67176 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

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: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend 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 proposing to

specify how (i.e., text, placement, and

type size) the disclaimer required by the

Federal Food, Drug, and Cosmetic Act

(the act) is to be presented with

statements of nutritional support.

Additionally, FDA is proposing to

remove the definition of ‘‘dietary

supplements’’ and to change the

terminology used to describe dietary

supplements in regulations governing

health claims for food products. This

action is being taken to implement in

part the Dietary Supplement Health and

Education Act of 1994 (the DSHEA).

DATES: Written comments by March 13,

1996. The agency is proposing that any

final rule that may issue based upon this

proposal become effective January 1,

1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

301–245–1064.

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 November 8, 1990, the President

signed into law the Nutrition Labeling

and Education Act of 1990 (the 1990

amendments) (Pub. L. 101–535). The

1990 amendments amended the act in a

number of important ways. One of the

most notable aspects of the 1990

amendments is that they established

FDA’s authority to regulate nutrient

content and health claims on food labels

and in food labeling. Section

403(r)(1)(A) of the act (21 U.S.C.

343(r)(1)(A)), which was added by the

1990 amendments, provides that a

product is misbranded if it bears a claim

in its label or labeling that either

expressly or implicitly characterizes the

level of any nutrient of the type required

to be declared as part of nutrition

labeling, unless such claim has been

specifically defined (or otherwise

exempted) by regulation. Section

403(r)(1)(B) of the act, also added by the

1990 amendments, provides that a

product is misbranded if it bears a claim

that characterizes the relationship of a

nutrient to a disease or health-related

condition, unless the claim is made in

accordance with sections 403(r)(3) of the

act (which pertains to foods in

conventional food form) or 403(r)(5)(D)

(which pertains to dietary supplements).

In the Federal Register of November

27, 1991 (56 FR 60421 and 56 FR

60478), FDA published two documents,

one general and the other on fat, fatty

acid, and cholesterol claims, in which

the agency proposed, among other

things, to define nutrient content

claims, to provide for their use on foods

labels, and to establish procedures for

the submission and review of petitions

regarding the use of specific nutrient

content claims. These proposals applied

to dietary supplements as well as to

foods in conventional food form. In the

same issue of the Federal Register, FDA

proposed general requirements on the

use of health claims and on petitions to

the agency to authorize health claims

(56 FR 60537).

On October 6, 1992, the President

signed into law the Dietary Supplement

Act of 1992 (the DS Act) (Pub. L. 102–

571). Section 202(a)(1) of the DS Act

established a moratorium on the

implementation of the 1990

amendments with respect to dietary

supplements until December 15, 1993.

Section 202(a)(2) of the DS Act required

that the Secretary of Health and Human

Services (the Secretary), and by

delegation FDA, issue new proposed

regulations applicable to dietary

supplements no later than June 15,

1993, and final regulations by December

31, 1993.

In the Federal Register of January 6,

1993, FDA published final regulations

that implemented the 1990 amendments

with respect to nutrient content claims

(hereinafter referred to as the ‘‘1993

nutrient content claims final rule’’) (58

FR 2302) and health claims (hereinafter

referred to as the ‘‘1993 health claims

final rule’’) (58 FR 2478) on foods in

conventional food form. In the Federal

Register of August 18, 1993 (58 FR

44020 and 44036), FDA made technical

amendments to these final regulations.

In response to the requirements of the

DS Act, FDA published in the Federal

Register of June 18, 1993 (58 FR 33731),

a proposal to: (1) Include dietary

supplements of vitamins, minerals,

herbs, and other similar nutritional

substances under the coverage of the

general principles for nutrient content

claims; (2) provide for the use of express

and implied nutrient content claims on

labels or in labeling of dietary

supplements; and (3) provide for

petitions for nutrient content claims for

dietary supplements (hereinafter

referred to as the ‘‘1993 nutrient content

claims for dietary supplements

proposal’’). In the same issue of the

Federal Register, FDA also proposed to

make dietary supplements of vitamins,

minerals, herbs, and other similar

nutritional substances subject to the

general requirements that apply to all

other types of food with respect to the

use of health claims (hereinafter referred

to as the ‘‘1993 dietary supplement

health claims proposal’’) (58 FR 33700).

FDA received approximately 500

letters in response to its 1993 nutrient

content claims for dietary supplements

proposal. A summary of the comments,

the agency’s responses to the comments,

and a complete discussion of the

agency’s conclusions with respect to

nutrient content claims for dietary

supplements were published in the

Federal Register of January 4, 1994 (59

FR 378), in the final rule on nutrient

content claims for dietary supplements

(hereinafter referred to as the ‘‘1994

nutrient content claims for dietary

supplements final rule’’). FDA received

over 1,200 letters in response to the

1993 dietary supplement health claims

proposal. FDA summarized and

responded to these comments in the

final rule on health claims for dietary

supplements in the same issue of the

Federal Register (59 FR 395).

On October 25, 1994, the President

signed into law the DSHEA (Pub. L.

103–417). The DSHEA, among other

things, defined ‘‘dietary supplement’’

(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 (adding

section 403(r)(2)(F) to the act), and

amended section 411 (b)(2) and (c)(1) of

the act (21 U.S.C. 350 (b)(2) and (c)(1))
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67177

1While all dietary ingredients can be ‘‘nutrients

of the type required by paragraph (q)(1) and (q)(2)

to be in the label or labeling of the food’’ in

appropriate circumstances, all dietary ingredients

are not nutrients as that term is generally

understood, in that they do not all have nutritive

value. The DSHEA recognizes this fact by using the

phrase ‘‘nutrient or dietary ingredient’’ (e.g., see

section 403(r)(6) of the act), indicating that the two

terms are not mutually inclusive. Furthermore, all

dietary ingredients are not necessarily

‘‘ingredients’’ within the traditional meaning of that

term under section 403(i) of the act. For example,

in a ‘‘calcium dietary supplement,’’ calcium would

be the ‘‘dietary ingredient,’’ whereas calcium

carbonate or some other calcium salt would be the

‘‘ingredient,’’ i.e., the ‘‘source’’ of the dietary

ingredient, calcium. In a dietary supplement of

garlic, garlic could be the dietary ingredient, while

the common or usual name of the ingredient might

be ‘‘dried, powdered garlic.’’ However, if the

manufacturer promoted the same supplement for its

allicin content, allicin could be the dietary

ingredient and the source of allicin, i.e., the

ingredient, would be ‘‘dried, powdered garlic.’’

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

nutritional support statement must

prominently contain the following

disclaimer:

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)).

This proposal addresses how this

disclaimer is to be presented on the

label or in labeling of a dietary

supplement. The agency is issuing this

proposal in response to requests from

the dietary supplement industry that

FDA define how this statement is to be

presented. In addition, this proposal

seeks to bring the agency’s nutrient

content claim and health claim

regulations into conformance with the

DSHEA and provides for the use of

statements that characterize the

percentage level of dietary ingredients

that do not have RDI’s or DRV’s on

labels and in labeling of dietary

supplements.

II. Proposed Regulations

A. Coverage

As discussed in the preamble to the

1994 nutrient content claims for dietary

supplements final rule (59 FR 378 at

379), 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, i.e., 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 must be

made in accordance with section

403(r)(3) or section 403(r)(5)(D). The

latter section, which addresses health

claims for dietary supplements of

vitamins, minerals, herbs, and other

similar nutritional substances, is

relevant to this proceeding. The

legislative history of the phrase ‘‘other

similar nutritional substances’’ reveals

that its coverage is broad (136

Congressional Record S16609 (October

24, 1990)).

Section 3(a) of the DSHEA amends

section 201 of the act by adding section

201(ff), which defines a ‘‘dietary

supplement’’ as a product, other than

tobacco, intended to supplement the

diet that bears or contains one or more

of the following dietary ingredients: A

vitamin; a mineral; an herb or other

botanical; an amino acid; a dietary

substance for use by man to supplement

the diet by increasing the total dietary

intake; or a concentrate, metabolite,

constituent, extract, or combination of

any of the aforementioned dietary

ingredients. In effect, the list of dietary

ingredients in section 201(ff)(1) is an

explication of the term ‘‘other similar

nutritional substances’’ in section

403(r)(5)(D). Thus, based on the

foregoing analysis, all dietary

ingredients may qualify, in appropriate

circumstances, as ‘‘nutrients of the type

required by paragraph (q)(1) and (q)(2)’’

for purposes of section 403(r) the act.1

To clarify this point in its regulations,

FDA is proposing to amend § 101.13(b)

(21 CFR 101.13(b)) by adding a reference

to § 101.36 Nutrition labeling of dietary

supplements of vitamins and minerals

(21 CFR 101.36), so that § 101.13(b) will

read, in part, if this amendment is

adopted: ‘‘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) * * *.’’

The broad range of substances that

can be dietary ingredients under section

201(ff) has the potential to create

ambiguities as to the coverage of the

nutrient content claim regime. With

respect to some substances that can be

dietary ingredients, the context in

which statements about them are made

will determine whether they are

nutrient content claims or not. For

example, garlic can be the dietary

ingredient. A claim on the label or in

the labeling of a dietary supplement that

it is ‘‘high in garlic,’’ or that it ‘‘now

contains more garlic,’’ is a nutrient

content claim within the meaning of the

act, and the food is misbranded unless

such a claim has been authorized by

FDA through regulation. The claim

characterizes the level of garlic in a food

in which the garlic is a ‘‘nutrient which

is of the type’’ required to be listed in

the nutrition label because the food is

intended to supplement the dietary

intake of garlic. On the other hand, a

label statement on garlic bread, for

example, that the product now contains

more garlic would not be a nutrient

content claim if the bread is not labeled

as a dietary supplement, and if it is clear

from the context in which the claim is

made that the claim refers to the taste

of the product. As FDA has provided in

§ 101.65(b)(3) (21 CFR 101.65(b)(3)), a

claim about the presence of an

ingredient that is perceived to add value

to the product, which would clearly be

the case when one adds more garlic to

garlic bread, is not an implied nutrient

content claim.

B. Terminology

1. Nutrient Content Claims

Current § 101.13(a), on nutrient

content claims, states:

This section and the regulations in subpart

D of this part apply to foods that are intended

for human consumption and that are offered

for sale, including foods in conventional food

form and dietary supplements of vitamins,

minerals, herbs, and other similar nutritional

substances (dietary supplements).

As discussed above, new section 201(ff)

of the act creates a new definition for

the term ‘‘dietary supplement.’’ To

reflect this definition and to simplify its

regulations in the manner that the new

definition permits, FDA is proposing to

amend § 101.13(a) to read as follows:

‘‘This section and the regulations in

subpart D of this part apply to foods that

are intended for human consumption
67178 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

and that are offered for sale, including

conventional foods and dietary

supplements.’’

2. Health Claims

Under the general principles

governing health claims, § 101.14(a)(4)

(21 CFR 101.14(a)(4)) currently states

that ‘‘dietary supplement’’ means a

food, not in conventional food form,

that supplies a component to

supplement the diet by increasing the

total dietary intake of that component.

This definition has been superseded by

the definition of ‘‘dietary supplement’’

found in new section 201(ff) of the act.

Further, because section 201(ff)(2)(A)

makes it clear that dietary supplements

can be in a variety of forms, including

conventional food form, FDA is

proposing to remove § 101.14(a)(4) and

redesignate current § 101.14 (a)(5) and

(a)(6) as § 101.14 (a)(4) and (a)(5),

respectively.

A similar conforming change is

necessary in § 101.14(b)(3)(i) in the

preliminary requirements for a

substance to be eligible to be the subject

of a health claim. This regulation refers

to the fact that the food in which a

substance is found may be ‘‘in

conventional food form or dietary

supplement form.’’

To bring this section into

conformance with section 201(ff) of the

act, FDA is proposing to revise

§ 101.14(b)(3)(i) to read as follows:

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 * * *.

Section § 101.14(d)(3) currently states:

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 of

vitamins or minerals, in accordance with

§ 101.36. The requirements of the

introductory text of paragraph (d)(3) of this

section are effective as of May 8, 1993,

except:

(i)–(ii) [Reserved]

(iii) For dietary supplements of vitamins,

minerals, herbs, or other similar nutritional

substances for which the requirements of

paragraph (d)(3) of this section will be

effective July 5, 1994.

In the Federal Register of March 31,

1994 (59 FR 15050), the effective date

was corrected for the nutrient content

claims provision to July 1, 1994.

Because of the passage of the DSHEA,

the agency published a notice in the

Federal Register of February 9, 1995 (60

FR 7711), stating that it does not intend

to enforce the Nutrient Content Claim

regulations for dietary supplements

until after December 31, 1996.

As above, the terminology for dietary

supplements (i.e., ‘‘dietary supplements

of vitamins and minerals’’) used in

§ 101.14(d)(3) is too narrowly drawn in

light of new section 201(ff) of the act. In

addition, since the effective date is past,

there is no longer a need to include it

in the regulations. Therefore, FDA is

proposing to revise § 101.14(d)(3) to

remove ‘‘of vitamins and minerals’’ as a

qualifier of the types of dietary

supplements and to remove the

language setting out the effective date in

the second sentence of § 101.14(d)(3).

These changes also mean that there is

no need for paragraphs (d)(3)(i) through

(d)(3)(iii). Accordingly, proposed

§ 101.14(d)(3) reads as follows:

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.

C. 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. Thus, section 403(r)(2)(A)(i)

of the act limits the type of nutrient

content claims that can be made to those

terms that are defined and authorized by

regulation. The effect of section

403(r)(2)(F) of the act is to permit the

use on the labels or in the labeling of

dietary supplements of statements that

have not been defined by FDA that

characterize the percentage level of a

dietary ingredient for which an RDI or

DRV has not been established.

In the absence of any substantive

legislative history on this provision, the

agency interprets section 403(r)(2)(F) of

the act as authorizing claims on the

label or in labeling of a dietary

supplement that disclose the percentage

level in the dietary supplement of a

dietary ingredient for which an RDI and

DRV has not been established in a

product (e.g., ‘‘40 percent omega-3 fatty

acids’’) as well as statements that

characterize the percentage of such

dietary ingredients in relation to an

equivalent or increased/decreased

amount found in another food product

(e.g., ‘‘100 percent of the allicin in a

bulb of garlic,’’ ‘‘twice the allicin as

(product alternative)’’ [where ‘‘twice’’ is

another way of saying 200 percent]).

Section 3(b)(1)(A)(iv) of the 1990

amendments directed the agency to

promulgate regulations that permit

statements describing the amount and

percentage of nutrients in food that are

not misleading and that are consistent

with the terms defined under section

403(r)(2)(A)(i) of the act. Consequently,

FDA provided in § 101.13(i) for

statements about the amount or

percentage of nutrients when specified

criteria are met. While this regulation

did not specifically include a provision

for the use of such statements with

respect to dietary ingredients for which

no RDI or DRV had been established,

§ 101.13(i)(3) allowed for the use of

amount or percentage statements that do

not implicitly characterize the level of

the nutrient in the food (e.g., claims that

do not imply whether the amount is

high or low based on an established RDI

or DRV value), and that are not

misleading in any way. In ‘‘Food

Labeling, Questions and Answers’’ (Ref.

1, p. 36, C23), FDA stated that

statements about a nutrient for which

there is no established daily value (i.e.,

no RDI or DRV) could be made under

§ 101.13(i)(3) as long as the claim

specifies only the amount of the

nutrient per serving and does not imply

that there is a lot or a little of that

nutrient in the product. The example ‘‘x

grams of omega-3 fatty acids’’ was given.

Accordingly, percentage claims such

as ‘‘40 percent omega-3 fatty acids’’ that

do not in any way characterize the level

of a nutrient in terms of defined claims

such as ‘‘high,’’ ‘‘low,’’ or ‘‘reduced’’

were permitted on dietary supplements

as well as conventional foods before the

enactment of the DSHEA. To

memorialize this fact and to implement

the DSHEA by reflecting that labels or

labeling of dietary supplements may

bear statements that characterize the

percentage level of a dietary ingredient

for which an RDI or DRV has not been

established even though those

statements have not been defined by

FDA, the agency is proposing to amend

§ 101.13 by adding new paragraph

(q)(3)(ii) to read as follows:

Under section 403(r)(2)(F) of the act, a

statement that characterizes the percentage

level of a dietary ingredient for which an RDI

or daily reference value (DRV) has not been

established (e.g., ‘‘40 percent omega-3 fatty

acids,’’ ‘‘100 percent of the allicin in a bulb

of garlic,’’ or ‘‘twice the allicin as (name of
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67179

product alternative)’’ * * *) may be made on

the label or in labeling of dietary

supplements without a regulation that

specifically defines such a statement. * * *

Because this provision allows for an

exemption to the nutrient content

claims rules and is somewhat similar to

the exemption in § 101.13(q)(3) for

percentage statements for vitamins and

minerals, the agency is placing the new

paragraph in § 101.13(q)(3) by

redesignating current § 101.13(q)(3) as

§ 101.13(q)(3)(i) and adding new

§ 101.13(q)(3)(ii).

The agency believes that percentage

statements on the label or in labeling of

a dietary supplement 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, such as ‘‘100 percent of

the allicin in a bulb of garlic’’ and

‘‘twice the allicin as (name of product

alternative),’’ 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 both foods

being compared and a meaningful

difference between the two foods being

contrasted. However, because many

dietary ingredients, which are the

subject of clause (F), do not have

established reference amounts for daily

consumption, there is not a single,

consistent way to describe the amount

or difference that would be considered

meaningful for the broad spectrum of

these dietary ingredients. Therefore,

firms will need to determine on a caseby-case basis whether the stated amount

of a dietary ingredient for which an RDI

or DRV has not been established, and

the difference between the amount of

such a dietary ingredient in two

products, is meaningful. In making such

a determination, published literature on

the dietary ingredient, knowledge of the

functional properties of the dietary

ingredient, and any additional

information available to the

manufacturer, packer, or distributor

should be taken into account.

It should be noted that while FDA is

proposing in § 101.13(q)(3)(ii) to provide

for statements that characterize the

percentage level of dietary ingredients

for which no RDI or DRV has been

established, the proposed regulations do

not provide for use of the defined terms,

such as ‘‘more,’’ ‘‘good source,’’ ‘‘high,’’

and ‘‘as much as.’’ For example, the

statement ‘‘300 percent of the

bioflavonoids in a large grapefruit’’ is

permissible, but a claim such as ‘‘high

in bioflavonoids’’ is not. As discussed in

the nutrient content claims for dietary

supplements proposal and final rule,

FDA has concluded that if the defined

term (i.e., the nutrient content claim) is

to have any meaning, there must be a

level that can be used as a reference in

determining whether the claim is valid

and appropriate. The RDI’s and DRV’s

provide such levels. Thus, FDA has

limited the use of ‘‘good source,’’

‘‘high,’’ and other defined terms to use

with nutrients for which RDI’s or DRV’s

have been established.

By way of exception, ‘‘contains’’ and

‘‘provides’’ are listed in § 101.54(c)(1)

(21 CFR 101.54(c)(1)) as synonyms for

‘‘good source’’ (e.g., ‘‘Contains vitamin

C’’ is considered synonymous with

‘‘good source of vitamin C’’) and are

therefore dependent on the

establishment of an RDI or DRV for the

nutrient to qualify for the claim.

However, the agency has stated that

these words may be used with nutrients

that do not have RDI’s or DRV’s when

specific amounts are given for the

nutrient (Ref. 1, p. 37, C24).

Accordingly, the agency has no

objection to statements such as

‘‘Contains 4 grams of omega-3 fatty

acids per serving’’ being made for

dietary ingredients for which RDI’s and

DRV’s have not been established

provided the specific amount of the

nutrient is stated.

It should be noted that section

403(r)(2)(F) of the act applies only to

dietary supplements. Congress did not

provide this exemption for conventional

foods. Therefore, except for the

statements discussed in the preceding

paragraph that come under

§ 101.13(i)(3), statements that

characterize the level of a dietary

ingredient without an established RDI or

DRV will continue to be prohibited on

conventional foods.

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) for

referral statements (i.e., ‘‘See [location]

for nutrition information’’) or from other

requirements for nutrient content

claims. Accordingly, FDA is proposing

to require in § 101.13(q)(3)(ii) that a

referral statement (or disclosure

statement when fat, saturated fat,

cholesterol, or sodium exceed specified

limits) accompany the claim in

accordance with § 101.13 (g) or (h).

In addition, the agency tentatively

concludes that when percentage

statements are made comparing or

contrasting the amount of a dietary

ingredient for which an RDI or DRV has

not been established in a dietary

supplement to that in a reference food,

information on the identity of the

reference food and on the quantitative

amount of the dietary ingredient in both

foods are material facts. Consumers

need this information to evaluate and

understand the claim being made, and

the claim would be misleading under

sections 403(a) and 201(n) of the act

without it (see 56 FR 60421 at 60446,

and 58 FR 2302 at 2365). This situation

is analogous to that encountered with

relative claims for nutrients, where

there is a requirement in

§ 101.13(j)(2)(iv) for quantitative

information comparing the amount of

the subject nutrient in the product with

that in the reference food. Inclusion of

this information is particularly

important because, while the nutrition

label on dietary supplements will

include information about the amount

of dietary ingredients for which RDI’s

and DRV’s have not been established

that are present in the food (see

proposed § 101.36(b)(3) 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), the nutrition label on

conventional foods will not (except for

nutrients provided for in § 101.9(c) such

as sugars and polyunsaturated fat that

do not have RDI’s and DRV’s

established). Accordingly, when

conventional foods are used as the

reference food, information about the

amount of a dietary ingredient for which

there is no RDI or DRV that is present

in the food is likely to only be available

when it is provided as accompanying

information, in accordance with

§ 101.13(j)(2)(iv).

For these reasons, FDA is proposing

in § 101.13(q)(3)(ii) to require that

whenever statements characterizing the

percentage level of a dietary ingredient

for which there is no RDI or DRV are

made in comparison to the amount in a

reference food, the reference food be

clearly identified, and information on

the actual amount of the dietary

ingredient in both foods be provided in

accordance with § 101.13(j)(2)(iv).

Section 101.13(j)(2)(iv)(B) requires that

this quantitative information be placed

adjacent to the most prominent claim or

to the nutrition label, except that when

the nutrition label is on the information

panel, the quantitative information may

be placed elsewhere on that panel in

accordance with § 101.2 (21 CFR 101.2)

(see 60 FR 17202, April 5, 1995).
67180 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

D. Disclaimer for Statements of

Nutritional Support

1. Exclusion From Drug Definition

As mentioned previously, the DSHEA

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

provides for certain statements of

nutritional support for dietary

supplements, including a statement that

‘‘describes the role of a nutrient or

dietary ingredient intended to affect the

structure or function in humans.’’

Section 201(g)(1)(C) of the act states that

a ‘‘drug’’ is an article (other than food)

intended to affect the structure or any

function of the body of man or other

animals. Section 10(a) of the DSHEA

adds the following statement to section

201(g)(1) of the act:

A food, dietary ingredient, or dietary

supplement for which a truthful and not

misleading statement is made in accordance

with section 403(r)(6) is not a drug under

clause (C) solely because the label or the

labeling contains such a statement.

Under section 10(a) of the DSHEA and

section 403(r)(6) of the act, for a firm to

take advantage of the exclusion from the

‘‘drug’’ definition for a statement of

nutritional support on the label or in

labeling of a dietary supplement, it must

meet each of the conditions established

under section 403(r)(6), including

having substantiation that the claim is

truthful and not misleading and having

the disclaimer required in section

403(r)(6) displayed in conjunction with

the statement. To implement the latter

requirement, FDA is proposing in

§ 101.94, as stated in proposed

§ 101.94(a), to set forth the requirements

for the text, placement, and typesize of

the disclaimer that must accompany the

statement of nutritional support for it to

be subject to the exemption in section

201(g)(1)(C) of the act.

2. Text

Section 403(r)(6)(C) requires the

following disclaimer to be prominently

displayed in boldface type:

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.

Based on inquiries that FDA has

received from the dietary supplement

industry, FDA tentatively finds that

aspects of the statutory requirements for

the disclaimer (e.g. ‘‘prominent

display’’) need to be defined and

implemented through regulations.

Prominence is a relative term, and

without regulations, the agency would

be forced to evaluate prominence on a

case-by-case basis. Such an approach

would not provide firms with sufficient

guidance to be assured that product

labels would not trigger regulatory

action.

A literal reading of section

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

nutritional support statement must

contain the disclaimer in its entirety,

without any deviation from the statutory

language. FDA tentatively concludes

that, where a label contains only one

nutritional support statement, there is

no reason not to adopt such a reading

of the act. Accordingly, the agency is

proposing in § 101.94(b)(1) that where

the label contains one statement of

nutritional support provided for in

section 403(r)(6) of the act, the label or

labeling must prominently contain the

disclaimer as required by the act

without modification to the text.

However, where there are multiple

nutritional support statements, or where

the same statement appears several

times, the agency recognizes that

repeated use of the statutory text with

each nutritional support statement

could be confusing to consumers and

burdensome to manufacturers. For

example, if a dietary supplement

includes three nutritional support

statements on the same label panel, or

in a piece of labeling such as a brochure,

the literal reading of the act would

require that each statement include the

complete disclaimer. Because the

statutory text is of some length, only

very large label panels could conform to

this requirement if they contained

multiple statements.

FDA wishes to implement the statute

in a practical way that still fully

effectuates the purposes of the statute.

In light of this fact, the agency

tentatively concludes that it is

appropriate to provide that the

disclaimer required in section

403(r)(6)(C) of the act can be slightly

modified to reflect the use of multiple

statements of nutritional support. FDA

is proposing in § 101.94(b)(2) to require

that, where there is more than one

statement of nutritional support, each

statement contain the disclaimer as

required by the act, or that the first

sentence of the disclaimer be modified

to the plural form to read as follows:

‘‘These statements have not been

evaluated by the Food and Drug

Administration.’’ Under this proposal,

the second sentence will remain as

required by the act. For convenience,

FDA will refer to this modified form of

the disclaimer as ‘‘the plural

disclaimer.’’

3. Placement

The juxtaposition of the disclaimer to

the statement of nutritional support as

required by the act is one way to ensure

prominence. Because the act states that

the statement of nutritional support

must ‘‘contain’’ the disclaimer, the

agency tentatively concludes that the

disclaimer must be part of the statement

of nutritional support. When there is

only one such statement, this inclusion

can be readily accomplished by

presenting the disclaimer as part of the

claim. Accordingly, FDA is proposing in

§ 101.94(c)(1) that the disclaimer be

contained in each statement of

nutritional support by placing the

disclaimer immediately adjacent to the

statement of nutritional support with no

intervening material.

However, consistent with its desire to

interpret section 403(r)(6) of the act in

a practical way, FDA is proposing to

provide for an alternative placement for

the disclaimer on the label or in labeling

in situations in which repetitive

presentation of the disclaimer could be

burdensome. In these situations, FDA

wants to provide an approach to

placement of the disclaimer that will

give the disclaimer a prominence that

will ensure that it will be read and

understood by consumers but that will

result in its presentation only once on

the label panel or in labeling.

FDA tentatively concludes that where

the label or labeling contains multiple

statements of nutritional support, and

the relationship between each of those

statements and the disclaimer can be

made obvious, the statutory requirement

of prominent display of the disclaimer

can be met without requiring that each

statement of nutritional support actually

include the disclaimer. FDA experience

has been that one of the most effective

ways of tieing two label statements that

are physically separated on the same

label panel is through the use of a

symbol such as an asterisk. Symbols

have been used within nutrition

labeling since its inception in 1973 and

have proven to be an effective way of

relating label information to explanatory

footnotes. For example, asterisks have

been used adjacent to names of vitamins

and minerals present at very low levels

to refer the consumer to a footnote

stating ‘‘Contains less than 2 percent of

the Daily Value (formerly the U.S.

Recommended Daily Allowance).’’ FDA

is unaware of any data indicating

consumer difficulties with such use of

symbols. The use of symbols would also

help consumers differentiate between

label statements to which the disclaimer

is referring and other label claims to

which the disclaimer does not apply

(e.g., authorized health claims or

nutrient content claims).

Accordingly, FDA is proposing in

§ 101.94(c)(2) that where there is more

than one statement of nutritional

support on a label panel or in labeling
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67181

other than a label, and the

manufacturer, packer, or distributor

wishes to comply with section 403(r)(6)

of the act without having to place the

disclaimer immediately after each

statement of nutritional support, it can

place a symbol (e.g., an asterisk) at the

end of each statement of nutritional

support that refers to the same symbol

placed elsewhere on the same label

panel or in the labeling that is followed

by the disclaimer.

In a citizen petition dated March 20,

1995 (petition number 95P–0079/CP 1),

the Nutritional Health Alliance (NHA)

requested, among other things, that FDA

issue regulations implementing section

403(r)(6) of the act. With respect to the

placement of the disclaimer, NHA

suggested that an asterisk follow each

statement of nutritional support to refer

the consumer to a specific place on the

label, such as the information panel,

where the disclaimer would appear only

once.

Although FDA is proposing to provide

most of what this petition seeks, the

agency tentatively rejects the last aspect

of this suggestion. Splitting the

statement of nutritional support from

the required disclaimer and allowing

the disclaimer to appear on another

panel does not establish an obvious

relationship between the two pieces of

information. The agency is concerned

that the placement of the disclaimer on

another panel would not reveal material

facts in conjunction with the statement

of nutritional support that are necessary

for consumers to fully understand the

significance of the statement. However,

the agency will consider establishing

provisions for the use of asterisks that

refer to the disclaimer in a single

specific location (such as the

information panel), instead of on each

panel bearing a statement of nutritional

support, if the comments convince it

that such an approach is consistent with

the statute and would be useful to

consumers. FDA requests any data that

bear on the question of the effect that

splitting a statement from a disclaimer

in this manner will have on the

likelihood that consumers will read the

disclaimer. Specifically, the agency

requests data on whether a consumer

will track a symbol from one label panel

or page of labeling to another to obtain

the information about a statement of

nutritional support that follows the

symbol.

In addition, the requirement in the act

for prominent display means that when

the disclaimer does not appear

immediately adjacent to a statement of

nutritional support, it must be presented

on the label or labeling in a manner that

renders it as readily observable and as

likely to be read as the statement of

nutritional support itself. In this regard,

the agency’s experience with the

graphic requirements for the new

nutrition label has been that a box

around required label information

greatly increases the prominence of the

information placed inside the box (Ref.

2). Moreover, focus group discussions

regarding warning labels show that

messages put in a boxed area help

consumers to distinguish the message

from other information as well as draw

attention to it (Ref. 3). Therefore, FDA

is proposing in § 101.94(c)(2) to require

that a box be drawn around the

disclaimer when the disclaimer is not

immediately adjacent to the statement of

nutritional support.

For example, a side panel of a dietary

supplement label may contain

paragraphs of text that include more

than one statement of nutritional

support. Assuming that the

manufacturer did not choose to place

the disclaimer immediately after each

statement of nutritional support, each

such statement would be followed by a

symbol, and the referenced symbol and

disclaimer would be placed in a box on

the same panel with the first sentence

reading ‘‘*These statements have not

been evaluated by the Food and Drug

Administration,’’ as proposed in section

§ 101.94(b)(2).

4. Type Size and Style

With respect to the style of type to be

used in the disclaimer, the DSHEA

specifies that ‘‘boldface type’’ shall be

used (section 403(r)(6)(C) of the act).

FDA has reiterated this provision in

proposed § 101.94(d).

With respect to type size

requirements, FDA notes that even

though section 403(r)(6) of the act does

not include specific type size

requirements for the accompanying

information referred to as the

disclaimer, other sections of the act, and

the regulations promulgated thereunder,

address a variety of requirements for

information that is to accompany a

claim. Sections 403(r)(2)(A)(iii) through

(r)(2)(A)(v) of the act require that

statements that disclose the level of fat,

saturated fat, or cholesterol, which must

be presented in conjunction with certain

nutrient content claims, ‘‘have

appropriate prominence which shall be

no less than one-half the size of the

claim.’’ The agency tentatively

concludes that, for consistency, this

requirement should be considered a key

element of ‘‘prominent display’’ for the

disclaimer.

FDA has long held that accompanying

information should be in a size

reasonably related to that of the

information that it modifies. This

relative prominence, when codified, has

(except in the case of provisions

pertaining to nutrient content claim

referral and disclosure statements in

§ 101.13) been one-half the type size of

the information modified (see, e.g.,

§§ 101.22(i)(2) and 102.5(b)(2)(ii)). For

nutrient content claims, FDA did

establish type size requirements for

referral and disclosure statements

related to the area of the surface bearing

the principal display panel rather than

to the type size used for the nutrient

content claim. However, nutrient

content claims often have very large

type size, whereas nutritional support

statements will likely not appear in

such large type because they are

intended to convey more lengthy

information. Certainly the statements

that would qualify as nutritional

support statements under section

403(r)(6) of the act that have appeared

in dietary supplement labeling are of

much greater length than most nutrient

content claims.

Because nutritional support

statements are likely to be more lengthy,

firms are likely to use relatively small

type for them. The agency is concerned

that one-half the size of the type

commonly used for long statements or

paragraphs may be too small for

consumers to read easily. Thus, FDA is

proposing one-sixteenth of an inch as

the minimum type size for the

disclaimer in § 101.94(d).

One-sixteenth of an inch is specified

in § 101.2(c) as the minimum type size

for most other mandatory information

on the principal display panel or

information panel, e.g., designation of

ingredients, name and place of business,

and warning and disclaimer statements.

Further, one-sixteenth of an inch is the

minimum size required in § 101.105(i)

for net quantity of contents statements.

Consequently, the agency tentatively

concludes that a minimum type size of

one-sixteenth of an inch for the

disclaimer is necessary to ensure that it

is prominently displayed in accordance

with section 403(r)(6)(C) of the act.

E. Prominence of Ingredients That Are

Not Vitamins or Minerals

Section 7(d) of the DSHEA strikes

section 411(b)(2)(B) of the act. Before it

was removed by the DSHEA, section

411(b)(2)(B) stated that the labeling and

advertising of dietary supplements of

vitamins and minerals could not give

prominence to or emphasize ingredients

that are not vitamins, minerals, or

represented as a source of vitamins or

minerals. Because of this provision, the

agency stated that nutrient content

claims about ingredients that are not
67182 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

vitamins or minerals (e.g., ‘‘more fiber,’’

‘‘high protein’’) could not be made on

dietary supplements of vitamins or

minerals (59 FR 378 at 387). This

limitation was carried through in the

final rule for nutrient content claims for

dietary supplements in § 101.54(b)(1),

(c)(1), and (e)(1) that addressed ‘‘high,’’

‘‘good source,’’ and ‘‘more’’ claims,

respectively, for dietary supplements.

For example, § 101.54(b)(1) as

amended by the nutrient content claims

for dietary supplements final rule (59

FR 378 at 394) reads:

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), main dish products as

defined in § 101.13(m), and dietary

supplements of vitamins or minerals to

characterize the level of any substance that

is not a vitamin or mineral, provided that the

food contains 20 percent or more of the RDI

or the DRV per reference amount customarily

consumed.

(emphasis added).

Similar restrictions were added to

§ 101.54(c)(1) and (e)(1) by the 1994

nutrient content claims for dietary

supplements final rule.

In response to section 7(d) of the

DSHEA, FDA is proposing to amend

§ 101.54(b)(1) for ‘‘high’’ claims,

§ 101.54(c)(1) for ‘‘good source’’ claims,

and § 101.54(e)(1) for ‘‘more,’’

‘‘fortified,’’ ‘‘enriched,’’ and ‘‘added’’

claims to remove these restrictions on

claims on dietary supplements that

characterize the levels of substances that

are not vitamins and minerals. These

restrictions are no longer required under

the act.

III. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. In accordance with the

Regulatory Flexibility Act, the agency

certifies that the proposed rule will not

have a significant economic impact on

a substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

The proposed 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

statements of nutritional support so long

as those statements include an

appropriate disclaimer, and the

manufacturer has substantiation that the

statement is truthful and not

misleading. 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 nutritional support statements

will incur the additional cost of

redesigning labels to include the

disclaimer. When the label or labeling

contains more than one nutritional

support statement, the cost of the

disclaimer will depend on whether the

disclaimer must be made on each label

panel, page, or piece of labeling that

contains a statement of nutritional

support, or whether the disclaimer need

only appear once.

FDA is unable to quantify the benefits

from this proposed rule. It may be that

some consumers will benefit from the

additional information about dietary

ingredients that will become available.

However, because statements of

nutritional support may now be made

for some dietary ingredients without

any publicly available information to

demonstrate that the dietary ingredient

is safe, or that it will have its claimed

effect, it is uncertain whether this

proposed rule will in fact provide any

significant benefits to consumers. FDA

requests comment on this issue.

IV. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(11) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

V. Paperwork Reduction Act

FDA tentatively concludes that this

proposed rule contains no reporting,

recordkeeping, labeling, or other third

party disclosure requirements; thus

there is no ‘‘information collection’’

necessitating clearance by the Office of

Management and Budget. However, to

ensure the accuracy of this tentative

conclusion, FDA is asking for comment

on whether this proposed rule to amend

its regulations establishing requirements

for the use of nutrient content claims

and health claims for dietary

supplements and to specify how the

disclaimer required by section

403(r)(6)(C) of the act is to be presented

on the labels or labeling or dietary

supplements imposes any paperwork

burden.

VI. Effective Date

FDA is proposing to make this

regulation effective on January 1, 1997.

This is consistent with section 7(e) of

the DSHEA, which states that dietary

supplements must be labeled in

accordance with the amendments of that

section after December 31, 1996.

VII. Comments

Interested persons may, on or before

March 13, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

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

Monday through Friday.

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. Office of Food Labeling, Center for Food

Safety and Applied Nutrition, Food and Drug

Administration, ‘‘Food Labeling, Questions

and Answers,’’ August, 1993.

2. Wilkening, Virginia L., Memo to the

Record, June 30, 1995.

3. Macro International Inc., ‘‘Iron

Supplement Warning Label Focus Group

Report,’’ U.S. Department of Health and

Human Services, Food and Drug

Administration, April 14, 1995.

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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67183

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 101 be 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(a) is amended by

revising paragraphs (a) and (b),

redesignating paragraph (q)(3) as

(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), with the exception of

such claims on restaurant menus, 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) Under section 403(r)(2)(F) of the

act, a statement that characterizes the

percentage level of a dietary ingredient

for which an RDI or daily reference

value (DRV) has not been established

(e.g., ‘‘40 percent omega-3 fatty acids,’’

‘‘100 percent of the allicin in a bulb of

garlic,’’ or ‘‘twice the allicin as (name of

product alternative)’’ [where ‘‘twice’’ is

another way of saying 200 percent]) 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. In

addition, whenever a statement that

characterizes the percentage level of a

dietary ingredient for which there is no

RDI or DRV is made in a way that draws

a comparison to the amount of the

dietary ingredient in a reference food,

the reference food shall be clearly

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.

* * * * *

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

(e)(1) introductory text 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. Section 101.94 is added to subpart

F to read as follows:

§ 101.94 Statements of nutritional support;

disclaimer.

(a) The requirements in this section

apply to the label or labeling of dietary

supplements where the dietary

supplement bears a statement of

nutritional support that is provided for

by section 403(r)(6) of the Federal Food,

Drug, and Cosmetic Act (the act), and

where the manufacturer, packer, or

distributor wishes to take advantage of

the exemption to section 201(g)(1)(C) of

the act by complying with section

403(r)(6) of the act.

(b) Text for disclaimer. (1) Where

there is one statement of nutritional

support on the label or in the labeling,

the disclaimer shall be placed in

accordance with paragraph (c)(1) 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

statement of nutritional support on the

label or in the labeling, each statement

shall bear the disclaimer in accordance

with paragraph (b)(1) of this section, or

a plural disclaimer may be placed in

accordance with paragraph (c)(2) 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.

(c) Placement. (1) Except as provided

in paragraph (c)(2) of this section, the

disclaimer shall be contained in each

statement of nutritional support. The

disclaimer shall be placed immediately

adjacent to the statement of nutritional

support with no intervening material.

(2) Where there is more than one

statement of nutritional support on a

label panel or in labeling other than a

label, and the manufacturer, packer, or

distributor wishes to comply with

section 403(r)(6) of the act without

having to place the disclaimer after each

statement of nutritional support, it shall

place a symbol (e.g., an asterisk) at the

end of each statement of nutritional

support that refers to the same symbol

placed elsewhere on the same label

panel or piece of labeling that is

followed by the disclaimer. In this
67184 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

situation, the referenced symbol and

disclaimer shall be placed in a box.

(d) Typesize. The disclaimer in

paragraph (b) of this section shall

appear in boldface type in letters of a

type size height no smaller than the

larger of:

(1) One-half the type size of the

largest statement of nutritional support;

or

(2) One-sixteenth inch.

Dated: September 26, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31193 Filed 12–27–95; 8:45 am]

BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95N–0347]

RIN 0910–AA23

Food Labeling; 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

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations to define the term

‘‘high potency’’ as a nutrient content

claim for dietary supplements; define

the term ‘‘antioxidant’’ for use in

nutrient content claims on labels or in

labeling of dietary supplements and

conventional foods; and 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 in response to provisions

of the Nutrition Labeling and Education

Act of 1990. This proposed rule will

benefit consumers by providing

established definitions for use in food

labeling for the terms ‘‘high potency,’’

‘‘antioxidant,’’ and ‘‘sugar free.’’

DATES: Written comments by March 13,

1996. The agency proposes that any

final rule that may issue based upon this

proposal become effective January 1,

1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Camille E. Brewer, Center for Food

Safety and Applied Nutrition (HFS–

165), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5483.

SUPPLEMENTARY INFORMATION:

I. Regulatory History

A. The Nutrition Labeling and

Education Act of 1990 and Subsequent

Proposals

On November 8, 1990, the President

signed into law the Nutrition Labeling

and Education Act of 1990 (the 1990

amendments) (Pub. L. 101–535). The

1990 amendments revised the Federal

Food, Drug, and Cosmetic Act (the act)

in a number of important ways. One of

the most notable aspects of the 1990

amendments is that they establish

FDA’s authority to regulate nutrient

content claims on food labels and in

food labeling. Section 403(r)(1)(A) of the

act (21 U.S.C. 343(r)(1)(A)), which was

added by the 1990 amendments,

provides that a product is misbranded if

it bears a claim in its label or labeling

that either expressly or implicitly

characterizes the level, in the food, of

any nutrient of the type required to be

declared as part of nutrition labeling,

unless such claim has been specifically

defined (or otherwise exempted) by

regulation.

In the Federal Register of November

27, 1991 (56 FR 60421 and 56 FR

60478), FDA published two documents

(‘‘Food Labeling: Nutrient Content

Claims, General Principles, Petitions,

Definition of Terms;’’ and ‘‘Food

Labeling: Definitions of Nutrient

Content Claims for the Fat, Fatty Acid,

and Cholesterol Content of Food’’) in

which it proposed, among other things,

to define nutrient content claims and to

provide for their use on food labels.

FDA intended that these proposals

would apply to dietary supplements as

well as conventional foods.

B. The Dietary Supplement Act of 1992,

Final Labeling Rules, and the Dietary

Supplement Health and Education Act

of 1994

On October 6, 1992, the President

signed into law the Dietary Supplement

Act of 1992, Title II of Pub. L. 102–571

(the DS Act). Section 202(a)(1) of the DS

Act established a moratorium on the

implementation of the 1990

amendments with respect to dietary

supplements until December 15, 1993.

Section 202(a)(2)(A) of the DS Act

directed the Secretary of Health and

Human Services to issue new proposed

regulations that are applicable to dietary

supplements of vitamins, minerals,

herbs, and other similar nutritional

substances.

FDA published final regulations that

implemented the 1990 amendments

with respect to nutrient content claims

in the Federal Register of January 6,

1993, in a document entitled ‘‘Food

Labeling; Nutrient Content Claims;

General Principles, Petitions, and

Definition of Terms’’ (hereinafter

referred to as ‘‘the 1993 nutrient content

claims final rule’’). As a result of the DS

Act, this final rule applied only to the

use of such claims on conventional

foods (58 FR 2302 as corrected at 58 FR

17341). FDA made technical corrections

to these final regulations in documents

published in the Federal Register on

August 18, 1993 (58 FR 44020).

In response to the requirements of the

1990 amendments and the DS Act, FDA

published in the Federal Register of

June 18, 1993 (58 FR 33731), 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) to: (1) Include dietary

supplements of vitamins, minerals,

herbs, and other similar nutritional

substances under the coverage of the

general principles for nutrient content

claims; (2) provide for the use of

expressed and implied nutrient content

claims on labels or in labeling of dietary

supplements; and (3) provide for

petitions for nutrient content claims for

dietary supplements. FDA received

approximately 500 letters in response to

its 1993 nutrient content claims

proposal. FDA issued final regulations

on nutrient content claims for dietary

supplements on January 4, 1994 (59 FR

378) (hereinafter referred to as the 1994

nutrient content claims final rule).

On October 25, 1994, the President

signed into law the Dietary Supplement

Health and Education Act of 1994 (the

DSHEA) (Pub. L. 103–417). Among

other things, the DSHEA provided a

statutory definition for ‘‘dietary

supplements,’’ provided for some

flexibility in the manner in which

ingredient and nutrition labeling

information is to be provided for dietary

supplements, and made provision for

statements that characterize the

percentage level of dietary ingredients

for which Reference Daily Intakes

(RDI’s) and Daily Reference Values

(DRV’s) have not been established.

However, these changes do not bear

directly on this rulemaking.

In the 1994 nutrient content claims

final rule, FDA used the terms ‘‘dietary

supplements of vitamins, minerals,

herbs, and other similar nutritional