[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Rules and Regulations]
[Pages 49826-49858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24739]



[[Page 49825]]

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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 101 Chapter I, and Part, 190



Food Labeling Regulation, Amendments; Food Regulation Uniform 
Compliance Date; and New Dietary Ingredient Premarket Notification; 
Final Rules

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

[[Page 49826]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 95N-0245 and 94P-0110]
RIN 0910-AA59


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its food 
labeling regulations to establish requirements for the identification 
of dietary supplements and for their nutrition labeling and ingredient 
labeling in response to the Dietary Supplement Health and Education Act 
of 1994 (the DSHEA). FDA is also responding to a citizen petition from 
the Council for Responsible Nutrition on type size requirements for 
these products. In addition, FDA is announcing the revocation of 
Compliance Policy Guide 530.400 (CPG 7121.02) entitled ``Vitamin 
Products for Human Use--Low Potency'' to eliminate inconsistencies with 
the new labeling requirements.

DATES: The regulation is effective March 23, 1999. The Director of the 
Office of the Federal Register approves the incorporations by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain 
publications in 21 CFR 101.4(h), effective March 23, 1999.

FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety 
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-5587.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 28, 1995 (60 FR 67194), FDA 
published a proposed rule entitled ``Food Labeling; Statement of 
Identity, Nutrition Labeling and Ingredient Labeling of Dietary 
Supplements'' (hereinafter identified as ``the December 1995 
proposal''). This document, which specifically responds to the DSHEA, 
superseded earlier documents responding to the Nutrition Labeling and 
Education Act of 1990 (the 1990 amendments)(Pub. L. 101-535) and the 
Dietary Supplement Act of 1992 (the DS act) (Pub. L. 102-571) with 
respect to dietary supplements.
    The 1990 amendments amended the Federal Food, Drug, and Cosmetic 
Act (the act) in a number of important ways. One of the notable aspects 
of the 1990 amendments is that they added section 403(q) to the act (21 
U.S.C. 343(q)). This section provides that most foods are misbranded 
unless they bear nutrition labeling.
    In particular, section 403(q)(5)(F) (originally section 
403(q)(5)(E)) of the act provided that separate regulations on the 
nutrition labeling of dietary supplements of vitamins and minerals 
could be established that are distinct from those for other foods. In 
response to this section, FDA proposed a regulation in Sec. 101.36 (21 
CFR 101.36) that was specifically on the nutrition labeling of dietary 
supplements of vitamins and minerals, and a separate general regulation 
that was on the nutrition labeling in Sec. 101.9 (21 CFR 101.9) of 
conventional foods and of all other dietary supplements (those of herbs 
and other nutritional substances) (56 FR 60366, November 27, 1991).
    On October 6, 1992, the President signed into law the DS act. The 
DS act established a moratorium until December 15, 1993, on the 
implementation of the 1990 amendments with respect to dietary 
supplements not in the form of conventional food. Also, it required 
that a new proposed regulation on the nutrition labeling of dietary 
supplements be issued by June 15, 1993, and a final rule by December 
31, 1993.
    In response to the DS act, FDA published a new proposed rule in the 
Federal Register of June 18, 1993 (58 FR 33715), and a final rule on 
January 4, 1994 (59 FR 354), on the nutrition labeling of dietary 
supplements. As mandated in section 403(q)(5)(F) of the act, the final 
rule established a regulation (Sec. 101.36) on the specific 
requirements for nutrition labeling of dietary supplements of vitamins 
and minerals.
    On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into 
law. The DSHEA amended the act by adding section 201(ff) (21 U.S.C. 
321(ff)), which defines a ``dietary supplement,'' in part, as a 
product, other than tobacco, intended to supplement the diet that 
contains at least one or more of the following ingredients: A vitamin; 
a mineral; an herb or other botanical; an amino acid; a dietary 
substance for use to supplement the diet by increasing the total 
dietary intake; or a concentrate, metabolite, constituent, extract, or 
combination of any of the previously mentioned ingredients. This 
section also states that the term ``dietary supplement'' means a 
product that is labeled as a dietary supplement.
    Furthermore, the DSHEA, among other things, amended section 
403(q)(5)(F) of the act by adding specific requirements that relate to 
the labeling of, and ingredient declaration on, dietary supplement 
products. Previously, this section had applied only to dietary 
supplements of vitamins and minerals and had not offered any 
description of how the labeling of these products should differ from 
the labeling of foods in general. As amended by the DSHEA, section 
403(q)(5)(F) of the act provides that dietary ingredients that do not 
have daily values (i.e., Reference Daily Intakes (RDI's) or Daily 
Reference Values (DRV's)) must be listed within the nutrition 
information, that the listing of dietary ingredients must include the 
quantity of each dietary ingredient (or of a proprietary blend of such 
dietary ingredients), and that the listing of dietary ingredients may 
include the source of a dietary ingredient. It also provides that the 
nutrition information must immediately precede the ingredient 
information required under the act.
     FDA received over 50 letters in response to the December 1995 
proposal. Each of these letters contained one or more comments. 
Responses were received from industry, trade associations, consumers, 
consumer advocacy organizations, health care professionals, 
professional societies, and city governments. Many comments supported 
the proposal generally or supported aspects of the proposal. Other 
comments objected to specific provisions of the proposal and requested 
revisions. Some comments addressed issues outside the scope of the 
proposal and will not be discussed here. A summary of the relevant 
comments, the agency's responses to the comments, and a discussion of 
the agency's conclusions follows.

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

    1. A number of comments objected to the proposed requirement in 
Sec. 101.3(g) (21 CFR 101.3(g)) that the term ``dietary supplement'' 
appear as part of the statement of identity of dietary supplements. 
Some of these comments requested the flexibility of allowing this term 
either in the statement of identity or elsewhere on the label, such as 
on the principal display panel or in the directions for use. A couple 
of comments stated that, if the nutrition label was given the title 
``Dietary Supplement Facts,'' a consumer could utilize the nutrition 
label to identify the

[[Page 49827]]

product as a dietary supplement, making it unnecessary to include the 
term as part of the statement of identity. Other comments requested 
that FDA allow for reasonable flexibility in the use of synonyms or 
modifiers for the term ``dietary supplement,'' such as ``Nutritional 
Supplement,'' ``Herbal Supplement,'' ``Multivitamin/Multimineral 
Supplement,'' or ``Amino Acid Blend.''
    The comments presented a number of reasons for their disagreement 
with the proposal. Several comments stated that the inclusion of the 
term ``dietary supplement'' as part of the statement of identity on the 
principal display panel overreaches the legislative intent of the 
DSHEA. These comments stated that the DSHEA does not specify where the 
term ``dietary supplement'' should be placed, and that, therefore, 
flexibility of placement of the term is warranted. One comment stated 
that it objected to FDA transforming an ``identify'' requirement in the 
DSHEA into an ``identity'' requirement in the use of the term ``dietary 
supplement.'' The comment asserted that the term ``identify'' in the 
DSHEA is different from the requirement in 15 U.S.C. 1453(a)(1) (i.e., 
``the identity of the commodity''), upon which the identity labeling 
provisions in Sec. 101.3 are based. Several comments stated that the 
term ``dietary supplement'' by itself is inappropriate as a common 
descriptor for dietary supplements because they include a wide range of 
products, which meet vastly different consumer needs. These comments 
stated that the term ``dietary'' does not add additional value to the 
statement of identity, and that consumers might interpret the term 
``dietary'' as part of the statement of identity to suggest that the 
supplement is a weight loss or meal replacement product. These comments 
stated that the statutory requirement that the term ``identify'' the 
product could be satisfied with the use of the term ``supplement.'' One 
comment submitted a market research study on consumer perception of the 
term ``dietary supplement,'' which indicated that over 50 percent of 
the subjects were confused by the term when used with the claim ``high 
potency.'' One comment stated that the United States Pharmacopeia (USP) 
has established a number of monographs of official names for specific 
nutritional supplements but they do not include the term ``dietary 
supplement.'' Several comments pointed out that use of the term 
``dietary supplement'' is not part of their products' trademarked 
terminology.
    Several comments suggested that the agency provide alternate 
requirements for dietary supplements in conventional food form to 
distinguish them from conventional foods (e.g., cereals, snack bars, 
drinks), requiring that the term ``dietary supplement'' appear on the 
principal display panel, although not necessarily as part of the 
statement of identity. These comments stated that dietary supplements 
in capsule or tablet form are obviously dietary supplements, are easily 
distinguished by consumers from conventional foods, and should not have 
the same identity requirement. A few comments argued that there are 
space limitations on the principal display panel of some dietary 
supplements, and that the term ``dietary supplement'' uses up available 
label space.
    The agency has carefully reviewed these comments but concludes that 
the best reading of the act, as well as the agency's longstanding 
regulations that implement the act, require that the term ``dietary 
supplement,'' or some form of this term, appear as part of the 
statement of identity. Section 201(ff)(2)(C) of the act, in defining 
the term ``dietary supplement,'' mandates that such a product must be 
labeled as a dietary supplement. Section 403(s)(2)(B) of the act states 
that a food shall be deemed to be misbranded if it is a dietary 
supplement, and the label or labeling of the dietary supplement fails 
to identify the product by using the term ``dietary supplement, which 
term may be modified with the name of such an ingredient.'' Section 
403(i)(1) of the act requires that a food label must bear the common or 
usual name of the food, that is, a statement that identifies the food. 
Dietary supplements are labeled subject to the provisions of section 
403(i)(1) of the act (see the last sentence of section 201(ff) of the 
act). Thus, when the act is read in its entirety, it is clear that 
sections 201(ff)(2)(C), 403(s)(2)(B), and 403(i)(1) of the act require 
that the statement of identity of a product that is marketed as a 
dietary supplement identify the product as such.
    FDA's longstanding regulations lead directly to this result. 
Section 102.5 (21 CFR 102.5) sets out how the common or usual name of a 
nonstandardized food is to be derived. Under this provision, the common 
or usual name must accurately identify or describe, in as simple and 
direct terms as possible, the basic nature of the food. The basic 
nature of a dietary supplement is that it is a dietary supplement. This 
is the point made in both sections 201(ff)(2)(C) and 403(s)(2)(B) of 
the act. Thus, under Sec. 102.5(a), the common or usual name of these 
products must, at least in part, identify them as a dietary supplement. 
Section 101.3(b) of FDA's regulation states that the statement of 
identity of a food shall be in terms of its common or usual name. Thus, 
Sec. 101.3(g) derives directly from the act and FDA's longstanding 
regulations that implement the act. Therefore, FDA is adopting 
Sec. 101.3(g).
    However, the agency is persuaded by the comments that flexibility 
in the use of the term ``dietary'' as part of the name ``dietary 
supplement''is warranted. The agency notes that section 403(s)(2)(B) of 
the act states that the product shall be identified ``by using the term 
`dietary supplement,' which term may be modified with the name of such 
an ingredient.'' The agency interprets this provision to mean that the 
term ``dietary supplement'' may be modified to include the name of a 
dietary ingredient or ingredients (e.g., ``Vitamin C Supplement''). 
Furthermore, to provide additional flexibility, an identifying term 
that describes the types of dietary ingredients contained in the 
product in appropriately descriptive terms (e.g., ``Multivitamin 
Supplement,'' ``Herbal Supplement'') may be used. Generic terms that 
are not descriptive (e.g., ``Food Supplement,'' ``Energy Bar'') would 
not be appropriate because they do not identify or describe the dietary 
ingredients (e.g., protein, folic acid, arrowroot) or combination of 
ingredients that the product supplies.
    Accordingly, FDA is revising Sec. 101.3(g) to provide that the term 
``dietary supplement'' may be modified by replacing the term 
``dietary'' with the name of a dietary ingredient or ingredients or an 
appropriately descriptive term indicating the type of dietary 
ingredients that are in the product. The agency notes that, with this 
increased flexibility, several concerns expressed by the comments 
(e.g., possible difficulties with space limitations, potential consumer 
confusion, possible effects on established trademarked names) should be 
alleviated.
    2. One comment asked that the agency change the type size 
requirements referred to in proposed Sec. 101.3(g), which stated that 
``* * * the label shall bear the term `dietary supplement' as part of 
the statement of identity in conformance with the provisions of 
paragraph (d) of this section.'' The comment stated that the type size 
requirements of Sec. 101.3(d) (i.e., that the statement of identity 
``shall be in a size reasonably related to the most prominent printed 
matter on such panel'') cross-referenced in proposed Sec. 101.3(g) 
might be counterproductive or impracticable for products in small 
packages with many dietary ingredients. The comment requested that the 
agency require the same minimum type size as

[[Page 49828]]

that for the declaration of the net quantity of contents 
(Sec. 101.105(i)(21 CFR 101.105(i))) because this would permit products 
to bear the statement of identity in a type size that would be a 
minimum of one-sixteenth of an inch.
    FDA points out that Sec. 101.3(d) does not include minimum type 
size requirements, but, as noted in the comment, it requires that the 
size of the statement of identity be related to the size of the most 
prominent printed matter on the label. Therefore, if the package size 
is small, and there are many dietary ingredients to be listed, it is 
reasonable to expect that even the most prominent printed matter will 
be relatively small, permitting the statement of identity to be 
proportionally smaller, in some cases as small as one-sixteenth of an 
inch. Therefore, the agency is taking no action based on this comment. 
However, because the reference in proposed Sec. 101.3(g) to paragraph 
(d) of that section is redundant, inasmuch as all foods must meet all 
regulatory requirements unless specific exceptions are noted, FDA has 
deleted the reference to paragraph (d).

III. Nutrition Labeling of Dietary Supplements

A. Serving Size

    3. Several comments stated that the term ``serving size'' is 
inappropriate on dietary supplements. One comment stated that the term 
``serving size'' should not appear in the nutrition label of dietary 
supplements, except for products in the physical form of conventional 
foods or for products with significant amounts of calories and 
macronutrients, which should be covered by Sec. 101.9. This comment 
recommended that the directions for use should provide the basis for 
the quantitative statements contained in the nutrition label. Another 
comment stated that the term ``serving size'' should not be used in the 
nutrition label of herbal products and suggested the terms 
``recommended use'' or ``suggested use.'' This comment suggested the 
terms ``dose'' or ``dosage'' in the case of products marketed to health 
professionals.
    The agency is not persuaded by the comments objecting to the term 
``serving size.'' As discussed in the final rule of January 4, 1994 (59 
FR 354 at 358), information on serving size is as essential on the 
nutrition label of dietary supplements as it is on that of conventional 
foods. The agency points out that the directions for use provide the 
basis for the serving size in the nutrition label of dietary 
supplements in that serving sizes are derived by the manufacturer in 
accordance with Sec. 101.12 (21 CFR 101.12). Section 101.12(b), Table 
2, states that the reference amount customarily consumed for dietary 
supplements is ``the maximum amount recommended, as appropriate, on the 
label for consumption per eating occasion * * *.''
    Section 403(q)(1)(A)(i) of the act states that a food is misbranded 
unless its nutrition information specifies the serving size, and 
nothing in the DSHEA directs the agency to eliminate the use of this 
term in the nutrition label of dietary supplements. To the contrary, 
section 403(q)(5)(F)(ii) of the act, which was added by the DSHEA, 
states that the listing of dietary ingredients shall include the 
quantity of each such ingredient per serving. This fact establishes 
that Congress contemplated that serving size would be a part of the 
nutrition labeling of dietary supplements.
    With respect to using other terms in place of the term ``serving 
size,'' the agency reiterates that the term ``serving size'' is 
consistent with the act, and that it would be confusing to consumers if 
the nutrition labels of dietary supplements used varied terms, such as 
``recommended use'' or ``dose,'' in place of the term ``serving size.'' 
Use of the same term in the same place on all labels will help to avoid 
confusion. Therefore, the agency has not made any changes in response 
to these comments.

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

    4. Several comments argued that some (sodium, vitamin A, vitamin C, 
calcium, and iron) or all of the 14 nutrients required under 
Sec. 101.9(c) should be required to be listed on the labels of dietary 
supplements only when they are added to the supplement, or when a claim 
is made about them. These comments argued that dietary supplements of 
herbs or botanicals, for example, are not generally consumed for their 
nutritional value, and that, thus, having to determine the levels of 
the required nutrients would be unduly burdensome and of little use to 
consumers who rely on the nutrition information to structure their 
diets to maintain healthy dietary practices. One comment from an 
independent analytical laboratory stated that mandatory requirements 
for the listing of nutrients should not pertain to herbal products. 
This comment stated that official methods of analysis do not apply to 
herbal products and suggested that these products should be excluded 
from labeling regulations requiring analysis until such time as 
official methodology is published. Other comments specifically 
supported the proposed rule in requiring that macronutrients be 
declared whenever they are present.
     FDA is not persuaded by the comments to modify Sec. 101.36(b)(2). 
Section 403(q)(1) of the act specifies the nutrients that are to be 
listed in the nutrition labeling of foods, and section 403(q)(2) of the 
act gives the Secretary of Health and Human Services (the Secretary) 
discretion to add to, or subtract from, this list for the purpose of 
assisting consumers in maintaining healthy dietary practices. Section 
403(q)(5)(F) of the act states that the labels of dietary supplements 
shall comply with the requirements of subparagraphs (q)(1) and (q)(2) 
in a manner that is appropriate.
    In its final rule on nutrition labeling, the agency concluded that 
information on the calorie, calories from fat, total fat, saturated 
fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, 
protein, vitamin A, vitamin C, calcium, and iron content of foods was 
necessary to assist consumers in maintaining healthy dietary practices 
(58 FR 2079, January 6,1993). Accordingly, these nutrients are required 
under Sec. 101.9(c) to be listed in nutrition labeling.
    In its December 1995 proposal, the agency tentatively concluded 
that these nutrients were equally as important to maintaining healthy 
dietary practices when present in dietary supplements and, therefore, 
should be mandatory on the labels of dietary supplement products as 
well. However, to ease label crowding and to be consistent with the 
DSHEA, FDA proposed that the 14 nutrients need only be listed on 
dietary supplement labels when present in quantitative amounts by 
weight that exceed the amount that can be declared as zero in 
accordance with Sec. 101.9(c). FDA tentatively concluded that this 
action would provide consumers with the information necessary to 
determine how dietary supplement products fit into dietary regimens 
that adhere to dietary recommendations.
    Dietary supplements are foods under section 201(ff) of the act, 
unless they are intended to be used as drugs. Moreover, under section 
201(ff) of the act and some of the other changes made by the DSHEA, 
dietary supplements may well be in conventional food form and contain 
many of the 14 nutrients required to be listed in the nutrition label 
under Sec. 101.9. Thus, as foods, it is appropriate to require that 
their labeling bear the same nutrients as the nutrition labeling on 
conventional foods, unless evidence is presented that justifies the 
contrary conclusion.

[[Page 49829]]

    The comments presented no evidence that would be a basis for the 
agency to reach a conclusion different than it did for conventional 
foods, i.e., that the listing of these nutrients will assist consumers 
in maintaining healthy dietary practices. The agency is not convinced 
that this requirement should be eliminated because of the argument that 
herbs and botanicals are not generally consumed for their nutritional 
value. The fact that a product is not generally consumed for its 
nutritional value is immaterial under the act and its implementing 
regulations. For example, certain spices, such as paprika, which are 
consumed for their flavor-enhancing properties, not for nutritional 
value, are not exempt from nutrition labeling under Sec. 101.9 if any 
nutrient is present at more than insignificant levels 
(Sec. 101.9(j)(4)). The agency concludes that it is appropriate for the 
nutrients required in Sec. 101.9 to be mandatory on the labels of 
dietary supplements. Thus, the agency is not modifying
    Moreover, one of the principles underlying the agency's food 
labeling initiative has been that, if nutrition labeling is to assist 
consumers in making dietary choices, it should provide consistent 
information for consumers to use (55 FR 29487 at 29490, July 19, 1990). 
For example, fat is mandatory on the labels of conventional foods 
because of scientific consensus that high dietary intakes of total fat 
are associated with an increased risk of coronary heart disease, some 
types of cancer, gallbladder disease, and obesity (55 FR 29487 at 
29495). Thus, the listing of fat on the nutrition label, when it is 
present, will assist consumers in meeting dietary recommendations to 
limit fat intake to no more than 30 percent of calories, irrespective 
of whether the nutrition labels are for conventional foods or dietary 
supplements.
    With respect to methodology issues, FDA is not persuaded that 
herbal products should be exempt from labeling until analytical 
methodology is validated for all herbal products. FDA is aware of the 
difficulties in adapting analytical methods to different matrices and 
specifically requested comment on this point in the proposal. The 
agency received comments from industry groups actively working on the 
development of official methodology, but these comments did not 
indicate that problems with methodology necessitate exempting herbs 
from nutrition labeling. Rather, FDA is aware that the adaptation of 
existing methods to different matrices (e.g., herbs) is ongoing. In 
addition, FDA has stated that analysis is not needed for nutrients 
where reliable data bases or scientific knowledge establish that a 
nutrient is not present in a serving of the product (58 FR 2079 at 
2109). Therefore, it may not be necessary to analyze for several 
nutrients in herbal products. For example, there is no need to analyze 
for cholesterol because food composition studies have shown it to be 
found only in animal products.
    Thus, FDA concludes based upon these comments and on its own 
experience that exempting herbs is unwarranted. Moreover, an exemption 
would be inconsistent with section 403(q)(5)(F) of the act. Therefore, 
the agency is not taking any action based on these comments.
    5. Several comments requested more flexibility with the language 
used in place of ``Amount Per Serving.'' The comments requested use of 
phases such as ``Amount per 2 Tablets'' or ``Two Tablets Contain.''
    The agency has no objection to the flexibility requested by these 
comments. The agency proposed in Sec. 101.36(b)(2)(i)(A) that when the 
serving size of the product is one unit, a heading consistent with the 
declaration of the serving size, such as ``Amount Per Tablet'' or 
``Each Tablet Contains,'' may be used in place of the heading ``Amount 
Per Serving.'' In response to these comments, the agency agrees that 
there is no reason to limit the language that can be used in this way. 
Therefore, the agency is deleting the words ``when the serving size of 
the product is one unit'' from Sec. 101.36(b)(2)(i)(A) and adding the 
example ``Amount Per 2 Tablets.''
    6. The agency received a couple of comments that recommended 
changes in nomenclature for thiamin and riboflavin. These comments 
requested that the name ``B<INF>1</INF>'' be used instead of 
``thiamin,'' and that ``B<INF>2</INF>'' 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 
B<INF>1</INF>'' and ``vitamin B<INF>2</INF>'' may be listed as synonyms 
for thiamin and riboflavin. The agency is adopting this provision, so 
manufacturers who wish to inform consumers that these nutrients are B 
vitamins will be free to do so. Thus, they will be able to address any 
consumer confusion as to why these nutrients are included in B-complex 
products.
    The agency concludes that the regulation it is adopting provides 
the requisite flexibility and yet ensures that the nutrition label 
conforms to up-to-date scientific views. Thus, FDA is not accepting the 
recommendation of these comments.
    7. One comment requested that ``folic acid'' be listed instead of 
``folate,'' stating that the use of ``folic acid'' is consistent with 
the final rule entitled ``Food Additives Permitted for Direct Addition 
to Food for Human Consumption; Folic Acid (Folacin),'' published in the 
Federal Register (61 FR 8797, March 5, 1996).
    The agency agrees that the term ``folic acid'' can be listed in 
place of ``folate.'' The December 1995 proposal stated in 
Sec. 101.36(b)(2)(i)(B)(2) that ``folic acid'' and ``folacin'' may be 
added in parentheses immediately following the listing of ``folate'' 
(60 FR 67194 at 67198). However, the health claims final rule on folate 
and neural tube defects, amended the nutrition labeling regulations 
that FDA had adopted for dietary supplements and conventional foods\1\ 
to allow the terms ``folic acid'' or ``folacin'' to be used 
synonymously (61 FR 8752 at 8759, March 5, 1996)). In that final rule, 
the agency acknowledged that the terms ``folic acid'' and ``folate'' 
are interchangeable in common usage, although technically ``folic 
acid'' refers

[[Page 49830]]

to the synthetic form of this vitamin, and ``folate'' is a general term 
that refers to both the synthetic and naturally-occurring forms.
---------------------------------------------------------------------------

    \1\ The regulations in place at that time were 
Secs. 101.9(c)(8)(v) for conventional foods and Sec. 101.36(b)(3)(v) 
for dietary supplements. Thus, FDA amended these regulations. FDA 
had yet to implement Sec. 101.36(b)(3)(v), however (see 60 FR 7711, 
February 9, 1995), and, as part of the changes included in the 
December 1995 proposal, it renumbered this provision as 
Sec. 101.36(b)(i)(B)(2).
---------------------------------------------------------------------------

    Thus, the agency agrees with the comment that it is appropriate for 
``folic acid'' to be listed by itself in place of ``folate.'' For 
clarity, the agency is modifying the language in 
Secs. 101.36(b)(2)(i)(B)(2) and 101.9(c)(8)(v) to state 
``alternatively, folic acid or folacin may be listed without 
parentheses in place of folate.''
    8. Several comments recommended that the agency require that 
information on the quantitative amount by weight of each dietary 
ingredient be placed immediately after the name of the dietary 
ingredient, rather than in a separate column. The comments requested 
this change because of space constraints on the label and the cost of 
reformatting. One of these comments stated that consumers are already 
familiar with a format in which amounts immediately follow names on 
both dietary supplement and traditional food labels, and that there is 
no evidence that they have difficulties understanding this information. 
Other comments stated that the use of a single column should be 
optional. At least one comment specifically supported the proposed two 
columns because of readability.
    The agency is persuaded that information on names and the 
corresponding amounts of dietary ingredients should be allowed to 
appear in one column to save space. In the January 4, 1994, final rule 
on labeling of dietary supplements, the agency required that the name 
of the nutrient and the quantitative amount by weight appear in a 
single column despite several comments that argued for a separate 
column for amounts. When the DSHEA amended the act to allow the source 
of a dietary ingredient to be listed in the nutrition label following 
the name, the agency's tentative view was that the additional 
information added sufficient complexity to make it appropriate to have 
the information on amount in a separate column. Some consumers buy 
dietary supplements on the basis of quantitative amounts, and FDA 
tentatively concluded that a separate column would help consumers to 
locate this information more readily . However, based on the facts the 
comments pointed out, that one column would make the dietary supplement 
nutrition label consistent with that on conventional foods, and that 
there are space and cost advantages to such a format, the agency has no 
objection to the optional listing of the quantitative information by 
weight immediately following the listing of names. The agency is 
modifying Sec. 101.36(b)(2)(ii) accordingly.
    9. A few comments stated that quantitative information should not 
be declared on the basis of ``per serving.'' Some of these comments 
requested that information be declared ``per day.'' These comments 
argued that what is consumed per day is more important than per 
serving. A couple of other comments preferred dual listing. One 
suggested ``per unit and per day,'' and the other suggested ``per 
serving and per day.'' Other comments specifically favored a ``per 
serving'' basis and opposed dual listing.
    The agency does not agree that quantitative information should be 
declared on a ``per unit'' or a ``per day'' basis instead of ``per 
serving.'' In its proposal on June 18, 1993 (58 FR 33715 at 33716), FDA 
tentatively concluded that listing information on the basis of ``per 
serving'' was preferable to ``per day'' because consumers might not 
actually consume the amount indicated ``per day.'' With respect to 
``per unit,'' FDA expressed concern that this basis alone could confuse 
consumers when more that 1 unit is to be consumed at one time (e.g. two 
capsules with each meal) because they might assume that the information 
is on a ``per serving'' basis because the labels of conventional foods 
are presented in this manner. For these reasons, the agency required a 
``per serving'' basis in the final rule of January 4, 1994 (59 FR 354 
at 359), and carried this forward in the December 1995 proposal (60 FR 
67194 at 67198). More importantly, the act states in section 
403(q)(5)(F)(ii) that the listing of dietary ingredients shall include 
the quantity of each such ingredient ``per serving.'' Therefore, FDA is 
not changing Sec. 101.36(b)(2)(ii), which requires that quantitative 
information be listed on the basis of ``per serving.''
    However, with respect to dual listing, the agency is persuaded that 
there may be some products on which the unit amount may be of interest 
to consumers, and, therefore, FDA is modifying the regulation to allow 
the option of listing information on a ``per unit'' basis in addition 
to a ``per serving'' basis. The agency notes that Sec. 101.9(b)(10)(ii) 
permits the percent of Daily Value (DV) on the labels of conventional 
foods to be listed in this manner when the product is in discrete 
units, and a serving is more than 1 unit. Thus, the agency is adding 
Sec. 101.36(b)(2)(iv) to provide for quantitative information to be 
presented voluntarily on the basis of ``per unit'' in addition to the 
required declaration ``per serving'' as noted in Sec. 101.36(b)(2)(ii). 
When information is presented on a ``per unit'' basis, it must be 
declared in additional columns to the right of the ``per serving'' 
information and must be clearly identified by appropriate headings, as 
illustrated in Figure 1.

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[[Page 49831]]

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BILLING CODE 4190-01-C

    10. One comment requested different rounding rules for sugars. The 
comment wanted to be able to declare amounts under 2 grams (g) in 
tenths of a g or to be able to declare 0, 0.5, 1.0, 1.5 and 2.0 g. This 
comment stated that sugars are present in much smaller amounts in 
dietary supplements than in conventional foods, and that the proposed 
rounding rules are inappropriate.
    The agency is not persuaded by the comment. Section 101.9(c)(6)(ii) 
provides that sugars are expressed to the nearest g, except that if a 
serving contains less than 1 g, the statement ``less than 1 gram'' may 
be used, and if the serving contains less than 0.5 g, the content may 
be expressed as zero. While sugars may be present in much smaller 
amounts in dietary supplements than in conventional foods, FDA points 
out that the comment did not justify why amounts of sugars that are 
under 2 g should be listed any differently on the labels of dietary 
supplements than on the labels of conventional foods. Moreover, given 
that amounts under 0.5 g are considered nutritionally insignificant, 
the agency is not convinced that being able to declare sugars in tenths 
of a g or half-gram increments up to 2 g is useful in helping consumers 
to maintain a healthy diet. Accordingly, the agency is not changing 
Sec. 101.36 in response to this comment.
    11. One comment requested clarification of the use of the word 
``actual'' in proposed Sec. 101.36(b)(2)(ii)(B), which states ``The 
amounts of vitamins and minerals, excluding sodium and potassium, shall 
be the actual amount of the vitamin or mineral included in one serving 
of the product * * *.'' This comment stated that overages of dietary 
ingredients that are subject to degradation are added to dietary 
supplement products to ensure that the products provide the labeled 
quantities throughout their shelf life. The comment asked FDA to 
acknowledge in the preamble of the final rule that the labeled amounts 
of vitamins and minerals are not necessarily the actual amounts added 
at the time of manufacture, and that the corresponding percent DV is 
based on the labeled amount.
    The agency agrees that the proposed language is not clear with 
respect to what amount is to be declared. The agency does not intend 
that the declared amount include any overages that a manufacturer 
includes in anticipation of degradation. By use of the word ``actual,'' 
the agency was trying to draw a distinction between sodium and 
potassium, which are required to be declared in the increments 
prescribed in Sec. 101.9(c), and other vitamins and minerals, for which 
increments are not prescribed in Sec. 101.9(c). (Section 101.9(c) does 
not require declaration of the quantitative amounts by weight for these 
other vitamins and minerals, only that they be declared as a percent of 
the DV for the nutrient. Thus, the increments for declaration of the 
quantitative amount of these nutrients are not specified in 
Sec. 101.9(c).)
    Given the reaction to Secs. 101.36(b)(2)(ii)(B) and 
101.36(b)(2)(iii)(B) that is reflected in the comments, FDA concludes 
that use of the word ``actual'' in these provisions is confusing. 
Therefore, the agency is revising these paragraphs to delete this word.
    12. Several comments agreed that the regulation should allow the 
use of ``<1%'' in place of ``less than 1%'' to save space. Some of 
these comments supported the use of ``<1%'' on the labels of 
conventional foods as well as on the labels of dietary supplements. One 
of these comments stated that this symbol for ``less than'' is taught 
in elementary math and science classes nationwide and is universally 
recognized. One comment from a trade association that represents 
manufacturers of conventional foods stated that the food industry has 
not been permitted the use of this symbol as there was no information 
demonstrating that consumers understand its meaning. This comment was 
opposed to the use of the symbol on the labels of dietary supplements 
until conventional foods are also able to use it.
    FDA is persuaded by the comments to allow for the use of the symbol 
``<'' for ``less than'' on the labels of dietary supplements and 
conventional foods to provide more flexibility when space is limited on 
the label. While there is no consumer survey data to show the level of 
consumer understanding of the symbol, the agency acknowledges that 
elementary and secondary schools are teaching its use, so that a 
growing number of consumers can be expected to understand its meaning. 
In addition, the agency is aware that the symbol ``<'' is being used on 
the labels of some conventional foods, and FDA has not received any 
consumer complaints about its use. Given these unique circumstances, 
FDA concludes that it is reasonable to allow use of the symbol, thereby 
reducing the possibility of overcrowding of information on some 
nutrition labels. Accordingly, Sec. 101.36(b)(2)(iii)(C) is finalized 
as proposed.
    The agency stated in the December 1995 proposal (60 FR 67194 at 
67200)

[[Page 49832]]

that if it allowed the symbol on the nutrition labels of dietary 
supplements, it intended ``to provide for such use'' on the nutrition 
labels of conventional foods as well. FDA finds that it reasonably 
follows from this statement, and from the conclusions that it has 
reached with respect to dietary supplements, for it to take this 
action. Accordingly, the agency is amending Sec. 101.9(c)(8)(iii) and 
(d)(7)(i) to allow the use of the symbol ``<'' in place of the words 
``less than.''
    13. Several comments supported the proposed use of the footnote 
``Daily Value not established''(Sec. 101.36(b)(2)(iii)(F)). However, 
three comments were against the use of this footnote in some cases. 
These comments stated that the footnote implied that a DV was not 
``yet'' established. Consequently, they stated that it should only be 
permitted for components having some legitimate claim to nutritional 
value. One comment said that dietary ingredients such as choline should 
have an asterisk and a footnote, while dietary ingredients such as bee 
pollen should have no asterisk and no footnote. This comment said that 
a product composed solely of dietary ingredients such as bee pollen 
should have no ``% Daily Value'' column, no asterisks, and no footnote.
    The agency does not agree with the comments that argued that the 
footnote apply only to dietary ingredients that ``have nutritional 
value.'' The comments did not suggest a definition for dietary 
ingredients that have a ``claim to nutritional value,'' or how to 
distinguish such dietary ingredients from the other dietary ingredients 
for which no DV has been established. Thus, the agency does not know 
how it would implement the suggested change. The act makes it clear in 
section 403(q)(5)(F)(i) that dietary ingredients not having a 
recommendation for daily consumption established by the Secretary are 
to be identified as ``having no such recommendation.'' Accordingly, FDA 
is adopting Sec. 101.36(b)(2)(iii)(F) unchanged from the proposal.

C. Other Dietary Ingredients

    14. Several comments recommended that ``other dietary ingredients'' 
(those not having recommendations, i.e., no RDI's or DRV's) should be 
listed outside the ``box'' format for nutrition information, and that 
products composed solely of these dietary ingredients, such as herbal 
supplements, should not be required to use the ``box'' format. One of 
these comments suggested not requiring a ``box'' format unless a claim 
is made. These comments stated that herbal supplements are not consumed 
for their nutritional value, and that it is not appropriate to use a 
format that mimics that of the Nutrition Facts panel. They said that 
the use of such a format would confuse consumers and would not convey 
any meaningful information. They argued that such a format goes beyond 
the intention of the DSHEA.
    One comment stated that simple ingredient listing should be an 
option in lieu of nutrition labeling. Another comment, which requested 
more flexibility, said that the agency should allow the ``labeler to 
present the information to the consumer in the best way they see fit.'' 
One other comment stated that flexibility in format was needed because 
of space constraints and recommended that the special labeling 
provisions in Sec. 101.9(j)(13) should apply to dietary supplements.
    The agency is not persuaded by these comments that the format that 
it proposed goes beyond the intention of the DSHEA. To the contrary, 
the agency concludes that the format is consistent with the DSHEA.
    As a result of the DSHEA, the act requires that nutrition 
information immediately precede the ingredient information (section 
403(q)(5)(F)(iv)), requires that the nutrition information list dietary 
ingredients not having recommendations (section 403(q)(5)(F)(i)), and 
defines herbs and other botanicals as dietary ingredients when present 
in dietary supplements (section 201(ff)(1)). Taken together, the only 
logical reading of these provisions is that herbal dietary ingredients 
are to be listed in the nutrition information. Accordingly, the agency 
is not making any change in Sec. 101.36 in response to these comments. 
The agency notes that Sec. 101.36(i)(2) provides that dietary 
supplements are subject to the special labeling provisions specified 
for small and intermediate-sized packages in Sec. 101.9(j)(13).
    15. Several comments requested that the ``other dietary 
ingredients,'' those not having RDI's or DRV's, including those in a 
proprietary blend, should be allowed to be declared in paragraph form 
beneath the bar required in Sec. 101.36(e)(6)(ii) (i.e., in a linear 
format with the quantity of each dietary ingredient immediately 
following the name of the ingredient itself) to save space. An example 
of such a label was included in one comment. One comment from a dietary 
supplement manufacturer stated that the majority of its products would 
qualify for an exemption or a linear layout under the special 
provisions for small or intermediate-sized packages in 
Sec. 101.9(j)(13) if they were labeled as conventional foods.
    FDA points out, as stated in response to the previous comment, that 
Sec. 101.36(i)(2) provides that dietary supplements are subject to the 
special labeling provisions specified in Sec. 101.9(j)(13) for foods in 
small or intermediate-sized packages, which includes the option of a 
linear layout when there is insufficient space for the vertical or 
tabular display. Also, Sec. 101.36(c)(2) provides that the ``other 
dietary ingredients'' contained in a proprietary blend may be listed in 
linear fashion indented under the term ``Proprietary Blend.'' In 
addition to the flexibility that these sections provide, FDA has no 
objection if a linear display is used for the listing of all ``other 
dietary ingredients'' on the labels of dietary supplement products, 
regardless of package size. However, as discussed in comment 18 below, 
when constituents (i.e., subcomponents) of ``other dietary 
ingredients'' are listed, they must be indented under the listing of 
the dietary ingredient. Thus, it is not possible to use a linear 
display for ``other dietary ingredients'' when constituents are listed 
for any of them.
    Therefore, the agency is revising Sec. 101.36(b)(3)(i) and 
(b)(3)(ii) to provide explicitly that other dietary ingredients may be 
declared in a linear display as long as none of the dietary ingredients 
list constituents. Figure 2 illustrates the declaration of other 
dietary ingredients in a linear display.

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[[Page 49833]]

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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 
Sec. 101.36(b)(3)(ii) that ``or any dietary ingredients that are liquid 
extracts, the weight shall not include the weight of solvents.'' The 
comments stated that the proposal is not practicable because in many 
cases there are no methods to determine the identity and quantity of 
entities dissolved in solvents. One comment from a trade association of 
manufacturers of natural food products stated that FDA should allow a 
truthful and nonmisleading description of the content of an extract, 
such as the ratio of the weight of the starting material to the volume 
of the solvent used. This comment said that the association is working 
with other industry groups to develop a uniform method of reporting 
this information that is not false or misleading. Another comment 
pointed out that the ratio method could be misleading in the absence of 
compendial standards because different supplies of the same herb can 
yield various strengths and potencies. For this reason, the comment 
discouraged the use of indicators of activity until compendial 
standards are established.
    Another comment stated that FDA should defer action on this issue 
until there is scientific agreement on appropriate methodology and, in 
the interim, require that extracts be listed with the weight of the 
entire extract. A comment from a trade association for herbal product 
manufacturers agreed that extracts should be listed with the weight of 
the entire extract, e.g. ``Dandelion root extract (0.5 fl oz).'' This 
comment said that the identity of the dietary ingredients of botanical 
liquid extracts are the herbal extracts themselves.
    The agency is persuaded by the comments that the proposed manner of 
declaring extracts is not appropriate. The agency acknowledged in the 
proposal that this matter is a difficult one and specifically requested 
comment on how these provisions should be implemented. The comments 
pointed out that the dietary supplement industry and others are 
developing methods that will result in better information on the 
composition of such extracts. However, FDA does not agree that it 
should defer action until validated methods are available or, in the 
meantime, require only that manufacturers list the weight of the entire 
extract. The agency is persuaded by the comment that recommended that 
extracts should be described by a ratio of the weight of the starting 
material to the volume of the solvent or a description of these values, 
which would indicate the concentration of the extract. The agency notes 
that the label must state whether the starting material is fresh or 
dry. Because fresh botanicals contain water, it is important that the 
label have this information so that consumers can determine whether the 
weight listed includes the weight of any water.
    FDA has subdivided proposed Sec. 101.36(b)(3)(ii) to address the 
listing of liquid extracts in Sec. 101.36(b)(3)(ii)(B) and of dried 
extracts in (b)(3)(ii)(C). The agency is requiring in 
Sec. 101.36(b)(3)(ii)(B) that the label of liquid extracts clearly 
state whether the

[[Page 49834]]

starting material is fresh or dry, what solvent is used, and the 
concentration of the botanical in the solvent, e.g., ``fresh dandelion 
root extract, x mg (y:z) in 70% ethanol'' where ``x'' is the number of 
mg of the entire extract, ``y'' is the number of mg of the starting 
material and ``z'' is the number of milliliters of solvent. Where the 
solvent has been partially removed (not to dryness), the final 
concentration should be stated (e.g., if the original extract had a 
ratio of 1:5, and 50 percent of the solvent were removed, the 
concentration listed would be 1:2.5).
    Section 101.36(b)(3)(ii)(C) of this final rule states that where 
the solvent is removed to dryness, the weight of the dried extract must 
be listed. Also, the dried extract must be described in a manner that 
includes the identity of the solvent because the solvent used 
determines the composition of an extract. For example, hexane as a 
solvent would concentrate nonpolar constituents, and water would 
concentrate polar constituents. These two dried extracts could have 
very different compositions. Thus, the type of extract (e.g., ``dried 
hexane extract of ________'' or ``________, dried hexane extract'') is 
a material fact under sections 201(n) and 403(a) of the act and must be 
specified on the label, even when the solvent is removed during 
processing.
    The agency points out that solvents removed during processing that 
do not have any technical or functional effect in a food are exempt 
from being listed in ingredient labeling in accordance with 
Sec. 101.100(a)(3)(ii)(a) (21 CFR 101.100(a)(3)(ii)(a). However, 
solvent information is needed in the nutrition label of dietary 
supplements to appropriately describe extracts because dietary 
ingredients do not have individual regulations, like the regulations 
for food additives, that specify how they are to be made, and, when 
needed for identity or safety reasons, what solvent can be used in the 
processing. For example, Sec. 172.580(b) (21 CFR 172.580(b)) states 
that safrole-free extract of sassafras is to be obtained by extracting 
the bark specified with dilute alcohol. There is no parallel provision 
for, nor is Sec. 172.580(b) applicable to, the use of this substance in 
a dietary supplement. Therefore, in the absence of individual 
regulations on dietary ingredients, the agency is requiring in 
Sec. 101.36(b)(3)(ii) that a dried extract be described by an 
appropriately descriptive term that identifies the solvent used.
    18. Several comments requested the flexibility of listing both a 
dietary ingredient and one or more of its constituents (i.e., 
subcomponents) to provide consumers with more information. One of the 
comments favoring this approach stated that, while two different 
supplements may both contain the same amount of a botanical, one 
product may yield twice as much of a particular constituent as the 
other brand. Most of these comments suggested that constituents of a 
dietary ingredient should be indented under the listing of the dietary 
ingredient because consumers are familiar with this format, as it is 
comparable to the format used for certain DRV nutrients and their 
subcomponents in the nutrition labeling of conventional foods. 
Alternatively, a couple of comments suggested that constituent 
information immediately follow the listing of the dietary ingredient 
within parentheses. Most of the comments gave examples where both the 
constituents and the dietary ingredients do not have RDI's or DRV's, 
but one comment suggested that vitamin A and vitamin C should be 
indented under fish oil. One comment stated that if FDA does not allow 
information about constituents inside the ``Supplement Facts'' box, it 
should clarify that such information is allowed elsewhere on the label.
     The agency is persuaded by the comments to allow more flexibility 
with respect to the listing of constituents of dietary ingredients that 
do not have RDI's or DRV's, as long as the resultant labels are not 
inconsistent with the act and are not confusing to consumers. The 
agency is requiring that constituents, when they are listed, be 
indented under the listing of the dietary ingredient in either a column 
or, to save space, in a horizontal linear display. Quantitative amounts 
of the constituents must be listed and also must be included in the 
total quantitative amount listed for the dietary ingredient. The agency 
is requiring that the dietary ingredient and its weight be presented on 
one line, and that any information on constituents be indented under 
the declaration of the dietary ingredient to help clarify to consumers 
that the constituents are contained in the dietary ingredient. 
Accordingly, the agency is adding new Sec. 101.36(b)(3)(iii) to provide 
that the constituents of dietary ingredients not having RDI's or DRV's 
may be listed. Proposed Sec. 101.36(b)(3)(iii) is redesignated as 
Sec. 101.36(b)(3)(iv).
    When constituents of other dietary ingredients are dietary 
ingredients described in Sec. 101.36(b)(2), they are to be listed in 
accordance with Sec. 101.36(b)(2). Section 403(q)(5)(F)(i) of the act 
provides that dietary ingredients having recognized dietary 
recommendations are to be listed first to be followed by the dietary 
ingredients not having recommendations. Accordingly, with respect to 
the fish oil example, Sec. 101.36(b)(2) requires that vitamin A and 
vitamin C be listed in the top half of the nutrition label, and that 
source information may be included following the listing of each in 
accordance with section 403(q)(5)(F)(iii) of the act , e.g., ``vitamin 
A (from fish oil).'' Listing vitamin A and vitamin C as constituents 
under the listing of fish oil is inconsistent with section 403(q)(5)(F) 
of the act.

D. Proprietary Blends

    19. One comment stated that there is no need to require a dietary 
supplement that is a proprietary blend to be identified specifically as 
a ``proprietary blend.'' This comment gave an example that used the 
word ``blend'' in place of ``proprietary blend'' and noted that there 
are synonyms of ``blend'' that would also accurately describe these 
products. However the comment did not list specific synonyms. The 
comment stated that there is no reason to limit label flexibility in 
this regard. Other comments supported the use of the term ``proprietary 
blend.'' One comment stated that, while a company has the obligation to 
identify such blends, most users of these blends have devised fanciful 
or trademarked names for them, and the term ``proprietary blend'' 
should not have to be repeated in the top half of the nutrition label 
when source information is included in parentheses, and the blend is a 
source of one or more of the 14 mandatory nutrients.
    FDA is persuaded by the comment that it is not necessary to include 
the term ``proprietary blend'' when the blend is identified by another 
term or fanciful or trademarked name. Inasmuch as the act does not 
require use of the term ``proprietary blend,'' and the formatting 
requirements (i.e., declaration of total weight of blend followed by 
listing of dietary ingredients in the blend) will make the presence of 
a proprietary blend apparent, the agency is modifying Sec. 101.36(c), 
(c)(2), and (c)(3) to state that the blend may be identified by the 
term ``Proprietary Blend'' or another appropriately descriptive term or 
fanciful name.
    Regarding the comment that stated that the name of a proprietary 
blend should not have to be repeated each time it is a source of a 
nutrient, the agency points out that this would not happen. Firms are 
to list the specific ingredient in a proprietary blend that supplies a 
nutrient, rather than list the name of the proprietary blend.

[[Page 49835]]

    20. Another comment requested that the words ``Proprietary Blend'' 
be allowed in bold type. The comment stated that in some instances, a 
bold type heading may be easier to see and to understand than an 
indented list of ingredients below the heading. The comment did not 
include a sample label illustrating its recommendation.
     The agency is not persuaded that bolding the term ``Proprietary 
Blend'' is preferable to indenting the dietary ingredients in the blend 
under the term to show that these ingredients are included in the 
blend. Indentation is used in other situations to convey the concept of 
inclusion (e.g., in the listing of subcomponents of nutrients in 
nutrition labels on conventional foods in Sec. 101.9(c) and on dietary 
supplements in Sec. 101.36(b)(2)(i)(B)). As an example, 
Sec. 101.9(c)(2)(i) provides that ``Saturated Fat'' be indented under 
the listing of ``Total Fat.''
    At the same time, Sec. 101.9(d)(1)(iv) provides that nutrients that 
are not indented, such as ``Total Fat'' and ``Total Carbohydrate,'' are 
to be bolded. Consequently, while the agency has decided to retain the 
requirement in Sec. 101.36(c)(2) that dietary ingredients contained in 
a proprietary blend be indented under the term ``Proprietary Blend'' or 
descriptive term or fanciful name used in its place, FDA does not 
object to the voluntary bolding of this term. Accordingly, the agency 
is changing Sec. 101.36(c) to permit bolding.
    21. One comment objected to the requirement that a proprietary 
blend list its dietary ingredients in descending order of predominance 
by weight. This comment requested that the agency permit the listing of 
a ``lesser ingredient'' first when the weight of the ingredient is 
specified. The comment did not give a reason for this request.
    FDA is rejecting this request. To allow a dietary ingredient in a 
proprietary blend to be listed first when its weight is voluntarily 
declared would create an implication that there is less of the other 
dietary ingredients in the blend than the ingredient that is listed 
first. The only way to avoid creating this impression would be to list 
the weight of each of the other ingredients. Yet, by definition, the 
amounts of the ingredients in the blend are proprietary. Thus, the 
agency concludes that, when a proprietary blend is involved, the only 
way to avoid misleading consumers is to require that the ingredients of 
the blend be listed in descending order of predominance. If a 
manufacturer wishes to voluntarily list the weights of ingredients, it 
is free to do so, but FDA is not requiring such a disclosure for other 
dietary ingredients in a proprietary blend. Therefore, FDA is not 
changing Sec. 101.36(c)(2) in response to this comment.

E. Sources

    22. Several comments requested that dietary ingredient sources be 
permitted to be declared in the nutrition label without parentheses or 
without the word ``as'' or ``from.'' One of these comments stated that 
these points should be left up to the judgment of the manufacturer. 
This comment stated that the meaning of ``calcium from calcium 
carbonate'' is clear without the use of parentheses, and that 
flexibility is needed to save space. One comment expressed support for 
the proposal and stated that the format proposed will help consumers to 
understand the relationship between the dietary ingredient and its 
source.
    The agency is not persuaded that space constraints justify making 
the use of parentheses, or of the words ``as'' or ``from,'' optional. 
In fact, some dietary supplements in small or intermediate-sized 
containers currently use the words ``as'' or ``from'' to help consumers 
understand that such compounds are the source of the dietary 
ingredients.
    The agency continues to be concerned that allowing flexibility in 
the manner in which dietary ingredient sources are listed in the 
nutrition label could lead to consumer confusion. FDA has received many 
inquiries over the years that questioned whether amounts specified on 
labels refer to the weight of a particular nutrient or to the salt of 
that nutrient used to make the supplement. Having parentheses around 
the source compound makes it clear that the quantitative amount and % 
DV pertain to the dietary ingredient listed and not to the source. 
Thus, FDA concludes that the format that it proposed is the most clear 
and should not be optional. Accordingly, FDA is not changing 
Sec. 101.36(d) in response to these comments.
    23. The agency received a comment on the proposed requirement (see 
proposed Secs. 101.4(g) and 101.36(d)) that the ingredient list on 
dietary supplements be preceded by the word ``Ingredients'' or, when 
some ingredients (i.e., sources) are identified within the nutrition 
label, by the words ``Other ingredients.'' The comment, which was from 
a trade association for conventional foods, noted that the term 
``Ingredients'' is in common usage in the labeling of conventional 
foods to denote the ingredient declaration but is not required. The 
comment stated that this requirement would set an adverse precedent for 
the labeling of conventional foods and requested that the use of these 
identifying terms be optional.
    The agency acknowledges that the ingredient declaration on the 
labels of conventional foods are not required to be preceded by the 
word ``Ingredient.'' However, the labels of conventional foods do not 
allow ingredient information in the nutrition label, so the potential 
for consumer confusion is not an issue. Given the fact that the DSHEA 
requires dietary ingredients not having RDI's or DRV's to be listed in 
the nutrition label of dietary supplements along with their amounts and 
also permits the sources of these dietary ingredients to be included in 
the nutrition label, the agency concludes that it is important that the 
nutrition information and the ingredient information on labels of 
dietary supplements be clearly identified. Inasmuch as no comments from 
the dietary supplement industry objected on this point, and as the 
situation presented by dietary supplements is distinguishable from that 
presented by conventional foods, FDA does not view this regulatory 
action as setting a precedent for conventional foods. Thus, the agency 
is not making any changes in Sec. 101.36(d) or Sec. 101.4(g) on the 
designation of ingredients in response to this comment.
    24. One comment urged the agency to abandon the requirement in 
proposed Secs. 101.36(d) and 101.4(h) that the common or usual name of 
ingredients that are botanicals be followed by the Latin binomial name 
of the plant. This comment stated that Latin binomials are generally 
meaningless to consumers and take up valuable label space. Another 
comment stated that Latin binomials should only be used on dietary 
supplements sold to health professionals because they have the training 
to understand them. Several other comments pointed out that the book 
Herbs of Commerce (Ref. 11) establishes individual common names for 
over 600 of the most prominent botanical ingredients in trade and gives 
the corresponding Latin name for each common name. These comments 
recommended that the agency require the use of these standardized 
common names in labeling and not require the listing of Latin names 
when they are available in this reference. Other comments did not 
object to listing Latin binomials but did object to including the 
designation of the author who published the name. Another comment 
requested that abbreviations of Latin binomials be allowed to save 
space.
    The agency is persuaded by the comments that the common names for 
botanicals standardized in the book

[[Page 49836]]

Herbs of Commerce (Ref. 11) should be used in labeling. Because this 
reference lists the Latin binomial for each standardized common name, 
the agency is persuaded that a Latin binomial need not be included on 
labels when this information is available in Herbs of Commerce (Ref. 
11). Thus, the agency is changing Secs. 101.36(d)(1) and 101.4(h) 
accordingly. Latin binomials will be required except when the common or 
usual name of the botanical is available in this reference, and the 
designation of the author will be needed when a positive identification 
can not be made in its absence (Sec. 101.4(h)(2)). The agency 
reiterates that when a Latin binomial is required, the complete 
binomial is required for each botanical present, even when multiple 
species of the same genus are present.
    With respect to the use of abbreviations of Latin binomials, the 
agency proposed that any name in Latin form shall be in accordance with 
internationally accepted rules on nomenclature, such as those found in 
the International Code of Botanical Nomenclature, which does not 
include rules for the use of abbreviations (Ref. 12). The comment that 
requested that abbreviations be permitted did not address why they 
should be permitted when they are not included in the International 
Code of Botanical Nomenclature (Ref. 12). In the absence of clearly 
defined rules, the agency is concerned that allowing abbreviations 
would cause a great deal of confusion. For example, there are 66 plant 
names that could be represented by the abbreviation ``A. alba.'' For 
this reason, the agency is not changing the regulation to allow for 
Latin binomials to be abbreviated.
    25. One comment requested that FDA not require the declaration of 
the part of the plant for botanical ingredients that are used as a 
source material for other dietary ingredients. This comment stated that 
section 403(s)(2)(C) of the act requires that the labeling identify the 
part of the plant from which an herb or other botanical dietary 
ingredient is derived. Thus, the comment contends that this information 
should not be required when an herb or other botanical is the source of 
a dietary ingredient.
    The agency agrees with this comment. As stated, the act, as a 
result of the DSHEA, requires identification of the part of a plant 
when a supplement contains a dietary ingredient that is an herb or 
other botanical. However, a constituent (i.e., a chemical component) of 
a botanical may be a dietary ingredient under section 201(ff)(1)(F) of 
the act. When a constituent is listed, the agency agrees that 
information on the part of the plant is not required by the act.
    26. Several comments objected to the requirement that the part of 
the plant be listed in parentheses after the listing of the Latin 
binomial. These comments requested that, as an alternative to allow 
flexibility and to save space, the listing of the part of the plant be 
permitted without parentheses following the common name of the plant. 
One of these comments stated that listing the part of the plant in this 
manner was more comprehensible.
    The agency points out that these final regulations do not require 
that Latin binomial names be included when they are available in Herbs 
of Commerce (Ref. 11) (see comment 24 in section III.E. of this 
document). In these cases, the part of a plant would immediately follow 
the listing of the common name. When a Latin binomial name is required, 
the agency has no objection to having it be listed after the part of 
the plant. Furthermore, FDA is persuaded that, to save space, the 
listing of the part of the plant should be permitted to follow the 
common name of the plant without parentheses. Therefore, the agency is 
reversing the order of proposed Sec. 101.4(h)(1) and (h)(2) to reflect 
the order in which the information is to be provided and is revising 
the paragraph renumbered as Sec. 101.4(h)(2) in response to these 
comments. The agency notes that Sec. 101.36(d)(1) does not need to be 
changed in response to these comments as it cross references Sec. 101.4 
and does not provide specific information on how to list the part of a 
plant.
    27. One comment requested the option of listing each of the 
separate parts of a plant instead of the words entire ``plant,'' when 
all parts of a plant are used. The comment stated that it is quite rare 
to actually use all parts of a plant. This comment also requested that 
the word ``herb'' be permitted to refer to the above ground parts of a 
plant. The comment said that Webster's New Universal Dictionary (2d 
ed., 1983) gives ``herbage'' as a definition of ``herb,'' and that 
``herbage'' is defined as ``the green foliage and juicy stem of 
herbs.''
    The agency does not object to the listing of each of the separate 
parts of a plant instead of the words ``entire plant.'' While this 
point was not addressed in the codified section of the proposal, the 
agency did make the statement in the preamble that when an entire plant 
is used, the label should specify ``entire plant'' to meet the 
requirements of the act. The agency made this statement assuming that 
manufacturers would not want to list all the parts of a plant. However, 
the agency would not object if a manufacturer listed all the individual 
parts of a plant because such a listing is consistent with the DSHEA.
    Regarding the request that the word ``herb'' be permitted to 
describe the above ground parts of a plant, the agency is not convinced 
that this usage is appropriate. FDA notes that the primary definition 
of the word ``herb'' in many dictionaries refers to a type of a plant, 
i.e., a nonwoody plant whose aerial portion is relatively short lived 
(only a single growing season in the temperate zone), rather than a 
part of a plant. Accordingly, the agency is not persuaded by the 
comment that consumers would understand the term ``herb'' to mean that 
part of the plant grown above ground and is denying this request. 
However, the agency has no objection to the use of the term ``aerial 
part'' to describe the above ground parts of a part.

F. Format

    28. Several comments requested that the nutrition label be entitled 
``Nutrition Facts'' for all dietary supplements. These comments stated 
that ``Nutrition Facts'' should be used for a variety of reasons, 
including that: (1) These products are marketed for their nutritional 
value, (2) the information presented is about nutrition, (3) the DSHEA 
uses the term ``nutrition information'' (see section 403(q)(5)(F)(i) of 
the act), (4) the heading should be consistent with the heading used 
for conventional foods, (5) some conventional foods do not have 
nutritional value; thus, ``Nutrition Facts'' on dietary supplements is 
acceptable, and (6) consumers would be confused by the heading 
``Supplement Facts'' and think that the products are of lesser value 
than conventional foods. One of these comments said that the heading 
``Supplement Facts'' is a misnomer because it implies that the 
information is supplemental and not complete. Another comment stated 
that the heading ``Supplement Facts'' would be a violation of 
Sec. 101.9(k)(6), which provides that a food is misbranded if its label 
differentiates in any way between vitamins that are naturally present 
and those that are added.
    Other comments recommended that the use of the heading ``Nutrition 
Facts'' or ``Supplement Facts'' should depend on the composition of a 
particular dietary supplement. Some of these comments stated that a 
product containing even one vitamin or mineral having a DV-nutrient 
should be able to use the heading ``Nutrition Facts'' because the 
product would have nutritional value. Another comment

[[Page 49837]]

wanted products containing only DV-nutrients to use the heading 
``Nutrition Facts'' and had no opinion on other products. Other 
comments said that products that were mostly DV-nutrients should use 
the heading ``Nutrition Facts,'' and products that were mostly herbals 
should use the heading ``Supplement Facts.'' One comment wanted the 
option of using both headings in one nutrition label, listing DV-
nutrients under the heading of ``Nutrition Facts'' and other dietary 
ingredients under a secondary heading of ``Supplement Facts.'' Some of 
these comments recommended that the use of ``Nutrition Facts'' or 
``Supplement Facts'' for combination products should depend upon how a 
product is marketed (i.e, the focus of the claims). A couple of these 
comments wanted the option of using ``Dietary Supplement Facts'' or 
``Herbal Facts'' in place of ``Supplement Facts.'' Additionally, at 
least one of these comments said that all dietary supplements in 
conventional food form should use the heading ``Nutrition Facts.''
    Several other comments supported the proposed heading of 
``Supplement Facts'' for all dietary supplements. One of these comments 
said that this heading is consistent with the DSHEA, and another said 
that it will help consumers recognize the differences between dietary 
supplements and conventional foods.
     FDA is not persuaded that the heading should be ``Nutrition 
Facts'' because the DSHEA uses the term ``nutrition information,'' 
because the information presented, at least in part, is about 
nutrition, or because these products are marketed for their nutritional 
value. The nutritional value of a particular product does not determine 
whether it is a dietary supplement or a conventional food. Many dietary 
supplements contain many DV-nutrients; many contain none. Additionally, 
the agency is not persuaded by the argument that consumers will be 
confused by the heading ``Supplement Facts'' and think that products 
labeled in this manner are of lesser value. ``Supplement'' is the 
single word that must be used in the statement of identity for all 
dietary supplements (see comment 1 in section II. of this document), so 
use of the term in the title of the nutrition label can assist 
consumers in identifying dietary supplement products. The agency is not 
convinced that the name ``Supplement Facts'' will result in any 
consumer judgment of the value of the product. Dietary supplements have 
been known as ``supplements'' for years, and FDA is not aware of any 
confusion caused by this term. Also, the supplemental nature of these 
products is supported by the new definition in section 201(ff)(2)(B) of 
the act, which states that a dietary supplement can not be 
``represented for use as the sole item of a meal or the diet.''
    The agency does not agree that use of the title ``Supplement 
Facts'' is a violation of Sec. 101.9(k)(6). The distinguishing 
characteristic between products bearing nutrition labeling entitled 
``Supplement Facts'' and those bearing nutrition labeling entitled 
``Nutrition Facts''is whether the products are dietary supplements or 
conventional foods, not whether the vitamins are natural or synthetic. 
Both conventional foods and dietary supplements can include natural and 
synthetic vitamins.
    Furthermore, the agency does not accept the suggestion that some 
dietary supplement products should have the heading ``Nutrition 
Facts,'' while others have various headings (``Supplements Facts,'' 
``Herbal Facts,'' and ``Dietary Supplements Facts'') or even two 
headings (``Nutrition Facts'' for the top half and ``Supplement Facts'' 
for the bottom half). The act does not support treating supplements of 
vitamins and minerals any differently than other types of supplements. 
Therefore, the agency is not doing so. In addition, if the agency 
consented to these recommendations, it would be possible for some 
chemically identical products to use up to four different headings. The 
agency concludes that so many different headings would only serve to 
confuse consumers.
    FDA agrees with the comments that said that the heading of the 
nutrition label for all dietary supplements should be entitled 
``Supplement Facts.'' While dietary supplements are a category of 
foods, the act distinguishes dietary supplements from conventional 
foods in many important ways, e.g., different requirements with respect 
to safety, to the types of claims that can be made, and to the kind of 
information that must be provided in the nutrition label. As stated in 
the preamble of the proposal and in one of the comments, the heading 
``Supplement Facts'' will help consumers to clearly distinguish between 
dietary supplements and conventional foods. Nothing in the comments has 
persuaded FDA that the heading ``Supplement Facts'' would not help 
consumers to readily identify these products as dietary supplements. 
Therefore, the agency is not changing Sec. 101.36(e)(1) in response to 
the comments.
    However, the agency does advise that the decision whether a product 
is sold as a dietary supplement is made by the manufacturer. Under the 
act, as amended by the DSHEA, the term ``dietary supplement'' is 
defined as a product (other than tobacco) intended to supplement the 
diet that bears or contains a vitamin, a mineral, an herb or other 
botanical, an amino acid, a dietary substance for use by man to 
supplement the diet by increasing the total dietary intake, or a 
concentrate, metabolite, constituent, extract, or combination of any of 
the above ingredients (section 201(ff)(1) of the act). Section 
201(ff)(2) of the act further states that dietary supplements are 
intended for ingestion in a form described in section 411(c)(1)(B)(i) 
of the act (21 U.S.C. 350 (c)(1)(B)(i)) or in compliance with section 
411(c)(1)(B)(ii) of the act, are not represented as conventional food 
or as a sole item of a meal or the diet, and are labeled as a dietary 
supplement.
    Thus, dietary supplements may be similar to conventional foods in 
composition and form. Whether a product is a dietary supplement or a 
conventional food, however, will depend on how it is represented. To be 
a dietary supplement, a product must bear the term ``dietary 
supplement'' as part of its common or usual name. (As stated in comment 
1 in section II. of this document, this term may be modified to include 
the name of the dietary ingredient or type of dietary ingredient, such 
as ``Vitamin C Supplement'' or ``Multivitamin Supplement.'')
    Products that are not represented as dietary supplements will be 
subject to regulation as conventional foods. For example, the 
manufacturer of a product that is in the form of a tablet or capsule 
that has nutritive value or a powdered herbal product with no nutritive 
value may choose to market the product as a conventional food that 
bears nutrition labeling in accordance with Sec. 101.9. In that 
situation, the nutrition labeling on the package of tablets with 
nutritive value would use the title ``Nutrition Facts,'' while the 
herbal product with no nutritive value would be exempt from nutrition 
labeling under Sec. 101.9(j)(4). Should the manufacturer choose to do 
this, however, the label or labeling could not represent the food as a 
``dietary supplement,'' and the product could not rely on any of the 
special provisions for dietary supplements that were added by the 
DSHEA. Thus, for example, the ingredients of the product would not be 
eligible for the exception for dietary ingredients from the definition 
of a ``food additive,'' and the product could not bear statements under 
the authority of section 403(r)(6) of the act.

[[Page 49838]]

    29. Several comments objected to the use of hairlines in the 
nutrition label for space and readability reasons. One of these 
comments said that the use of hairlines should be optional, and another 
said that hairlines should not be required if there are more than eight 
dietary ingredients to be declared. Another comment requested that dots 
be allowed instead of hairlines when the use of hairlines would cause 
the type size to fall under 4.5 points. This comment sent sample labels 
with hairlines, without hairlines, and with dots. The dots connected 
the name of a dietary ingredient to the quantitative amount and the 
amount to the percent DV (see sample label in Figure 3).

BILLING CODE 4190-01-F
[GRAPHIC] [TIFF OMITTED] TR23SE97.009


BILLING CODE 4190-01-C

     The comments did not provide information to show that the 
legibility of the nutrition label is maintained if hairlines are 
allowed to be used optionally. Section 2(b)(1)(A) of the 1990 
amendments directed the Secretary (and by delegation FDA) to require 
that the information required in nutrition labeling be conveyed in a 
manner that enables the public to readily observe and comprehend such 
information. To implement this provision of the 1990 amendments, FDA 
issued a rule that required hairlines in the nutrition label. Hairlines 
make the nutrition label easier to read by aiding consumers' eye 
movement from the name of the nutrient to the percent DV. Consumer 
surveys have shown that the graphic requirements in the nutrition 
labeling in Sec. 101.9 were successful in that the majority of shoppers 
who are aware of the new label think it is clear and understandable 
(Ref. 3). Therefore, FDA is not willing to remove the requirement for 
hairlines without evidence that the legibility and readability of the 
nutrition label will be maintained on dietary supplement products, 
particularly when the product contains a large number of dietary 
ingredients.
    However, the agency finds that the sample label submitted that uses 
dots to connect the nutrient name to the weight and percent DV is a 
satisfactory substitute to assist eye movement when the only other 
option would be to reduce type size below 4.5 points, the minimum type 
size consistent with the Nonprescription Drug Manufacturers Association 
(NDMA) Label Readability Guidelines used for over-the-counter drugs 
(Ref. 4). This suggested flexibility appears to offer a reasonable 
balance between the competing needs for label space and readability on 
small and intermediate-sized packages. Accordingly, the agency is 
adding Sec. 101.36(i)(2)(v) to provide that dots connecting columns of 
nutrient names and quantitative amounts are allowed in place of 
hairlines between rows of type on small and intermediate-sized packages 
when it is not possible to meet the minimum type size requirements of 
4.5 points if hairlines are used.
    30. Several comments objected to the bar that separates the dietary 
ingredients having RDI's or DRV's from other dietary ingredients 
because it may imply to consumers that other dietary ingredients are of 
lesser importance and it takes up space. One comment said that the bar 
should be optional because the asterisk and footnote ``Daily Value not 
established'' are sufficient to distinguish other dietary ingredients. 
One trade association said that some of their members disliked this bar 
because it creates an artificial and illogical separation in some 
cases, e.g., for a product containing only vitamins and minerals, but 
with some minerals for which an RDI has not been established. This 
comment said that other members liked the bar because it highlights the 
second portion of the list of dietary ingredients. Other comments 
supported the proposed use of the bar.
    The agency is not persuaded by the comments that the bar should be 
eliminated because it may imply that the dietary ingredients below it 
are of lesser importance. While the agency acknowledges that the use of 
a bar is not expressly required by the act, section 403(q)(5)(F)(i) of 
the act states that ``nutrition information shall first list those 
dietary ingredients * * * for which a recommendation for daily 
consumption has been established by the Secretary * * * and shall list 
any other dietary ingredient present and identified as having no such 
recommendation.'' As discussed in the December 1995 proposal (60 FR 
67194 at 67206), the bar helps consumers to readily distinguish these 
two types of dietary ingredients, just as a bar differentiates between 
macronutrients and vitamins or minerals in the nutrition labeling of 
conventional foods. The agency does not agree that the asterisk and the 
footnote are sufficient for consumers to readily distinguish between 
these two groups because there are some cases where the asterisk and 
the footnote would be required for dietary ingredients listed above the 
bar (e.g., sugars). For these reasons, the agency is not willing to 
eliminate the bar to conserve space. The agency points out that it has 
made a number of changes to save space, such as allowing the names of 
dietary ingredients and the corresponding amounts to appear in one 
column. Thus, the agency is not making any change in 
Sec. 101.36(e)(6)(ii) in response to these comments.

G. Compliance

    31. Several comments objected to the statement in proposed 
Sec. 101.36(f)(1) that compliance will be determined in accordance with 
Sec. 101.9(g)(1) through (g)(8). In particular, the comments objected 
to the application of Sec. 101.9(g)(4)(i), which provides that the 
content of added nutrients should be at least 100 percent of the value 
declared in the nutrition label, except for variability because of 
analytical methods. One comment supported the proposal and said that 
products should contain the levels that are declared.
    Many of the comments in opposition requested that Sec. 101.36(f)(1) 
be revised to state that supplements claiming to comply with compendial 
standards shall be judged ``based on compliance procedures specified or 
incorporated by reference in the compendial specifications.'' 
Specifically, these comments requested that the compliance level be a 
fixed minimum of 90 percent that does not allow for variability because 
of methods, in accordance with standards in the USP.

[[Page 49839]]

 A comment from USP stated that its lower limit is not a moving target 
depending on analytical precision or on whose laboratory is performing 
the test.
     Another comment explained that some nutrients are subject to 
degradation. This comment said that overages of these nutrients are 
added to dietary supplement products to ensure that the products 
provide the labeled amounts throughout their shelf life. To avoid 
excessive overages, the USP has required that at any time that a 
product is analyzed during its shelf life, the product must be shown to 
supply at least 90 percent of the labeled amount of any ingredient. 
These comments argued that Congress called for compendial products to 
meet compendial specifications (see section 403(s)(2)(D) of the act), 
and that FDA should not alter those requirements.
     The agency is not persuaded that a fixed minimum of 90 percent of 
the labeled amount should be acceptable for the nutrition panel of 
dietary supplements. FDA agrees that section 403(s)(2)(D) of the act 
provides that a dietary supplement is misbranded if it is covered by 
the specifications of an official compendium, is represented as 
conforming to those specifications, but fails to do so. Thus, dietary 
supplement products that are represented to meet the specifications of 
an official compendium, such as the USP, and fail to do so are 
misbranded under this section. However, the agency points out that 
products not misbranded under this section may be misbranded under 
other sections of the act.
    The issue of the acceptable amount of an added vitamin or mineral 
in a dietary supplement has been raised in earlier final rules (58 FR 
2079 at 2171, January 6, 1993; and 59 FR 354 at 369, January 4, 1994). 
As discussed in those final rules, the agency informed USP in 1991 that 
anything less that 100 percent of the value declared on the label was 
not acceptable with the exception of a deviation that is attributable 
to the analytical method (Ref. 5). FDA finds nothing in the comments 
that would justify accepting less than 100 percent of the value 
declared as compliance for added nutrients in dietary supplements. The 
argument that 90 percent is appropriate because some nutrients degrade 
is not sufficient justification for the agency to change its position. 
Because the degradation is foreseeable, FDA expects that manufacturers 
will take it into account when fabricating dietary supplements. 
Manufacturers have complete control over the level of dietary 
ingredients added to their products. Thus, the manufacturers are 
appropriately charged with ensuring that the amounts present are at 
least 100 percent of the amounts declared throughout the shelf life of 
their products, except for any variability that is attributable to 
methods. The agency concludes that a dietary supplement not meeting 
this requirement is misbranded under section 403(a)(1) of the act. 
Therefore, the agency is not modifying Sec. 101.36(f)(1) in response to 
these comments.
    Furthermore, FDA advises that it is aware that Compliance Policy 
Guide 530.400 (CPG 7121.02), entitled ``Vitamin Products for Human 
Use--Low Potency,'' is inconsistent with Sec. 101.36(f)(1). CPG 530.400 
sets forth the criteria for multivitamin products and states that legal 
action is recommended when a deficiency is found in excess of 20 
percent in one or more nutrients. Because this position is contrary to 
Sec. 101.36(f)(1), FDA is revoking CPG 530.400.
    Additionally, based on its review of the proposed regulations in 
preparation of this final rule, FDA has come to recognize that the 
requirement in Sec. 101.9(g)(2) that a sample for analysis shall 
consist of a composite of 12 subsamples (consumer units) taken 1 from 
each of 12 different shipping cases is impractical for many dietary 
supplement products. The agency has found that it is not always 
possible to locate 12 different shipping cases of dietary supplement 
products. Inventories of dietary supplement products are often smaller 
than those of conventional foods, particularly at distribution and 
retail sites. Accordingly, when 12 shipping cases are not available, it 
is not possible for FDA to collect a compliance sample that complies 
with Sec. 101.9(g)(2).
    To provide for greater flexibility, the agency is modifying 
Sec. 101.36(f)(1) to eliminate the requirement that consumer units come 
from 12 different shipping cases. The agency is requiring only that the 
consumer units come from the same inspection lot (that is, the product 
available for inspection at a specific location) and be randomly 
selected to be representative of that lot.
    Furthermore, the agency is providing flexibility with respect to 
the number of consumer units that are to be collected. FDA is requiring 
in Sec. 101.36(f)(1) that the ``sample for analysis shall consist of a 
composite of 12 subsamples (consumer packages) or 10 percent of the 
number of packages in the same inspection lot, whichever is smaller''. 
In other words, the entire contents of 12 packages would be needed when 
there are over 120 packages available. Fewer packages would be needed 
when the total number of consumer units available is less than 120. In 
this case, the agency concludes that a 10 percent sample is 
sufficiently representative for compliance purposes. While not 
statistically based, the 10 percent sample has been well accepted in 
enforcement proceedings (Ref. 6, pp. 818 through 821). This approach 
allows the agency to take compliance actions as necessary, without 
being impeded by the low availability of the product in question. At 
the same time, FDA is introducing the term ``packages'' to clarify that 
this section pertains to packages labeled for retail sale rather than 
individual units of the product, e.g., tablets or capsules, as the term 
``unit'' is defined in other parts of this document.
    This provision is a logical outgrowth of the proposal because by 
cross-referencing Sec. 101.9(g)(1) through (g)(8) in the proposal, FDA 
raised the question of whether these provisions appropriately apply to 
dietary supplements. Based on the factors discussed above, FDA 
concludes that the requirements regarding the number of consumer units 
in Sec. 101.9(g)(2) should not apply to dietary supplements and is 
modifying Sec. 101.36(f)(1) accordingly.

H. Special Provisions and Misbranding

    32. One comment stated that small-sized packages (i.e., those 
having a total surface area available to bear labeling of less than 12 
square inches) should be allowed to use a minimum type size of 4.0 
point when there are more than eight dietary ingredients to be listed 
in the nutrition label. The comment stated that the proposed minimum of 
4.5 point is impractical for certain dietary supplements products, and 
that a type size of 4.0 point is still legible. The comment included 
sample labels using a type size of 4.0 point. Another comment requested 
that small-sized packages be allowed to use a minimum type size of 3 
point. This comment did not include sample labels.
    FDA is not persuaded by these comments. As discussed in the final 
rule of January 4, 1994, FDA set the minimum type size at 4.5 point in 
response to the majority of the comments, which stated that this 
minimum is consistent with the NDMA's Label Readability Guidelines used 
for over-the-counter drugs (Ref. 4). FDA has received information from 
NDMA that shows that it did not set this minimum arbitrarily or 
subjectively, but that it arrived at this minimum type size based on 
studies of visual acuity and demographics (Ref. 7). While one of the 
comments that objected included sample labels using a type size of 4.0

[[Page 49840]]

point, it did not present any visual acuity studies in support of its 
contention that a type size of 4.0 point is legible. FDA has been 
persuaded by NDMA's data and points out that the vast majority of 
comments did not object to a minimum type size of 4.5 point. Moreover, 
firms in need of special allowances may seek alternative means of 
compliance or an exemption under Sec. 101.36(f)(2). Therefore, FDA is 
not modifying Sec. 101.36(i)(2)(i) in response to this comment.
    33. Several comments requested that Sec. 101.2(c) be amended to 
include Sec. 101.36. This amendment would allow type size smaller than 
1/16th inch in certain instances. One of these comments said that this 
request is reasonable because the labels of dietary supplements 
commonly include information not found on the labels of conventional 
foods, e.g., the iron warning statement.
    The agency is not persuaded by these comments. As discussed in the 
December 1995 proposal, the request to amend several paragraphs in 
Sec. 101.2(c) to include Sec. 101.36 was included in a citizen petition 
(Docket No. 94P-0110/CP1) submitted to FDA by the Council for 
Responsible Nutrition in 1994. The agency denied this request because 
Sec. 101.36 addresses the type size requirements for information in the 
nutrition label of dietary supplements (60 FR 67194 at 67208). The 
agency noted that Sec. 101.9 covers the corresponding requirements for 
conventional foods. The purpose of Sec. 101.2(c)(1) through (c)(3) was 
to encourage voluntary declaration of nutrition information and 
complete ingredient listing on all foods before declaration became 
mandatory under the 1990 amendments. FDA gave notice of its intention 
to revoke the exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) in its 
December 1995 proposal (60 FR 67194 at 67208), and proposed to do so in 
the Federal Register of June 12, 1996 (61 FR 29708), because they are 
obsolete. Therefore, FDA is not accepting these comments.
    34. At least one comment recommended that a minimum type size of 
4.5 point be allowed for dietary supplement packages that have a total 
surface area available to bear labeling of less than 40 square inches 
and have more than 8 dietary ingredients to be listed in the nutrition 
label. The comment said that it is impracticable to comply with the 
proposed type size requirements for dietary supplement products that 
contain many dietary ingredients.
    FDA is not persuaded by the comment that a minimum type size of 4.5 
point should be allowed on dietary supplement packages with 20 to less 
than 40 square inches of total surface area available to bear labeling 
that have more than 8 dietary ingredients to be listed. The agency 
proposed to require a minimum type size of 4.5 point for packages of 
less than 12 square inches and 6 point for packages of 12 to 40 square 
inches, except that it proposed that 4.5 point may be used on packages 
of less than 20 square inches that have more than 8 dietary ingredients 
to be listed in the nutrition label. This exception for packages of 
less than 20 square inches was in response to a citizen petition filed 
by the Council for Responsible Nutrition (Docket No. 94P-0110/CP1).
    In its proposal (60 FR 67194 at 67208), FDA explained how it 
arrived at its tentative determination that a minimum of 4.5 point 
should be allowed only on packages of less than 20 square inches that 
have more than 8 dietary ingredients. Agency precedent provided that 
not more than 30 percent of the total surface area of a package should 
be required to be devoted to FDA-required information that is not on 
the principal display panel. The agency calculated that this 30 percent 
level would likely be exceeded on packages of 12 to 20 square inches of 
surface area available to bear labeling if more than 8 dietary 
ingredients were listed using 6 point type size. Accordingly, FDA 
proposed to allow those packages to bear nutrition labeling that uses 
the smaller type.
    Applying the same calculations as discussed in the preamble of the 
proposed rule, the agency estimates that listing 24 dietary ingredients 
in 6 point type size plus 1 point leading between each line of type 
could use up to 6 square inches of label space. This would be 
equivalent to 30 percent of the total surface area of a package having 
20 square inches of surface area available to bear labeling (i.e., 20 X 
0.3). Accordingly, in response to the comment, the agency will allow 
for the use of a minimum 4.5 type size in such situations. In addition, 
based on the agency's observation that about 20 percent of dietary 
ingredients listed in sample labels submitted with comments that 
include ingredient information require two lines of type, the agency 
concludes that it is reasonable to allow the minimum type size of 4.5 
point for packages with 20 to 40 square inches of label space available 
to bear labeling having more than 16 dietary ingredients. Section 
101.36(i)(2)(ii) is revised accordingly.
    This final rule represents a full response to the Council for 
Responsible Nutrition's citizen petition referred to above (Docket No. 
94P-0110/CP1), in accordance with 21 CFR 10.30(e).
    35. Several comments supported the proposed deletion of 
Sec. 101.9(k)(2) and (k)(5). Some of these comments recommended that 
all of Sec. 101.9(k) be deleted, asserting that it is not 
scientifically defensible, and that it is not consistent with the 
protection of free speech provided in the First Amendment and the 
Supreme Court decision of Rubin v. Coors Brewing Co., 517 U.S.____, 115 
S. Ct. 1585 (1995). While these comments specifically addressed the 
deletion of Sec. 101.9(k)(3), (k)(4), and (k)(6), none addressed 
Sec. 101.9(k)(1).
    Two comments addressed Sec. 101.9(k)(3) and (k)(4), which prohibit 
statements that represent, suggest, or imply that the suboptimal 
nutritional quality of a food because of soil conditions or storage, 
transportation, or processing methods may be responsible for an 
inadequacy in the quality of the daily diet. One comment argued that 
these paragraphs should be deleted because any conditions that 
adversely affect the nutritional quality of foods will ultimately 
affect the nutritional quality of diets, even if such effects are not 
so extensive as to lead to widespread nutritional deficiencies. Two 
other comments addressed Sec. 101.9(k)(4) specifically, citing evidence 
to show that various food processing techniques do cause nutrient 
losses and stating that national food consumption patterns are 
changing, leading to reduced consumption of fresh foods and increased 
use of processed convenience foods.
    A few comments recommended deletion of Sec. 101.9(k)(6), which 
prohibits any representation that naturally-occurring vitamins are 
superior to added or synthetic vitamins or any differentiation between 
added and naturally occurring vitamins. The comments argued that FDA 
should not forbid truthful representations on the label of the 
composition and biochemical forms of natural and synthetic vitamins, 
citing biochemical distinctions between naturally occurring and 
synthetic vitamins and stating that this information enables consumers 
to make more informed purchasing decisions.
    FDA has considered the comments pertaining to Sec. 101.9(k)(3) and 
(k)(4) and is not persuaded that they are no longer supportable. The 
agency agrees with the comments that stated that the nutritional 
quality of a diet is affected by the nutritional quality of the foods 
contained in that diet. However, when diets are inadequate, many 
factors must

[[Page 49841]]

be considered as causal, and it would be misleading to attribute such a 
result only to soil conditions and storage, transportation, and 
processing methods. For example, the food choices a person makes are a 
major determinant of the quality of his/her diet. Recent research has 
shown that the more a diet adheres to the Food Guide Pyramid (Ref. 8) 
and to dietary recommendations to eat a variety of foods and to 
moderate the consumption of fat, saturated fat, cholesterol, and 
sodium, the greater the likelihood that nutrient requirements will be 
met (Ref. 9).
    The comment that suggested that the consumption of fresh fruits and 
vegetables is decreasing is not supported by recent research on the 
U.S. food supply by the U.S. Department of Agriculture Economic 
Research Service. This research found that the per capita consumption 
of fresh fruits rose 25 percent from 1970 to 1994, while the per capita 
consumption of fresh vegetables rose 33 percent from 1970 to 1994 (Ref. 
10, pp. 18-19).
    Accordingly, FDA concludes that it is still appropriate to prohibit 
misleading and unsubstantiated generalizations on the label or in 
labeling about dietary inadequacies because of nutrient losses 
resulting from poor soil conditions or storage, transportation, or 
processing methods. Nothing in Rubin v. Coors Brewing Co., supra, 
prevents the government from regulating misleading speech. (See 115 S. 
Ct. at 1589.)
    As stated earlier, current Sec. 101.9(k)(3) and (k)(4) 
(redesignated as Sec. 101.9(k)(2) and (k)(3)) do not preclude a 
producer, manufacturer, or vendor from indicating a higher nutrient 
retention in a particular product as compared to other similar 
products. Nor do they preclude an indication that such retention 
results from special handling of the product, provided that such 
indications are factual and is not misleading (58 FR 2079 at 2167).
     In regard to Sec. 101.9(k)(6), FDA has stated in the past that 
this section permitted truthful designation of any nutrient as natural 
in origin (38 FR 6950 at 6958, March 14, 1973; and 58 FR 2079 at 2167). 
However, the agency is persuaded by the comments that the phrase 
``differentiate in any way between vitamins naturally present from 
those added'' in Sec. 101.9(k)(6) is easily misinterpreted to mean that 
labels cannot identify nutrients as naturally-occurring or synthetic. 
Accordingly, FDA is modifying that paragraph (renumbered as 
Sec. 101.9(k)(4)) to remove the prohibition on differentiating between 
naturally-occurring and synthetic vitamins.
    It should be noted that FDA addressed the use of the term 
``natural'' in rulemaking implementing the 1990 amendments (58 FR 2302 
at 2407, January 6, 1993). At that time, the agency said it was not 
establishing a definition for ``natural,'' but that it would maintain 
its policy not to restrict truthful and non-misleading use of the term, 
except for products with added color, synthetic substances, or 
artificial flavors as provided in Sec. 101.22, for which use of the 
term ``natural'' on the label would be considered misleading. However, 
the agency advises that the term ``natural'' should not be used when 
referring to a vitamin that is only obtained through chemical synthesis 
(e.g., use of ``natural vitamin E'' for a product containing dl-alpha 
tocopheryl acetate).
    Comments did not specifically address that part of current 
Sec. 101.9(k)(6) that prohibits any suggestion that a natural vitamin 
is superior to an added vitamin. Comments pointed out, and FDA is in 
agreement, that differences between natural and synthetic vitamins are 
often really differences in the form of the nutrient. For example, 
comments pointed out that vitamin E occurs in natural oils in the d-
alpha form and exists in synthetic products as a racemic mixture, with 
less biological activity. Comments did not, however, provide 
information to support any difference between a natural or synthetic 
version of the same form of a nutrient. Thus, the agency is aware of 
nothing that establishes that a claim of difference between the natural 
and synthetic version of the same form of a nutrient is not misleading. 
Therefore, FDA is maintaining the prohibition against statements that a 
natural vitamin is superior to an added one in Sec. 101.9(k)(4).
    However, the agency advises that there are no restrictions in the 
regulations on identification of the chemical form of the nutrient. In 
fact, such identification is helpful on certain nutrients, such as 
carotene, whose biological activity varies according to its isomeric 
composition. FDA notes that when the chemical form of the vitamin is 
identified on the label or in labeling, manufacturers are free to use 
statements that characterize the structure and function of that 
stereoisomer. Label statements may thus differentiate between the 
different forms of a vitamin.

I. Miscellaneous Issues

    36. One comment asked whether nutrition labeling is required on 
samples of dietary supplements that are distributed free of charge, 
such as at trade shows.
    The nutrition labeling requirements of the 1990 amendments apply to 
foods offered for sale (section 403(q)(1) of the act). Nutrition 
labeling would not be required on dietary supplements that are not 
offered for sale because there is nothing in the DSHEA that requires 
dietary supplements to be treated any differently than conventional 
foods in this respect. FDA inadvertently did not make this clear in the 
December 1995 proposal. Accordingly, FDA is revising Sec. 101.36(a) to 
state ``The label of a dietary supplement that is offered for sale 
shall bear nutrition labeling in accordance with this regulation unless 
an exemption is provided for the product in paragraph (h) of this 
section.''
    37. One comment stated that products composed only of mixtures of 
free amino acids should be able to declare ``protein'' in the nutrition 
label and list the total weight of the amino acids as the amount of 
protein in the product. The comment said that the only difference 
between free amino acids and protein is that the amino acids in protein 
are connected to each other by peptide bonds. Another comment stated 
that amino acids that are essential should be distinguished from those 
that are nonessential. This comment also stated that the dangers of 
using single amino acids should also be listed with a warning that many 
of the uses are unproven. With respect to protein supplements, the 
comment said that such products should indicate their sources of 
protein, and ``when collagen with a little tryptophan added is called a 
protein supplement it should be stated that this is not a complete 
protein and cannot support life or tissue building on its own.'' The 
comment recommended that protein supplements used for body building 
should contain a statement that muscle building requires not only 
protein, but calories and especially carbohydrates.
    FDA agrees that protein differs from free amino acids in that 
protein is composed of amino acids connected to each other by peptide 
bonds (60 FR 67194 at 67198). In recognition of this difference, FDA 
proposed that the nutrition label of dietary supplements list whatever 
is actually present, i.e., protein or individual amino acids. The 
comment did not justify why it was not misleading to declare protein 
content in the nutrition label of a dietary supplement that contains 
only free amino acids. Therefore, FDA concludes that this requirement 
is appropriate and consistent with section 201(ff)(1) of the act, which 
lists amino acids in

[[Page 49842]]

subparagraph (D) as a separate entity from protein, which would be 
covered in subparagraph (E) as a dietary substance.
    Furthermore, FDA is not persuaded to require that amino acids be 
identified as essential or nonessential in the nutrition label of 
dietary supplements because the act does not require this information 
in the nutrition label, and the comment did not provide any reason for 
this approach. In fact, the comment in question did not state clearly 
where this information should be presented. FDA points out that such 
information may be stated outside of the nutrition label on the labels 
of dietary supplements and conventional foods as well.
    In response to the comment that requested that the source of 
protein supplements should be identified, the agency points out that, 
under the act, manufacturers of dietary supplements, including protein 
supplements, may choose either to list the source of any dietary 
ingredient in the nutrition label or in the ingredient statement that 
appears below the nutrition label. While the concerns of the comment 
would apparently be better addressed by the former approach, FDA is not 
aware of any reason to require it. The other points in this comment 
about warning or other statements are beyond the scope of this 
rulemaking.
    38. One comment recommended that herbal products be required to 
declare any possible drug interactions. The comment stated that herbs 
were the first medicines and should be treated as such.
    FDA disagrees with this comment. The herbal products that are the 
subject of this rulemaking are foods and not drugs. To the extent that 
herbal products are intended for use as medicines, they are drugs under 
the act and subject to regulation under Chapter V of the act, not 
Chapter IV (the food provisions). As for possible drug interactions, 
FDA will consider the need for warnings under sections 201(a), 403(a), 
and 701(a) of the act (21 U.S.C. 371(a)), but warnings about drug 
interactions are not typically the subject of food labeling 
requirements.

IV. Other Provisions

    FDA has made a few editorial changes in certain provisions of 
Sec. 101.36. Specifically, Sec. 101.36(h)(2) (designated as 
Sec. 101.36(f)(2) in the final rule on small business exemptions in the 
Federal Register of August 7, 1996 (61 FR 40963), has been revised to 
make it clear that either a manufacturer, packer, or distributor may 
file a claim for an exemption. This change is consistent with the 
language in Sec. 101.9(j)(18). Also, to avoid confusion, the first 
sentence in Sec. 101.36(h)(1) through (h)(3) reads ``foods'' instead of 
``dietary supplements.''
     FDA did not receive any comments that dealt specifically with the 
other provisions of the proposal. In the absence of any basis for doing 
otherwise, FDA is adopting those provisions as proposed.

V. Effective Date

    39. Several comments recommended that the compliance date of this 
final rule be coordinated with other final rules on dietary 
supplements. Most of these comments requested that a uniform effective 
date be set at 18 months after the publication of the last final rule 
concerning dietary supplements based on any pending proposals, although 
3 comments requested 12 months, and 1 comment requested 24 months. One 
comment stated that multiple effective dates will balloon the cost of 
all label changes to the industry and to consumers, who ultimately will 
bear the cost of multiple revisions. Other comments stated that an 18-
month extension is needed because of the great number of labels to be 
redesigned. One comment said that they may manufacture an identical 
multivitamin product for more than 100 different retail customers that 
sell the product under their own private label name, e.g., store brand 
names. Thus, this manufacturer has to make new labels for each 
customer, not for each product. Another comment stated that a 
manufacturer of ``private label'' products may have over 10,000 labels 
to redesign.
    FDA is persuaded by the majority of the comments that it is 
appropriate to have the effective date of this final rule be 18 months 
after its publication, consistent with the time period allowed for the 
labels of conventional foods to comply with the final rules 
implementing the 1990 amendments. As discussed in section VI. of this 
document, an 18-month compliance period will minimize the cost of the 
changeover compared to a 12-month compliance period. The agency does 
not agree with the comment that requested a 24-month compliance period 
because the majority of the comments stated that an 18-month compliance 
period is sufficient.
    Moreover, the agency agrees that it is reasonable and practical to 
have the same date apply to the other final rules on dietary supplement 
labeling that are published elsewhere in this issue of the Federal 
Register, as multiple effective dates will increase costs and are 
unjustified. Therefore, the agency concludes that the effective date of 
this final rule is 18 months from the date of its publication and that 
this date shall apply to the other final rules on dietary supplements 
that are published in this issue of the Federal Register.
    The same will also apply to the enforcement of prescribed iron 
statements on products that currently bear voluntary iron warning 
statements, as discussed in the final rule on iron statements (62 FR 
2218, January 15, 1997). In that final rule, the agency stated that it 
intended to use enforcement discretion for these products that bear a 
voluntary warning until the date for label changes made in response to 
the DSHEA (62 FR 2218 at 2246).
    The agency notes that this effective date is not in accordance with 
the uniform compliance date of January 1, 2000, established by 
regulation on December 27, 1996 (61 FR 68145). As stated in that 
document, ``If any food labeling regulation involves special 
circumstances that justify a compliance date other than January 1, 
2000, the agency will determine for that regulation an appropriate 
compliance date, which will be specified when the final regulation is 
published'' (61 FR 68145 at 68146). The DSHEA states that dietary 
supplement products shall be labeled in accordance with its amendments 
after December 31, 1996. Because final rules were not published in 
sufficient time for the industry to be in compliance with them by 
January 1, 1997, FDA stated on April 15, 1996, that it would exercise 
its enforcement discretion such that it would not enforce the 
provisions of the DSHEA until January 1, 1998 (61 FR 16423). At this 
time, FDA is extending this period of nonenforcement until March 23, 
1999. Any further extension (i.e., to January 1, 2000) would be 
unresponsive to the directives of the statute, as well as unnecessary 
based on comments received.
    In addition, in response to the directive in the DSHEA that dietary 
supplements ``be labeled'' after December 31, 1996, and consistent with 
the approach taken by Congress in the 1990 amendments, the agency 
advises that the effective date of this regulation, the other dietary 
supplement regulations published in this issue of the Federal Register, 
and the final rule on iron statements, will apply to the attachment of 
labels to dietary supplement products rather than to the introduction 
of products into interstate commerce as specified in the agency's final 
rule on uniform compliance dates for food labeling regulations (61 FR

[[Page 49843]]

68145). In other words, products bearing labels that are affixed prior 
to March 23, 1999 do not have to be in compliance with these final 
rules, and products labeled after March 23, 1999 do.
    Although the effective date is 18 months hence, FDA encourages 
manufacturers to have new labels that are in compliance with these 
final rules printed as soon as current inventories are exhausted to 
assure a smooth and timely changeover. The agency does not anticipate 
extending its use of enforcement discretion any further.

VI. Analysis of Impacts

    FDA has examined the economic implications of the final rule as 
required by Executive Order 12866 and the Regulatory Flexibility Act (5 
U.S.C. 601-612). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select the regulatory approach which 
maximizes net benefits (including potential economic, environmental, 
public health and safety effects; distributive impacts; and equity). 
Executive Order 12866 classifies a rule as significant if it meets any 
one of a number of specified conditions, including having an annual 
effect on the economy of $100 million or adversely affecting in a 
material way a sector of the economy, competition, or jobs, or if it 
raises novel legal or policy issues. If a rule has a significant impact 
on a substantial number of small entities, the Regulatory Flexibility 
Act requires agencies to analyze options that would minimize the 
economic impact of that rule on small entities. FDA finds that this 
final rule is not an economically significant rule as defined by 
Executive Order 12866 and finds under the Regulatory Flexibility Act, 
that the final rule will have a significant impact on a substantial 
number of small entities.
    There are several different types of products that may be 
considered to be dietary supplements. These products include but are 
not limited to vitamin or mineral supplements, herbal products, and 
products that contain other similar nutritional substances. An estimate 
of the number of such products is approximately 29,000. The number of 
stockkeeping units, a more accurate count of the number of labels, is 
approximately 75,000. Estimates of the number of dietary supplements 
are approximate because no one source collects information on all types 
of dietary supplements. In fact, until the DSHEA, there was no agreed 
upon definition of a dietary supplement. Some sources include only 
dietary supplements of vitamin or minerals, others include herbals or 
botanicals, and still others include other types of products that may 
or may not be dietary supplements, such as sports nutrition products 
and ``functional foods,'' a term for which there is no recognized 
definition.
    In its proposed analysis, FDA estimated the number of dietary 
supplement firms to be between 150 and 650 firms. According to Duns 
Market Identifiers, there are approximately 250 manufacturers of 
vitamin and mineral products. According to Nutrition Business Journal 
(August 1996), the dietary supplement industry includes 850 supplement 
manufacturing companies. The Journal reports 1995 industry revenues at 
$4.5 billion. Although FDA concludes that there are clearly at least 
250 firms, the Journal's estimate of 850 is most likely an overestimate 
of the dietary supplement industry because it includes homeopathic 
products, which are drugs by statutory definition, and ``functional 
foods'' and sports nutrition products, which may be either conventional 
foods or dietary supplements depending on how they are marketed and 
used. Although the Journal does not break down the number of firms by 
the type of dietary supplement produced, it does specify that 250 firms 
produce herbal or botanical products. FDA received one comment on its 
proposed analysis that suggested that estimates of the number of firms 
should include the product manufacturer, label printer, product 
packager, label/brand owner, and brand wholesaler. FDA notes that, with 
the exception of administrative costs, costs of labeling regulations 
are calculated on a per product or per label basis, not on a per firm 
basis. Administrative costs, which are typically calculated on a per 
firm basis, include the cost of reading and interpreting the regulation 
and formulating a compliance policy which must be done once for each 
regulation, not for each product.
    For purposes of determining the costs of this regulation, FDA will 
use 850 as an upper bound estimate of the number of firms. As a lower 
bound estimate, FDA will use 500 (250 vitamin/mineral firms + 250 
herbal/botanical firms).

A. Costs

    Categories of costs for relabeling include administrative, 
analytical, printing, and inventory disposal.
    The administrative costs associated with a labeling regulation 
result from the incremental administrative labor expended in order to 
comply with a regulation. FDA received one comment objecting to the 
estimated administrative costs. The comment stated that administrative 
costs fail to include both scientific and legal review, but the comment 
did not provide any information to help FDA modify its previous 
estimate. Therefore, FDA will continue to estimate administrative costs 
at $425 per firm for a 1-year compliance period and approximately $320 
for an 18-month compliance period. Longer compliance periods decrease 
administrative effort because firm executives often delegate downward 
decisions that are less immediate. Total administrative costs are 
estimated to be between $160,000 ($320 x 500 firms) and $272,000 ($320 
x 850 firms) with an 18-month compliance period.
    FDA received one comment stating that its estimate of analytical 
costs substantially underestimated the true costs. The comment 
estimated analytical costs at $340 per product. FDA notes, however, 
that although the comment stated that FDA's estimates were too low, the 
comment's per product estimate is lower than FDA's estimate of $615 per 
product. Therefore, FDA will continue to estimate costs at $615 per 
product for each of 29,000 products. All products will be tested once 
during the 18-month compliance period in order to determine initial 
compliance. In the proposed rule, FDA assumed that products would 
undergo retesting once every 5 years. FDA received no objections to 
that assumption. Therefore, FDA estimates total discounted analytical 
costs of $75 million (discounted to infinity at 7 percent), of which 
$17.8 million ($615 x 29,000 products) will occur during the 18-month 
compliance period.
    FDA received several comments that its estimates of printing/
redesign costs were too low. One comment suggested that costs would be 
$1,370 for each printed label and $3,870 for each direct-printed 
package label. Estimates from other comments ranged from $50 to $3,500 
per label. Based on an average of the estimates provided by the 
comments, FDA estimates that the average per label redesign cost for a 
1-year compliance period is $1,700. However, because FDA is allowing a 
compliance period of 18 months, firms will be able to combine planned 
label changes with mandated changes, thus lowering redesign costs. 
Redesign costs associated with an 18-month compliance are typically 3/4 
of those for a 1-year compliance period. Therefore, FDA estimates 
redesign costs to be $1,300 for each of 75,000 labels, or a total $97.5 
million.
    FDA received one comment indicating that inventory disposal costs 
would range between $8 and $15

[[Page 49844]]

million depending on the length of the compliance period. In the 
analysis to the proposed rule, FDA estimated inventory disposal costs 
at $6.5 million assuming the rules would become effective 12 months 
after publication of the final regulations. FDA will not alter its 
previous estimates based on the comment because dietary supplement 
firms have known about these label changes since at least January 1994, 
and the majority of firms have been taking the necessary steps to 
reduce their label inventories. However, because FDA is providing firms 
with 18 months to comply, firms will have an additional 6 months to 
dispose of label inventory. As with redesign costs, inventory disposal 
costs associated with an 18-month compliance period are approximately 
3/4 of the costs associated with a 1-year compliance period. Therefore, 
disposal costs for this rule are estimated at $4.8 million.
    FDA has estimated the impact of the final regulations and has 
determined that administrative costs would be between $160,000 and 
$272,000, discounted analytical costs would be $75 million (discounted 
to infinity at 7 percent), redesign costs would be $97.5 million, and 
inventory disposal costs would be $4.8 million. Therefore, total 
discounted costs are estimated to be $177.8 million (discounted to 
infinity at 7 percent). Costs during the 18-month compliance period are 
estimated to be $120 million. If we assume that the rate at which firms 
comply is evenly distributed throughout the compliance period, then 
costs during the most expensive 12-month period, the first year, would 
be $80.3 million. Costs in the second year would be $39.7 million. 
Recurring costs would be $17.8 million every 5 years. According to 
basic economic principles, firms are profit maximizers. Therefore, it 
is logical to assume that firms will select the least costly 
alternative. The supply of label redesign and analytical laboratory 
services is limited in the short run. When demand for those services 
increases as a result of regulatory requirements, the cost of those 
services also increases. If compliance were skewed toward one end of 
the compliance period, then the demands places on those services would 
cause prices to increase more than if the demand were more evenly 
distributed. Firms are aware of this phenomenon and will, therefore, 
attempt to spread out the demands on the redesign and laboratory 
services. Also, because the capacity for these services is fixed in the 
short run, the suppliers of redesign and laboratory services will force 
firms to space out their demand. Because it is unlikely that the rate 
at which firms comply is heavily skewed toward one end of the 
compliance period, it is unlikely that costs will exceed $100 million 
during any single year. Therefore, FDA concludes that this rule is not 
economically significant as defined by Executive Order 12866.

B. Benefits

    Although almost all dietary supplements of vitamins and minerals 
currently contain substantial nutrition information, many other dietary 
supplements do not. This regulation will benefit consumers by assuring 
that adequate and complete nutrition information is provided accurately 
and consistently to aid consumers in their choices.

C. Regulatory Flexibility

    According to the Regulatory Flexibility Act, the definition of a 
small entity is a business independently owned and operated and not 
dominant in its field. The Small Business Administration (SBA) has set 
size standards for most business categories through use of four-digit 
Standard Industrial Classification codes. For dietary supplements of 
vitamins and minerals, a business is considered small if it has fewer 
than 750 employees. According to Duns Market Identifiers, there are 
approximately 250 producers of vitamin and mineral supplements, of 
which 200 have fewer than 750 employees. The remaining dietary 
supplement products come closest to the industry groups Food 
Preparations N.E.C. (SIC 2099) and Medicinal Chemicals and Botanical 
Products (SIC 2834). The SBA size standards are 500 or fewer employees 
for food preparations and 750 or fewer employees for medicinal and 
botanical products. Under either employee-based size standard, 
virtually all firms could be classified as small, including some firms 
that are among the leaders in sales revenues. Therefore, FDA is basing 
size classifications on sales revenue rather than employees.
    According to Nutrition Business Journal, of the 850 dietary 
supplement manufacturing firms, 11 have total revenues over $100 
million, accounting for 53 percent of total sales; 30 firms have sales 
revenues between $20 and $100 million, accounting for 28 percent of 
industry sales; and 809 firms have sales under $20 million, accounting 
for 19 percent of industry sales. The 809 firms in the under $20 
million category have an average sales revenue of $800,000 and will be 
considered small by FDA. The SBA sales revenue standard for businesses 
that cannot be classified into a specific industry is $5 million. FDA 
concludes therefore that as many as 809 firms in the dietary supplement 
industry, or 95 percent of firms, could be considered small (sales 
under $20 million). As stated previously in this analysis, this may be 
an overestimate because it counts firms that produce homeopathic 
products, which are drugs, and sports nutrition products and 
``functional foods,'' which may be foods or dietary supplements. If 
there are as few as 500 dietary supplement firms, there may be 475 
small dietary supplement firms.
    The agency has published an exemption from mandatory nutrition 
labeling for small businesses in Sec. 101.9(j)(1) and has proposed an 
exemption for low-volume food products of small businesses in 
Sec. 101.9(j)(18) (59 FR 11872, March 14, 1994). These regulations are 
cross-referenced in this final rule on labeling of dietary supplements, 
in Sec. 101.36(h)(1) and (h)(2), respectively. As of January 1, 1997, 
Sec. 101.9(j)(1) will only apply to retailers. As of May 1997, 
Sec. 101.9(j)(18) will apply to manufacturers, packers, distributors, 
or retailers of low volume products, defined as fewer than 100,000 
units, produced by firms with fewer than 100 employees. FDA does not 
have information to show how many dietary supplement products would be 
exempted under this provision. Comments to the proposed analysis 
suggested that very few products will qualify for exemptions for low 
volume products. According to the limited information available to the 
FDA, approximately 72 percent of vitamin/mineral producers and 86 
percent of herbal/botanical producers have fewer than 100 employees. 
Even if every firm with fewer than 100 employees produced low volume 
products, between 9 and 13 percent of the firms with annual sales less 
than $20 million would still not meet the definition. Therefore, 
although it is likely that many firms will be able to take advantage of 
the small business exemption, FDA concludes that this rule will impact 
on a substantial number of small entities.
    Dietary supplement firms each produce between 3 and over 50 
distinct products. A firm that produces three products will incur costs 
of $14,000 during the compliance period. A firm that produces 50 
products will incur costs of $236,000 during the compliance period. If 
the average small firm incurs costs of $125,000 ((14,000 + 236,000)/2), 
using an average annual sales of $800,000, the increase in costs due to 
this regulation will be 16 percent of

[[Page 49845]]

sales for the average small firm. Therefore, FDA concludes this rule 
will result in a significant economic impact on a substantial number of 
small entities.
    The Regulatory Flexibility Act requires agencies to examine 
regulatory alternatives that would minimize the impact on small 
entities. Because the DSHEA mandates nutrition labeling for all dietary 
supplement products, except low-volume products as described above, 
there are very few alternatives available to the agency. However, as 
discussed elsewhere in this document, FDA received many comments 
requesting that firms be given 18 months to comply with these 
regulations. FDA has examined the impact of different compliance 
periods and has determined that extending the compliance to 18 months 
reduces the burden on small entities. With a 12-month compliance 
period, first year costs for an average small entity would be $158,500, 
or 20 percent of sales. Extending the compliance period to 18 months 
reduces first year costs to the average small firm by $33,500. If FDA 
did not extend the compliance period, the total discounted costs of 
this regulation would be $209.5 million, of which $152 million would 
occur in the first year. The longer compliance period reduces total 
discounted costs of the regulation by $31.2 million.

D. Summary

    Total discounted costs of this regulation are estimated to be 
between $177.8 million (discounted to infinity at 7 percent). These 
costs include administrative, analytical, printing, and inventory 
disposal costs. The benefits are improved and more consistent 
information with which consumers can refine their choices for health or 
other reasons. FDA is unable to quantify this benefit.
    FDA has analyzed the costs and benefits of this proposed rule and 
has determined that, because neither costs nor benefits are likely to 
exceed $100 million in any single year, it does not constitute an 
economically significant rule as defined by Executive Order 12866.
    FDA has also analyzed the impacts on small firms according to the 
Regulatory Flexibility Act and has determined that these rules will 
have a significant impact on a substantial number of small entities. 
FDA has reviewed alternatives to reduce the burden on small entities 
and has concluded that providing for a compliance period of 18 months 
will alleviate that burden.

E. Public Outreach

    FDA has conducted extensive outreach to a wide audience, including 
small businesses, on the labeling of dietary supplements. This outreach 
included independent FDA activities as well as cooperative efforts 
between FDA and professional trade organizations.
    FDA has informed small businesses of the requirements in the DSHEA 
regarding dietary supplements and of FDA's implementation of these 
requirements in a number of ways. Since passage of the DSHEA, FDA 
representatives have responded on a daily basis to numerous inquiries 
on supplements, including inquiries from small businesses. In addition, 
FDA has had meetings on the regulation of dietary supplements with 
representatives of at least four trade organizations that include small 
businesses in their membership. Furthermore, FDA has participated in a 
number of trade organization conferences on dietary supplements and has 
cooperated with the Drug Information Association, which has sponsored 
conferences on botanicals.
    FDA has issued a number of publications on dietary supplements that 
have been available to small businesses, including an article in the 
FDA Consumer of November 1993 and an ``FDA Backgrounder'' of August 
1995, which described the DSHEA. FDA has distributed about 500 reprints 
of its December 1995 proposals on the labeling of dietary supplements 
to various interested parties, including small businesses. FDA has also 
placed information on these proposed rules in the FDA News section of 
the agency's home page on the World Wide Web. In response to these 
proposals, FDA has received numerous comments from small businesses. 
FDA concludes that its efforts to inform small businesses of activity 
in this area have been successful.

VII. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (60 FR 67194, December 28, 
1995). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

VIII. Paperwork Reduction Act

    This rule contains information collection requirements that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title, 
description, and respondent description of the information collection 
are shown below with an estimate of the annual reporting and 
recordkeeping burden. Included in the estimate is the time for 
reviewing procedures, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Requirements for Nutrition and Ingredient Labeling of 
Dietary Supplements.
    Description: In a final rule, FDA is amending Sec. 101.36 to 
require that most dietary supplements provide on their labels, and in 
their labeling, information on the quantity of specific nutrients 
present in them, along with the daily value for each, and the quantity 
of other dietary ingredients. This requirement implements the 
requirements of the 1990 amendments and the DSHEA. The agency is also 
providing a mechanism by which firms may request an alternative 
approach to providing the necessary nutrition information.
    Section 101.36(b)(2) specifies the nutrients for which the amount 
must be present on the labels of dietary supplements and 
Sec. 101.36(b)(3) provides for the listing of the quantity of other 
dietary ingredients, respectively. Other paragraphs of Sec. 101.36 
provide information to assist manufacturers and distributors of dietary 
supplements in determining how the amount of nutrients that their 
products contain should be disclosed on the labels of the products. 
Section 101.36(f)(2) provides a mechanism whereby firms may request in 
writing from FDA alternative means of compliance or additional 
exemptions when it is not technologically feasible, or some other 
circumstance makes it impracticable, for the firm to comply with the 
requirements of Sec. 101.36.
    FDA had submitted these information collection requirements to OMB 
for review under section 3504(h) of the Paperwork Reduction Act (44 
U.S.C. 3501  et seq.) at the time the December 1995 proposal was 
published. In response, OMB disapproved the information collection but 
gave an OMB control number, 0910-0314, and requested that FDA respond 
to the following concerns at the time of resubmission for OMB approval 
of the information collection package at the final rule stage:
    OMB does not approve this package. OMB is concerned about the 
accuracy of the cost and hour burden estimates, as well as the 
utility of the nutrition info. required to be disclosed on the 
labels of dietary supplements and whether the labels are 
sufficiently clear to the third party recipients

[[Page 49846]]

of this information. When the package is resubmitted to OMB for 
approval at the final stage, the agency will address OMB's concerns 
and the public comments received on these issues in the preamble of 
the final rule and in the paperwork submission package.
    FDA estimates the total annual disclosure and reporting hour burden 
for the information collection requirements contained in this final 
rule to be 136,040 hours, as follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
----------------------------------------------------------------------------------------------------------------
                                No. of                                                                          
  21 CFR        No. of       Responses per   Total Annual      Hours per       Total Annual    Total Operating &
  Section     Respondents     Respondent         Hours         Response           Hours        Maintenance Costs
----------------------------------------------------------------------------------------------------------------
101.36                                                                                                          
 (b)(2)                                                                                                         
 and                                                                                                            
 (b)(3)                                                                                                         
 (disclosu                                                                                                      
 re)            850              40          34,000               4            136,000         40,000,000       
101.36(f)(                                                                                                      
 2)                                                                                                             
 (reportin                                                                                                      
 g)              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 Sec. 101.9(g)(9) for conventional foods. Thus, there will be a 
significant decrease in the number of respondents and product labels 
requiring revision in succeeding years with a corresponding decrease in 
annual burden hour cost. The hour burden estimates contained above are 
for the information collection requirements established by regulation 
alone and do not include those that stem solely from the act or the 
DSHEA.
    FDA has estimated that the total annualized operating and 
maintenance costs will approximate $40,000,000 over the next 3 to 4 
years. This is based on annualized estimated relabeling costs of $32.5 
million, analytical costs of $6 million, and labor and overhead costs 
of $1.5 million over the next 3 to 4 years. The agency believes that 
these costs will decrease significantly over succeeding years. FDA will 
reexamine these estimates at the end of 3 to 4 years. The agency has 
determined that the requirements in Sec. 101.36 do not require capital 
costs on the part of respondents.
    The first concern expressed by OMB was about the accuracy of the 
cost and hour burden estimates for the information collection 
requirements. FDA received one comment in response to the proposal that 
estimates of the number of firms should include the product 
manufacturer, label printer, product packager, label/brand owner, and 
the brand wholesaler. FDA received no comments that suggested 
alternative costs or hour burdens from the agency's estimates. As 
discussed in more detail in section V. of this document and as 
indicated in the preceding table ``Estimated Annual Reporting Burden,'' 
the agency has modified the number of respondents that will be affected 
by the information collection requirements from 600 to 850 but has 
retained the estimates of hour burden per response that was contained 
in the December 1995 proposal.
    OMB also expressed its concern about the utility of the nutrition 
information required to be disclosed on the labels of dietary 
supplements and whether the labels are sufficiently clear to the third-
party recipients of this information. Several comments to the December 
1995 proposal recommended that nutrients should be listed on dietary 
supplements only when they are added. Other comments expressed concerns 
about the format requirements for the nutrition facts panel. As 
discussed in more detail above, FDA is not persuaded by the comments 
that it should change the requirements for the listing of nutrients on 
dietary supplements. As also noted above, the agency points out that, 
except for certain specified exceptions, section 403(q) of the act 
requires nutrition labeling on most foods. With respect to dietary 
supplements, section 403(q)(5)(F) of the act, as amended by the DSHEA, 
specifies that the labels of dietary supplements shall comply with the 
requirements for nutrition labeling contained in subparagraphs (q)(1) 
and (q)(2) in a manner which is appropriate. Furthermore, the agency 
believes that nutrition information on dietary supplements is essential 
for those that are interested to be able to calculate their daily 
intakes of nutrients.
    As to OMB's concern that the information will be sufficiently clear 
to the third-party recipients, FDA notes that consumer surveys have 
indicated that the graphic requirements in the nutrition labeling rules 
for food (i.e., Sec. 101.9) were successful in that the majority of 
shoppers who are aware of the new label think it is clear and 
understandable. FDA has no reason to believe that the requirements for 
nutrition labeling of dietary supplements will be any less clear.
    FDA has resubmitted the information collection requirements 
contained in this rule to OMB for its review under the Paperwork 
Reduction Act of 1995. Interested persons are requested to send 
comments regarding information collection by October 23, 1997 to the 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA. No 
person may be required to respond to, or may be subjected a penalty for 
failure to comply with, these information collection requirements until 
they have been approved by OMB and FDA has displayed the assigned OMB 
control number. The OMB control number, when assigned, will be 
announced by separate notice in the Federal Register.

IX. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Machlin, L. J., editor, Handbook of Vitamins, 2d ed., pp. 239 
and 285, Dekker, NY, 1991.
    2. Subcommittee on the 10th Edition of the RDA's, Food and 
Nutrition Board, Commission of Life Sciences, National Research 
Council, ``Recommended Dietary Allowances, 10th Ed.,'' pp. 125 and 
132, Washington, DC, National Academy Press, 1989.

[[Page 49847]]

    3. Food Marketing Institute Prevention Magazine Report, 
``Shopping for Health 1995,'' Food Marketing Institute, Washington, 
DC, and Prevention Magazine, Emmaus, PA, 1995.
    4. Nonprescription Drug Manufacturers Association's Special Task 
Force on Label Readability, ``Label Readability Guidelines,'' 
Washington, DC, 1991.
    5. Tanner, J. T., letter to V. Srinivasan, U.S. Pharmacopeial 
Convention, Inc., May 7, 1991.
    6. Deming, W. E., ``On the Presentation of the Results of Sample 
Surveys as Legal Evidence,'' The Journal of the American Statistical 
Association, 49:818-821, December 1954.
    7. Memorandum between Bill Bradley, Nonprescription Drug 
Manufacturers Association, and Susan Thompson, CFSAN, FDA, October 
15, 1993.
    8. U.S. Department of Agriculture, Human Nutrition Information 
Service, ``The Food Guide Pyramid,'' Home and Garden Bulletin Number 
252, August 1992.
    9. U.S. Department of Agriculture, Center for Nutrition Policy 
and Promotion, ``The Healthy Eating Index,'' October 1995.
     10. U.S. Department of Agriculture, Economic Research Service, 
``Food Consumption, Prices, and Expenditures, 1996,'' Statistical 
Bulletin Number 928, pp. 18-19.
    11. Foster, S., editor, Herbs of Commerce, Amercian Herbal 
Products Association, Bethesda, MD, 1992.
    12. Greuter, W., editor (chairperson), International Code of 
Botanical Nomenclature (Tokyo Code), adopted by the 15th 
International Botanical Congress, Koeltz Scientific Books, D-61453 
Konigstein, Germany, 1994.

 List of Subjects in 21 CFR Part 101

    Food labeling, Incorporation by reference, Nutrition, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

    2. Section 101.2 is amended by revising paragraphs (b), (d)(1), and 
(f) to read as follows:

Sec. 101.2  Information panel of package form food.

 *   *   *   *   *
    (b) All information required to appear on the label of any package 
of food under Secs. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, 
subpart D of part 101, and part 105 of this chapter shall appear either 
on the principal display panel or on the information panel, unless 
otherwise specified by regulations in this chapter.
 *   *   *   *   *
    (d)(1) Except as provided by Secs. 101.9(j)(13) and (j)(17) and 
101.36(i)(2) and (i)(5), all information required to appear on the 
principal display panel or on the information panel under this section 
shall appear on the same panel unless there is insufficient space. In 
determining the sufficiency of the available space, except as provided 
by Secs. 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and 
other nonmandatory label information shall not be considered. If there 
is insufficient space for all of this information to appear on a single 
panel, it may be divided between these two panels, except that the 
information required under any given section or part shall all appear 
on the same panel. A food whose label is required to bear the 
ingredient statement on the principal display panel may bear all other 
information specified in paragraph (b) of this section on the 
information panel.
 *   *   *   *   *
    (f) If the label of any package of food is too small to accommodate 
all of the information required by Secs. 101.4, 101.5, 101.8, 101.9, 
101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this 
chapter, the Commissioner may establish by regulation an acceptable 
alternative method of disseminating such information to the public, 
e.g., a type size smaller than one-sixteenth inch in height, or 
labeling attached to or inserted in the package or available at the 
point of purchase. A petition requesting such a regulation, as an 
amendment to this paragraph, shall be submitted under part 10 of this 
chapter.
    3. Section 101.3 is amended by adding new paragraph (g) to read as 
follows:

Sec. 101.3  Identity labeling of food in packaged form.

 *   *   *   *   *
    (g) Dietary supplements shall be identified by the term ``dietary 
supplement'' as a part of the statement of identity, except that the 
word ``dietary'' may be deleted and replaced by the name of the dietary 
ingredients in the product (e.g., calcium supplement) or an 
appropriately descriptive term indicating the type of dietary 
ingredients that are in the product (e.g., herbal supplement with 
vitamins).
    4. Section 101.4 is amended by revising paragraph (a)(1) and adding 
new paragraphs (g) and (h) to read as follows:

Sec. 101.4   Food; designation of ingredients.

    (a)(1) Ingredients required to be declared on the label or labeling 
of a food, including foods that comply with standards of identity, 
except those ingredients exempted by Sec. 101.100, shall be listed by 
common or usual name in descending order of predominance by weight on 
either the principal display panel or the information panel in 
accordance with the provisions of Sec. 101.2, except that ingredients 
in dietary supplements that are listed in the nutrition label in 
accordance with Sec. 101.36 need not be repeated in the ingredient 
list. Paragraph (g) of this section describes the ingredient list on 
dietary supplement products.
 *   *   *   *   *
    (g) When present, the ingredient list on dietary supplement 
products shall be located immediately below the nutrition label, or, if 
there is insufficient space below the nutrition label, immediately 
contiguous and to the right of the nutrition label and shall be 
preceded by the word ``Ingredients,'' unless some ingredients (i.e., 
sources) are identified within the nutrition label in accordance with 
Sec. 101.36(d), in which case the ingredients listed outside the 
nutrition label shall be in a list preceded by the words ``Other 
ingredients.'' Ingredients in dietary supplements that are not dietary 
ingredients or that do not contain dietary ingredients, such as 
excipients, fillers, artificial colors, artificial sweeteners, flavors, 
or binders, shall be included in the ingredient list.
    (h) The common or usual name of ingredients of dietary supplements 
that are botanicals (including fungi and algae) shall be consistent 
with the names standardized in Herbs of Commerce, 1992 edition, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies may be obtained from the American Herbal Products 
Association, 4733 Bethesda Ave., suite 345, Bethesda, MD 20814, or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of 
the Federal Register, 800 Capital St. NW., suite 700, Washington, DC. 
The listing of these names on the label shall be followed by statements 
of:
    (1) The part of the plant (e.g., root, leaves) from which the 
dietary ingredient is derived (e.g., ``Garlic bulb'' or ``Garlic 
(bulb)''), except that this designation is not required for algae. The 
name of the part of the plant shall

[[Page 49848]]

pressed in English (e.g., ``flower'' rather than ``flos'');
    (2) The Latin binomial name of the plant, in parentheses, except 
that this name is not required when it is available in the reference 
entitled: Herbs of Commerce for the common or usual name listed on the 
label, and, when required, the Latin binomial name may be listed before 
the part of the plant. Any name in Latin form shall be in accordance 
with internationally accepted rules on nomenclature, such as those 
found in the International Code of Botanical Nomenclature and shall 
include the designation of the author or authors who published the 
Latin name, when a positive identification cannot be made in its 
absence. The International Code of Botanical Nomenclature (Tokyo Code), 
1994 edition, a publication of the International Association for Plant 
Taxonomy, is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies of the International Code of Botanical 
Nomenclature may be obtained from Koeltz Scientific Books, D-61453 
Konigstein, Germany, and University Bookstore, Southern Illinois 
University, Carbondale, IL 62901-4422, 618-536-3321, FAX 618-453-5207, 
or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 200 C St. SW., rm. 3321, Washington DC, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington DC.
    (3) On labels of single-ingredient dietary supplements that do not 
include an ingredient list, the identification of the Latin binomial 
name, when needed, and the part of the plant may be prominently placed 
on the principal display panel or information panel, or included in the 
nutrition label.
    5. Section 101.9 is amended by removing paragraphs (k)(2) and 
(k)(5), by redesignating paragraphs (k)(3), (k)(4), and (k)(6) as 
paragraphs (k)(2), (k)(3), and (k)(4), respectively, and by revising 
paragraphs (c)(8)(iii), (c)(8)(v), (d)(7)(i), (j)(6), and newly 
redesignated (k)(4) to read as follows:

Sec. 101.9  Nutrition labeling of food.

 *   *   *   *   *
    (c) *   *   *
    (8) *    *   *
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment up to and including the 10-percent 
level, the nearest 5-percent increment above 10 percent and up to and 
including the 50-percent level, and the nearest 10-percent increment 
above the 50-percent level. Amounts of vitamins and minerals present at 
less than 2 percent of the RDI are not required to be declared in 
nutrition labeling but may be declared by a zero or by the use of an 
asterisk (or other symbol) that refers to another asterisk (or symbol) 
that is placed at the bottom of the table and that is followed by the 
statement ``Contains less than 2 percent of the Daily Value of this 
(these) nutrient (nutrients)'' or ``Contains < 2 percent of the Daily 
Value of this (these) nutrient (nutrients).'' Alternatively, except as 
provided for in paragraph (f) of this section, if vitamin A, vitamin C, 
calcium, or iron is present in amounts less than 2 percent of the RDI, 
label declaration of the nutrient(s) is not required if the statement 
``Not a significant source of ______ (listing the vitamins or minerals 
omitted)'' is placed at the bottom of the table of nutrient values. 
Either statement shall be in the same type size as nutrients that are 
indented.
 *   *   *   *   *
    (v) The following synonyms may be added in parentheses immediately 
following the name of the nutrient or dietary component:
Calories--Energy,
Vitamin C--Ascorbic acid,
Thiamin--Vitamin B<INF>1</INF>,
Riboflavin--Vitamin B<INF>2</INF>,
Folate--Folic acid or Folacin. Alternatively, folic acid or folacin may 
be listed without parentheses in place of folate.
 *   *   *  *   *
    (d) *   *   *
    (7) *   *   *
    (i) The name of each nutrient, as specified in paragraph (c) of 
this section, shall be given in a column and followed immediately by 
the quantitative amount by weight for that nutrient appended with a 
``g'' for grams or a ``mg'' for milligrams as shown in paragraph 
(d)(12) of this section. The symbol ``<'' may be used in place of 
``less than.''
 * * * * *
     (j) *   *   *
    (6) Dietary supplements, except that such foods shall be labeled in 
compliance with Sec. 101.36.
*   *   *   *   *
    (k) *   *   *
    (4) That a natural vitamin in a food is superior to an added or 
synthetic vitamin.
    6. Section 101.12 is amended in paragraph (b), Table 2, under the 
subheading ``Miscellaneous category'' by revising the entry ``Dietary 
supplements not in conventional food form'' to read as follows:

Sec. 101.12  Reference amounts customarily consumed per eating 
occasion.

 *   *   *   *   *
    (b) *   *   *

        Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply<SUP>1,2,3,4        
----------------------------------------------------------------------------------------------------------------
     Product category            Reference amount                           Label statement<SUP>5                    
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Miscellaneous category:                                                                                         
  Dietary supplements       The maximum amount              ______tablet(s), ______capsule(s), ______packet(s), 
                             recommended, as                                       ______tsp(s), (______g), etc 
                             appropriate, on the                                                                
                             label for consumption                                                              
                             per eating occasion, or,                                                           
                             in the absence of                                                                  
                             recommendations, 1 unit,                                                           
                             e.g., tablet, capsule,                                                             
                             packet, teaspoonsful,                                                              
                             etc.                                                                               
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
  primarily derived from the 1977-78 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.                                                                                    
\2\ Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or  
  almost ready-to-serve form of the product (i.e, heat and serve, brown and serve). If not listed separately,   
  the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; fresh and frozen  
  pasta) is the amount required to make the reference amount of the prepared form. Prepared means prepared for  
  consumption (e.g., cooked).                                                                                   
\3\ Manufacturers are required to convert the reference amount to the label serving size in a household measure 
  most appropriate to their specific product using the procedures in 21 CFR 101.9(b).                           

[[Page 49849]]

                                                                                                                
\4\ Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-
  150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington,  
  DC 20204.                                                                                                     
\5\ The label statements are meant to provide guidance to manufacturers on the presentation of serving size     
  information on the label, but they are not required. The term ``piece'' is used as a generic description of a 
  discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific   
  product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided
  is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not 
  apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless
  specifically stated in the product category, reference amount, or label statement column that it is for these 
  forms of the product. For products that require further preparation, manufacturers must determine the label   
  statement following the rules in Sec.  101.9(b) using the reference amount determined according to Sec.       
  101.12(c).                                                                                                    

* * * * *
    7. Section 101.36 is revised to read as follows:

Sec. 101.36  Nutrition labeling of dietary supplements.

    (a) The label of a dietary supplement that is offered for sale 
shall bear nutrition labeling in accordance with this regulation unless 
an exemption is provided for the product in paragraph (h) of this 
section.
    (b) The declaration of nutrition information on the label and in 
labeling shall contain the following information, using the subheadings 
and the format specified in paragraph (e) of this section.
    (1) Serving size--(i) The subheading ``Serving Size'' shall be 
placed under the heading ``Supplement Facts'' and aligned on the left 
side of the nutrition label. The serving size shall be determined in 
accordance with Secs. 101.9(b) and 101.12(b), Table 2. Serving size for 
dietary supplements shall be expressed using a term that is appropriate 
for the form of the supplement, such as ``tablets,'' ``capsules,'' 
``packets,'' or ``teaspoonfuls.''
    (ii) The subheading ``Servings Per Container'' shall be placed 
under the subheading ``Serving Size'' and aligned on the left side of 
the nutrition label, except that this information need not be provided 
when it is stated in the net quantity of contents declaration.
    (2) Information on dietary ingredients that have a Reference Daily 
Intake (RDI) or a Daily Reference Value (DRV) as established in 
Sec. 101.9(c) and their subcomponents (hereinafter referred to as 
``(b)(2)-dietary ingredients'')--(i) The (b)(2)-dietary ingredients to 
be declared, that is, total calories, calories from fat, total fat, 
saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, 
sugars, protein, vitamin A, vitamin C, calcium and iron, shall be 
declared when they are present in a dietary supplement in quantitative 
amounts by weight that exceed the amount that can be declared as zero 
in nutrition labeling of foods in accordance with Sec. 101.9(c). 
Calories from saturated fat and polyunsaturated fat, monounsaturated 
fat, soluble fiber, insoluble fiber, sugar alcohol, and other 
carbohydrate may be declared, but they shall be declared when a claim 
is made about them. Any other vitamins or minerals listed in 
Sec. 101.9(c)(8)(iv) or (c)(9) may be declared, but they shall be 
declared when they are added to the product for purposes of 
supplementation, or when a claim is made about them. Any (b)(2)-dietary 
ingredients that are not present, or that are present in amounts that 
can be declared as zero in Sec. 101.9(c), shall not be declared (e.g., 
amounts corresponding to less than 2 percent of the RDI for vitamins 
and minerals). Protein shall not be declared on labels of products 
that, other than ingredients added solely for technological reasons, 
contain only individual amino acids.
    (A) The names and the quantitative amounts by weight of each 
(b)(2)-dietary ingredient shall be presented under the heading ``Amount 
Per Serving.'' When the quantitative amounts by weight are presented in 
a separate column, the heading may be centered over a column of 
quantitative amounts, described by paragraph (b)(2)(ii) of this 
section, if space permits. A heading consistent with the declaration of 
the serving size, such as ``Each Tablet Contains,'' or ``Amount Per 2 
Tablets'' may be used in place of the heading ``Amount Per Serving.'' 
Other appropriate terms, such as capsule, packet, or teaspoonful, also 
may be used in place of the term ``Serving.''
    (B) The names of dietary ingredients that are declared under 
paragraph (b)(2)(i) of this section shall be presented in a column 
aligned on the left side of the nutrition label in the order and manner 
of indentation specified in Sec. 101.9(c), except that calcium and iron 
shall follow pantothenic acid, and sodium and potassium shall follow 
chloride. This results in the following order for vitamins and 
minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, 
thiamin, riboflavin, niacin, vitamin B<INF>6</INF>, folate, vitamin 
B<INF>12</INF>, biotin, pantothenic acid, calcium, iron, phosphorus, 
iodine, magnesium, zinc, selenium, copper, manganese, chromium, 
molybdenum, chloride, sodium, and potassium. The (b)(2)-dietary 
ingredients shall be listed according to the nomenclature specified in 
Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
    (1) When ``Calories'' are declared, they shall be listed first in 
the column of names, beneath a light bar separating the heading 
``Amount Per Serving'' from the list of names. When ``Calories from 
fat'' or ``Calories from saturated fat'' are declared, they shall be 
indented beneath ``Calories.''
    (2) The following synonyms may be added in parentheses immediately 
following the name of these (b)(2)-dietary ingredients: Vitamin C 
(ascorbic acid), thiamin (vitamin B<INF>1</INF>), riboflavin (vitamin 
B<INF>2</INF>), folate (folacin or folic acid), and calories (energy). 
Alternatively, the term ``folic acid'' or ``folacin'' may be listed 
without parentheses in place of ``folate.'' Energy content per serving 
may be expressed in kilojoules units, added in parentheses immediately 
following the statement of caloric content.
    (3) Beta-carotene may be declared as the percent of vitamin A that 
is present as beta-carotene, except that the declaration is required 
when a claim is made about beta-carotene. When declared, the percent 
shall be declared to the nearest whole percent, immediately adjacent to 
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of international 
units (IU) may be included in parentheses following the percent 
statement (e.g., ``Vitamin A (90% (4500 IU) as beta-carotene)'').
    (ii) The number of calories, if declared, and the quantitative 
amount by weight per serving of each dietary ingredient required to be 
listed under paragraph (b)(2)(i) of this section shall be presented 
either in a separate column aligned to the right of the column of names 
or immediately following the listing of names within the same column. 
The quantitative amounts by weight shall represent the weight of the 
dietary ingredient rather than the weight of the source of the dietary 
ingredient (e.g., the weight of calcium rather than that of calcium 
carbonate).
    (A) These amounts shall be expressed in the increments specified in 
Sec. 101.9(c)(1) through (c)(7), which includes increments for sodium 
and potassium.

[[Page 49850]]

    (B) The amounts of vitamins and minerals, excluding sodium and 
potassium, shall be the amount of the vitamin or mineral included in 
one serving of the product, using the units of measurement and the 
levels of significance given in Sec. 101.9(c)(8)(iv), except that zeros 
following decimal points may be dropped, and additional levels of 
significance may be used when the number of decimal places indicated is 
not sufficient to express lower amounts (e.g., the RDI for zinc is 
given in whole milligrams (mg), but the quantitative amount may be 
declared in tenths of a mg).
    (iii) The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed, 
except that the percent for protein may be omitted as provided in 
Sec. 101.9(c)(7); no percent shall be given for subcomponents for which 
DRV's have not been established (e.g., sugars); and, for labels of 
dietary supplements of vitamins and minerals that are represented or 
purported to be for use by infants, children less than 4 years of age, 
or pregnant or lactating women, no percent shall be given for total 
fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, 
vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium, 
or potassium.
    (A) When information on the percent of Daily Values is listed, this 
information shall be presented in one column aligned under the heading 
of ``% Daily Value'' and to the right of the column of amounts. The 
headings ``% Daily Value (DV),'' ``% DV,'' ``Percent Daily Value,'' or 
``Percent DV'' may be substituted for ``% Daily Value.'' The heading 
``% Daily Value'' shall be placed on the same line as the heading 
``Amount Per Serving.'' When the acronym ``DV'' is unexplained in the 
heading and a footnote is required under (b)(2)(iii)(D), 
(b)(2)(iii)(F), or (b)(3)(iv) of this section, the footnote shall 
explain the acronym (e.g. ``Daily Value (DV) not established'').
    (B) The percent of Daily Value shall be calculated by dividing the 
quantitative amount by weight of each (b)(2)-dietary ingredient by the 
RDI as established in Sec. 101.9(c)(8)(iv) or the DRV as established in 
Sec. 101.9(c)(9) for the specified dietary ingredient and multiplying 
by 100, except that the percent of Daily Value for protein, when 
present, shall be calculated as specified in Sec. 101.9(c)(7)(ii). The 
quantitative amount by weight of each dietary ingredient in this 
calculation shall be the unrounded amount, except that for total fat, 
saturated fat, cholesterol, sodium, potassium, total carbohydrate, and 
dietary fiber, the quantitative amount by weight declared on the label 
(i.e, rounded amount) may be used. The numerical value shall be 
followed by the symbol for percent (i.e., %).
    (C) The percentages based on RDI's and on DRV's shall be expressed 
to the nearest whole percent, except that for dietary ingredients for 
which DRV's have been established, ``Less than 1%'' or ``<1%'' shall be 
used to declare the ``% Daily Value'' when the quantitative amount of 
the dietary ingredient by weight is great enough to require that the 
dietary ingredient be listed, but the amount is so small that the ``% 
Daily Value'' when rounded to the nearest percent is zero (e.g., a 
product that contains 1 gram of total carbohydrate would list the 
percent Daily Value as ``Less than 1%'' or ``<1%'').
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, a symbol 
shall follow the value listed for those nutrients that refers to the 
same symbol that is placed at the bottom of the nutrition label, below 
the bar required under paragraph (e)(6) of this section and inside the 
box, that is followed by the statement ``Percent Daily Values are based 
on a 2,000 calorie diet.''
    (E) The percent of Daily Value shall be based on RDI and DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women, in which case the 
column heading shall clearly state the intended group. If the product 
is for persons within more than one group, the percent of Daily Value 
for each group shall be presented in separate columns as shown in 
paragraph (e)(10)(ii) of this section.
    (F) For declared subcomponents that have no DRV's and, on the 
labels of dietary supplements of vitamins and minerals that are 
represented or purported to be for use by infants, children less that 4 
years of age, or pregnant or lactating women, for total fat, saturated 
fat, cholesterol, total carbohydrate, dietary fiber, vitamin K, 
selenium, manganese, chromium, molybdenum, chloride, sodium, or 
potassium, a symbol (e.g., an asterisk) shall be placed in the 
``Percent Daily Value'' column that shall refer to the same symbol that 
is placed at the bottom of the nutrition label, below the last heavy 
bar and inside the box, and followed by the statement ``Daily Value not 
established.''
    (G) When calories, calories from fat, or calories from saturated 
fat are declared, the space under the ``% Daily Value'' column shall be 
left blank for these items. When there are no other (b)(2)-dietary 
ingredients listed for which a value must be declared in the ``% Daily 
Value'' column, the column may be omitted as shown in paragraph 
(e)(10)(vii) of this section. When the ``% Daily Value'' column is not 
required, but the dietary ingredients listed are subject to paragraph 
(b)(2)(iii)(F) of this section, the symbol required in that paragraph 
shall immediately follow the quantitative amount by weight for each 
dietary ingredient listed under ``Amount Per Serving.''
    (iv) The quantitative amount by weight and the percent of Daily 
Value may be presented on a ``per unit'' basis in addition to on a 
``per serving'' basis, as required in paragraph (b)(2)(ii) of this 
section. This information shall be presented in additional columns and 
clearly identified by appropriate headings.
    (3) Information on dietary ingredients for which RDI's and DRV's 
have not been established--(i) Dietary ingredients for which FDA has 
not established RDI's or DRV's and that are not subject to regulation 
under paragraph (b)(2) of this section (hereinafter referred to as 
``other dietary ingredients'') shall be declared by their common or 
usual name when they are present in a dietary supplement, in a column 
that is under the column of names described in paragraph (b)(2)(i)(B) 
of this section or, as long as the constituents of an other dietary 
ingredient are not listed, in a linear display, under the heavy bar 
described in paragraph (e)(6) of this section, except that if no 
(b)(2)-dietary ingredients are declared, other dietary ingredients 
shall be declared directly beneath the heading ``Amount Per Serving'' 
described in paragraph (b)(2)(i)(A) of this section.
    (ii) The quantitative amount by weight per serving of other dietary 
ingredients shall be presented in the same manner as the corresponding 
information required in paragraph (b)(2)(ii) of this section or, when a 
linear display is used, shall be presented immediately following the 
name of the other dietary ingredient. The quantitative amount by weight 
shall be the weight of the other dietary ingredient listed and not the 
weight of any component, or the source, of that dietary ingredient.
    (A) These amounts shall be expressed using metric measures in 
appropriate units (i.e., 1,000 or more units shall be declared in the 
next higher set of units, e.g., 1,100 mg shall be declared as 1.1 g).
    (B) For any dietary ingredient that is a liquid extract from which 
the solvent

[[Page 49851]]

has not been removed, the quantity listed shall be the weight of the 
total extract with information on the concentration of the dietary 
ingredient, the solvent used, and the condition of the starting 
material (i.e., whether it is fresh or dried), e.g., ``fresh dandelion 
root extract, x mg (y:z) in 70% ethanol,'' where x is the number of mg 
of the entire extract, y is the weight of the starting material and z 
is the volume (milliliters) of solvent. Where the solvent has been 
partially removed (not to dryness), the final concentration shall be 
stated (e.g., if the original extract was 1:5 and 50 percent of the 
solvent was removed, then the final concentration shall be stated as 
1:2.5).
    (C) For a dietary ingredient that is an extract from which the 
solvent has been removed, the weight of the ingredient shall be the 
weight of the dried extract. The dried extract shall be described by an 
appropriately descriptive term that identifies the solvent used, e.g., 
``dried hexane extract of ________'' or ``________, dried hexane 
extract.''
    (iii) The constituents of a dietary ingredient described in 
paragraph (b)(3)(i) of this section may be listed indented under the 
dietary ingredient and followed by their quantitative amounts by 
weight, except that dietary ingredients described in paragraph (b)(2) 
of this section shall be listed in accordance with that section. When 
the constituents of a dietary ingredient described in paragraph 
(b)(3)(i) of this section are listed, all other dietary ingredients 
shall be declared in a column; however, the constituents themselves may 
be declared in a column or in a linear display.
    (iv) Other dietary ingredients shall bear a symbol (e.g., an 
asterisk) in the column under the heading of ``% Daily Value'' that 
refers to the same symbol placed at the bottom of the nutrition label 
and followed by the statement ``Daily Value not established,'' except 
that when the heading ``% Daily Value'' is not used, the symbol shall 
follow the quantitative amount by weight for each dietary ingredient 
listed.
    (c) A proprietary blend of dietary ingredients shall be included in 
the list of dietary ingredients described in paragraph (b)(3)(i) of 
this section and identified by the term ``Proprietary Blend'' or other 
appropriately descriptive term or fanciful name and may be highlighted 
by bold type. Except as specified in this paragraph, all other 
requirements for the listing of dietary ingredients in dietary 
supplements are applicable.
    (1) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(2) of this section shall be declared in 
accordance with paragraph (b)(2) of this section.
    (2) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(3) of this section (i.e., ``other dietary 
ingredients'') shall be declared in descending order of predominance by 
weight, in a column or linear fashion, and indented under the term 
``Proprietary Blend'' or other appropriately descriptive term or 
fanciful name.
    (3) The quantitative amount by weight specified for the proprietary 
blend shall be the total weight of all other dietary ingredients 
contained in the proprietary blend and shall be placed on the same line 
to the right of the term ``Proprietary Blend'' or other appropriately 
descriptive term or fanciful name underneath the column of amounts 
described in paragraph (b)(2)(ii) of this section. A symbol (e.g., 
asterisk), which refers to the same symbol placed at the bottom of the 
nutrition label that is followed by the statement ``Daily Value not 
established,'' shall be placed under the heading ``% Daily Value,'' if 
present, or immediately following the quantitative amount by weight for 
the proprietary blend.
    (4) The sample label shown in paragraph (e)(10)(v) of this section 
illustrates one method of nutrition labeling a proprietary blend of 
dietary ingredients.
    (d) The source ingredient that supplies a dietary ingredient may be 
identified within the nutrition label in parentheses immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the words ``as'' or ``from'', e.g., ``Calcium (as calcium 
carbonate),'' except that manner of presentation is unnecessary when 
the name of the dietary ingredient (e.g., Oriental ginseng) or its 
synonym (e.g., ascorbic acid) is itself the source ingredient. When a 
source ingredient is identified in parentheses within the nutrition 
label, or when the name of the dietary ingredient or its synonym is the 
source ingredient, it shall not be required to be listed again in the 
ingredient statement that appears outside of the nutrition label. When 
a source ingredient is not identified within the nutrition label, it 
shall be listed in an ingredient statement in accordance with 
Sec. 101.4(g), which shall appear outside and immediately below the 
nutrition label or, if there is insufficient space below the nutrition 
label, immediately contiguous and to the right of the nutrition label.
    (1) Source ingredients shall be identified in accordance with 
Sec. 101.4 (i.e., shall be listed by common or usual name, and the 
listing of botanicals shall specify the part of the plant from which 
the ingredient is derived) regardless of whether they are listed in an 
ingredient statement or in the nutrition label.
    (2) When source ingredients are listed within the nutrition label, 
and two or more are used to provide a single dietary ingredient, all of 
the sources shall be listed within the parentheses in descending order 
by weight.
    (3) Representations that the source ingredient conforms to an 
official compendium may be included either in the nutrition label or in 
the ingredient list (e.g., ``Calcium (as calcium carbonate USP)'').
    (e) Nutrition information specified in this section shall be 
presented as follows:

    (1) The title, ``Supplement Facts,'' shall be set in a type size 
larger than all other print size in the nutrition label and, unless 
impractical, shall be set full width of the nutrition label. The title 
and all headings shall be bolded to distinguish them from other 
information.
    (2) The nutrition information shall be enclosed in a box by using 
hairlines.
    (3) All information within the nutrition label shall utilize:
    (i) A single easy-to-read type style,
    (ii) All black or one color type, printed on a white or other 
neutral contrasting background whenever practical,
    (iii) Upper- and lowercase letters, except that all uppercase 
lettering may be utilized for packages that have a total surface area 
available to bear labeling of less than 12 square inches,
    (iv) At least one point leading (i.e., space between lines of 
text), and
    (v) Letters that do not touch.
    (4) Except as provided for small and intermediate-sized packages 
under paragraph (i)(2) of this section, information other than the 
title, headings, and footnotes shall be in uniform type size no smaller 
than 8 point. Type size no smaller than 6 point may be used for column 
headings (e.g., ``Amount Per Serving'' and ``% Daily Value'') and for 
footnotes (e.g., ``Percent Daily Values are based on a 2,000 calorie 
diet'').
    (5) A hairline rule that is centered between the lines of text 
shall separate each dietary ingredient required in paragraph (b)(2) and 
(b)(3) of this section from the dietary ingredient above and beneath 
it, as shown in paragraph (e)(10) of this section.
    (6) A heavy bar shall be placed:
    (i) Beneath the subheading ``Servings Per Container'' except that 
if ``Servings Per Container'' is not required and, as a result, not 
declared, the bar shall be

[[Page 49852]]

placed beneath the subheading ``Serving Size,''
    (ii) Beneath the last dietary ingredient to be listed under 
paragraph (b)(2)(i) of this section, if any, and
    (iii) Beneath the last other dietary ingredient to be listed under 
paragraph (b)(3) of this section, if any.
    (7) A light bar shall be placed beneath the headings ``Amount Per 
Serving'' and ``% Daily Value.''
    (8) If the product contains two or more separately packaged dietary 
supplements that differ from each other (e.g., the product has a packet 
of supplements to be taken in the morning and a different packet to be 
taken in the afternoon), the quantitative amounts and percent of Daily 
Value may be presented as specified in this paragraph in individual 
nutrition labels or in one aggregate nutrition label as illustrated in 
paragraph (e)(10)(iii) of this section.
    (9) In the interest of uniformity of presentation, FDA urges that 
the information be presented using the graphic specifications set forth 
in Appendix B to part 101, as applicable.
    (10) The following sample labels are presented for the purpose of 
illustration:

BILLING CODE 4190-01-F

[[Page 49853]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.010



[[Page 49854]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.011



[[Page 49855]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.012



[[Page 49856]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.013



BILLING CODE 4190-01-C
    (11) If space is not adequate to list the required information as 
shown in the sample labels in paragraph (e)(10) of this section, the 
list may be split and continued to the right as long as the headings 
are repeated. The list to the right shall be set off by a line that 
distinguishes it and sets it apart from the dietary ingredients and 
percent of Daily Value information given to the left. The following 
sample label illustrates this display:

[[Page 49857]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.014



BILLING CODE 4190-01-C

[[Page 49858]]

    (f)(1) Compliance with this section will be determined in 
accordance with Sec. 101.9(g)(1) through (g)(8), except that the sample 
for analysis shall consist of a composite of 12 subsamples (consumer 
packages) or 10 percent of the number of packages in the same 
inspection lot, whichever is smaller, randomly selected to be 
representative of the lot. The criteria on class I and class II 
nutrients given in Sec. 101.9(g)(3) and (g)(4) also are applicable to 
other dietary ingredients described in paragraph (b)(3)(i) of this 
section. Reasonable excesses of these other dietary ingredients over 
labeled amounts are acceptable within current good manufacturing 
practice.
    (2) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section, FDA may permit alternative means of 
compliance or additional exemptions to deal with the situation in 
accordance with Sec. 101.9(g)(9). Firms in need of such special 
allowances shall make their request in writing to the Office of Food 
Labeling (HFS-150), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204.
    (g) Except as provided in paragraphs (i)(2) and (i)(5) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec. 101.2.
    (h) Dietary supplements are subject to the exemptions specified as 
follows in:
    (1) Section 101.9(j)(1) for foods that are offered for sale by a 
person who makes direct sales to consumers (i.e., a retailer) who has 
annual gross sales or business done in sales to consumers that is not 
more than $500,000 or has annual gross sales made or business done in 
sales of food to consumers of not more than $50,000, and whose labels, 
labeling, and advertising do not provide nutrition information or make 
a nutrient content or health claim;
    (2) Section 101.9(j)(18) for foods that are low-volume products 
(that is, they meet the requirements for units sold in 
Sec. 101.9(j)(18)(i) or (j)(18)(ii)); that, except as provided in 
Sec. 101.9(j)(18)(iv), are the subject of a claim for an exemption that 
provides the information required under Sec. 101.9(j)(18)(iv), that is 
filed before the beginning of the time period for which the exemption 
is claimed, and that is filed by a person, whether it is the 
manufacturer, packer, or distributor, that qualifies to claim the 
exemption under the requirements for average full-time equivalent 
employees in Sec. 101.9(j)(18)(i) or (j)(18)(ii), and whose labels, 
labeling, and advertising do not provide nutrition information or make 
a nutrient content or health claim;
    (3) Section 101.9(j)(9) for foods shipped in bulk form that are not 
for distribution to consumers in such form and that are for use solely 
in the manufacture of other dietary supplements or that are to be 
processed, labeled, or repacked at a site other than where originally 
processed or packed.
    (i) Dietary supplements are subject to the special labeling 
provisions specified in:
    (1) Section 101.9(j)(5)(i) for foods, other than infant formula, 
represented or purported to be specifically for infants and children 
less than 2 years of age, in that nutrition labels on such foods shall 
not include calories from fat, calories from saturated fat, saturated 
fat, polyunsaturated fat, monounsaturated fat, and cholesterol;
    (2) Section 101.9(j)(13) for foods in small or intermediate-sized 
packages, except that:
    (i) All information within the nutrition label on small-sized 
packages, which have a total surface area available to labeling of less 
than 12 square inches, shall be in type size no smaller than 4.5 point;
    (ii) All information within the nutrition label on intermediate-
sized packages, which have from 12 to 40 square inches of surface area 
available to bear labeling, shall be in type size no smaller than 6 
point, except that type size no smaller than 4.5 point may be used on 
packages that have less than 20 square inches available for labeling 
and more than 8 dietary ingredients to be listed and on packages that 
have 20 to 40 square inches available for labeling and more than 16 
dietary ingredients to be listed.
    (iii) When the nutrition information is presented on any panel 
under Sec. 101.9(j)(13)(ii)(D), the ingredient list shall continue to 
be located immediately below the nutrition label, or, if there is 
insufficient space below the nutrition label, immediately contiguous 
and to the right of the nutrition label as specified in Sec. 101.4(g).
    (iv) When it is not possible for a small or intermediate-sized 
package that is enclosed in an outer package to comply with these type 
size requirements, the type size of the nutrition label on the primary 
(inner) container may be as small as needed to accommodate all of the 
required label information provided that the primary container is 
securely enclosed in outer packaging, the nutrition labeling on the 
outer packaging meets the applicable type size requirements, and such 
outer packaging is not intended to be separated from the primary 
container under conditions of retail sale.
    (v) Where there is not sufficient space on a small or intermediate-
sized package for a nutrition label that meets minimum type size 
requirements of 4.5 points if hairlines are used in accordance with 
paragraph (e)(5) of this section, the hairlines may be omitted and 
replaced by a row of dots connecting the columns containing the name of 
each dietary ingredient and the quantitative amounts (by weight and as 
a percent of Daily Value).
     (3) Section 101.9(j)(15) for foods in multiunit food containers;
    (4) Section 101.9(j)(16) for foods sold in bulk containers; and
    (5) Section 101.9(j)(17) for foods in packages that have a total 
surface area available to bear labeling greater than 40 square inches 
but whose principal display panel and information panel do not provide 
sufficient space to accommodate all required label information, except 
that the ingredient list shall continue to be located immediately below 
the nutrition label, or, if there is insufficient space below the 
nutrition label, immediately contiguous and to the right of the 
nutrition label as specified in Sec. 101.4(g).
    (j) Dietary supplements shall be subject to the misbranding 
provisions of Sec. 101.9(k).
    7. Section 101.65 is amended by revising paragraph (b)(4) to read 
as follows:

Sec. 101.65  Implied nutrient content claims and related label 
statements.

 *   *   *   *   *
    (b) *   *   *
    (4) A statement of identity for a food in which an ingredient 
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' 
``oat bran,'' ``dietary supplement of vitamin C 60 mg tablet'').
 *   *   *   *   *

    Dated: September 11, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-24739 Filed 9-22-97; 8:45 am]
BILLING CODE 4160-01-F