 403(r)(1)(A) and 403(r)(1)(B) of the act

and that the 403(r)(5)(D) language (i.e., ``other similar nutritional

substances'') is subsumed under the ``nutrients of the type'' language

that appears in 403(r)(1)(B) as well as in 430(r)(1)(A) of the act.

    The comments to this rulemaking did not provide any information to

persuade the agency to modify its tentative conclusions. The comments

construed the language in section 403(1)(A) and (1)(B) of the act too

narrowly. As the discussion from the proposal quoted above makes clear,

the structure of the law itself compels FDA's conclusion with respect

to the coverage of the language in question. Nor is there anything in

the DSHEA that would suggest a different result with regard to the

coverage of these provisions. FDA therefore rejects the comments that

disagreed with the proposal on the coverage of the nutrient content

claim provisions.

    2. Several comments from the conventional food industry expressed

concern that the statutory requirements for claims on dietary

supplements can result in claims that give the misleading impression

that dietary supplements provide more health benefits than conventional

foods, as well as the erroneous impression that the presence of a

dietary ingredient in a supplement is superior to the same ingredient

provided in a matrix of conventional food by allowing dietary

supplements to make claims that foods cannot. To illustrate these

points, one comment stated that powdered, dehydrated cranberries sold

in capsule form could bear a claim stating that they are beneficial for

urinary tract health, while cranberry juice cocktail may not. The

comment argued that such a claim is denied cranberry juice despite the

fact that it has been demonstrated in clinical trials to prevent

recurrence of urinary tract infections in women.

    Other comments stated that the percentage claim provisions are an

example of inequality in the regulatory treatment of conventional foods

and dietary supplements. One comment stated that under the proposal,

comparative percentage claims (e.g. ``as much as,'' ``twice the amount

of * * *,'' ``500 percent of * * *'') for dietary ingredients that do

not have RDI's or DRV's are forbidden to conventional food marketers,

because the 1990 amendments prohibit claims that ``characterize'' the

level of these dietary ingredients unless such claims have been defined

by the agency in a regulation, but not to dietary supplement marketers.

The comment argued that this situation is inequitable and internally

inconsistent because it permits dietary supplement marketers to make,

by circuitous language, claims that they cannot make directly. As an

example, the comment stated that the effect of the agency's proposal is

to lay down for dietary supplement marketers the following two rules:

(1) You cannot claim that your product has ``more'' of a dietary

ingredient than ``x'' product; but (2) you can claim that your product

has ``twice as much'' of a dietary ingredient as ``x'' product. The

comment argued that virtually every consumer will understand the latter

claim to communicate the impermissible message contained in the former

claim.

    Another comment from a trade association for conventional food

manufacturers stated that accurate statements describing the quantity

of a dietary ingredient for which there is no RDI or DRV would be more

appropriate than percentage claims. The comment stated that should FDA

allow quantitative declarations for dietary ingredients without RDI's

or DRV's, equity and fairness require that such statements also be

allowed on conventional foods. The comment stated that such

quantitative statements will be meaningful to consumers, and that

conventional foods will be placed at a competitive disadvantage if

prohibited from using these statements.

    One comment stated that labeling claims for which there is no

scientific basis are not in the public interest. The comment maintained

that such statements undermine the public's confidence in the

government's ability to protect consumers from products that may pose

health risks. Further, the comment stated that the proposed regulations

will undermine the credibility of FDA's regulations on nutrient content

and health claims for foods.

    On the other hand, a comment from a trade association for dietary

supplement manufacturers stated that dietary supplements should be

treated differently than conventional foods because the supplement

industry thrives on open competition and does not seek government

regulation to limit competition. The comment also stated that the

dietary supplement industry wants to be able to make content claims for

its products without FDA's approval because consumers are protected

under the agency's general misbranding authority.

    FDA acknowledges that there are some differences between dietary

supplements and conventional foods with respect to the types of claims

that can be made on their product labels, and that the content claims

that can be made on both types of products without FDA authorization

are limited. These differences and limitations, however, are created by

the statute itself. FDA has no authority to modify the regulatory

regime that is established by the act.

    Section 201(g)(1)(B) of the act states that the term ``drug'' means

articles intended for use in diagnosis, cure, mitigation, treatment, or

prevention of disease. FDA points out that the claim that cranberry

juice cocktail prevents the recurrence of urinary tract infections

mentioned by one of the comments is a claim that brings the product

within the ``drug'' definition whether it appears on a conventional

food or on a dietary supplement because it is a claim that the product

will prevent disease. However, a claim that cranberry products help to

maintain urinary tract health may be permissible on both cranberry

products in conventional food form and dietary supplement form if it is

truthful, not misleading, and derives from the nutritional value of

cranberries. If the effect derives from the nutritive value of

cranberries, the claim would describe an effect of a food on the

structure or function of the body and thus fall under one exception to

the definition for the term ``drug'' found in 201(g)(1)(C) of the act.

The claim is not a health claim because no disease is mentioned

explicitly or implicitly (see section 403(r)(1)(B) of the act).

    Only if the claimed benefit did not derive from the nutritional

value of cranberries would it be true that the

 

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claim could appear on a dietary supplement but not a conventional food.

This result is dictated by section 403(r)(6) of the DSHEA.

    With regard to percentage claims, section 7(c) of the DSHEA amends

section 403(r)(2) of the act by adding clause (F) which reads:

    Subclause (i) clause (A) does not apply to a statement in the

labeling of a dietary supplement that characterizes the percentage

level of a dietary ingredient for which the Secretary has not

established a reference daily intake, daily recommended value, or

other recommendation for daily consumption.

    This new provision refers to section 403(r)(2)(A)(i) of the act,

which states that nutrient content claims may be made only if the

characterization of the level made in the claim uses terms which are

defined in regulations of the Secretary. The effect of section

403(r)(2)(F) of the act is to permit, on dietary supplement labels or

in dietary supplement labeling, the use of statements that have not

been defined by FDA but that, nonetheless, characterize the percentage

level of a dietary ingredient for which an RDI or DRV has not been

established.

    In the dietary supplement proposal (60 FR 67176), the agency

interpreted section 403(r)(2)(F) of the act as permitting percentage

claims for substances for which an RDI or DRV has not been established

on labels or labeling of dietary supplements but not on conventional

foods. Significantly, while comments objected to FDA doing so, no

comments argued that the agency had misinterpreted this aspect of

section 403(r)(2)(F). The limited legislative history does not make

clear why Congress chose to differentiate between these two types of

food in this way.

    However, the structure of the DSHEA suggests that Congress

recognized that dietary supplements are not necessarily like other

foods. Where other foods are consumed for taste, aroma, or nutritive

value, some dietary supplements are consumed for none of these reasons.

Congress apparently concluded that the labeling of dietary supplements

should be able to accommodate this fact. Thus, Congress provided for

the inclusion in the nutrition label of dietary ingredients for which

no daily consumption recommendations have been established, as well as

for the use of percentage claims about such ingredients. Congress did

not make similar provision for such ingredients in conventional foods,

presumably because it saw no reason to distract consumers from the

traditional reasons why they choose particular conventional foods.

    In the percentage claims provisions in Sec. 101.13(q)(3)(ii) (21

CFR 101.13(q)(3)(ii)), the agency sought to interpret section

403(r)(2)(F) of the act in a flexible manner. Giving section

403(r)(2)(F) of the act a significantly broader or different

application must be accomplished through the legislative process. For

now, however, it remains the case that, except for the provisions for

amount or percentage statements under Sec. 101.13(i)(3), statements

that characterize the level of a dietary ingredient without an

established RDI or DRV will misbrand a conventional food.

    It is important to note that the use of defined nutrient content

claims, such as ``more'' and ``high,'' remains limited, for both

conventional foods and dietary supplements, to those dietary

ingredients that have RDI's or DRV's. Consumer research shows that the

defined nutrient content claims are widely recognized and used by

consumers, and that consumers understand that the defined claims have

specific meanings (Ref. 1). The agency is not convinced that consumers

will automatically associate comparative percentage statements on

dietary supplements with these defined nutrient content claims.

Consumer research shows that public confidence in the food label is

high (Ref. 2), and FDA has no reason to believe that the comparative

percentage claims provisions for dietary supplements will undermine

public confidence in the agency's regulations.

    Moreover, as the agency has previously stated (60 FR 67175 at

67177), FDA is not without recourse to curtail percentage claims that

are misleading on the labels and in the labeling of dietary

supplements. Percentage statements on the label or in labeling of

dietary supplements that characterize the percentage level of a dietary

ingredient for which there is no established RDI or DRV in relation to

an equivalent or increased/decreased amount of the dietary ingredient

in another food, would be misleading under sections 403(a) and 201(n)

of the act if there is not a meaningful amount of the dietary

ingredient in either of the foods being compared, or if there is not a

meaningful difference in the level of the dietary ingredient between

the two foods.

    The agency recognizes that it cannot provide a completely

satisfying resolution for the differences in the types of percentage

claims that can be made on the labels and in labeling of dietary

supplements as opposed to conventional foods. FDA is committed,

however, to as much parity between dietary supplements and conventional

foods as is possible within the statute. The agency rejects the comment

that dietary supplements should be treated differently than

conventional foods because differences in treatment are in the interest

of a free market in dietary supplements. The agency has an obligation

to implement the law that Congress has enacted in a fair and equitable

manner. FDA is doing exactly that in its regulation of content claims

for dietary supplements as well as for conventional foods.

    3. One comment from a food manufacturer interpreted the proposal to

mean that food companies may no longer make percentage statements about

ingredients contained in their products (e.g., ``70% milk,'' ``twice as

much milk as the leading brand'') because FDA has not adopted RDI's or

DRV's for these ingredients. The manufacturer argued that there is

nothing in any statute or regulation that prohibits a food manufacturer

from stating that its product contains a particular ingredient, or from

comparing the amount of the ingredient to the amount present in another

food.

    FDA concludes that this comment misconstrues the statute. The

agency proposed to implement section 403(r)(2)(F) of the act, which, as

stated above, applies only to claims in the labeling of a dietary

supplement that characterize the percentage of a dietary ingredient for

which FDA has not established an RDI or DRV (e.g., omega-3 fatty acids,

amino acids, phytochemicals). This provision has no application to

conventional foods.

    As for the milk claims that the comment cites, the agency advises

that it has no intention of limiting percentage statements on

conventional foods that clearly describe ingredients in a manner that

relates to their organoleptic properties or that presents them as

adding value to the product. Manufacturers of conventional foods may

continue to state that products contain particular ingredients and to

compare the amounts of such ingredients to the amounts present in other

foods (see 21 CFR 101.65(b)(3)). However, the agency will continue to

evaluate the context in which claims such as ``70% milk'' and ``twice

as much milk as a leading brand'' are made to determine whether they

fall under the nutrient content claims regime. Such claims can be, in

some cases, implied nutrient content claims about the level of calcium

in the product that bears the claim. If such statements are found to be

implied nutrient content claims for calcium by the agency, they may be

used as long as they meet the criteria for the claim (see 21 CFR

101.54). If they are not implied claims, nothing in the regulations

precludes the use of such

 

Page 49862

 

statements so long as they are truthful and nonmisleading.

    4. One comment argued that the new definition of ``dietary

supplement'' is ambiguous and would include products marketed in

``traditional food form.'' The comment requested that the agency

clarify whether conventional food products that contain high levels of

nutrients, such as breakfast cereals and fruits and vegetables can be

marketed as supplements.

    The distinction between dietary supplements and conventional foods

becomes more apparent when the act is read carefully. The DSHEA added

section 201(ff)(2) which provides that a ``dietary supplement'' is a

product that is not represented for use as a conventional food. It also

struck the provision that excluded products that simulate conventional

foods from the coverage of section 411 of the act (see section 3(c)(2)

of the DSHEA). Thus, under the act, as amended by the DSHEA, a dietary

supplement may be ``in conventional food form.'' In other words, a

dietary supplement may be a product with physical attributes (e.g.,

product size, shape, taste, packaging) that are essentially the same as

a conventional food, so long as it is not represented for use as a

conventional food.

    Thus, whether a product is a dietary supplement or a conventional

food will depend on how it is labeled. To be a dietary supplement, a

product must bear the term ``dietary supplement'' as part of its common

or usual name. This term may be modified to include the name of the

dietary ingredient (e.g, ``vitamin C supplement'') or an appropriately

descriptive term (e.g., ``multivitamin supplement''). (See comment

number 1 in the companion document entitled ``Food Labeling; Statement

of Identity, Nutrition Labeling and Ingredient Labeling of Dietary

Supplements'' published elsewhere in this issue of the Federal Register

for further discussion of this issue.) All other food products, that

is, those that are not identified as dietary supplements, will be

subject to regulation as conventional foods.

    While use of the term ``dietary supplement'' in the statement of

identity is a necessary condition for a product to be represented as a

dietary supplement, it may not be enough to establish that the food is

appropriately regulated as one. If the food is represented as a dietary

supplement and is only intended to increase the dietary intake of

specific substances (e.g., vitamins), then the product would likely be

subject to regulation as a dietary supplement (section 201(ff)(1) of

the act). It would not be subject to regulation as a dietary

supplement, however, if it bears a statement that associates it with a

conventional food. For example, a product in bar form that is labeled

as a dietary supplement but that also bears label statements that

represent it as a snack food or as a substitute for a candy bar would

be subject to regulation as a conventional food. Similarly, a breakfast

cereal-type product could characterize itself as a dietary supplement

if it did not represent itself as a breakfast food or use the term

``cereal'' as a statement of identity. Either of the latter two

scenarios would represent the product as a conventional food.

    This result is compelled by section 201(ff)(1) of the act, which

states that a dietary supplement is intended to supplement the diet.

Claims that represent the product as being a snack food or a breakfast

cereal would evidence that the product is intended to do more than

supplement the diet and thus would subject it to the regime that

applies to foods other than dietary supplements.

 

B. Quantitative Amounts for Percentage Claims

 

    5. A comment from a manufacturer of a dietary supplement stated

that percentage claims such as ``40 percent omega-3 fatty acids'' do

not give the consumer any meaningful information because the consumer

will not know whether the claim means that 40 percent of the product is

omega-3 fatty acids, or that the product contains an ingredient that is

composed of 40 percent omega-3 fatty acids, or even that the product

contains 40 percent of the omega-3 fatty acids as compared to another

brand or another food. The comment stated that the only way to make

this information useful and nonmisleading is to require that the

percentage level be immediately accompanied by a statement of the

quantity of the dietary ingredient per serving of the product.

    The comment also stated that there are inherent problems in

comparing a manufactured or synthetic dietary ingredient with a dietary

ingredient in its natural source because natural sources are subject to

wide variability in composition. For example, the comment maintained

that there would be no way to accurately quantify the actual amount

that comprises ``100 percent of the dietary ingredient `X' in a bulb of

garlic.'' The comment stated that this example is meaningless and would

mislead consumers. The comment suggested that to provide any meaningful

comparative information to consumers, there must be some generally

recognized quantitative amount of the dietary ingredient in the

reference substance. The comment also suggested that in the absence of

a scientifically accepted standard for measuring the dietary ingredient

in a natural source, FDA should clarify that when there is a comparison

of an added, or a synthetic, dietary ingredient to a natural source

(e.g., garlic bulb, fish liver oil), the natural source is the

``reference food,'' which is subject to the requirement for clear

identification. The comment suggested that the actual amounts of the

dietary ingredient in the labeled and reference foods be declared.

    The agency is persuaded that percentage claims will provide more

useful information to the consumer, and that the potential for

misleading claims will be limited, if quantitative information is

provided along with the percentage information. This information will

facilitate comparisons of the amounts of dietary ingredients in

products that bear percentage claims, which, in turn, will assist

consumers in selecting products with the amount of the dietary

ingredient that they are seeking and will allow consumers to make

comparisons of the content of specific dietary ingredients across

products.

    Accordingly, FDA is revising Sec. 101.13(q)(3)(ii) by adding

Sec. 101.13(q)(3)(ii)(A) to state that, for dietary supplements,

whenever a statement is made that characterizes the percentage level of

a dietary ingredient for which there is no RDI or DRV, the actual

amount of the dietary ingredient in a serving of the product shall also

be declared (e.g., ``40 percent omega-3 fatty acids, 10 mg per

capsule'').

    In addition, FDA is adding Sec. 101.13(q)(3)(ii)(B), which states

that, for dietary supplements, where a statement that characterizes the

percentage level for a dietary ingredient for which there is no RDI or

DRV is used to compare the amount of the ingredient in the food that

bears the claim to the amount in a reference food, the amount of the

dietary ingredient in the food must be declared and the amount of the

dietary ingredient in the reference food to which the product is being

compared must also be declared. Moreover, the reference food must be

clearly identified (e.g., ``twice the omega-3 fatty acids per capsule

(80 mg) as in 100 mg of menhaden oil (40 mg)'').

    While FDA acknowledges that there may be variability in the content

of certain dietary ingredients in natural source products (e.g.,

garlic) based on a variety of conditions (e.g., soil, cultivars,

climate), FDA is not persuaded that the inherent variability

 

Page 49863

 

in the content of a dietary ingredient is a barrier to the declaration

of the quantitative amount of the dietary ingredient on the product

label. Variability in nutrient content is a factor that the agency

takes into consideration in evaluating label statements for all foods,

not just dietary supplements. Implicit in the compliance sampling

provisions in 21 CFR 101.9(g) is the concept that there will be

variation in naturally-occurring nutrients present in subsamples of a

product. Variability is taken into consideration in the development of

data bases and food composition tables. FDA expects that, as more

analyses are performed in support of label values for naturally-

occurring dietary ingredients that have and do not have RDI's or DRV's,

guidance on sampling strategies, weighing procedures, and statistical

treatment to account for variation among samples will improve. Because

of potential variation in the dietary ingredient content, firms may

label the dietary ingredient values on products conservatively, so that

the products declaring such values have a high probability of passing

the FDA compliance evaluation. Statistical procedures for doing so are

discussed in ``FDA Nutrition Labeling Manual: A Guide for Developing

and Using Databases.'' At the same time, consumers have the right to

expect, with a reasonable probability, that label values honestly and

reasonably represent the content in the products they purchase.

    6. A couple of comments noted that in many instances there are no

validated methods to analyze for a variety of dietary ingredients,

particularly herbal ingredients. The comments pointed out that the

accuracy of label claims will be impossible to verify because of the

lack of accepted quantitative analytical methods or standards.

    FDA recognizes that analytical methods are needed for a variety of

dietary ingredients. The agency encourages the dietary supplement

industry to participate in developing and in validating analytical

methods for dietary ingredients for which there are not generally

accepted methods. The lack of methodology to assess the validity of

label claims is of concern because it increases the possibility of

consumer fraud. However, FDA has every expectation that dietary

supplement manufacturers will make claims in a responsible manner. This

is the premise on which section 403(r)(6) of the act (see section

403(r)(6)(B)) was apparently based. Therefore, FDA expects that firms

will not make claims unless they are in possession of evidence that

establishes the validity of their claims.

    7. Several comments suggested that all examples discussing the

amount of allicin in garlic (e.g., ``100 percent of the allicin in a

bulb of garlic'') be dropped because there is no allicin in a bulb of

garlic or in dietary supplements of garlic. One comment stated that

allicin is produced as a result of an enzymatic reaction of alliin with

the enzyme alliinase (which are both components of raw garlic), and

that this reaction occurs only when the garlic clove is ruptured by

crushing, cutting, or some other manner. The comment stated that

allicin is associated with garlic only during the process of

decomposition, and that it has a half-life of less than 24 hours at

room temperature. The comment stated that it is helpful to have some

examples that illustrate the distinction between ``ingredient'' and

``dietary ingredient.''

    The agency used the allicin and garlic examples only to illustrate

distinctions in label statements about dietary ingredients and

ingredients. Based on the comments, the agency concludes that the

examples, which were taken from statements by representatives of the

dietary supplement industry, were not the best choices to illustrate

this distinction. Questions regarding the presence or absence of

allicin are beyond the scope of this rulemaking. Accordingly, the

agency will remove all examples referring to garlic and allicin from

Sec. 101.13(q).

    The agency agrees that examples that show the difference between a

dietary ingredient and an ingredient are helpful. Calcium, iron, and

omega-3 fatty acids are examples of dietary ingredients, while calcium

carbonate, ferrous sulfate, and cod liver oil respectively, are

examples of ingredients.

    8. One comment requested that the agency drop the proposed

requirements for referral statements, disclosure statements, and

accompanying information for percentage claims on dietary supplements.

    The comment did not provide any explanation to support its request,

and therefore, the agency has no basis upon which to change its

position on these requirements. While section 403(r)(2)(F) of the act

states that section 403(r)(2)(A)(i) does not apply to statements on the

labels of dietary supplements that characterize the percent level of

dietary ingredients, there is nothing in the DSHEA that exempts such

statements from the requirement in section 403(r)(2)(B) of the act for

referral statements (i.e., ``See location for nutrition

information'') or from other requirements for nutrient content claims.

Therefore, FDA has made no change in response to this comment.

 

C. Disclaimer

 

    9. Several comments requested that FDA clarify that the disclaimer

for statements made under section 403(r)(6) of the act is required only

when the manufacturer wishes to take advantage of the provisions for

exemption from the drug definition. Other comments requested that the

agency clarify that section 6 of the DSHEA (which added section

403(r)(6) to the act) does not apply to recognized nutrients with RDI's

or DRV's. Other comments requested that the agency clarify the type of

claims that may be made, the form and amount of substantiation that FDA

will require, and to whom and in what form the 30-day notification must

be made.

    Section 403(r)(6) of the act sets out the circumstances in which

certain types of statements can be made about all of the substances

listed in section 201(ff) of the act in the label or labeling of

dietary supplements. FDA is no longer referring to these statements as

``statements of nutritional support,'' even though this phrase is used

in the title of section 6 of the DSHEA, because many of the substances

that can be the subject of this type of claim do not have nutritional

value. Thus, the term ``statement of nutritional support'' is not

accurate in all instances.

    The agency agrees that the disclaimer provided for in section

403(r)(6) of the act is required only when the manufacturer wishes to

take advantage of the exception from the drug definition that is

provided for in section 201(g)(1) of the act for products that comply

with section 403(r)(6). Section 201(g)(1)(C) of the act recognizes that

common sense foods, that is, products with nutritional value, affect

the structure or function of the body because of their nutritional

value. Thus, the types of claims described in section 403(r)(6)(A) of

the act can be made to describe the nutritive value of a product

without fear of action against the product as a drug (e.g., ``calcium

builds strong bones and teeth'') so long as the claims are not false or

misleading. The claim would simply describe the nutritive value of the

substance in question. However, a dietary supplement manufacturer may

still choose to comply with section 403(r)(6) of the act in making a

claim about a substance with nutritive value if the manufacturer

chooses to take advantage of the protection provided by that section

and the last sentence of section of section 201(g)(1) of the act.

Products without nutritive value, however, would be subject to

regulatory action as drugs

 

Page 49864

 

under section 201(g)(1)(C) of the act if they make any of the claims

listed in section 403(r)(6)(A) of the act without compliance with all

of the provisions of section 403(r)(6).

    Questions regarding substantiation and notification requirements

for statements provided for under section 403(r)(6) of the act are

outside the scope of this rulemaking. The agency advises that it

published a proposed rule on notification procedures for such

statements in the Federal Register on September 27, 1996 (61 FR 50771).

The agency's tentative conclusions with respect to notification

procedures are discussed in that proposal.

    The agency concludes that it is desirable to streamline its

regulations by covering all provisions addressing statements provided

for under section 403(r)(6) of the act in one section. For consistency

with the proposed regulation on notification procedures, the agency is

changing the title and the section number from ``Sec. 101.94 Statements

of nutritional support; disclaimer'' to ``Sec. 101.93 Notification

procedures for certain types of statements on dietary supplements.''

Additionally, the agency is redesignating proposed Sec. 101.94(a), (b),

(c), and (d) as Sec. 101.93 (b), (c), (d), and (e) and reserving

Sec. 101.93(a) in anticipation of the final rule on notification

procedures.

    10. One comment requested that the agency eliminate a reference to

``the exemption to section 201(g)(1)(C) of the act'' from proposed

Sec. 101.94(a) (redesignated as Sec. 101.93(b)) because there are two

exceptions to 201(g)(1)(C) of the act. The comment stated that the

first exemption is the exception for ``food'' in section 201(g)(1)(C)

of the act. The comment stated that the second exemption is the one

that was added by the DSHEA. The comment stated that the DSHEA provides

that those dietary ingredients that are not covered by the first

exception from the drug definition (i.e., for food) are covered by the

mechanism in section 403(r)(6) of the act that permits claims to be

made concerning the role of other dietary ingredients in the body while

avoiding classification as a ``drug.''

    FDA acknowledges that there are now two exceptions to section

201(g)(1)(C) of the act. Accordingly, the agency is clarifying that

Sec. 101.93(b) refers to the second exception, that is, for dietary

supplements that are labeled in compliance with section 403(r)(6) of

the act. FDA is revising Sec. 101.93(b) to reflect the comment's point

that there are now two exceptions to section 201(g)(1)(C) of the act.

    However, FDA disagrees with the comment in two respects. First, the

comment seems to imply that all dietary supplements are covered per se

by the exception, which is not the case. Dietary supplements have to

comply with section 403(r)(6) of the act to be subject to the exception

(unless, of course, as stated above, they are subject to the other

exception for ``food'' as that term has been interpreted by the courts,

see Nutrilab Inc. v. Schweiker, 713 F.2d. 335, 338 (7th Cr. 1983)). In

addition, paragraph (a) of the conforming amendments found in section

10 of the DSHEA states that a product that bears a statement made in

accordance with section 403(r)(6) of the act is not a drug under

section 201(g)(1)(C) of the act ``solely because the label or the

labeling contains such a statement.'' Thus, the dietary supplement may

be found to be a drug based on some evidence of intended use other than

the statement made in accordance with section 403(r)(6) of the act.

    11. Several comments supported the proposal to place the disclaimer

adjacent to the statement provided for under section 403(r)(6) of the

act where there is a single statement. Other comments disagreed with

this aspect of the proposal. The latter comments stated that it is

sufficient to tie the statement to the disclaimer through the use of

asterisks. These comments maintained that dietary supplement packages

tend to be small, that space is at a premium on dietary supplement

labels, and that consumers are sufficiently accustomed to the asterisk

to locate the disclaimer elsewhere on the label.

    Similarly, other comments supported the proposal that the

disclaimer be placed on the same panel or page where there are multiple

statements. Other comments objected to this placement and stated that

the repetition of the disclaimer on every panel or page on which a

statement appears is redundant and unnecessary. To justify the

placement of the disclaimer on an alternate panel, one comment stated

that safety claims are often found on separate label panels, and that

there is no evidence that separating a message on different parts of a

label leads to a lack of consumer understanding of the safety

information on these products. Other comments stated that the agency's

proposed approach is not required by statute, places an undue burden on

dietary supplement manufacturers and distributors, and would inhibit,

rather than aid, consumer understanding of information on the labeling

of these products. These comments also maintained that there is

typically insufficient space to repeat the disclaimer on every panel or

page.

    One comment urged the agency to use a single ``global'' disclaimer

for all claims made on a dietary supplement label and claimed that if

the agency did so, no asterisks or symbols would be necessary.

    A variety of locations were suggested for the placement of the

disclaimer. A couple of comments suggested that the disclaimer be

placed under, or adjacent to, the nutrition label. Other comments

suggested that the disclaimer be placed on the panel to the left of the

principal display panel. Another comment suggested that the disclaimer

be placed next to the most prominent claim.

    FDA has evaluated the comments and concludes that the placement of

the disclaimer on a panel other than where the statement is made would

not meet the statutory requirement for the placement of the disclaimer.

Section 403(r)(6)(C) of the act requires that the statement ``contain''

the disclaimer, prominently displayed in boldface type. A literal

reading of section 403(r)(6)(C) of the act suggests that each statement

must contain the disclaimer in its entirety.

    In the case of multiple statements, the agency sought to minimize

the burdens imposed by the act by proposing that when the statements

provided for in section 403(r)(6) of the act are tied to the disclaimer

by means of an asterisk or other symbol, the statutory requirement that

the statement contain the disclaimer would be met because the two

discrete pieces would be linked together.

    Based on its experience with asterisks within the nutrition label,

the agency concludes that consumers are accustomed to using asterisks

on labels to associate two discrete pieces of important information

when they are in the same field of vision (Ref. 3). For this reason,

the agency is persuaded that the use of an asterisk or other symbol

that links the statement to the disclaimer meets the statutory

requirement for single statements. Ideally, the disclaimer should be

placed immediately adjacent to each statement, but the agency is

convinced that the use of asterisks or other symbols will adequately

serve the same purpose while providing flexibility to the

manufacturers. The agency is revising proposed Sec. 101.94(c)

(redesignated as Sec. 101.93(d)) to reflect this judgement.

    The agency rejects the comments that stated that repetition of the

disclaimer on every panel or page where a statement made in accordance

with section 403(r)(6) of the act appears is unnecessary. The agency

concludes that

 

Page 49865

 

to meet the statutory requirement that the disclaimer be ``contained''

within the statement, the disclaimer must be within the same field of

vision as the statement itself. Because the agency concludes that the

placement of the disclaimer anywhere on the same page or panel of

labeling is equivalent to meeting the requirement of being

``contained,'' each of the suggestions for the placement of a single

disclaimer on a product label (e.g., under the nutrition label,

adjacent to the most prominent claim) would not provide an acceptable

alternative.

    The agency points out that the requirements for the disclaimer also

extend to labeling: There are potentially many vehicles (e.g.,

placards, pamphlets, catalogs, books) that would have to bear the

disclaimer. The agency is concerned that the disclaimer be prominent in

these forms of labeling. Even with the flexibility of the use of an

asterisk to tie the claim and the disclaimer to a single statement, the

disclaimer could be obscured in pages of text of a package insert,

pamphlet, or book if it did not appear on the same page or panel (i.e.,

in the same field of vision) as the statement itself. Because of the

variety of possibilities for the presentation of the disclaimer, the

agency concludes that for labeling, as for labels, it is important to

retain the provision that the disclaimer appear within the same field

of vision, that is, on each package panel or page where a statement is

made, under section 403(r)(6) of the act.

    The use of the statements provided for in section 403(r)(6) of the

act is entirely voluntary, and the agency is not persuaded that the use

of the disclaimer would be unduly burdensome to manufacturers that

choose to use such statements.

    The agency rejects the concept of a ``global'' disclaimer because

its application would be undefined and thus could create misleading or

false impressions. For example, some products may bear a variety of

claims, including nutrient content and health claims, which are

authorized by the agency. In this case, the use of a ``global''

disclaimer could create the impression that these claims had not been

evaluated by FDA, which would be false.

    Accordingly, the agency is revising proposed Sec. 101.94(c)

(redesignated as Sec. 101.93(d)) to state that a symbol (e.g., an

asterisk) can be used to link a single statement to the disclaimer. On

product labels and in labeling for single and multiple statements, the

disclaimer shall appear on each panel or page where there is a

statement.

    12. A couple of comments supported the placement of the disclaimer

within a box. These comments stated that placement of the statement

within a box should help ensure that consumers will read the disclaimer

and will give adequate prominence to the statutory statement. Other

comments disagreed with the placement of the disclaimer within a box.

Several comments stated that the DSHEA makes no reference to a box. A

couple of comments stated that warnings are typically set out in boxes

in labeling, and the disclaimer is not intended to be a warning.

Another comment objected to boldface type.

    One comment referred to the definition of prominence in section

403(f) of the act and stated that all this section requires is that the

information be placed such that consumers are likely to read it under

customary conditions of purchase and use. One comment stated that it

should be left to the discretion of the manufacturer to ensure that the

disclaimer is prominently featured, through some combination of

boldface type, color, a box, or other design features.

    The agency is not aware of any research that specifically examines

whether consumers associate boxed information with warning information.

No evidence was included in the comments to persuade the agency that

boxed information is viewed by consumers as a warning. Manufacturers

may voluntarily enhance the disclaimer by a variety of other graphic

measures. However, section 403(r)(6)(C) of the act requires that the

disclaimer be in boldface type. Graphic devices such as boxing are used

to draw attention to important information. For example, the nutrition

label is placed in a box. Thus, the relevant question is whether the

information is important enough to be boxed, not whether it will be

seen as a warning.

    Congress has made the judgment that the disclaimer is important

information by requiring that the statement be in boldface type.

Because the statue explicitly requires boldface type, FDA is not

persuaded that the standard for prominence in 403(f) of that act is

sufficient to meet the standard for prominence for the disclaimer

intended by the Congress. FDA is providing that the statement may be

physically separated from the statements made under section 403(r)(6)

of the act. To ensure that the disclaimer gets the prominence that

Congress intended, FDA is requiring that it be put in a box if it is

separated from the statement made under section 403(r)(6) of the act.

Therefore, the agency is is retaining the requirement in

Sec. 101.94(c)(2) (redesignated as Sec. 101.93(d)) that the disclaimer

be set off in a box where it is not adjacent to the statement.

    13. One comment requested that the type size requirement be revised

to meet the requirements in Sec. 101.2 (21 CFR 101.2) which provide

one-sixteenth of an inch as a general minimum type size. The comment

maintained that inasmuch as FDA has determined that the requirements in

Sec. 101.2 are adequate to satisfy section 403(f) of the act, the

requirements of Sec. 101.2 are also appropriate in implementing the

disclaimer provisions specified in section 403(r)(6) of the act. In

addition, the comment urged the agency to clarify that the type size

options for special package sizes are available to dietary supplements

which often come in small packages.

    Based on the plain language of section 403(r)(6)(C) of the act, the

agency concludes that it was Congress' intent that the disclaimer be

prominent and not obscured on the label or in labeling. For that

reason, the agency proposed that the typesize for the disclaimer be no

smaller than the larger of one-half the type size of the largest

statement provided for in section 403(r)(6) of the act, but in no case

no smaller than one-sixteenth of an inch. FDA tentatively concluded

that in this manner, prominence could be assured because the disclaimer

would be proportional to the section 403(r)(6) of the act statement or,

at minimum, one-sixteenth of an inch (60 FR 67176 at 6781).

    Because FDA is retaining the provisions that the disclaimer be on

the same panel or page as the statement, and that the disclaimer be

boxed when it is not adjacent to the statement, the agency concludes

that the disclaimer can be readily located and, thus, that the

statutory requirement for prominence is largely met. Readability is a

clear attribute of prominence, and based on its experience with food

labeling, one-sixteenth of an inch is generally readable (Ref. 3).

Section 403(r)(6)(C) of the act requires that the disclaimer be in

boldface type, which should also facilitate readability. Therefore, FDA

has no objection to a minimum typesize of one-sixteenth of an inch for

the disclaimer. Accordingly, the agency is revising proposed

Sec. 101.94(d) (redesignated as Sec. 101.93(e)) to specify that one-

sixteenth inch is the minimum typesize for the disclaimer.

    Statements provided for in section 403(r)(6) of the act are

entirely voluntary. All required information must first be considered

in designing labels. Moreover, the firm must consider that the

disclaimer must be prominent as required by the statute. Therefore,

 

Page 49866

 

there will be instances in which statements under section 403(r)(6) of

the act should not be used on a label or in labeling because it is not

feasible to accommodate both the required information and the statutory

requirement for prominence for the disclaimer.

    Inasmuch as the purpose of Sec. 101.2(c)(1) through (c)(3) was to

encourage voluntary declaration of nutrition information and complete

ingredient listing on all foods before the provision of this

information was made mandatory by the 1990 amendments, FDA gave notice

of its intention to revoke the exemptions in Sec. 101.2(c)(1), (c)(2),

and (c)(3) in its December 1995 proposal entitled ``Food Labeling:

Statement of Identity, Nutrition Labeling, and Ingredient Labeling of

Dietary Supplements'' (60 FR 67194 at 67208) and proposed to do so in

the Federal Register of June 12, 1996 (61 FR 29708). These provisions

are now obsolete. Therefore, FDA is not accepting the recommendation of

these comments, and the request to include the options for small

package size listed under Sec. 101.2(c) is denied.

 

III. Effective Date

 

    14. Several comments recommended an effective date of 18 months

following the publication of the final rule. One comment stated that

the dietary supplement industry is unique because of the number of

dietary supplement products sold that are ``private label,'' that is

manufactured for or distributed by the company named on the label (the

brand owner). The comment noted that many products in the ``private

label'' category are store brands. The comment stated that these facts

mean that many manufacturers must prepare a wide variety of labels for

the same product. The comment used the example of one company producing

private label merchandise that may have over 10,000 labels that will

need to be conformed to the new regulations, and that for such store

brand private label products, the time it would take to deplete the

inventory of labels is well over 18 months. The comment noted that the

period to use labels that state ``manufactured for'' and ``distributed

by'' could be easily as long.

    FDA is persuaded by the majority of the comments that it is

appropriate to have the effective date of this final rule be 18 months

from the date of its publication, consistent with the time period

allowed for the labels of conventional foods to comply with the 1990

amendments. FDA is addressing the issues raised by these comments in

greater detail in the final rule entitled ``Food Labeling: Statement of

Identity, Nutrition Labeling and Ingredient Labeling of Dietary

Supplements'' published elsewhere in this issue of the Federal

Register.

 

IV. 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.

 

V. Environmental Impact

 

    The agency has previously considered the environmental effects of

this rule as announced in the proposed rule (60 FR 67176). No new

information or comments have been received that would affect the

agency's previous determination that there is no significant impact of

the human environment and that an environmental impact statement is not

required.

 

VI. Paperwork Reduction Act

 

    In the dietary supplement proposal, FDA stated its tentative

conclusion that the proposed rule contains no reporting, recordkeeping,

labeling, or other third party disclosure requirements and asked for

comments on whether the proposed rule imposed any paperwork burden. No

comments were received addressing the question of paperwork burden. FDA

concludes that the labeling requirement in this document are not

subject to review by the Office of Management and Budget because they

do not constitute a ``collection of information'' under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling

statements are a ``public disclosure of information originally supplied

by the Federal government to the recipient for the purpose of

disclosure to the public'' (5 CFR 1320.3(c)(2)).

 

VII. Analysis of Impacts

 

    FDA has examined the economic implications of the final rule as

required by Executive Order 12866 and the Regulatory Flexibility Act (5

U.S.C. 601-612). Executive Order 12866 directs agencies to assess all

costs and benefits of available regulatory alternatives and, when

regulation is necessary, to select the regulatory approach that

maximizes net benefits (including potential economic, environmental,

public health and safety effects; and other advantages; distributive

impacts; and equity). Executive Order 12866 classifies a rule as

significant if it meets any one of a number of specified conditions,

including having an annual effect on the economy of $100 million or

adversely affecting in a material way a sector of the economy,

competition, or jobs, or if it raises novel legal or policy issues. If

a rule has a significant impact on a substantial number of small

entities, the Regulatory Flexibility Act requires agencies to analyze

options that would minimize the economic impact of that rule on small

entities. FDA finds that this final rule is not a significant rule as

defined by Executive Order 12866, and finds under the Regulatory

Flexibility Act, that the final rule will not have a significant impact

on a substantial number of small entities. Similarly, it has been

determined that this rule is not a major rule for the purpose of

congressional review (Pub. L. 104-121).

    The final rule does not significantly change the way in which

claims are made with three exceptions: (1) Percentage claims for

dietary supplements that do not have RDI's or DRV's are no longer

prohibited; (2) dietary supplements of vitamins and minerals may now

highlight an ingredient that is not a vitamin or mineral; and (3)

labels or labeling of dietary supplements may include the types of

statements listed in 403(r)(6) of the act so long as those statements

are made in accordance with requirements of that section. With regards

to these actions, costs of redesigning labels will be incurred only by

those firms wishing to take advantage of the DSHEA. With respect to the

third, firms who wish to make the statements provided for in section

403(r)(6) of the act will incur the additional cost of redesigning

labels to include the disclaimer.

    FDA is unable to quantify the benefits from this final rule. Some

consumers will benefit from the additional information about dietary

ingredients that will become available. However, because statements may

now be made under section 403(r)(6) of the act for some dietary

ingredients without any information being submitted to FDA to

demonstrate that the dietary ingredient is safe, or that it will have

its claimed effect, it is uncertain whether this final rule will have

any significant health benefits.

    This rule provides small entities with the opportunity to use

certain claims that were previously prohibited. Small entities will

incur the cost of redesigning labels to include claims only if making

the claim will be profitable to the firm. In the proposed rule (60 FR

67176), FDA certified that this rule will not have a significant impact

on a substantial number of small entities. FDA received no objections

to that certification.

 

Page 49867

 

VIII. References

 

    The following references have been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

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

    1. The Research Department, Food Marketing Institute, ``Trends

in the United States: Consumer Attitudes & the Supermarket,'' 1996.

    2. Levy, A. S., and B. M. Derby, ''The Impact of the NLEA on

Consumer: Recent Findings from FDA's Food Label and Nutrition

Tracking System. Executive Summary, January 23, 1996.

    3. Levy, A. S., memorandum to Camille Brewer: Likely

Effectiveness of Proposed Format Requirements for Disclaimer

Statement on Dietary Supplement Products, January 16, 1997.

 

List of Subjects in 21 CFR Part 101

 

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 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 is amended by revising paragraph (a), the

introductory text of paragraph (b), and redesignating paragraph (q)(3)

as paragraph (q)(3)(i), and adding new paragraph (q)(3)(ii) 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 conventional foods and dietary supplements.

    (b) A claim that expressly or implicitly characterizes the level of

a nutrient of the type required to be in nutrition labeling under

Sec. 101.9 or under Sec. 101.36 (that is, a nutrient content claim) may

not be made on the label or in labeling of foods unless the claim is

made in accordance with this regulation and with the applicable

regulations in subpart D of this part or in part 105 or part 107 of

this chapter.

* * * * *

    (q) * * *

    (3) * * *

    (ii) Percentage claims for dietary supplements. Under section

403(r)(2)(F) of the act, a statement that characterizes the percentage

level of a dietary ingredient for which a reference daily intake (RDI)

or daily reference value (DRV) has not been established may be made on

the label or in labeling of dietary supplements without a regulation

that specifically defines such a statement. All such claims shall be

accompanied by a referral or disclosure statement in accordance with

paragraphs (g) or (h) of this section.

    (A) Simple percentage claims. Whenever a statement is made that

characterizes the percentage level of a dietary ingredient for which

there is no RDI or DRV, the statement of the actual amount of the

dietary ingredient per serving shall be declared next to the percentage

statement (e.g., ``40 percent omega-3 fatty acids, 10 mg per

capsule'').

    (B) Comparative percentage claims. Whenever a statement is made

that characterizes the percentage level of a dietary ingredient for

which there is no RDI or DRV and the statement draws a comparison to

the amount of the dietary ingredient in a reference food, the reference

food shall be clearly identified, the amount of that food shall be

identified, and the information on the actual amount of the dietary

ingredient in both foods shall be declared in accordance with paragraph

(j)(2)(iv) of this section (e.g., ``twice the omega-3 fatty acids per

capsule (80 mg) as in 100 mg of menhaden oil (40 mg)'').

* * * * *

    3. Section 101.14 is amended by removing paragraph (a)(4), by

redesignating paragraphs (a)(5) and (a)(6) as paragraphs (a)(4) and

(a)(5), respectively; and by revising paragraphs (b)(3)(i) and (d)(3)

to read as follows:

 

Sec. 101.14  Health claims: general requirements.

 

* * * * *

    (b) * * *

    (3) * * *

    (i) The substance must, regardless of whether the food is a

conventional food or a dietary supplement, contribute taste, aroma, or

nutritive value, or any other technical effect listed in Sec. 170.3(o)

of this chapter, to the food and must retain that attribute when

consumed at levels that are necessary to justify a claim; and

* * * * *

    (d) * * *

    (3) Nutrition labeling shall be provided in the label or labeling

of any food for which a health claim is made in accordance with

Sec. 101.9; for restaurant foods, in accordance with Sec. 101.10; or

for dietary supplements, in accordance with Sec. 101.36.

* * * * *

    4. Section 101.54 is amended by revising paragraphs (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.''

 

* * * * *

    (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) and main dish

products as defined in Sec. 101.13(m), 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 and in the

labeling of foods, except meal products as defined in Sec. 101.13(l)

and main dish products as defined in Sec. 101.13(m), 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) and main dish products as defined in Sec. 101.13(m),

provided that:

* * * * *

    5. New Sec. 101.93 is amended by adding paragraphs (b) through (e)

to read as follows:

 

Sec. 101.93  Notification procedures for certain types of statements on

dietary supplements.

 

    (a) * * *

    (b) Disclaimer. The requirements in this section apply to the label

or labeling of dietary supplements where the dietary supplement bears a

statement that is provided for by section 403(r)(6) of the Federal

Food, Drug, and Cosmetic Act (the act), and the manufacturer, packer,

or distributor wishes to take advantage of the exemption to section

201(g)(1)(C) of the act that is provided by compliance with section

403(r)(6) of the act.

    (c) Text for disclaimer. (1) Where there is one statement, the

disclaimer shall be placed in accordance with

 

Page 49868

 

paragraph (d) of this section and shall state:

    This statement has not been evaluated by the Food and Drug

Administration. This product is not intended to diagnose, treat,

cure, or prevent any disease.

    (2) Where there is more than one such statement on the label or in

the labeling, each statement shall bear the disclaimer in accordance

with paragraph (c)(1) of this section, or a plural disclaimer may be

placed in accordance with paragraph (d) of this section and shall

state:

    These statements have not been evaluated by the Food and Drug

Administration. This product is not intended to diagnose, treat,

cure, or prevent any disease.

    (d) Placement. The disclaimer shall be placed adjacent to the

statement with no intervening material or linked to the statement with

a symbol (e.g., an asterisk) at the end of each such statement that

refers to the same symbol placed adjacent to the disclaimer specified

in paragraphs (c)(1) or (c)(2) of this section. On product labels and

in labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on

each panel or page where there such is a statement. The disclaimer

shall be set off in a box where it is not adjacent to the statement in

question.

    (e) Typesize. The disclaimer in paragraph (c) of this section shall

appear in boldface type in letters of a typesize no smaller than one-

sixteenth inch.

 

    Dated: September 11, 1997.

 William B. Schultz,

 Deputy Commissioner for Policy.

FR Doc. 97-24730 Filed 9-22-97; 8:45 am

BILLING CODE 4160-01-F