Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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 Sec. 101.36) and to

require that dietary supplements of herbs or other similar nutritional

substances comply with the general regulation on nutrition labeling

(Sec. 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 (Sec. 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

Sec. 101.36, and for dietary supplements of herbs and other nutritional

substances, which the agency said were subject to Sec. 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 Sec. 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

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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

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

Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 102.5 pertaining to uniformity of common or

usual

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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 Sec. 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 Sec. 101.36

A. Foods Covered by Sec. 101.36

The agency is proposing to revise Sec. 101.36(a) to state that the

label of a dietary supplement shall bear nutrition labeling in

accordance with Sec. 101.36, unless an exemption is provided for the

product in Sec. 101.36(h). Previously, only dietary supplements of

vitamins and minerals were subject to the provisions of Sec. 101.36. As

stated above, dietary supplements of herbs and other similar

nutritional substances were to follow the general nutrition labeling

requirements in Sec. 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 Sec. 101.36(a) to reflect this change.

B. General Requirements

In Sec. 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 Sec. 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

Sec. 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 Sec. 101.36.

C. Serving Size

Proposed Sec. 101.36 (b)(1)(i) and (b)(1)(ii) on serving size and

on servings per container, respectively, differ only slightly from

current Sec. 101.36 (b)(1) and (b)(2). In the first sentence of

proposed Sec. 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 Sec. 101.36(b)(1)(i) for

clarity.

On a related note, the agency points out that it is proposing to

change the language in Sec. 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 Sec. 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

Sec. 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 Sec. 101.9 (c)(7)(iii) and (c)(8)(iv) or a Daily

Reference Value (DRV) as established in Sec. 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 Sec. 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

Sec. 101.36(b)(2) and the information required in the listing of other

dietary ingredients in proposed Sec. 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 Sec. 101.36(b)(2)(i)

that the 14 nutrients

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that, under Sec. 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 Sec. 101.9(c). For clarity, the agency is identifying these

nutrients by name in this proposed paragraph. This requirement is

consistent with current Sec. 101.36(b)(3), except that the current

provision calls for ``a listing of all nutrients required in

Sec. 101.9(c),'' rather than specifying the name of each nutrient.

However, current Sec. 101.36(b)(3) is silent on the subcomponents

(e.g., polyunsaturated fat, soluble fiber, sugar alcohols) specified in

Sec. 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 Sec. 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., Sec. 101.36). Therefore, the agency has tentatively

concluded that it is appropriate to provide for the listing of the

subcomponents specified in Sec. 101.9(c). Accordingly, the agency is

providing in proposed Sec. 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 Sec. 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

Sec. 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 Sec. 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 Sec. 101.9 and dietary supplements under

Sec. 101.36 (section 2(b)(1)(A) of the 1990 amendments). Thus, the

agency is proposing that subcomponents that are not specified in

Sec. 101.9(c), e.g., individual amino acids, be listed under proposed

Sec. 101.36(b)(3) as dietary ingredients for which RDI's and DRV's have

not been established.1

\1\ To 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 Sec. 101.36(b)(2) as

``(b)(2)-dietary ingredients'' and to all other dietary ingredients

as ``other dietary ingredients.''

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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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 101.36(b)(3) requires a listing of

``nutrients required in Sec. 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 Sec. 101.9(c),'' while

Sec. 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 Sec. 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 Sec. 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

[[Page 67198]]

elsewhere in this issue of the Federal Register), their listing is

covered by the reference to all other vitamins or minerals listed in

Sec. 101.9(c)(8)(iv) in proposed Sec. 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

Sec. 101.36(b)(3).

FDA is also providing in proposed Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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

Sec. 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

Sec. 101.36(b)(2)(i)(B). Proposed Sec. 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

Sec. 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 Sec. 101.9(d)(5).

Proposed Sec. 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 Sec. 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 Secs. 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 Sec. 101.9 (58 FR 2079 at 2178) and issued

Sec. 101.36 (59 FR 373). Before the agency took these actions,

Sec. 101.9 had listed ``folic acid'' as the preferred term, with

``folacin'' as an allowable parenthetical synonym. When amendments to

Sec. 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 Sec. 101.36(b)(3)(v) to include ``folic acid'' as

an allowable synonym for folate. The agency advises that it intends to

revise Sec. 101.9(c)(8)(v) to allow the listing of folic acid as a

synonym for folate on conventional foods as well.

In proposed Sec. 101.36(b)(2)(i)(B)(3), the agency provides that

the percent of vitamin A that is present as beta-carotene may be

declared immediately adjacent to or beneath the listing of vitamin A.

This proposed provision essentially carries forward current

Sec. 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 Sec. 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

[[Page 67199]]

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.

\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.)

---------------------------------------------------------------------------

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 Sec. 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 Sec. 101.9(c)(1) through (c)(7), which

includes increments for sodium and potassium. This proposed provision

is carried forward from current Sec. 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 Sec. 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

Sec. 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 Sec. 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

Sec. 101.36(b)(3)(i).

3. Declaration of Percent Daily Value for Each (b)(2)-Dietary

Ingredient

In proposed Sec. 101.36(b)(2)(iii), the agency is requiring that a

percent Daily Value, where appropriate, be listed for the dietary

ingredients declared under Sec. 101.36(b)(2)(i), except that: (1) The

percent for protein may be omitted as provided in Sec. 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 Sec. 101.36. The listing of no percent Daily Value

for subcomponents is new in this proposal, but it is consistent with

current Sec. 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 Sec. 101.9(c) because

Sec. 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 Sec. 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 Sec. 101.36. The agency

points out that, in current Sec. 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

[[Page 67200]]

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 (Sec. 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 Sec. 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 Sec. 101.36(b)(4), except that

the heading need not appear on a line lower than the heading ``Amount

Per Serving.'' Current Sec. 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 Sec. 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

Sec. 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 Sec. 101.9(c)

provides for the declaration of their weight in rounded increments.

The agency is also rewording current Sec. 101.36(b)(4)(ii), which

it is carrying forward as proposed Sec. 101.36(b)(2)(iii)(C), to make

clear when ``Less than 1%'' (or ``1,2,3,4

----------------------------------------------------------------------------------------------------------------

Product category Reference amount Label statement \5\

----------------------------------------------------------------------------------------------------------------

* * * * * *

*

Miscellaneous Category--

* * * * * *

*

Dietary supplements.......................... The maximum amount recommended, ______ tablet(s) ______

as appropriate, on the label capsule(s), ____ packet(s),

for consumption per eating tsp(s) (______g), etc.

occasion, or, in the absence of

recommendations, 1 unit, e.g.,

tablet, capsule, packet,

teaspoonsful, etc.

* * * * * *

*

----------------------------------------------------------------------------------------------------------------

\1\ These 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.

\5\ The 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 Sec. 101.9(b) using the reference amount determined according to Sec.

101.12(c).

[[Page 67215]]

* * * * *

6. Section 101.36 is revised to read as follows:

Sec. 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 Secs. 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

Sec. 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 Sec. 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 Sec. 101.9(c)(8)(iv) or in Sec. 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 Sec. 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 Sec. 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 Sec. 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 beta-carotene in terms of international

units (IU) may be included in parentheses following the percent

statement (e.g., ``Vitamin A (90% (4500 IU) as beta-carotene)'').

(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

Sec. 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 Sec. 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

Sec. 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

[[Page 67216]]

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 Sec. 101.9(c)(8)(iv) or the DRV as established in

Sec. 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 Sec. 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.

[[Page 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

Sec. 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

Sec. 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

[[Page 67218]]

[GRAPHIC][TIFF OMITTED]TP28DE95.000

[[Page 67219]]

[GRAPHIC][TIFF OMITTED]TP28DE95.001

[[Page 67220]]

[GRAPHIC][TIFF OMITTED]TP28DE95.002

[[Page 67221]]

[GRAPHIC][TIFF OMITTED]TP28DE95.003

BILLING CODE 4160-01-C

[[Page 67222]]

(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

[[Page 67223]]

[GRAPHIC][TIFF OMITTED]TP28DE95.004

BILLING CODE 4160-01-C

[[Page 67224]]

(f)(1) Compliance with this section will be determined in

accordance with Sec. 101.9 (g)(1) through (g)(8). The criteria on class

I and class II nutrients given in Sec. 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 Sec. 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 Sec. 101.2.

(h) Dietary supplements are subject to the exemptions specified in:

(1) Sec. 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) Sec. 101.9(j)(18) for dietary supplements that are low- volume

products (that is, they meet the requirements for units sold in

Sec. 101.9(j)(18) (i) or (ii)) that, except as provided in

Sec. 101.9(j)(18)(iv), are the subject of a claim for an exemption that

provides the information required under Sec. 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 Sec. 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) Sec. 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) Sec. 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) Sec. 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 Sec. 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 Sec. 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) Sec. 101.9(j)(15) for foods in multiunit food containers;

(4) Sec. 101.9(j)(16) for foods sold in bulk containers; and

(5) Sec. 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 Sec. 101.4(g).

(j) Dietary supplements shall be subject to the misbranding

provisions of Sec. 101.9(k).

7. Section 101.65 is amended by revising paragraph (b)(4) to read

as follows:

Sec. 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