Law Library


Federal Register: September 23, 1997 (Volume 62, Number 184)

Rules and Regulations

Page 49825-49858
 

Page 49825

 

_______________________________________________________________________

 

Part III

 

 

Department of Health and Human Services

 

_______________________________________________________________________

 

 

Food and Drug Administration

 

_______________________________________________________________________

 

 

21 CFR Part 101 Chapter I, and Part, 190

 

 

Food Labeling Regulation, Amendments; Food Regulation Uniform

Compliance Date; and New Dietary Ingredient Premarket Notification;

Final Rules

 

 

Page 49826

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

 

21 CFR Part 101

 

Docket Nos. 95N-0245 and 94P-0110

RIN 0910-AA59

 

 

Food Labeling; Statement of Identity, Nutrition Labeling and

Ingredient Labeling of Dietary Supplements; Compliance Policy Guide,

Revocation

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION: Final rule.

 

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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.

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

 

    \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.

 

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    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%'' in place of ``less than 1%'' to save space. Some of

these comments supported the use of ``<1%'' on the labels of

conventional foods as well as on the labels of dietary supplements. One

of these comments stated that this symbol for ``less than'' is taught

in elementary math and science classes nationwide and is universally

recognized. One comment from a trade association that represents

manufacturers of conventional foods stated that the food industry has

not been permitted the use of this symbol as there was no information

demonstrating that consumers understand its meaning. This comment was

opposed to the use of the symbol on the labels of dietary supplements

until conventional foods are also able to use it.

    FDA is persuaded by the comments to allow for the use of the symbol

``<'' for ``less than'' on the labels of dietary supplements and

conventional foods to provide more flexibility when space is limited on

the label. While there is no consumer survey data to show the level of

consumer understanding of the symbol, the agency acknowledges that

elementary and secondary schools are teaching its use, so that a

growing number of consumers can be expected to understand its meaning.

In addition, the agency is aware that the symbol ``<'' is being used on

the labels of some conventional foods, and FDA has not received any

consumer complaints about its use. Given these unique circumstances,

FDA concludes that it is reasonable to allow use of the symbol, thereby

reducing the possibility of overcrowding of information on some

nutrition labels. Accordingly, Sec. 101.36(b)(2)(iii)(C) is finalized

as proposed.

    The agency stated in the December 1995 proposal (60 FR 67194 at

67200)

 

Page 49832

 

that if it allowed the symbol on the nutrition labels of dietary

supplements, it intended ``to provide for such use'' on the nutrition

labels of conventional foods as well. FDA finds that it reasonably

follows from this statement, and from the conclusions that it has

reached with respect to dietary supplements, for it to take this

action. Accordingly, the agency is amending Sec. 101.9(c)(8)(iii) and

(d)(7)(i) to allow the use of the symbol ``<'' in place of the words

``less than.''

    13. Several comments supported the proposed use of the footnote

``Daily Value not established''(Sec. 101.36(b)(2)(iii)(F)). However,

three comments were against the use of this footnote in some cases.

These comments stated that the footnote implied that a DV was not

``yet'' established. Consequently, they stated that it should only be

permitted for components having some legitimate claim to nutritional

value. One comment said that dietary ingredients such as choline should

have an asterisk and a footnote, while dietary ingredients such as bee

pollen should have no asterisk and no footnote. This comment said that

a product composed solely of dietary ingredients such as bee pollen

should have no ``% Daily Value'' column, no asterisks, and no footnote.

    The agency does not agree with the comments that argued that the

footnote apply only to dietary ingredients that ``have nutritional

value.'' The comments did not suggest a definition for dietary

ingredients that have a ``claim to nutritional value,'' or how to

distinguish such dietary ingredients from the other dietary ingredients

for which no DV has been established. Thus, the agency does not know

how it would implement the suggested change. The act makes it clear in

section 403(q)(5)(F)(i) that dietary ingredients not having a

recommendation for daily consumption established by the Secretary are

to be identified as ``having no such recommendation.'' Accordingly, FDA

is adopting Sec. 101.36(b)(2)(iii)(F) unchanged from the proposal.

 

C. Other Dietary Ingredients

 

    14. Several comments recommended that ``other dietary ingredients''

(those not having recommendations, i.e., no RDI's or DRV's) should be

listed outside the ``box'' format for nutrition information, and that

products composed solely of these dietary ingredients, such as herbal

supplements, should not be required to use the ``box'' format. One of

these comments suggested not requiring a ``box'' format unless a claim

is made. These comments stated that herbal supplements are not consumed

for their nutritional value, and that it is not appropriate to use a

format that mimics that of the Nutrition Facts panel. They said that

the use of such a format would confuse consumers and would not convey

any meaningful information. They argued that such a format goes beyond

the intention of the DSHEA.

    One comment stated that simple ingredient listing should be an

option in lieu of nutrition labeling. Another comment, which requested

more flexibility, said that the agency should allow the ``labeler to

present the information to the consumer in the best way they see fit.''

One other comment stated that flexibility in format was needed because

of space constraints and recommended that the special labeling

provisions in Sec. 101.9(j)(13) should apply to dietary supplements.

    The agency is not persuaded by these comments that the format that

it proposed goes beyond the intention of the DSHEA. To the contrary,

the agency concludes that the format is consistent with the DSHEA.

    As a result of the DSHEA, the act requires that nutrition

information immediately precede the ingredient information (section

403(q)(5)(F)(iv)), requires that the nutrition information list dietary

ingredients not having recommendations (section 403(q)(5)(F)(i)), and

defines herbs and other botanicals as dietary ingredients when present

in dietary supplements (section 201(ff)(1)). Taken together, the only

logical reading of these provisions is that herbal dietary ingredients

are to be listed in the nutrition information. Accordingly, the agency

is not making any change in Sec. 101.36 in response to these comments.

The agency notes that Sec. 101.36(i)(2) provides that dietary

supplements are subject to the special labeling provisions specified

for small and intermediate-sized packages in Sec. 101.9(j)(13).

    15. Several comments requested that the ``other dietary

ingredients,'' those not having RDI's or DRV's, including those in a

proprietary blend, should be allowed to be declared in paragraph form

beneath the bar required in Sec. 101.36(e)(6)(ii) (i.e., in a linear

format with the quantity of each dietary ingredient immediately

following the name of the ingredient itself) to save space. An example

of such a label was included in one comment. One comment from a dietary

supplement manufacturer stated that the majority of its products would

qualify for an exemption or a linear layout under the special

provisions for small or intermediate-sized packages in

Sec. 101.9(j)(13) if they were labeled as conventional foods.

    FDA points out, as stated in response to the previous comment, that

Sec. 101.36(i)(2) provides that dietary supplements are subject to the

special labeling provisions specified in Sec. 101.9(j)(13) for foods in

small or intermediate-sized packages, which includes the option of a

linear layout when there is insufficient space for the vertical or

tabular display. Also, Sec. 101.36(c)(2) provides that the ``other

dietary ingredients'' contained in a proprietary blend may be listed in

linear fashion indented under the term ``Proprietary Blend.'' In

addition to the flexibility that these sections provide, FDA has no

objection if a linear display is used for the listing of all ``other

dietary ingredients'' on the labels of dietary supplement products,

regardless of package size. However, as discussed in comment 18 below,

when constituents (i.e., subcomponents) of ``other dietary

ingredients'' are listed, they must be indented under the listing of

the dietary ingredient. Thus, it is not possible to use a linear

display for ``other dietary ingredients'' when constituents are listed

for any of them.

    Therefore, the agency is revising Sec. 101.36(b)(3)(i) and

(b)(3)(ii) to provide explicitly that other dietary ingredients may be

declared in a linear display as long as none of the dietary ingredients

list constituents. Figure 2 illustrates the declaration of other

dietary ingredients in a linear display.

 

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    16. One comment recommended that the listing of other dietary

ingredients be alphabetical. The comment stated that this order would

be user-friendly and assist consumers in making comparisons between

various products. Several other comments specifically stated that they

agreed with the proposed rule, which would allow the manufacturer to

determine the order of these dietary ingredients. One of these comments

stated that there is no obvious benefit to alphabetical order or to

descending order of predominance by weight because the quantity of each

dietary ingredient is included. Another comment stated that order based

on predominance by weight could confuse consumers by incorrectly

implying that the dietary ingredients that are present in greater

predominance are of greater value.

    As discussed in the proposal (60 FR 67194 at 67210), the agency

considered proposing to require alphabetical order but did not because

it is not scientifically meaningful. The agency requested comments on

this issue. Because the majority of the comments supported the

flexibility provided in the proposal, the agency is not persuaded that

it is necessary to require that other dietary ingredients be listed in

alphabetical order. Manufacturers may, of course, do so if they choose.

    17. Several comments strongly opposed the statement in proposed

Sec. 101.36(b)(3)(ii) that ``or any dietary ingredients that are liquid

extracts, the weight shall not include the weight of solvents.'' The

comments stated that the proposal is not practicable because in many

cases there are no methods to determine the identity and quantity of

entities dissolved in solvents. One comment from a trade association of

manufacturers of natural food products stated that FDA should allow a

truthful and nonmisleading description of the content of an extract,

such as the ratio of the weight of the starting material to the volume

of the solvent used. This comment said that the association is working

with other industry groups to develop a uniform method of reporting

this information that is not false or misleading. Another comment

pointed out that the ratio method could be misleading in the absence of

compendial standards because different supplies of the same herb can

yield various strengths and potencies. For this reason, the comment

discouraged the use of indicators of activity until compendial

standards are established.

    Another comment stated that FDA should defer action on this issue

until there is scientific agreement on appropriate methodology and, in

the interim, require that extracts be listed with the weight of the

entire extract. A comment from a trade association for herbal product

manufacturers agreed that extracts should be listed with the weight of

the entire extract, e.g. ``Dandelion root extract (0.5 fl oz).'' This

comment said that the identity of the dietary ingredients of botanical

liquid extracts are the herbal extracts themselves.

    The agency is persuaded by the comments that the proposed manner of

declaring extracts is not appropriate. The agency acknowledged in the

proposal that this matter is a difficult one and specifically requested

comment on how these provisions should be implemented. The comments

pointed out that the dietary supplement industry and others are

developing methods that will result in better information on the

composition of such extracts. However, FDA does not agree that it

should defer action until validated methods are available or, in the

meantime, require only that manufacturers list the weight of the entire

extract. The agency is persuaded by the comment that recommended that

extracts should be described by a ratio of the weight of the starting

material to the volume of the solvent or a description of these values,

which would indicate the concentration of the extract. The agency notes

that the label must state whether the starting material is fresh or

dry. Because fresh botanicals contain water, it is important that the

label have this information so that consumers can determine whether the

weight listed includes the weight of any water.

    FDA has subdivided proposed Sec. 101.36(b)(3)(ii) to address the

listing of liquid extracts in Sec. 101.36(b)(3)(ii)(B) and of dried

extracts in (b)(3)(ii)(C). The agency is requiring in

Sec. 101.36(b)(3)(ii)(B) that the label of liquid extracts clearly

state whether the

 

Page 49834

 

starting material is fresh or dry, what solvent is used, and the

concentration of the botanical in the solvent, 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 number of mg of the starting

material and ``z'' is the number of milliliters of solvent. Where the

solvent has been partially removed (not to dryness), the final

concentration should be stated (e.g., if the original extract had a

ratio of 1:5, and 50 percent of the solvent were removed, the

concentration listed would be 1:2.5).

    Section 101.36(b)(3)(ii)(C) of this final rule states that where

the solvent is removed to dryness, the weight of the dried extract must

be listed. Also, the dried extract must be described in a manner that

includes the identity of the solvent because the solvent used

determines the composition of an extract. For example, hexane as a

solvent would concentrate nonpolar constituents, and water would

concentrate polar constituents. These two dried extracts could have

very different compositions. Thus, the type of extract (e.g., ``dried

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

a material fact under sections 201(n) and 403(a) of the act and must be

specified on the label, even when the solvent is removed during

processing.

    The agency points out that solvents removed during processing that

do not have any technical or functional effect in a food are exempt

from being listed in ingredient labeling in accordance with

Sec. 101.100(a)(3)(ii)(a) (21 CFR 101.100(a)(3)(ii)(a). However,

solvent information is needed in the nutrition label of dietary

supplements to appropriately describe extracts because dietary

ingredients do not have individual regulations, like the regulations

for food additives, that specify how they are to be made, and, when

needed for identity or safety reasons, what solvent can be used in the

processing. For example, Sec. 172.580(b) (21 CFR 172.580(b)) states

that safrole-free extract of sassafras is to be obtained by extracting

the bark specified with dilute alcohol. There is no parallel provision

for, nor is Sec. 172.580(b) applicable to, the use of this substance in

a dietary supplement. Therefore, in the absence of individual

regulations on dietary ingredients, the agency is requiring in

Sec. 101.36(b)(3)(ii) that a dried extract be described by an

appropriately descriptive term that identifies the solvent used.

    18. Several comments requested the flexibility of listing both a

dietary ingredient and one or more of its constituents (i.e.,

subcomponents) to provide consumers with more information. One of the

comments favoring this approach stated that, while two different

supplements may both contain the same amount of a botanical, one

product may yield twice as much of a particular constituent as the

other brand. Most of these comments suggested that constituents of a

dietary ingredient should be indented under the listing of the dietary

ingredient because consumers are familiar with this format, as it is

comparable to the format used for certain DRV nutrients and their

subcomponents in the nutrition labeling of conventional foods.

Alternatively, a couple of comments suggested that constituent

information immediately follow the listing of the dietary ingredient

within parentheses. Most of the comments gave examples where both the

constituents and the dietary ingredients do not have RDI's or DRV's,

but one comment suggested that vitamin A and vitamin C should be

indented under fish oil. One comment stated that if FDA does not allow

information about constituents inside the ``Supplement Facts'' box, it

should clarify that such information is allowed elsewhere on the label.

     The agency is persuaded by the comments to allow more flexibility

with respect to the listing of constituents of dietary ingredients that

do not have RDI's or DRV's, as long as the resultant labels are not

inconsistent with the act and are not confusing to consumers. The

agency is requiring that constituents, when they are listed, be

indented under the listing of the dietary ingredient in either a column

or, to save space, in a horizontal linear display. Quantitative amounts

of the constituents must be listed and also must be included in the

total quantitative amount listed for the dietary ingredient. The agency

is requiring that the dietary ingredient and its weight be presented on

one line, and that any information on constituents be indented under

the declaration of the dietary ingredient to help clarify to consumers

that the constituents are contained in the dietary ingredient.

Accordingly, the agency is adding new Sec. 101.36(b)(3)(iii) to provide

that the constituents of dietary ingredients not having RDI's or DRV's

may be listed. Proposed Sec. 101.36(b)(3)(iii) is redesignated as

Sec. 101.36(b)(3)(iv).

    When constituents of other dietary ingredients are dietary

ingredients described in Sec. 101.36(b)(2), they are to be listed in

accordance with Sec. 101.36(b)(2). Section 403(q)(5)(F)(i) of the act

provides that dietary ingredients having recognized dietary

recommendations are to be listed first to be followed by the dietary

ingredients not having recommendations. Accordingly, with respect to

the fish oil example, Sec. 101.36(b)(2) requires that vitamin A and

vitamin C be listed in the top half of the nutrition label, and that

source information may be included following the listing of each in

accordance with section 403(q)(5)(F)(iii) of the act , e.g., ``vitamin

A (from fish oil).'' Listing vitamin A and vitamin C as constituents

under the listing of fish oil is inconsistent with section 403(q)(5)(F)

of the act.

 

D. Proprietary Blends

 

    19. One comment stated that there is no need to require a dietary

supplement that is a proprietary blend to be identified specifically as

a ``proprietary blend.'' This comment gave an example that used the

word ``blend'' in place of ``proprietary blend'' and noted that there

are synonyms of ``blend'' that would also accurately describe these

products. However the comment did not list specific synonyms. The

comment stated that there is no reason to limit label flexibility in

this regard. Other comments supported the use of the term ``proprietary

blend.'' One comment stated that, while a company has the obligation to

identify such blends, most users of these blends have devised fanciful

or trademarked names for them, and the term ``proprietary blend''

should not have to be repeated in the top half of the nutrition label

when source information is included in parentheses, and the blend is a

source of one or more of the 14 mandatory nutrients.

    FDA is persuaded by the comment that it is not necessary to include

the term ``proprietary blend'' when the blend is identified by another

term or fanciful or trademarked name. Inasmuch as the act does not

require use of the term ``proprietary blend,'' and the formatting

requirements (i.e., declaration of total weight of blend followed by

listing of dietary ingredients in the blend) will make the presence of

a proprietary blend apparent, the agency is modifying Sec. 101.36(c),

(c)(2), and (c)(3) to state that the blend may be identified by the

term ``Proprietary Blend'' or another appropriately descriptive term or

fanciful name.

    Regarding the comment that stated that the name of a proprietary

blend should not have to be repeated each time it is a source of a

nutrient, the agency points out that this would not happen. Firms are

to list the specific ingredient in a proprietary blend that supplies a

nutrient, rather than list the name of the proprietary blend.

 

Page 49835

 

    20. Another comment requested that the words ``Proprietary Blend''

be allowed in bold type. The comment stated that in some instances, a

bold type heading may be easier to see and to understand than an

indented list of ingredients below the heading. The comment did not

include a sample label illustrating its recommendation.

     The agency is not persuaded that bolding the term ``Proprietary

Blend'' is preferable to indenting the dietary ingredients in the blend

under the term to show that these ingredients are included in the

blend. Indentation is used in other situations to convey the concept of

inclusion (e.g., in the listing of subcomponents of nutrients in

nutrition labels on conventional foods in Sec. 101.9(c) and on dietary

supplements in Sec. 101.36(b)(2)(i)(B)). As an example,

Sec. 101.9(c)(2)(i) provides that ``Saturated Fat'' be indented under

the listing of ``Total Fat.''

    At the same time, Sec. 101.9(d)(1)(iv) provides that nutrients that

are not indented, such as ``Total Fat'' and ``Total Carbohydrate,'' are

to be bolded. Consequently, while the agency has decided to retain the

requirement in Sec. 101.36(c)(2) that dietary ingredients contained in

a proprietary blend be indented under the term ``Proprietary Blend'' or

descriptive term or fanciful name used in its place, FDA does not

object to the voluntary bolding of this term. Accordingly, the agency

is changing Sec. 101.36(c) to permit bolding.

    21. One comment objected to the requirement that a proprietary

blend list its dietary ingredients in descending order of predominance

by weight. This comment requested that the agency permit the listing of

a ``lesser ingredient'' first when the weight of the ingredient is

specified. The comment did not give a reason for this request.

    FDA is rejecting this request. To allow a dietary ingredient in a

proprietary blend to be listed first when its weight is voluntarily

declared would create an implication that there is less of the other

dietary ingredients in the blend than the ingredient that is listed

first. The only way to avoid creating this impression would be to list

the weight of each of the other ingredients. Yet, by definition, the

amounts of the ingredients in the blend are proprietary. Thus, the

agency concludes that, when a proprietary blend is involved, the only

way to avoid misleading consumers is to require that the ingredients of

the blend be listed in descending order of predominance. If a

manufacturer wishes to voluntarily list the weights of ingredients, it

is free to do so, but FDA is not requiring such a disclosure for other

dietary ingredients in a proprietary blend. Therefore, FDA is not

changing Sec. 101.36(c)(2) in response to this comment.

 

E. Sources

 

    22. Several comments requested that dietary ingredient sources be

permitted to be declared in the nutrition label without parentheses or

without the word ``as'' or ``from.'' One of these comments stated that

these points should be left up to the judgment of the manufacturer.

This comment stated that the meaning of ``calcium from calcium

carbonate'' is clear without the use of parentheses, and that

flexibility is needed to save space. One comment expressed support for

the proposal and stated that the format proposed will help consumers to

understand the relationship between the dietary ingredient and its

source.

    The agency is not persuaded that space constraints justify making

the use of parentheses, or of the words ``as'' or ``from,'' optional.

In fact, some dietary supplements in small or intermediate-sized

containers currently use the words ``as'' or ``from'' to help consumers

understand that such compounds are the source of the dietary

ingredients.

    The agency continues to be concerned that allowing flexibility in

the manner in which dietary ingredient sources are listed in the

nutrition label could lead to consumer confusion. FDA has received many

inquiries over the years that questioned whether amounts specified on

labels refer to the weight of a particular nutrient or to the salt of

that nutrient used to make the supplement. Having parentheses around

the source compound makes it clear that the quantitative amount and %

DV pertain to the dietary ingredient listed and not to the source.

Thus, FDA concludes that the format that it proposed is the most clear

and should not be optional. Accordingly, FDA is not changing

Sec. 101.36(d) in response to these comments.

    23. The agency received a comment on the proposed requirement (see

proposed Secs. 101.4(g) and 101.36(d)) that the ingredient list on

dietary supplements be preceded by the word ``Ingredients'' or, when

some ingredients (i.e., sources) are identified within the nutrition

label, by the words ``Other ingredients.'' The comment, which was from

a trade association for conventional foods, noted that the term

``Ingredients'' is in common usage in the labeling of conventional

foods to denote the ingredient declaration but is not required. The

comment stated that this requirement would set an adverse precedent for

the labeling of conventional foods and requested that the use of these

identifying terms be optional.

    The agency acknowledges that the ingredient declaration on the

labels of conventional foods are not required to be preceded by the

word ``Ingredient.'' However, the labels of conventional foods do not

allow ingredient information in the nutrition label, so the potential

for consumer confusion is not an issue. Given the fact that the DSHEA

requires dietary ingredients not having RDI's or DRV's to be listed in

the nutrition label of dietary supplements along with their amounts and

also permits the sources of these dietary ingredients to be included in

the nutrition label, the agency concludes that it is important that the

nutrition information and the ingredient information on labels of

dietary supplements be clearly identified. Inasmuch as no comments from

the dietary supplement industry objected on this point, and as the

situation presented by dietary supplements is distinguishable from that

presented by conventional foods, FDA does not view this regulatory

action as setting a precedent for conventional foods. Thus, the agency

is not making any changes in Sec. 101.36(d) or Sec. 101.4(g) on the

designation of ingredients in response to this comment.

    24. One comment urged the agency to abandon the requirement in

proposed Secs. 101.36(d) and 101.4(h) that the common or usual name of

ingredients that are botanicals be followed by the Latin binomial name

of the plant. This comment stated that Latin binomials are generally

meaningless to consumers and take up valuable label space. Another

comment stated that Latin binomials should only be used on dietary

supplements sold to health professionals because they have the training

to understand them. Several other comments pointed out that the book

Herbs of Commerce (Ref. 11) establishes individual common names for

over 600 of the most prominent botanical ingredients in trade and gives

the corresponding Latin name for each common name. These comments

recommended that the agency require the use of these standardized

common names in labeling and not require the listing of Latin names

when they are available in this reference. Other comments did not

object to listing Latin binomials but did object to including the

designation of the author who published the name. Another comment

requested that abbreviations of Latin binomials be allowed to save

space.

    The agency is persuaded by the comments that the common names for

botanicals standardized in the book

 

Page 49836

 

Herbs of Commerce (Ref. 11) should be used in labeling. Because this

reference lists the Latin binomial for each standardized common name,

the agency is persuaded that a Latin binomial need not be included on

labels when this information is available in Herbs of Commerce (Ref.

11). Thus, the agency is changing Secs. 101.36(d)(1) and 101.4(h)

accordingly. Latin binomials will be required except when the common or

usual name of the botanical is available in this reference, and the

designation of the author will be needed when a positive identification

can not be made in its absence (Sec. 101.4(h)(2)). The agency

reiterates that when a Latin binomial is required, the complete

binomial is required for each botanical present, even when multiple

species of the same genus are present.

    With respect to the use of abbreviations of Latin binomials, the

agency proposed that any name in Latin form shall be in accordance with

internationally accepted rules on nomenclature, such as those found in

the International Code of Botanical Nomenclature, which does not

include rules for the use of abbreviations (Ref. 12). The comment that

requested that abbreviations be permitted did not address why they

should be permitted when they are not included in the International

Code of Botanical Nomenclature (Ref. 12). In the absence of clearly

defined rules, the agency is concerned that allowing abbreviations

would cause a great deal of confusion. For example, there are 66 plant

names that could be represented by the abbreviation ``A. alba.'' For

this reason, the agency is not changing the regulation to allow for

Latin binomials to be abbreviated.

    25. One comment requested that FDA not require the declaration of

the part of the plant for botanical ingredients that are used as a

source material for other dietary ingredients. This comment stated that

section 403(s)(2)(C) of the act requires that the labeling identify the

part of the plant from which an herb or other botanical dietary

ingredient is derived. Thus, the comment contends that this information

should not be required when an herb or other botanical is the source of

a dietary ingredient.

    The agency agrees with this comment. As stated, the act, as a

result of the DSHEA, requires identification of the part of a plant

when a supplement contains a dietary ingredient that is an herb or

other botanical. However, a constituent (i.e., a chemical component) of

a botanical may be a dietary ingredient under section 201(ff)(1)(F) of

the act. When a constituent is listed, the agency agrees that

information on the part of the plant is not required by the act.

    26. Several comments objected to the requirement that the part of

the plant be listed in parentheses after the listing of the Latin

binomial. These comments requested that, as an alternative to allow

flexibility and to save space, the listing of the part of the plant be

permitted without parentheses following the common name of the plant.

One of these comments stated that listing the part of the plant in this

manner was more comprehensible.

    The agency points out that these final regulations do not require

that Latin binomial names be included when they are available in Herbs

of Commerce (Ref. 11) (see comment 24 in section III.E. of this

document). In these cases, the part of a plant would immediately follow

the listing of the common name. When a Latin binomial name is required,

the agency has no objection to having it be listed after the part of

the plant. Furthermore, FDA is persuaded that, to save space, the

listing of the part of the plant should be permitted to follow the

common name of the plant without parentheses. Therefore, the agency is

reversing the order of proposed Sec. 101.4(h)(1) and (h)(2) to reflect

the order in which the information is to be provided and is revising

the paragraph renumbered as Sec. 101.4(h)(2) in response to these

comments. The agency notes that Sec. 101.36(d)(1) does not need to be

changed in response to these comments as it cross references Sec. 101.4

and does not provide specific information on how to list the part of a

plant.

    27. One comment requested the option of listing each of the

separate parts of a plant instead of the words entire ``plant,'' when

all parts of a plant are used. The comment stated that it is quite rare

to actually use all parts of a plant. This comment also requested that

the word ``herb'' be permitted to refer to the above ground parts of a

plant. The comment said that Webster's New Universal Dictionary (2d

ed., 1983) gives ``herbage'' as a definition of ``herb,'' and that

``herbage'' is defined as ``the green foliage and juicy stem of

herbs.''

    The agency does not object to the listing of each of the separate

parts of a plant instead of the words ``entire plant.'' While this

point was not addressed in the codified section of the proposal, the

agency did make the statement in the preamble that when an entire plant

is used, the label should specify ``entire plant'' to meet the

requirements of the act. The agency made this statement assuming that

manufacturers would not want to list all the parts of a plant. However,

the agency would not object if a manufacturer listed all the individual

parts of a plant because such a listing is consistent with the DSHEA.

    Regarding the request that the word ``herb'' be permitted to

describe the above ground parts of a plant, the agency is not convinced

that this usage is appropriate. FDA notes that the primary definition

of the word ``herb'' in many dictionaries refers to a type of a plant,

i.e., a nonwoody plant whose aerial portion is relatively short lived

(only a single growing season in the temperate zone), rather than a

part of a plant. Accordingly, the agency is not persuaded by the

comment that consumers would understand the term ``herb'' to mean that

part of the plant grown above ground and is denying this request.

However, the agency has no objection to the use of the term ``aerial

part'' to describe the above ground parts of a part.

 

F. Format

 

    28. Several comments requested that the nutrition label be entitled

``Nutrition Facts'' for all dietary supplements. These comments stated

that ``Nutrition Facts'' should be used for a variety of reasons,

including that: (1) These products are marketed for their nutritional

value, (2) the information presented is about nutrition, (3) the DSHEA

uses the term ``nutrition information'' (see section 403(q)(5)(F)(i) of

the act), (4) the heading should be consistent with the heading used

for conventional foods, (5) some conventional foods do not have

nutritional value; thus, ``Nutrition Facts'' on dietary supplements is

acceptable, and (6) consumers would be confused by the heading

``Supplement Facts'' and think that the products are of lesser value

than conventional foods. One of these comments said that the heading

``Supplement Facts'' is a misnomer because it implies that the

information is supplemental and not complete. Another comment stated

that the heading ``Supplement Facts'' would be a violation of

Sec. 101.9(k)(6), which provides that a food is misbranded if its label

differentiates in any way between vitamins that are naturally present

and those that are added.

    Other comments recommended that the use of the heading ``Nutrition

Facts'' or ``Supplement Facts'' should depend on the composition of a

particular dietary supplement. Some of these comments stated that a

product containing even one vitamin or mineral having a DV-nutrient

should be able to use the heading ``Nutrition Facts'' because the

product would have nutritional value. Another comment

 

Page 49837

 

wanted products containing only DV-nutrients to use the heading

``Nutrition Facts'' and had no opinion on other products. Other

comments said that products that were mostly DV-nutrients should use

the heading ``Nutrition Facts,'' and products that were mostly herbals

should use the heading ``Supplement Facts.'' One comment wanted the

option of using both headings in one nutrition label, listing DV-

nutrients under the heading of ``Nutrition Facts'' and other dietary

ingredients under a secondary heading of ``Supplement Facts.'' Some of

these comments recommended that the use of ``Nutrition Facts'' or

``Supplement Facts'' for combination products should depend upon how a

product is marketed (i.e, the focus of the claims). A couple of these

comments wanted the option of using ``Dietary Supplement Facts'' or

``Herbal Facts'' in place of ``Supplement Facts.'' Additionally, at

least one of these comments said that all dietary supplements in

conventional food form should use the heading ``Nutrition Facts.''

    Several other comments supported the proposed heading of

``Supplement Facts'' for all dietary supplements. One of these comments

said that this heading is consistent with the DSHEA, and another said

that it will help consumers recognize the differences between dietary

supplements and conventional foods.

     FDA is not persuaded that the heading should be ``Nutrition

Facts'' because the DSHEA uses the term ``nutrition information,''

because the information presented, at least in part, is about

nutrition, or because these products are marketed for their nutritional

value. The nutritional value of a particular product does not determine

whether it is a dietary supplement or a conventional food. Many dietary

supplements contain many DV-nutrients; many contain none. Additionally,

the agency is not persuaded by the argument that consumers will be

confused by the heading ``Supplement Facts'' and think that products

labeled in this manner are of lesser value. ``Supplement'' is the

single word that must be used in the statement of identity for all

dietary supplements (see comment 1 in section II. of this document), so

use of the term in the title of the nutrition label can assist

consumers in identifying dietary supplement products. The agency is not

convinced that the name ``Supplement Facts'' will result in any

consumer judgment of the value of the product. Dietary supplements have

been known as ``supplements'' for years, and FDA is not aware of any

confusion caused by this term. Also, the supplemental nature of these

products is supported by the new definition in section 201(ff)(2)(B) of

the act, which states that a dietary supplement can not be

``represented for use as the sole item of a meal or the diet.''

    The agency does not agree that use of the title ``Supplement

Facts'' is a violation of Sec. 101.9(k)(6). The distinguishing

characteristic between products bearing nutrition labeling entitled

``Supplement Facts'' and those bearing nutrition labeling entitled

``Nutrition Facts''is whether the products are dietary supplements or

conventional foods, not whether the vitamins are natural or synthetic.

Both conventional foods and dietary supplements can include natural and

synthetic vitamins.

    Furthermore, the agency does not accept the suggestion that some

dietary supplement products should have the heading ``Nutrition

Facts,'' while others have various headings (``Supplements Facts,''

``Herbal Facts,'' and ``Dietary Supplements Facts'') or even two

headings (``Nutrition Facts'' for the top half and ``Supplement Facts''

for the bottom half). The act does not support treating supplements of

vitamins and minerals any differently than other types of supplements.

Therefore, the agency is not doing so. In addition, if the agency

consented to these recommendations, it would be possible for some

chemically identical products to use up to four different headings. The

agency concludes that so many different headings would only serve to

confuse consumers.

    FDA agrees with the comments that said that the heading of the

nutrition label for all dietary supplements should be entitled

``Supplement Facts.'' While dietary supplements are a category of

foods, the act distinguishes dietary supplements from conventional

foods in many important ways, e.g., different requirements with respect

to safety, to the types of claims that can be made, and to the kind of

information that must be provided in the nutrition label. As stated in

the preamble of the proposal and in one of the comments, the heading

``Supplement Facts'' will help consumers to clearly distinguish between

dietary supplements and conventional foods. Nothing in the comments has

persuaded FDA that the heading ``Supplement Facts'' would not help

consumers to readily identify these products as dietary supplements.

Therefore, the agency is not changing Sec. 101.36(e)(1) in response to

the comments.

    However, the agency does advise that the decision whether a product

is sold as a dietary supplement is made by the manufacturer. Under the

act, as amended by the DSHEA, the term ``dietary supplement'' is

defined as a product (other than tobacco) intended to supplement the

diet that bears or contains a vitamin, a mineral, an herb or other

botanical, an amino acid, a dietary substance for use by man to

supplement the diet by increasing the total dietary intake, or a

concentrate, metabolite, constituent, extract, or combination of any of

the above ingredients (section 201(ff)(1) of the act). Section

201(ff)(2) of the act further states that dietary supplements are

intended for ingestion in a form described in section 411(c)(1)(B)(i)

of the act (21 U.S.C. 350 (c)(1)(B)(i)) or in compliance with section

411(c)(1)(B)(ii) of the act, are not represented as conventional food

or as a sole item of a meal or the diet, and are labeled as a dietary

supplement.

    Thus, dietary supplements may be similar to conventional foods in

composition and form. Whether a product is a dietary supplement or a

conventional food, however, will depend on how it is represented. To be

a dietary supplement, a product must bear the term ``dietary

supplement'' as part of its common or usual name. (As stated in comment

1 in section II. of this document, this term may be modified to include

the name of the dietary ingredient or type of dietary ingredient, such

as ``Vitamin C Supplement'' or ``Multivitamin Supplement.'')

    Products that are not represented as dietary supplements will be

subject to regulation as conventional foods. For example, the

manufacturer of a product that is in the form of a tablet or capsule

that has nutritive value or a powdered herbal product with no nutritive

value may choose to market the product as a conventional food that

bears nutrition labeling in accordance with Sec. 101.9. In that

situation, the nutrition labeling on the package of tablets with

nutritive value would use the title ``Nutrition Facts,'' while the

herbal product with no nutritive value would be exempt from nutrition

labeling under Sec. 101.9(j)(4). Should the manufacturer choose to do

this, however, the label or labeling could not represent the food as a

``dietary supplement,'' and the product could not rely on any of the

special provisions for dietary supplements that were added by the

DSHEA. Thus, for example, the ingredients of the product would not be

eligible for the exception for dietary ingredients from the definition

of a ``food additive,'' and the product could not bear statements under

the authority of section 403(r)(6) of the act.

 

Page 49838

 

    29. Several comments objected to the use of hairlines in the

nutrition label for space and readability reasons. One of these

comments said that the use of hairlines should be optional, and another

said that hairlines should not be required if there are more than eight

dietary ingredients to be declared. Another comment requested that dots

be allowed instead of hairlines when the use of hairlines would cause

the type size to fall under 4.5 points. This comment sent sample labels

with hairlines, without hairlines, and with dots. The dots connected

the name of a dietary ingredient to the quantitative amount and the

amount to the percent DV (see sample label in Figure 3).

 

BILLING CODE 4190-01-F

GRAPHIC TIFF OMITTED TR23SE97.009

 

 

BILLING CODE 4190-01-C

 

     The comments did not provide information to show that the

legibility of the nutrition label is maintained if hairlines are

allowed to be used optionally. Section 2(b)(1)(A) of the 1990

amendments directed the Secretary (and by delegation FDA) to require

that the information required in nutrition labeling be conveyed in a

manner that enables the public to readily observe and comprehend such

information. To implement this provision of the 1990 amendments, FDA

issued a rule that required hairlines in the nutrition label. Hairlines

make the nutrition label easier to read by aiding consumers' eye

movement from the name of the nutrient to the percent DV. Consumer

surveys have shown that the graphic requirements in the nutrition

labeling in Sec. 101.9 were successful in that the majority of shoppers

who are aware of the new label think it is clear and understandable

(Ref. 3). Therefore, FDA is not willing to remove the requirement for

hairlines without evidence that the legibility and readability of the

nutrition label will be maintained on dietary supplement products,

particularly when the product contains a large number of dietary

ingredients.

    However, the agency finds that the sample label submitted that uses

dots to connect the nutrient name to the weight and percent DV is a

satisfactory substitute to assist eye movement when the only other

option would be to reduce type size below 4.5 points, the minimum type

size consistent with the Nonprescription Drug Manufacturers Association

(NDMA) Label Readability Guidelines used for over-the-counter drugs

(Ref. 4). This suggested flexibility appears to offer a reasonable

balance between the competing needs for label space and readability on

small and intermediate-sized packages. Accordingly, the agency is

adding Sec. 101.36(i)(2)(v) to provide that dots connecting columns of

nutrient names and quantitative amounts are allowed in place of

hairlines between rows of type on small and intermediate-sized packages

when it is not possible to meet the minimum type size requirements of

4.5 points if hairlines are used.

    30. Several comments objected to the bar that separates the dietary

ingredients having RDI's or DRV's from other dietary ingredients

because it may imply to consumers that other dietary ingredients are of

lesser importance and it takes up space. One comment said that the bar

should be optional because the asterisk and footnote ``Daily Value not

established'' are sufficient to distinguish other dietary ingredients.

One trade association said that some of their members disliked this bar

because it creates an artificial and illogical separation in some

cases, e.g., for a product containing only vitamins and minerals, but

with some minerals for which an RDI has not been established. This

comment said that other members liked the bar because it highlights the

second portion of the list of dietary ingredients. Other comments

supported the proposed use of the bar.

    The agency is not persuaded by the comments that the bar should be

eliminated because it may imply that the dietary ingredients below it

are of lesser importance. While the agency acknowledges that the use of

a bar is not expressly required by the act, section 403(q)(5)(F)(i) of

the act states that ``nutrition information shall first list those

dietary ingredients * * * for which a recommendation for daily

consumption has been established by the Secretary * * * and shall list

any other dietary ingredient present and identified as having no such

recommendation.'' As discussed in the December 1995 proposal (60 FR

67194 at 67206), the bar helps consumers to readily distinguish these

two types of dietary ingredients, just as a bar differentiates between

macronutrients and vitamins or minerals in the nutrition labeling of

conventional foods. The agency does not agree that the asterisk and the

footnote are sufficient for consumers to readily distinguish between

these two groups because there are some cases where the asterisk and

the footnote would be required for dietary ingredients listed above the

bar (e.g., sugars). For these reasons, the agency is not willing to

eliminate the bar to conserve space. The agency points out that it has

made a number of changes to save space, such as allowing the names of

dietary ingredients and the corresponding amounts to appear in one

column. Thus, the agency is not making any change in

Sec. 101.36(e)(6)(ii) in response to these comments.

 

G. Compliance

 

    31. Several comments objected to the statement in proposed

Sec. 101.36(f)(1) that compliance will be determined in accordance with

Sec. 101.9(g)(1) through (g)(8). In particular, the comments objected

to the application of Sec. 101.9(g)(4)(i), which provides that the

content of added nutrients should be at least 100 percent of the value

declared in the nutrition label, except for variability because of

analytical methods. One comment supported the proposal and said that

products should contain the levels that are declared.

    Many of the comments in opposition requested that Sec. 101.36(f)(1)

be revised to state that supplements claiming to comply with compendial

standards shall be judged ``based on compliance procedures specified or

incorporated by reference in the compendial specifications.''

Specifically, these comments requested that the compliance level be a

fixed minimum of 90 percent that does not allow for variability because

of methods, in accordance with standards in the USP.

 

Page 49839

 

 A comment from USP stated that its lower limit is not a moving target

depending on analytical precision or on whose laboratory is performing

the test.

     Another comment explained that some nutrients are subject to

degradation. This comment said that overages of these nutrients are

added to dietary supplement products to ensure that the products

provide the labeled amounts throughout their shelf life. To avoid

excessive overages, the USP has required that at any time that a

product is analyzed during its shelf life, the product must be shown to

supply at least 90 percent of the labeled amount of any ingredient.

These comments argued that Congress called for compendial products to

meet compendial specifications (see section 403(s)(2)(D) of the act),

and that FDA should not alter those requirements.

     The agency is not persuaded that a fixed minimum of 90 percent of

the labeled amount should be acceptable for the nutrition panel of

dietary supplements. FDA agrees that section 403(s)(2)(D) of the act

provides that a dietary supplement is misbranded if it is covered by

the specifications of an official compendium, is represented as

conforming to those specifications, but fails to do so. Thus, dietary

supplement products that are represented to meet the specifications of

an official compendium, such as the USP, and fail to do so are

misbranded under this section. However, the agency points out that

products not misbranded under this section may be misbranded under

other sections of the act.

    The issue of the acceptable amount of an added vitamin or mineral

in a dietary supplement has been raised in earlier final rules (58 FR

2079 at 2171, January 6, 1993; and 59 FR 354 at 369, January 4, 1994).

As discussed in those final rules, the agency informed USP in 1991 that

anything less that 100 percent of the value declared on the label was

not acceptable with the exception of a deviation that is attributable

to the analytical method (Ref. 5). FDA finds nothing in the comments

that would justify accepting less than 100 percent of the value

declared as compliance for added nutrients in dietary supplements. The

argument that 90 percent is appropriate because some nutrients degrade

is not sufficient justification for the agency to change its position.

Because the degradation is foreseeable, FDA expects that manufacturers

will take it into account when fabricating dietary supplements.

Manufacturers have complete control over the level of dietary

ingredients added to their products. Thus, the manufacturers are

appropriately charged with ensuring that the amounts present are at

least 100 percent of the amounts declared throughout the shelf life of

their products, except for any variability that is attributable to

methods. The agency concludes that a dietary supplement not meeting

this requirement is misbranded under section 403(a)(1) of the act.

Therefore, the agency is not modifying Sec. 101.36(f)(1) in response to

these comments.

    Furthermore, FDA advises that it is aware that Compliance Policy

Guide 530.400 (CPG 7121.02), entitled ``Vitamin Products for Human

Use--Low Potency,'' is inconsistent with Sec. 101.36(f)(1). CPG 530.400

sets forth the criteria for multivitamin products and states that legal

action is recommended when a deficiency is found in excess of 20

percent in one or more nutrients. Because this position is contrary to

Sec. 101.36(f)(1), FDA is revoking CPG 530.400.

    Additionally, based on its review of the proposed regulations in

preparation of this final rule, FDA has come to recognize that the

requirement in Sec. 101.9(g)(2) that a sample for analysis shall

consist of a composite of 12 subsamples (consumer units) taken 1 from

each of 12 different shipping cases is impractical for many dietary

supplement products. The agency has found that it is not always

possible to locate 12 different shipping cases of dietary supplement

products. Inventories of dietary supplement products are often smaller

than those of conventional foods, particularly at distribution and

retail sites. Accordingly, when 12 shipping cases are not available, it

is not possible for FDA to collect a compliance sample that complies

with Sec. 101.9(g)(2).

    To provide for greater flexibility, the agency is modifying

Sec. 101.36(f)(1) to eliminate the requirement that consumer units come

from 12 different shipping cases. The agency is requiring only that the

consumer units come from the same inspection lot (that is, the product

available for inspection at a specific location) and be randomly

selected to be representative of that lot.

    Furthermore, the agency is providing flexibility with respect to

the number of consumer units that are to be collected. FDA is requiring

in Sec. 101.36(f)(1) 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''.

In other words, the entire contents of 12 packages would be needed when

there are over 120 packages available. Fewer packages would be needed

when the total number of consumer units available is less than 120. In

this case, the agency concludes that a 10 percent sample is

sufficiently representative for compliance purposes. While not

statistically based, the 10 percent sample has been well accepted in

enforcement proceedings (Ref. 6, pp. 818 through 821). This approach

allows the agency to take compliance actions as necessary, without

being impeded by the low availability of the product in question. At

the same time, FDA is introducing the term ``packages'' to clarify that

this section pertains to packages labeled for retail sale rather than

individual units of the product, e.g., tablets or capsules, as the term

``unit'' is defined in other parts of this document.

    This provision is a logical outgrowth of the proposal because by

cross-referencing Sec. 101.9(g)(1) through (g)(8) in the proposal, FDA

raised the question of whether these provisions appropriately apply to

dietary supplements. Based on the factors discussed above, FDA

concludes that the requirements regarding the number of consumer units

in Sec. 101.9(g)(2) should not apply to dietary supplements and is

modifying Sec. 101.36(f)(1) accordingly.

 

H. Special Provisions and Misbranding

 

    32. One comment stated that small-sized packages (i.e., those

having a total surface area available to bear labeling of less than 12

square inches) should be allowed to use a minimum type size of 4.0

point when there are more than eight dietary ingredients to be listed

in the nutrition label. The comment stated that the proposed minimum of

4.5 point is impractical for certain dietary supplements products, and

that a type size of 4.0 point is still legible. The comment included

sample labels using a type size of 4.0 point. Another comment requested

that small-sized packages be allowed to use a minimum type size of 3

point. This comment did not include sample labels.

    FDA is not persuaded by these comments. As discussed in the final

rule of January 4, 1994, FDA set the minimum type size at 4.5 point in

response to the majority of the comments, which stated that this

minimum is consistent with the NDMA's Label Readability Guidelines used

for over-the-counter drugs (Ref. 4). FDA has received information from

NDMA that shows that it did not set this minimum arbitrarily or

subjectively, but that it arrived at this minimum type size based on

studies of visual acuity and demographics (Ref. 7). While one of the

comments that objected included sample labels using a type size of 4.0

 

Page 49840

 

point, it did not present any visual acuity studies in support of its

contention that a type size of 4.0 point is legible. FDA has been

persuaded by NDMA's data and points out that the vast majority of

comments did not object to a minimum type size of 4.5 point. Moreover,

firms in need of special allowances may seek alternative means of

compliance or an exemption under Sec. 101.36(f)(2). Therefore, FDA is

not modifying Sec. 101.36(i)(2)(i) in response to this comment.

    33. Several comments requested that Sec. 101.2(c) be amended to

include Sec. 101.36. This amendment would allow type size smaller than

1/16th inch in certain instances. One of these comments said that this

request is reasonable because the labels of dietary supplements

commonly include information not found on the labels of conventional

foods, e.g., the iron warning statement.

    The agency is not persuaded by these comments. As discussed in the

December 1995 proposal, the request to amend several paragraphs in

Sec. 101.2(c) to include Sec. 101.36 was included in a citizen petition

(Docket No. 94P-0110/CP1) submitted to FDA by the Council for

Responsible Nutrition in 1994. The agency denied this request because

Sec. 101.36 addresses the type size requirements for information in the

nutrition label of dietary supplements (60 FR 67194 at 67208). The

agency noted that Sec. 101.9 covers the corresponding requirements for

conventional foods. The purpose of Sec. 101.2(c)(1) through (c)(3) was

to encourage voluntary declaration of nutrition information and

complete ingredient listing on all foods before declaration became

mandatory under the 1990 amendments. FDA gave notice of its intention

to revoke the exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) in its

December 1995 proposal (60 FR 67194 at 67208), and proposed to do so in

the Federal Register of June 12, 1996 (61 FR 29708), because they are

obsolete. Therefore, FDA is not accepting these comments.

    34. At least one comment recommended that a minimum type size of

4.5 point be allowed for dietary supplement packages that have a total

surface area available to bear labeling of less than 40 square inches

and have more than 8 dietary ingredients to be listed in the nutrition

label. The comment said that it is impracticable to comply with the

proposed type size requirements for dietary supplement products that

contain many dietary ingredients.

    FDA is not persuaded by the comment that a minimum type size of 4.5

point should be allowed on dietary supplement packages with 20 to less

than 40 square inches of total surface area available to bear labeling

that have more than 8 dietary ingredients to be listed. The agency

proposed to require a minimum type size of 4.5 point for packages of

less than 12 square inches and 6 point for packages of 12 to 40 square

inches, except that it proposed that 4.5 point may be used on packages

of less than 20 square inches that have more than 8 dietary ingredients

to be listed in the nutrition label. This exception for packages of

less than 20 square inches was in response to a citizen petition filed

by the Council for Responsible Nutrition (Docket No. 94P-0110/CP1).

    In its proposal (60 FR 67194 at 67208), FDA explained how it

arrived at its tentative determination that a minimum of 4.5 point

should be allowed only on packages of less than 20 square inches that

have more than 8 dietary ingredients. Agency precedent provided that

not more than 30 percent of the total surface area of a package should

be required to be devoted to FDA-required information that is not on

the principal display panel. The agency calculated that this 30 percent

level would likely be exceeded on packages of 12 to 20 square inches of

surface area available to bear labeling if more than 8 dietary

ingredients were listed using 6 point type size. Accordingly, FDA

proposed to allow those packages to bear nutrition labeling that uses

the smaller type.

    Applying the same calculations as discussed in the preamble of the

proposed rule, the agency estimates that listing 24 dietary ingredients

in 6 point type size plus 1 point leading between each line of type

could use up to 6 square inches of label space. This would be

equivalent to 30 percent of the total surface area of a package having

20 square inches of surface area available to bear labeling (i.e., 20 X

0.3). Accordingly, in response to the comment, the agency will allow

for the use of a minimum 4.5 type size in such situations. In addition,

based on the agency's observation that about 20 percent of dietary

ingredients listed in sample labels submitted with comments that

include ingredient information require two lines of type, the agency

concludes that it is reasonable to allow the minimum type size of 4.5

point for packages with 20 to 40 square inches of label space available

to bear labeling having more than 16 dietary ingredients. Section

101.36(i)(2)(ii) is revised accordingly.

    This final rule represents a full response to the Council for

Responsible Nutrition's citizen petition referred to above (Docket No.

94P-0110/CP1), in accordance with 21 CFR 10.30(e).

    35. Several comments supported the proposed deletion of

Sec. 101.9(k)(2) and (k)(5). Some of these comments recommended that

all of Sec. 101.9(k) be deleted, asserting that it is not

scientifically defensible, and that it is not consistent with the

protection of free speech provided in the First Amendment and the

Supreme Court decision of Rubin v. Coors Brewing Co., 517 U.S.____, 115

S. Ct. 1585 (1995). While these comments specifically addressed the

deletion of Sec. 101.9(k)(3), (k)(4), and (k)(6), none addressed

Sec. 101.9(k)(1).

    Two comments addressed Sec. 101.9(k)(3) and (k)(4), which prohibit

statements that represent, suggest, or imply that the suboptimal

nutritional quality of a food because of soil conditions or storage,

transportation, or processing methods may be responsible for an

inadequacy in the quality of the daily diet. One comment argued that

these paragraphs should be deleted because any conditions that

adversely affect the nutritional quality of foods will ultimately

affect the nutritional quality of diets, even if such effects are not

so extensive as to lead to widespread nutritional deficiencies. Two

other comments addressed Sec. 101.9(k)(4) specifically, citing evidence

to show that various food processing techniques do cause nutrient

losses and stating that national food consumption patterns are

changing, leading to reduced consumption of fresh foods and increased

use of processed convenience foods.

    A few comments recommended deletion of Sec. 101.9(k)(6), which

prohibits any representation that naturally-occurring vitamins are

superior to added or synthetic vitamins or any differentiation between

added and naturally occurring vitamins. The comments argued that FDA

should not forbid truthful representations on the label of the

composition and biochemical forms of natural and synthetic vitamins,

citing biochemical distinctions between naturally occurring and

synthetic vitamins and stating that this information enables consumers

to make more informed purchasing decisions.

    FDA has considered the comments pertaining to Sec. 101.9(k)(3) and

(k)(4) and is not persuaded that they are no longer supportable. The

agency agrees with the comments that stated that the nutritional

quality of a diet is affected by the nutritional quality of the foods

contained in that diet. However, when diets are inadequate, many

factors must

 

Page 49841

 

be considered as causal, and it would be misleading to attribute such a

result only to soil conditions and storage, transportation, and

processing methods. For example, the food choices a person makes are a

major determinant of the quality of his/her diet. Recent research has

shown that the more a diet adheres to the Food Guide Pyramid (Ref. 8)

and to dietary recommendations to eat a variety of foods and to

moderate the consumption of fat, saturated fat, cholesterol, and

sodium, the greater the likelihood that nutrient requirements will be

met (Ref. 9).

    The comment that suggested that the consumption of fresh fruits and

vegetables is decreasing is not supported by recent research on the

U.S. food supply by the U.S. Department of Agriculture Economic

Research Service. This research found that the per capita consumption

of fresh fruits rose 25 percent from 1970 to 1994, while the per capita

consumption of fresh vegetables rose 33 percent from 1970 to 1994 (Ref.

10, pp. 18-19).

    Accordingly, FDA concludes that it is still appropriate to prohibit

misleading and unsubstantiated generalizations on the label or in

labeling about dietary inadequacies because of nutrient losses

resulting from poor soil conditions or storage, transportation, or

processing methods. Nothing in Rubin v. Coors Brewing Co., supra,

prevents the government from regulating misleading speech. (See 115 S.

Ct. at 1589.)

    As stated earlier, current Sec. 101.9(k)(3) and (k)(4)

(redesignated as Sec. 101.9(k)(2) and (k)(3)) do not preclude a

producer, manufacturer, or vendor from indicating a higher nutrient

retention in a particular product as compared to other similar

products. Nor do they preclude an indication that such retention

results from special handling of the product, provided that such

indications are factual and is not misleading (58 FR 2079 at 2167).

     In regard to Sec. 101.9(k)(6), FDA has stated in the past that

this section permitted truthful designation of any nutrient as natural

in origin (38 FR 6950 at 6958, March 14, 1973; and 58 FR 2079 at 2167).

However, the agency is persuaded by the comments that the phrase

``differentiate in any way between vitamins naturally present from

those added'' in Sec. 101.9(k)(6) is easily misinterpreted to mean that

labels cannot identify nutrients as naturally-occurring or synthetic.

Accordingly, FDA is modifying that paragraph (renumbered as

Sec. 101.9(k)(4)) to remove the prohibition on differentiating between

naturally-occurring and synthetic vitamins.

    It should be noted that FDA addressed the use of the term

``natural'' in rulemaking implementing the 1990 amendments (58 FR 2302

at 2407, January 6, 1993). At that time, the agency said it was not

establishing a definition for ``natural,'' but that it would maintain

its policy not to restrict truthful and non-misleading use of the term,

except for products with added color, synthetic substances, or

artificial flavors as provided in Sec. 101.22, for which use of the

term ``natural'' on the label would be considered misleading. However,

the agency advises that the term ``natural'' should not be used when

referring to a vitamin that is only obtained through chemical synthesis

(e.g., use of ``natural vitamin E'' for a product containing dl-alpha

tocopheryl acetate).

    Comments did not specifically address that part of current

Sec. 101.9(k)(6) that prohibits any suggestion that a natural vitamin

is superior to an added vitamin. Comments pointed out, and FDA is in

agreement, that differences between natural and synthetic vitamins are

often really differences in the form of the nutrient. For example,

comments pointed out that vitamin E occurs in natural oils in the d-

alpha form and exists in synthetic products as a racemic mixture, with

less biological activity. Comments did not, however, provide

information to support any difference between a natural or synthetic

version of the same form of a nutrient. Thus, the agency is aware of

nothing that establishes that a claim of difference between the natural

and synthetic version of the same form of a nutrient is not misleading.

Therefore, FDA is maintaining the prohibition against statements that a

natural vitamin is superior to an added one in Sec. 101.9(k)(4).

    However, the agency advises that there are no restrictions in the

regulations on identification of the chemical form of the nutrient. In

fact, such identification is helpful on certain nutrients, such as

carotene, whose biological activity varies according to its isomeric

composition. FDA notes that when the chemical form of the vitamin is

identified on the label or in labeling, manufacturers are free to use

statements that characterize the structure and function of that

stereoisomer. Label statements may thus differentiate between the

different forms of a vitamin.

 

I. Miscellaneous Issues

 

    36. One comment asked whether nutrition labeling is required on

samples of dietary supplements that are distributed free of charge,

such as at trade shows.

    The nutrition labeling requirements of the 1990 amendments apply to

foods offered for sale (section 403(q)(1) of the act). Nutrition

labeling would not be required on dietary supplements that are not

offered for sale because there is nothing in the DSHEA that requires

dietary supplements to be treated any differently than conventional

foods in this respect. FDA inadvertently did not make this clear in the

December 1995 proposal. Accordingly, FDA is revising Sec. 101.36(a) to

state ``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.''

    37. One comment stated that products composed only of mixtures of

free amino acids should be able to declare ``protein'' in the nutrition

label and list the total weight of the amino acids as the amount of

protein in the product. The comment said that the only difference

between free amino acids and protein is that the amino acids in protein

are connected to each other by peptide bonds. Another comment stated

that amino acids that are essential should be distinguished from those

that are nonessential. This comment also stated that the dangers of

using single amino acids should also be listed with a warning that many

of the uses are unproven. With respect to protein supplements, the

comment said that such products should indicate their sources of

protein, and ``when collagen with a little tryptophan added is called a

protein supplement it should be stated that this is not a complete

protein and cannot support life or tissue building on its own.'' The

comment recommended that protein supplements used for body building

should contain a statement that muscle building requires not only

protein, but calories and especially carbohydrates.

    FDA agrees that protein differs from free amino acids in that

protein is composed of amino acids connected to each other by peptide

bonds (60 FR 67194 at 67198). In recognition of this difference, FDA

proposed that the nutrition label of dietary supplements list whatever

is actually present, i.e., protein or individual amino acids. The

comment did not justify why it was not misleading to declare protein

content in the nutrition label of a dietary supplement that contains

only free amino acids. Therefore, FDA concludes that this requirement

is appropriate and consistent with section 201(ff)(1) of the act, which

lists amino acids in

 

Page 49842

 

subparagraph (D) as a separate entity from protein, which would be

covered in subparagraph (E) as a dietary substance.

    Furthermore, FDA is not persuaded to require that amino acids be

identified as essential or nonessential in the nutrition label of

dietary supplements because the act does not require this information

in the nutrition label, and the comment did not provide any reason for

this approach. In fact, the comment in question did not state clearly

where this information should be presented. FDA points out that such

information may be stated outside of the nutrition label on the labels

of dietary supplements and conventional foods as well.

    In response to the comment that requested that the source of

protein supplements should be identified, the agency points out that,

under the act, manufacturers of dietary supplements, including protein

supplements, may choose either to list the source of any dietary

ingredient in the nutrition label or in the ingredient statement that

appears below the nutrition label. While the concerns of the comment

would apparently be better addressed by the former approach, FDA is not

aware of any reason to require it. The other points in this comment

about warning or other statements are beyond the scope of this

rulemaking.

    38. One comment recommended that herbal products be required to

declare any possible drug interactions. The comment stated that herbs

were the first medicines and should be treated as such.

    FDA disagrees with this comment. The herbal products that are the

subject of this rulemaking are foods and not drugs. To the extent that

herbal products are intended for use as medicines, they are drugs under

the act and subject to regulation under Chapter V of the act, not

Chapter IV (the food provisions). As for possible drug interactions,

FDA will consider the need for warnings under sections 201(a), 403(a),

and 701(a) of the act (21 U.S.C. 371(a)), but warnings about drug

interactions are not typically the subject of food labeling

requirements.

 

IV. Other Provisions

 

    FDA has made a few editorial changes in certain provisions of

Sec. 101.36. Specifically, Sec. 101.36(h)(2) (designated as

Sec. 101.36(f)(2) in the final rule on small business exemptions in the

Federal Register of August 7, 1996 (61 FR 40963), has been revised to

make it clear that either a manufacturer, packer, or distributor may

file a claim for an exemption. This change is consistent with the

language in Sec. 101.9(j)(18). Also, to avoid confusion, the first

sentence in Sec. 101.36(h)(1) through (h)(3) reads ``foods'' instead of

``dietary supplements.''

     FDA did not receive any comments that dealt specifically with the

other provisions of the proposal. In the absence of any basis for doing

otherwise, FDA is adopting those provisions as proposed.

 

V. Effective Date

 

    39. Several comments recommended that the compliance date of this

final rule be coordinated with other final rules on dietary

supplements. Most of these comments requested that a uniform effective

date be set at 18 months after the publication of the last final rule

concerning dietary supplements based on any pending proposals, although

3 comments requested 12 months, and 1 comment requested 24 months. One

comment stated that multiple effective dates will balloon the cost of

all label changes to the industry and to consumers, who ultimately will

bear the cost of multiple revisions. Other comments stated that an 18-

month extension is needed because of the great number of labels to be

redesigned. One comment said that they may manufacture an identical

multivitamin product for more than 100 different retail customers that

sell the product under their own private label name, e.g., store brand

names. Thus, this manufacturer has to make new labels for each

customer, not for each product. Another comment stated that a

manufacturer of ``private label'' products may have over 10,000 labels

to redesign.

    FDA is persuaded by the majority of the comments that it is

appropriate to have the effective date of this final rule be 18 months

after its publication, consistent with the time period allowed for the

labels of conventional foods to comply with the final rules

implementing the 1990 amendments. As discussed in section VI. of this

document, an 18-month compliance period will minimize the cost of the

changeover compared to a 12-month compliance period. The agency does

not agree with the comment that requested a 24-month compliance period

because the majority of the comments stated that an 18-month compliance

period is sufficient.

    Moreover, the agency agrees that it is reasonable and practical to

have the same date apply to the other final rules on dietary supplement

labeling that are published elsewhere in this issue of the Federal

Register, as multiple effective dates will increase costs and are

unjustified. Therefore, the agency concludes that the effective date of

this final rule is 18 months from the date of its publication and that

this date shall apply to the other final rules on dietary supplements

that are published in this issue of the Federal Register.

    The same will also apply to the enforcement of prescribed iron

statements on products that currently bear voluntary iron warning

statements, as discussed in the final rule on iron statements (62 FR

2218, January 15, 1997). In that final rule, the agency stated that it

intended to use enforcement discretion for these products that bear a

voluntary warning until the date for label changes made in response to

the DSHEA (62 FR 2218 at 2246).

    The agency notes that this effective date is not in accordance with

the uniform compliance date of January 1, 2000, established by

regulation on December 27, 1996 (61 FR 68145). As stated in that

document, ``If any food labeling regulation involves special

circumstances that justify a compliance date other than January 1,

2000, the agency will determine for that regulation an appropriate

compliance date, which will be specified when the final regulation is

published'' (61 FR 68145 at 68146). The DSHEA states that dietary

supplement products shall be labeled in accordance with its amendments

after December 31, 1996. Because final rules were not published in

sufficient time for the industry to be in compliance with them by

January 1, 1997, FDA stated on April 15, 1996, that it would exercise

its enforcement discretion such that it would not enforce the

provisions of the DSHEA until January 1, 1998 (61 FR 16423). At this

time, FDA is extending this period of nonenforcement until March 23,

1999. Any further extension (i.e., to January 1, 2000) would be

unresponsive to the directives of the statute, as well as unnecessary

based on comments received.

    In addition, in response to the directive in the DSHEA that dietary

supplements ``be labeled'' after December 31, 1996, and consistent with

the approach taken by Congress in the 1990 amendments, the agency

advises that the effective date of this regulation, the other dietary

supplement regulations published in this issue of the Federal Register,

and the final rule on iron statements, will apply to the attachment of

labels to dietary supplement products rather than to the introduction

of products into interstate commerce as specified in the agency's final

rule on uniform compliance dates for food labeling regulations (61 FR

 

Page 49843

 

68145). In other words, products bearing labels that are affixed prior

to March 23, 1999 do not have to be in compliance with these final

rules, and products labeled after March 23, 1999 do.

    Although the effective date is 18 months hence, FDA encourages

manufacturers to have new labels that are in compliance with these

final rules printed as soon as current inventories are exhausted to

assure a smooth and timely changeover. The agency does not anticipate

extending its use of enforcement discretion any further.

 

VI. Analysis of Impacts

 

    FDA has examined the economic implications of the final rule as

required by Executive Order 12866 and the Regulatory Flexibility Act (5

U.S.C. 601-612). Executive Order 12866 directs agencies to assess all

costs and benefits of available regulatory alternatives and, when

regulation is necessary, to select the regulatory approach which

maximizes net benefits (including potential economic, environmental,

public health and safety effects; distributive impacts; and equity).

Executive Order 12866 classifies a rule as significant if it meets any

one of a number of specified conditions, including having an annual

effect on the economy of $100 million or adversely affecting in a

material way a sector of the economy, competition, or jobs, or if it

raises novel legal or policy issues. If a rule has a significant impact

on a substantial number of small entities, the Regulatory Flexibility

Act requires agencies to analyze options that would minimize the

economic impact of that rule on small entities. FDA finds that this

final rule is not an economically significant rule as defined by

Executive Order 12866 and finds under the Regulatory Flexibility Act,

that the final rule will have a significant impact on a substantial

number of small entities.

    There are several different types of products that may be

considered to be dietary supplements. These products include but are

not limited to vitamin or mineral supplements, herbal products, and

products that contain other similar nutritional substances. An estimate

of the number of such products is approximately 29,000. The number of

stockkeeping units, a more accurate count of the number of labels, is

approximately 75,000. Estimates of the number of dietary supplements

are approximate because no one source collects information on all types

of dietary supplements. In fact, until the DSHEA, there was no agreed

upon definition of a dietary supplement. Some sources include only

dietary supplements of vitamin or minerals, others include herbals or

botanicals, and still others include other types of products that may

or may not be dietary supplements, such as sports nutrition products

and ``functional foods,'' a term for which there is no recognized

definition.

    In its proposed analysis, FDA estimated the number of dietary

supplement firms to be between 150 and 650 firms. According to Duns

Market Identifiers, there are approximately 250 manufacturers of

vitamin and mineral products. According to Nutrition Business Journal

(August 1996), the dietary supplement industry includes 850 supplement

manufacturing companies. The Journal reports 1995 industry revenues at

$4.5 billion. Although FDA concludes that there are clearly at least

250 firms, the Journal's estimate of 850 is most likely an overestimate

of the dietary supplement industry because it includes homeopathic

products, which are drugs by statutory definition, and ``functional

foods'' and sports nutrition products, which may be either conventional

foods or dietary supplements depending on how they are marketed and

used. Although the Journal does not break down the number of firms by

the type of dietary supplement produced, it does specify that 250 firms

produce herbal or botanical products. FDA received one comment on its

proposed analysis that suggested that estimates of the number of firms

should include the product manufacturer, label printer, product

packager, label/brand owner, and brand wholesaler. FDA notes that, with

the exception of administrative costs, costs of labeling regulations

are calculated on a per product or per label basis, not on a per firm

basis. Administrative costs, which are typically calculated on a per

firm basis, include the cost of reading and interpreting the regulation

and formulating a compliance policy which must be done once for each

regulation, not for each product.

    For purposes of determining the costs of this regulation, FDA will

use 850 as an upper bound estimate of the number of firms. As a lower

bound estimate, FDA will use 500 (250 vitamin/mineral firms + 250

herbal/botanical firms).

 

A. Costs

 

    Categories of costs for relabeling include administrative,

analytical, printing, and inventory disposal.

    The administrative costs associated with a labeling regulation

result from the incremental administrative labor expended in order to

comply with a regulation. FDA received one comment objecting to the

estimated administrative costs. The comment stated that administrative

costs fail to include both scientific and legal review, but the comment

did not provide any information to help FDA modify its previous

estimate. Therefore, FDA will continue to estimate administrative costs

at $425 per firm for a 1-year compliance period and approximately $320

for an 18-month compliance period. Longer compliance periods decrease

administrative effort because firm executives often delegate downward

decisions that are less immediate. Total administrative costs are

estimated to be between $160,000 ($320 x 500 firms) and $272,000 ($320

x 850 firms) with an 18-month compliance period.

    FDA received one comment stating that its estimate of analytical

costs substantially underestimated the true costs. The comment

estimated analytical costs at $340 per product. FDA notes, however,

that although the comment stated that FDA's estimates were too low, the

comment's per product estimate is lower than FDA's estimate of $615 per

product. Therefore, FDA will continue to estimate costs at $615 per

product for each of 29,000 products. All products will be tested once

during the 18-month compliance period in order to determine initial

compliance. In the proposed rule, FDA assumed that products would

undergo retesting once every 5 years. FDA received no objections to

that assumption. Therefore, FDA estimates total discounted analytical

costs of $75 million (discounted to infinity at 7 percent), of which

$17.8 million ($615 x 29,000 products) will occur during the 18-month

compliance period.

    FDA received several comments that its estimates of printing/

redesign costs were too low. One comment suggested that costs would be

$1,370 for each printed label and $3,870 for each direct-printed

package label. Estimates from other comments ranged from $50 to $3,500

per label. Based on an average of the estimates provided by the

comments, FDA estimates that the average per label redesign cost for a

1-year compliance period is $1,700. However, because FDA is allowing a

compliance period of 18 months, firms will be able to combine planned

label changes with mandated changes, thus lowering redesign costs.

Redesign costs associated with an 18-month compliance are typically 3/4

of those for a 1-year compliance period. Therefore, FDA estimates

redesign costs to be $1,300 for each of 75,000 labels, or a total $97.5

million.

    FDA received one comment indicating that inventory disposal costs

would range between $8 and $15

 

Page 49844

 

million depending on the length of the compliance period. In the

analysis to the proposed rule, FDA estimated inventory disposal costs

at $6.5 million assuming the rules would become effective 12 months

after publication of the final regulations. FDA will not alter its

previous estimates based on the comment because dietary supplement

firms have known about these label changes since at least January 1994,

and the majority of firms have been taking the necessary steps to

reduce their label inventories. However, because FDA is providing firms

with 18 months to comply, firms will have an additional 6 months to

dispose of label inventory. As with redesign costs, inventory disposal

costs associated with an 18-month compliance period are approximately

3/4 of the costs associated with a 1-year compliance period. Therefore,

disposal costs for this rule are estimated at $4.8 million.

    FDA has estimated the impact of the final regulations and has

determined that administrative costs would be between $160,000 and

$272,000, discounted analytical costs would be $75 million (discounted

to infinity at 7 percent), redesign costs would be $97.5 million, and

inventory disposal costs would be $4.8 million. Therefore, total

discounted costs are estimated to be $177.8 million (discounted to

infinity at 7 percent). Costs during the 18-month compliance period are

estimated to be $120 million. If we assume that the rate at which firms

comply is evenly distributed throughout the compliance period, then

costs during the most expensive 12-month period, the first year, would

be $80.3 million. Costs in the second year would be $39.7 million.

Recurring costs would be $17.8 million every 5 years. According to

basic economic principles, firms are profit maximizers. Therefore, it

is logical to assume that firms will select the least costly

alternative. The supply of label redesign and analytical laboratory

services is limited in the short run. When demand for those services

increases as a result of regulatory requirements, the cost of those

services also increases. If compliance were skewed toward one end of

the compliance period, then the demands places on those services would

cause prices to increase more than if the demand were more evenly

distributed. Firms are aware of this phenomenon and will, therefore,

attempt to spread out the demands on the redesign and laboratory

services. Also, because the capacity for these services is fixed in the

short run, the suppliers of redesign and laboratory services will force

firms to space out their demand. Because it is unlikely that the rate

at which firms comply is heavily skewed toward one end of the

compliance period, it is unlikely that costs will exceed $100 million

during any single year. Therefore, FDA concludes that this rule is not

economically significant as defined by Executive Order 12866.

 

B. Benefits

 

    Although almost all dietary supplements of vitamins and minerals

currently contain substantial nutrition information, many other dietary

supplements do not. This regulation will benefit consumers by assuring

that adequate and complete nutrition information is provided accurately

and consistently to aid consumers in their choices.

 

C. Regulatory Flexibility

 

    According to the Regulatory Flexibility Act, the definition of a

small entity is a business independently owned and operated and not

dominant in its field. The Small Business Administration (SBA) has set

size standards for most business categories through use of four-digit

Standard Industrial Classification codes. For dietary supplements of

vitamins and minerals, a business is considered small if it has fewer

than 750 employees. According to Duns Market Identifiers, there are

approximately 250 producers of vitamin and mineral supplements, of

which 200 have fewer than 750 employees. The remaining dietary

supplement products come closest to the industry groups Food

Preparations N.E.C. (SIC 2099) and Medicinal Chemicals and Botanical

Products (SIC 2834). The SBA size standards are 500 or fewer employees

for food preparations and 750 or fewer employees for medicinal and

botanical products. Under either employee-based size standard,

virtually all firms could be classified as small, including some firms

that are among the leaders in sales revenues. Therefore, FDA is basing

size classifications on sales revenue rather than employees.

    According to Nutrition Business Journal, of the 850 dietary

supplement manufacturing firms, 11 have total revenues over $100

million, accounting for 53 percent of total sales; 30 firms have sales

revenues between $20 and $100 million, accounting for 28 percent of

industry sales; and 809 firms have sales under $20 million, accounting

for 19 percent of industry sales. The 809 firms in the under $20

million category have an average sales revenue of $800,000 and will be

considered small by FDA. The SBA sales revenue standard for businesses

that cannot be classified into a specific industry is $5 million. FDA

concludes therefore that as many as 809 firms in the dietary supplement

industry, or 95 percent of firms, could be considered small (sales

under $20 million). As stated previously in this analysis, this may be

an overestimate because it counts firms that produce homeopathic

products, which are drugs, and sports nutrition products and

``functional foods,'' which may be foods or dietary supplements. If

there are as few as 500 dietary supplement firms, there may be 475

small dietary supplement firms.

    The agency has published an exemption from mandatory nutrition

labeling for small businesses in Sec. 101.9(j)(1) and has proposed an

exemption for low-volume food products of small businesses in

Sec. 101.9(j)(18) (59 FR 11872, March 14, 1994). These regulations are

cross-referenced in this final rule on labeling of dietary supplements,

in Sec. 101.36(h)(1) and (h)(2), respectively. As of January 1, 1997,

Sec. 101.9(j)(1) will only apply to retailers. As of May 1997,

Sec. 101.9(j)(18) will apply to manufacturers, packers, distributors,

or retailers of low volume products, defined as fewer than 100,000

units, produced by firms with fewer than 100 employees. FDA does not

have information to show how many dietary supplement products would be

exempted under this provision. Comments to the proposed analysis

suggested that very few products will qualify for exemptions for low

volume products. According to the limited information available to the

FDA, approximately 72 percent of vitamin/mineral producers and 86

percent of herbal/botanical producers have fewer than 100 employees.

Even if every firm with fewer than 100 employees produced low volume

products, between 9 and 13 percent of the firms with annual sales less

than $20 million would still not meet the definition. Therefore,

although it is likely that many firms will be able to take advantage of

the small business exemption, FDA concludes that this rule will impact

on a substantial number of small entities.

    Dietary supplement firms each produce between 3 and over 50

distinct products. A firm that produces three products will incur costs

of $14,000 during the compliance period. A firm that produces 50

products will incur costs of $236,000 during the compliance period. If

the average small firm incurs costs of $125,000 ((14,000 + 236,000)/2),

using an average annual sales of $800,000, the increase in costs due to

this regulation will be 16 percent of

 

Page 49845

 

sales for the average small firm. Therefore, FDA concludes this rule

will result in a significant economic impact on a substantial number of

small entities.

    The Regulatory Flexibility Act requires agencies to examine

regulatory alternatives that would minimize the impact on small

entities. Because the DSHEA mandates nutrition labeling for all dietary

supplement products, except low-volume products as described above,

there are very few alternatives available to the agency. However, as

discussed elsewhere in this document, FDA received many comments

requesting that firms be given 18 months to comply with these

regulations. FDA has examined the impact of different compliance

periods and has determined that extending the compliance to 18 months

reduces the burden on small entities. With a 12-month compliance

period, first year costs for an average small entity would be $158,500,

or 20 percent of sales. Extending the compliance period to 18 months

reduces first year costs to the average small firm by $33,500. If FDA

did not extend the compliance period, the total discounted costs of

this regulation would be $209.5 million, of which $152 million would

occur in the first year. The longer compliance period reduces total

discounted costs of the regulation by $31.2 million.

 

D. Summary

 

    Total discounted costs of this regulation are estimated to be

between $177.8 million (discounted to infinity at 7 percent). These

costs include administrative, analytical, printing, and inventory

disposal costs. The benefits are improved and more consistent

information with which consumers can refine their choices for health or

other reasons. FDA is unable to quantify this benefit.

    FDA has analyzed the costs and benefits of this proposed rule and

has determined that, because neither costs nor benefits are likely to

exceed $100 million in any single year, it does not constitute an

economically significant rule as defined by Executive Order 12866.

    FDA has also analyzed the impacts on small firms according to the

Regulatory Flexibility Act and has determined that these rules will

have a significant impact on a substantial number of small entities.

FDA has reviewed alternatives to reduce the burden on small entities

and has concluded that providing for a compliance period of 18 months

will alleviate that burden.

 

E. Public Outreach

 

    FDA has conducted extensive outreach to a wide audience, including

small businesses, on the labeling of dietary supplements. This outreach

included independent FDA activities as well as cooperative efforts

between FDA and professional trade organizations.

    FDA has informed small businesses of the requirements in the DSHEA

regarding dietary supplements and of FDA's implementation of these

requirements in a number of ways. Since passage of the DSHEA, FDA

representatives have responded on a daily basis to numerous inquiries

on supplements, including inquiries from small businesses. In addition,

FDA has had meetings on the regulation of dietary supplements with

representatives of at least four trade organizations that include small

businesses in their membership. Furthermore, FDA has participated in a

number of trade organization conferences on dietary supplements and has

cooperated with the Drug Information Association, which has sponsored

conferences on botanicals.

    FDA has issued a number of publications on dietary supplements that

have been available to small businesses, including an article in the

FDA Consumer of November 1993 and an ``FDA Backgrounder'' of August

1995, which described the DSHEA. FDA has distributed about 500 reprints

of its December 1995 proposals on the labeling of dietary supplements

to various interested parties, including small businesses. FDA has also

placed information on these proposed rules in the FDA News section of

the agency's home page on the World Wide Web. In response to these

proposals, FDA has received numerous comments from small businesses.

FDA concludes that its efforts to inform small businesses of activity

in this area have been successful.

 

VII. Environmental Impact

 

    The agency has previously considered the environmental effects of

this rule as announced in the proposed rule (60 FR 67194, December 28,

1995). No new information or comments have been received that would

affect the agency's previous determination that there is no significant

impact on the human environment and that an environmental impact

statement is not required.

 

VIII. Paperwork Reduction Act

 

    This rule contains information collection requirements that are

subject to review by the Office of Management and Budget (OMB) under

the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,

description, and respondent description of the information collection

are shown below with an estimate of the annual reporting and

recordkeeping burden. Included in the estimate is the time for

reviewing procedures, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection of information.

    Title: Requirements for Nutrition and Ingredient Labeling of

Dietary Supplements.

    Description: In a final rule, FDA is amending Sec. 101.36 to

require that most dietary supplements provide on their labels, and in

their labeling, information on the quantity of specific nutrients

present in them, along with the daily value for each, and the quantity

of other dietary ingredients. This requirement implements the

requirements of the 1990 amendments and the DSHEA. The agency is also

providing a mechanism by which firms may request an alternative

approach to providing the necessary nutrition information.

    Section 101.36(b)(2) specifies the nutrients for which the amount

must be present on the labels of dietary supplements and

Sec. 101.36(b)(3) provides for the listing of the quantity of other

dietary ingredients, respectively. Other paragraphs of Sec. 101.36

provide information to assist manufacturers and distributors of dietary

supplements in determining how the amount of nutrients that their

products contain should be disclosed on the labels of the products.

Section 101.36(f)(2) provides a mechanism whereby firms may request in

writing from FDA alternative means of compliance or additional

exemptions when it is not technologically feasible, or some other

circumstance makes it impracticable, for the firm to comply with the

requirements of Sec. 101.36.

    FDA had submitted these information collection requirements to OMB

for review under section 3504(h) of the Paperwork Reduction Act (44

U.S.C. 3501  et seq.) at the time the December 1995 proposal was

published. In response, OMB disapproved the information collection but

gave an OMB control number, 0910-0314, and requested that FDA respond

to the following concerns at the time of resubmission for OMB approval

of the information collection package at the final rule stage:

    OMB does not approve this package. OMB is concerned about the

accuracy of the cost and hour burden estimates, as well as the

utility of the nutrition info. required to be disclosed on the

labels of dietary supplements and whether the labels are

sufficiently clear to the third party recipients

 

Page 49846

 

of this information. When the package is resubmitted to OMB for

approval at the final stage, the agency will address OMB's concerns

and the public comments received on these issues in the preamble of

the final rule and in the paperwork submission package.

    FDA estimates the total annual disclosure and reporting hour burden

for the information collection requirements contained in this final

rule to be 136,040 hours, as follows:

 

   Table 1.--Estimated Annual Reporting Burden

 

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

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

No. of

 

  21 CFR        No. of       Responses per   Total Annual      Hours per       T

otal Annual    Total Operating &

  Section     Respondents     Respondent         Hours         Response

  Hours        Maintenance Costs

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

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

101.36

 

 (b)(2)

 

 and

 

 (b)(3)

 

 (disclosu

 

 re)            850              40          34,000               4            1

36,000         40,000,000

101.36(f)(

 

 2)

 

 (reportin

 

 g)              20               1              20               2

    40  0

Totals       34,020            1

36,040         40,000,000

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

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

 

    FDA estimates that each supplier of dietary supplements will revise

the labels for each product that is not otherwise exempt to comply with

the requirements for nutrition labeling within the first 18 months

after publication of the final rule. The agency estimates that, on

average, each supplier will have 40 products whose labels will require

revision. The agency expects that the number of respondents and

corresponding annual burden hours will decrease over succeeding years

because it does not believe that firms will modify the composition of

each of their products and revise the labeling for each of their

products each year. Similarly requests for alternative approaches for

providing nutrition information are most likely to be submitted within

the first 18 months. The agency estimated the number of such requests

based on its experience with the similar requirement that is provided

in Sec. 101.9(g)(9) for conventional foods. Thus, there will be a

significant decrease in the number of respondents and product labels

requiring revision in succeeding years with a corresponding decrease in

annual burden hour cost. The hour burden estimates contained above are

for the information collection requirements established by regulation

alone and do not include those that stem solely from the act or the

DSHEA.

    FDA has estimated that the total annualized operating and

maintenance costs will approximate $40,000,000 over the next 3 to 4

years. This is based on annualized estimated relabeling costs of $32.5

million, analytical costs of $6 million, and labor and overhead costs

of $1.5 million over the next 3 to 4 years. The agency believes that

these costs will decrease significantly over succeeding years. FDA will

reexamine these estimates at the end of 3 to 4 years. The agency has

determined that the requirements in Sec. 101.36 do not require capital

costs on the part of respondents.

    The first concern expressed by OMB was about the accuracy of the

cost and hour burden estimates for the information collection

requirements. FDA received one comment in response to the proposal that

estimates of the number of firms should include the product

manufacturer, label printer, product packager, label/brand owner, and

the brand wholesaler. FDA received no comments that suggested

alternative costs or hour burdens from the agency's estimates. As

discussed in more detail in section V. of this document and as

indicated in the preceding table ``Estimated Annual Reporting Burden,''

the agency has modified the number of respondents that will be affected

by the information collection requirements from 600 to 850 but has

retained the estimates of hour burden per response that was contained

in the December 1995 proposal.

    OMB also expressed its concern about the utility of the nutrition

information required to be disclosed on the labels of dietary

supplements and whether the labels are sufficiently clear to the third-

party recipients of this information. Several comments to the December

1995 proposal recommended that nutrients should be listed on dietary

supplements only when they are added. Other comments expressed concerns

about the format requirements for the nutrition facts panel. As

discussed in more detail above, FDA is not persuaded by the comments

that it should change the requirements for the listing of nutrients on

dietary supplements. As also noted above, the agency points out that,

except for certain specified exceptions, section 403(q) of the act

requires nutrition labeling on most foods. With respect to dietary

supplements, section 403(q)(5)(F) of the act, as amended by the DSHEA,

specifies that the labels of dietary supplements shall comply with the

requirements for nutrition labeling contained in subparagraphs (q)(1)

and (q)(2) in a manner which is appropriate. Furthermore, the agency

believes that nutrition information on dietary supplements is essential

for those that are interested to be able to calculate their daily

intakes of nutrients.

    As to OMB's concern that the information will be sufficiently clear

to the third-party recipients, FDA notes that consumer surveys have

indicated that the graphic requirements in the nutrition labeling rules

for food (i.e., Sec. 101.9) were successful in that the majority of

shoppers who are aware of the new label think it is clear and

understandable. FDA has no reason to believe that the requirements for

nutrition labeling of dietary supplements will be any less clear.

    FDA has resubmitted the information collection requirements

contained in this rule to OMB for its review under the Paperwork

Reduction Act of 1995. Interested persons are requested to send

comments regarding information collection by October 23, 1997 to the

Office of Information and Regulatory Affairs, OMB, New Executive Office

Bldg., rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA. No

person may be required to respond to, or may be subjected a penalty for

failure to comply with, these information collection requirements until

they have been approved by OMB and FDA has displayed the assigned OMB

control number. The OMB control number, when assigned, will be

announced by separate notice in the Federal Register.

 

IX. References

 

    The following references have been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

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

    1. Machlin, L. J., editor, Handbook of Vitamins, 2d ed., pp. 239

and 285, Dekker, NY, 1991.

    2. Subcommittee on the 10th Edition of the RDA's, Food and

Nutrition Board, Commission of Life Sciences, National Research

Council, ``Recommended Dietary Allowances, 10th Ed.,'' pp. 125 and

132, Washington, DC, National Academy Press, 1989.

 

Page 49847

 

    3. Food Marketing Institute Prevention Magazine Report,

``Shopping for Health 1995,'' Food Marketing Institute, Washington,

DC, and Prevention Magazine, Emmaus, PA, 1995.

    4. Nonprescription Drug Manufacturers Association's Special Task

Force on Label Readability, ``Label Readability Guidelines,''

Washington, DC, 1991.

    5. Tanner, J. T., letter to V. Srinivasan, U.S. Pharmacopeial

Convention, Inc., May 7, 1991.

    6. Deming, W. E., ``On the Presentation of the Results of Sample

Surveys as Legal Evidence,'' The Journal of the American Statistical

Association, 49:818-821, December 1954.

    7. Memorandum between Bill Bradley, Nonprescription Drug

Manufacturers Association, and Susan Thompson, CFSAN, FDA, October

15, 1993.

    8. U.S. Department of Agriculture, Human Nutrition Information

Service, ``The Food Guide Pyramid,'' Home and Garden Bulletin Number

252, August 1992.

    9. U.S. Department of Agriculture, Center for Nutrition Policy

and Promotion, ``The Healthy Eating Index,'' October 1995.

     10. U.S. Department of Agriculture, Economic Research Service,

``Food Consumption, Prices, and Expenditures, 1996,'' Statistical

Bulletin Number 928, pp. 18-19.

    11. Foster, S., editor, Herbs of Commerce, Amercian Herbal

Products Association, Bethesda, MD, 1992.

    12. Greuter, W., editor (chairperson), International Code of

Botanical Nomenclature (Tokyo Code), adopted by the 15th

International Botanical Congress, Koeltz Scientific Books, D-61453

Konigstein, Germany, 1994.

 

 List of Subjects in 21 CFR Part 101

 

    Food labeling, Incorporation by reference, Nutrition, Reporting and

recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

101 is amended as follows:

 

PART 101--FOOD LABELING

 

    1. The authority citation for 21 CFR part 101 continues to read as

follows:

 

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 371).

 

    2. Section 101.2 is amended by revising paragraphs (b), (d)(1), and

(f) to read as follows:

 

Sec. 101.2  Information panel of package form food.

 

 *   *   *   *   *

    (b) All information required to appear on the label of any package

of food under Secs. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36,

subpart D of part 101, and part 105 of this chapter shall appear either

on the principal display panel or on the information panel, unless

otherwise specified by regulations in this chapter.

 *   *   *   *   *

    (d)(1) Except as provided by Secs. 101.9(j)(13) and (j)(17) and

101.36(i)(2) and (i)(5), all information required to appear on the

principal display panel or on the information panel under this section

shall appear on the same panel unless there is insufficient space. In

determining the sufficiency of the available space, except as provided

by Secs. 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and

other nonmandatory label information shall not be considered. If there

is insufficient space for all of this information to appear on a single

panel, it may be divided between these two panels, except that the

information required under any given section or part shall all appear

on the same panel. A food whose label is required to bear the

ingredient statement on the principal display panel may bear all other

information specified in paragraph (b) of this section on the

information panel.

 *   *   *   *   *

    (f) If the label of any package of food is too small to accommodate

all of the information required by Secs. 101.4, 101.5, 101.8, 101.9,

101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this

chapter, the Commissioner may establish by regulation an acceptable

alternative method of disseminating such information to the public,

e.g., a type size smaller than one-sixteenth inch in height, or

labeling attached to or inserted in the package or available at the

point of purchase. A petition requesting such a regulation, as an

amendment to this paragraph, shall be submitted under part 10 of this

chapter.

    3. Section 101.3 is amended by adding new paragraph (g) to read as

follows:

 

Sec. 101.3  Identity labeling of food in packaged form.

 

 *   *   *   *   *

    (g) Dietary supplements shall be identified by the term ``dietary

supplement'' as a part of the statement of identity, except that the

word ``dietary'' may be deleted and replaced by the name of the dietary

ingredients in the product (e.g., calcium supplement) or an

appropriately descriptive term indicating the type of dietary

ingredients that are in the product (e.g., herbal supplement with

vitamins).

    4. Section 101.4 is amended by revising paragraph (a)(1) and adding

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

 

Sec. 101.4   Food; designation of ingredients.

 

    (a)(1) Ingredients required to be declared on the label or labeling

of a food, including foods that comply with standards of identity,

except those ingredients exempted by Sec. 101.100, shall be listed by

common or usual name in descending order of predominance by weight on

either the principal display panel or the information panel in

accordance with the provisions of Sec. 101.2, except that ingredients

in dietary supplements that are listed in the nutrition label in

accordance with Sec. 101.36 need not be repeated in the ingredient

list. Paragraph (g) of this section describes the ingredient list on

dietary supplement products.

 *   *   *   *   *

    (g) When present, the ingredient list on dietary supplement

products shall be located immediately below the nutrition label, or, if

there is insufficient space below the nutrition label, immediately

contiguous and to the right of the nutrition label and shall be

preceded by the word ``Ingredients,'' unless some ingredients (i.e.,

sources) are identified within the nutrition label in accordance with

Sec. 101.36(d), in which case the ingredients listed outside the

nutrition label shall be in a list preceded by the words ``Other

ingredients.'' Ingredients in dietary supplements that are not dietary

ingredients or that do not contain dietary ingredients, such as

excipients, fillers, artificial colors, artificial sweeteners, flavors,

or binders, shall be included in the ingredient list.

    (h) The common or usual name of ingredients of dietary supplements

that are botanicals (including fungi and algae) shall be consistent

with the names standardized in Herbs of Commerce, 1992 edition, which

is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies may be obtained from the American Herbal Products

Association, 4733 Bethesda Ave., suite 345, Bethesda, MD 20814, or may

be examined at the Center for Food Safety and Applied Nutrition's

Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of

the Federal Register, 800 Capital St. NW., suite 700, Washington, DC.

The listing of these names on the label shall be followed by statements

of:

    (1) The part of the plant (e.g., root, leaves) from which the

dietary ingredient is derived (e.g., ``Garlic bulb'' or ``Garlic

(bulb)''), except that this designation is not required for algae. The

name of the part of the plant shall

 

Page 49848

 

pressed in English (e.g., ``flower'' rather than ``flos'');

    (2) The Latin binomial name of the plant, in parentheses, except

that this name is not required when it is available in the reference

entitled: Herbs of Commerce for the common or usual name listed on the

label, and, when required, the Latin binomial name may be listed before

the part of the plant. Any name in Latin form shall be in accordance

with internationally accepted rules on nomenclature, such as those

found in the International Code of Botanical Nomenclature and shall

include the designation of the author or authors who published the

Latin name, when a positive identification cannot be made in its

absence. The International Code of Botanical Nomenclature (Tokyo Code),

1994 edition, a publication of the International Association for Plant

Taxonomy, is incorporated by reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies of the International Code of Botanical

Nomenclature may be obtained from Koeltz Scientific Books, D-61453

Konigstein, Germany, and University Bookstore, Southern Illinois

University, Carbondale, IL 62901-4422, 618-536-3321, FAX 618-453-5207,

or may be examined at the Center for Food Safety and Applied

Nutrition's Library, 200 C St. SW., rm. 3321, Washington DC, or at the

Office of the Federal Register, 800 North Capitol St. NW., suite 700,

Washington DC.

    (3) On labels of single-ingredient dietary supplements that do not

include an ingredient list, the identification of the Latin binomial

name, when needed, and the part of the plant may be prominently placed

on the principal display panel or information panel, or included in the

nutrition label.

    5. Section 101.9 is amended by removing paragraphs (k)(2) and

(k)(5), by redesignating paragraphs (k)(3), (k)(4), and (k)(6) as

paragraphs (k)(2), (k)(3), and (k)(4), respectively, and by revising

paragraphs (c)(8)(iii), (c)(8)(v), (d)(7)(i), (j)(6), and newly

redesignated (k)(4) to read as follows:

 

Sec. 101.9  Nutrition labeling of food.

 

 *   *   *   *   *

    (c) *   *   *

    (8) *    *   *

    (iii) The percentages for vitamins and minerals shall be expressed

to the nearest 2-percent increment up to and including the 10-percent

level, the nearest 5-percent increment above 10 percent and up to and

including the 50-percent level, and the nearest 10-percent increment

above the 50-percent level. 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 or by the use of an

asterisk (or other symbol) that refers to another asterisk (or symbol)

that is placed at the bottom of the table and that is followed by the

statement ``Contains less than 2 percent of the Daily Value of this

(these) nutrient (nutrients)'' or ``Contains < 2 percent of the Daily

Value of this (these) nutrient (nutrients).'' Alternatively, except as

provided for in paragraph (f) of this section, if vitamin A, vitamin C,

calcium, or iron is present in amounts less than 2 percent of the RDI,

label declaration of the nutrient(s) is not required if the statement

``Not a significant source of ______ (listing the vitamins or minerals

omitted)'' is placed at the bottom of the table of nutrient values.

Either statement shall be in the same type size as nutrients that are

indented.

 *   *   *   *   *

    (v) The following synonyms may be added in parentheses immediately

following the name of the nutrient or dietary component:

Calories--Energy,

Vitamin C--Ascorbic acid,

Thiamin--Vitamin B1,

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 ``<'' may be used in place of

``less than.''

 * * * * *

     (j) *   *   *

    (6) Dietary supplements, except that such foods shall be labeled in

compliance with Sec. 101.36.

*   *   *   *   *

    (k) *   *   *

    (4) That a natural vitamin in a food is superior to an added or

synthetic vitamin.

    6. Section 101.12 is amended in paragraph (b), Table 2, under the

subheading ``Miscellaneous category'' by revising the entry ``Dietary

supplements not in conventional food form'' to read as follows:

 

Sec. 101.12  Reference amounts customarily consumed per eating

occasion.

 

 *   *   *   *   *

    (b) *   *   *

 

        Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion: Ge

neral Food Supply1,2,3,4

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

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

     Product category            Reference amount           Labe

l 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 consu

med per eating occasion and were

  primarily derived from the 1977-78 and the 1987-1988 Nationwide Food Consumpti

on 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 serv

e). If not listed separately,

  the reference amount for the unprepared form (e.g., dry mixes; concentrates; d

ough; batter; fresh and frozen

  pasta) is the amount required to make the reference amount of the prepared for

m. Prepared means prepared for

  consumption (e.g., cooked).

 

\3\ Manufacturers are required to convert the reference amount to the label serv

ing 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 Administrati

on, 200 C St. SW., Washington,

  DC 20204.

 

\5\ The label statements are meant to provide guidance to manufacturers on the p

resentation of serving size

  information on the label, but they are not required. The term ``piece'' is use

d 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 cr

eam bars). The guidance provided

  is for the label statement of products in ready-to-serve or almost ready-to-se

rve 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 statem

ent column that it is for these

  forms of the product. For products that require further preparation, manufactu

rers must determine the label

  statement following the rules in Sec.  101.9(b) using the reference amount det

ermined 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