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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67185

substances’’ and ‘‘food in conventional

food form.’’ With the passage of the

DSHEA, however, Congress has defined

the term ‘‘dietary supplement’’ and has

modified the act in sections 201(ff) and

411(c)(1) (21 U.S.C. 321(ff) and

350(c)(1)) to make clear that the form of

the food is not necessarily determinative

of whether it is a dietary supplement or

not. Therefore, in this document, FDA

will use the more simple terms ‘‘dietary

supplement’’ and ‘‘conventional food.’’

II. FDA Authority

Section 403(r)(2)(A)(i) of the act states

that claims that characterize the level of

a nutrient may be made only if the claim

uses terms that are defined in

regulations. In response to this section,

the agency is proposing to amend its

regulations on nutrient content claims

to define the term ‘‘high potency’’ as a

nutrient content claim for use on labels

and in labeling of dietary supplements

and the term ‘‘antioxidant’’ for use in

nutrient content claims for dietary

supplements and conventional foods.

FDA has authority to take these

actions regarding nutrient content

claims under sections 201(n) and 403(a),

as well as section 403(r), of the act (21

U.S.C. 321(n) and 343(a)). These

sections prohibit labeling that: (1) Is

false or misleading in that it fails to

reveal facts that are material in light of

other representations made in the

labeling or that are material with respect

to the consequences that may result

from use of the food, and (2) uses terms

to characterize the level of any nutrient

in a food that have not been defined by

regulation by FDA.

III. Proposed Rules

A. ‘‘High Potency’’

1. Background

In the 1993 nutrient content claims

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 are

established meanings for these terms,

and, if so, whether they characterize the

level of the nutrients in the food. The

agency received about 10 comments

from trade associations, manufacturers

of dietary supplements and

conventional foods, academicians, and

consumer groups regarding the term

‘‘high potency.’’

FDA was persuaded, based on

comments that suggested definitions for

the term, that ‘‘high potency’’ is a claim

that characterizes the level of a nutrient

or nutrients and, therefore, meets the

definition in § 101.13(b) of a nutrient

content claim (59 FR 378 at 391).

However, given the time constraints

under which FDA prepared the final

rule, and the range and diversity of the

suggested definitions, the agency was

not able to adopt a definition of ‘‘high

potency’’ in the final rule on nutrient

content claims for dietary supplements.

FDA announced its intention to review

the suggestions for a definition of ‘‘high

potency’’ and, based on information

received in the comments, to propose an

appropriate definition for this term (59

FR 378 at 391). In this document, the

agency is proceeding with its

commitment to propose a definition for

‘‘high potency.’’

2. Limitation to Dietary Supplements

In the 1994 nutrient content claims

final rule, the agency determined that,

in many respects, the regulations issued

in the 1993 nutrient content claims final

rule (58 FR 2302) are directly applicable

to dietary supplements (59 FR 378 at

380). However, FDA acknowledged that

dietary supplements differ in several

respects from conventional foods in

their history of use and in their

perceived function in the diet (59 FR

378 at 380). This fact and the fact that

certain dietary supplements are likely to

contain much higher levels of nutrients

than conventional foods led FDA to

conclude that nutrient content claims

that are specific for dietary supplements

may be appropriate (59 FR 378 at 380).

Comments to the nutrient content

claims proposal for dietary supplements

stated that the term ‘‘high potency’’

seems more appropriate for dietary

supplements than for conventional

foods (59 FR 378 at 390).

In considering the coverage of this

term, FDA has relied, in part, on the

National Academy of Sciences’ (NAS)

Institute of Medicine’s (IOM)

recommendations found in ‘‘Nutrition

Labeling, Issues and Directions for the

1990’s’’ (Ref. 1). In discussing claims,

the IOM suggested that the terms that

should be defined are those that are

most commonly used (Ref. 1, p. 296).

FDA has no evidence that the term

‘‘high potency’’ is used with any

frequency on conventional foods, that

the term was used on conventional

foods before the enactment of the 1990

amendments, or that consumers expect

or would understand it in association

with conventional foods. In contrast, the

term ‘‘high potency’’ was in widespread

use on the labels of dietary supplements

before the enactment of the 1990

amendments, continues to be used on

dietary supplements, and appears to

convey information to the consumer

about the level of the nutrients in

dietary supplements.

Lacking a clear history of use, or any

other indication of the usefulness, of the

term ‘‘high potency’’ on conventional

foods, the agency tentatively concludes

that this term should be limited to use

on dietary supplements. Accordingly,

FDA is proposing to amend part 101 (21

CFR part 101) by adding new

§ 101.13(b)(6), which states that the term

‘‘high potency’’ may be used only on

dietary supplements.

FDA recognizes that defining a

nutrient content claim exclusively for

use on labels and in labeling of dietary

supplements is a departure from

previous practice. However, the agency

tentatively concludes that limiting this

claim to dietary supplements is the

appropriate course for the reasons stated

above. Comment is requested on this

tentative conclusion.

3. Definition of ‘‘High Potency’’ as a

Nutrient Content Claim

a. Describing a nutrient. FDA received

several comments that presented a wide

range of views on how ‘‘high potency’’

should be defined. One comment to the

proposed rule on nutrient content

claims suggested that the term ‘‘high

potency’’ have the same definition as

‘‘high’’ (i.e., 20 percent or more of the

RDI), but did not provide any

elaboration on why this suggested

definition is appropriate. Other

comments asserted that this term could

be used to establish an hierarchy of

absolute claims (i.e., ‘‘good source,’’

‘‘high,’’ and ‘‘high potency’’) to describe

dietary supplements. This hierarchy, the

comments suggested, will enable

consumers to use the claims to quickly

differentiate between varying nutrient

levels in dietary supplements.

A few comments suggested that the

term be defined to mean that the

product contains 200 percent of the RDI.

These comments argued that while a

multivitamin supplement at 100 percent

of the RDI might be ‘‘high potency’’

compared to a conventional food, it is

not ‘‘high potency’’ when compared to

other dietary supplements. These

comments suggested that defining ‘‘high

potency’’ as twice the RDI or more

would more accurately reflect the level

of nutrients found in dietary

supplements. One of these comments

stated that, in addition to requiring that

single nutrient supplements be twice

the RDI for that nutrient, FDA should

require that the principal display panel

disclose what multiple of the RDI the

supplement contains. For example, the

comment suggested that the principal

display panel of a 250 milligram (mg)
67186 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

1In the 1993 nutrient content claims proposal,

FDA stated that consensus reports and dietary

recommendations generally encourage the

increased consumption of complex carbohydrates,

while suggesting that sugars be consumed in

moderation (56 FR 60421 at 60444). The agency

concluded that a nutrient content claim such as

‘‘high in carbohydrate’’ may provide misleading

dietary advice because the claim does not allow for

the distinction between high levels of complex

carbohydrates and high levels of sugars (56 FR

60421 at 60444).

vitamin C supplement carry an asterisk

next to the words ‘‘high potency’’ with

the following disclosure: ‘‘Contains four

times the RDI for vitamin C.’’ The

comment went on to state that under

this scheme, some nutrients, such as

calcium and selenium, would not

qualify to carry a ‘‘high potency’’ claim

because they are rarely sold at 200

percent of the RDI. The comment

suggested that if the supplement

industry begins to market those

nutrients at higher doses to make ‘‘high

potency’’ claims, FDA could establish a

lower minimum level, such as 50

percent of the RDI for selenium and 50

percent of the RDI for calcium. The

comment stated that those minimum

levels would apply to those nutrients

only.

Several comments, however, argued

that the term ‘‘high potency’’ should

mean 100 percent or more of the RDI

because that is the current industry

practice, and it has been helpful in

directing consumers in their choice of

products. One comment from the

dietary supplement industry stated that,

in their experience, the term ‘‘high

potency’’ has generally been used for

the last 20 years to refer to formulations

that are at levels above the U.S.

Recommended Daily Allowances (U.S.

RDA’s).

FDA acknowledges that many dietary

supplements, particularly dietary

supplements of vitamins or minerals,

are likely to contain much higher levels

of nutrients than conventional foods

(Ref. 2). Currently approved nutrient

content claims are of limited value in

identifying those dietary supplements

that contain amounts of vitamins or

minerals at or above the Daily Value

(DV). Claims such as ‘‘good source’’ and

‘‘high’’ are adequate to describe nutrient

levels found in the majority of

conventional foods, but they do not

allow for differentiation of dietary

supplement products containing much

higher levels of nutrients. Therefore, the

agency is in agreement with the

comments that suggested that the term

‘‘high potency’’ should be defined in a

way that permits such differentiation.

Accordingly, FDA rejects the

comment that suggested that ‘‘high

potency’’ be defined as 20 percent or

more of the RDI. Such a definition

would make ‘‘high potency’’

synonymous with ‘‘high’’ and thus

would not help consumers differentiate

between relatively low nutrient levels in

many dietary supplements in the

marketplace and those at higher levels.

FDA is not persuaded by the

comments that suggested that 200

percent of the RDI is an appropriate

definition for ‘‘high potency.’’ While the

agency acknowledges that dietary

supplements of vitamins and minerals

often contain levels that meet or exceed

200 percent of the RDI per unit, that fact

alone does not justify defining ‘‘high

potency’’ at that level.

Supplement users report a variety of

reasons for taking dietary supplements,

including ensuring adequacy of intake

of specific nutrients (Refs. 3, 4, and 5).

FDA is interested in ensuring, and the

nutrient content claim provisions were

intended to ensure (see, e.g., section

403(r)(2)(A)(ii)(II) of the act) that

consumers have useful label

information that will help them

maintain healthy dietary practices, in

part by constructing nutritionally

adequate diets. However, the agency is

not persuaded that proposing a

definition for ‘‘high potency’’ at 200

percent or more of the RDI will

contribute to this goal. The RDI’s are

based on the NAS Recommended

Dietary Allowances (RDA’s), which are

intended to reflect ‘‘the levels of intake

of essential nutrients that, on the basis

of scientific knowledge, are judged by

the Food and Nutrition Board, NAS to

be adequate to meet the known nutrient

needs of practically all healthy persons’’

(Ref. 6). FDA is aware that the NAS is

in the process of reevaluating the basis

on which RDA’s are determined and is

considering expanding the RDA concept

to include reducing the risk of chronic

disease (Ref. 7). Until that debate is

resolved, the agency tentatively

concludes that it is appropriate to define

‘‘high potency’’ at a level that will assist

consumers interested in using dietary

supplements in obtaining an adequate

intake as determined by established RDI

values.

The agency tentatively concludes that

100 percent of the RDI per serving is a

reasonable definition of ‘‘high potency’’

because this level is high enough ‘‘to

meet the needs of practically all healthy

persons.’’ RDI values represent the

highest NAS RDA values from among

the various age/sex groups specified by

the NAS for persons 4 or more years of

age (58 FR 2206 at 2210). Thus, a person

consuming a ‘‘high potency’’ vitamin or

mineral will be assured of meeting his

or her need for the nutrient described as

‘‘high potency.’’ Such action would be

a healthy dietary practice.

FDA tentatively concludes that the

proposed definition of ‘‘high potency’’

makes sense for two additional reasons.

First, as stated in the comments, it is

consistent with current industry

practice. Second, as a matter of common

sense, providing of 100 percent of the

RDI for a vitamin or mineral is to

provide an amount of the vitamin or

mineral that is highly potent.

FDA’s tentative conclusion does not

mean, however, that the agency is

opposed to the presence of more than

100 percent of the RDI of a nutrient per

serving. Manufacturers can formulate

and describe the level of a nutrient as

multiples of the RDI (e.g., using the

terminology ‘‘Daily Value’’ to represent

RDI’s on the label, a vitamin C tablet

containing 500 mg would declare ‘‘833

percent of the Daily Value of vitamin

C’’). Nonetheless, because the purpose

of nutrient content claims is to assist

consumers in maintaining healthy

dietary practices, and given the

recommendations of the NAS on which

the RDI’s are based, FDA tentatively

concludes that it is appropriate to tie a

‘‘high potency’’ claim to the RDI itself.

In addition to the nutrients for which

RDI’s have been established, FDA is

proposing that the claim ‘‘high potency’’

may be used to describe protein and

dietary fiber for which DRV’s have been

established in § 101.9(c)(9). Because

dietary guidelines recommend that

consumers moderate or reduce dietary

levels of four other nutrients for which

DRV’s have been established (i.e., total

fat, saturated fat, cholesterol, and

sodium) to reduce the risk of developing

certain chronic diseases (Ref. 8), FDA

does not expect, and, therefore, is not

proposing, that ‘‘high potency’’ claims

be used to apply to them.

Additionally, the agency is not

proposing that ‘‘high potency’’ claims be

used to apply to two other nutrients,

total carbohydrate and potassium, for

which DRV’s have been established.

Section 101.54(a) precludes the use of

the claims listed in that section in

relation to total carbohydrate.1 In the

case of potassium, tablets containing

potassium chloride or other potassium

salts, which supply 100 mg or more of

potassium per tablet, are considered to

be drugs. (See 21 CFR 201.306.)

The agency is not aware of any reason

why ‘‘high potency’’ claims should not

be allowed to be used with protein and

dietary fiber. FDA established the DRV’s

at levels for each nutrient that represent

scientific consensus on the

characteristics of foods Americans

should choose both to have a healthier

diet and to reduce risk factors for

chronic diseases and conditions (58 FR
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67187

2206 at 2217). Nutrient content claims

that assist consumers in constructing

diets by identifying foods, including

dietary supplements, that contain

protein and dietary fiber at such levels

should be allowed.

FDA tentatively concludes that,

consistent with the agency’s treatment

of the claim for nutrients for which

RDI’s have been established, ‘‘high

potency’’ should be defined for protein

and dietary fiber at 100 percent of the

DRV. The agency notes that throughout

its rulemakings on nutrient content

claims, it has used identical values for

nutrients for which a DRV has been

established as for those that are the

subject of an RDI (e.g., ‘‘good source’’

claims are defined in § 101.54(c) as 10

to 19 percent of the RDI or DRV per

reference amount customarily

consumed).

Accordingly, FDA is proposing in

§ 101.54(f)(1) that the term ‘‘high

potency’’ may be used on the label or in

labeling of a dietary supplement to

describe a nutrient that is present at 100

percent or more of the RDI for vitamins

and minerals or the DRV for protein or

dietary fiber per reference amount

customarily consumed.

In response to the comment that

suggested that FDA require that the

principal display panel disclose what

multiple of the nutrient’s RDI is present

(e.g., ‘‘Contains 400 percent of the Daily

Value of Vitamin C’’), FDA is not

persuaded that this action would be

helpful to consumers. The referral

statement, ‘‘See ——————— for

nutrition information,’’ which directs

the consumer to the nutrition panel is

required for all nutrient content claims

as specified in § 101.13(g). As proposed

in a companion document published

elsewhere in this issue of the Federal

Register and entitled ‘‘Food Labeling;

Statement of Identity; Nutrition

Labeling and Ingredient Labeling of

Dietary Supplements,’’ the nutrition

label for dietary supplements of

vitamins and minerals will have to

provide quantitative information on the

levels of specific nutrients as well as the

percent Daily Value (DV) for each

nutrient. Consequently, the consumer

will have easy access to information

regarding the levels of specific nutrients

and may adjust their level of intake

accordingly.

In addition, not requiring any

additional information or disclosure

beyond the referral statement is

consistent with rules for the use of other

expressed nutrient content claims, e.g.,

‘‘good source’’ and ‘‘high’’ claims,

which do not have to disclose the

fraction of the RDI present. While FDA

tentatively concludes that there is no

need for additional disclosure

requirements for products bearing a

‘‘high potency’’ claim, the agency points

out that manufacturers may voluntarily

place a statement on the label that

discloses the amount or percentage of

nutrients in relation to the DV as

provided for in § 101.13(i) and (q)(3)

(e.g., ‘‘50 percent of the RDI for

calcium,’’ ‘‘10 mg of iron’’).

In response to the comment that

suggested that the agency consider

establishing a definition for ‘‘high

potency’’ at lower levels for some

nutrients if manufacturers start

increasing amounts of the nutrients so

that they can meet the criterion for the

claim ‘‘high potency,’’ the agency

believes that such action is unnecessary

and potentially confusing to consumers.

The agency tentatively concludes that

the term ‘‘high potency’’ should have

the same definition for all nutrients. In

instances in which the product does not

meet the proposed criteria for the claim

‘‘high potency,’’ the product may

qualify to use another nutrient content

claim, such as ‘‘good source’’ (defined

in § 101.54(c) as 10 to 19 percent of the

RDI or DRV) or ‘‘high’’ (defined in

§ 101.54(b) as 20 percent or more of the

RDI or DRV). For example, when

calcium is present in a dietary

supplement at 20 percent or more of the

RDI, the manufacturer can use the

nutrient content claim ‘‘high’’ to

describe the level of calcium. In

addition, as stated above, under

§ 101.13(i) and (q)(3) the manufacturer

may declare the amount or percentage of

the nutrient on the label.

b. Describing a dietary supplement

product. The comments stated that in

addition to being used to describe the

level of a nutrient in a product, the term

‘‘high potency’’ is also often used to

describe multinutrient dietary

supplement products themselves.

Several comments discussed the use of

a ‘‘high potency’’ claim on multinutrient

products, and whether all nutrients in

such a product would have to be present

at levels that would meet the criterion

for the claim. One comment stated that

the claim should be permitted on any

supplement that contains 100 percent of

the RDI for each vitamin and mineral

that is included in the product and for

which an RDI has been established. The

comment went on to state that the

presence or absence of vitamins,

minerals, or other substances for which

no RDI’s have been established should

not affect a product’s eligibility to bear

the claim, so long as those nutrients for

which RDI’s have been established are

present at required levels.

In contrast with this comment, a few

comments stated that multinutrient

products should be termed ‘‘high

potency’’ when the majority of nutrients

with RDI’s are present at levels equal to

or in excess of the RDI. Another

comment stated that FDA should allow

‘‘high potency’’ claims on multinutrient

supplements when more than one-third

of the nutrients that they contain meet

the minimum level required for a ‘‘high

potency’’ claim. The latter comment

stated that it is not reasonable to require

that all of the nutrients in a

multiingredient supplement be present

at the level that is defined as ‘‘high

potency’’ because many nutrients are

not, and should not, be sold in such

high doses. For example, the comment

stated that ‘‘high potency’’ claims

should be allowed on a multinutrient

supplement that contains high levels of

vitamins A, C, E, B6, B12, thiamin,

riboflavin, and niacin, but smaller

amounts of vitamin D, iron, calcium,

magnesium, zinc, and copper. The

comment stated that the latter nutrients

are typically sold at lower doses, and

some may pose a risk at high levels.

FDA has considered the comments

that ‘‘all,’’ ‘‘most,’’ or ‘‘one-third’’ of the

nutrients in a dietary supplement be

present at 100 percent of the RDI or DRV

for the supplement to qualify to bear the

term ‘‘high potency.’’ A review of an

informal FDA survey of labels of dietary

supplements that bear the term ‘‘high

potency’’ revealed that most

multinutrient products that used the

claim contained a majority, but not all,

nutrients at 100 percent or more of the

RDI (Ref. 9). FDA agrees with the

comment that it may be impracticable to

include 100 percent of the RDI or DRV

for several nutrients for technological

reasons. For instance, the bulkiness of

calcium, phosphorus, magnesium, and

fiber may make it difficult to provide

sufficient amounts of those nutrients for

them to be included in ‘‘high potency’’

tablets if they must be present at 100

percent of the RDI or DRV.

FDA tentatively concludes that it is

not necessary to prohibit the use of a

‘‘high potency’’ claim on multinutrient

dietary supplements if the supplements

do not contain 100 percent or more of

the RDI for each vitamin and mineral

that is present, or 100 percent of the

DRV for protein or dietary fiber, when

present. The agency is persuaded by the

comments that the public will be better

served from a public health perspective

if some nutrients are allowed to be

present in such products at levels that

are below 100 percent of the RDI or

DRV. Without such an allowance, those

nutrients that cannot be included at 100

percent levels because of technological

difficulties could not be included at all

if the dietary supplement is to bear a
67188 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

‘‘high potency’’ claim. The exclusion of

these nutrients will not necessarily help

consumers to engage in healthy dietary

practices.

Having tentatively concluded that

some nutrients may be present in a

‘‘high potency’’ multinutrient dietary

supplement at less than 100 percent of

the RDI or DRV, the agency must

determine what percentage of nutrients

must be present in the product at 100

percent of the RDI or DRV for the

product to qualify to make a ‘‘high

potency’’ claim. A logical starting point

is determination of: (1) How many

nutrients have had RDI’s and DRV’s

established for them, and (2) of those

nutrients, how many cannot, or should

not, be expected to be present at 100

percent of the RDI or DRV for

technological reasons or because of

public health concerns.

In the RDI/DRV final rules published

on January 6, 1993 (58 FR 2206), FDA

established RDI’s in § 101.9(c)(8)(iv) for

19 vitamins and minerals (i.e., vitamin

A, vitamin C, calcium, iron, vitamin D,

vitamin E, thiamin, riboflavin, niacin,

vitamin B6, folate, vitamin B12, biotin,

pantothenic acid, phosphorus, iodine,

magnesium, zinc, and copper) and

DRV’s in § 101.9(c)(9) for eight nutrients

(i.e., total fat, saturated fat, cholesterol,

total carbohydrate, dietary fiber,

sodium, potassium, and protein). In

addition, in a companion document

entitled ‘‘Food Labeling: Reference

Daily Intakes’’ published elsewhere in

this issue of the Federal Register, FDA

is establishing RDI’s for six additional

vitamins and minerals (i.e., vitamin K,

selenium, chloride, manganese,

chromium, molybdenum). Thus, there

are a total of 33 nutrients for which

RDI’s or DRV’s have been established.

Of these 33 nutrients, 4 (i.e., calcium,

phosphorus, magnesium, and fiber)

have already been mentioned as being

difficult to include in dietary

supplements in amounts equal to 100

percent of the DV because of

technological problems related to their

bulk.

Other nutrients that should not be

expected to be present at 100 percent of

the DV include total fat, saturated fat,

cholesterol, and sodium. It would be

nonsensical to associate the term ‘‘high

potency’’ with these nutrients because,

as discussed earlier, dietary guidelines

recommend that intake of these

nutrients be limited or moderated in the

diet (Ref. 8). In addition, it is not useful

to include chloride at high levels in

multinutrient supplements. Salt is the

primary source of dietary chloride, and

the typical American diet already

contains significant levels of chloride

because of high intakes of salt (Refs. 6

and 10). (See the discussion of the

exemption of chloride in § 101.3(e)(4)(ii)

in the final rule entitled ‘‘Food Labeling:

Reference Daily Intakes’’ published

elsewhere in this issue of the Federal

Register.) Lastly, as discussed earlier,

potassium would be considered a drug

at such high levels, so it should not be

included in dietary supplements at 100

percent of the DRV.

Therefore, FDA tentatively concludes

that there are 11 nutrients (calcium,

phosphorus, magnesium, dietary fiber,

total carbohydrate, total fat, saturated

fat, cholesterol, sodium, chloride, and

potassium) for which it would be

impracticable or imprudent to require

that, when present in a multinutrient

product, they be present at levels at or

above 100 percent of the RDI or DRV for

the product to qualify for the use of the

nutrient content claim ‘‘high potency.’’

This amounts to one-third of the

nutrients for which RDI’s and DRV’s

have been established (11 out of 33

nutrients). Accordingly, the agency

believes that it would be reasonable to

expect that the remaining two-thirds of

the nutrients for which RDI’s and DRV’s

have been established could be present

at 100 percent of the RDI or DRV in a

‘‘high potency’’ multinutrient dietary

supplement product that contained all

33 nutrients for which RDI’s and DRV’s

have been established.

FDA finds merit in the comment that

suggested that not all nutrients need be

present at or above the RDI for the

product to qualify for the claim. This

comment suggests that the agency

establish a standard for ‘‘high potency’’

that applies to supplements that do not

contain all of the 33 nutrients for which

RDI’s and DRV’s have been established

as well as those that do. FDA tentatively

concludes that two-thirds represents a

reasonable standard; it provides

flexibility for supplements that do not

contain all 33 nutrients, and it provides

a consistent standard for all supplement

products. Finally, it is a familiar fraction

that is easy to use. With a two-thirds

standard, the manufacturer would have

latitude to decide, in formulating a

product that will qualify to bear a ‘‘high

potency’’ claim, which nutrients to

include at 100 percent of the RDI or

DRV. The alternative would be to

require that any of the 22 nutrients that

can be present at 100 percent of the DRV

be present at that level if the

supplement is to bear a ‘‘high potency’’

claim. FDA is concerned, however, that

such a requirement would set too high

a standard and not provide appropriate

flexibility. Comment is requested on the

agency’s tentative conclusion.

Based on these factors, the agency is

proposing in § 101.54(f)(2) that the term

‘‘high potency’’ may be used on the

label or in the labeling of a dietary

supplement to describe the product

(e.g., ‘‘High potency multivitamin,

multimineral dietary supplement

tablets’’) if the product contains 100

percent or more of the RDI or DRV for

at least two-thirds of the vitamins,

minerals, protein, and dietary fiber

present in the product. This proposed

requirement will mean that each

nutrient (i.e., vitamin, mineral, protein,

or dietary fiber) in a dietary supplement

containing only one or two nutrients

will have to be present at 100 percent

or more of the RDI or DRV because twothirds of one or two nutrients does not

result in a whole number that is

different from the original number (e.g.,

2 times 2/3 equals 1.34; the product 1.34

indicates that more than one nutrient is

needed to meet the criterion; therefore

both nutrients would have to meet or

exceed 100 percent of the RDI or DRV).

The agency recognizes that dietary

supplements that consist of an

assortment of dietary ingredients are

widely available in the marketplace.

FDA agrees with the comment that

stated that the presence or absence of

dietary ingredients for which RDI’s or

DRV’s have not been established (e.g.,

omega-3 fatty acids, choline, boron)

(hereinafter referred to as ‘‘other dietary

ingredients’’) should not affect the claim

so long as those nutrients with RDI’s or

DRV’s are present at levels required for

the claim. The presence or absence of

other dietary ingredients for which

RDI’s and DRV’s have not been

established is immaterial to the claim,

and, therefore, the agency finds no basis

for proposing alternate requirements for

such products. It is important to note

that because the definition that FDA is

proposing is based on the presence of a

nutrient at 100 percent of the RDI or

DRV, dietary supplements that do not

contain nutrients for which RDI’s or

DRV’s have been established will not be

able to use the term ‘‘high potency.’’

c. Disclosure requirement. One

comment stated that the label of a ‘‘high

potency’’ multivitamin product should

disclose the names or number of

nutrients that are present at high levels.

For example, the comment suggested

that the label could carry an asterisk

next to the claim, with the following

disclosure: ‘‘contains high levels of

[number] vitamins.’’

The agency rejects this comment. The

agency tentatively concludes that such a

requirement for the label or labeling of

a ‘‘high potency’’ multinutrient dietary

supplement is not needed to prevent

consumers from being misled by the

claim. Section 403(s) of the act, added

by the DSHEA, states that a dietary
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67189

supplement is misbranded if its label or

labeling fails to list the quantity of each

dietary ingredient present. (See

implementing regulations proposed in a

companion document published

elsewhere in this issue of the Federal

Register entitled ‘‘Food Labeling;

Statement of Identity, Nutrition

Labeling and Ingredient Labeling of

Dietary Supplements.’’) In accordance

with the proposed and current nutrition

labeling regulations, information on

what, and how many, nutrients are

present at 100 percent or more of the

RDI or DRV can be readily determined

from the nutrition label.

In addition, it would be cumbersome

for a product containing 100 percent of

the RDI for several nutrients for which

RDI’s or DRV’s have been established to

list all of those nutrients on the

principal display panel. Many

comments to the agency’s proposals on

the labeling of dietary supplements have

addressed the lack of available space to

meet current labeling requirements on

multinutrient dietary supplement

products. Therefore, the agency

tentatively concludes that it is

unnecessary, and would be

impracticable, to require a list on the

principal display panel of the number or

names of all nutrients present at 100

percent or more of the RDI or DRV.

4. Synonyms

Although the agency asked for

specific comment on the term ‘‘high

potency,’’ several comments in response

to the nutrient content claims proposal

for dietary supplements used the term

‘‘full potency’’ in discussions. FDA

requests comment on whether the term

‘‘full potency’’ is generally viewed by

consumers as a synonym to ‘‘high

potency,’’ and if there are other terms

that appropriately can be defined as

synonymous with ‘‘high potency.’’ If

reasonable synonyms are suggested in

the comments, and the comments

establish that use of these terms will not

be misleading, the agency will consider

defining them as synonyms with ‘‘high

potency’’ in the final rule.

B. Nutrient Content Claims Using the

Term ‘‘Antioxidants’’

1. Background

One comment to the 1993 nutrient

content claims proposal (58 FR 33731)

stated that FDA failed to address

whether the currently used claim of

‘‘high in antioxidants’’ was within the

scope of the proposed regulation. The

agency stated in the 1994 nutrient

content claims final rule that while this

claim was not explicitly discussed in

the 1993 nutrient content claims

proposal. FDA considered it to be a

nutrient content claim (59 FR 378 at

389). One problem noted with the claim,

however, was that there is no

established definition of the term

‘‘antioxidants.’’

In an informal survey of dietary

supplement products sold in the

Washington, DC area, FDA found that

the claim ‘‘high in antioxidants’’ often

refers to a variety of nutrients and other

dietary ingredients that are present in

widely varying amounts (Ref. 9). This

inconsistent use of the claim can lead to

consumer confusion. To ensure that

consumers are not confused or misled,

Congress found in passing the 1990

amendments that it is appropriate for

FDA to establish specific definitions to

standardize the terms used by

manufacturers to describe the nutrient

content of foods. Accordingly, in this

document, FDA is proposing to define

‘‘antioxidants’’ so that it can be used in

a clear and consistent manner in

conjunction with currently defined

nutrient content claims such as ‘‘good

source,’’ ‘‘high,’’ and ‘‘more’’ and the

proposed ‘‘high potency’’ claim. The

agency is following up on the

commitment that it made in the 1994

nutrient content claims final rule to

propose to adopt a definition for the

term (59 FR 378 at 389).

The term ‘‘antioxidants’’ is unique in

comparison to the names of other

nutrients associated with nutrient

content claims. Unlike previously

approved nutrient content claims that

characterize the level of a particular

nutrient (e.g., ‘‘low sodium’’), a term

such as ‘‘high in antioxidants’’ ties a

claim (i.e., ‘‘high’’) to a class of nutrients

that share a specific characteristic (i.e.,

they are antioxidants) whose very name

indicates a metabolic function. Because

of this fact, it is important to make a

clear distinction between the term when

used as part of a nutrient content claim

and possible uses of the term as part of

a health claim or a statement of

nutritional support.

Nutrient content claims expressly or

implicitly characterize the level of a

nutrient in a food and are regulated

under § 101.13. Health claims are claims

that expressly or by implication

characterize the relationship of any

substance to a disease or health-related

condition. They are regulated under

§ 101.14. Moreover, statements of

nutritional support, authorized by

section 403(r)(6) of the act, which was

added by the DSHEA, encompass label

statements on dietary supplements that

claim a benefit related to a classical

nutrient deficiency disease, describe

how a nutrient or dietary ingredient

affects the structure or function in

humans, characterize the documented

mechanism by which a nutrient or

dietary ingredient acts to maintain the

structure or function, or describe

general well-being from consumption of

a nutrient or dietary ingredient.

In the case of a claim such as ‘‘high

in antioxidants,’’ a set of substances is

clearly identified (i.e., ‘‘antioxidants’’)

and a level of nutrients is stated (i.e.,

‘‘high’’), but there is no disease or

health-related condition stated or

implied, and the descriptive or

characterizing aspects of nutritional

support statements are not present.

Accordingly, such a term is properly

regulated as a nutrient content claim.

2. Express Versus Implied Nutrient

Content Claims

In the 1994 nutrient content claims

final rule, FDA stated that it considered

‘‘high in antioxidants’’ to be an implied

nutrient content claim that would come

under § 101.65 (59 FR 378 at 389).

However, after further consideration,

the agency tentatively concludes that

when the term ‘‘antioxidants’’ appears

in association with expressed nutrient

content claims (i.e., ‘‘good source,’’

‘‘high,’’ ‘‘more,’’ and the proposed ‘‘high

potency’’), the claim is more properly

classified as an expressed claim.

Therefore, the agency is defining the

term ‘‘antioxidants’’ in § 101.54 Nutrient

Content Claims for ‘‘Good Source,’’

‘‘High,’’ and ‘‘More.’’ This placement is

consistent with the manner in which

fiber claims (e.g., ‘‘high in fiber’’) are

regulated. (See § 101.54(d).)

Accordingly, the agency is proposing to

add paragraph (g) to § 101.54 to address

nutrient content claims using the term

‘‘antioxidants.’’

3. Definition of ‘‘Antioxidants’’

As stated, the agency is proposing to

define the term ‘‘antioxidants’’ for use

with nutrient content claims such as

‘‘good source,’’ ‘‘high,’’ and ‘‘more’’ that

are defined in § 101.54, and with the

proposed ‘‘high potency.’’ This task

entails determining which nutrients are

to be included within the coverage of

the term ‘‘antioxidants.’’

In a previous rulemaking, FDA has

reviewed the characteristics of three

vitamins that function as antioxidants.

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

amendments directed the agency to

address the relationship between

antioxidant vitamins and cancer. In its

proposed regulations to implement the

1990 amendments, FDA considered the

effects of vitamin C, vitamin E, and betacarotene on cancer (56 FR 60624,

November 27, 1991). In that document,

FDA summarized the antioxidant

properties of those nutrients.
67190 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

FDA stated that vitamin C serves as an

effective free-radical scavenger to

protect cells from damage by reactive

oxygen molecules (a free-radical being

an atom containing an unpaired electron

which tends to give the atom more

reactivity, often leading to a prooxidative chain reaction which can

damage cells). The basic biological

function of vitamin E was found to be

as an antioxidant where it acts as a

defense against potentially harmful

reactions with oxygen by deactivation of

the free-radicals. In the case of betacarotene, the agency stated that it was

chosen because it is an antioxidant, and,

although it is not recognized as a

vitamin itself, it is a provitamin and

makes important contributions to the

vitamin A activity of most diets. Betacarotene acts by trapping, deactivating,

and destroying reactive oxygen

molecules and preventing the damage

that they can cause. FDA did not

include vitamin A (retinol) and retinoic

acid in its consideration because their

biological functions are not achieved

through an antioxidant role, and

because vitamin A cannot function in a

fashion similar to that of beta carotene

(carotenoids) and vitamins C and E

(Refs. 11 and 12).

In the final rule on antioxidant

vitamins and cancer, FDA concluded

that this selection of nutrients was

appropriate (58 FR 2622, January 6,

1993).

In addition, a recent conference

entitled ‘‘Antioxidant Vitamins and

Cancer and Cardiovascular Disease,’’

initiated by FDA, supported this

conclusion and affirmed that the

biological role of other vitamins as

direct antioxidants remains

unsubstantiated (Ref. 13). Riboflavin

and niacin, two of the B-vitamins, are

precursors of coenzymes that are

involved in large numbers of oxidation

and reduction reactions. By themselves,

however, these vitamins do not have

direct antioxidant activities. Moreover,

after conversion to their coenzyme

forms, they have indirect effects that are

both antioxidant and pro-oxidative in

character (Refs. 14 and 15). When prooxidative conditions (i.e., the opposite

of antioxidative) predominate, oxidative

damage occurs to cells, lipids, proteins,

and carbohydrates (Ref. 16). Thus, FDA

tentatively concludes that these

nutrients should not be classed as

antioxidants.

As stated earlier, the 1990

amendments specifically required that

the agency evaluate the relationship of

antioxidant vitamins to cancer.

Antioxidant minerals were not

mentioned in the statute and were not

considered by the agency. However, in

this rulemaking to define ‘‘antioxidants’’

for use in nutrient content claims, FDA

is not restricted in the nutrients that are

to be encompassed by this term. Based

on its informal survey, the agency notes

that some dietary supplements,

including both single nutrient and

multinutrient products, use the term

‘‘antioxidant’’ on their label and in

labeling to describe minerals such as

copper, zinc, manganese, iron, and

selenium (Ref. 9). Accordingly, FDA has

reviewed the literature on the biological

activities of these minerals.

As a result of its review, the agency

tentatively concludes that there is no

evidence that these substances have

direct antioxidant properties, and that,

in fact, some of them are pro-oxidative

at certain levels. For example, copper,

manganese, and zinc activate specific

forms of the enzyme superoxide

dismutase (SOD) which acts to remove

the superoxide radical, and thus these

minerals have indirect antioxidant

effects (Refs. 17, 18, and 19). However,

copper and manganese, in their free

forms, are effective catalysts for

oxidation reactions (i.e., pro-oxidants).

Their role as an indirect antioxidant

would be expected to predominate only

at intakes at or below the quantities

needed to saturate SOD. Higher intakes

would be expected to have prooxidative effects (Refs. 17 and 18). Zinc

does not have direct antioxidant or

oxidant effects. It activates one form of

SOD and thus has only indirect

antioxidant activity (Ref. 19). Iron,

another mineral, is an activator of

catalase, which destroys peroxides, and

thus has indirect antioxidant effects,

but, again, iron itself catalyzes oxidative

reactions (Ref. 20). Selenium is required

for the activity of the enzyme

glutathione peroxidase and thus has

indirect antioxidant effects (Ref. 21).

The agency’s tentative view is that it

is appropriate to identify only those

nutrients having a clear, direct

antioxidant function in defining the

coverage of the term ‘‘antioxidants.’’

Because none of the minerals discussed

above function directly as antioxidants,

the agency tentatively concludes that

they should not be included in the

definition of the term ‘‘antioxidants’’ for

purposes of making a nutrient content

claim. Accordingly, FDA is proposing in

§ 101.54(g)(1), in part, that

‘‘antioxidants’’ be defined as a collective

term inclusive of vitamin C, vitamin E,

and beta-carotene when used as a part

of nutrient content claims (e.g., ‘‘good

source of antioxidants,’’ ‘‘high in

antioxidants’’) that describe food

products. FDA also provides in the

proposed regulation that the food must

contain the requisite amounts of each of

the three nutrients to qualify to bear the

claim (e.g., for ‘‘high in antioxidants,’’

the product must contain 20 percent or

more of the RDI for vitamin C and

vitamin E per reference amount

customarily consumed, and 20 percent

or more of the RDI for vitamin A must

be present as beta-carotene per reference

amount customarily consumed).

Because there is a recent history of

use of nutrient content claims for

‘‘antioxidants’’ on both dietary

supplements and conventional foods,

the agency is proposing in § 101.54(g)(1)

that such claims be allowed on both

types of foods. It should be noted,

however, that because the agency is

proposing in this document that the

term ‘‘high potency’’ be limited to

dietary supplements, the term ‘‘high

potency antioxidants’’ could be used

only on dietary supplements.

FDA notes that some herbs and other

dietary ingredients use the term

‘‘antioxidants’’ in association with a

nutrient content claim (e.g., ‘‘raspberry

leaf—high in antioxidants’’). The agency

advises that the regulations being

proposed would not permit such

nutrient content claims unless the

product contains the nutrients

identified in the proposed definition of

‘‘antioxidants.’’

4. Beta-carotene

Nutrient content claims are

authorized for nutrients for which there

are RDI’s or DRV’s. This approach has

the advantage of linking nutrient

content claims to established reference

values, thereby providing a consistent

and quantitative basis for defining

terms. As a pro-vitamin, beta-carotene

does not have an RDI or DRV. However,

FDA stated in the final rule on nutrient

content claims for dietary supplements

that claims regarding beta-carotene (e.g.,

‘‘contains beta-carotene’’) are claims

that make implied representations about

the level of vitamin A that is present in

the food as beta-carotene (59 FR 378 at

384). Accordingly, the agency stated

that it considers that the claim

‘‘contains beta-carotene’’ implies that

there is enough beta-carotene in the

food for the food to qualify as a ‘‘good

source’’ of vitamin A (i.e., it contains 10

percent or more of the DV for vitamin

A from beta-carotene) (59 FR 378 at

384). Such a claim is provided for in

§ 101.65(c).

The agency tentatively concludes that

this standard should also apply to betacarotene when it, either by itself or in

association with other antioxidants, is

the subject of an ‘‘antioxidant’’ claim.

This standard allows beta-carotene to be

tied to vitamin A, a nutrient with an

RDI, as an implied claim, thereby
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67191

permitting nutrient content claims to be

made about this substance. Therefore,

proposed § 101.54(g)(1) includes a

requirement that vitamin A present as

beta-carotene be present at a sufficient

level to qualify for the claim (e.g., for

‘‘high in antioxidants,’’ 20 percent or

more of the DV for vitamin A must be

present as beta-carotene; for ‘‘high

potency antioxidant,’’ 100 percent or

more of the DV for vitamin A must be

present as beta-carotene).

FDA acknowledges that the

antioxidant role of beta-carotene was

not taken into account by the NAS in

setting the RDA’s for vitamin A (Ref. 6).

Therefore, there is no reason to believe

that the amount of beta-carotene

potentially useful as an antioxidant is

related to the RDI for vitamin A.

However, the agency tentatively

concludes that the above approach is a

practical means of quantifying the level

of beta-carotene that must be present for

a food to qualify to bear an antioxidant

nutrient content claim.

5. Disclosure Requirement

FDA is aware of the availability of

products that do not contain all three of

the nutrients included in the proposed

definition of ‘‘antioxidants’’ (i.e.,

vitamin C, vitamin E, and beta-carotene)

yet that highlight the antioxidant

properties of a particular nutrient (e.g.,

‘‘Contains antioxidant vitamin E’’) on

the label or in labeling. FDA tentatively

concludes that it is appropriate to allow

products to bear such claims because

the antioxidant properties of each

nutrient are significant enough to

highlight. However, the agency finds

that when a food makes a claim for

‘‘antioxidants’’ yet fails to contain all

three nutrients, the disclosure of the

specific antioxidant nutrients that are

present in the product is necessary to

ensure that consumers are not misled

into thinking that the product contains

all three nutrients. Such a disclosure is

necessary to reveal a fact that is material

in light of the antioxidant claim (section

201(n) of the act), that is, to disclose

which nutrients with antioxidant effects

are present in the product at the

highlighted level.

Accordingly, the agency is proposing

in § 101.54(g)(2) that when a nutrient

content claim using the term

‘‘antioxidant’’ is included on the label

or in labeling of a product that does not

contain all three antioxidants at the

required levels, the claim may only be

used on the label or in labeling when

the food contains at least one of the

nutrients at the requisite level, and the

label or labeling discloses the

antioxidants contained in the product in

sufficient amounts to qualify for the

claim (e.g., ‘‘High in antioxidant

vitamins C and E’’).

6. Collective Claims

Collective claims such as ‘‘complete

antioxidant complex’’ and ‘‘antioxidant

formula’’ seem to convey that the

product contains each antioxidant.

Because FDA has identified three

vitamins with direct antioxidant

activity, it is reasonable to expect that

a dietary supplement or conventional

food making such a collective claim

about antioxidants will contain each of

these vitamins. Further, such claims

imply that each nutrient is present at a

level sufficient to make a significant

contribution to the total daily diet, or at

a minimum, is a ‘‘good source’’ of each

nutrient.

Therefore, FDA tentatively concludes

that collective claims about

antioxidants, such as ‘‘complete

antioxidant complex’’ or ‘‘antioxidant

formula’’ state that the labeled product

contains 10 percent or more of the RDI

of vitamin C and vitamin E, and that 10

percent or more of the RDI for vitamin

A is present as beta-carotene.

Accordingly, FDA is proposing to add

§ 101.54(g)(3) to provide for the use,

under section 403(r)(2)(A)(i) of the act,

of such collective antioxidant terms

(e.g., ‘‘complete antioxidant formula,’’

‘‘antioxidant complex’’) as nutrient

content claims provided that vitamin C

and vitamin E are present at 10 percent

or more of the RDI per reference amount

customarily consumed, and that 10

percent or more of the RDI for vitamin

A is present as beta-carotene per

reference amount customarily

consumed when such a term is used.

This definition, if adopted, would not

preclude the presence of other nutrients

(e.g., selenium and zinc) in the product,

nor would this definition preclude

manufacturers from making other

nutrient content claims that characterize

the level of other nutrients that have

RDI’s or DRV’s. Further, manufacturers

may also describe the nutritional

properties of other ingredients as long as

the statements are not false or

misleading or do not constitute

unauthorized health claims or

unapproved drug claims.

C. Limitation of ‘‘High Potency’’ and

Nutrient Content Claims Using the Term

‘‘Antioxidant’’ on Products for Infants

and Toddlers

The agency points out that

§ 101.13(b)(3) states that except for

percentage claims regarding vitamins

and minerals described in

§ 101.13(q)(3), no nutrient content

claims may be made on food intended

specifically for use by infants and

children less than 2 years of age unless

the claim is specifically provided for in

parts 101, 105, or 107 (21 CFR parts 105

and 107).

The agency sees no reason why an

exception should be made to extend the

use of the terms discussed in this

rulemaking to products for infants and

toddlers. FDA is not aware of any

evidence that the intake of dietary

supplements at ‘‘high potency’’ levels,

or that an increased intake of

antioxidants, are appropriate for infants

and toddlers. Relatively little attention

has been given to the role of the diet of

children less than 2 years of age in

modifying the risk of chronic diseases,

such as hypertension and cancer, found

in adults (Refs. 10 and 22). Thus, FDA

is not aware of any basis on which to

conclude that these claims would be

useful to the parents of young children.

In fact, such terms would be misleading

on foods for infants and toddlers

because they imply benefits that have

not been demonstrated.

In addition, the definitions of nutrient

content claims for both ‘‘high potency’’

and for the several possible levels of

‘‘antioxidants’’ (e.g., ‘‘good source,’’

‘‘high,’’ and ‘‘more’’) are dependent

upon calculation of the percent of the

RDI for the appropriate nutrient present

in the product. However, no RDI’s are

currently established for infants and

children less than 2 years of age. The

agency has stated that it intends to

address the issue of RDI’s for infants,

children less than 4 years, and pregnant

and lactating women in future

rulemaking (59 FR 427 at 430, January

4, 1994), and it reiterates that intention

in the final rule on RDI’s published

elsewhere in this issue of the Federal

Register. However, until it establishes

these levels, there is no basis on which

to define these terms for use on foods

intended for infants and children less

than 2 years of age.

D. Amendment to § 101.60 Concerning

Nutrient Content Claims for the Calorie

Content of Foods for Dietary

Supplements

Section 101.60(c)(1) states that

consumers may reasonably be expected

to regard terms that represent that the

food contains no sugars or sweeteners as

an indication that a product is low in

calories or is significantly reduced in

calories. This section also states that a

food cannot be labeled ‘‘sugar free’’ or

‘‘no sugar’’ unless it meets the following

conditions: (1) The food contains less

than 0.5 gram (g) of sugars per reference

amount and per labeled serving, (2) the

food contains no ingredient that is a

sugar or that is generally understood by

consumers to contain sugars unless the
67192 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

listing of the ingredient in the

ingredient statement is followed by an

asterisk that refers to a statement below

the list of ingredients such as ‘‘adds a

negligible amount of sugar,’’ and (3) it

is labeled ‘‘low calorie’’ or ‘‘reduced

calorie’’ or bears a relative claim of

special dietary usefulness, or is labeled

‘‘not a reduced calorie food,’’ ‘‘not a low

calorie food,’’ or ‘‘not for weight

control.’’

In the 1994 nutrient content claims

final rule, FDA added paragraph

§ 101.60(a)(4) to state that ‘‘calorie free’’

and ‘‘low calorie’’ claims may not be

made on dietary supplement products,

except when an equivalent amount of a

dietary supplement that the labeled food

resembles and for which it substitutes

(e.g., another protein supplement),

normally exceeds the definition for

‘‘low calorie’’ in § 101.60(b)(2). The

agency also similarly revised

§ 101.13(b)(5). This change in

§§ 101.13(b)(5) and 101.60(a)(4) had the

unintended effect of limiting the use of

‘‘sugar free’’ or ‘‘no sugar’’ claims on

dietary supplements that would

otherwise meet the requirements for

‘‘low calorie’’ in § 101.60(b)(2) but are

not permitted to bear the claim because

they do not substitute for a similar

dietary supplement that normally

exceeds the definition for ‘‘low calorie.’’

In the 1994 nutrient content claims

final rule, FDA had found that, because

the level of sugars in dietary

supplements can vary substantially,

claims about the sugars content of

dietary supplements may be useful in

helping consumers make purchasing

decisions that will assist them in

maintaining healthy dietary practices

(59 FR 378 at 382). Thus, the agency

concluded that extending the

definitions of ‘‘sugar free’’ and ‘‘reduced

sugar’’ to dietary supplements was

appropriate irrespective of the calorie

level of the dietary supplement.

Therefore, FDA did not modify the

requirements governing claims for

sugars in § 101.60(c) for dietary

supplements. In not making a change to

§ 101.60(c), however, FDA overlooked

the impact of new §§ 101.13(b)(5) and

101.60(a)(4).

In order to allow for ‘‘sugar free’’ or

‘‘no sugar’’ claims on dietary

supplements that meet the other criteria

for the claim (i.e., contain less than 0.5

g of sugars per reference amount and

contain no ingredient that is a sugar or

that is generally understood by

consumers to contain sugars unless an

appropriate statement is added after the

ingredient list), the requirement that the

product be labeled ‘‘low calorie’’ should

have been modified for dietary

supplements that were prohibited from

making ‘‘low calorie’’ claims because no

other dietary supplement that the

labeled food resembles and for which it

substitutes exceeded the definition for

‘‘low calorie.’’ FDA is proposing to

make that change now. No modification

is needed for dietary supplements

labeled ‘‘reduced calorie’’ since that

claim was not changed by the final rules

on nutrient content claims for dietary

supplements or for those dietary

supplements that are not low or reduced

in calories.

The agency is not aware of any reason

why its position in § 101.60(c)(1) that

consumers may be expected to regard

‘‘sugar free’’ and ‘‘no sugar’’ claims as

indicative of a product that is low or

reduced in calories should be different

for dietary supplements than for

conventional foods. Therefore, FDA is

proposing to revise § 101.60(c)(1)(iii)(A)

to excuse only dietary supplements that

otherwise meet the definition of ‘‘low

calorie’’ under § 101.60(b)(2) but that are

prohibited by §§ 101.13(b)(5) and

101.60(a)(4) from bearing the claim.

IV. Effective Date

FDA is proposing an effective date of

January 1, 1997. This date is consistent

with the effective date proposed in two

companion proposals published

elsewhere in this issue of the Federal

Register entitled ‘‘Food Labeling;

Statement of Identity, Nutrition

Labeling and Ingredient Labeling of

Dietary Supplements’’ and ‘‘Food

Labeling; Requirements for Nutrient

Content Claims, Health Claims, and

Statements of Nutritional Support for

Dietary Supplements.’’ This date will

allow firms to make all label changes

associated with the DSHEA and with

the two companion proposals at the

same time.

V. Economic Impact

FDA has examined the economic

implications of the proposed rule

amending 21 CFR as required by

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 which maximize

net benefits (including potential

economic, environmental, public health

and safety effects; distributive impacts;

and equity). The Regulatory Flexibility

Act requires analyzing options for

regulatory relief for small businesses.

FDA finds that this proposed rule is not

a significant rule as defined by

Executive Order 12866. In accordance

with the Regulatory Flexibility Act, the

agency certifies that the proposed rule

will not have a significant impact on a

substantial number of small businesses.

Many currently marketed foods and

dietary supplements use the terms ‘‘high

potency’’ and ‘‘high in antioxidants’’ to

describe the level of nutrients in the

products. Without definitions for these

terms, manufacturers will not be able to

continue to use them. This proposed

rule will require that any manufacturer

currently using the terms ‘‘high

potency’’ or ‘‘antioxidant’’ bear the costs

of removing such statements from their

labels only if the products do not meet

the proposed definition. FDA does not

believe that the number of products that

would not meet the proposed definition

is high.

VI. 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 define

the term ‘‘high potency’’ as a nutrient

content claim for dietary supplements,

to define the term ‘‘antioxidant’’ for use

in nutrient content claims for dietary

supplements, and to correct an omission

pertaining to the use of ‘‘sugar free’’

claims on dietary supplements imposes

any paperwork burden.

VII. Environmental Impact

The agency has determined under 21

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

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VIII. 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.

IX. References

The following references have been

placed on file in the Dockets

Management Branch (address above)

and may be seen by interested persons
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67193

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

through Friday.

1. Committee on the Nutrition Components

of Food Labeling, Food and Nutrition Board,

Institute of Medicine, National Academy of

Sciences, ‘‘Nutrition Labeling, Issues and

Directions for the 1990’s,’’ Washington, DC,

National Academy Press, 1990.

2. Park, Y. K., I. Kim, and E. A. Yetley,

‘‘Characteristics of Vitamin and Mineral

Supplement Products in the United States,’’

American Journal of Clinical Nutrition,

54:750–759, 1991.

3. Moss, A. J., A. S. Levy, I. Kim, and Y.

Park, ‘‘Use of Vitamin and Mineral

Supplements in the United States, Current

Users, Types of Products and Nutrients,

Advance Data from Vital and Health

Statistics of the National Center for Health

Statistics,’’ No. 174, July 18, 1989.

4. Bender, M. M., A. S. Levy, R. E.

Schucker, and E. A. Yetley, ‘‘Trends in

Prevalence and Magnitude of Vitamin and

Mineral Supplement Usage and Correlation

with Health Status,’’ Journal of the American

Dietetic Association, 92:1096–1101, 1992.

5. Levy, A. S. and R. E. Schucker, ‘‘Patterns

of Nutrient Intake Among Dietary

Supplement Users: Attitudinal and

Behavioral Correlates,’’ Journal of the

American Dietetic Association, 87:754–760,

1987.

6. Subcommittee on the 10th Edition of the

Recommended Dietary Allowances, Food and

Nutrition Board, Commission on Life

Sciences, National Research Council,

‘‘Recommended Dietary Allowances, 10th

ed.,’’ Washington, DC, National Academy

Press, 1989.

7. Food and Nutrition Board, Institute of

Medicine, National Academy of Sciences,

‘‘How Should the Recommended Dietary

Allowances Be Revised,’’ Washington, DC,

National Academy Press, 1994.

8. U.S. Department of Agriculture and U.S.

Department of Health and Human Services,

‘‘Nutrition and Your Health, Dietary

Guidelines for Americans,’’ Washington, DC,

Home and Garden Bulletin, 3d ed., U.S.

Government Printing Office, 1990.

9. Memorandum from C. E. Brewer, FDA,

to file, nutrient content of multinutrient

products, March 28, 1994.

10. Committee on Diet and Health, Food

and Nutrition Board, Commission on Life

Sciences, National Research Council,

National Academy of Sciences, ‘‘Diet and

Health, Implications for Reducing Chronic

Disease Risk,’’ National Academy Press,

Washington, DC, 1989.

11. Merrill, A. H., Jr., A. Foltz, D. B.

McCormick, ‘‘Vitamins and Cancer,’’ edited

by Alfin-Slater, R. B., and D. Kritchevsky,

Cancer and Nutrition, pp. 261–320, Plenum

Press, New York, 1991.

12. Olson, J. A., ‘‘Vitamin A, Retinoids, and

Carotenoids,’’ edited by Shils, M. E., J. A.

Olson, and M. Shike, Modern Nutrition in

Health and Disease, pp. 287–307, Lea &

Febiger, Philadelphia, 1994.

13. Transcript to Docket 93N–0389 for

FDA-initiated public conference on

antioxidant vitamins and cancer and

cardiovascular disease, November, 1993.

14. McCormick, D. B., ‘‘Riboflavin,’’ edited

by Shils, M. E., J. A. Olson, and M. Shike,

Modern Nutrition in Health and Disease, pp.

367–375, Lea & Febiger, Philadelphia, 1994.

15. Swendseid, M. E., and R. A. Jacob,

‘‘Niacin,’’ edited by Shils, M. E., J. A. Olson,

and M. Shike, Modern Nutrition in Health

and Disease, pp. 376–382, Lea & Febiger,

Philadelphia, 1994.

16. Thomas, J. A. ‘‘Oxidative Stress,

Oxidant Defense, and Dietary Constituents,’’

edited by Shils, M. E., J. A. Olson, and M.

Shike, Modern Nutrition in Health and

Disease, pp. 501–512, Lea & Febiger,

Philadelphia, 1994.

17. Turnland, J. R., ‘‘Copper,’’ edited by

Shils, M. E., J. A. Olson, and M. Shike,

Modern Nutrition in Health and Disease, pp.

231–241, Lea & Febiger, Philadelphia, 1994.

18. Nielsen, F. H., ‘‘Ultratrace Elements,’’

edited by Shils, M. E., J. A. Olson, and M.

Shike, Modern Nutrition in Health and

Disease, pp. 269–286, Lea & Febiger,

Philadelphia, 1994.

19. King, J. C., and C. L. Keen, ‘‘Zinc,’’

edited by Shils, M. E., J. A. Olson, and M.

Shike, Modern Nutrition in Health and

Disease, pp. 214–230, Lea & Febiger,

Philadelphia, 1994.

20. Fairbanks, V. F., ‘‘Iron in Medicine and

Nutrition,’’ edited by Shils, M. E., J. A. Olson,

and M. Shike, Modern Nutrition in Health

and Disease, pp. 185–213, Lea & Febiger,

Philadelphia, 1994.

21. Levander, O. A., and R. F. Burk,

‘‘Selenium,’’ edited by Shils, M. E., J. A.

Olson, and M. Shike, Modern Nutrition in

Health and Disease, pp. 242–251, Lea &

Febiger, Philadelphia, 1994.

22. U.S. Department of Health and Human

Services, ‘‘The Surgeon General’s Report on

Nutrition and Health,’’ DHHS (Public Health

Service) Publication No. 88–50210

(Government Printing Office Stock No. 017–

001–00465–1), U.S. Government Printing

Office, Washington, DC, 1988.

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, 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 is amended by

adding new paragraph (b)(6) to read as

follows:

§ 101.13 Nutrient content claims—general

principles.

* * * * *

(b) * * *

(6) The term ‘‘high potency’’ may only

be used on the labels or in the labeling

of dietary supplements as defined by

section 201(ff) of the Federal Food,

Drug, and Cosmetic Act.

* * * * *

3. Section 101.54 is amended by

revising the section heading and adding

new paragraphs (f) and (g) to read as

follows:

§ 101.54 Nutrient content claims for ‘‘good

source,’’ ‘‘high,’’ ‘‘more,’’ and ‘‘high

potency.’’

* * * * *

(f) ‘‘High potency’’ claims. (1) The

term ‘‘high potency’’ may be used on the

label or in the labeling of dietary

supplements to describe a nutrient that

is present at 100 percent or more of the

RDI for vitamins and minerals or of the

DRV for protein and dietary fiber per

reference amount customarily

consumed.

(2) The term ‘‘high potency’’ may be

used on the label or in the labeling of

dietary supplements to describe a

product that contains 100 percent or

more of the RDI, or of the DRV, for at

least two-thirds of the vitamins and

minerals, and of the protein and dietary

fiber, present in the product (e.g., ‘‘High

potency multivitamin, multimineral

dietary supplement tablets’’).

(g) ‘‘Antioxidants’’ claims. (1) The

term ‘‘antioxidants’’ is defined as a

collective term inclusive of vitamin C,

vitamin E, and the provitamin betacarotene when used as part of a nutrient

content claim (e.g., ‘‘good source of

antioxidants,’’ ‘‘high in antioxidants’’)

on labels or in labeling of conventional

foods or dietary supplements. The levels

of vitamin C and vitamin E and the level

of vitamin A present as beta-carotene in

the food that bears the claim all must be

sufficient to qualify for the claim (i.e.,

for ‘‘high in antioxidants,’’ the product

must contain 20 percent or more of the

RDI for vitamin C and vitamin E per

reference amount customarily

consumed and 20 percent or more of the

RDI for vitamin A must be present as

beta-carotene per reference amount

customarily consumed).

(2) The term ‘‘antioxidants’’ may only

be used on the label or in labeling of a

food that does not contain each of the

three antioxidants (i.e., vitamin C,

vitamin E, and beta-carotene) in

sufficient amounts to qualify for the

claim if the food contains at least one of

these nutrients at the requisite level,

and the claim discloses which

antioxidants in the food meet the

required level (e.g., ‘‘High in antioxidant

vitamins C and E’’).

(3) A collective claim about

antioxidant nutrients (e.g., ‘‘complete

antioxidant formula,’’ ‘‘antioxidant

complex’’) may be used on the label or

in labeling of foods provided that
67194 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

vitamin C and vitamin E are present at

10 percent or more of the RDI per

reference amount customarily

consumed, and that 10 percent or more

of the RDI for vitamin A is present as

beta-carotene per reference amount

customarily consumed.

4. Section 101.60 is amended by

revising paragraph (c)(1)(iii)(A) to read

as follows:

§ 101.60 Nutrient content claims for the

calorie content of foods.

* * * * *

(c) * * *

(1) * * *

(iii)(A) It is labeled ‘‘low calorie’’ or

‘‘reduced calorie’’ or bears a relative

claim of special dietary usefulness

labeled in compliance with paragraphs

(b)(2), (b)(3), (b)(4), or (b)(5) of this

section, or, if a dietary supplement, it

meets the definition in paragraph (b)(2)

of this section for ‘‘low calorie’’ but is

prohibited by §§ 101.13(b)(5) and

101.60(a)(4) from bearing the claim; or

* * * * *

Dated: December 18, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31194 Filed 12–27–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95N–0245]

RIN 0910–AA59

Food Labeling; Statement of Identity,

Nutrition Labeling and Ingredient

Labeling of Dietary Supplements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its food labeling regulations to

require that dietary supplements be

identified with the statement of identity

‘‘Dietary Supplement’’ on the principal

display panel of the label and modify

the nutrition labeling and ingredient

labeling requirements for these foods.

FDA is proposing these actions in

response to the Dietary Supplement

Health and Education Act of 1994 (the

DSHEA). FDA is also responding to a

citizen petition on type size

requirements for these products.

DATES: Written comments by March 13,

1996; except that comments regarding

information collection should be

submitted by January 29, 1996, but not

later than February 26, 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.

Written comments regarding paperwork

burden estimates should be sent to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Building, rm. 10235, Washington, DC

20503, ATTN: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Susan Thompson, Center for Food

Safety and Applied Nutrition (HFS–

165), Food and Drug Administration,

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

202–205–5587.

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). This

new law amended the Federal Food,

Drug, and Cosmetic Act (the act) in a

number of important ways. One of the

notable aspects of the 1990 amendments

is that they added section 403(q) to the

act (21 U.S.C. 343(q)). This section

provided that most foods are

misbranded unless they bear nutrition

labeling.

In particular, section 403(q)(5)(F) of

the act (originally section 403(q)(5)(E))

provided that if a food to which section

411 of the act (21 U.S.C. 350) applies

(i.e., a dietary supplement of vitamins or

minerals) contained any of the nutrients

required to be listed in nutrition

labeling, ‘‘the label or labeling of such

food shall comply with requirements of

subparagraphs (1) and (2) [of section

403(q) of the act] in a manner which is

appropriate for such food and which is

specified in regulations of the

Secretary.’’

In response to this provision of the

1990 amendments, FDA published a

proposal on nutrition labeling in the

Federal Register of November 27, 1991

(56 FR 60366 at 60393). The document

proposed, among other things, specific

nutrition labeling requirements for

dietary supplements of vitamins or

minerals (proposed § 101.36) and to

require that dietary supplements of

herbs or other similar nutritional

substances comply with the general

regulation on nutrition labeling (§ 101.9)

(21 CFR 101.9).

On October 6, 1992, the President

signed into law the Dietary Supplement

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

571). In section 202(a)(1) (21 U.S.C. 343

note), the DS act established a

moratorium until December 15, 1993, on

the implementation of the 1990

amendments with respect to dietary

supplements not in the form of

conventional food. 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 (58 FR 2079), FDA published a

final rule on the nutrition labeling of

food in conventional food form

(§ 101.9). Because of the DS act,

however, this final rule did not cover

the nutrition labeling of dietary

supplements.

In the Federal Register of June 18,

1993 (58 FR 33715), FDA published a

new proposed rule on the nutrition

labeling of dietary supplements, as

required by the DS act. FDA received

over 400 responses to that proposed

rule. In the Federal Register of January

4, 1994 (59 FR 354), FDA published a

final rule (hereinafter referred to as ‘‘the

1994 dietary supplement final rule’’)

based on the June 1993 proposed rule.

Consistent with section 403(q)(5)(F) of

the act, the 1994 dietary supplement

final rule included separate nutrition

labeling requirements for dietary

supplements of vitamins or minerals,

which are set out in § 101.36, and for

dietary supplements of herbs and other

nutritional substances, which the

agency said were subject to § 101.9.

In the Federal Register of January 4,

1994 (59 FR 427), the agency proposed

to expand the list of nutrients for which

there are Reference Daily Intake (RDI)

values in § 101.9(c)(8)(iv) to include

vitamin K, selenium, chloride,

manganese, fluoride, chromium, and

molybdenum. The final rule based on

that proposed rule is published

elsewhere in this issue of the Federal

Register.

On October 25, 1994, the DSHEA

(Pub. L. 103–417) was signed into law.

The DSHEA, among other things,

amended the act by adding section

201(ff) (21 U.S.C. 321(ff)), which defines

a ‘‘dietary supplement,’’ in part, as a

product, other than tobacco, intended to

supplement the diet that contains at

least one or more of the following

ingredients: A vitamin; a mineral; an

herb or other botanical; an amino acid;

a dietary substance for use to

supplement the diet by increasing the

total dietary intake; or a concentrate,

metabolite, constituent, extract, or