49826 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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.

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superseded earlier documents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 § 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 § 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 (§ 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 §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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 § 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

§ 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, § 101.3(g) derives

directly from the act and FDA’s

longstanding regulations that implement

the act. Therefore, FDA is adopting

§ 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

§ 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 § 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 § 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

§ 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
49828 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

that for the declaration of the net

quantity of contents (§ 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 § 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

§ 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 § 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

§ 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 § 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 § 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 § 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 § 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 § 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.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49829

1The regulations in place at that time were

§§ 101.9(c)(8)(v) for conventional foods and

§ 101.36(b)(3)(v) for dietary supplements. Thus,

FDA amended these regulations. FDA had yet to

implement § 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 § 101.36(b)(i)(B)(2).

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 § 101.9 if any nutrient is present

at more than insignificant levels

(§ 101.9(j)(4)). The agency concludes

that it is appropriate for the nutrients

required in § 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

§ 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

§ 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-todate 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

§ 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

foods1 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
49830 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

to the synthetic form of this vitamin,

and ‘‘folate’’ is a general term that refers

to both the synthetic and naturallyoccurring forms.

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

§§ 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 § 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 § 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 § 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 § 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

§ 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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Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49831

BILLING CODE 4190–01–C

10. One comment requested different

rounding rules for sugars. The comment

wanted to be able to declare amounts

under 2 grams (g) in tenths of a g or to

be able to declare 0, 0.5, 1.0, 1.5 and 2.0

g. This comment stated that sugars are

present in much smaller amounts in

dietary supplements than in

conventional foods, and that the

proposed rounding rules are

inappropriate.

The agency is not persuaded by the

comment. Section 101.9(c)(6)(ii)

provides that sugars are expressed to the

nearest g, except that if a serving

contains less than 1 g, the statement

‘‘less than 1 gram’’ may be used, and if

the serving contains less than 0.5 g, the

content may be expressed as zero. While

sugars may be present in much smaller

amounts in dietary supplements than in

conventional foods, FDA points out that

the comment did not justify why

amounts of sugars that are under 2 g

should be listed any differently on the

labels of dietary supplements than on

the labels of conventional foods.

Moreover, given that amounts under 0.5

g are considered nutritionally

insignificant, the agency is not

convinced that being able to declare

sugars in tenths of a g or half-gram

increments up to 2 g is useful in helping

consumers to maintain a healthy diet.

Accordingly, the agency is not changing

§ 101.36 in response to this comment.

11. One comment requested

clarification of the use of the word

‘‘actual’’ in proposed

§ 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

§ 101.9(c), and other vitamins and

minerals, for which increments are not

prescribed in § 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 § 101.9(c).)

Given the reaction to

§§ 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,

§ 101.36(b)(2)(iii)(C) is finalized as

proposed.

The agency stated in the December

1995 proposal (60 FR 67194 at 67200)
49832 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

§ 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’’(§ 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 § 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 § 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 § 101.36 in response to

these comments. The agency notes that

§ 101.36(i)(2) provides that dietary

supplements are subject to the special

labeling provisions specified for small

and intermediate-sized packages in

§ 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

§ 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

§ 101.9(j)(13) if they were labeled as

conventional foods.

FDA points out, as stated in response

to the previous comment, that

§ 101.36(i)(2) provides that dietary

supplements are subject to the special

labeling provisions specified in

§ 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,

§ 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

§ 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.

BILLING CODE 4190–01–F
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49833

BILLING CODE 4190–01–C

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

§ 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

§ 101.36(b)(3)(ii) to address the listing of

liquid extracts in § 101.36(b)(3)(ii)(B)

and of dried extracts in (b)(3)(ii)(C). The

agency is requiring in

§ 101.36(b)(3)(ii)(B) that the label of

liquid extracts clearly state whether the
49834 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

llll’’ or ‘‘llll, 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 § 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, § 172.580(b)

(21 CFR 172.580(b)) states that safrolefree extract of sassafras is to be obtained

by extracting the bark specified with

dilute alcohol. There is no parallel

provision for, nor is § 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 § 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

§ 101.36(b)(3)(iii) to provide that the

constituents of dietary ingredients not

having RDI’s or DRV’s may be listed.

Proposed § 101.36(b)(3)(iii) is

redesignated as § 101.36(b)(3)(iv).

When constituents of other dietary

ingredients are dietary ingredients

described in § 101.36(b)(2), they are to

be listed in accordance with

§ 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, § 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

§ 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.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 § 101.9(c) and on dietary

supplements in § 101.36(b)(2)(i)(B)). As

an example, § 101.9(c)(2)(i) provides

that ‘‘Saturated Fat’’ be indented under

the listing of ‘‘Total Fat.’’

At the same time, § 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

§ 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 § 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 § 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 intermediatesized 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

§ 101.36(d) in response to these

comments.

23. The agency received a comment

on the proposed requirement (see

proposed §§ 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

§ 101.36(d) or § 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

§§ 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
49836 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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 §§ 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 (§ 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

§ 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 § 101.4(h)(2) in response

to these comments. The agency notes

that § 101.36(d)(1) does not need to be

changed in response to these comments

as it cross references § 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 § 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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49837

wanted products containing only DVnutrients 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 § 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

§ 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 § 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

§ 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.
49838 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

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 § 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

§ 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 § 101.36(e)(6)(ii) in

response to these comments.

G. Compliance

31. Several comments objected to the

statement in proposed § 101.36(f)(1) that

compliance will be determined in

accordance with § 101.9(g)(1) through

(g)(8). In particular, the comments

objected to the application of

§ 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 § 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.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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

§ 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

§ 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

§ 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

§ 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 § 101.9(g)(2).

To provide for greater flexibility, the

agency is modifying § 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 § 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 crossreferencing § 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 § 101.9(g)(2)

should not apply to dietary supplements

and is modifying § 101.36(f)(1)

accordingly.

H. Special Provisions and Misbranding

32. One comment stated that smallsized 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
49840 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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 § 101.36(f)(2). Therefore, FDA is

not modifying § 101.36(i)(2)(i) in

response to this comment.

33. Several comments requested that

§ 101.2(c) be amended to include

§ 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 § 101.2(c)

to include § 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

§ 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 § 101.9 covers the

corresponding requirements for

conventional foods. The purpose of

§ 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 § 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 § 101.9(k)(2) and

(k)(5). Some of these comments

recommended that all of § 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.ll, 115 S. Ct. 1585 (1995).

While these comments specifically

addressed the deletion of § 101.9(k)(3),

(k)(4), and (k)(6), none addressed

§ 101.9(k)(1).

Two comments addressed

§ 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

§ 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 § 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 § 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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 § 101.9(k)(3)

and (k)(4) (redesignated as § 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 § 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 § 101.9(k)(6) is easily

misinterpreted to mean that labels

cannot identify nutrients as naturallyoccurring or synthetic. Accordingly,

FDA is modifying that paragraph

(renumbered as § 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 § 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 § 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

§ 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

§ 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
49842 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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 § 101.36.

Specifically, § 101.36(h)(2) (designated

as § 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 § 101.9(j)(18). Also,

to avoid confusion, the first sentence in

§ 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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 directprinted 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
49844 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

§ 101.9(j)(1) and has proposed an

exemption for low-volume food

products of small businesses in

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

1994). These regulations are crossreferenced in this final rule on labeling

of dietary supplements, in § 101.36(h)(1)

and (h)(2), respectively. As of January 1,

1997, § 101.9(j)(1) will only apply to

retailers. As of May 1997, § 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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 § 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 § 101.36(b)(3) provides

for the listing of the quantity of other

dietary ingredients, respectively. Other

paragraphs of § 101.36 provide

information to assist manufacturers and

distributors of dietary supplements 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 § 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
49846 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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

21 CFR Section No. of

Respondents

No. of Responses per

Respondent

Total Annual

Hours

Hours per

Response Total Annual Hours Total Operating &Maintenance Costs

101.36 (b)(2) and (b)(3)

(disclosure) 850 40 34,000 4 136,000 40,000,000

101.36(f)(2) (reporting) 20 1 20 2 40 0

Totals 34,020 136,040 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 § 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 § 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 thirdparty 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.,

§ 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.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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:

§ 101.2 Information panel of package form

food.

* * * * *

(b) All information required to appear

on the label of any package of food

under §§ 101.4, 101.5, 101.8, 101.9,

101.13, 101.17, 101.36, subpart D of part

101, and part 105 of this chapter shall

appear either on the principal display

panel or on the information panel,

unless otherwise specified by

regulations in this chapter.

* * * * *

(d)(1) Except as provided by

§§ 101.9(j)(13) and (j)(17) and

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

required to appear on the principal

display panel or on the information

panel under this section shall appear on

the same panel unless there is

insufficient space. In determining the

sufficiency of the available space,

except as provided by §§ 101.9(j)(17)

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

and other nonmandatory label

information shall not be considered. If

there is insufficient space for all of this

information to appear on a single panel,

it may be divided between these two

panels, except that the information

required under any given section or part

shall all appear on the same panel. A

food whose label is required to bear the

ingredient statement on the principal

display panel may bear all other

information specified in paragraph (b) of

this section on the information panel.

* * * * *

(f) If the label of any package of food

is too small to accommodate all of the

information required by §§ 101.4, 101.5,

101.8, 101.9, 101.13, 101.17, 101.36,

subpart D of part 101, and part 105 of

this chapter, the Commissioner may

establish by regulation an acceptable

alternative method of disseminating

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

type size smaller than one-sixteenth

inch in height, or labeling attached to or

inserted in the package or available at

the point of purchase. A petition

requesting such a regulation, as an

amendment to this paragraph, shall be

submitted under part 10 of this chapter.

3. Section 101.3 is amended by

adding new paragraph (g) to read as

follows:

§ 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:

§ 101.4 Food; designation of ingredients.

(a)(1) Ingredients required to be

declared on the label or labeling of a

food, including foods that comply with

standards of identity, except those

ingredients exempted by § 101.100,

shall be listed by common or usual

name in descending order of

predominance by weight on either the

principal display panel or the

information panel in accordance with

the provisions of § 101.2, except that

ingredients in dietary supplements that

are listed in the nutrition label in

accordance with § 101.36 need not be

repeated in the ingredient list.

Paragraph (g) of this section describes

the ingredient list on dietary

supplement products.

* * * * *

(g) When present, the ingredient list

on dietary supplement products shall be

located immediately below the nutrition

label, or, if there is insufficient space

below the nutrition label, immediately

contiguous and to the right of the

nutrition label and shall be preceded by

the word ‘‘Ingredients,’’ unless some

ingredients (i.e., sources) are identified

within the nutrition label in accordance

with § 101.36(d), in which case the

ingredients listed outside the nutrition

label shall be in a list preceded by the

words ‘‘Other ingredients.’’ Ingredients

in dietary supplements that are not

dietary ingredients or that do not

contain dietary ingredients, such as

excipients, fillers, artificial colors,

artificial sweeteners, flavors, or binders,

shall be included in the ingredient list.

(h) The common or usual name of

ingredients of dietary supplements that

are botanicals (including fungi and

algae) shall be 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
49848 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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:

§ 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 lll (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 § 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:

§ 101.12 Reference amounts customarily

consumed per eating occasion.

* * * * *

(b) * * *

TABLE 2.—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD SUPPLY1,2,3,4

Product category Reference amount Label statement5

* * * * * * *

Miscellaneous category: .

Dietary supplements The maximum amount recommended,

as appropriate, on the label for consumption per eating occasion, or, in

the absence of recommendations, 1

unit, e.g., tablet, capsule, packet,

teaspoonsful, etc.

llltablet(s), lllcapsule(s), lllpacket(s),

llltsp(s), (lllg), etc.

* * * * * * *

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

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

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

prepared for consumption (e.g., cooked). 3 Manufacturers are required to convert the reference amount to the label serving size in a household measure most appropriate to their specific product using the procedures in 21 CFR 101.9(b).
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49849

4 Copies of the list of products for each product category are available from the Office of Food Labeling (HFS–150), Center for Food Safety

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

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

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

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

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

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

statement following the rules in § 101.9(b) using the reference amount determined according to § 101.12(c).

* * * * *

7. Section 101.36 is revised to read as

follows:

§ 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

§§ 101.9(b) and 101.12(b), Table 2.

Serving size for dietary supplements

shall be expressed using a term that is

appropriate for the form of the

supplement, such as ‘‘tablets,’’

‘‘capsules,’’ ‘‘packets,’’ or

‘‘teaspoonfuls.’’

(ii) The subheading ‘‘Servings Per

Container’’ shall be placed under the

subheading ‘‘Serving Size’’ and aligned

on the left side of the nutrition label,

except that this information need not be

provided when it is stated in the net

quantity of contents declaration.

(2) Information on dietary ingredients

that have a Reference Daily Intake (RDI)

or a Daily Reference Value (DRV) as

established in § 101.9(c) and their

subcomponents (hereinafter referred to

as ‘‘(b)(2)-dietary ingredients’’)—(i) The

(b)(2)-dietary ingredients to be declared,

that is, total calories, calories from fat,

total fat, saturated fat, cholesterol,

sodium, total carbohydrate, dietary

fiber, sugars, protein, vitamin A,

vitamin C, calcium and iron, shall be

declared when they are present in a

dietary supplement in quantitative

amounts by weight that exceed the

amount that can be declared as zero in

nutrition labeling of foods in accordance

with § 101.9(c). Calories from saturated

fat and polyunsaturated fat,

monounsaturated fat, soluble fiber,

insoluble fiber, sugar alcohol, and other

carbohydrate may be declared, but they

shall be declared when a claim is made

about them. Any other vitamins or

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

(c)(9) may be declared, but they shall be

declared when they are added to the

product for purposes of

supplementation, or when a claim is

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

ingredients that are not present, or that

are present in amounts that can be

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

be declared (e.g., amounts

corresponding to less than 2 percent of

the RDI for vitamins and minerals).

Protein shall not be declared on labels

of products that, other than ingredients

added solely for technological reasons,

contain only individual amino acids.

(A) The names and the quantitative

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

ingredient shall be presented under the

heading ‘‘Amount Per Serving.’’ 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 § 101.9(c), except that

calcium and iron shall follow

pantothenic acid, and sodium and

potassium shall follow chloride. This

results in the following order for

vitamins and minerals: Vitamin A,

vitamin C, vitamin D, vitamin E,

vitamin K, thiamin, riboflavin, niacin,

vitamin B6, folate, vitamin B12, biotin,

pantothenic acid, calcium, iron,

phosphorus, iodine, magnesium, zinc,

selenium, copper, manganese,

chromium, molybdenum, chloride,

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

dietary ingredients shall be listed

according to the nomenclature specified

in § 101.9 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 betacarotene in terms of international units

(IU) may be included in parentheses

following the percent statement (e.g.,

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

(ii) The number of calories, if

declared, and the quantitative amount

by weight per serving of each dietary

ingredient required to be listed under

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

be presented 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

§ 101.9(c)(1) through (c)(7), which

includes increments for sodium and

potassium.
49850 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

(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 § 101.9(c)(8)(iv),

except that zeros following decimal

points may be dropped, and additional

levels of significance may be used when

the number of decimal places indicated

is not sufficient to express lower

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

in whole milligrams (mg), but the

quantitative amount may be declared in

tenths of a mg).

(iii) The percent of the Daily Value of

all dietary ingredients declared under

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

be listed, except that the percent for

protein may be omitted as provided in

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

for subcomponents for which DRV’s

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

and, for labels of dietary supplements of

vitamins and minerals that are

represented or purported to be for use

by infants, children less than 4 years of

age, or pregnant or lactating women, no

percent shall be given for total fat,

saturated fat, cholesterol, total

carbohydrate, dietary fiber, 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 § 101.9(c)(8)(iv) or the

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

the specified dietary ingredient and

multiplying by 100, except that the

percent of Daily Value for protein, when

present, shall be calculated as specified

in § 101.9(c)(7)(ii). The 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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 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 llll’’ or

‘‘llll, 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 § 101.4(g), which shall

appear outside and immediately below

the nutrition label or, if there is

insufficient space below the nutrition

label, immediately contiguous and to

the right of the nutrition label.

(1) Source ingredients shall be

identified in accordance with § 101.4

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

name, and the listing of botanicals shall

specify the 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
49852 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49853
49854 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49855
49856 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

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:
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49857

BILLING CODE 4190–01–C
49858 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

(f)(1) Compliance with this section

will be determined in accordance with

§ 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 § 101.9(g)(3)

and (g)(4) also are applicable to other

dietary ingredients described in

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

Reasonable excesses of these other

dietary ingredients over labeled

amounts are acceptable within current

good manufacturing practice.

(2) When it is not technologically

feasible, or some other circumstance

makes it impracticable, for firms to

comply with the requirements of this

section, FDA may permit alternative

means of compliance or additional

exemptions to deal with the situation in

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

need of such special allowances shall

make their request in writing to the

Office of Food Labeling (HFS–150),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204.

(g) Except as provided in paragraphs

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

location of nutrition information on a

label shall be in compliance with

§ 101.2.

(h) Dietary supplements are subject to

the exemptions specified 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

§ 101.9(j)(18)(i) or (j)(18)(ii)); that,

except as provided in § 101.9(j)(18)(iv),

are the subject of a claim for an

exemption that provides the information

required under § 101.9(j)(18)(iv), that is

filed before the beginning of the time

period for which the exemption is

claimed, and that is filed by a person,

whether it is the manufacturer, packer,

or distributor, that qualifies to claim the

exemption under the requirements for

average full-time equivalent employees

in § 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

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

shall continue to be located

immediately below the nutrition label,

or, if there is insufficient space below

the nutrition label, immediately

contiguous and to the right of the

nutrition label as specified in § 101.4(g).

(iv) When it is not possible for a small

or intermediate-sized package that is

enclosed in an outer package to comply

with these type size requirements, the

type size of the nutrition label on the

primary (inner) container may be as

small as needed to accommodate all of

the required label information provided

that the primary container is securely

enclosed in outer packaging, the

nutrition labeling on the outer

packaging meets the applicable type size

requirements, and such outer packaging

is not intended to be separated from the

primary container under conditions of

retail sale.

(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 § 101.4(g).

(j) Dietary supplements shall be

subject to the misbranding provisions of

§ 101.9(k).

7. Section 101.65 is amended by

revising paragraph (b)(4) to read as

follows:

§ 101.65 Implied nutrient content claims

and related label statements.

* * * * *

(b) * * *

(4) A statement of identity for a food

in which an ingredient constitutes

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

‘‘corn oil,’’ ‘‘oat bran,’’ ‘‘dietary

supplement of vitamin C 60 mg tablet’’).

* * * * *

Dated: September 11, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

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

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