Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49859

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.

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:

[t]he 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 healthrelated 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
49860 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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, calciumEAP (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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49861

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

§ 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 § 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., omega3 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
49862 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

§ 101.13(q)(3)(ii) by adding

§ 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

§ 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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 § 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
49864 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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 ‘‘§ 101.94

Statements of nutritional support;

disclaimer’’ to ‘‘§ 101.93 Notification

procedures for certain types of

statements on dietary supplements.’’

Additionally, the agency is

redesignating proposed § 101.94(a), (b),

(c), and (d) as § 101.93 (b), (c), (d), and

(e) and reserving § 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 § 101.94(a)

(redesignated as § 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 § 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 § 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 § 101.94(c) (redesignated as

§ 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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 § 101.94(c) (redesignated as

§ 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 § 101.94(c)(2)

(redesignated as § 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 § 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 § 101.2 are adequate to

satisfy section 403(f) of the act, the

requirements of § 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 onesixteenth 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, onesixteenth 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 § 101.94(d)

(redesignated as § 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,
49866 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

§ 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 § 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 § 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.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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:

§ 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 § 101.9 or

under § 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:

§ 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 § 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 § 101.9; for

restaurant foods, in accordance with

§ 101.10; or for dietary supplements, in

accordance with § 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:

§ 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 § 101.13(l) and main dish

products as defined in § 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 § 101.13(l) and

main dish products as defined in

§ 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 § 101.13(j)(1)(i) and

except meal products as defined in

§ 101.13(l) and main dish products as

defined in § 101.13(m), provided that:

* * * * *

5. New § 101.93 is amended by adding

paragraphs (b) through (e) to read as

follows:

§ 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
49868 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 95N–0245, 95N–0282, and

95N–0347]

RIN 0905–AD96

Food Labeling; Nutrient Content

Claims: Definition for ‘‘High Potency’’

and Definition of ‘‘Antioxidant’’ for Use

in Nutrient Content Claims for Dietary

Supplements and Conventional Foods

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to: Define the term ‘‘high

potency’’ as a nutrient content claim;

define nutrient content claims using the

term ‘‘antioxidant’’ (e.g., ‘‘good source

of antioxidants,’’ ‘‘high in antioxidants,’’

‘‘more antioxidants’’); and to correct an

omission pertaining to the use of ‘‘sugar

free’’ claims on dietary supplements.

FDA is taking these actions to provide

for the use of additional nutrient

content claims on labels or in labeling

in accordance with provisions of the

Nutrition Labeling and Education Act of

1990.

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.

I. Background

On June 18, 1993 (58 FR 33731), FDA

published a proposal entitled ‘‘Food

Labeling; Requirements for Nutrient

Content Claims for Dietary Supplements

of Vitamins, Minerals, Herbs, and Other

Similar Nutritional Substances’’

(hereinafter referred to as the 1993

nutrient content claims proposal). In

that proposal FDA requested comment

on several terms, including ‘‘high

potency’’ that are often encountered on

labels or in labeling of dietary

supplements and that seem to imply

that the dietary supplement will

contribute to good health (58 FR 33731

at 33748). The agency requested

comment on whether there were

established meanings for these terms,

and, if so, whether they characterized

the level of the nutrients in the food and

thus should be considered to be nutrient

content claims. In 1994, in its final rule

in the nutrient content claims

proceeding (hereinafter referred to as

the 1994 nutrient content claims final

rule), based on the comments that it

received, FDA determined that ‘‘high

potency’’ is a claim that characterizes

the level of a nutrient or nutrients and,

therefore, meets the definition of a

nutrient content claim in § 101.13(b) (21

CFR 101.13(b)) (59 FR 378 at 391,

January 4, 1994).

One comment to the 1993 nutrient

content claims proposal stated that FDA

failed to address whether certain claims

regarding antioxidants were within the

scope of the proposed regulation. In the

1994 nutrient content claims final rule,

the agency stated that while such claims

were not explicitly discussed in the

1993 nutrient content claims proposal,

they also are nutrient content claims (59

FR 378 at 389).

However, given the time constraints

under which FDA prepared the 1994

nutrient content claims final rule, the

agency was not able to adopt a

definition either for ‘‘high potency’’ or

for nutrient content claims for

antioxidants. FDA announced its

intention to review the suggestions for

a definition of ‘‘high potency’’ and

‘‘antioxidant’’ claims and, based on

information received in the comments,

to propose an appropriate definition for

these terms (59 FR 378 at 391). In the

Federal Register of December 28, 1995

(60 FR 67184), the agency published a

proposed rule entitled ‘‘Nutrient

Content Claims: Definition for ‘High

Potency’ Claim for Dietary Supplements

and Definition of ‘Antioxidant’ for Use

in Nutrient Content Claims for Dietary

Supplements and Conventional Foods’’

(hereinafter referred to as the high

potency/antioxidant proposal).

The agency received approximately

70 comments in response to the high

potency/antioxidant proposal. A

number of comments supported the

proposal, while others disagreed with

various aspects of the proposal. A few

comments addressed issues that are

outside the scope of this rulemaking. A

summary of the comments, the agency’s

responses to the comments, and a

discussion of the agency’s conclusions

follow.

II. High Potency

In the high potency/antioxidant

proposal, FDA proposed that the term

‘‘high potency’’ may be used on the

labels or in the labeling of dietary

supplements to describe a nutrient that

is present at 100 percent or more of the

Reference Daily Intake (RDI) for

vitamins and minerals, or of the Daily

Reference Value (DRV) for protein and

dietary fiber, per reference amount

customarily consumed. To describe

multinutrient products as ‘‘high

potency,’’ FDA proposed that at least

two-thirds of the nutrients in a product

must be present at 100 percent of the

RDI for vitamins and minerals or of the

DRV for protein and dietary fiber per

reference amount customarily

consumed.

A. ‘‘High Potency’’ as a Nutrient Content

Claim

1. The majority of the comments

agreed that ‘‘high potency’’ is a nutrient

content claim. These comments stated

that the agency’s definition has a basis

in the labeling practices of the dietary

supplement industry, and that

consumers are already familiar with this

definition. Some comments stated that

the term ‘‘high potency’’ is commonly

understood to describe the level of a

nutrient or nutrients in a product,

particularly on dietary supplements of

vitamins and minerals.

On the other hand, a few comments

stated that ‘‘high potency’’ is not a