Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation

SUMMARY: The Food and Drug Administration (FDA) is amending its food

labeling regulations to establish requirements for the identification

of dietary supplements and for their nutrition labeling and ingredient

labeling in response to the Dietary Supplement Health and Education Act

of 1994 (the DSHEA). FDA is also responding to a citizen petition from

the Council for Responsible Nutrition on type size requirements for

these products. In addition, FDA is announcing the revocation of

Compliance Policy Guide 530.400 (CPG 7121.02) entitled ``Vitamin

Products for Human Use--Low Potency'' to eliminate inconsistencies with

the new labeling requirements.

DATES: The regulation is effective March 23, 1999. The Director of the

Office of the Federal Register approves the incorporations by reference

in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain

publications in 21 CFR 101.4(h), effective March 23, 1999.

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

In the Federal Register of December 28, 1995 (60 FR 67194), FDA

published a proposed rule entitled ``Food Labeling; Statement of

Identity, Nutrition Labeling and Ingredient Labeling of Dietary

Supplements'' (hereinafter identified as ``the December 1995

proposal''). This document, which specifically responds to the DSHEA,

superseded earlier documents responding to the Nutrition Labeling and

Education Act of 1990 (the 1990 amendments)(Pub. L. 101-535) and the

Dietary Supplement Act of 1992 (the DS act) (Pub. L. 102-571) with

respect to dietary supplements.

The 1990 amendments 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 provides that most foods are misbranded

unless they bear nutrition labeling.

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

403(q)(5)(E)) of the act provided that separate regulations on the

nutrition labeling of dietary supplements of vitamins and minerals

could be established that are distinct from those for other foods. In

response to this section, FDA proposed a regulation in Sec. 101.36 (21

CFR 101.36) that was specifically on the nutrition labeling of dietary

supplements of vitamins and minerals, and a separate general regulation

that was on the nutrition labeling in Sec. 101.9 (21 CFR 101.9) of

conventional foods and of all other dietary supplements (those of herbs

and other nutritional substances) (56 FR 60366, November 27, 1991).

On October 6, 1992, the President signed into law the DS act. 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. Also, it required

that a new proposed regulation on the nutrition labeling of dietary

supplements be issued by June 15, 1993, and a final rule by December

31, 1993.

In response to the DS act, FDA published a new proposed rule in the

Federal Register of June 18, 1993 (58 FR 33715), and a final rule on

January 4, 1994 (59 FR 354), on the nutrition labeling of dietary

supplements. As mandated in section 403(q)(5)(F) of the act, the final

rule established a regulation (Sec. 101.36) on the specific

requirements for nutrition labeling of dietary supplements of vitamins

and minerals.

On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into

law. The DSHEA 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

combination of any of the previously mentioned ingredients. This

section also states that the term ``dietary supplement'' means a

product that is labeled as a dietary supplement.

Furthermore, the DSHEA, among other things, amended section

403(q)(5)(F) of the act by adding specific requirements that relate to

the labeling of, and ingredient declaration on, dietary supplement

products. Previously, this section had applied only to dietary

supplements of vitamins and minerals and had not offered any

description of how the labeling of these products should differ from

the labeling of foods in general. As amended by the DSHEA, section

403(q)(5)(F) of the act provides that dietary ingredients that do not

have daily values (i.e., Reference Daily Intakes (RDI's) or Daily

Reference Values (DRV's)) must be listed within the nutrition

information, that the listing of dietary ingredients must include the

quantity of each dietary ingredient (or of a proprietary blend of such

dietary ingredients), and that the listing of dietary ingredients may

include the source of a dietary ingredient. It also provides that the

nutrition information must immediately precede the ingredient

information required under the act.

FDA received over 50 letters in response to the December 1995

proposal. Each of these letters contained one or more comments.

Responses were received from industry, trade associations, consumers,

consumer advocacy organizations, health care professionals,

professional societies, and city governments. Many comments supported

the proposal generally or supported aspects of the proposal. Other

comments objected to specific provisions of the proposal and requested

revisions. Some comments addressed issues outside the scope of the

proposal and will not be discussed here. A summary of the relevant

comments, the agency's responses to the comments, and a discussion of

the agency's conclusions follows.

II. The Term ``Dietary Supplement'' in the Statement of Identity

1. A number of comments objected to the proposed requirement in

Sec. 101.3(g) (21 CFR 101.3(g)) that the term ``dietary supplement''

appear as part of the statement of identity of dietary supplements.

Some of these comments requested the flexibility of allowing this term

either in the statement of identity or elsewhere on the label, such as

on the principal display panel or in the directions for use. A couple

of comments stated that, if the nutrition label was given the title

``Dietary Supplement Facts,'' a consumer could utilize the nutrition

label to identify the

[[Page 49827]]

product as a dietary supplement, making it unnecessary to include the

term as part of the statement of identity. Other comments requested

that FDA allow for reasonable flexibility in the use of synonyms or

modifiers for the term ``dietary supplement,'' such as ``Nutritional

Supplement,'' ``Herbal Supplement,'' ``Multivitamin/Multimineral

Supplement,'' or ``Amino Acid Blend.''

The comments presented a number of reasons for their disagreement

with the proposal. Several comments stated that the inclusion of the

term ``dietary supplement'' as part of the statement of identity on the

principal display panel overreaches the legislative intent of the

DSHEA. These comments stated that the DSHEA does not specify where the

term ``dietary supplement'' should be placed, and that, therefore,

flexibility of placement of the term is warranted. One comment stated

that it objected to FDA transforming an ``identify'' requirement in the

DSHEA into an ``identity'' requirement in the use of the term ``dietary

supplement.'' The comment asserted that the term ``identify'' in the

DSHEA is different from the requirement in 15 U.S.C. 1453(a)(1) (i.e.,

``the identity of the commodity''), upon which the identity labeling

provisions in Sec. 101.3 are based. Several comments stated that the

term ``dietary supplement'' by itself is inappropriate as a common

descriptor for dietary supplements because they include a wide range of

products, which meet vastly different consumer needs. These comments

stated that the term ``dietary'' does not add additional value to the

statement of identity, and that consumers might interpret the term

``dietary'' as part of the statement of identity to suggest that the

supplement is a weight loss or meal replacement product. These comments

stated that the statutory requirement that the term ``identify'' the

product could be satisfied with the use of the term ``supplement.'' One

comment submitted a market research study on consumer perception of the

term ``dietary supplement,'' which indicated that over 50 percent of

the subjects were confused by the term when used with the claim ``high

potency.'' One comment stated that the United States Pharmacopeia (USP)

has established a number of monographs of official names for specific

nutritional supplements but they do not include the term ``dietary

supplement.'' Several comments pointed out that use of the term

``dietary supplement'' is not part of their products' trademarked

terminology.

Several comments suggested that the agency provide alternate

requirements for dietary supplements in conventional food form to

distinguish them from conventional foods (e.g., cereals, snack bars,

drinks), requiring that the term ``dietary supplement'' appear on the

principal display panel, although not necessarily as part of the

statement of identity. These comments stated that dietary supplements

in capsule or tablet form are obviously dietary supplements, are easily

distinguished by consumers from conventional foods, and should not have

the same identity requirement. A few comments argued that there are

space limitations on the principal display panel of some dietary

supplements, and that the term ``dietary supplement'' uses up available

label space.

The agency has carefully reviewed these comments but concludes that

the best reading of the act, as well as the agency's longstanding

regulations that implement the act, require that the term ``dietary

supplement,'' or some form of this term, appear as part of the

statement of identity. Section 201(ff)(2)(C) of the act, in defining

the term ``dietary supplement,'' mandates that such a product must be

labeled as a dietary supplement. Section 403(s)(2)(B) of the act 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.'' Section

403(i)(1) of the act requires that a food label must bear the common or

usual name of the food, that is, a statement that identifies the food.

Dietary supplements are labeled subject to the provisions of section

403(i)(1) of the act (see the last sentence of section 201(ff) of the

act). Thus, when the act is read in its entirety, it is clear that

sections 201(ff)(2)(C), 403(s)(2)(B), and 403(i)(1) of the act require

that the statement of identity of a product that is marketed as a

dietary supplement identify the product as such.

FDA's longstanding regulations lead directly to this result.

Section 102.5 (21 CFR 102.5) sets out how the common or usual name of a

nonstandardized food is to be derived. Under this provision, the common

or usual name must accurately identify or describe, in as simple and

direct terms as possible, the basic nature of the food. The basic

nature of a dietary supplement is that it is a dietary supplement. This

is the point made in both sections 201(ff)(2)(C) and 403(s)(2)(B) of

the act. Thus, under Sec. 102.5(a), the common or usual name of these

products must, at least in part, identify them as a dietary supplement.

Section 101.3(b) of FDA's regulation states that the statement of

identity of a food shall be in terms of its common or usual name. Thus,

Sec. 101.3(g) derives directly from the act and FDA's longstanding

regulations that implement the act. Therefore, FDA is adopting

Sec. 101.3(g).

However, the agency is persuaded by the comments that flexibility

in the use of the term ``dietary'' as part of the name ``dietary

supplement''is warranted. The agency notes that section 403(s)(2)(B) of

the act states that the product shall be identified ``by using the term

`dietary supplement,' which term may be modified with the name of such

an ingredient.'' The agency interprets this provision to mean that the

term ``dietary supplement'' may be modified to include the name of a

dietary ingredient or ingredients (e.g., ``Vitamin C Supplement'').

Furthermore, to provide additional flexibility, an identifying term

that describes the types of dietary ingredients contained in the

product in appropriately descriptive terms (e.g., ``Multivitamin

Supplement,'' ``Herbal Supplement'') may be used. Generic terms that

are not descriptive (e.g., ``Food Supplement,'' ``Energy Bar'') would

not be appropriate because they do not identify or describe the dietary

ingredients (e.g., protein, folic acid, arrowroot) or combination of

ingredients that the product supplies.

Accordingly, FDA is revising Sec. 101.3(g) to provide that the term

``dietary supplement'' may be modified by replacing the term

``dietary'' with the name of a dietary ingredient or ingredients or an

appropriately descriptive term indicating the type of dietary

ingredients that are in the product. The agency notes that, with this

increased flexibility, several concerns expressed by the comments

(e.g., possible difficulties with space limitations, potential consumer

confusion, possible effects on established trademarked names) should be

alleviated.

2. One comment asked that the agency change the type size

requirements referred to in proposed Sec. 101.3(g), which stated that

``* * * the label shall bear the term `dietary supplement' as part of

the statement of identity in conformance with the provisions of

paragraph (d) of this section.'' The comment stated that the type size

requirements of Sec. 101.3(d) (i.e., that the statement of identity

``shall be in a size reasonably related to the most prominent printed

matter on such panel'') cross-referenced in proposed Sec. 101.3(g)

might be counterproductive or impracticable for products in small

packages with many dietary ingredients. The comment requested that the

agency require the same minimum type size as

[[Page 49828]]

that for the declaration of the net quantity of contents

(Sec. 101.105(i)(21 CFR 101.105(i))) because this would permit products

to bear the statement of identity in a type size that would be a

minimum of one-sixteenth of an inch.

FDA points out that Sec. 101.3(d) does not include minimum type

size requirements, but, as noted in the comment, it requires that the

size of the statement of identity be related to the size of the most

prominent printed matter on the label. Therefore, if the package size

is small, and there are many dietary ingredients to be listed, it is

reasonable to expect that even the most prominent printed matter will

be relatively small, permitting the statement of identity to be

proportionally smaller, in some cases as small as one-sixteenth of an

inch. Therefore, the agency is taking no action based on this comment.

However, because the reference in proposed Sec. 101.3(g) to paragraph

(d) of that section is redundant, inasmuch as all foods must meet all

regulatory requirements unless specific exceptions are noted, FDA has

deleted the reference to paragraph (d).

III. Nutrition Labeling of Dietary Supplements

A. Serving Size

3. Several comments stated that the term ``serving size'' is

inappropriate on dietary supplements. One comment stated that the term

``serving size'' should not appear in the nutrition label of dietary

supplements, except for products in the physical form of conventional

foods or for products with significant amounts of calories and

macronutrients, which should be covered by Sec. 101.9. This comment

recommended that the directions for use should provide the basis for

the quantitative statements contained in the nutrition label. Another

comment stated that the term ``serving size'' should not be used in the

nutrition label of herbal products and suggested the terms

``recommended use'' or ``suggested use.'' This comment suggested the

terms ``dose'' or ``dosage'' in the case of products marketed to health

professionals.

The agency is not persuaded by the comments objecting to the term

``serving size.'' As discussed in the final rule of January 4, 1994 (59

FR 354 at 358), information on serving size is as essential on the

nutrition label of dietary supplements as it is on that of conventional

foods. The agency points out that the directions for use provide the

basis for the serving size in the nutrition label of dietary

supplements in that serving sizes are derived by the manufacturer in

accordance with Sec. 101.12 (21 CFR 101.12). Section 101.12(b), Table

2, states that the reference amount customarily consumed for dietary

supplements is ``the maximum amount recommended, as appropriate, on the

label for consumption per eating occasion * * *.''

Section 403(q)(1)(A)(i) of the act states that a food is misbranded

unless its nutrition information specifies the serving size, and

nothing in the DSHEA directs the agency to eliminate the use of this

term in the nutrition label of dietary supplements. To the contrary,

section 403(q)(5)(F)(ii) of the act, which was added by the DSHEA,

states that the listing of dietary ingredients shall include the

quantity of each such ingredient per serving. This fact establishes

that Congress contemplated that serving size would be a part of the

nutrition labeling of dietary supplements.

With respect to using other terms in place of the term ``serving

size,'' the agency reiterates that the term ``serving size'' is

consistent with the act, and that it would be confusing to consumers if

the nutrition labels of dietary supplements used varied terms, such as

``recommended use'' or ``dose,'' in place of the term ``serving size.''

Use of the same term in the same place on all labels will help to avoid

confusion. Therefore, the agency has not made any changes in response

to these comments.

B. Information on Dietary Ingredients Having RDI's or DRV's

4. Several comments argued that some (sodium, vitamin A, vitamin C,

calcium, and iron) or all of the 14 nutrients required under

Sec. 101.9(c) should be required to be listed on the labels of dietary

supplements only when they are added to the supplement, or when a claim

is made about them. These comments argued that dietary supplements of

herbs or botanicals, for example, are not generally consumed for their

nutritional value, and that, thus, having to determine the levels of

the required nutrients would be unduly burdensome and of little use to

consumers who rely on the nutrition information to structure their

diets to maintain healthy dietary practices. One comment from an

independent analytical laboratory stated that mandatory requirements

for the listing of nutrients should not pertain to herbal products.

This comment stated that official methods of analysis do not apply to

herbal products and suggested that these products should be excluded

from labeling regulations requiring analysis until such time as

official methodology is published. Other comments specifically

supported the proposed rule in requiring that macronutrients be

declared whenever they are present.

FDA is not persuaded by the comments to modify Sec. 101.36(b)(2).

Section 403(q)(1) of the act specifies the nutrients that are to be

listed in the nutrition labeling of foods, and section 403(q)(2) of the

act gives the Secretary of Health and Human Services (the Secretary)

discretion to add to, or subtract from, this list for the purpose of

assisting consumers in maintaining healthy dietary practices. Section

403(q)(5)(F) of the act states that the labels of dietary supplements

shall comply with the requirements of subparagraphs (q)(1) and (q)(2)

in a manner that is appropriate.

In its final rule on nutrition labeling, the agency concluded that

information on the calorie, calories from fat, total fat, saturated

fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars,

protein, vitamin A, vitamin C, calcium, and iron content of foods was

necessary to assist consumers in maintaining healthy dietary practices

(58 FR 2079, January 6,1993). Accordingly, these nutrients are required

under Sec. 101.9(c) to be listed in nutrition labeling.

In its December 1995 proposal, the agency tentatively concluded

that these nutrients were equally as important to maintaining healthy

dietary practices when present in dietary supplements and, therefore,

should be mandatory on the labels of dietary supplement products as

well. However, to ease label crowding and to be consistent with the

DSHEA, FDA proposed that the 14 nutrients need only be listed on

dietary supplement labels when present in quantitative amounts by

weight that exceed the amount that can be declared as zero in

accordance with Sec. 101.9(c). FDA tentatively concluded that this

action would provide consumers with the information necessary to

determine how dietary supplement products fit into dietary regimens

that adhere to dietary recommendations.

Dietary supplements are foods under section 201(ff) of the act,

unless they are intended to be used as drugs. Moreover, under section

201(ff) of the act and some of the other changes made by the DSHEA,

dietary supplements may well be in conventional food form and contain

many of the 14 nutrients required to be listed in the nutrition label

under Sec. 101.9. Thus, as foods, it is appropriate to require that

their labeling bear the same nutrients as the nutrition labeling on

conventional foods, unless evidence is presented that justifies the

contrary conclusion.

[[Page 49829]]

The comments presented no evidence that would be a basis for the

agency to reach a conclusion different than it did for conventional

foods, i.e., that the listing of these nutrients will assist consumers

in maintaining healthy dietary practices. The agency is not convinced

that this requirement should be eliminated because of the argument that

herbs and botanicals are not generally consumed for their nutritional

value. The fact that a product is not generally consumed for its

nutritional value is immaterial under the act and its implementing

regulations. For example, certain spices, such as paprika, which are

consumed for their flavor-enhancing properties, not for nutritional

value, are not exempt from nutrition labeling under Sec. 101.9 if any

nutrient is present at more than insignificant levels

(Sec. 101.9(j)(4)). The agency concludes that it is appropriate for the

nutrients required in Sec. 101.9 to be mandatory on the labels of

dietary supplements. Thus, the agency is not modifying

Moreover, one of the principles underlying the agency's food

labeling initiative has been that, if nutrition labeling is to assist

consumers in making dietary choices, it should provide consistent

information for consumers to use (55 FR 29487 at 29490, July 19, 1990).

For example, fat is mandatory on the labels of conventional foods

because of scientific consensus that high dietary intakes of total fat

are associated with an increased risk of coronary heart disease, some

types of cancer, gallbladder disease, and obesity (55 FR 29487 at

29495). Thus, the listing of fat on the nutrition label, when it is

present, will assist consumers in meeting dietary recommendations to

limit fat intake to no more than 30 percent of calories, irrespective

of whether the nutrition labels are for conventional foods or dietary

supplements.

With respect to methodology issues, FDA is not persuaded that

herbal products should be exempt from labeling until analytical

methodology is validated for all herbal products. FDA is aware of the

difficulties in adapting analytical methods to different matrices and

specifically requested comment on this point in the proposal. The

agency received comments from industry groups actively working on the

development of official methodology, but these comments did not

indicate that problems with methodology necessitate exempting herbs

from nutrition labeling. Rather, FDA is aware that the adaptation of

existing methods to different matrices (e.g., herbs) is ongoing. In

addition, FDA has stated that analysis is not needed for nutrients

where reliable data bases or scientific knowledge establish that a

nutrient is not present in a serving of the product (58 FR 2079 at

2109). Therefore, it may not be necessary to analyze for several

nutrients in herbal products. For example, there is no need to analyze

for cholesterol because food composition studies have shown it to be

found only in animal products.

Thus, FDA concludes based upon these comments and on its own

experience that exempting herbs is unwarranted. Moreover, an exemption

would be inconsistent with section 403(q)(5)(F) of the act. Therefore,

the agency is not taking any action based on these comments.

5. Several comments requested more flexibility with the language

used in place of ``Amount Per Serving.'' The comments requested use of

phases such as ``Amount per 2 Tablets'' or ``Two Tablets Contain.''

The agency has no objection to the flexibility requested by these

comments. The agency proposed in Sec. 101.36(b)(2)(i)(A) that when the

serving size of the product is one unit, 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.'' In response to these comments, the agency agrees that

there is no reason to limit the language that can be used in this way.

Therefore, the agency is deleting the words ``when the serving size of

the product is one unit'' from Sec. 101.36(b)(2)(i)(A) and adding the

example ``Amount Per 2 Tablets.''

6. The agency received a couple of comments that recommended

changes in nomenclature for thiamin and riboflavin. These comments

requested that the name ``B1'' be used instead of

``thiamin,'' and that ``B2'' be used for ``riboflavin.'' One

comment stated that consumers do not know that these are B vitamins and

have been confused by the listing of thiamin and riboflavin on ``B-

complex'' products. The comment stated that the mandatory use of

``thiamin'' and ``riboflavin'' is inconsistent with the educational

purposes of the 1990 amendments and the DSHEA and recommended that the

use of these names be optional following the numerical names. The

comment recommended that this approach be followed on the labels of

conventional foods as well.

The agency has previously considered this issue. As discussed in

the proposal, the use of numerical terminology for these vitamins is

obsolete (29487 at 29502). ``The Handbook of Vitamins'' concurs with

this conclusion (Ref. 1, pp. 239 and 285). Also, the National Academy

of Sciences' National Research Council (NAS/NRC) publication on

``Recommended Dietary Allowances'' (Ref. 2, pp. 125 and 132) uses the

terminology ``thiamin'' and ``riboflavin,'' as does the nutrition

labeling of conventional foods. Consistent terminology is needed for

consumers to be able to calculate their total intake of these vitamins

from all food products.

To provide flexibility in the labeling of dietary supplements, the

agency proposed in the December 1995 proposal that the terms ``vitamin

B1'' and ``vitamin B2'' may be listed as synonyms

for thiamin and riboflavin. The agency is adopting this provision, so

manufacturers who wish to inform consumers that these nutrients are B

vitamins will be free to do so. Thus, they will be able to address any

consumer confusion as to why these nutrients are included in B-complex

products.

The agency concludes that the regulation it is adopting provides

the requisite flexibility and yet ensures that the nutrition label

conforms to up-to-date scientific views. Thus, FDA is not accepting the

recommendation of these comments.

7. One comment requested that ``folic acid'' be listed instead of

``folate,'' stating that the use of ``folic acid'' is consistent with

the final rule entitled ``Food Additives Permitted for Direct Addition

to Food for Human Consumption; Folic Acid (Folacin),'' published in the

Federal Register (61 FR 8797, March 5, 1996).

The agency agrees that the term ``folic acid'' can be listed in

place of ``folate.'' The December 1995 proposal stated in

Sec. 101.36(b)(2)(i)(B)(2) that ``folic acid'' and ``folacin'' may be

added in parentheses immediately following the listing of ``folate''

(60 FR 67194 at 67198). However, the health claims final rule on folate

and neural tube defects, amended the nutrition labeling regulations

that FDA had adopted for dietary supplements and conventional foods\1\

to allow the terms ``folic acid'' or ``folacin'' to be used

synonymously (61 FR 8752 at 8759, March 5, 1996)). In that final rule,

the agency acknowledged that the terms ``folic acid'' and ``folate''

are interchangeable in common usage, although technically ``folic

acid'' refers

[[Page 49830]]

to the synthetic form of this vitamin, and ``folate'' is a general term

that refers to both the synthetic and naturally-occurring forms.

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\1\ The regulations in place at that time were

Secs. 101.9(c)(8)(v) for conventional foods and Sec. 101.36(b)(3)(v)

for dietary supplements. Thus, FDA amended these regulations. FDA

had yet to implement Sec. 101.36(b)(3)(v), however (see 60 FR 7711,

February 9, 1995), and, as part of the changes included in the

December 1995 proposal, it renumbered this provision as

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

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

Thus, the agency agrees with the comment that it is appropriate for

``folic acid'' to be listed by itself in place of ``folate.'' For

clarity, the agency is modifying the language in

Secs. 101.36(b)(2)(i)(B)(2) and 101.9(c)(8)(v) to state

``alternatively, folic acid or folacin may be listed without

parentheses in place of folate.''

8. Several comments recommended that the agency require that

information on the quantitative amount by weight of each dietary

ingredient be placed immediately after the name of the dietary

ingredient, rather than in a separate column. The comments requested

this change because of space constraints on the label and the cost of

reformatting. One of these comments stated that consumers are already

familiar with a format in which amounts immediately follow names on

both dietary supplement and traditional food labels, and that there is

no evidence that they have difficulties understanding this information.

Other comments stated that the use of a single column should be

optional. At least one comment specifically supported the proposed two

columns because of readability.

The agency is persuaded that information on names and the

corresponding amounts of dietary ingredients should be allowed to

appear in one column to save space. In the January 4, 1994, final rule

on labeling of dietary supplements, the agency required that the name

of the nutrient and the quantitative amount by weight appear in a

single column despite several comments that argued for a separate

column for amounts. When the DSHEA amended the act to allow the source

of a dietary ingredient to be listed in the nutrition label following

the name, the agency's tentative view was that the additional

information added sufficient complexity to make it appropriate to have

the information on amount in a separate column. Some consumers buy

dietary supplements on the basis of quantitative amounts, and FDA

tentatively concluded that a separate column would help consumers to

locate this information more readily . However, based on the facts the

comments pointed out, that one column would make the dietary supplement

nutrition label consistent with that on conventional foods, and that

there are space and cost advantages to such a format, the agency has no

objection to the optional listing of the quantitative information by

weight immediately following the listing of names. The agency is

modifying Sec. 101.36(b)(2)(ii) accordingly.

9. A few comments stated that quantitative information should not

be declared on the basis of ``per serving.'' Some of these comments

requested that information be declared ``per day.'' These comments

argued that what is consumed per day is more important than per

serving. A couple of other comments preferred dual listing. One

suggested ``per unit and per day,'' and the other suggested ``per

serving and per day.'' Other comments specifically favored a ``per

serving'' basis and opposed dual listing.

The agency does not agree that quantitative information should be

declared on a ``per unit'' or a ``per day'' basis instead of ``per

serving.'' In its proposal on June 18, 1993 (58 FR 33715 at 33716), FDA

tentatively concluded that listing information on the basis of ``per

serving'' was preferable to ``per day'' because consumers might not

actually consume the amount indicated ``per day.'' With respect to

``per unit,'' FDA expressed concern that this basis alone could confuse

consumers when more that 1 unit is to be consumed at one time (e.g. two

capsules with each meal) because they might assume that the information

is on a ``per serving'' basis because the labels of conventional foods

are presented in this manner. For these reasons, the agency required a

``per serving'' basis in the final rule of January 4, 1994 (59 FR 354

at 359), and carried this forward in the December 1995 proposal (60 FR

67194 at 67198). More importantly, the act states in section

403(q)(5)(F)(ii) that the listing of dietary ingredients shall include

the quantity of each such ingredient ``per serving.'' Therefore, FDA is

not changing Sec. 101.36(b)(2)(ii), which requires that quantitative

information be listed on the basis of ``per serving.''

However, with respect to dual listing, the agency is persuaded that

there may be some products on which the unit amount may be of interest

to consumers, and, therefore, FDA is modifying the regulation to allow

the option of listing information on a ``per unit'' basis in addition

to a ``per serving'' basis. The agency notes that Sec. 101.9(b)(10)(ii)

permits the percent of Daily Value (DV) on the labels of conventional

foods to be listed in this manner when the product is in discrete

units, and a serving is more than 1 unit. Thus, the agency is adding

Sec. 101.36(b)(2)(iv) to provide for quantitative information to be

presented voluntarily on the basis of ``per unit'' in addition to the

required declaration ``per serving'' as noted in Sec. 101.36(b)(2)(ii).

When information is presented on a ``per unit'' basis, it must be

declared in additional columns to the right of the ``per serving''

information and must be clearly identified by appropriate headings, as

illustrated in Figure 1.

BILLING CODE 4190-01-F

[[Page 49831]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.007

BILLING CODE 4190-01-C

10. One comment requested different rounding rules for sugars. The

comment wanted to be able to declare amounts under 2 grams (g) in

tenths of a g or to be able to declare 0, 0.5, 1.0, 1.5 and 2.0 g. This

comment stated that sugars are present in much smaller amounts in

dietary supplements than in conventional foods, and that the proposed

rounding rules are inappropriate.

The agency is not persuaded by the comment. Section 101.9(c)(6)(ii)

provides that sugars are expressed to the nearest g, except that if a

serving contains less than 1 g, the statement ``less than 1 gram'' may

be used, and if the serving contains less than 0.5 g, the content may

be expressed as zero. While sugars may be present in much smaller

amounts in dietary supplements than in conventional foods, FDA points

out that the comment did not justify why amounts of sugars that are

under 2 g should be listed any differently on the labels of dietary

supplements than on the labels of conventional foods. Moreover, given

that amounts under 0.5 g are considered nutritionally insignificant,

the agency is not convinced that being able to declare sugars in tenths

of a g or half-gram increments up to 2 g is useful in helping consumers

to maintain a healthy diet. Accordingly, the agency is not changing

Sec. 101.36 in response to this comment.

11. One comment requested clarification of the use of the word

``actual'' in proposed Sec. 101.36(b)(2)(ii)(B), which states ``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 * * *.'' This comment stated that overages of dietary

ingredients that are subject to degradation are added to dietary

supplement products to ensure that the products provide the labeled

quantities throughout their shelf life. The comment asked FDA to

acknowledge in the preamble of the final rule that the labeled amounts

of vitamins and minerals are not necessarily the actual amounts added

at the time of manufacture, and that the corresponding percent DV is

based on the labeled amount.

The agency agrees that the proposed language is not clear with

respect to what amount is to be declared. The agency does not intend

that the declared amount include any overages that a manufacturer

includes in anticipation of degradation. By use of the word ``actual,''

the agency was trying to draw a distinction between sodium and

potassium, which are required to be declared in the increments

prescribed in Sec. 101.9(c), and other vitamins and minerals, for which

increments are not prescribed in Sec. 101.9(c). (Section 101.9(c) does

not require declaration of the quantitative amounts by weight for these

other vitamins and minerals, only that they be declared as a percent of

the DV for the nutrient. Thus, the increments for declaration of the

quantitative amount of these nutrients are not specified in

Sec. 101.9(c).)

Given the reaction to Secs. 101.36(b)(2)(ii)(B) and

101.36(b)(2)(iii)(B) that is reflected in the comments, FDA concludes

that use of the word ``actual'' in these provisions is confusing.

Therefore, the agency is revising these paragraphs to delete this word.

12. Several comments agreed that the regulation should allow the

use of ``1,

Riboflavin--Vitamin B2,

Folate--Folic acid or Folacin. Alternatively, folic acid or folacin may

be listed without parentheses in place of folate.

* * * * *

(d) * * *

(7) * * *

(i) The name of each nutrient, as specified in paragraph (c) of

this section, shall be given in a column and followed immediately by

the quantitative amount by weight for that nutrient appended with a

``g'' for grams or a ``mg'' for milligrams as shown in paragraph

(d)(12) of this section. The symbol ``1,2,3,4

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

Product category Reference amount Label statement5

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

* * * * * *

*

Miscellaneous category:

Dietary supplements The maximum amount ______tablet(s), ______capsule(s), ______packet(s),

recommended, as ______tsp(s), (______g), etc

appropriate, on the

label for consumption

per eating 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; 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).

[[Page 49849]]

\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).

* * * * *

7. Section 101.36 is revised to read as follows:

Sec. 101.36 Nutrition labeling of dietary supplements.

(a) The label of a dietary supplement that is offered for sale

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 (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.'' When the quantitative amounts by weight are presented in

a separate column, the heading may be centered over a column of

quantitative amounts, described by paragraph (b)(2)(ii) of this

section, if space permits. A heading consistent with the declaration of

the serving size, such as ``Each Tablet Contains,'' or ``Amount Per 2

Tablets'' 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 or in paragraph (b)(2)(i)(B)(2) of this section.

(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).

Alternatively, the term ``folic acid'' or ``folacin'' may be listed

without parentheses in place of ``folate.'' 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

either in a separate column aligned to the right of the column of names

or immediately following the listing of names within the same column.

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.

[[Page 49850]]

(B) The amounts of vitamins and minerals, excluding sodium and

potassium, shall be the 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,

vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium,

or potassium.

(A) When information on the percent of Daily Values is listed, this

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.'' When the acronym ``DV'' is unexplained in the

heading and a footnote is required under (b)(2)(iii)(D),

(b)(2)(iii)(F), or (b)(3)(iv) of this section, the footnote shall

explain the acronym (e.g. ``Daily Value (DV) not established'').

(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

quantitative amount by weight of each dietary ingredient in this

calculation shall be the unrounded amount, except that for total fat,

saturated fat, cholesterol, sodium, potassium, total carbohydrate, and

dietary fiber, the quantitative amount by weight declared on the label

(i.e, rounded amount) may be used. 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., a

product that contains 1 gram of total carbohydrate would list the

percent Daily Value 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, vitamin K,

selenium, manganese, chromium, molybdenum, chloride, sodium, or

potassium, 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.''

(iv) The quantitative amount by weight and the percent of Daily

Value may be presented on a ``per unit'' basis in addition to on a

``per serving'' basis, as required in paragraph (b)(2)(ii) of this

section. This information shall be presented in additional columns and

clearly identified by appropriate headings.

(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 RDI's or DRV's 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 or, as long as the constituents of an other dietary

ingredient are not listed, in a linear display, 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 declared directly beneath the heading ``Amount Per Serving''

described in paragraph (b)(2)(i)(A) of this section.

(ii) The quantitative amount by weight per serving of other dietary

ingredients shall be presented in the same manner as the corresponding

information required in paragraph (b)(2)(ii) of this section or, when a

linear display is used, shall be presented immediately following the

name of the other dietary ingredient. 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.

(A) 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).

(B) For any dietary ingredient that is a liquid extract from which

the solvent

[[Page 49851]]

has not been removed, the quantity listed shall be the weight of the

total extract with information on the concentration of the dietary

ingredient, the solvent used, and the condition of the starting

material (i.e., whether it is fresh or dried), e.g., ``fresh dandelion

root extract, x mg (y:z) in 70% ethanol,'' where x is the number of mg

of the entire extract, y is the weight of the starting material and z

is the volume (milliliters) of solvent. Where the solvent has been

partially removed (not to dryness), the final concentration shall be

stated (e.g., if the original extract was 1:5 and 50 percent of the

solvent was removed, then the final concentration shall be stated as

1:2.5).

(C) For a dietary ingredient that is an extract from which the

solvent has been removed, the weight of the ingredient shall be the

weight of the dried extract. The dried extract shall be described by an

appropriately descriptive term that identifies the solvent used, e.g.,

``dried hexane extract of ________'' or ``________, dried hexane

extract.''

(iii) The constituents of a dietary ingredient described in

paragraph (b)(3)(i) of this section may be listed indented under the

dietary ingredient and followed by their quantitative amounts by

weight, except that dietary ingredients described in paragraph (b)(2)

of this section shall be listed in accordance with that section. When

the constituents of a dietary ingredient described in paragraph

(b)(3)(i) of this section are listed, all other dietary ingredients

shall be declared in a column; however, the constituents themselves may

be declared in a column or in a linear display.

(iv) 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'' or other

appropriately descriptive term or fanciful name and may be highlighted

by bold type. 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'' or other appropriately descriptive term or

fanciful name.

(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'' or other appropriately

descriptive term or fanciful name 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.

(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., Oriental 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 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 lowercase 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

[[Page 49852]]

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 4190-01-F

[[Page 49853]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.010

[[Page 49854]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.011

[[Page 49855]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.012

[[Page 49856]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.013

BILLING CODE 4190-01-C

(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:

[[Page 49857]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.014

BILLING CODE 4190-01-C

[[Page 49858]]

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

accordance with Sec. 101.9(g)(1) through (g)(8), except that the sample

for analysis shall consist of a composite of 12 subsamples (consumer

packages) or 10 percent of the number of packages in the same

inspection lot, whichever is smaller, randomly selected to be

representative of the lot. 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 as

follows in:

(1) Section 101.9(j)(1) for foods 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) Section 101.9(j)(18) for foods that are low-volume products

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

Sec. 101.9(j)(18)(i) or (j)(18)(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, whether it is the

manufacturer, packer, or distributor, that qualifies to claim the

exemption under the requirements for average full-time equivalent

employees in Sec. 101.9(j)(18)(i) or (j)(18)(ii), and whose labels,

labeling, and advertising do not provide nutrition information or make

a nutrient content or health claim;

(3) Section 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 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) Section 101.9(j)(5)(i) for foods, 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) Section 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 type size no smaller than 4.5 point may be used on

packages that have less than 20 square inches available for labeling

and more than 8 dietary ingredients to be listed and on packages that

have 20 to 40 square inches available for labeling and more than 16

dietary ingredients to be listed.

(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.

(v) Where there is not sufficient space on a small or intermediate-

sized package for a nutrition label that meets minimum type size

requirements of 4.5 points if hairlines are used in accordance with

paragraph (e)(5) of this section, the hairlines may be omitted and

replaced by a row of dots connecting the columns containing the name of

each dietary ingredient and the quantitative amounts (by weight and as

a percent of Daily Value).

(3) Section 101.9(j)(15) for foods in multiunit food containers;

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

(5) Section 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: September 11, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97-24739 Filed 9-22-97; 8:45 am]

BILLING CODE 4160-01-F