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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67195

combination of any of the previously

mentioned ingredients (section

201(ff)(1) of the act). These ingredients

are referred to in the provisions added

to the act by the DSHEA, and in this

document, as ‘‘dietary ingredients.’’

Additionally, the DSHEA amended

section 403(q)(5)(F) of the act. While

this section continues to provide that

dietary supplement products shall

comply with section 403 (q)(1) and

(q)(2) of the act and provide nutrition

labeling, it has been changed in a

number of significant ways. First, it no

longer distinguishes between

supplements of vitamins and minerals

and other dietary supplements. Second,

it now contains specific provisions on:

(1) The order in which dietary

ingredients are to be listed in the

nutrition information, (2) the listing of

the quantity of each dietary ingredient,

(3) the optional listing of the source of

a dietary ingredient within the nutrition

label, and (4) the listing of the other

ingredients of the dietary supplement.

Given these changes in the law that

requires that dietary supplements be

nutrition labeled, changes in the

regulations that FDA adopted to

implement the 1990 amendments for

dietary supplements are also necessary.

In this document, the agency is

proposing changes in its regulations that

are necessary to reflect the changes that

were enacted as part of the DSHEA.

FDA’s regulations were scheduled to go

into effect on July 1, 1995. Given the

need for these revisions, however, the

agency has published notice of its

intention not to enforce the regulations

until after it has conformed its labeling

regulations to the DSHEA, and industry

has had an opportunity to relabel their

products; that is, until after December

31, 1996 (60 FR 7711, February 9, 1995).

In this preamble, the agency will

explain the proposed revisions to

§ 101.36 (21 CFR 101.36) and state

which provisions of that regulation it is

not proposing to change. The latter

provisions will be discussed only to the

extent necessary to understand how the

revised provisions fit in the overall

scheme on the nutrition labeling of

dietary supplements. The agency seeks

comments on the proposed changes to

implement the DSHEA with respect to

nutrition labeling. Although the

codified section will be reproduced in

its entirety, the agency urges those who

comment to focus on the provisions in

which changes are being proposed.

Cooperation in this respect will hasten

the publication of the final rule and thus

maximize the time that industry will

have to plan changes in its labeling.

II. The Term ‘‘Dietary Supplement’’ in

the Statement of Identity

The DSHEA definition of ‘‘dietary

supplement’’ provides, in part (section

201(ff)(2)(C) of the act), that such a

product must be labeled as a dietary

supplement. In addition, the DSHEA

amended section 403 of the act by

adding a new paragraph (s)(2)(B), which

states that a food shall be deemed to be

misbranded if it is a dietary supplement,

and the label or labeling of the dietary

supplement fails to identify the product

by using the term ‘‘dietary supplement,’’

which term may be modified with the

name of such an ingredient.

Thus, the label of a dietary

supplement clearly must bear the term

‘‘dietary supplement.’’ However, no

provision of the DSHEA explicitly

addresses where on the food label

identification with this term must

appear. The Statement of Agreement on

the bill that ultimately became the

DSHEA states clearly that there is no

legislative history for the DSHEA other

than that agreement, and the agreement

is silent with respect to where this term

must appear (140 Congressional Record

S14801 (October 7, 1994)).

It is a general rule of statutory

construction that the act must be read as

a whole. Thus, section 403(s)(2)(B) of

the act, which states that the term must

‘‘identify the product,’’ must be read in

conjunction with the other provisions of

the act that address how food products

are to be identified. These provisions,

which have been in effect for many

years, are section 403 (g)(2) and (i)(1) of

the act. Section 403(g)(2) of the act,

which pertains to a food for which a

definition and standard of identity have

been prescribed by regulation, provides

that the food label must bear the name

of the food specified in the definition

and standard. Section 403(i)(1) of the

act, which pertains to all other foods,

provides that the food label must bear

the common or usual name of the food,

if any exists. Dietary supplements are

labeled subject to the provisions of

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

FDA has implemented section

403(g)(2) and (i)(1) of the act by

adopting § 101.3 (21 CFR 101.3) on the

identity of food in packaged form. This

regulation states that the principal

display panel of a food shall bear as one

of its principal features a statement of

the identity of the commodity

(§ 101.3(a)). The regulation goes on in

§ 101.3(b) to state that the statement of

identity shall be in terms of: (1) The

name specified in or required by any

applicable Federal law or regulation; or,

in the absence thereof, (2) the common

or usual name of the food; or, in the

absence thereof, (3) an appropriately

descriptive term, or when the nature of

the food is obvious, a fanciful name

commonly used by the public for such

food.

When the requirement of section

403(s)(2)(B) of the act that the food be

identified as a ‘‘dietary supplement’’ is

read in conjunction with section

403(i)(1), which requires that the label

of the food bear its common or usual

name, that is, a statement that identifies

the food (see § 102.5(a) (21 CFR

102.5(a))), it is clear that the term

‘‘dietary supplement’’ needs to appear

as part of the common or usual name of

any food that is to be marketed subject

to the definition in section 201(ff) of the

act. While under section 403(s)(2)(B) of

this act this term may be modified with

the name of a dietary ingredient, FDA

tentatively concludes that the term

‘‘dietary supplement’’ must appear in

the statement of identity of such

products. To reflect this tentative

conclusion, FDA is proposing to require

in § 101.3(g) that when a food is

marketed as a dietary supplement, its

label shall bear the term ‘‘dietary

supplement’’ as part of its statement of

identity.

This proposed requirement is further

supported by § 102.5 of FDA’s

regulations. This regulation sets out

general principles for arriving at the

common or usual name of a

nonstandardized product, that is, a

product that is not subject to a

definition adopted under section 401 of

the act (21 U.S.C. 341). Section 102.5(a)

states in part:

The common or usual name of a food,

which may be a coined term, shall accurately

identify or describe, in as simple and direct

terms as possible, the basic nature of the food

or its characterizing properties or ingredients.

The name shall be uniform among all

identical or similar products and may not be

confusingly similar to the name of any other

food that is not reasonably encompassed

within the same name. Each class or subclass

of food shall be given its own common or

usual name that states, in clear terms, what

it is in a way that distinguishes it from

different foods.

Requiring that ‘‘dietary supplement’’

be included as part of the statement of

identity of such foods is consistent with

§ 102.5 in several important respects.

First, it will ensure that a term that

accurately describes the basic nature of

the food will appear prominently on the

label of each dietary supplement.

Second, it will ensure that there is

consistency in the labeling of dietary

supplements by requiring that they bear

a consistent term. The agency stresses

that the provisions of § 102.5 pertaining

to uniformity of common or usual
67196 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

names among all identical or similar

products could be seriously

compromised unless the term ‘‘dietary

supplement’’ is included in the common

or usual name of such a supplement. As

explained below, the potential for

compromising this requirement would

be particularly great where dietary

supplements are in other than tablet,

capsule, powder, softgel, gelcap, or

liquid form. Finally, use of this term as

part of the statement of identity of

dietary supplements will distinguish

this potentially broad class of products

from other types of food.

New section 201(ff)(2) of the act

provides that a ‘‘dietary supplement’’ is

a product that is not represented for use

as a conventional food. At the same

time, the DSHEA struck the provision

that excluded products that simulate

conventional foods from the coverage of

section 411 of the act. (See section

3(c)(2) of the DSHEA.) As a result of the

latter change, however, there may now

be dietary supplements for which the

presence of the term ‘‘dietary

supplement’’ constitutes the primary, if

not the only, means by which

consumers will be able to determine

that the food is a dietary supplement.

Under such circumstances, it seems

imperative that the term ‘‘dietary

supplement’’ appear in the statement of

identity.

For the foregoing reasons, FDA is

proposing to add § 101.3(g), which

states that products marketed as dietary

supplements shall bear the term

‘‘dietary supplement’’ as part of their

statement of identity, to its regulations.

III. Provisions of Proposed § 101.36

A. Foods Covered by § 101.36

The agency is proposing to revise

§ 101.36(a) to state that the label of a

dietary supplement shall bear nutrition

labeling in accordance with § 101.36,

unless an exemption is provided for the

product in § 101.36(h). Previously, only

dietary supplements of vitamins and

minerals were subject to the provisions

of § 101.36. As stated above, dietary

supplements of herbs and other similar

nutritional substances were to follow

the general nutrition labeling

requirements in § 101.9. This separation

was in accordance with section

403(q)(5)(F) of the act as passed in the

1990 amendments, which instructed the

Secretary to issue nutrition labeling

regulations appropriate for dietary

supplements of vitamins and minerals.

However, the DSHEA revised

403(q)(5)(F) of the act to provide that it

covers all dietary supplements, that is,

all products that meet the definition in

section 201(ff) of the act. Consequently,

the agency is proposing to amend

§ 101.36(a) to reflect this change.

B. General Requirements

In § 101.36(b), the agency is proposing

to require that nutrition information on

dietary supplements include the

information specified in this section of

the regulations, and that it be presented

in the format specified in proposed

§ 101.36(e). These proposed

requirements reflect the requirements in

section 403(q)(1) of the act and in

section 2(b)(1)(A) of the 1990

amendments, which states that the

information required under section

403(q) is to ‘‘be conveyed to the public

in a manner which enables the public to

readily observe and comprehend such

information and to understand its

relative significance in the context of

the total daily diet.’’

The agency notes that it has been

asked whether current § 101.36(b) is to

be interpreted as requiring nutrition

labeling in all dietary supplement

labeling (i.e., printed material

accompanying a product) as well as on

the label attached to a product. The

agency advises that it does not intend

that nutrition labeling appear on all

labeling. It generally must appear on the

label of dietary supplement products,

although there may be circumstances in

which it appears in labeling in lieu of

the label. When nutrition labeling is

presented, however, it must conform to

the requirements of § 101.36.

C. Serving Size

Proposed § 101.36 (b)(1)(i) and

(b)(1)(ii) on serving size and on servings

per container, respectively, differ only

slightly from current § 101.36 (b)(1) and

(b)(2). In the first sentence of proposed

§ 101.36(b)(1)(i), the agency is stating

that the subheading ‘‘Serving Size’’ is to

be placed under the heading of

‘‘Supplement Facts.’’ The agency is

proposing to include the name of the

heading (i.e., ‘‘Supplement Facts’’) in

§ 101.36(b)(1)(i) for clarity.

On a related note, the agency points

out that it is proposing to change the

language in § 101.12(b), Table 2, to read

‘‘Dietary supplements’’ instead of

‘‘Dietary supplements not in

conventional food form’’ in response to

the DSHEA. The language in current

§ 101.12(b) reflected the DS act, which,

in its legislative history, made clear that

the moratorium it effected applied only

to dietary supplements of vitamins,

minerals, herbs, or other similar

nutritional substances not in the form of

conventional food. (See 138

Congressional Record S17240 (Joint

Statement Senators Kennedy and Hatch)

(October 7, 1992).) The DSHEA,

however, evidences an intent, for

labeling purposes, to treat all dietary

supplements in a similar manner. In

particular, section 7 of the DSHEA

addresses dietary supplement labeling

and does not distinguish between

dietary supplements that are not in

conventional food form and those that

are. Therefore, FDA is proposing to

amend § 101.12(b), Table 2, to reflect

this development.

D. Requirements for Dietary Ingredients

Having Recommendations for Daily

Consumption

The DSHEA added four subclauses to

section 403(q)(5)(F) of the act. Subclause

(i) states that the Secretary (and, by

delegation, FDA) shall provide by

regulation that the nutrition information

on dietary supplements first list those

dietary ingredients that are present in

the product in a significant amount and

for which a recommendation for daily

consumption has been established by

the Secretary, except that a dietary

ingredient shall not be required to be

listed if it is not present in a significant

amount, and shall list any other dietary

ingredient present and identified as

having no such recommendation. The

agency tentatively concludes that by a

dietary ingredient ‘‘for which a

recommendation for daily consumption

has been established by the Secretary,’’

the DSHEA is referring to a nutrient

having an RDI as established in § 101.9

(c)(7)(iii) and (c)(8)(iv) or a Daily

Reference Value (DRV) as established in

§ 101.9 (c)(7)(iii) and (c)(9).

The requirement in section

403(q)(5)(F)(i) of the act that the dietary

ingredients for which there are no RDI’s

or DRV’s be listed in the nutrition label

following the listing of dietary

ingredients for which RDI’s or DRV’s

have been established necessitates

changes in the organization of § 101.36.

The agency is therefore consolidating all

of the information required in the listing

of dietary ingredients for which RDI’s or

DRV’s have been established under

proposed § 101.36(b)(2) and the

information required in the listing of

other dietary ingredients in proposed

§ 101.36(b)(3). (See section III. E. of this

document.)

1. Listing of Dietary Ingredients for

Which RDI’s and DRV’s Have Been

Established

With respect to the listing of dietary

ingredients for which RDI’s and DRV’s

have been established, the agency

tentatively concludes that no major

change in the 1994 dietary supplement

final rule is needed as a result of the

DSHEA. The agency is proposing in

§ 101.36(b)(2)(i) that the 14 nutrients
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67197

1To save space and to help the reader

differentiate between these two types of dietary

ingredients, the agency will refer to the dietary

ingredients listed in proposed § 101.36(b)(2) as

‘‘(b)(2)-dietary ingredients’’ and to all other dietary

ingredients as ‘‘other dietary ingredients.’’

that, under § 101.9(c), must be listed in

the nutrition labeling of a conventional

food, when they are present, shall be

listed in the nutrition label of a dietary

supplement when they are present in

the supplement in amounts greater than

that that can be declared as zero under

§ 101.9(c). For clarity, the agency is

identifying these nutrients by name in

this proposed paragraph. This

requirement is consistent with current

§ 101.36(b)(3), except that the current

provision calls for ‘‘a listing of all

nutrients required in § 101.9(c),’’ rather

than specifying the name of each

nutrient.

However, current § 101.36(b)(3) is

silent on the subcomponents (e.g.,

polyunsaturated fat, soluble fiber, sugar

alcohols) specified in § 101.9(c) that

provide additional information about

some of the nutrients required to be

listed in the nutrition labeling of

conventional foods. The listing of most

subcomponents is voluntary under

§ 101.9(c). Generally, it is required only

when claims are made. For example, the

listing of soluble fiber is voluntary for

conventional foods, except when a

nutrient content claim is made about

this nutrient. The agency did not require

a listing of subcomponents in the 1994

dietary supplement final rule because it

concluded that such labeling was not

appropriate for such foods under section

403(q)(5)(F) of the act because that

section applied only to dietary

supplements of vitamins and minerals.

Therefore, a fiber supplement, for

example, did not come under the scope

of supplement labeling.

Now, however, all dietary

supplements, including products such

as fiber supplements, are to be covered

by the same nutrition labeling

regulation (i.e., § 101.36). Therefore, the

agency has tentatively concluded that it

is appropriate to provide for the listing

of the subcomponents specified in

§ 101.9(c). Accordingly, the agency is

providing in proposed § 101.36(b)(2)(i)

that calories from saturated fat and

amounts of polyunsaturated fat,

monounsaturated fat, soluble fiber,

insoluble fiber, sugar alcohol, and other

carbohydrate may be declared in the

nutrition label of dietary supplements

and is proposing to require that they be

declared when a claim is made about

them.

There are other subcomponents of the

nutrients that are required under

§ 101.9(c) to be listed in nutrition

labeling that are not mentioned in that

regulation (e.g., amino acids

(subcomponents of protein), omega-3

fatty acids (subcomponents of fat)), and

that may not be included in the

nutrition label on conventional foods

(see § 101.9(c)). However, because these

subcomponents may be classified as

dietary ingredients under section

201(ff)(1) of the act, manufacturers of

dietary supplements may list them in

the nutrition label under § 101.36. The

difference in treatment of these

subcomponents when they are present

in dietary supplements as compared to

when they are present in conventional

foods creates the possibility of

consumer confusion. To minimize this

possibility, FDA is trying to retain as

much consistency as possible between

the nutrition labeling of conventional

foods under § 101.9 and dietary

supplements under § 101.36 (section

2(b)(1)(A) of the 1990 amendments).

Thus, the agency is proposing that

subcomponents that are not specified in

§ 101.9(c), e.g., individual amino acids,

be listed under proposed § 101.36(b)(3)

as dietary ingredients for which RDI’s

and DRV’s have not been established.1

Among the 14 nutrients required to be

listed in nutrition labeling of

conventional foods are sodium, vitamin

A, vitamin C, calcium, and iron. The

other vitamins and minerals for which

RDI’s have been established in

§ 101.9(c)(8)(iv) are not required to be

listed in the nutrition label of

conventional foods except when they

are added for the purpose of

supplementation, or when a claim is

made about them. (See § 101.9(c)(8)(ii).)

The agency did not include this

distinction among vitamins and

minerals in the 1994 dietary supplement

final rule because that rule pertained

exclusively to supplements of vitamins

and minerals. Because dietary

supplements of vitamins and minerals

are usually fabricated and, with few

exceptions, contain only vitamins and

minerals that are added for purposes of

supplementation, the agency requires in

current § 101.36(b)(3) that vitamins and

minerals be listed whenever they are

present in significant amounts.

Although the act, as amended by the

DSHEA, requires that all dietary

ingredients and their amounts be listed,

the agency tentatively finds that

requiring the listing of all vitamins and

minerals with RDI’s or DRV’s that are

present in herbal products, for example,

would be unduly burdensome and in

conflict with section 403(q)(1)(E) of the

act, which requires the listing of

vitamins and minerals only if the

Secretary (and, by delegation, FDA)

determines that such information will

assist consumers in maintaining healthy

dietary practices. In implementing the

1990 amendments, the agency made

such a finding only for sodium, vitamin

A, vitamin C, calcium, and iron (58 FR

2079 at 2106). Requiring all dietary

ingredients in herbal products to be

listed would necessitate extensive

nutritional analyses of the vitamin and

mineral content of all such products.

While manufacturers are free to do so,

FDA tentatively finds that it is

unnecessary and inappropriate to

require that such analyses be done.

Thus, FDA tentatively concludes that,

because the act must be read as a whole,

and because section 403(q)(5)(F)(i) of

the act must be read in conjunction with

section 403(q)(1)(E) (in fact, it explicitly

references that section), it is appropriate

for the agency to follow the approach

that it used in § 101.9 for conventional

foods and to require the listings of

vitamins and minerals (including

potassium) other than sodium, vitamin

A, vitamin C, calcium, and iron in the

nutrition label of dietary supplements

only when such other vitamins and

minerals are added to the product for

purposes of supplementation, or when a

claim is made about them. Comments

are requested on this tentative

conclusion.

The agency observes that it did not

clearly express in the 1994 dietary

supplement final rule the amounts of

vitamins and minerals that are not to be

declared on the labels of dietary

supplements because they are so small.

Current § 101.36(b)(3) requires a listing

of ‘‘nutrients required in § 101.9(c) that

are present in the dietary supplement in

quantitative amounts by weight that

exceed the amount that can be declared

as zero in § 101.9(c),’’ while

§ 101.9(c)(8)(iii) states that amounts of

vitamins and minerals present at less

than 2 percent of the RDI are not

required to be declared in nutrition

labeling but may be declared by a zero.

For clarity on what amounts do not have

to be declared, the agency is proposing

to include a statement in

§ 101.36(b)(2)(i) that amounts of

vitamins and minerals corresponding to

less than 2 percent of the RDI shall not

be declared. The agency points out that

this statement does not represent a

change from the 1994 dietary

supplement final rule but is merely a

clarification of its provisions.

The agency notes that current

§ 101.36(b)(3) specifies that vitamin K,

chloride, chromium, fluoride,

manganese, molybdenum, and selenium

shall be listed, when present. Because

the agency has established RDI’s for

these nutrients (except for fluoride) (see

the final rule on RDI’s published
67198 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

elsewhere in this issue of the Federal

Register), their listing is covered by the

reference to all other vitamins or

minerals listed in § 101.9(c)(8)(iv) in

proposed § 101.36(b)(2). Accordingly,

special mention of vitamin K, chloride,

chromium, manganese, molybdenum,

and selenium is no longer needed.

Because FDA has not established an RDI

for fluoride, if it is declared in nutrition

labeling, under the proposed rule, it will

have to be listed with the other dietary

ingredients, as provided for in proposed

§ 101.36(b)(3).

FDA is also providing in proposed

§ 101.36(b)(2)(i) that protein not be

declared in the nutrition label of dietary

supplements that, other than ingredients

added solely for technological reasons,

contain only individual amino acids.

While § 101.9(c)(7) allows protein

content to be calculated as 6.25 times

the nitrogen content of the food, the

agency tentatively finds that it is

misleading to declare the protein

content in the nutrition label of a

dietary supplement that contains free

(individual) amino acids because

protein, by definition, is composed of

chains of amino acids connected

together by peptide bonds. Such

linkages are not found in products

composed of free amino acids (Ref. 1,

pp. 57 and 58).

The agency is proposing to require in

§ 101.36(b)(2)(i)(A) use of the heading

‘‘Amount Per Serving,’’ except that the

agency is proposing to allow other

appropriate headings when the serving

size of the product is one unit. This

aspect of the proposal is unchanged

from what appeared in the 1994 dietary

supplement final rule. The agency

tentatively concludes that the proposed

requirement is consistent with section

403(q)(1)(A) of the act, which provides

that nutrition information is to be

expressed on a ‘‘per serving’’ basis.

The agency notes that because it is

proposing that quantitative amounts be

presented in a separate column, rather

than immediately following the listing

of names as provided in the 1994

dietary supplement final rule, the

agency is proposing that the heading

may appear over the column of amounts

rather than the column of names. The

agency is proposing to provide

flexibility in the placement of this

heading because space constraints may

make placement over the column of

amounts impractical in some cases.

Comments are requested on the

placement of this heading.

The agency points out that, under

current § 101.36(b)(3), the heading

‘‘Amount Per Serving’’ must be

separated from the other information on

the nutrition label by a bar above and

beneath it. While the agency is

proposing to carry forward this

requirement, it is doing so in proposed

§ 101.36(e) on format. FDA will discuss

this proposed requirement in more

detail as part of its description of that

paragraph.

The agency is proposing in

§ 101.36(b)(2)(i)(B) that (b)(2)-dietary

ingredients be listed in a column on the

left side of the nutrition label in the

order and manner of indentation that is

specified in that paragraph. No change

in the order from current

§ 101.36(b)(3)(ii) is required as a result

of the DSHEA, and FDA is not

proposing to make any change.

The agency is addressing issues

related to the column of names of (b)(2)-

dietary ingredients in three paragraphs

under proposed § 101.36(b)(2)(i)(B).

Proposed § 101.36(b)(2)(i)(B)(1) specifies

how calorie information is to be

presented. The agency is proposing that,

instead of listing calories above the

column of names, they be listed first in

the column of names, under a bar that

separates the list from the heading

‘‘Amount Per Serving.’’ The agency

tentatively concludes that giving

calories prominence over other

nutrients is not appropriate for

supplements, which usually do not

contain many calories. In addition, this

change will save space. Proposed

§ 101.36(b)(2)(i)(B)(1) also requires that

when ‘‘Calories from fat’’ or ‘‘Calories

from saturated fat’’ are declared, they

are to be indented beneath ‘‘Calories’’ in

a manner similar to the indentation

specified in § 101.9(d)(5).

Proposed § 101.36(b)(2)(i)(B)(2)

specifies the synonyms that may be

added in parentheses following the

names of the (b)(2)-dietary ingredients.

This paragraph is identical to the

current regulation on synonyms in

dietary supplement labeling (current

§ 101.36(b)(3)(v)), except that the agency

is proposing to permit the use of ‘‘folic

acid’’ as a synonym for folate. FDA

recognizes that current regulations for

nutrition labeling in §§ 101.9 and 101.36

do not include the term ‘‘folic acid’’ as

an allowable synonym for folate. This

omission was an oversight when FDA

amended § 101.9 (58 FR 2079 at 2178)

and issued § 101.36 (59 FR 373). Before

the agency took these actions, § 101.9

had listed ‘‘folic acid’’ as the preferred

term, with ‘‘folacin’’ as an allowable

parenthetical synonym. When

amendments to § 101.9 were initially

proposed (55 FR 29847, July 19, 1990),

the agency explained why the term

‘‘folate’’ was preferred to ‘‘folacin.’’

However, an explanation for the

transition from ‘‘folic acid’’ to ‘‘folate’’

was inadvertently omitted, as was

inclusion of the term ‘‘folic acid’’ as a

synonym.

In light of common usage and FDA

policy, and for consistency among the

nutrition labeling and health claim

regulations, the agency is proposing to

correct § 101.36(b)(3)(v) to include

‘‘folic acid’’ as an allowable synonym

for folate. The agency advises that it

intends to revise § 101.9(c)(8)(v) to

allow the listing of folic acid as a

synonym for folate on conventional

foods as well.

In proposed § 101.36(b)(2)(i)(B)(3), the

agency provides that the percent of

vitamin A that is present as betacarotene may be declared immediately

adjacent to or beneath the listing of

vitamin A. This proposed provision

essentially carries forward current

§ 101.36(b)(3)(iv). The agency

tentatively finds that no change is

needed in this provision as a result of

the DSHEA, except that the agency is

deleting the amount of vitamin A from

the example given in this provision

because, under this proposal,

information on the quantity of each

dietary ingredient will no longer appear

immediately following the name but

instead in a separate column.

2. Quantity of Each (b)(2)-Dietary

Ingredient

The DSHEA added section

403(q)(5)(F)(ii) to the act. This section

states that the listing of dietary

ingredients shall include the quantity of

each such ingredient (described in

section 413(q)(5)(F)(i)), per serving,

except that only the total quantity is

required for proprietary blends, as

discussed elsewhere in this preamble.

Consistent with this section, the agency

is proposing to require in

§ 101.36(b)(2)(ii) that the number of

calories, if declared, and the

quantitative amounts by weight of the

(b)(2)-dietary ingredients be listed in a

column to the right of the column of

names. As previously discussed, this

proposal differs from the 1994 dietary

supplement final rule in that this

information is to be listed in a separate

column instead of immediately

following the name of any dietary

ingredient listed. The agency is

proposing this change to allow space for

information on the source of the dietary

ingredient to be included immediately

following the name, as discussed

elsewhere in this document. The agency

considered continuing to have the

weight of the dietary ingredient placed

immediately after the name of the

dietary ingredient or its source but

tentatively concluded that the wide

variation in placement that could result

when some dietary ingredients are listed
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67199

2 It is important to distinguish between the terms

‘‘ingredient’’ and ‘‘dietary ingredient.’’ The DSHEA

uses the term ‘‘dietary ingredient’’ to refer to the

primary substances to be listed in nutrition

labeling, as opposed to ‘‘ingredients’’ that are the

compounds used in the manufacture of the product.

For instance, when calcium carbonate is an

ingredient used to provide calcium in the

manufacture of a dietary supplement, calcium is the

‘‘dietary ingredient,’’ and calcium carbonate is the

‘‘ingredient,’’ or, as specified in new section

403(q)(5)(F)(iii) of the act, the ‘‘source of’’ the

dietary ingredient. Similarly, omega-3 fatty acids

are ‘‘dietary ingredients,’’ while their source, fish

liver oil, is the ‘‘ingredient.’’ (See section III., G. of

this document for a further discussion.)

by name only, while others include the

source ingredient, would make it

difficult for some consumers to find the

declaration of weight. Comments on this

tentative conclusion, and on its possible

impact on space requirements for the

nutrition label, are requested.

The agency emphasizes that,

consistent with the 1994 dietary

supplement final rule (59 FR 354 at 360)

and the DSHEA, the quantitative

amount by weight declared for any

dietary ingredient is to be the weight of

the dietary ingredient rather than the

weight of the source of the dietary

ingredient.2 The agency points out that

new section 403(s)(2)(A) of the act states

that a dietary supplement is misbranded

if its label or labeling fails to list, among

other things, the ‘‘name of each

ingredient of the supplement that is

described in section 201(ff)’’ and the

quantity of each such ingredient. The

use of the word ‘‘ingredient’’ in section

403(s)(2)(A) of the act, instead of

‘‘dietary ingredient,’’ creates some

ambiguity. However, the agency

tentatively concludes that in this section

the phrase ‘‘that is described in section

201(ff)’’ modifies the word ‘‘ingredient’’

rather than ‘‘supplement.’’ Thus, this

provision is referring to a listing of the

names and amounts of dietary

ingredients. Accordingly, using the

example of calcium carbonate, the

weight of calcium would be declared,

rather than the weight of calcium

carbonate, the source of the dietary

ingredient.

Section 403(s)(2)(A)(ii) of the act is

also unclear on what basis the

quantitative information should be

reported (e.g., per dosage unit). The

agency tentatively concludes that it is

appropriate to require that this

quantitative information be provided on

a ‘‘per serving’’ basis because

interpreting this provision in this way

will mean that there need only be one

list of the quantitative amounts of

dietary ingredients in a supplement.

Section 403(q)(5)(F) of the act also

requires a list of dietary ingredients, but

it specifies that the listing be on a ‘‘per

serving’’ basis. If FDA were to interpret

section 403(s)(2)(A)(ii) of the act

differently, for example, to require

information on a per dosage unit basis,

it would mean that for dietary

supplements whose serving size is two

capsules, there would have to be two

lists of dietary ingredient amounts on

the label, one per capsule, the other per

serving (two capsules). The agency

tentatively concludes that such an

interpretation would result in

overcrowded labels with essentially

redundant information. The agency

recognizes, however, that the

interpretation that it is proposing

renders section 403(s)(2)(A) of the act

somewhat redundant to section

403(q)(5)(F), and that the rules of

statutory construction generally do not

favor such a reading. Therefore, FDA

specifically requests comments on the

proposed interpretation.

In proposed § 101.36(b)(2)(ii)(A), the

agency states that the declaration of

quantitative amounts by weight shall be

expressed using the increments

specified in § 101.9(c)(1) through (c)(7),

which includes increments for sodium

and potassium. This proposed provision

is carried forward from current

§ 101.36(b)(3)(i). As explained in the

proposal of June 18, 1993 (58 FR 33715

at 33719), the agency was not aware of

any reason for treating dietary

supplements of vitamins and minerals

any differently in this regard than

conventional food. The agency is still

unaware of any reason to modify this

approach.

In proposed § 101.36(b)(2)(ii)(B), the

agency states that the amounts of

vitamins and minerals, excluding

sodium and potassium, shall be the

actual amounts present, using the units

of measurement given in

§ 101.9(c)(8)(iv). The agency points out

that in a final rule published elsewhere

in this issue of the Federal Register

entitled ‘‘Food Labeling; Reference

Daily Intakes,’’ it is amending § 101.9 to

change the units for biotin and folate to

micrograms (mcg) and for calcium and

phosphorus to milligrams (mg). The

proposed specifications pertaining to

the manner in which quantitative

amounts by weight are to be declared

simply carry forward those found in

current § 101.36(b)(3)(i).

3. Declaration of Percent Daily Value for

Each (b)(2)-Dietary Ingredient

In proposed § 101.36(b)(2)(iii), the

agency is requiring that a percent Daily

Value, where appropriate, be listed for

the dietary ingredients declared under

§ 101.36(b)(2)(i), except that: (1) The

percent for protein may be omitted as

provided in § 101.9(c)(7) because the

methods for analyzing protein are

costly, and protein deficiency is not a

public health concern in the United

States; (2) no percent shall be given for

the subcomponents for which DRV’s

have not been established (e.g., sugars)

because it is not possible to calculate

percent Daily Values when there are no

DRV’s; and (3) for the labels of dietary

supplements that are represented or

purported to be for use by infants,

children less than 4 years of age, or

pregnant or lactating women, no percent

shall be given for total fat, saturated fat,

cholesterol, total carbohydrate, dietary

fiber, sodium, potassium, vitamin K,

chloride, chromium, manganese,

molybdenum, or selenium because

RDI’s or DRV’s have not been

established for these groups.

The agency points out that the

exception for protein is carried forward

from current § 101.36. The listing of no

percent Daily Value for subcomponents

is new in this proposal, but it is

consistent with current § 101.36(b)(4)

which states that ‘‘no percent shall be

given for sugars.’’ As discussed

previously, the agency did not address

the listing of other subcomponents

specified in § 101.9(c) because § 101.36

had applied only to dietary supplements

of vitamins and minerals. Thus, the

exception for these subcomponents was

not needed because they were not

declared.

The exception for total fat, saturated

fat, cholesterol, total carbohydrate,

dietary fiber, sodium, and potassium on

the labels of dietary supplements for use

by infants, children less than 4 years of

age, or pregnant or lactating women is

new in this proposal and was omitted

inadvertently in current § 101.36.

Because DRV’s are not established for

these groups, percents of Daily Values

cannot be calculated. Hence, the

exception is needed.

Finally, the exception for vitamin K,

chloride, chromium, manganese,

molybdenum, and selenium for the

population subgroups specified above is

carried forward from current § 101.36.

The agency points out that, in current

§ 101.36(b)(4), this exception had

covered products intended for adults

and children 4 or more years of age.

Because the agency is adopting RDI’s for

these nutrients for adults and children

4 or more years of age in the final rule

on RDI’s published elsewhere in this

issue of the Federal Register, this

exception is no longer needed for

products for that group.

The agency acknowledges that there

are no RDI values codified for infants,

children less than 4 years of age, or

pregnant or lactating women for any of

the vitamins and minerals. However, as

explained in the 1994 dietary
67200 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

supplement final rule (58 FR 33721),

FDA had intended to codify RDI values

for these groups but did not in

accordance with section 203 of the DS

act, which provided that the agency

could not adopt recommended daily

values different from the values set forth

in the agency regulation then in effect

(§ 101.9(c)(7)(1992)) before November 8,

1993. To provide guidance to

manufacturers in lieu of codifying

values, the agency published label

reference values for these groups in the

preamble of the final rule on RDI’s and

DRV’s on January 6, 1993 (58 FR 2206

at 2213). The agency encourages

manufacturers to use these values for

the labels of products intended for use

by these groups. FDA intends to propose

to codify RDI values for these groups in

the near future for both the nutrients

listed on the bottom of page 2213 of the

final rule on RDI’s and DRV’s (58 FR

2206 at 2213) and the nutrients for

which FDA is establishing RDI’s for

adults and children 4 or more years of

age in the final rule published

elsewhere in this issue of the Federal

Register.

In proposed § 101.36(b)(2)(iii)(A), the

agency is requiring that, when

information on the percent of Daily

Values is listed, the percentages be

presented in a column on the right side

of the nutrition label under the heading

‘‘% Daily Value.’’ This requirement is

not different from what appears in

current § 101.36(b)(4), except that the

heading need not appear on a line lower

than the heading ‘‘Amount Per

Serving.’’ Current § 101.36(b)(4)

provides for ‘‘% Daily Value’’ to appear

below ‘‘Amount Per Serving’’ when

calorie information is presented. Under

this proposal, calorie information will

go in the column of dietary ingredients.

Therefore, FDA is proposing that

‘‘Amount Per Serving’’ and ‘‘% Daily

Value’’ appear on the same line.

In proposed § 101.36(b)(2)(iii)(B), the

agency set forth how the percent Daily

Value is to be calculated. Although the

agency is making no change in this

calculation, it is rewording current

§ 101.36(b)(4)(i) to clarify that the actual

amount is to be used in the calculation

for vitamins and minerals (except for

sodium and potassium), and that either

the actual amount or the rounded

amount may be used for other nutrients,

e.g., fat. Under the proposed regulation,

sodium and potassium are treated in the

same manner as the other nutrients for

which DRV’s are established because

§ 101.9(c) provides for the declaration of

their weight in rounded increments.

The agency is also rewording current

§ 101.36(b)(4)(ii), which it is carrying

forward as proposed

§ 101.36(b)(2)(iii)(C), to make clear

when ‘‘Less than 1%’’ (or ‘‘<1%’’) is to

be used. Under proposed

§ 101.36(b)(2)(iii)(C), it is to be used to

describe the percent Daily Value of a

dietary ingredient when the dietary

ingredient is present in an amount by

weight that requires declaration (i.e.,

exceeds the amount that can be declared

as zero), yet the amount is so small that

the percent Daily Value when rounded

to the nearest percent comes to ‘‘0%.’’

In place of ‘‘0%,’’ which might be

confusing to consumers when a

quantitative amount by weight is listed,

‘‘Less than 1%’’ is to be listed as the

percent Daily Value for these

substances. For example, for 1 gram (g)

of total carbohydrate, the manufacturer

could list ‘‘Less than 1%’’ as the percent

of Daily Value.

As previously discussed, vitamins

and minerals at less than 2 percent of

the RDI shall not be declared, except

that sodium and potassium can be listed

at values less than 2 percent, consistent

with § 101.9(c)(4) and (c)(5),

respectively. Thus, proposed

§ 101.36(b)(2)(iii)(C), if adopted, will not

apply to vitamins and minerals other

than to sodium and potassium.

The agency is proposing that ‘‘<1%’’

may be used in place of ‘‘Less than 1%’’

to provide more flexibility when space

is limited on the label. FDA did not

provide for use of the symbol ‘‘<’’ for

‘‘less than’’ in regulations implementing

the 1990 amendments because of

concerns that a large number of persons

would not understand its meaning. The

agency has received numerous requests,

however, to permit use of the symbol

and is aware that it is being used on

some nutrition labels with tight space

constraints. FDA requests comments on

the advisability of allowing use of the

symbol ‘‘<’’ and the submission of any

available data that would demonstrate

consumers’ comprehension of it. If the

agency allows the symbol on nutrition

labels of dietary supplements, it intends

to provide for such use on conventional

foods as well.

The agency points out that proposed

§ 101.36(b)(2)(iii)(D) through (F) parallel

provisions in the current regulations.

Proposed § 101.36(b)(2)(iii)(D) carries

forward the requirement in current

§ 101.36(b)(4)(v) that the footnote

‘‘Percent Daily Values are based on a

2,000 calorie diet’’ be present when the

percent of Daily Value is declared for

total fat, saturated fat, total

carbohydrate, dietary fiber, or protein.

The agency is proposing to require that

the symbol that refers to the footnote,

when needed, immediately follow the

value listed. For clarity, the agency is

proposing to add to this provision that

the footnote is to go below the last

heavy bar required under proposed

§ 101.36(e)(6) and inside the box.

Consistent with current

§ 101.36(b)(4)(iii), in proposed

§ 101.36(b)(2)(iii)(E), the agency

provides that the percent of Daily Value

shall be based upon values for adults

and children 4 or more years of age,

unless the product is represented for

one of the subgroups specified, in which

case the column heading shall clearly

state the intended subgroup. If the

product is for persons within more than

one group, the percent of Daily Value

for each group shall be presented in

separate columns, as shown in the

sample label in § 101.36(e)(10)(ii).

Finally, proposed

§ 101.36(b)(2)(iii)(F), consistent with

current § 101.36(b)(4)(vi), requires the

use of the footnote ‘‘Daily Value not

established’’ for dietary ingredients that

have no RDI’s or DRV’s and, therefore,

for which a percent Daily Value cannot

be calculated. Under this proposed rule,

this footnote will apply to most

subcomponents and, on labels of dietary

supplements that are intended for use

by infants, children less than 4 years of

age, and pregnant and lactating women,

to total fat, saturated fat, cholesterol,

total carbohydrate, dietary fiber,

sodium, potassium, vitamin K, chloride,

chromium, manganese, molybdenum, or

selenium. As previously explained, a

final rule published elsewhere in this

issue of the Federal Register establishes

RDI values for vitamin K, chloride,

chromium, manganese, molybdenum

and selenium for adults and children 4

or more years of age, and, thus, percent

Daily Values can now be calculated for

those nutrients for that group.

Therefore, the proposed footnote will

have a more narrow application than

under current § 101.36(b)(4)(vi). The

agency points out that when both the

footnotes ‘‘Daily Value not established’’

and ‘‘Percent Daily Values are based on

a 2,000 calorie diet’’ are required,

different symbols must be used to refer

to each footnote so that consumers will

not be confused.

Proposed § 101.36(b)(2)(iii)(G) is new

and specifies that when calories,

calories from fat, or calories from

saturated fat are declared, the space

under the ‘‘% Daily Value’’ column

must be left blank for these items. This

provision is necessary as a result of

proposed § 101.36(b)(2)(i)(B)(1) that

includes calories in the list of (b)(2)-

dietary ingredients that are placed

beneath the line in which the column

headings, ‘‘Amount Per Serving’’ and

‘‘% Daily Value,’’ are specified. In

nutrition labels of foods labeled in

accordance with § 101.9, calories are
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67201

listed above the heading ‘‘% Daily

Value.’’

In addition, proposed paragraph

§ 101.36(b)(2)(iii)(G) provides that the

column ‘‘% Daily Value’’ may be

omitted when there are no numerical

values declared beneath it. For example,

this situation will occur when only

calories and protein are listed (a percent

Daily Value cannot be calculated for

calories in the absence of an RDI or

DRV, and this declaration is optional for

protein except as noted in

§ 101.9(c)(7)(i)), or when only calories or

dietary ingredients subject to proposed

§ 101.36(b)(2)(iii)(F) are listed. Where

the latter situation occurs, and the

footnote ‘‘Daily Value not established’’

is required, the symbol (e.g., asterisk)

must immediately follow the

quantitative amount by weight for each

dietary ingredient listed under ‘‘Amount

Per Serving.’’

E. Requirements for Other Dietary

Ingredients

The agency is proposing in

§ 101.36(b)(3) to prescribe how dietary

ingredients that do not have RDI’s or

DRV’s, and that are not subject to

regulation under § 101.36(b)(2), are to be

declared in the nutrition label when

present in a dietary supplement. The

agency is proposing this provision,

which did not appear in the 1994

dietary supplement final rule, in

response to section 403(q)(5)(F)(i) of the

act, which was added by the DSHEA. As

stated above, this provision states that

the nutrition information on a dietary

supplement shall first list those dietary

ingredients for which RDI’s or DRV’s

have been established and then list ‘‘any

other dietary ingredient present and

identified as having no such

recommendation’’ (i.e., no RDI or DRV).

As discussed earlier, to avoid confusion,

the agency is proposing to refer to the

latter group of dietary ingredients as

‘‘other dietary ingredients.’’ FDA is also

proposing in § 101.36(b)(3) to set out

how the quantitative amounts of these

dietary ingredients are to be presented.

1. Names of Other Dietary Ingredients

The agency is proposing in

§ 101.36(b)(3)(i) that other dietary

ingredients are to be listed in the

nutrition label by their common or

usual name in a column that is

underneath the column of names of

(b)(2)-dietary ingredients and the heavy

bar described in proposed § 101.36(e)(6).

The agency tentatively concludes that it

is appropriate to list these names in a

column because it is consistent with the

format proposed for the listing of names

of (b)(2)-dietary ingredients.

Consistency makes the label more

comprehensible to consumers. To

enable consumers to distinguish

between these two columns of dietary

ingredients, the agency is proposing that

they be separated by a heavy bar (see

section H of this preamble on format

specifications).

The agency considered specifying that

the other dietary ingredients be listed in

a particular order, such as alphabetical

order or descending order of

predominance by weight, to provide for

a consistent theme in their presentation

to assist consumers. Alphabetical order

would have the advantage of being user

friendly but would not be scientifically

meaningful. Descending order of

predominance by weight would be

consistent with § 101.4 which specifies

the order used in the ingredient

statement on conventional foods.

Because conventional foods are not

required to declare the amounts of

ingredients, this manner of listing gives

consumers an indication of the relative

amount of ingredients present.

However, imposing this requirement on

dietary supplements may be

unnecessary because the amounts of the

dietary ingredients (although not

necessarily the ingredient sources of the

dietary ingredients) are required to be

listed in the nutrition label under

section 403(q)(5)(F)(ii) of the act.

Furthermore, such a listing would not

necessarily reflect the relative biological

activity of the dietary ingredients.

Consequently, the agency has

tentatively concluded that specifying a

particular order is not justified. The

agency requests comments on this issue.

The agency is proposing in

§ 101.36(b)(3)(i) that other dietary

ingredients be listed by their common or

usual name. This requirement is

consistent with § 101.4 which requires

that the ingredients of conventional

foods be listed by common or usual

name. To the extent that another dietary

ingredient is covered by an official

compendium, FDA would expect that

the dietary ingredient’s common or

usual name to be drawn from that

source (see section 403(s)(2)(D) of the

act).

With regard to herbs and other

botanicals, the agency encourages

manufacturers to use common or usual

names that are found in botanical data

bases and that are widely used. Many of

these names are part of our everyday

language and are easily recognized by

consumers. However, the agency

realizes that arriving at an appropriate

name for botanicals may be a problem

because some plants have more than

one common or usual name, or one

name is used to describe many different

species. In other cases, a particular

species may not even have a common or

usual name. Furthermore, the agency

notes that uncertainty may exist as to

which dietary ingredients are

botanicals. For example, those in the

trade may regard fungi (i.e., yeasts,

molds, mushrooms) as ‘‘botanicals,’’

while a taxonomist may not (Ref. 2).

For the purposes of this regulation,

the agency considers the term

‘‘botanical’’ as used in section

201(ff)(1)(C) of the act to include fungi

and algae. While some questions may be

raised about fungi, the agency believes

there is general agreement that they are

botanicals (Ref. 2). With respect to

bacteria, the agency believes it is clear

from both a botanical as well as a

commercial viewpoint, they are not

botanicals (Ref. 2).

2. Quantity of Other Dietary Ingredients

The agency is proposing in

§ 101.36(b)(3)(ii) that the quantitative

amount by weight per serving of other

dietary ingredients shall be presented in

a column aligned to the right of the

column of names and beneath the

column of amounts described in

proposed § 101.36(b)(2)(ii). The agency

is proposing § 101.36(b)(3)(ii) in

response to section 403(q)(5)(F)(ii) of the

act, which was added by the DSHEA.

This provision specifies that the listing

of dietary ingredients shall include the

quantity of each such ingredient per

serving.

FDA is proposing to require that the

quantitative amount listed in the

nutrition label for a declared dietary

ingredient be the total weight of that

dietary ingredient and not the weight of

a component of that dietary ingredient

or of the source of that dietary

ingredient. While a component of an

ingredient may be listed as the dietary

ingredient, under the proposed

regulation, the name of that component

ought to appear in the left column, and

the weight of that component is what

would be listed. For example, if a

dietary supplement lists garlic as a

dietary ingredient and makes no

reference to a component of garlic, then

the weight specified should be the

weight of garlic. However, if the

nutrition label lists allicin as the dietary

ingredient, with garlic noted as the

source ingredient, the weight specified

should be the weight of allicin only.

Liquid extracts of dietary ingredients are

not to be treated any differently in that

the weight specified should be the

weight of the dietary ingredient listed

that is in the extract and not include the

weight of any solvent. The agency

appreciates that such determinations

may be difficult and seeks comments on

this issue.
67202 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

Manufacturers have the option of

deciding what to list as a dietary

ingredient (e.g., either garlic or the

constituent, allicin). The agency is

proposing this flexibility in accordance

with section 201(ff) of the act, which

provides, among other things, that a

dietary ingredient may be a botanical or

a constituent of a botanical. Thus, the

agency is proposing that either the

botanical or one or more constituents of

a botanical may be declared as the

dietary ingredient. The agency

considered allowing manufacturers to

declare both the botanical and one or

more constituents as dietary ingredients

within a single product, with the

constituents of the botanical indented

beneath the listing of the botanical. The

quantitative amounts for the botanical

and listed constituents would also be

declared. This approach would possibly

give consumers more information.

However, the agency has tentatively

rejected this approach because of

concern that it would be potentially

confusing to consumers who may not

understand that the indented items are

constituents of the nonindented dietary

ingredient listed immediately above, or

that the quantitative amounts of the

constituents are also included in the

quantitative amount of the nonindented

dietary ingredient. The agency requests

comments on whether it should

consider allowing declaration of

constituent information in the manner

described above, whether there are

alterative approaches to providing this

type of information, and whether such

flexibility is consistent with the DSHEA.

The agency notes that the DSHEA

provides that dietary ingredients having

RDI’s or DRV’s need be listed only when

present in ‘‘significant amounts.’’ This

limitation on listing in section

403(q)(5)(F)(i) of the act does not apply

to other dietary ingredients, apparently

because they do not have RDI’s or

DRV’s, and, consequently, there is no

basis for determining what constitutes a

‘‘significant amount’’ with respect to

daily consumption. Hence, under the

act, for other dietary ingredients there is

no level below which declaration is not

required.

In the absence of RDI’s or DRV’s,

which are expressed in the units

suitable for the declaration of nutrients

in the nutrition label (i.e., mg for

vitamin C), the agency is proposing to

require that manufacturers express the

amounts of other dietary ingredients in

metric units that are appropriate. While

it is not possible to specify appropriate

units for every possible other dietary

ingredient, for uniformity, FDA is

proposing that any declaration of 1,000

or more units (mcg, mg, g) be declared

in the next higher set of units (e.g.,

1,100 mg should be declared as 1.1 g).

3. Symbol To Reflect Lack of Daily

Value

In accordance with section

403(q)(5)(F)(i) of the act, which requires

that other dietary ingredients be

identified as having no recommendation

for daily consumption, the agency is

proposing in § 101.36(b)(3)(iii) that

other dietary ingredients bear a symbol

(e.g., an asterisk) in the column under

the heading of ‘‘% Daily Value’’ that

refers to another symbol placed at the

bottom of the nutrition label that is

followed by the statement ‘‘Daily Value

not established.’’ When no dietary

ingredients are declared in accordance

with § 101.36(b)(2)(i), and the heading

‘‘% Daily Value’’ is not used, the agency

is proposing that the symbol shall

follow the declaration of the

quantitative amount by weight for each

other dietary ingredient listed. The

agency considered placing the symbol

elsewhere on the label (e.g., following

the heading ‘‘Amount Per Serving’’ or

with the name of each dietary

ingredient) but tentatively concluded

that it is most appropriate with the

declaration of amounts because these

values are used in the calculation of

percent Daily Values when there are

RDI’s or DRV’s.

The agency gave extensive

consideration to the most appropriate

wording for the statement to which the

symbol refers. The agency considered a

statement such as ‘‘Not currently

determined essential,’’ which was

suggested in a letter from a dietary

supplement trade association (Ref. 3).

The agency is unsure if such a statement

would be more useful to consumers

than the proposed statement, ‘‘Daily

Value not established,’’ which is

consistent with the statement used in

current § 101.36(b)(4)(vi) and proposed

§ 101.36(b)(2)(iii)(F) for dietary

ingredients without Daily Values. The

agency requests comments on this issue.

F. Proprietary Blends

The agency is proposing in § 101.36(c)

to provide for the listing of dietary

ingredients in proprietary blends. New

section 403(q)(5)(F)(ii) of the act

provides that ‘‘the listing of dietary

ingredients shall include the quantity of

each such ingredient (or of a proprietary

blend of such ingredients) per serving.’’

New section 403(s)(2)(A)(ii)(II) of the act

contains a similar provision that

requires ‘‘the quantity of each such

ingredient; or with respect to a

proprietary blend of such ingredients,

the total quantity of all ingredients in

the blend.’’ The ingredients referred to

in this section are those in section

403(s)(2)(A)(i) of the act that are

described in 201(ff), i.e., dietary

ingredients. The agency notes that

section 403(q)(5)(F)(ii) of the act

specifies that the information is to be

reported on a ‘‘per serving’’ basis. While

section 403(s)(2)(A)(ii)(II) of the act does

not specify any basis, FDA tentatively

concludes, for the reasons set out in the

earlier discussion of section

403(s)(2)(A)(ii) (see section III. D. 2. of

this document) that the more specific

instructions given in section 403(q),

which directly addresses nutrition

labeling and the listing of dietary

ingredients, provide an appropriate

basis for the declaration of the

information required under section

403(s)(2)(A)(ii)(II) of the act.

Accordingly, the agency is proposing

in § 101.36(c) to provide that a blend of

dietary ingredients shall be identified by

the term ‘‘Proprietary Blend,’’ which

may be modified by an appropriate

descriptive term or fanciful name (e.g.,

‘‘Proprietary Blend of Bioflavonoids’’).

To promote uniform presentation and,

thereby, to minimize consumer

confusion, FDA is proposing that the

dietary ingredients in the proprietary

blend be indented under the term

‘‘Proprietary Blend’’ (or a modification

of this term) and be listed in a column

or in a linear fashion.

The agency is proposing that the total

weight of the dietary ingredients listed

as components of the proprietary blend

appear on the same line as the name of

the blend, as illustrated in the sample

label in § 101.36(e)(10)(v), to make it

clear that the weight represents the total

weight of the dietary ingredients listed.

As previously explained, the

manufacturer has the discretion to

decide what to list as a dietary

ingredient, e.g., whether to list garlic or

a component of garlic, such as allicin.

Regardless of what is considered to be

the dietary ingredient, it is the weight of

the dietary ingredient declared that is to

be used in calculating the total weight

of the blend.

Proposed § 101.36(c) also requires that

the list of other dietary ingredients in a

proprietary blend be given in order of

predominance by weight since the

weights of the individual dietary

ingredients need not be specified

(proposed § 101.36(c)(2)). The required

listing by order of predominance by

weight is consistent with ingredient

labeling of conventional foods under

§ 101.4(a)(1) and is intended to give

consumers an indication of the relative

amounts of the other dietary ingredients

present in the absence of information on

their actual amounts.
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67203

All other requirements for the listing

of dietary ingredients remain in effect

for dietary supplements containing, or

consisting solely of, a proprietary blend.

For example, under proposed

§ 101.36(c)(3), the total weight must be

specified to the right (beneath the

column of amounts described in

paragraph (b)(2)(ii) of § 101.36), and the

symbol (e.g., asterisk) referring to the

statement ‘‘Daily Value not established’’

must be placed in the column under the

heading of ‘‘% Daily Value,’’ if present,

or immediately following the

quantitative amount by weight for the

proprietary blend.

In addition, the agency is proposing to

require that a dietary supplement

containing a proprietary blend comply

with § 101.36(b)(2) (§ 101.36(c)(1)). If the

proprietary blend furnishes more than

insignificant amounts of any required

(b)(2)-dietary ingredients (i.e., calories,

calories from fat, total fat, saturated fat,

cholesterol, sodium, total carbohydrate,

sugars, dietary fiber, protein, vitamin A,

vitamin C, calcium, iron, or any other

dietary ingredient listed in proposed

§ 101.36(b)(2)(i) that is added for

purposes of supplementation or about

which claims are made), that dietary

ingredient must be declared, as well as

the amount of the ingredient and the

percent of the Daily Value that the

supplement supplies. While FDA

recognizes some ambiguity in the

language of section 403 (q)(5)(F)(ii) and

(s)(2)(ii)(II) of the act, the agency

tentatively concludes that an

interpretation of these provisions of the

act to mean that amounts of (b)(2)-

dietary ingredients need not be listed

individually, but rather be included in

the total weight of the proprietary blend,

would be inconsistent with section

403(q)(5)(F) of the act, which states that

dietary supplement products ‘‘shall

comply with the requirements of

subparagraphs (1) and (2),’’ albeit in a

manner which is appropriate for the

product. Section 403(q)(1) and (q)(2) of

the act require the listing of the

individual nutrients determined by the

Secretary to assist consumers in

maintaining healthy dietary practices.

FDA tentatively concludes that it would

be contrary to the intent of the 1990

amendments to fail to list nutrients such

as calories, total fat, sodium, or vitamin

C, when present, in the nutrition

labeling of dietary supplements

containing proprietary blends.

Inasmuch as FDA is proposing that

any (b)(2)-dietary ingredients present in

the proprietary blend be listed in

accordance with § 101.36(b)(2) (e.g.,

above the heavy bar separating (b)(2)-

dietary ingredients and other dietary

ingredients), these (b)(2)-dietary

ingredients in the blend would not need

to be listed a second time under the

term ‘‘Proprietary Blend’’ and, if not

listed, would not be included in the

weight specified for such blend.

G. Information on the Source of a

Dietary Ingredient and Other Ingredient

Labeling Issues

In response to sections 403

(q)(5)(F)(iii) and (q)(5)(F)(iv) of the act,

which were added by the DSHEA, FDA

is proposing in new § 101.36(d) to allow

the source of a dietary ingredient to be

declared in the nutrition label. Section

403(q)(5)(F)(iii) of the act states that

‘‘the listing of dietary ingredients may

include the source of a dietary

ingredient,’’ and subclause (iv) states

that ‘‘the nutrition information shall

immediately precede the ingredient

information required under subclause

(i), except that no ingredient identified

pursuant to subclause (i) shall be

required to be identified a second time.’’

With respect to subclause (iv), the

agency observes that it has received

questions regarding the intent of the

phrase ‘‘except that no ingredient

identified pursuant to subclause (i) shall

be required to be identified a second

time.’’ The agency acknowledges that

the meaning of this phrase is not clear

and has speculated whether the

reference to ‘‘subclause (i)’’ is intended

to refer to section 403(i) of the act.

Given this ambiguity, the agency is

interpreting subclause (iv) to mean that

any ingredient listed in the nutrition

label need not be listed a second time

in the ingredient statement required in

§ 101.4. For example, under the agency’s

proposal, if an ingredient such as

calcium carbonate is listed as the source

of ‘‘calcium’’ in the nutrition

information, it would not need to be

listed again in the ingredient statement.

Accordingly, the agency is proposing to

revise § 101.4(a)(1) to provide that any

ingredient of a dietary supplement that

is listed in the nutrition label in

accordance with proposed § 101.36(d)

(i.e., inside the box) need not be

repeated in the ingredient list.

The agency notes that one of the

analyses of the DSHEA that it has

received addressed section

403(q)(5)(F)(iv) of the act in detail (Ref.

4). The analysis stated: ‘‘The listing [of

dietary ingredients] can also include the

source ingredient of the dietary

ingredient, and the traditional

ingredient declaration need not repeat

those ingredients (although a technical

correction is needed so that the first

cross reference in section

403(q)(5)(F)(iv) of the act is to

‘subsection (i)’ rather than to

‘subclause(i)’).’’ Hence, this analysis is

suggesting the first cross reference is to

section 403(i) of the act that deals with

the ingredient statement that is required

in § 101.4. This analysis is consistent

with FDA’s interpretation that: (1) A

source ingredient may be included in

the nutrition information, (2) the

nutrition information must immediately

precede the ingredient statement

required in § 101.4, and (3) no

ingredient listed in the nutrition label is

required to be declared a second time in

the ingredient statement.

Accordingly, the agency is proposing

in § 101.36(d) that the source of any

dietary ingredient (i.e., the ingredient

supplying the dietary ingredient) may

be added in parentheses immediately

following or indented beneath the name

of the dietary ingredient, and that the

words ‘‘as’’ or ‘‘from’’ must precede the

name of the source ingredient, e.g.,

‘‘calcium (as calcium carbonate)’’ or

‘‘calcium (from oyster shell powder).’’

By way of exception, the agency is

proposing that, if the name of the

dietary ingredient (e.g., Siberian

ginseng) or its synonym (e.g., ascorbic

acid as a synonym for vitamin C) is

itself the source ingredient, the listing of

the dietary ingredient will fulfill the

requirement for the listing of the

ingredient. In regard to the use of the

words ‘‘as’’ or ‘‘from,’’ many dietary

supplements in the marketplace

currently use such terminology. The

agency tentatively concludes that these

words will help to convey to consumers

the understanding that such compounds

are the source of the dietary ingredients.

If this proposal becomes final, when

a source is disclosed in parentheses in

the nutrition label, or when the name of

a dietary ingredient or its synonym (e.g.,

ascorbic acid) is itself the source

ingredient, the ingredient need not be

listed in the ingredient statement that is

required under section 403(i)(2) of the

act. When a source is not identified

within the nutrition label, proposed

§ 101.36(d) provides that it shall be

listed in the ingredient statement in

accordance with proposed § 101.4(g).

Under proposed § 101.4(g), the

ingredient statement on a dietary

supplement shall appear outside and

immediately below the nutrition label

or, if there is insufficient space below

the nutrition label, immediately

contiguous and to the right of the

nutrition label. This provision is in

accordance with section 403(q)(5)(F)(iv)

of the act, which was added by the

DSHEA. It requires that the nutrition

information immediately precede the

ingredient information. The agency

tentatively concludes that when there is

insufficient space below the nutrition

label, it is appropriate to allow the
67204 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

flexibility indicated and have the

nutrition label precede the ingredient

statement horizontally.

FDA is proposing in § 101.4(g) to

require that the ingredient list be

preceded by the word ‘‘Ingredients,’’

unless some ingredients (i.e., dietary

ingredients or sources of dietary

ingredients) are identified within the

nutrition label, in which case the

ingredients listed outside the nutrition

label shall be in a list preceded by the

words ‘‘Other Ingredients.’’ FDA is

proposing that the word ‘‘Ingredients’’

precede the list of ingredients so that

the appearance of this aspect of the label

is as consistent as possible with the

labeling of other foods. As stated above,

consistency in the presentation of food

labeling information enhances

consumer understanding. FDA is

proposing that the term ‘‘Other

Ingredients’’ be used to indicate to

consumers that some ingredient

information appears in the nutrition

information that precedes the ingredient

list.

Proposed § 101.4(g) also requires that

ingredients that are not, or do not

contain, dietary ingredients, such as

excipients, fillers, artificial colors,

artificial sweeteners, flavors, or binders,

be listed in the ingredient statement.

The agency acknowledges that a 1942

Trade Correspondence identified as TC387 (Ref. 5) exempted ‘‘excipients,

fillers, binders, and other fabricating

ingredients’’ from complete ingredient

declaration when used in manufacturing

dietary supplements (i.e., labels could

list ‘‘excipients’’ rather than listing

excipients by name). As explained in

the final rule on ingredient labeling (58

FR 2850 at 2869, January 6, 1993),

however, although TC–387 has not been

officially revoked, its position has been

overturned by more recent agency

statements of policy on this subject, as

expressed in the Federal Register of

August 2, 1973 (38 FR 20730), the

Federal Register of March 16, 1979 (44

FR 16005), and in subsequent

correspondence with industry (Refs. 6

and 7). These more recent statements of

policy make it clear that the label for

dietary supplements must contain a list

of nutrients and a full statement of

ingredients (except those exempted

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

declared by their common or usual

name. At this time, because TC–387

expresses a position contrary to the

agency’s policy since 1973, the agency

is revoking TC–387.

In proposed § 101.36(d)(1), the agency

is providing that source ingredients in

dietary supplements be identified in

accordance with § 101.4 that addresses

ingredient labeling for all food products.

A basic requirement of this section is

that ingredients be listed by common or

usual name (see § 101.4(a)). To help

ensure correct identification of herbs or

other botanicals, including algae and

fungi, the agency is proposing in

§ 101.4(h)(1) that the botanical name in

Latin binomial form be included in

parentheses following the common or

usual name. Proper scientific reference

to a species is done with its Latin

binomial, representing the genus in

which the species has been placed and

the species epithet, followed by the

designation of the author or authors

who published the name. When an

author has moved a species from one

genus to another, the name of the

original author is enclosed in

parentheses followed by the author who

made the transfer. To ensure that there

is consistency and clarity in declaration,

the agency is proposing that any

botanical name declared should be in

accordance with internationally

accepted rules on nomenclature, such as

those found in the International Code of

Botanical Nomenclature (Ref. 8). The

agency requests comments on this issue.

FDA recognizes that it is possible to

have more than one acceptable botanical

name in Latin form (i.e., a synonym).

FDA advises manufacturers to choose

the name that is most currently used in

commerce and in appropriate references

and, in cases of confusion, to consult

with the agency.

Section 403(s)(2)(C) of the act, which

was added by the DSHEA, provides that

a dietary supplement is misbranded if it

contains an herb or other botanical, and

the label or labeling of the supplement

fails to identify any part of the plant

from which the dietary ingredient is

derived. Accordingly, FDA is proposing

in § 101.4(h)(2) that this information be

provided as part of the required

ingredient information. While nothing

in the act requires that information on

the part of the plant from which a

botanical is derived be in a particular

place on the label, FDA tentatively finds

that it would be in the interest of

consumers if the information were

presented as part of the ingredient

information because it would ensure

that all the identifying information

about the herb or other botanical (i.e.,

common or usual name, Latin binomial,

and part of plant from which it is

derived) is presented in one place.

FDA is proposing in § 101.4(h)(2) to

require that the part or parts of the plant

(e.g., leaf, flower, root, fruit, seed, or

bark) be presented in parentheses

immediately following the Latin

binomial name of the botanical

ingredient. This manner of presentation

is consistent with the way other

clarifying information is presented in

ingredient statements (see § 101.4(d)

and (e)). Whenever information on the

part of the plant is presented on the

label or in labeling, FDA is proposing to

require that the name of the part of the

plant be expressed in English. FDA

tentatively concludes that

pharmaceutical names such as ‘‘flos’’ for

flower, ‘‘radix’’ for root, or ‘‘fructus’’ for

fruit should not be used because they

are not recognized in botanical

nomenclature, and their meanings

would not be commonly understood by

American consumers. When an entire

plant is used, the label should specify

‘‘entire plant’’ to meet the requirements

of the act.

The requirements of proposed

§ 101.4(h)(1) and (2) apply whether the

botanical ingredient is listed in an

ingredient statement or in the nutrition

label as provided by proposed

§ 101.36(d). However, inasmuch as

section 403(i) of the act does not require

ingredients to be listed when the food

contains only one ingredient, FDA is

proposing in § 101.36(h)(3) that for

single-ingredient dietary supplements,

the Latin binomial name and the part of

the plant from which the dietary

ingredient is derived may be

prominently placed on the principal

display panel or the information panel,

or included in the nutrition label.

In proposed § 101.36(d)(2), the agency

is requiring that when two or more

sources are listed within a parentheses,

they be listed in descending order by

weight, which is consistent with the

way ingredients are to be listed in

§ 101.4. This listing of ingredients in

descending order by weight will provide

consumers with an indication of the

relative amount of each ingredient in

the absence of information on their

actual amounts. As discussed elsewhere

in this preamble, the agency is not

proposing that other dietary ingredients

be listed in descending order by weight

because the amounts of these dietary

ingredients are required to be listed.

In proposed § 101.36(d)(3), the agency

is providing that representations that a

source ingredient conforms to an official

compendium may be included such as

by a reference to the compendium (e.g.,

‘‘Calcium (from calcium carbonate

USP)’’). This provision is consistent

with the discussion in the preamble of

the 1994 dietary supplement final rule

that explained that the agency would

not object to the use of the U.S.P.

symbol in the ingredient list to identify

those ingredients that are U.S.P. grade

(59 FR 354 at 369), as long as the

ingredients meet FDA’s compliance

requirements in § 101.9(g)(4), which are

discussed below under Compliance and
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67205

Location Requirements. The agency

recognizes that in some cases individual

dietary ingredients may conform to

compendial specifications even though

the entire product does not. Thus, the

agency is proposing in § 101.36(d)(3) to

allow individual dietary ingredients to

be so represented.

If such a representation is made, and

the ingredient does not comply with the

specifications of the official

compendium, the supplement would be

misbranded under 403(a) of the act. The

agency notes that section 403(s)(2)(D) of

the act provides that a dietary

supplement is misbranded if it is

represented as complying with an

official compendium and fails to do so.

Proposed § 101.36(d)(3) applies to

representations about a particular

ingredient and not the entire

supplement, as does section 403(s)(2)(D)

of the act.

H. Format Requirements

As stated above, the agency continues

to believe that consistency in the

presentation of nutrition information on

all foods will help consumers observe

and comprehend such information, as

required by section 2(b)(1)(A) of the

1990 amendments. Accordingly, FDA is

proposing in § 101.36(e) that the

information required in proposed

§ 101.36 (b) and (c) be presented in a

manner that is similar to the

requirements listed in § 101.9(d) for

conventional foods, as well as those in

current § 101.36 for dietary supplements

of vitamins and minerals. In this

rulemaking, the agency is proposing to

alter slightly the organization in current

§ 101.36 to combine all format

requirements in proposed § 101.36(e),

all exemptions in § 101.36(h), and all

special labeling provisions (such as

those for small or intermediate-sized

containers) in § 101.36(i), respectively.

Despite the desire for consistency in

the appearance of nutrition information

on dietary supplements and

conventional foods, the requirements

adopted in the DSHEA, such as the

listing of the names and amounts of

other dietary ingredients and the

optional listing of source information,

necessitate that there be some

differences in format. Accordingly, to

signal to consumers that nutrition

labeling on dietary supplements differs

in several significant respects from that

on conventional foods, FDA is

proposing in § 101.36(e)(1) that the title

for the nutrition information on

packages of dietary supplements be

‘‘Supplement Facts.’’ The agency

tentatively concludes that the title

‘‘Supplement Facts’’ and the proposed

format structure are sufficiently similar

to the title ‘‘Nutrition Facts’’ and the

format requirements used in nutrition

labeling of conventional foods for the

consumer to immediately recognize that

the information in the two boxes is

related. However, by the use of a

different name, the consumer can be

taught to recognize the basic structural

differences in nutrition information on

the two different types of food products.

For example, the nutrition information

on dietary supplements will have the

quantitative amounts by weight located

in a separate column; may include

source ingredients; and may not have a

‘‘% Daily Value’’ column if no dietary

ingredients having RDI’s or DRV’s are

present in the product. Comments are

requested on the appropriateness of the

title ‘‘Supplement Facts.’’

FDA is proposing in § 101.36 (e)(1)

through (e)(3) to maintain the graphic

requirements in current § 101.36(b) and

(c)(1) through (c)(5). These sections

require the use of the largest type size

within the nutrition label for the title;

bolding of the title and column

headings; a hairline box around the

nutrition label; a single easy-to-read

type style; all black or one color type on

a white or other neutral contrasting

background, whenever practical; upper

and lower case letters, except on very

small packages; at least one point

leading; and letters that do not touch.

The agency is retaining these

requirements because they are

responsible, in large measure, for the

appearance of the nutrition label and are

designed to maximize the legibility of

the label.

The agency is addressing type size

requirements in proposed § 101.36(e)(4).

Current § 101.36(c)(6) requires that: (1)

packages with less than 12 square

inches of total surface area available to

bear labeling (i.e., small-sized packages)

use a type size no smaller than 4.5 point

for the nutrition label, (2) packages with

12 to 40 square inches of total surface

area available to bear labeling (i.e.,

intermediate-sized packages) use a type

size no smaller than 6 point, and (3)

packages with more than 40 square

inches of total surface area available to

bear labeling use type size no smaller

than 8 point, except that these larger

packages could use 6 point type for

column headings, footnotes, and

information on beta-carotene, when

present. Because the DSHEA does not

necessitate any changes in type size, the

agency is proposing in § 101.36(e)(4) to

carry forward the requirement for largersized packages of 8 point type with 6

point type for column headings and

footnotes. (The agency is not proposing

to carry forward 6 point type for the

information on beta-carotene because

the agency tentatively concludes that

the type size for all dietary ingredients

should be uniform.) To be more

consistent with the organization of

§ 101.9, FDA is proposing to move the

exceptions in type size for small and

intermediate-sized packages to

§ 101.36(i)(2). The agency will discuss

these exceptions under section III.J. of

this document.

Proposed § 101.36(e)(5) requires a

hairline rule between the listing of each

dietary ingredient. This requirement is

identical to that in current

§ 101.36(c)(7). Following publication of

the 1994 dietary supplement final rule,

the agency received comment on this

requirement and on the effect that the

multiple hairlines could have on the

legibility of labels of products with large

numbers of dietary ingredients, where

labels have severe space constraints,

and where the minimum type size (i.e.,

4.5 point type) is used. FDA requests

comments on the use of hairlines to

separate the dietary ingredients listed.

Such comments will be particularly

helpful if actual sample labels are

included as well as suggestions for

when relief from such a requirement

should be provided, e.g., should

hairlines be omitted when more than 8

(or some other number) dietary

ingredients that qualify to use 4.5 point

type are listed? Comments should set

out in detail the basis for their

recommendations.

Comments received by the agency

since publication of the 1994 dietary

supplement final rule suggest that there

is some confusion about the relative size

of bars used to separate parts of the

nutrition label, and whether the bars are

required by regulation. It appears that

many persons were unable to find the

regulatory references to the bars in

current § 101.36 (b)(3), (b)(3)(ii), and

(b)(4). Therefore, FDA is proposing to

focus two paragraphs, § 101.36 (e)(6)

and (e)(7), specifically on bars, rather

than addressing them as ancillary issues

in broader provisions. These paragraphs

identify the points in the label format

where bars are required and

differentiate the thickness of the bars

(i.e., ‘‘heavy bars’’ versus ‘‘light bars’’).

In proposed § 101.36(e)(6), the agency

is requiring that a heavy bar be placed

beneath the subheading ‘‘Serving Size’’

or the subheading ‘‘Servings Per

Container’’ when it is required, beneath

the last dietary ingredient to be listed in

proposed § 101.36(b)(2)(i), and beneath

the last other dietary ingredient to be

listed in proposed § 101.36(b)(3). Also,

in proposed § 101.36(e)(7), the agency is

proposing that a light bar be placed

beneath the headings ‘‘Amount Per

Serving’’ and ‘‘% Daily Value,’’ which
67206 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

will be above the listing of ‘‘Calories,’’

when the latter is required.

Except for the introduction in this

rulemaking of a bar above, rather than

below, the listing of ‘‘Calories’’ and of

a bar to separate (b)(2)-dietary

ingredients from other dietary

ingredients, FDA is proposing no

change from the bars as currently

required above and beneath the

‘‘Amount Per Serving’’ heading in

current § 101.36(b)(3) and at the bottom

of the nutrition label in current

§ 101.36(b)(3)(ii). The use of the bars

and their respective thickness is

illustrated in sample labels under

proposed § 101.36(e)(10).

For products that contain both (b)(2)-

dietary ingredients and other dietary

ingredients, the heavy bar that FDA is

proposing to require in § 101.36(e)(6)(ii)

beneath the last (b)(2)-dietary ingredient

will result in a bar separating the list of

(b)(2)-dietary ingredients from that of

other dietary ingredients. FDA has

tentatively concluded that this visual

separation will assist consumers to

differentiate dietary ingredients for

which RDI’s and DRV’s have been

established from other dietary

ingredients for which such daily values

have not been established.

The agency interprets the direction

given in section 403(q)(5)(F)(i) of the act

that ‘‘nutrition information shall first

list those dietary ingredients * * * for

which a recommendation for daily

consumption has been established

* * * and shall list any other dietary

ingredient present and identified as

having no such recommendation’’ as

evidencing that such a differentiation

should be made. FDA has tentatively

concluded that the use of a heavy bar,

similar to that which is used in § 101.9

to differentiate vitamins and minerals

from preceding nutrients, will

distinguish the two groups of dietary

ingredients while helping to maintain

some consistency in the appearance

between nutrition labels on dietary

supplements and products represented

as conventional foods.

Proposed § 101.36(e)(8) addresses

how nutrition information is to be

presented on products that contain two

or more separately packaged dietary

supplements that differ from each other.

This section, which allows

manufacturers to choose between

separate nutrition labels for each

product or one aggregate nutrition label,

is analogous to § 101.9(d)(13) for

conventional foods and maintains the

provisions of current § 101.36(b)(3)(iii),

except that there is no longer a need to

specify that separate columns be used to

list quantitative amounts because the

agency is proposing to require that the

quantitative amounts on all dietary

supplements be listed in separate

columns.

Proposed § 101.36(e)(9), which

encourages uniformity in presentation,

and proposed § 101.36(e)(11), which

allows for flexibility when there is

insufficient continuous vertical space to

accommodate the required components

of the nutrition label, are identical to

current § 101.36(c)(8) and (c)(10).

Proposed § 101.36(e)(10) provides

sample labels to illustrate the format

requirements of § 101.36.

I. Compliance and Location

Requirements

FDA is proposing in § 101.36(f)(1) to

provide that compliance with § 101.36

will be determined using the procedures

outlined in § 101.9(g)(1) through (g)(8)

for conventional foods. These

regulations, which are cited in current

§ 101.36(d)(1), describe how FDA will

collect samples for compliance reviews

and the types of analytical methods that

it will use, set quantitative criteria (e.g.,

allowable margins of error) for added

and naturally occurring nutrients, and

provide for the use of FDA-approved

data bases.

An issue addressed in the preamble to

the 1994 dietary supplement final rule

was the requirement in § 101.9(g)(4)(i)

for added vitamins, minerals, protein,

dietary fiber, or potassium to be present

in amounts ‘‘at least equal to the value

for that nutrient declared on the label’’

(59 FR 354 at 369). A comment pointed

out that U.S.P. monographs for several

nutritional products require a minimum

nutrient content of 90 percent of the

label declaration, and that this

specification was in conflict with FDA’s

requirement that added nutrients be

present at 100 percent of declared value

when tested during the shelf life of the

product. In responding, the agency

noted an inconsistency in U.S.P.

directives in that the General Notices of

the U.S.P. state that a dosage should be

formulated to provide 100 percent of the

labeled amount (Ref. 9).

In light of new section 403(s)(2)(D) of

the act, the agency questioned whether

it should alter its long-standing

compliance criterion in § 101.9(g)(4)(i).

The agency reviewed its response to the

comment mentioned above and earlier

correspondence from the agency to

U.S.P. informing that organization that

anything less than 100 percent of the

value declared on the label for vitamin

and mineral products is not acceptable,

and that the only permissible deviation

from this requirement would be a

deviation that is attributable to the

variability of the analytical method (Ref.

10).

The agency tentatively concludes that

any deviation from the criterion in

§ 101.9(g)(4)(i) that is attributable to

reasons other than variability of

analytical methods would be a material

fact and would need to be disclosed on

the label if the agency were to allow less

than 100 percent of the value declared.

Accordingly, FDA has considered

proposing that, on labels of products

where U.S.P. specifications are met but

less than 100 percent of the labeled

amount is present, the U.S.P.

designation would be allowed with a

disclosure of the lack of the declared

amount (e.g., a symbol by the U.S.P.

designation that refers to a footnote that

states ‘‘May contain only ——% of the

amount listed’’). However, the agency is

concerned that such a message could

diminish consumer confidence in the

values declared in nutrition labeling for

all foods. Therefore, FDA tentatively

concludes that its previous position is

the better course of action (i.e., that,

other than deviations that are

attributable to the variability of the

analytical method, anything less than

100 percent of the value declared on the

label is not acceptable for added

nutrients). Consequently, FDA is not

proposing any change in its position

that the requirements for the nutrients

listed in § 101.9(g)(4) should pertain

regardless of whether these nutrients are

present in conventional foods or in

dietary supplements.

Likewise, the agency is proposing in

§ 101.36(f)(1) that the criteria in

§ 101.9(g)(3) and (g)(4) are applicable to

other dietary ingredients described in

proposed § 101.36(b)(3)(i). The agency is

unaware of any reason why these

criteria that pertain to dietary

ingredients that are nutrients should not

apply to other dietary ingredients.

Hence, the agency tentatively concludes

that other dietary ingredients, when

they are added, be present in amounts

at least equal to the values declared in

the nutrition label and, when they occur

naturally, be present in amounts at least

equal to 80 percent of the value

declared. The agency is also proposing

that reasonable excesses of other dietary

ingredients over labeled amounts are

acceptable within current good

manufacturing practice, which is

consistent with § 101.9(g)(6). The

agency is unaware of any reason at this

time for applying the approach in

§ 101.9(g)(5) to any other dietary

ingredients. This section provides that

food with a label declaration of calories,

sugars, total fat, saturated fat,

cholesterol, or sodium shall be deemed

to be misbranded under section 403(a)

of the act if a composite of the product
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67207

is found to contain more than 20

percent in excess of the amount

declared for one of these nutrients. FDA

is not aware of any other dietary

ingredient that should be singled out in

this way. The agency requests

comments on the proposed criteria for

other dietary ingredients.

In recognition of the fact that the

exemptive provisions referenced in

proposed § 101.36(f)(1) may not include

all situations in which nutrition

information is technologically infeasible

or impracticable on a particular

package, the agency is proposing in

§ 101.36(f)(2) to carry forward current

§ 101.36(d)(2), which provides the

opportunity in such a situation for firms

to write to the Office of Food Labeling,

FDA, to request additional exemptions

or alternative means of compliance.

This provision is identical to that in

§ 101.9(g)(9) for conventional foods. In

such a situation, the firm should state

why it is technologically infeasible or

impracticable for the specified products

to comply with the nutrition labeling

regulations, identify alternative means

of compliance that would be used to

provide nutrition information for the

product (e.g., specify type size

variations needed), and explain why

this mode of compliance would be

consistent with the intent of the 1990

amendments and the DSHEA.

With respect to analytical procedures

for compliance programs, § 101.9(g)(2)

states that FDA will use methods as

given in the ‘‘Official Methods of

Analysis of the AOAC [Association of

Official Analytical Chemists]

International’’ unless no AOAC method

is available or appropriate, in which

case other reliable and appropriate

analytical procedures will be used.

AOAC methods and other reliable

analytical methods exist for most

vitamins and minerals used as, or as a

component of, dietary supplements.

However, AOAC methods do not exist

for most other dietary ingredients,

including many botanicals.

Accordingly, the agency is interested in

identifying a variety of analytical

procedures and sources of information

that can be used for other dietary

ingredients. FDA requests comments on

appropriate analytical procedures or

other alternative approaches for

determining whether the dietary

supplement provides the quantity of

dietary ingredient listed in the nutrition

label for the supplement. Additionally,

FDA is requesting information on

organizations that establish such

procedures.

The agency is proposing in § 101.36(g)

to require that the location of nutrition

information on a label be in compliance

with § 101.2, except as provided in

proposed paragraphs (i)(2) and (i)(5) of

§ 101.36. Proposed (i)(2) states that

dietary supplements are subject to the

special labeling provisions specified in

§ 101.9(j)(13) for foods in small or

intermediate-sized packages. Section

101.9(j)(13)(ii)(D) provides that foods in

packages that have a total surface area

available to bear labeling of 40 or less

square inches may present the required

nutrition information on any label

panel. In addition, proposed (i)(5) states

that dietary supplements are subject to

the special labeling provision specified

in § 101.9(j)(17) for foods in packages

that have a total surface area available

to bear labeling greater than 40 square

inches but whose principal display

panel and information panel do not

provide sufficient space to

accommodate all required label

information (see 50 FR 17202, April 5,

1995). Section 101.9(j)(17) allows the

nutrition label on such packages to be

moved to any other label panel that is

readily seen by consumers. However,

because of the requirement in section

403(q)(5)(F)(iv) of the act that the

ingredient list immediately follow the

nutrition label, proposed § 101.36(i)(5)

states that the ingredient list shall

continue to be located immediately

below the nutrition label, or, if there is

insufficient space below the nutrition

label, immediately contiguous and to

the right of the nutrition label as

specified in § 101.4(g), which FDA has

proposed to adopt in this document.

J. Exemptions and Special Labeling

Provisions

FDA is proposing in § 101.36(h)(1)

and (h)(2) to provide for small business

exemptions in accordance with the 1990

amendments and the Nutrition Labeling

and Education Act Amendments of 1993

(the 1993 amendments) (Pub. L. 103–

80), which (1) stated that, after May 8,

1995, section 403(q)(5)(D) of the act,

which provides an exemption based on

total gross annual sales, shall apply to

food from retailers only, and (2)

established a new exemption for lowvolume food products from

manufacturers, packers, distributors,

and retailers that are small businesses.

A proposed rule to implement this

change in § 101.9(j) and current

§ 101.36(f) was published on March 14,

1994 (59 FR 11872). A final rule has not

yet been published.

To streamline the regulations and be

consistent with the manner in which

other exemptions and special labeling

provisions are listed in current

§ 101.36(f) and (g) (proposed § 101.36(h)

and (i)), FDA is proposing in

§ 101.36(h)(1) and (2) to cross reference

the small business exemption in

§ 101.9(j)(1) and the exemption for lowvolume food products of small

businesses in proposed § 101.9(j)(18),

respectively, rather than to

independently codify those exemptions

under § 101.36.

Proposed § 101.36(h)(3) incorporates

the exemption in § 101.9(j)(9) for foods

shipped in bulk form that are not for

distribution to consumers in such form

and that are for use solely in the

manufacture of other foods or that are to

be processed, labeled, or repacked at a

site other than where originally

processed or packed. This exemption

was incorrectly listed in current

§ 101.36(g) and identified as a special

labeling condition. Inasmuch as

nutrition labeling is not required on

products shipped in bulk form that are

not intended to be seen by consumers

(section 403(q)(5)(A)(v)) of the act, it is

being redesignated as an exemption

under proposed § 101.36(h)(3).

Special labeling provisions (or

conditions) are provided for specific

situations in which the product is not

exempt from nutrition labeling

requirements, but deviations from the

general nutrition labeling requirements

are necessary for a variety of reasons.

For example, proposed § 101.36(i)(1),

which was carried forward from current

§ 101.36(g), references § 101.9(j)(5)(i)

which describes a special labeling

provision that pertains to the nutrition

labeling of foods represented or

purported to be for children less the 2

years of age. In the nutrition labeling of

these foods, other than infant formula,

the listing of calories from fat, calories

from saturated fat, saturated fat,

polysaturated fat, monounsaturated fat,

and cholesterol is prohibited. FDA

included this special labeling provision

in its regulations to discourage the

inappropriate application of adult

dietary guidelines to infants and

toddlers (55 FR 29487 at 29506, July 19,

1990, as modified in 58 FR 2079 at

2150). While current § 101.36(g) also

cross references § 101.9(j)(5)(ii), which

addresses broader issues of the format of

nutrition labeling on foods intended for

children less than 4 years of ages, these

format issues are addressed elsewhere

in this proposed regulation (e.g., the

exclusion of percent Daily Value in

proposed § 101.36(b)(2)(iii)(F) for total

fat, saturated fat, cholesterol, sodium,

potassium, total carbohydrate, and

dietary fiber because DRV’s have not

been established for this age group).

Accordingly, proposed § 101.36(i)(1)

references only that portion of

§ 101.9(j)(5)(i) that prohibits the

inclusion of calories from fat, calories

from saturated fat, saturated fat,
67208 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

polyunsaturated fat, monounsaturated

fat, and cholesterol in the nutrition label

of foods, other than infant formula,

represented or purported to be for

children less than 2 years of age.

Proposed § 101.36(i)(2) describes

special labeling provisions for small and

intermediate-sized containers. Special

labeling provisions are provided for

these containers in current § 101.36(g)

which cross references § 101.9(j)(13).

Section 101.9(j)(13)(i) allows small

packages with less than 12 square

inches of space available to bear

labeling to supply an address or

telephone number for the consumer’s

use in obtaining nutrition information

in lieu of nutrition labeling when no

claims or other nutrition information are

present on the label or in labeling or

advertising, or, if they are present, to

provide the required nutrition

information in 6 point type or in all

upper case type of 1/16 inches

minimum height. Section 101.9(j)(13)(ii)

allows packages with 40 or less square

inches of space available to bear

labeling to present the nutrition label in

a tabular format when the package

shape and size cannot accommodate a

standard vertical display and in a linear

display if the label will not

accommodate a tabular display; to use

specified abbreviations; to shorten the

required footnotes; and to place the

required nutrition information on any

label panel.

In addition to cross referencing these

special labeling provisions, current

§ 101.36(c)(6) provides for smaller type

size requirements for dietary

supplements in small and intermediatesized containers. That provision allows

labels of dietary supplements in

packages with less than 12 square

inches of total surface area available to

bear labeling to use a type size no

smaller than 4.5 point in the nutrition

label, in packages with 12 to 40 square

inches of total surface area available to

bear labeling to use a type size no

smaller than 6 point, and in packages

with more than 40 square inches of total

surface area available to bear labeling to

use type size no smaller than 8 point,

except that these larger packages can

use 6 point type for column headings,

footnotes, and information on betacarotene, when present.

In proposed § 101.36(i)(2), FDA is

continuing to cross reference the special

provisions in § 101.9(j)(13) and to allow

the use of 4.5 point type on packages

with less than 12 square inches of

available label space and the use of 6

point type on packages with 12 to 40

square inches of available label space.

However, in response to a citizen

petition (Docket No. 94P–0110/CP1)

(Ref. 11) from a trade association, the

agency is proposing to provide

additional flexibility for multiingredient dietary supplements in

packages with less than 20 square

inches of available label space. The

petition stated that the majority of

dietary supplement products on the

market have labels that are 12 to 20

square inches in size, and that, while 6

point type in the nutrition label is

feasible on single-nutrient products

with this size label, there is insufficient

space for all the required information on

multinutrient products. The petitioner

submitted sample labels in support of

their position.

FDA is persuaded by this citizen

petition that it is infeasible to use 6

point type on many products containing

multiple dietary ingredients in packages

with less than 20 square inches of space

available to bear labeling. However, the

agency tentatively finds that 6 point

type is feasible on products with a

limited number of dietary ingredients

based on the following calculations. The

agency calculates that a listing of 8

dietary ingredients in 6 point type plus

one point leading between each name

would take less than 1 inch of vertical

space. Adding another inch to this for

the title, headings, bars, and footnote

would result in a nutrition label for a

product declaring up to 8 dietary

ingredients of no more, and possibly

less, than 2 inches in height. Assuming

a 11⁄2 inch width, such a nutrition label

would take no more than 3 square

inches of surface area.

In the preamble to the final rule

implementing the 1990 amendments,

FDA based decisions on small package

sizes on the assumption that not more

than 30 percent of the total surface area

of a package should be required to be

devoted to FDA-required information

that is not on the principal display

panel (58 FR 2079 at 2155). On a

package with 12 square inches of

available label space, 30 percent of the

total surface area is 3.6 square inches.

Inasmuch as the ingredient list can be

included in the nutrition label and

based on the above calculations, the

agency tentatively concludes that it is

reasonable to require that 6 point type

be used on a package with 12 to 20

square inches of space available to bear

labeling when 8 or fewer dietary

ingredients are listed. However, when a

dietary supplement is in a package that

has from 12 to 20 square inches of

surface area available to bear labeling,

and the nutrition label lists more than

8 dietary ingredients, the use of 6 point

type would likely mean that more than

30 percent of the total surface area of the

package would have to be devoted to

FDA required information. Therefore,

FDA is proposing in § 101.36(i)(2)(ii) to

provide for the use of a smaller type size

(i.e., a minimum of 4.5 point type) in

such circumstances.

It should be noted that the

dimensions used by the agency are

inclusive of ‘‘space available to bear

labeling,’’ not merely the dimensions of

the current label. When there is space

on the container to enlarge the current

label (i.e., unused surface area available

to bear labeling), and the current label

is not large enough to provide the

required information in accordance with

format and type size specifications, FDA

considers it is reasonable to expect that

the manufacturer, packer, or distributor

will increase the size of the label.

This action (i.e., proposing to allow

only those products with more than

eight dietary ingredients to use the

smaller type size) is supported by the

petitioner referred to above (Ref. 11),

who stated in followup correspondence

that, in a survey of its membership,

‘‘responding companies agreed that

eight or ten would be an appropriate

cutoff number, triggering the smaller

type size for multinutrient products,’’

and that the responding companies

believed that the cutoff should be set at

eight nutrients (Ref. 12).

The aforementioned citizen petition

(Ref. 11) also requested that § 101.2(c)

be amended to allow the type size

requirements in § 101.2 (c)(1) through

(c)(3) to apply to the labeling of dietary

supplements of vitamins and minerals.

Current § 101.36 and proposed § 101.36

include type size requirements for

varying sizes of packages of dietary

supplements. Therefore, the agency is

denying the request to have the type

size requirements in § 101.2(c) pertain

to the nutrition labeling of dietary

supplements.

The agency notes that § 101.2 (c)(1)

through (c)(3) were added to the

regulations in 1974 (39 FR 15268), in

part, in an effort to encourage

manufacturers, packers, and distributors

to include nutrition labeling on

conventional foods. However, because

the final rule on nutrition labeling (58

FR 2079) includes type size

requirements, the agency believes there

is no longer a need for § 101.2 (c)(1)

through (c)(3) to address the type size of

information in the nutrition label. The

agency plans to amend § 101.2 (c)(1)

through (c)(3) accordingly in a later

document dealing with the labeling of

conventional foods, as well as dietary

supplements, so that the rulemaking

will be seen by the greatest number of

persons who may be affected by such

action.
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67209

The agency is proposing, however, to

amend § 101.2 (b) and (f) to include

§ 101.36 among the list of sections

noted. Section 101.2(b) states that the

information required to appear under

the sections noted shall appear either on

the principal display panel or the

information panel unless otherwise

specified by regulation. Section 101.2(f)

provides that when the label of any

package is too small to accommodate all

of the information required under the

sections noted, FDA may establish by

regulation an acceptable alternative

method of disseminating such

information to the public (e.g., by the

use of smaller type size).

FDA is proposing a special labeling

provision in proposed § 101.36(i)(2)(iii)

for dietary supplements in packages that

have a surface area available to bear

labeling of 40 or less square inches.

Under this provision, when the

nutrition label on packages of this size

is presented on a label panel other than

the principal display or information

panels, as allowed in

§ 101.9(j)(13)(ii)(D), the ingredient

information must move in conjunction

with the nutrition label. This provision

is in response to section 403(q)(5)(F)(iv)

of the act as added by the DSHEA,

which states that nutrition information

shall immediately precede the

ingredient information.

In proposed § 101.36(i)(2)(iv), the

agency is providing additional

flexibility for dietary supplements in

packages that have a surface area

available to bear labeling of 40 or less

square inches. When it is not possible

for primary (inner) containers of this

size to comply with the type size

requirements, the agency is proposing

that type as small as needed may be

used in the nutrition label as long as the

primary container is securely enclosed

in outer packaging that bears nutrition

labeling in required type size. In the

preamble of the 1994 dietary

supplement final rule (59 FR 354 at

367), the agency erroneously advised

that it considered outer packaging that

securely encloses a primary container

and that is not intended to be separated

from the primary container under

conditions of retail sale to be the

equivalent of the product label. In these

situations, the agency stated that

manufacturers did not have to repeat the

nutrition information on the primary

container, although it encouraged them

to do so to give consumers easy access

to the information once the container is

removed from the outer packaging.

These statements were inconsistent with

section 201(k) of the act which defines

the term ‘‘label’’ as ‘‘* * * a display of

written, printed, or graphic matter upon

the immediate container of any article

* * *’’ as well as with previous agency

policy that requires that other required

information appear on the primary

container (e.g., statement of identity,

quantity of contents, name and place of

business of the manufacturer, packer, or

distributor). Therefore, nutrition

labeling is required to appear on the

label of the primary container. However,

consistent with FDA’s intent in the

preamble of the 1994 dietary

supplement final rule to allow

flexibility, the agency is proposing in

§ 101.36(i)(2)(iv) that when nutrition

labeling is presented in required type

size on outer packaging that securely

encloses a primary container and is not

intended to be separated from the

primary container under conditions of

retail sale, the nutrition labeling on the

primary container may use type size as

small as needed to accommodate all of

the required information on the label.

FDA is proposing to carry forward the

special labeling provisions in current

§ 101.36(g) for foods in multiunit

containers in proposed § 101.36(i)(3)

and for foods sold in bulk containers in

proposed § 101.36(i)(4).

FDA is proposing to add a special

labeling provision in proposed

§ 101.36(i)(5) for foods in packages that

have a total surface area available to

bear labeling greater than 40 square

inches but whose principal display

panel and information panel do not

provide sufficient space to

accommodate all required label

information. This provision cross

references § 101.9(j)(17), which was

recently added to the regulations (60 FR

17202, April 5, 1995) and allows the

nutrition label on such packages to be

placed on any alternate panel that can

be readily seen by consumers. However,

as previously discussed, ingredient

information must move in conjunction

with the nutrition label. Accordingly,

proposed § 101.36(i)(5) includes an

exception to § 101.9(j)(17) whereby the

ingredient list would continue to be

located immediately beneath the

nutrition label, or, if there is insufficient

space below the nutrition label,

immediately contiguous and to the right

of the nutrition label as proposed in

§ 101.4(g).

K. Misbranding Provisions

Current § 101.36(h), redesignated as

§ 101.36(j) in this proposed rulemaking,

cross references the misbranding

provisions of § 101.9(k) that were first

proposed in the Federal Register of

March 30, 1972 (37 FR 6493) and that

were issued and published in the

Federal Register of January 19, 1973 (38

FR 2125). These provisions were based

on findings of fact and conclusions of

law resulting from 1968–1970 Special

Dietary Hearings (38 FR 2143).

Following a comment period, these

regulations were modified and

published as final regulations in § 1.17

(i)(2) through (i)(6) on March 14, 1973

(38 FR 6961). In the reorganization and

republication of Title 21 of the Code of

Federal Regulations that appeared in the

Federal Register of March 15, 1977 (42

FR 14308), § 1.17(i) was recodified as

§ 101.9(i).

No changes were made to the original

codified language of the subject

paragraphs until regulations

implementing the 1990 amendments

were published on January 6, 1993, at

which time FDA redesignated the

paragraphs as § 101.9(k) and modified

§ 101.9(k)(1) to incorporate a reference

to the general requirements for health

claims in §§ 101.14 and 101.9(k)(5) in

response to requests to remove

restrictions about the incorporation of

substances such as rutin, inositol, and

other similar substances to conventional

foods or dietary supplements (38 FR

2478 at 2502 and 38 FR 2079 at 2166,

respectively).

The current misbranding provisions

in § 101.9(k) state that a food will be

considered to be misbranded under

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

its label or labeling represents, suggests,

or implies: (1) That the food, because of

the presence or absence of certain

dietary properties, is adequate or

effective in the prevention, cure,

mitigation, or treatment of any disease

or symptom except as provided for in

health claim regulations; (2) that a

balanced diet of ordinary foods cannot

supply adequate amounts of nutrients;

(3) that the lack of optimum nutritive

quality of a food, by reason of the soil

on which the food was grown, is or may

be responsible for an inadequacy or

deficiency in the quality of the diet; (4)

that the storage, transportation,

processing, or cooking of a food is or

may be responsible for an inadequacy or

deficiency in the quality of the diet; (5)

that the food has special dietary

properties when such properties are of

no significant value or need in human

nutrition; and (6) that a natural vitamin

in a food is superior to an added or

synthetic vitamin or to differentiate in

any way between vitamins naturally

present from those added.

FDA has reviewed these misbranding

provisions in light of the DSHEA and

current scientific knowledge. As a result

of its review, the agency is proposing to

delete current § 101.9 (k)(2) and (k)(5).

Section 101.9(k)(2) states that a food is

misbranded if its label or labeling

represents, suggests, or implies that a
67210 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

balanced diet of ordinary foods cannot

supply adequate amounts of nutrients.

The agency is deleting this provision

based on the acknowledgment by

scientific and consensus groups that

there are certain situations in which the

use of dietary supplements may be

needed for persons to obtain adequate

nutrient intakes. For example, the

National Academy of Sciences has

stated in the 10th edition of

‘‘Recommended Dietary Allowances’’

that ‘‘In a few cases where deficiency is

commonly observed (e.g., iron

deficiency in women), food fortification

and individual supplementation are

appropriate’’ (Ref. 13, p. 14). Also, the

‘‘Dietary Guidelines for Americans’’

states that supplements may be needed

by pregnant or lactating women; other

women in their childbearing years;

people who are unable to be active and

eat little food; and people, especially

older people, who take medicines that

interact with nutrients (Ref. 14). These

conclusions are supported by other

documents such as ‘‘Diet and Health,

Implications for Reducing Chronic

Disease Risk’’ (Ref. 15, pp. 509–525) and

a task force representing the American

Dietetic Association, National Council

Against Health Fraud, Inc., Society for

Nutrition Education, American Society

for Clinical Nutrition, and the American

Institute of Nutrition (Ref. 16).

Section 101.9(k)(5) states that a food

is misbranded if its label or labeling

represents, suggests, or implies that ‘‘the

food has dietary properties when such

properties are of no significant value or

need in human nutrition.’’ New section

403(r)(6) of the act, which was added by

the DSHEA, provides for statements

that, in part, describe the role of a

nutrient or dietary ingredient intended

to affect the structure or function in

humans or which describe general wellbeing from consumption of a nutrient or

dietary ingredient. There is no

requirement in this new section that the

subject of the statement be of significant

value or need in human nutrition.

Therefore, to eliminate any

inconsistency between section 403(r)(6)

of the act and the agency’s regulations,

FDA is proposing to delete § 101.9(k)(5).

If it adopts the proposed deletion of

§ 101.9 (k)(2) and (k)(5), the agency will

redesignate current § 101.9(k)(3) as

(k)(2), § 101.9(k)(4) as (k)(3), and

§ 101.9(k)(6) as (k)(4).

FDA is not aware of grounds for

eliminating the other provisions under

§ 101.9(k). However, if information is

provided in comments to this proposed

rule that persuades the agency that the

findings of fact and conclusions of law

resulting from 1968–1970 special

dietary hearings (38 FR 2143) that

underlie the other provisions in

§ 101.9(k) are no longer supportable,

FDA will consider deleting the subject

provisions in the final rule.

IV. Conforming Amendments

As previously discussed (in section

III.J. of this document), FDA is

proposing to amend § 101.2 (b) and (f)

to include § 101.36 in the lists of

sections noted. The agency is also

proposing to amend § 101.2(d)(1), which

states that all required label information

shall appear on the principal display

panel or the information panel. This

paragraph was recently amended in a

document entitled ‘‘Food Labeling;

Placement of the Nutrition Label on

Food Packages’’ (60 FR 17202, April 5,

1995) to exclude from its coverage

products that are exempt under

§ 101.9(j)(13), which allows flexibility in

the placement of the nutrition label on

packages that have less than 40 square

inches of space available to bear

labeling, and § 101.9(j)(17), which

allows the nutrition label on packages

that have a total surface area available

to bear labeling greater than 40 square

inches but whose principal display

panel and information panel do not

provide sufficient space to

accommodate all required information

to be placed on any alternate panel that

can be readily seen by consumers.

Inasmuch as proposed § 101.36 (i)(2)

and (i)(5) cross reference § 101.9 (j)(13)

and (j)(17), respectively, and therefore

similarly exclude dietary supplements

that meet the criteria in § 101.9 (j)(13)

and (j)(17) from coverage of

§ 101.2(d)(1), FDA is proposing to

amend that paragraph to cite § 101.36

(i)(2) and (i)(5) as exceptions.

Section 101.9(j)(6) of the nutrition

labeling regulations lists as an

exemption: Dietary supplements of

vitamins and minerals that have an RDI

as established in § 101.9(c)(8)(iv) of this

section or a DRV as established in

§ 101.9(c)(9) of this section shall be

labeled in compliance with § 101.36,

except that dietary supplements of

vitamins and minerals in food in

conventional form (e.g., a breakfast

cereals), of herbs, and of other similar

nutritional substances shall conform to

the labeling of this section.

As discussed previously (in section

III. of this document), the definition of

dietary supplements in new section

201(ff) of the act broadens the coverage

of proposed § 101.36 and eliminates

differentiation based on the form of the

food. Therefore, FDA is proposing to

amend § 101.9(j)(6) to exempt all dietary

supplements from coverage under

§ 101.9, noting that such foods must be

labeled in compliance with § 101.36.

The agency is also proposing to

amend § 101.65(b)(4) to modify the

example given of the statement of

identity of a dietary supplement of

vitamin C to incorporate the term

‘‘dietary supplement’’ in accordance

with proposed § 101.3(g). The amended

paragraph will state:

A statement of identity for a food in which

an ingredient constitutes essentially 100

percent of a food (e.g., ‘‘corn oil,’’ ‘‘oat bran,’’

‘‘dietary supplement of vitamin C 60 mg

tablet’’).

V. Regulatory Review Under Executive

Order 12866

This proposed rule has been deemed

by the Office of Information and

Regulatory Affairs (OIRA) of the Office

of Management and Budget to be a

significant regulatory action pursuant to

Section 3(f)(4) of Executive Order 12866

because it raises novel legal and/or

policy issues arising out of a legal

mandate, namely the DSHEA, or

principles set forth in Executive Order

12866. Accordingly, this proposed rule

has been formally reviewed by OIRA

pursuant to the provisions of Executive

Order 12866.

VI. Economic Impact

FDA has examined the economic

implications of the proposed rule as

required by Executive Order 12866 and

the Regulatory Flexibility Act (Pub. Law

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 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

an economically 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.

There are several different types of

products that may be considered to be

dietary supplements. These products

include, but are not limited to, vitamin

and mineral supplements, herbal

products, and products that contain

other similar nutritional substances.

Estimates of the number of such

products range from 4,000 to over

25,000 such products. Similarly,

estimates of the number of dietary

supplement manufacturers range from

150 to 600.
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67211

A. Costs

Categories of costs for relabeling

include administrative, analytical,

printing, inventory disposal, and

reformulation. The administrative costs

associated with a labeling regulation

result from the incremental

administrative labor expended in order

to comply with it. The administrative

activities that FDA anticipates will be

undertaken in response to a change in

regulation include: Identifying the

underlying policy of the regulation,

interpreting that policy relative to a

firm’s products, determining the scope

and coverage related to product labels,

establishing a corporate position,

formulating a method for compliance,

and managing the compliance method.

Longer compliance periods decrease

administrative costs because firm

executives often delegate downward

decisions that are less immediate. Many

firms estimate that administrative effort

would be twice as high for a 6-month

compliance period as for a 12- month

compliance period (Ref. 17). FDA is

proposing that any final rule that may

issue based upon this proposal become

effective January 1, 1997. This effective

date leads to a compliance period of

approximately 1 year. FDA estimates

that for a 1-year compliance period,

manufacturers of dietary supplements

will incur administrative costs of $425

per firm for each of between 150 and

600 firms, or a total of between

approximately $65,000 and $300,000.

FDA requests comments on whether

dietary supplement products will

undergo analytical testing as a result of

these regulations if implemented as

proposed. Dietary supplement products

need only list those nutrients present in

significant amounts. The agency

assumes that manufacturers of vitamin

and mineral supplements are already

aware of the nutritional content of their

products, and that those products will

not undergo any additional testing.

However, it is possible that herbal and

other botanical products may undergo

additional testing for their nutritional

content. The agency estimates that

between 4,000 and 20,000 products may

undergo testing once every 5 years for

a total discounted analytical cost over

the next 20 years of between $8.3 and

$41 million (7 percent discount rate).

However, many herbs do not contain

significant amounts of the nutrients that

must be listed in the nutrition label, and

this fact may be determinable from

reference works without testing. Thus,

some herbal and botanical products may

not require nutrient testing at all. FDA

requests comments on this issue.

FDA estimates that printing/redesign

costs for dietary supplement

manufacturers would be approximately

$1,000 per label for each of 75,000

labels with a 6-month compliance

period, or a total of $75 million.

However, the length of the compliance

period determines a firm’s ability to

combine planned label changes with

mandated changes. Therefore,

incremental labeling and redesign

activities are less costly with lengthier

compliance periods. With the proposed

compliance period of 1 year, printing

and redesign costs would be

approximately half that of a 6-month

compliance period, or approximately

$37.5 million.

FDA estimates the cost of inventory

disposal associated with a 1-year

compliance period to be approximately

$13 million. However, manufacturers of

these products have been aware of the

potential for regulated labeling changes

due to recent regulatory and legal

activities. FDA assumes that the

majority of these manufacturers have

been taking the necessary steps to

reduce their label inventories since

January of 1994, the date of publication

of FDA’s previous regulations regarding

the labeling of dietary supplements.

Therefore, the cost of inventory disposal

is more accurately calculated on a

compliance period of 2 years, or

approximately $6.5 million.

FDA has examined the impact of the

proposed regulations on dietary

supplement manufacturers and has

determined that administrative costs

would be between $65,000 and

$300,000, discounted analytical testing

costs would be between $8.3 and $41

million over the next 20 years (7 percent

discount rate), printing and redesign

costs would be $37.5 million, and

inventory disposal costs would be $6.5

million. Therefore, total discounted

costs are estimated to be between $52

and $85 million.

B. Benefits

According to Congress as stated in the

DSHEA, almost 50 percent of the

260,000,000 Americans regularly

consume dietary supplements of

vitamins, minerals, or herbs as a means

of improving their nutrition. Although

almost all dietary supplements of

vitamins and minerals currently contain

substantial nutrition information, many

other dietary supplements do not

typically provide such information.

Moreover, the information that is

presented is not presented in any

particular order or following any

particular format.

This proposed regulation will benefit

consumers by ensuring that adequate

and complete nutrition information is

provided accurately and consistently in

order to aid consumers in their dietary

choices. As consumers are given more

informative labeling in an improved

format, uncertainty and ignorance

concerning the ingredient and nutrient

content of the products they consume

will decrease, and some consumers may

select more nutritious, healthier

products. Moreover, since FDA began its

food labeling initiative in 1989, a theme

that has been consistently sounded is

that consumers will benefit from

nutrition labeling that is presented in a

consistent manner, not only within a

particular product class but also across

all foods. Such a consistent manner will

not only help to make the information

presented more comprehensible but will

facilitate comparisons among food

products. This proposed rule, if

adopted, will help to ensure that dietary

supplements are nutrition labeled in a

manner that is as consistent as possible

with other foods, yet, with such features

as the listing of substances for which no

daily reference amount has been

established, in a manner that is fully

tailored to the special nature of those

products.

All told, this action, if adopted, will

benefit consumers by ensuring that

nutrition labeling is provided on dietary

supplements in a manner that will help

consumers to follow healthy dietary

practices.

C. Regulatory Flexibility

According to the Regulatory

Flexibility Act, the definition of small

business is a business independently

owned and operated and not dominant

in its field. The Small Business

Administration (SBA) has set size

standards for most business categories

through use of four-digit Standard

Industrial Classification codes. For most

food processing industries, a business is

considered small if it has fewer than 500

employees. For dietary supplements, a

business is considered small if it has

fewer than 750 employees. FDA

estimates that the majority of

manufacturers of dietary supplements

meet the SBA definition of a small

business.

The agency has published an

exemption from mandatory nutrition

labeling for small businesses in

§ 101.9(j)(1) (incorporated in this

proposed rule in § 101.36(h)(1)) and has

proposed an exemption for low-volume

food products of small businesses in

§ 101.9(j)(18) (59 FR 11872, March 14,

1994) (incorporated in this proposed

rule in § 101.36(h)(2)). As of the date

this subject rulemaking is proposed to

become effective, January 1, 1997,
67212 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

§ 101.9(j)(1) (and proposed

§ 101.36(h)(1)) will only apply to

retailers. Proposed § 101.9(j)(18) (and

proposed § 101.36(h)(2)) will apply to

manufacturers, packers, distributors, or

retailers of low volume products,

defined as fewer than 200,000 units,

produced by firms with fewer than 200

employees. As of May 1997, criteria for

meeting the definition of low volume

product will be reduced to 100,000

units and 100 employees. FDA does not

have information to show how many

dietary supplement products would be

exempted under this provision. The

agency believes that several herbal and

botanical products will have unit sales

and firm size low enough to meet this

definition. Therefore, many of the

products produced by businesses

defined as small by the SBA will not be

subject to the rules if issued as

proposed.

The agency requests information

regarding the impact of this regulation

on small firms. Most of the costs

associated with labeling regulations are

fixed costs which are typically more

burdensome for small firms than for

large firms because of the smaller sales

base on which to spread costs. Estimates

of annual sales for the dietary

supplement industry range from $2.9

billion to over $4 billion. The estimated

cost of between $52 and $85 million is

approximately one to three percent of

industry annual sales. In relation to the

volume of sales, this amount does not

appear to represent a significant cost.

D. Summary

Total discounted costs of this

regulation is estimated to be between

$52 and $85 million over the next 20

years (7 percent discount rate). These

costs include administrative, analytical,

printing, and inventory disposal costs.

The benefits are improved and more

consistent information with which

consumers can refine their choices for

health or other reasons. FDA is unable

to quantify this benefit.

FDA has analyzed the costs and

benefits of this proposed rule and has

determined that it does not constitute an

economically significant rule as defined

by Executive Order 12866.

FDA has also analyzed the impacts on

small firms according to the Regulatory

Flexibility Act and has determined that

the proposed rules will probably not

have an adverse impact on a substantial

number of small businesses.

Nonetheless, the agency requests

comments on the impact on small

businesses and any burden-reducing

options.

VII. Environmental Impact

The agency has determined under

§ 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 environment assessment nor

an environmental impact statement is

required.

VIII. Paperwork Reduction Act of 1995

This proposed rule contains

information collections that are subject

to review by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (Pub. L. 104–13).

In particular, the proposed regulations

would require that manufacturers and

distributors of dietary supplements

disclose information on the levels of

specific nutrients on the label or in

labeling of their products with some

exceptions. Additionally, the proposed

regulations would require that these

firms disclose the quantity of other

dietary ingredients in their dietary

supplements. Therefore, in accordance

with 5 CFR Part 1320, FDA is providing

below the title, description, and

respondent descriptions for the

information collection requirements that

will be submitted to OMB along with an

estimate of the annual collection of

information burden. Included in the

estimate is the time for reviewing

instructions, searching existing data

sources, gathering necessary

information, and disclosure of the

information.

FDA is soliciting comments to: (1)

Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility; (2) evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) evaluate the quality,

utility, and clarity of the information to

be collected; and (4) minimize the

burden of the collection of information

on those who are to respond, including

through the use of automated collection

techniques or other forms of information

technology, when appropriate.

Title: Requirements for Nutrition and

Ingredient Labeling of Dietary

Supplements.

Description: The proposed rule,

§ 101.36, would require that most

dietary supplements provide on their

labels and in their labeling information

on the quantity of specific nutrients

present in them, along with daily value

for each, and the quantity of other

dietary ingredients. This requirement is

being proposed to implement the

requirements of the 1990 amendments

and the DSHEA.

The DSHEA requires that dietary

supplements provide information on

their labels as to the level of nutrients

and other dietary ingredients present in

them. The DSHEA requires that FDA

issue regulations to implement these

requirements within specific

timeframes. Section 101.36(b)(2)

specifies the nutrients for which amount

must be present on the labels of dietary

supplements and § 101.36(b)(3) provides

for the listing of the quantity of other

dietary ingredients, respectively. Other

paragraphs of § 101.36 provide

information to assist manufacturers and

distributors of dietary supplements to

determine the amount of nutrient that

their products contain and that should

be disclosed on the labels of the

products.

Description of Respondents: Persons

and businesses, including small

businesses.

Title 21 No. of respondents

No. of responses per

respondent

Total annual

responses

Hours per

response

Total annual

hours

Total operating maintenance

costs

101.36 ............................................................................... 600 40 24,000 4 96,000 $51,616,000

FDA estimates that each supplier of

dietary supplements will revise the

labels for each product that is not

otherwise exempt to comply with the

requirements for nutrition labeling

within the first year after publication of

a final rule. The agency expects that the

number of respondents and

corresponding annual burden hours will

decrease over succeeding years because

it does not believe that firms will

modify the composition of each of their

products and revise the labeling for each

of their products each year. FDA has

estimated the total annual operating and
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67213

maintenance costs of $51,616,000 based

on maximum estimated relabeling costs

of $34 million, all of which will be

incurred in the first year; annualized

analytical costs of $13.2 million; and

labor and overhead costs of $4.616

million for the first year. The agency

believes that these costs will decrease

significantly over succeeding years. The

agency does not believe that this

proposed regulation requires capital

costs on the part of respondents.

The agency has submitted copies of

the proposed rule to OMB for its review

of these requirements. Interested

persons are requested to send comments

regarding information collection by

Janaury 29, 1996, but not later than

February 26, 1996 to the Office of

Information and Regulatory Affairs,

OMB, New Executive Office Building,

rm. 10235, Washington, DC 20503,

ATTN: Desk Officer for FDA.

IX. Effective Date

FDA is proposing to make this

regulation effective on January 1, 1997.

This date is consistent with section 7(e)

of the DSHEA, which states that dietary

supplements must be labeled in

accordance with its provisions after

December 31, 1996.

X. 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.

XI. 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. Lehninger, A. L., ‘‘Biochemistry,’’

Second Edition, pp. 57–58, Worth Publishers,

Inc., New York, NY, 1977.

2. Memorandum of telephone conversation

between Mr. Mark Blumenthal, American

Botanical Council, and Susan Thompson,

FDA, March 16, 1995.

3. Bass, I. S., A. L. Young, and S. C. Stolzer,

Piper & Marbury, letter to F. E. Scarbrough,

January 31, 1995.

4. Covington & Burling, ‘‘Dietary

Supplement Health and Education Act of

1994,’’ October 12, 1994.

5. FDA trade correspondence letter (387),

June 23, 1942.

6. FDA opinion letter, Taylor M. Quinn,

Office of Compliance, Bureau of Foods, to

Stanley Skelskie, March 30, 1979.

7. FDA opinion letter, Taylor M. Quinn,

Office of Compliance, Bureau of Foods, to

Stanley Skelskie, January 25, 1980.

8. Greuter, W., editor (chairperson),

International Code of Botanical

Nomenclature (Tokyo Code) Adopted by the

15th International Botanical Congress, Koeltz

Scientific Books, D–61453 Konigstein,

Germany, 1994.

9. U. S. Pharmacopeial Convention, Inc.

USP XXII, NF XVII, The United States

Pharmacopeia, The National Formulary,

General Notices and Requirements Applying

to Standards, Test, Assays, and Other

Specifications of the United States

Pharmacopeia, pp. 1 to 3, January 1, 1990.

10. Tanner, J. T., letter to V. Srinivasan,

U.S. Pharmacopeial Convention, Inc., May 7,

1991.

11. Citizen Petition, Docket No. 94P–0110/

CP1.

12. Dickinson, Annette, Council for

Responsible Nutrition, Letter to Susan

Thompson, FDA, February 28, 1995.

13. Subcommittee on the 10th Edition of

the RDA’s, Food and Nutrition Board,

Commission of Life Sciences, National

Research Council, ‘‘Recommended Dietary

Allowances, 10th Ed.,’’ p. 14, Washington,

DC, National Academy Press, 1989.

14. U.S. Department of Agriculture and

U.S. Department of Health and Human

Services, ‘‘Nutrition and Your Health, Dietary

Guidelines for Americans,’’ Home and

Garden Bulletin No. 232, U.S. Government

Printing Office, Washington DC, 1990.

15. Committee on Diet and Health, Food

and Nutrition Board, Commission of Life

Sciences, National Research Council, ‘‘Diet

and Health, Implications for Reducing

Chronic Disease Risk,’’ Chapter 18, Dietary

Supplements, National Academy Press,

Washington, DC, 1989.

16. ‘‘Recommendations concerning

supplement usage: ADA statement,’’ Journal

of the American Dietetic Association,

87:1742–3, 1987.

17. Center for Economics Research,

‘‘Compliance Costs of Food Labeling

Regulations Final Report,’’ prepared under

FDA Contract No. 223–87–2097, Washington,

DC, FDA, DHHS, 1991.

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 is revised 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,

501, 502, 505, 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 351, 352, 355, 371).

1. Section 101.2 is amended by

revising paragraphs (b), (d)(1), and (f) to

read as follows:

§ 101.2 Information panel of package form

food.

* * * * *

(b) All information required to appear

on the label of any package of food

pursuant to §§ 101.4, 101.5, 101.8,

101.9, 101.13, 101.17, 101.36, subpart D

of part 101, and part 105 of this chapter

shall appear either on the principal

display panel or on the information

panel, unless otherwise specified by

regulations in this chapter.

* * * * *

(d)(1) Except as provided by

§ 101.9(j)(13) and (j)(17) and

§ 101.36(i)(2) and (i)(5), all information

required to appear on the principal

display panel or on the information

panel under this section shall appear on

the same panel unless there is

insufficient space. In determining the

sufficiency of the available space,

except as provided by § 101.9(j)(17) and

§ 101.36(i)(5), any vignettes, designs,

and other nonmandatory label

information shall not be considered. If

there is insufficient space for all of this

information to appear on a single panel,

it may be divided between these two

panels except that the information

required under any given section or part

shall all appear on the same panel. A

food whose label is required to bear the

ingredient statement on the principal

display panel may bear all other

information specified in paragraph (b) of

this section on the information panel.

* * * * *

(f) If the label of any package of food

is too small to accommodate all of the

information required by §§ 101.4, 101.5,

101.8, 101.9, 101.13, 101.17, 101.36,

subpart D of part 101, and part 105 of

this chapter, the Commissioner may

establish by regulation an acceptable

alternative method of disseminating

such information to the public, e.g., a

type size smaller than one-sixteenth

inch in height, or labeling attached to or

inserted in the package or available at

the point of purchase. A petition

requesting such a regulation, as an

amendment to this paragraph, shall be

submitted under part 10 of this chapter.

2. Section 101.3 is amended by

adding new paragraph (g) to read as

follows:

§ 101.3 Identity labeling of food in

packaged form.

* * * * *

(g) When a food is marketed as a

dietary supplement, the label shall bear

the term ‘‘dietary supplement’’ as a part

of the statement of identity in
67214 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

conformance with the provisions of

paragraph (d) of this section.

3. Section 101.4 is amended by

revising paragraph (a)(1) and adding

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

follows:

§ 101.4 Food; designation of ingredients.

(a)(1) Ingredients required to be

declared on the label or labeling of a

food, including foods that comply with

standards of identity, except those

ingredients exempted by § 101.100,

shall be listed by common or usual

name in descending order of

predominance by weight on either the

principal display panel or the

information panel in accordance with

the provisions of § 101.2, except that

ingredients in dietary supplements that

are listed in the nutrition label in

accordance with § 101.36 need not be

repeated in the ingredient list.

Paragraph (g) of this section describes

the ingredient list on dietary

supplement products.

* * * * *

(g) When present, the ingredient list

on dietary supplement products shall be

located immediately below the nutrition

label, or, if there is insufficient space

below the nutrition label, immediately

contiguous and to the right of the

nutrition label and shall be preceded by

the word ‘‘Ingredients,’’ unless some

ingredients (i.e., sources) are identified

within the nutrition label in accordance

with § 101.36(d), in which case the

ingredients listed outside the nutrition

label shall be in a list preceded by the

words ‘‘Other Ingredients.’’ Ingredients

in dietary supplements that are not

dietary ingredients or that do not

contain dietary ingredients, such as

excipients, fillers, artificial colors,

artificial sweeteners, flavors, or binders,

shall be included in the ingredient list.

(h) The common or usual name of

ingredients of dietary supplements that

are botanicals (including fungi and

algae) shall be immediately followed by

parenthetical statements of:

(1) The Latin binomial name of the

plant. Any name in Latin form shall be

in accordance with internationally

accepted rules on nomenclature, such as

those found in the International Code of

Botanical Nomenclature, and shall

include the designation of the author or

authors who published the Latin name,

when appropriate; and

(2) The part of the plant (e.g., root,

leaves) from which the dietary

ingredient is derived (e.g., ‘‘Garlic

(Allium sativum L.) (bulb)’’), except that

this designation is not required for

algae. The name of the part of the plant

shall be expressed in English (e.g.,

‘‘flower’’ rather than ‘‘flos’’).

(3) On labels of single-ingredient

dietary supplements that do not include

an ingredient list, the required

identification of the Latin binomial

name and the part of the plant may be

prominently placed on the principal

display panel or information panel, or

included in the nutrition label.

4. Section 101.9 is amended by

revising paragraph (j)(6), by removing

paragraphs (k)(2) and (k)(5), and by

redesignating paragraphs (k)(3), (k)(4),

and (k)(6) as (k)(2), (k)(3), and (k)(4),

respectively, to read as follows:

§ 101.9 Nutrition labeling of food.

* * * * *

(j) * * *

(6) Dietary supplements, except that

such foods shall be labeled in

compliance with § 101.36.

* * * * *

5. Section 101.12 is amended in

paragraph (b), Table 2, by revising the

entry ‘‘Dietary supplements not in

conventional food form’’ under the

subheading ‘‘Miscellaneous category’’ to

read as follows:

§ 101.12 Reference amounts customarily

consumed per eating occasion.

* * * * *

(b) * * *

TABLE 2.—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY 1,2,3,4

Product category Reference amount Label statement 5

* * * * * * *

Miscellaneous Category—

* * * * * * *

Dietary supplements ........... The maximum amount recommended, as appropriate,

on the label for consumption per eating occasion, or,

in the absence of recommendations, 1 unit, e.g., tablet, capsule, packet, teaspoonsful, etc.

lll tablet(s) lll capsule(s), ll packet(s),

tsp(s) (lllg), etc.

* * * * * * *

1These values represent the amount (edible portion) of food customarily consumed per eating occasion and were primarily derived from the

1977–78 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or almost ready-to-serve form of

the product (i.e, heat and serve, brown and serve). If not listed separately, the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; dry, fresh, and frozen pasta) is the amount required to make the reference amount of the prepared form. Prepared

means prepared for consumption (e.g., cooked). 3 Manufacturers are required to convert the reference amount to the label serving size in a household measure most appropriate to their specific product using the procedures in 21 CFR 101.9(b). 4 Copies of the list of products for each product category are available from the Office of Food Labeling (HFS–150), Center for Food Safety

and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204. 5The label statements are meant to provide guidance to manufacturers on the presentation of serving size information on the label, but they

are not required. The term ‘‘piece’’ is used as a generic description of a discrete unit. Manufacturers should use the description of a unit that is

most appropriate for the specific product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided

is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not apply to the products which require

further preparation for consumption (e.g., dry mixes, concentrates) unless specifically stated in the product category, reference amount, or label

statement column that it is for these forms of the product. For products that require further preparation, manufacturers must determine the label

statement following the rules in § 101.9(b) using the reference amount determined according to § 101.12(c).
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67215

* * * * *

6. Section 101.36 is revised to read as

follows:

§ 101.36 Nutrition labeling of dietary

supplements.

(a) The label of a dietary supplement

shall bear nutrition labeling in

accordance with this regulation unless

an exemption is provided for the

product in paragraph (h) of this section.

(b) The declaration of nutrition

information on the label and in labeling

shall contain the following information,

using the subheadings and the format

specified in paragraph (e) of this

section.

(1) Serving size. (i) The subheading

‘‘Serving Size’’ shall be placed under

the heading ‘‘Supplement Facts’’ and

aligned on the left side of the nutrition

label. The serving size shall be

determined in accordance with

§§ 101.9(b) and 101.12(b), Table 2.

Serving size for dietary supplements

shall be expressed using a term that is

appropriate for the form of the

supplement, such as ‘‘tablets,’’

‘‘capsules,’’ ‘‘packets,’’ or

‘‘teaspoonfuls.’’

(ii) The subheading ‘‘Servings Per

Container’’ shall be placed under the

subheading ‘‘Serving Size’’ and aligned

on the left side of the nutrition label,

except that this information need not be

provided when it is stated in the net

quantity of contents declaration.

(2) Information on dietary ingredients

that have a Reference Daily Intake (RDI)

or a Daily Reference Value (DRV) as

established in § 101.9(c) and their

subcomponents (hereinafter referred to

as ‘‘(b)(2)-dietary ingredients’’).

(i) The (b)(2)-dietary ingredients to be

declared, that is, total calories, calories

from fat, total fat, saturated fat,

cholesterol, sodium, total carbohydrate,

dietary fiber, sugars, protein, vitamin A,

vitamin C, calcium and iron, shall be

declared when they are present in a

dietary supplement in quantitative

amounts by weight that exceed the

amount that can be declared as zero in

nutrition labeling of foods in accordance

with § 101.9(c). Calories from saturated

fat and polyunsaturated fat,

monounsaturated fat, soluble fiber,

insoluble fiber, sugar alcohol, and other

carbohydrate may be declared, but they

shall be declared when a claim is made

about them. Any other vitamins or

minerals listed in § 101.9(c)(8)(iv) or in

§ 101.9(c)(9) may be declared, but they

shall be declared when they are added

to the product for purposes of

supplementation, or when a claim is

made about them. Any (b)(2)-dietary

ingredients that are not present, or that

are present in amounts that can be

declared as zero in § 101.9(c), shall not

be declared (e.g., amounts

corresponding to less than 2 percent of

the RDI for vitamins and minerals).

Protein shall not be declared on labels

of products that, other than ingredients

added solely for technological reasons,

contain only individual amino acids.

(A) The names and the quantitative

amounts by weight of each (b)(2)-dietary

ingredient shall be presented under the

heading ‘‘Amount Per Serving.’’ The

heading may be centered over the

column of quantitative amounts,

described by paragraph (b)(2)(ii) of this

section, if space permits. When the

serving size of the product is one unit

(e.g., one tablet), a heading consistent

with the declaration of the serving size,

such as ‘‘Amount Per Tablet’’ or ‘‘Each

Tablet Contains,’’ may be used in place

of the heading ‘‘Amount Per Serving.’’

Other appropriate terms, such as

capsule, packet, or teaspoonful, also

may be used in place of the term

‘‘Serving.’’

(B) The names of dietary ingredients

that are declared under paragraph

(b)(2)(i) of this section shall be

presented in a column aligned on the

left side of the nutrition label in the

order and manner of indentation

specified in § 101.9(c) except that

calcium and iron shall follow

pantothenic acid, and sodium and

potassium shall follow chloride. This

results in the following order for

vitamins and minerals: Vitamin A,

vitamin C, vitamin D, vitamin E,

vitamin K, thiamin, riboflavin, niacin,

vitamin B6, folate, vitamin B12, biotin,

pantothenic acid, calcium, iron,

phosphorus, iodine, magnesium, zinc,

selenium, copper, manganese,

chromium, molybdenum, chloride,

sodium, and potassium. The (b)(2)-

dietary ingredients shall be listed

according to the nomenclature specified

in § 101.9.

(1) When ‘‘Calories’’ are declared,

they shall be listed first in the column

of names, beneath a light bar separating

the heading ‘‘Amount Per Serving’’ from

the list of names. When ‘‘Calories from

fat’’ or ‘‘Calories from saturated fat’’ are

declared, they shall be indented beneath

‘‘Calories.’’

(2) The following synonyms may be

added in parentheses immediately

following the name of these (b)(2)-

dietary ingredients: Vitamin C (ascorbic

acid), thiamin (vitamin B1), riboflavin

(vitamin B2), folate (folacin or folic

acid), and calories (energy). Energy

content per serving may be expressed in

kilojoules units, added in parentheses

immediately following the statement of

caloric content.

(3) Beta-carotene may be declared as

the percent of vitamin A that is present

as beta-carotene, except that the

declaration is required when a claim is

made about beta-carotene. When

declared, the percent shall be declared

to the nearest whole percent,

immediately adjacent to or beneath the

name vitamin A (e.g., ‘‘Vitamin A (90%

as beta-carotene)’’). The amount of betacarotene in terms of international units

(IU) may be included in parentheses

following the percent statement (e.g.,

‘‘Vitamin A (90% (4500 IU) as betacarotene)’’).

(ii) The number of calories, if

declared, and the quantitative amount

by weight per serving of each dietary

ingredient required to be listed under

paragraph (b)(2)(i) of this section shall

be presented in a separate column

aligned to the right of the column of

names. The quantitative amounts by

weight shall represent the weight of the

dietary ingredient rather than the weight

of the source of the dietary ingredient

(e.g., the weight of calcium rather than

that of calcium carbonate).

(A) These amounts shall be expressed

in the increments specified in § 101.9

(c)(1) through (c)(7), which includes

increments for sodium and potassium.

(B) The amounts of vitamins and

minerals, excluding sodium and

potassium, shall be the actual amount of

the vitamin or mineral included in one

serving of the product, using the units

of measurement and the levels of

significance given in § 101.9(c)(8)(iv),

except that zeros following decimal

points may be dropped, and additional

levels of significance may be used when

the number of decimal places indicated

is not sufficient to express lower

amounts (e.g., the RDI for zinc is given

in whole milligrams (mg), but the

quantitative amount may be declared in

tenths of a mg).

(iii) The percent of the Daily Value of

all dietary ingredients declared under

paragraph (b)(2)(i) of this section shall

be listed except that the percent for

protein may be omitted as provided in

§ 101.9(c)(7), no percent shall be given

for subcomponents for which DRV’s

have not been established (e.g., sugars),

and, for labels of dietary supplements of

vitamins and minerals that are

represented or purported to be for use

by infants, children less than 4 years of

age, or pregnant or lactating women, no

percent shall be given for total fat,

saturated fat, cholesterol, total

carbohydrate, dietary fiber, sodium,

potassium, vitamin K, chloride,

chromium, manganese, molybdenum, or

selenium.

(A) When information on the percent

of Daily Values is listed, this
67216 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

information shall be presented in one

column aligned under the heading of

‘‘% Daily Value’’ and to the right of the

column of amounts. The headings ‘‘%

Daily Value (DV),’’ ‘‘% DV,’’ ‘‘Percent

Daily Value,’’ or ‘‘Percent DV’’ may be

substituted for ‘‘% Daily Value.’’ The

heading ‘‘% Daily Value’’ shall be

placed on the same line as the heading

‘‘Amount Per Serving.’’

(B) The percent of Daily Value shall

be calculated by dividing the

quantitative amount by weight of each

(b)(2)-dietary ingredient by the RDI as

established in § 101.9(c)(8)(iv) or the

DRV as established in § 101.9(c)(9) for

the specified dietary ingredient and

multiplying by 100, except that the

percent of Daily Value for protein, when

present, shall be calculated as specified

in § 101.9(c)(7)(ii). The actual

quantitative amount by weight of each

dietary ingredient shall be used in this

calculation, except that for total fat,

saturated fat, cholesterol, sodium,

potassium, total carbohydrate, and

dietary fiber, the percent shall be

calculated by dividing either the

quantitative amount by weight declared

on the label or the actual amount (i.e.,

before rounding) by the DRV for the

dietary ingredient. The numerical value

shall be followed by the symbol for

percent (i.e., %).

(C) The percentages based on RDI’s

and on DRV’s shall be expressed to the

nearest whole percent, except that for

dietary ingredients for which DRV’s

have been established, ‘‘Less than 1%’’

or ‘‘<1%’’ shall be used to declare the

‘‘% Daily Value’’ when the quantitative

amount of the dietary ingredient by

weight is great enough to require that

the dietary ingredient be listed, but the

amount is so small that the ‘‘% Daily

Value’’ when rounded to the nearest

percent is zero (e.g., the percent Daily

Value for 1 gram of total carbohydrate

is to be listed as ‘‘Less than 1%’’ or

‘‘<1%’’).

(D) If the percent of Daily Value is

declared for total fat, saturated fat, total

carbohydrate, dietary fiber, or protein, a

symbol shall follow the value listed for

those nutrients that refers to the same

symbol that is placed at the bottom of

the nutrition label, below the bar

required under paragraph (e)(6) of this

section and inside the box, that is

followed by the statement ‘‘Percent

Daily Values are based on a 2,000

calorie diet.’’

(E) The percent of Daily Value shall

be based on RDI and DRV values for

adults and children 4 or more years of

age, unless the product is represented or

purported to be for use by infants,

children less than 4 years of age,

pregnant women, or lactating women, in

which case the column heading shall

clearly state the intended group. If the

product is for persons within more than

one group, the percent of Daily Value

for each group shall be presented in

separate columns as shown in paragraph

(e)(10)(ii) of this section.

(F) For declared subcomponents that

have no DRV’s and, on the labels of

dietary supplements of vitamins and

minerals that are represented or

purported to be for use by infants,

children less that 4 years of age, or

pregnant or lactating women, for total

fat, saturated fat, cholesterol, total

carbohydrate, dietary fiber, sodium,

potassium, vitamin K, chloride,

chromium, manganese, molybdenum, or

selenium, a symbol (e.g., an asterisk)

shall be placed in the ‘‘Percent Daily

Value’’ column that shall refer to the

same symbol that is placed at the

bottom of the nutrition label, below the

last heavy bar and inside the box, and

followed by the statement ‘‘Daily Value

not established.’’

(G) When calories, calories from fat,

or calories from saturated fat are

declared, the space under the ‘‘% Daily

Value’’ column shall be left blank for

these items. When there are no other

(b)(2)-dietary ingredients listed for

which a value must be declared in the

‘‘% Daily Value’’ column, the column

may be omitted as shown in paragraph

(e)(10)(vii) of this section. When the ‘‘%

Daily Value’’ column is not required,

but the dietary ingredients listed are

subject to paragraph (b)(2)(iii)(F) of this

section, the symbol required in that

paragraph shall immediately follow the

quantitative amount by weight for each

dietary ingredient listed under ‘‘Amount

Per Serving.’’

(3) Information on dietary ingredients

for which RDI’s and DRV’s have not

been established. (i) Dietary ingredients

for which FDA has not established an

RDI or DRV and that are not subject to

regulation under paragraph (b)(2) of this

section (hereinafter referred to as ‘‘other

dietary ingredients’’) shall be declared

by their common or usual name when

they are present in a dietary

supplement, in a column that is under

the column of names described in

paragraph (b)(2)(i)(B) of this section and

under the heavy bar described in

paragraph (e)(6) of this section, except

that if no (b)(2)-dietary ingredients are

declared, other dietary ingredients shall

be listed directly beneath the heading

‘‘Amount Per Serving’’ described in

paragraph (b)(2)(i)(A).

(ii) The quantitative amount by

weight per serving of other dietary

ingredients shall be presented in a

separate column aligned to the right of

the column of names and underneath

the column of amounts described in

paragraph (b)(2)(ii) of this section. The

quantitative amount by weight shall be

the weight of the other dietary

ingredient listed and not the weight of

any component, or the source, of that

dietary ingredient. These amounts shall

be expressed using metric measures in

appropriate units (i.e., 1,000 or more

units shall be declared in the next

higher set of units, e.g., 1,100 mg shall

be declared as 1.1 g). For any dietary

ingredients that are liquid extracts, the

weight shall not include the weight of

solvents.

(iii) Other dietary ingredients shall

bear a symbol (e.g., an asterisk) in the

column under the heading of ‘‘% Daily

Value’’ that refers to the same symbol

placed at the bottom of the nutrition

label and followed by the statement

‘‘Daily Value not established,’’ except

that when the heading ‘‘% Daily Value’’

is not used, the symbol shall follow the

quantitative amount by weight for each

dietary ingredient listed.

(c) A proprietary blend of dietary

ingredients shall be included in the list

of dietary ingredients described in

paragraph (b)(3)(i) of this section and

identified by the term ‘‘Proprietary

Blend,’’ which may be modified by an

appropriate descriptive term or fanciful

name. Except as specified in this

paragraph, all other requirements for the

listing of dietary ingredients in dietary

supplements are applicable.

(1) Dietary ingredients contained in

the proprietary blend that are listed

under paragraph (b)(2) of this section

shall be declared in accordance with

paragraph (b)(2) of this section.

(2) Dietary ingredients contained in

the proprietary blend that are listed

under paragraph (b)(3) of this section

(i.e., ‘‘other dietary ingredients’’) shall

be declared in descending order of

predominance by weight, in a column or

linear fashion, and indented under the

term ‘‘Proprietary Blend.’’

(3) The quantitative amount by weight

specified for the proprietary blend shall

be the total weight of all other dietary

ingredients contained in the proprietary

blend and shall be placed on the same

line to the right of the term ‘‘Proprietary

Blend’’ underneath the column of

amounts described in paragraph

(b)(2)(ii) of this section. A symbol (e.g.,

asterisk), which refers to the same

symbol placed at the bottom of the

nutrition label that is followed by the

statement ‘‘Daily Value not

established,’’ shall be placed under the

heading ‘‘% Daily Value,’’ if present, or

immediately following the quantitative

amount by weight for the proprietary

blend.
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67217

(4) The sample label shown in

paragraph (e)(10)(v) of this section

illustrates one method of nutrition

labeling a proprietary blend of dietary

ingredients.

(d) The source ingredient that

supplies a dietary ingredient may be

identified within the nutrition label in

parentheses immediately following or

indented beneath the name of a dietary

ingredient and preceded by the words

‘‘as’’ or ‘‘from’’, e.g., ‘‘Calcium (as

calcium carbonate),’’ except that manner

of presentation is unnecessary when the

name of the dietary ingredient (e.g.,

Siberian ginseng) or its synonym (e.g.,

ascorbic acid) is itself the source

ingredient. When a source ingredient is

identified in parentheses within the

nutrition label, or when the name of the

dietary ingredient or its synonym is the

source ingredient, it shall not be

required to be listed again in the

ingredient statement that appears

outside of the nutrition label. When a

source ingredient is not identified

within the nutrition label, it shall be

listed in an ingredient statement in

accordance with § 101.4(g), which shall

appear outside and immediately below

the nutrition label or, if there is

insufficient space below the nutrition

label, immediately contiguous and to

the right of the nutrition label.

(1) Source ingredients shall be

identified in accordance with § 101.4

(i.e., shall be listed by common or usual

name, and the listing of botanicals shall

specify the Latin binomial name and the

part of the plant from which the

ingredient is derived) regardless of

whether they are listed in an ingredient

statement or in the nutrition label.

(2) When source ingredients are listed

within the nutrition label, and two or

more are used to provide a single

dietary ingredient, all of the sources

shall be listed within the parentheses in

descending order by weight.

(3) Representations that the source

ingredient conforms to an official

compendium may be included either in

the nutrition label or in the ingredient

list (e.g., ‘‘Calcium (as calcium

carbonate USP)’’).

(e) Nutrition information specified in

this section shall be presented as

follows:

(1) The title, ‘‘Supplement Facts,’’

shall be set in a type size larger than all

other print size in the nutrition label

and, unless impractical, shall be set full

width of the nutrition label. The title

and all headings shall be bolded to

distinguish them from other

information.

(2) The nutrition information shall be

enclosed in a box by using hairlines.

(3) All information within the

nutrition label shall utilize:

(i) A single easy-to-read type style,

(ii) All black or one color type,

printed on a white or other neutral

contrasting background whenever

practical,

(iii) Upper and lower case letters,

except that all uppercase lettering may

be utilized for packages that have a total

surface area available to bear labeling of

less than 12 square inches,

(iv) At least one point leading (i.e.,

space between lines of text), and

(v) Letters that do not touch.

(4) Except as provided for small and

intermediate-sized packages under

paragraph (i)(2) of this section,

information other than the title,

headings, and footnotes shall be in

uniform type size no smaller than 8

point. Type size no smaller than 6 point

may be used for column headings (e.g.,

‘‘Amount Per Serving’’ and ‘‘% Daily

Value’’) and for footnotes (e.g., ‘‘Percent

Daily Values are based on a 2,000

calorie diet’’).

(5) A hairline rule that is centered

between the lines of text shall separate

each dietary ingredient required in

paragraph (b)(2) and (b)(3) of this

section from the dietary ingredient

above and beneath it, as shown in

paragraph (e)(10) of this section.

(6) A heavy bar shall be placed:

(i) Beneath the subheading ‘‘Servings

Per Container’’ except that if ‘‘Servings

Per Container’’ is not required and, as a

result, not declared, the bar shall be

placed beneath the subheading ‘‘Serving

Size,’’

(ii) Beneath the last dietary ingredient

to be listed under paragraph (b)(2)(i) of

this section, if any, and

(iii) Beneath the last other dietary

ingredient to be listed under paragraph

(b)(3) of this section, if any.

(7) A light bar shall be placed beneath

the headings ‘‘Amount Per Serving’’ and

‘‘% Daily Value.’’

(8) If the product contains two or

more separately packaged dietary

supplements that differ from each other

(e.g., the product has a packet of

supplements to be taken in the morning

and a different packet to be taken in the

afternoon), the quantitative amounts

and percent of Daily Value may be

presented as specified in this paragraph

in individual nutrition labels or in one

aggregate nutrition label as illustrated in

paragraph (e)(10)(iii) of this section.

(9) In the interest of uniformity of

presentation, FDA urges that the

information be presented using the

graphic specifications set forth in

Appendix B to part 101, as applicable.

(10) The following sample labels are

presented for the purpose of illustration:

BILLING CODE 4160–01–P
67218 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67219
67220 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67221

BILLING CODE 4160–01–C
67222 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

(11) If space is not adequate to list the

required information as shown in the

sample labels in paragraph (e)(10) of

this section, the list may be split and

continued to the right as long as the

headings are repeated. The list to the

right shall be set off by a line that

distinguishes it and sets it apart from

the dietary ingredients and percent of

Daily Value information given to the

left. The following sample label

illustrates this display:

BILLING CODE 4160–01–P
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules 67223

BILLING CODE 4160–01–C
67224 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Proposed Rules

(f)(1) Compliance with this section

will be determined in accordance with

§ 101.9 (g)(1) through (g)(8). The criteria

on class I and class II nutrients given in

§ 101.9 (g)(3) and (g)(4) also are

applicable to other dietary ingredients

described in paragraph (b)(3)(i) of this

section. Reasonable excesses of these

other dietary ingredients over labeled

amounts are acceptable within current

good manufacturing practice.

(2) When it is not technologically

feasible, or some other circumstance

makes it impracticable, for firms to

comply with the requirements of this

section, FDA may permit alternative

means of compliance or additional

exemptions to deal with the situation in

accordance with § 101.9(g)(9). Firms in

need of such special allowances shall

make their request in writing to the

Office of Food Labeling (HFS–150),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204.

(g) Except as provided in paragraphs

(i)(2) and (i)(5) of this section, the

location of nutrition information on a

label shall be in compliance with

§ 101.2.

(h) Dietary supplements are subject to

the exemptions specified in:

(1) § 101.9(j)(1) for dietary

supplements that are offered for sale by

a person who makes direct sales to

consumers (i.e., a retailer) who has

annual gross sales or business done in

sales to consumers that is not more than

$500,000 or has annual gross sales made

or business done in sales of food to

consumers of not more than $50,000,

and whose labels, labeling, and

advertising do not provide nutrition

information or make a nutrient content

or health claim;

(2) § 101.9(j)(18) for dietary

supplements that are low- volume

products (that is, they meet the

requirements for units sold in

§ 101.9(j)(18) (i) or (ii)) that, except as

provided in § 101.9(j)(18)(iv), are the

subject of a claim for an exemption that

provides the information required under

§ 101.9(j)(18)(iv), that is filed before the

beginning of the time period for which

the exemption is claimed, and that is

filed by a person that qualifies to claim

the exemption under the requirements

for average full-time equivalent

employees in § 101.9(j)(18) (i) or (ii),

and whose labels, labeling, and

advertising do not provide nutrition

information or make a nutrient content

or health claim;

(3) § 101.9(j)(9) for dietary

supplements shipped in bulk form that

are not for distribution to consumers in

such form and that are for use solely in

the manufacture of other dietary

supplements or that are to be processed,

labeled, or repacked at a site other than

where originally processed or packed.

(i) Dietary supplements are subject to

the special labeling provisions specified

in:

(1) § 101.9(j)(5)(i) for food, other than

infant formula, represented or purported

to be specifically for infants and

children less than 2 years of age, in that

nutrition labels on such foods shall not

include calories from fat, calories from

saturated fat, saturated fat,

polyunsaturated fat, monounsaturated

fat, and cholesterol;

(2) § 101.9(j)(13) for foods in small or

intermediate-sized packages, except

that:

(i) All information within the

nutrition label on small-sized packages,

which have a total surface area available

to labeling of less than 12 square inches,

shall be in type size no smaller than 4.5

point;

(ii) All information within the

nutrition label on intermediate-sized

packages, which have from 12 to 40

square inches of surface area available

to bear labeling, shall be in type size no

smaller than 6 point, except that dietary

supplements in which there are more

than 8 dietary ingredients to be listed in

the nutrition label, and that are in

packages that have less than 20 square

inches of surface area available to bear

labeling, may use type size no smaller

than 4.5 point when necessary.

(iii) When the nutrition information is

presented on any panel under

§ 101.9(j)(13)(ii)(D), the ingredient list

shall continue to be located

immediately below the nutrition label,

or, if there is insufficient space below

the nutrition label, immediately

contiguous and to the right of the

nutrition label as specified in § 101.4(g).

(iv) When it is not possible for a small

or intermediate-sized package that is

enclosed in an outer package to comply

with these type size requirements, the

type size of the nutrition label on the

primary (inner) container may be as

small as needed to accommodate all of

the required label information provided

that the primary container is securely

enclosed in outer packaging, the

nutrition labeling on the outer

packaging meets the applicable type size

requirements, and such outer packaging

is not intended to be separated from the

primary container under conditions of

retail sale.

(3) § 101.9(j)(15) for foods in multiunit

food containers;

(4) § 101.9(j)(16) for foods sold in bulk

containers; and

(5) § 101.9(j)(17) for foods in packages

that have a total surface area available

to bear labeling greater than 40 square

inches but whose principal display

panel and information panel do not

provide sufficient space to

accommodate all required label

information, except that the ingredient

list shall continue to be located

immediately below the nutrition label,

or, if there is insufficient space below

the nutrition label, immediately

contiguous and to the right of the

nutrition label as specified in § 101.4(g).

(j) Dietary supplements shall be

subject to the misbranding provisions of

§ 101.9(k).

7. Section 101.65 is amended by

revising paragraph (b)(4) to read as

follows:

§ 101.65 Implied Nutrient Content Claims

and Related Label Statements.

* * * * *

(b) * * *

(4) A statement of identity for a food

in which an ingredient constitutes

essentially 100 percent of a food (e.g.,

‘‘corn oil,’’ ‘‘oat bran,’’ ‘‘dietary

supplement of vitamin C 60 mg tablet’’).

* * * * *

Dated: October 11, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 95–31196 Filed 12–27–95; 8:45 am]

BILLING CODE 4160–01–P