[Federal Register Volume 60, Number 249 (Thursday, December 28, 1995)]
[Proposed Rules]
[Pages 67194-67224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31196]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
21 CFR Part 101
[Docket No. 95N-0245]
RIN 0910-AA59

Food Labeling; Statement of Identity, Nutrition Labeling and 
Ingredient Labeling of Dietary Supplements
AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its food labeling regulations to require that dietary supplements be 
identified with the statement of identity ``Dietary Supplement'' on the 
principal display panel of the label and modify the nutrition labeling 
and ingredient labeling requirements for these foods. FDA is proposing 
these actions in response to the Dietary Supplement Health and 
Education Act of 1994 (the DSHEA). FDA is also responding to a citizen 
petition on type size requirements for these products.

DATES: Written comments by March 13, 1996; except that comments 
regarding information collection should be submitted by January 29, 
1996, but not later than February 26, 1996. The agency is proposing 
that any final rule that may issue based upon this proposal become 
effective January 1, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857. Written comments regarding paperwork burden 
estimates should be sent to the Office of Information and Regulatory 
Affairs, OMB, New Executive Office Building, rm. 10235, Washington, DC 
20503, ATTN: Desk Officer for FDA.

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

SUPPLEMENTARY INFORMATION:
I. Background
    On November 8, 1990, the President signed into law the Nutrition 
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). This new law amended the Federal Food, Drug, and Cosmetic Act 
(the act) in a number of important ways. One of the notable aspects of 
the 1990 amendments is that they added section 403(q) to the act (21 
U.S.C. 343(q)). This section provided that most foods are misbranded 
unless they bear nutrition labeling.
    In particular, section 403(q)(5)(F) of the act (originally section 
403(q)(5)(E)) provided that if a food to which section 411 of the act 
(21 U.S.C. 350) applies (i.e., a dietary supplement of vitamins or 
minerals) contained any of the nutrients required to be listed in 
nutrition labeling, ``the label or labeling of such food shall comply 
with requirements of subparagraphs (1) and (2) [of section 403(q) of 
the act] in a manner which is appropriate for such food and which is 
specified in regulations of the Secretary.''
    In response to this provision of the 1990 amendments, FDA published 
a proposal on nutrition labeling in the Federal Register of November 
27, 1991 (56 FR 60366 at 60393). The document proposed, among other 
things, specific nutrition labeling requirements for dietary 
supplements of vitamins or minerals (proposed Sec. 101.36) and to 
require that dietary supplements of herbs or other similar nutritional 
substances comply with the general regulation on nutrition labeling 
(Sec. 101.9) (21 CFR 101.9).
    On October 6, 1992, the President signed into law the Dietary 
Supplement Act of 1992 (the DS act) (Pub. L. 102-571). In section 
202(a)(1) (21 U.S.C. 343 note), the DS act established a moratorium 
until December 15, 1993, on the implementation of the 1990 amendments 
with respect to dietary supplements not in the form of conventional 
food. Section 202(a)(2) of the DS act required that the Secretary of 
Health and Human Services (the Secretary), and by delegation FDA, issue 
new proposed regulations applicable to dietary supplements no later 
than June 15, 1993, and final regulations by December 31, 1993.
    In the Federal Register of January 6, 1993 (58 FR 2079), FDA 
published a final rule on the nutrition labeling of food in 
conventional food form (Sec. 101.9). Because of the DS act, however, 
this final rule did not cover the nutrition labeling of dietary 
supplements.
    In the Federal Register of June 18, 1993 (58 FR 33715), FDA 
published a new proposed rule on the nutrition labeling of dietary 
supplements, as required by the DS act. FDA received over 400 responses 
to that proposed rule. In the Federal Register of January 4, 1994 (59 
FR 354), FDA published a final rule (hereinafter referred to as ``the 
1994 dietary supplement final rule'') based on the June 1993 proposed 
rule. Consistent with section 403(q)(5)(F) of the act, the 1994 dietary 
supplement final rule included separate nutrition labeling requirements 
for dietary supplements of vitamins or minerals, which are set out in 
Sec. 101.36, and for dietary supplements of herbs and other nutritional 
substances, which the agency said were subject to Sec. 101.9.
    In the Federal Register of January 4, 1994 (59 FR 427), the agency 
proposed to expand the list of nutrients for which there are Reference 
Daily Intake (RDI) values in Sec. 101.9(c)(8)(iv) to include vitamin K, 
selenium, chloride, manganese, fluoride, chromium, and molybdenum. The 
final rule based on that proposed rule is published elsewhere in this 
issue of the Federal Register.
    On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into 
law. The DSHEA, among other things, amended the act by adding section 
201(ff) (21 U.S.C. 321(ff)), which defines a ``dietary supplement,'' in 
part, as a product, other than tobacco, intended to supplement the diet 
that contains at least one or more of the following ingredients: A 
vitamin; a mineral; an herb or other botanical; an amino acid; a 
dietary substance for use to supplement the diet by increasing the 
total dietary intake; or a concentrate, metabolite, constituent, 
extract, or 

[[Page 67195]]

combination of any of the previously mentioned ingredients (section 
201(ff)(1) of the act). These ingredients are referred to in the 
provisions added to the act by the DSHEA, and in this document, as 
``dietary ingredients.''
    Additionally, the DSHEA amended section 403(q)(5)(F) of the act. 
While this section continues to provide that dietary supplement 
products shall comply with section 403 (q)(1) and (q)(2) of the act and 
provide nutrition labeling, it has been changed in a number of 
significant ways. First, it no longer distinguishes between supplements 
of vitamins and minerals and other dietary supplements. Second, it now 
contains specific provisions on: (1) The order in which dietary 
ingredients are to be listed in the nutrition information, (2) the 
listing of the quantity of each dietary ingredient, (3) the optional 
listing of the source of a dietary ingredient within the nutrition 
label, and (4) the listing of the other ingredients of the dietary 
supplement.
    Given these changes in the law that requires that dietary 
supplements be nutrition labeled, changes in the regulations that FDA 
adopted to implement the 1990 amendments for dietary supplements are 
also necessary. In this document, the agency is proposing changes in 
its regulations that are necessary to reflect the changes that were 
enacted as part of the DSHEA. FDA's regulations were scheduled to go 
into effect on July 1, 1995. Given the need for these revisions, 
however, the agency has published notice of its intention not to 
enforce the regulations until after it has conformed its labeling 
regulations to the DSHEA, and industry has had an opportunity to 
relabel their products; that is, until after December 31, 1996 (60 FR 
7711, February 9, 1995).
    In this preamble, the agency will explain the proposed revisions to 
Sec. 101.36 (21 CFR 101.36) and state which provisions of that 
regulation it is not proposing to change. The latter provisions will be 
discussed only to the extent necessary to understand how the revised 
provisions fit in the overall scheme on the nutrition labeling of 
dietary supplements. The agency seeks comments on the proposed changes 
to implement the DSHEA with respect to nutrition labeling. Although the 
codified section will be reproduced in its entirety, the agency urges 
those who comment to focus on the provisions in which changes are being 
proposed. Cooperation in this respect will hasten the publication of 
the final rule and thus maximize the time that industry will have to 
plan changes in its labeling.

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

    The DSHEA definition of ``dietary supplement'' provides, in part 
(section 201(ff)(2)(C) of the act), that such a product must be labeled 
as a dietary supplement. In addition, the DSHEA amended section 403 of 
the act by adding a new paragraph (s)(2)(B), which states that a food 
shall be deemed to be misbranded if it is a dietary supplement, and the 
label or labeling of the dietary supplement fails to identify the 
product by using the term ``dietary supplement,'' which term may be 
modified with the name of such an ingredient.
    Thus, the label of a dietary supplement clearly must bear the term 
``dietary supplement.'' However, no provision of the DSHEA explicitly 
addresses where on the food label identification with this term must 
appear. The Statement of Agreement on the bill that ultimately became 
the DSHEA states clearly that there is no legislative history for the 
DSHEA other than that agreement, and the agreement is silent with 
respect to where this term must appear (140 Congressional Record S14801 
(October 7, 1994)).
    It is a general rule of statutory construction that the act must be 
read as a whole. Thus, section 403(s)(2)(B) of the act, which states 
that the term must ``identify the product,'' must be read in 
conjunction with the other provisions of the act that address how food 
products are to be identified. These provisions, which have been in 
effect for many years, are section 403 (g)(2) and (i)(1) of the act. 
Section 403(g)(2) of the act, which pertains to a food for which a 
definition and standard of identity have been prescribed by regulation, 
provides that the food label must bear the name of the food specified 
in the definition and standard. Section 403(i)(1) of the act, which 
pertains to all other foods, provides that the food label must bear the 
common or usual name of the food, if any exists. Dietary supplements 
are labeled subject to the provisions of section 403(i)(1) of the act.
    FDA has implemented section 403(g)(2) and (i)(1) of the act by 
adopting Sec. 101.3 (21 CFR 101.3) on the identity of food in packaged 
form. This regulation states that the principal display panel of a food 
shall bear as one of its principal features a statement of the identity 
of the commodity (Sec. 101.3(a)). The regulation goes on in 
Sec. 101.3(b) to state that the statement of identity shall be in terms 
of: (1) The name specified in or required by any applicable Federal law 
or regulation; or, in the absence thereof, (2) the common or usual name 
of the food; or, in the absence thereof, (3) an appropriately 
descriptive term, or when the nature of the food is obvious, a fanciful 
name commonly used by the public for such food.
    When the requirement of section 403(s)(2)(B) of the act that the 
food be identified as a ``dietary supplement'' is read in conjunction 
with section 403(i)(1), which requires that the label of the food bear 
its common or usual name, that is, a statement that identifies the food 
(see Sec. 102.5(a) (21 CFR 102.5(a))), it is clear that the term 
``dietary supplement'' needs to appear as part of the common or usual 
name of any food that is to be marketed subject to the definition in 
section 201(ff) of the act. While under section 403(s)(2)(B) of this 
act this term may be modified with the name of a dietary ingredient, 
FDA tentatively concludes that the term ``dietary supplement'' must 
appear in the statement of identity of such products. To reflect this 
tentative conclusion, FDA is proposing to require in Sec. 101.3(g) that 
when a food is marketed as a dietary supplement, its label shall bear 
the term ``dietary supplement'' as part of its statement of identity.
    This proposed requirement is further supported by Sec. 102.5 of 
FDA's regulations. This regulation sets out general principles for 
arriving at the common or usual name of a nonstandardized product, that 
is, a product that is not subject to a definition adopted under section 
401 of the act (21 U.S.C. 341). Section 102.5(a) states in part:

    The common or usual name of a food, which may be a coined term, 
shall accurately identify or describe, in as simple and direct terms 
as possible, the basic nature of the food or its characterizing 
properties or ingredients. The name shall be uniform among all 
identical or similar products and may not be confusingly similar to 
the name of any other food that is not reasonably encompassed within 
the same name. Each class or subclass of food shall be given its own 
common or usual name that states, in clear terms, what it is in a 
way that distinguishes it from different foods.

    Requiring that ``dietary supplement'' be included as part of the 
statement of identity of such foods is consistent with Sec. 102.5 in 
several important respects. First, it will ensure that a term that 
accurately describes the basic nature of the food will appear 
prominently on the label of each dietary supplement. Second, it will 
ensure that there is consistency in the labeling of dietary supplements 
by requiring that they bear a consistent term. The agency stresses that 
the provisions of Sec. 102.5 pertaining to uniformity of common or 
usual 

[[Page 67196]]
names among all identical or similar products could be seriously 
compromised unless the term ``dietary supplement'' is included in the 
common or usual name of such a supplement. As explained below, the 
potential for compromising this requirement would be particularly great 
where dietary supplements are in other than tablet, capsule, powder, 
softgel, gelcap, or liquid form. Finally, use of this term as part of 
the statement of identity of dietary supplements will distinguish this 
potentially broad class of products from other types of food.
    New section 201(ff)(2) of the act provides that a ``dietary 
supplement'' is a product that is not represented for use as a 
conventional food. At the same time, the DSHEA struck the provision 
that excluded products that simulate conventional foods from the 
coverage of section 411 of the act. (See section 3(c)(2) of the DSHEA.) 
As a result of the latter change, however, there may now be dietary 
supplements for which the presence of the term ``dietary supplement'' 
constitutes the primary, if not the only, means by which consumers will 
be able to determine that the food is a dietary supplement. Under such 
circumstances, it seems imperative that the term ``dietary supplement'' 
appear in the statement of identity.
    For the foregoing reasons, FDA is proposing to add Sec. 101.3(g), 
which states that products marketed as dietary supplements shall bear 
the term ``dietary supplement'' as part of their statement of identity, 
to its regulations.

III. Provisions of Proposed Sec. 101.36

A. Foods Covered by Sec. 101.36

    The agency is proposing to revise Sec. 101.36(a) to state that the 
label of a dietary supplement shall bear nutrition labeling in 
accordance with Sec. 101.36, unless an exemption is provided for the 
product in Sec. 101.36(h). Previously, only dietary supplements of 
vitamins and minerals were subject to the provisions of Sec. 101.36. As 
stated above, dietary supplements of herbs and other similar 
nutritional substances were to follow the general nutrition labeling 
requirements in Sec. 101.9. This separation was in accordance with 
section 403(q)(5)(F) of the act as passed in the 1990 amendments, which 
instructed the Secretary to issue nutrition labeling regulations 
appropriate for dietary supplements of vitamins and minerals.
    However, the DSHEA revised 403(q)(5)(F) of the act to provide that 
it covers all dietary supplements, that is, all products that meet the 
definition in section 201(ff) of the act. Consequently, the agency is 
proposing to amend Sec. 101.36(a) to reflect this change.

B. General Requirements

    In Sec. 101.36(b), the agency is proposing to require that 
nutrition information on dietary supplements include the information 
specified in this section of the regulations, and that it be presented 
in the format specified in proposed Sec. 101.36(e). These proposed 
requirements reflect the requirements in section 403(q)(1) of the act 
and in section 2(b)(1)(A) of the 1990 amendments, which states that the 
information required under section 403(q) is to ``be conveyed to the 
public in a manner which enables the public to readily observe and 
comprehend such information and to understand its relative significance 
in the context of the total daily diet.''
    The agency notes that it has been asked whether current 
Sec. 101.36(b) is to be interpreted as requiring nutrition labeling in 
all dietary supplement labeling (i.e., printed material accompanying a 
product) as well as on the label attached to a product. The agency 
advises that it does not intend that nutrition labeling appear on all 
labeling. It generally must appear on the label of dietary supplement 
products, although there may be circumstances in which it appears in 
labeling in lieu of the label. When nutrition labeling is presented, 
however, it must conform to the requirements of Sec. 101.36.

C. Serving Size

    Proposed Sec. 101.36 (b)(1)(i) and (b)(1)(ii) on serving size and 
on servings per container, respectively, differ only slightly from 
current Sec. 101.36 (b)(1) and (b)(2). In the first sentence of 
proposed Sec. 101.36(b)(1)(i), the agency is stating that the 
subheading ``Serving Size'' is to be placed under the heading of 
``Supplement Facts.'' The agency is proposing to include the name of 
the heading (i.e., ``Supplement Facts'') in Sec. 101.36(b)(1)(i) for 
clarity.
    On a related note, the agency points out that it is proposing to 
change the language in Sec. 101.12(b), Table 2, to read ``Dietary 
supplements'' instead of ``Dietary supplements not in conventional food 
form'' in response to the DSHEA. The language in current Sec. 101.12(b) 
reflected the DS act, which, in its legislative history, made clear 
that the moratorium it effected applied only to dietary supplements of 
vitamins, minerals, herbs, or other similar nutritional substances not 
in the form of conventional food. (See 138 Congressional Record S17240 
(Joint Statement Senators Kennedy and Hatch) (October 7, 1992).) The 
DSHEA, however, evidences an intent, for labeling purposes, to treat 
all dietary supplements in a similar manner. In particular, section 7 
of the DSHEA addresses dietary supplement labeling and does not 
distinguish between dietary supplements that are not in conventional 
food form and those that are. Therefore, FDA is proposing to amend 
Sec. 101.12(b), Table 2, to reflect this development.

D. Requirements for Dietary Ingredients Having Recommendations for 
Daily Consumption

    The DSHEA added four subclauses to section 403(q)(5)(F) of the act. 
Subclause (i) states that the Secretary (and, by delegation, FDA) shall 
provide by regulation that the nutrition information on dietary 
supplements first list those dietary ingredients that are present in 
the product in a significant amount and for which a recommendation for 
daily consumption has been established by the Secretary, except that a 
dietary ingredient shall not be required to be listed if it is not 
present in a significant amount, and shall list any other dietary 
ingredient present and identified as having no such recommendation. The 
agency tentatively concludes that by a dietary ingredient ``for which a 
recommendation for daily consumption has been established by the 
Secretary,'' the DSHEA is referring to a nutrient having an RDI as 
established in Sec. 101.9 (c)(7)(iii) and (c)(8)(iv) or a Daily 
Reference Value (DRV) as established in Sec. 101.9 (c)(7)(iii) and 
(c)(9).
    The requirement in section 403(q)(5)(F)(i) of the act that the 
dietary ingredients for which there are no RDI's or DRV's be listed in 
the nutrition label following the listing of dietary ingredients for 
which RDI's or DRV's have been established necessitates changes in the 
organization of Sec. 101.36. The agency is therefore consolidating all 
of the information required in the listing of dietary ingredients for 
which RDI's or DRV's have been established under proposed 
Sec. 101.36(b)(2) and the information required in the listing of other 
dietary ingredients in proposed Sec. 101.36(b)(3). (See section III. E. 
of this document.)
1. Listing of Dietary Ingredients for Which RDI's and DRV's Have Been 
Established
    With respect to the listing of dietary ingredients for which RDI's 
and DRV's have been established, the agency tentatively concludes that 
no major change in the 1994 dietary supplement final rule is needed as 
a result of the DSHEA. The agency is proposing in Sec. 101.36(b)(2)(i) 
that the 14 nutrients 

[[Page 67197]]
that, under Sec. 101.9(c), must be listed in the nutrition labeling of 
a conventional food, when they are present, shall be listed in the 
nutrition label of a dietary supplement when they are present in the 
supplement in amounts greater than that that can be declared as zero 
under Sec. 101.9(c). For clarity, the agency is identifying these 
nutrients by name in this proposed paragraph. This requirement is 
consistent with current Sec. 101.36(b)(3), except that the current 
provision calls for ``a listing of all nutrients required in 
Sec. 101.9(c),'' rather than specifying the name of each nutrient.
    However, current Sec. 101.36(b)(3) is silent on the subcomponents 
(e.g., polyunsaturated fat, soluble fiber, sugar alcohols) specified in 
Sec. 101.9(c) that provide additional information about some of the 
nutrients required to be listed in the nutrition labeling of 
conventional foods. The listing of most subcomponents is voluntary 
under Sec. 101.9(c). Generally, it is required only when claims are 
made. For example, the listing of soluble fiber is voluntary for 
conventional foods, except when a nutrient content claim is made about 
this nutrient. The agency did not require a listing of subcomponents in 
the 1994 dietary supplement final rule because it concluded that such 
labeling was not appropriate for such foods under section 403(q)(5)(F) 
of the act because that section applied only to dietary supplements of 
vitamins and minerals. Therefore, a fiber supplement, for example, did 
not come under the scope of supplement labeling.
    Now, however, all dietary supplements, including products such as 
fiber supplements, are to be covered by the same nutrition labeling 
regulation (i.e., Sec. 101.36). Therefore, the agency has tentatively 
concluded that it is appropriate to provide for the listing of the 
subcomponents specified in Sec. 101.9(c). Accordingly, the agency is 
providing in proposed Sec. 101.36(b)(2)(i) that calories from saturated 
fat and amounts of polyunsaturated fat, monounsaturated fat, soluble 
fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be 
declared in the nutrition label of dietary supplements and is proposing 
to require that they be declared when a claim is made about them.
    There are other subcomponents of the nutrients that are required 
under Sec. 101.9(c) to be listed in nutrition labeling that are not 
mentioned in that regulation (e.g., amino acids (subcomponents of 
protein), omega-3 fatty acids (subcomponents of fat)), and that may not 
be included in the nutrition label on conventional foods (see 
Sec. 101.9(c)). However, because these subcomponents may be classified 
as dietary ingredients under section 201(ff)(1) of the act, 
manufacturers of dietary supplements may list them in the nutrition 
label under Sec. 101.36. The difference in treatment of these 
subcomponents when they are present in dietary supplements as compared 
to when they are present in conventional foods creates the possibility 
of consumer confusion. To minimize this possibility, FDA is trying to 
retain as much consistency as possible between the nutrition labeling 
of conventional foods under Sec. 101.9 and dietary supplements under 
Sec. 101.36 (section 2(b)(1)(A) of the 1990 amendments). Thus, the 
agency is proposing that subcomponents that are not specified in 
Sec. 101.9(c), e.g., individual amino acids, be listed under proposed 
Sec. 101.36(b)(3) as dietary ingredients for which RDI's and DRV's have 
not been established.<SUP>1

    \1\ To save space and to help the reader differentiate between 
these two types of dietary ingredients, the agency will refer to the 
dietary ingredients listed in proposed Sec. 101.36(b)(2) as 
``(b)(2)-dietary ingredients'' and to all other dietary ingredients 
as ``other dietary ingredients.''
---------------------------------------------------------------------------

    Among the 14 nutrients required to be listed in nutrition labeling 
of conventional foods are sodium, vitamin A, vitamin C, calcium, and 
iron. The other vitamins and minerals for which RDI's have been 
established in Sec. 101.9(c)(8)(iv) are not required to be listed in 
the nutrition label of conventional foods except when they are added 
for the purpose of supplementation, or when a claim is made about them. 
(See Sec. 101.9(c)(8)(ii).) The agency did not include this distinction 
among vitamins and minerals in the 1994 dietary supplement final rule 
because that rule pertained exclusively to supplements of vitamins and 
minerals. Because dietary supplements of vitamins and minerals are 
usually fabricated and, with few exceptions, contain only vitamins and 
minerals that are added for purposes of supplementation, the agency 
requires in current Sec. 101.36(b)(3) that vitamins and minerals be 
listed whenever they are present in significant amounts.
    Although the act, as amended by the DSHEA, requires that all 
dietary ingredients and their amounts be listed, the agency tentatively 
finds that requiring the listing of all vitamins and minerals with 
RDI's or DRV's that are present in herbal products, for example, would 
be unduly burdensome and in conflict with section 403(q)(1)(E) of the 
act, which requires the listing of vitamins and minerals only if the 
Secretary (and, by delegation, FDA) determines that such information 
will assist consumers in maintaining healthy dietary practices. In 
implementing the 1990 amendments, the agency made such a finding only 
for sodium, vitamin A, vitamin C, calcium, and iron (58 FR 2079 at 
2106). Requiring all dietary ingredients in herbal products to be 
listed would necessitate extensive nutritional analyses of the vitamin 
and mineral content of all such products. While manufacturers are free 
to do so, FDA tentatively finds that it is unnecessary and 
inappropriate to require that such analyses be done. Thus, FDA 
tentatively concludes that, because the act must be read as a whole, 
and because section 403(q)(5)(F)(i) of the act must be read in 
conjunction with section 403(q)(1)(E) (in fact, it explicitly 
references that section), it is appropriate for the agency to follow 
the approach that it used in Sec. 101.9 for conventional foods and to 
require the listings of vitamins and minerals (including potassium) 
other than sodium, vitamin A, vitamin C, calcium, and iron in the 
nutrition label of dietary supplements only when such other vitamins 
and minerals are added to the product for purposes of supplementation, 
or when a claim is made about them. Comments are requested on this 
tentative conclusion.
    The agency observes that it did not clearly express in the 1994 
dietary supplement final rule the amounts of vitamins and minerals that 
are not to be declared on the labels of dietary supplements because 
they are so small. Current Sec. 101.36(b)(3) requires a listing of 
``nutrients required in Sec. 101.9(c) that are present in the dietary 
supplement in quantitative amounts by weight that exceed the amount 
that can be declared as zero in Sec. 101.9(c),'' while 
Sec. 101.9(c)(8)(iii) states that amounts of vitamins and minerals 
present at less than 2 percent of the RDI are not required to be 
declared in nutrition labeling but may be declared by a zero. For 
clarity on what amounts do not have to be declared, the agency is 
proposing to include a statement in Sec. 101.36(b)(2)(i) that amounts 
of vitamins and minerals corresponding to less than 2 percent of the 
RDI shall not be declared. The agency points out that this statement 
does not represent a change from the 1994 dietary supplement final rule 
but is merely a clarification of its provisions.
    The agency notes that current Sec. 101.36(b)(3) specifies that 
vitamin K, chloride, chromium, fluoride, manganese, molybdenum, and 
selenium shall be listed, when present. Because the agency has 
established RDI's for these nutrients (except for fluoride) (see the 
final rule on RDI's published 

[[Page 67198]]
elsewhere in this issue of the Federal Register), their listing is 
covered by the reference to all other vitamins or minerals listed in 
Sec. 101.9(c)(8)(iv) in proposed Sec. 101.36(b)(2). Accordingly, 
special mention of vitamin K, chloride, chromium, manganese, 
molybdenum, and selenium is no longer needed. Because FDA has not 
established an RDI for fluoride, if it is declared in nutrition 
labeling, under the proposed rule, it will have to be listed with the 
other dietary ingredients, as provided for in proposed 
Sec. 101.36(b)(3).
    FDA is also providing in proposed Sec. 101.36(b)(2)(i) that protein 
not be declared in the nutrition label of dietary supplements that, 
other than ingredients added solely for technological reasons, contain 
only individual amino acids. While Sec. 101.9(c)(7) allows protein 
content to be calculated as 6.25 times the nitrogen content of the 
food, the agency tentatively finds that it is misleading to declare the 
protein content in the nutrition label of a dietary supplement that 
contains free (individual) amino acids because protein, by definition, 
is composed of chains of amino acids connected together by peptide 
bonds. Such linkages are not found in products composed of free amino 
acids (Ref. 1, pp. 57 and 58).
    The agency is proposing to require in Sec. 101.36(b)(2)(i)(A) use 
of the heading ``Amount Per Serving,'' except that the agency is 
proposing to allow other appropriate headings when the serving size of 
the product is one unit. This aspect of the proposal is unchanged from 
what appeared in the 1994 dietary supplement final rule. The agency 
tentatively concludes that the proposed requirement is consistent with 
section 403(q)(1)(A) of the act, which provides that nutrition 
information is to be expressed on a ``per serving'' basis.
    The agency notes that because it is proposing that quantitative 
amounts be presented in a separate column, rather than immediately 
following the listing of names as provided in the 1994 dietary 
supplement final rule, the agency is proposing that the heading may 
appear over the column of amounts rather than the column of names. The 
agency is proposing to provide flexibility in the placement of this 
heading because space constraints may make placement over the column of 
amounts impractical in some cases. Comments are requested on the 
placement of this heading.
    The agency points out that, under current Sec. 101.36(b)(3), the 
heading ``Amount Per Serving'' must be separated from the other 
information on the nutrition label by a bar above and beneath it. While 
the agency is proposing to carry forward this requirement, it is doing 
so in proposed Sec. 101.36(e) on format. FDA will discuss this proposed 
requirement in more detail as part of its description of that 
paragraph.
    The agency is proposing in Sec. 101.36(b)(2)(i)(B) that (b)(2)-
dietary ingredients be listed in a column on the left side of the 
nutrition label in the order and manner of indentation that is 
specified in that paragraph. No change in the order from current 
Sec. 101.36(b)(3)(ii) is required as a result of the DSHEA, and FDA is 
not proposing to make any change.
    The agency is addressing issues related to the column of names of 
(b)(2)-dietary ingredients in three paragraphs under proposed 
Sec. 101.36(b)(2)(i)(B). Proposed Sec. 101.36(b)(2)(i)(B)(1) specifies 
how calorie information is to be presented. The agency is proposing 
that, instead of listing calories above the column of names, they be 
listed first in the column of names, under a bar that separates the 
list from the heading ``Amount Per Serving.'' The agency tentatively 
concludes that giving calories prominence over other nutrients is not 
appropriate for supplements, which usually do not contain many 
calories. In addition, this change will save space. Proposed 
Sec. 101.36(b)(2)(i)(B)(1) also requires that when ``Calories from 
fat'' or ``Calories from saturated fat'' are declared, they are to be 
indented beneath ``Calories'' in a manner similar to the indentation 
specified in Sec. 101.9(d)(5).
    Proposed Sec. 101.36(b)(2)(i)(B)(2) specifies the synonyms that may 
be added in parentheses following the names of the (b)(2)-dietary 
ingredients. This paragraph is identical to the current regulation on 
synonyms in dietary supplement labeling (current Sec. 101.36(b)(3)(v)), 
except that the agency is proposing to permit the use of ``folic acid'' 
as a synonym for folate. FDA recognizes that current regulations for 
nutrition labeling in Secs. 101.9 and 101.36 do not include the term 
``folic acid'' as an allowable synonym for folate. This omission was an 
oversight when FDA amended Sec. 101.9 (58 FR 2079 at 2178) and issued 
Sec. 101.36 (59 FR 373). Before the agency took these actions, 
Sec. 101.9 had listed ``folic acid'' as the preferred term, with 
``folacin'' as an allowable parenthetical synonym. When amendments to 
Sec. 101.9 were initially proposed (55 FR 29847, July 19, 1990), the 
agency explained why the term ``folate'' was preferred to ``folacin.'' 
However, an explanation for the transition from ``folic acid'' to 
``folate'' was inadvertently omitted, as was inclusion of the term 
``folic acid'' as a synonym.
    In light of common usage and FDA policy, and for consistency among 
the nutrition labeling and health claim regulations, the agency is 
proposing to correct Sec. 101.36(b)(3)(v) to include ``folic acid'' as 
an allowable synonym for folate. The agency advises that it intends to 
revise Sec. 101.9(c)(8)(v) to allow the listing of folic acid as a 
synonym for folate on conventional foods as well.
    In proposed Sec. 101.36(b)(2)(i)(B)(3), the agency provides that 
the percent of vitamin A that is present as beta-carotene may be 
declared immediately adjacent to or beneath the listing of vitamin A. 
This proposed provision essentially carries forward current 
Sec. 101.36(b)(3)(iv). The agency tentatively finds that no change is 
needed in this provision as a result of the DSHEA, except that the 
agency is deleting the amount of vitamin A from the example given in 
this provision because, under this proposal, information on the 
quantity of each dietary ingredient will no longer appear immediately 
following the name but instead in a separate column.
2. Quantity of Each (b)(2)-Dietary Ingredient
    The DSHEA added section 403(q)(5)(F)(ii) to the act. This section 
states that the listing of dietary ingredients shall include the 
quantity of each such ingredient (described in section 
413(q)(5)(F)(i)), per serving, except that only the total quantity is 
required for proprietary blends, as discussed elsewhere in this 
preamble. Consistent with this section, the agency is proposing to 
require in Sec. 101.36(b)(2)(ii) that the number of calories, if 
declared, and the quantitative amounts by weight of the (b)(2)-dietary 
ingredients be listed in a column to the right of the column of names. 
As previously discussed, this proposal differs from the 1994 dietary 
supplement final rule in that this information is to be listed in a 
separate column instead of immediately following the name of any 
dietary ingredient listed. The agency is proposing this change to allow 
space for information on the source of the dietary ingredient to be 
included immediately following the name, as discussed elsewhere in this 
document. The agency considered continuing to have the weight of the 
dietary ingredient placed immediately after the name of the dietary 
ingredient or its source but tentatively concluded that the wide 
variation in placement that could result when some dietary ingredients 
are listed 

[[Page 67199]]
by name only, while others include the source ingredient, would make it 
difficult for some consumers to find the declaration of weight. 
Comments on this tentative conclusion, and on its possible impact on 
space requirements for the nutrition label, are requested.
    The agency emphasizes that, consistent with the 1994 dietary 
supplement final rule (59 FR 354 at 360) and the DSHEA, the 
quantitative amount by weight declared for any dietary ingredient is to 
be the weight of the dietary ingredient rather than the weight of the 
source of the dietary ingredient.<SUP>2 The agency points out that new 
section 403(s)(2)(A) of the act states that a dietary supplement is 
misbranded if its label or labeling fails to list, among other things, 
the ``name of each ingredient of the supplement that is described in 
section 201(ff)'' and the quantity of each such ingredient. The use of 
the word ``ingredient'' in section 403(s)(2)(A) of the act, instead of 
``dietary ingredient,'' creates some ambiguity. However, the agency 
tentatively concludes that in this section the phrase ``that is 
described in section 201(ff)'' modifies the word ``ingredient'' rather 
than ``supplement.'' Thus, this provision is referring to a listing of 
the names and amounts of dietary ingredients. Accordingly, using the 
example of calcium carbonate, the weight of calcium would be declared, 
rather than the weight of calcium carbonate, the source of the dietary 
ingredient.

    \2\ It is important to distinguish between the terms 
``ingredient'' and ``dietary ingredient.'' The DSHEA uses the term 
``dietary ingredient'' to refer to the primary substances to be 
listed in nutrition labeling, as opposed to ``ingredients'' that are 
the compounds used in the manufacture of the product. For instance, 
when calcium carbonate is an ingredient used to provide calcium in 
the manufacture of a dietary supplement, calcium is the ``dietary 
ingredient,'' and calcium carbonate is the ``ingredient,'' or, as 
specified in new section 403(q)(5)(F)(iii) of the act, the ``source 
of'' the dietary ingredient. Similarly, omega-3 fatty acids are 
``dietary ingredients,'' while their source, fish liver oil, is the 
``ingredient.'' (See section III., G. of this document for a further 
discussion.)
---------------------------------------------------------------------------

    Section 403(s)(2)(A)(ii) of the act is also unclear on what basis 
the quantitative information should be reported (e.g., per dosage 
unit). The agency tentatively concludes that it is appropriate to 
require that this quantitative information be provided on a ``per 
serving'' basis because interpreting this provision in this way will 
mean that there need only be one list of the quantitative amounts of 
dietary ingredients in a supplement. Section 403(q)(5)(F) of the act 
also requires a list of dietary ingredients, but it specifies that the 
listing be on a ``per serving'' basis. If FDA were to interpret section 
403(s)(2)(A)(ii) of the act differently, for example, to require 
information on a per dosage unit basis, it would mean that for dietary 
supplements whose serving size is two capsules, there would have to be 
two lists of dietary ingredient amounts on the label, one per capsule, 
the other per serving (two capsules). The agency tentatively concludes 
that such an interpretation would result in overcrowded labels with 
essentially redundant information. The agency recognizes, however, that 
the interpretation that it is proposing renders section 403(s)(2)(A) of 
the act somewhat redundant to section 403(q)(5)(F), and that the rules 
of statutory construction generally do not favor such a reading. 
Therefore, FDA specifically requests comments on the proposed 
interpretation.
    In proposed Sec. 101.36(b)(2)(ii)(A), the agency states that the 
declaration of quantitative amounts by weight shall be expressed using 
the increments specified in Sec. 101.9(c)(1) through (c)(7), which 
includes increments for sodium and potassium. This proposed provision 
is carried forward from current Sec. 101.36(b)(3)(i). As explained in 
the proposal of June 18, 1993 (58 FR 33715 at 33719), the agency was 
not aware of any reason for treating dietary supplements of vitamins 
and minerals any differently in this regard than conventional food. The 
agency is still unaware of any reason to modify this approach.
    In proposed Sec. 101.36(b)(2)(ii)(B), the agency states that the 
amounts of vitamins and minerals, excluding sodium and potassium, shall 
be the actual amounts present, using the units of measurement given in 
Sec. 101.9(c)(8)(iv). The agency points out that in a final rule 
published elsewhere in this issue of the Federal Register entitled 
``Food Labeling; Reference Daily Intakes,'' it is amending Sec. 101.9 
to change the units for biotin and folate to micrograms (mcg) and for 
calcium and phosphorus to milligrams (mg). The proposed specifications 
pertaining to the manner in which quantitative amounts by weight are to 
be declared simply carry forward those found in current 
Sec. 101.36(b)(3)(i).
3. Declaration of Percent Daily Value for Each (b)(2)-Dietary 
Ingredient
    In proposed Sec. 101.36(b)(2)(iii), the agency is requiring that a 
percent Daily Value, where appropriate, be listed for the dietary 
ingredients declared under Sec. 101.36(b)(2)(i), except that: (1) The 
percent for protein may be omitted as provided in Sec. 101.9(c)(7) 
because the methods for analyzing protein are costly, and protein 
deficiency is not a public health concern in the United States; (2) no 
percent shall be given for the subcomponents for which DRV's have not 
been established (e.g., sugars) because it is not possible to calculate 
percent Daily Values when there are no DRV's; and (3) for the labels of 
dietary supplements that are represented or purported to be for use by 
infants, children less than 4 years of age, or pregnant or lactating 
women, no percent shall be given for total fat, saturated fat, 
cholesterol, total carbohydrate, dietary fiber, sodium, potassium, 
vitamin K, chloride, chromium, manganese, molybdenum, or selenium 
because RDI's or DRV's have not been established for these groups.
    The agency points out that the exception for protein is carried 
forward from current Sec. 101.36. The listing of no percent Daily Value 
for subcomponents is new in this proposal, but it is consistent with 
current Sec. 101.36(b)(4) which states that ``no percent shall be given 
for sugars.'' As discussed previously, the agency did not address the 
listing of other subcomponents specified in Sec. 101.9(c) because 
Sec. 101.36 had applied only to dietary supplements of vitamins and 
minerals. Thus, the exception for these subcomponents was not needed 
because they were not declared.
    The exception for total fat, saturated fat, cholesterol, total 
carbohydrate, dietary fiber, sodium, and potassium on the labels of 
dietary supplements for use by infants, children less than 4 years of 
age, or pregnant or lactating women is new in this proposal and was 
omitted inadvertently in current Sec. 101.36. Because DRV's are not 
established for these groups, percents of Daily Values cannot be 
calculated. Hence, the exception is needed.
    Finally, the exception for vitamin K, chloride, chromium, 
manganese, molybdenum, and selenium for the population subgroups 
specified above is carried forward from current Sec. 101.36. The agency 
points out that, in current Sec. 101.36(b)(4), this exception had 
covered products intended for adults and children 4 or more years of 
age. Because the agency is adopting RDI's for these nutrients for 
adults and children 4 or more years of age in the final rule on RDI's 
published elsewhere in this issue of the Federal Register, this 
exception is no longer needed for products for that group.
    The agency acknowledges that there are no RDI values codified for 
infants, children less than 4 years of age, or pregnant or lactating 
women for any of the vitamins and minerals. However, as explained in 
the 1994 dietary 

[[Page 67200]]
supplement final rule (58 FR 33721), FDA had intended to codify RDI 
values for these groups but did not in accordance with section 203 of 
the DS act, which provided that the agency could not adopt recommended 
daily values different from the values set forth in the agency 
regulation then in effect (Sec. 101.9(c)(7)(1992)) before November 8, 
1993. To provide guidance to manufacturers in lieu of codifying values, 
the agency published label reference values for these groups in the 
preamble of the final rule on RDI's and DRV's on January 6, 1993 (58 FR 
2206 at 2213). The agency encourages manufacturers to use these values 
for the labels of products intended for use by these groups. FDA 
intends to propose to codify RDI values for these groups in the near 
future for both the nutrients listed on the bottom of page 2213 of the 
final rule on RDI's and DRV's (58 FR 2206 at 2213) and the nutrients 
for which FDA is establishing RDI's for adults and children 4 or more 
years of age in the final rule published elsewhere in this issue of the 
Federal Register.
    In proposed Sec. 101.36(b)(2)(iii)(A), the agency is requiring 
that, when information on the percent of Daily Values is listed, the 
percentages be presented in a column on the right side of the nutrition 
label under the heading ``% Daily Value.'' This requirement is not 
different from what appears in current Sec. 101.36(b)(4), except that 
the heading need not appear on a line lower than the heading ``Amount 
Per Serving.'' Current Sec. 101.36(b)(4) provides for ``% Daily Value'' 
to appear below ``Amount Per Serving'' when calorie information is 
presented. Under this proposal, calorie information will go in the 
column of dietary ingredients. Therefore, FDA is proposing that 
``Amount Per Serving'' and ``% Daily Value'' appear on the same line.
    In proposed Sec. 101.36(b)(2)(iii)(B), the agency set forth how the 
percent Daily Value is to be calculated. Although the agency is making 
no change in this calculation, it is rewording current 
Sec. 101.36(b)(4)(i) to clarify that the actual amount is to be used in 
the calculation for vitamins and minerals (except for sodium and 
potassium), and that either the actual amount or the rounded amount may 
be used for other nutrients, e.g., fat. Under the proposed regulation, 
sodium and potassium are treated in the same manner as the other 
nutrients for which DRV's are established because Sec. 101.9(c) 
provides for the declaration of their weight in rounded increments.
    The agency is also rewording current Sec. 101.36(b)(4)(ii), which 
it is carrying forward as proposed Sec. 101.36(b)(2)(iii)(C), to make 
clear when ``Less than 1%'' (or ``<1%'') is to be used. Under proposed 
Sec. 101.36(b)(2)(iii)(C), it is to be used to describe the percent 
Daily Value of a dietary ingredient when the dietary ingredient is 
present in an amount by weight that requires declaration (i.e., exceeds 
the amount that can be declared as zero), yet the amount is so small 
that the percent Daily Value when rounded to the nearest percent comes 
to ``0%.'' In place of ``0%,'' which might be confusing to consumers 
when a quantitative amount by weight is listed, ``Less than 1%'' is to 
be listed as the percent Daily Value for these substances. For example, 
for 1 gram (g) of total carbohydrate, the manufacturer could list 
``Less than 1%'' as the percent of Daily Value.
    As previously discussed, vitamins and minerals at less than 2 
percent of the RDI shall not be declared, except that sodium and 
potassium can be listed at values less than 2 percent, consistent with 
Sec. 101.9(c)(4) and (c)(5), respectively. Thus, proposed 
Sec. 101.36(b)(2)(iii)(C), if adopted, will not apply to vitamins and 
minerals other than to sodium and potassium.
    The agency is proposing that ``<1%'' may be used in place of ``Less 
than 1%'' to provide more flexibility when space is limited on the 
label. FDA did not provide for use of the symbol ``<'' for ``less 
than'' in regulations implementing the 1990 amendments because of 
concerns that a large number of persons would not understand its 
meaning. The agency has received numerous requests, however, to permit 
use of the symbol and is aware that it is being used on some nutrition 
labels with tight space constraints. FDA requests comments on the 
advisability of allowing use of the symbol ``<'' and the submission of 
any available data that would demonstrate consumers' comprehension of 
it. If the agency allows the symbol on nutrition labels of dietary 
supplements, it intends to provide for such use on conventional foods 
as well.
    The agency points out that proposed Sec. 101.36(b)(2)(iii)(D) 
through (F) parallel provisions in the current regulations. Proposed 
Sec. 101.36(b)(2)(iii)(D) carries forward the requirement in current 
Sec. 101.36(b)(4)(v) that the footnote ``Percent Daily Values are based 
on a 2,000 calorie diet'' be present when the percent of Daily Value is 
declared for total fat, saturated fat, total carbohydrate, dietary 
fiber, or protein. The agency is proposing to require that the symbol 
that refers to the footnote, when needed, immediately follow the value 
listed. For clarity, the agency is proposing to add to this provision 
that the footnote is to go below the last heavy bar required under 
proposed Sec. 101.36(e)(6) and inside the box.
    Consistent with current Sec. 101.36(b)(4)(iii), in proposed 
Sec. 101.36(b)(2)(iii)(E), the agency provides that the percent of 
Daily Value shall be based upon values for adults and children 4 or 
more years of age, unless the product is represented for one of the 
subgroups specified, in which case the column heading shall clearly 
state the intended subgroup. 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 the sample label in 
Sec. 101.36(e)(10)(ii).
    Finally, proposed Sec. 101.36(b)(2)(iii)(F), consistent with 
current Sec. 101.36(b)(4)(vi), requires the use of the footnote ``Daily 
Value not established'' for dietary ingredients that have no RDI's or 
DRV's and, therefore, for which a percent Daily Value cannot be 
calculated. Under this proposed rule, this footnote will apply to most 
subcomponents and, on labels of dietary supplements that are intended 
for use by infants, children less than 4 years of age, and pregnant and 
lactating women, to total fat, saturated fat, cholesterol, total 
carbohydrate, dietary fiber, sodium, potassium, vitamin K, chloride, 
chromium, manganese, molybdenum, or selenium. As previously explained, 
a final rule published elsewhere in this issue of the Federal Register 
establishes RDI values for vitamin K, chloride, chromium, manganese, 
molybdenum and selenium for adults and children 4 or more years of age, 
and, thus, percent Daily Values can now be calculated for those 
nutrients for that group. Therefore, the proposed footnote will have a 
more narrow application than under current Sec. 101.36(b)(4)(vi). The 
agency points out that when both the footnotes ``Daily Value not 
established'' and ``Percent Daily Values are based on a 2,000 calorie 
diet'' are required, different symbols must be used to refer to each 
footnote so that consumers will not be confused.
    Proposed Sec. 101.36(b)(2)(iii)(G) is new and specifies that when 
calories, calories from fat, or calories from saturated fat are 
declared, the space under the ``% Daily Value'' column must be left 
blank for these items. This provision is necessary as a result of 
proposed Sec. 101.36(b)(2)(i)(B)(1) that includes calories in the list 
of (b)(2)-dietary ingredients that are placed beneath the line in which 
the column headings, ``Amount Per Serving'' and ``% Daily Value,'' are 
specified. In nutrition labels of foods labeled in accordance with 
Sec. 101.9, calories are 

[[Page 67201]]
listed above the heading ``% Daily Value.''
    In addition, proposed paragraph Sec. 101.36(b)(2)(iii)(G) provides 
that the column ``% Daily Value'' may be omitted when there are no 
numerical values declared beneath it. For example, this situation will 
occur when only calories and protein are listed (a percent Daily Value 
cannot be calculated for calories in the absence of an RDI or DRV, and 
this declaration is optional for protein except as noted in 
Sec. 101.9(c)(7)(i)), or when only calories or dietary ingredients 
subject to proposed Sec. 101.36(b)(2)(iii)(F) are listed. Where the 
latter situation occurs, and the footnote ``Daily Value not 
established'' is required, the symbol (e.g., asterisk) must immediately 
follow the quantitative amount by weight for each dietary ingredient 
listed under ``Amount Per Serving.''

E. Requirements for Other Dietary Ingredients

    The agency is proposing in Sec. 101.36(b)(3) to prescribe how 
dietary ingredients that do not have RDI's or DRV's, and that are not 
subject to regulation under Sec. 101.36(b)(2), are to be declared in 
the nutrition label when present in a dietary supplement. The agency is 
proposing this provision, which did not appear in the 1994 dietary 
supplement final rule, in response to section 403(q)(5)(F)(i) of the 
act, which was added by the DSHEA. As stated above, this provision 
states that the nutrition information on a dietary supplement shall 
first list those dietary ingredients for which RDI's or DRV's have been 
established and then list ``any other dietary ingredient present and 
identified as having no such recommendation'' (i.e., no RDI or DRV). As 
discussed earlier, to avoid confusion, the agency is proposing to refer 
to the latter group of dietary ingredients as ``other dietary 
ingredients.'' FDA is also proposing in Sec. 101.36(b)(3) to set out 
how the quantitative amounts of these dietary ingredients are to be 
presented.
1. Names of Other Dietary Ingredients
    The agency is proposing in Sec. 101.36(b)(3)(i) that other dietary 
ingredients are to be listed in the nutrition label by their common or 
usual name in a column that is underneath the column of names of 
(b)(2)-dietary ingredients and the heavy bar described in proposed 
Sec. 101.36(e)(6). The agency tentatively concludes that it is 
appropriate to list these names in a column because it is consistent 
with the format proposed for the listing of names of (b)(2)-dietary 
ingredients. Consistency makes the label more comprehensible to 
consumers. To enable consumers to distinguish between these two columns 
of dietary ingredients, the agency is proposing that they be separated 
by a heavy bar (see section H of this preamble on format 
specifications).
    The agency considered specifying that the other dietary ingredients 
be listed in a particular order, such as alphabetical order or 
descending order of predominance by weight, to provide for a consistent 
theme in their presentation to assist consumers. Alphabetical order 
would have the advantage of being user friendly but would not be 
scientifically meaningful. Descending order of predominance by weight 
would be consistent with Sec. 101.4 which specifies the order used in 
the ingredient statement on conventional foods. Because conventional 
foods are not required to declare the amounts of ingredients, this 
manner of listing gives consumers an indication of the relative amount 
of ingredients present. However, imposing this requirement on dietary 
supplements may be unnecessary because the amounts of the dietary 
ingredients (although not necessarily the ingredient sources of the 
dietary ingredients) are required to be listed in the nutrition label 
under section 403(q)(5)(F)(ii) of the act. Furthermore, such a listing 
would not necessarily reflect the relative biological activity of the 
dietary ingredients. Consequently, the agency has tentatively concluded 
that specifying a particular order is not justified. The agency 
requests comments on this issue.
    The agency is proposing in Sec. 101.36(b)(3)(i) that other dietary 
ingredients be listed by their common or usual name. This requirement 
is consistent with Sec. 101.4 which requires that the ingredients of 
conventional foods be listed by common or usual name. To the extent 
that another dietary ingredient is covered by an official compendium, 
FDA would expect that the dietary ingredient's common or usual name to 
be drawn from that source (see section 403(s)(2)(D) of the act).
    With regard to herbs and other botanicals, the agency encourages 
manufacturers to use common or usual names that are found in botanical 
data bases and that are widely used. Many of these names are part of 
our everyday language and are easily recognized by consumers. However, 
the agency realizes that arriving at an appropriate name for botanicals 
may be a problem because some plants have more than one common or usual 
name, or one name is used to describe many different species. In other 
cases, a particular species may not even have a common or usual name. 
Furthermore, the agency notes that uncertainty may exist as to which 
dietary ingredients are botanicals. For example, those in the trade may 
regard fungi (i.e., yeasts, molds, mushrooms) as ``botanicals,'' while 
a taxonomist may not (Ref. 2).
    For the purposes of this regulation, the agency considers the term 
``botanical'' as used in section 201(ff)(1)(C) of the act to include 
fungi and algae. While some questions may be raised about fungi, the 
agency believes there is general agreement that they are botanicals 
(Ref. 2). With respect to bacteria, the agency believes it is clear 
from both a botanical as well as a commercial viewpoint, they are not 
botanicals (Ref. 2).
2. Quantity of Other Dietary Ingredients
    The agency is proposing in Sec. 101.36(b)(3)(ii) that the 
quantitative amount by weight per serving of other dietary ingredients 
shall be presented in a column aligned to the right of the column of 
names and beneath the column of amounts described in proposed 
Sec. 101.36(b)(2)(ii). The agency is proposing Sec. 101.36(b)(3)(ii) in 
response to section 403(q)(5)(F)(ii) of the act, which was added by the 
DSHEA. This provision specifies that the listing of dietary ingredients 
shall include the quantity of each such ingredient per serving.
    FDA is proposing to require that the quantitative amount listed in 
the nutrition label for a declared dietary ingredient be the total 
weight of that dietary ingredient and not the weight of a component of 
that dietary ingredient or of the source of that dietary ingredient. 
While a component of an ingredient may be listed as the dietary 
ingredient, under the proposed regulation, the name of that component 
ought to appear in the left column, and the weight of that component is 
what would be listed. For example, if a dietary supplement lists garlic 
as a dietary ingredient and makes no reference to a component of 
garlic, then the weight specified should be the weight of garlic. 
However, if the nutrition label lists allicin as the dietary 
ingredient, with garlic noted as the source ingredient, the weight 
specified should be the weight of allicin only. Liquid extracts of 
dietary ingredients are not to be treated any differently in that the 
weight specified should be the weight of the dietary ingredient listed 
that is in the extract and not include the weight of any solvent. The 
agency appreciates that such determinations may be difficult and seeks 
comments on this issue. 

[[Page 67202]]

    Manufacturers have the option of deciding what to list as a dietary 
ingredient (e.g., either garlic or the constituent, allicin). The 
agency is proposing this flexibility in accordance with section 201(ff) 
of the act, which provides, among other things, that a dietary 
ingredient may be a botanical or a constituent of a botanical. Thus, 
the agency is proposing that either the botanical or one or more 
constituents of a botanical may be declared as the dietary ingredient. 
The agency considered allowing manufacturers to declare both the 
botanical and one or more constituents as dietary ingredients within a 
single product, with the constituents of the botanical indented beneath 
the listing of the botanical. The quantitative amounts for the 
botanical and listed constituents would also be declared. This approach 
would possibly give consumers more information. However, the agency has 
tentatively rejected this approach because of concern that it would be 
potentially confusing to consumers who may not understand that the 
indented items are constituents of the nonindented dietary ingredient 
listed immediately above, or that the quantitative amounts of the 
constituents are also included in the quantitative amount of the 
nonindented dietary ingredient. The agency requests comments on whether 
it should consider allowing declaration of constituent information in 
the manner described above, whether there are alterative approaches to 
providing this type of information, and whether such flexibility is 
consistent with the DSHEA.
    The agency notes that the DSHEA provides that dietary ingredients 
having RDI's or DRV's need be listed only when present in ``significant 
amounts.'' This limitation on listing in section 403(q)(5)(F)(i) of the 
act does not apply to other dietary ingredients, apparently because 
they do not have RDI's or DRV's, and, consequently, there is no basis 
for determining what constitutes a ``significant amount'' with respect 
to daily consumption. Hence, under the act, for other dietary 
ingredients there is no level below which declaration is not required.
    In the absence of RDI's or DRV's, which are expressed in the units 
suitable for the declaration of nutrients in the nutrition label (i.e., 
mg for vitamin C), the agency is proposing to require that 
manufacturers express the amounts of other dietary ingredients in 
metric units that are appropriate. While it is not possible to specify 
appropriate units for every possible other dietary ingredient, for 
uniformity, FDA is proposing that any declaration of 1,000 or more 
units (mcg, mg, g) be declared in the next higher set of units (e.g., 
1,100 mg should be declared as 1.1 g).
3. Symbol To Reflect Lack of Daily Value
    In accordance with section 403(q)(5)(F)(i) of the act, which 
requires that other dietary ingredients be identified as having no 
recommendation for daily consumption, the agency is proposing in 
Sec. 101.36(b)(3)(iii) that other dietary ingredients bear a symbol 
(e.g., an asterisk) in the column under the heading of ``% Daily 
Value'' that refers to another symbol placed at the bottom of the 
nutrition label that is followed by the statement ``Daily Value not 
established.'' When no dietary ingredients are declared in accordance 
with Sec. 101.36(b)(2)(i), and the heading ``% Daily Value'' is not 
used, the agency is proposing that the symbol shall follow the 
declaration of the quantitative amount by weight for each other dietary 
ingredient listed. The agency considered placing the symbol elsewhere 
on the label (e.g., following the heading ``Amount Per Serving'' or 
with the name of each dietary ingredient) but tentatively concluded 
that it is most appropriate with the declaration of amounts because 
these values are used in the calculation of percent Daily Values when 
there are RDI's or DRV's.
    The agency gave extensive consideration to the most appropriate 
wording for the statement to which the symbol refers. The agency 
considered a statement such as ``Not currently determined essential,'' 
which was suggested in a letter from a dietary supplement trade 
association (Ref. 3). The agency is unsure if such a statement would be 
more useful to consumers than the proposed statement, ``Daily Value not 
established,'' which is consistent with the statement used in current 
Sec. 101.36(b)(4)(vi) and proposed Sec. 101.36(b)(2)(iii)(F) for 
dietary ingredients without Daily Values. The agency requests comments 
on this issue.

F. Proprietary Blends

    The agency is proposing in Sec. 101.36(c) to provide for the 
listing of dietary ingredients in proprietary blends. New section 
403(q)(5)(F)(ii) of the act provides that ``the listing of dietary 
ingredients shall include the quantity of each such ingredient (or of a 
proprietary blend of such ingredients) per serving.'' New section 
403(s)(2)(A)(ii)(II) of the act contains a similar provision that 
requires ``the quantity of each such ingredient; or with respect to a 
proprietary blend of such ingredients, the total quantity of all 
ingredients in the blend.'' The ingredients referred to in this section 
are those in section 403(s)(2)(A)(i) of the act that are described in 
201(ff), i.e., dietary ingredients. The agency notes that section 
403(q)(5)(F)(ii) of the act specifies that the information is to be 
reported on a ``per serving'' basis. While section 403(s)(2)(A)(ii)(II) 
of the act does not specify any basis, FDA tentatively concludes, for 
the reasons set out in the earlier discussion of section 
403(s)(2)(A)(ii) (see section III. D. 2. of this document) that the 
more specific instructions given in section 403(q), which directly 
addresses nutrition labeling and the listing of dietary ingredients, 
provide an appropriate basis for the declaration of the information 
required under section 403(s)(2)(A)(ii)(II) of the act.
    Accordingly, the agency is proposing in Sec. 101.36(c) to provide 
that a blend of dietary ingredients shall be identified by the term 
``Proprietary Blend,'' which may be modified by an appropriate 
descriptive term or fanciful name (e.g., ``Proprietary Blend of 
Bioflavonoids''). To promote uniform presentation and, thereby, to 
minimize consumer confusion, FDA is proposing that the dietary 
ingredients in the proprietary blend be indented under the term 
``Proprietary Blend'' (or a modification of this term) and be listed in 
a column or in a linear fashion.
    The agency is proposing that the total weight of the dietary 
ingredients listed as components of the proprietary blend appear on the 
same line as the name of the blend, as illustrated in the sample label 
in Sec. 101.36(e)(10)(v), to make it clear that the weight represents 
the total weight of the dietary ingredients listed. As previously 
explained, the manufacturer has the discretion to decide what to list 
as a dietary ingredient, e.g., whether to list garlic or a component of 
garlic, such as allicin. Regardless of what is considered to be the 
dietary ingredient, it is the weight of the dietary ingredient declared 
that is to be used in calculating the total weight of the blend.
    Proposed Sec. 101.36(c) also requires that the list of other 
dietary ingredients in a proprietary blend be given in order of 
predominance by weight since the weights of the individual dietary 
ingredients need not be specified (proposed Sec. 101.36(c)(2)). The 
required listing by order of predominance by weight is consistent with 
ingredient labeling of conventional foods under Sec. 101.4(a)(1) and is 
intended to give consumers an indication of the relative amounts of the 
other dietary ingredients present in the absence of information on 
their actual amounts.

[[Page 67203]]

    All other requirements for the listing of dietary ingredients 
remain in effect for dietary supplements containing, or consisting 
solely of, a proprietary blend. For example, under proposed 
Sec. 101.36(c)(3), the total weight must be specified to the right 
(beneath the column of amounts described in paragraph (b)(2)(ii) of 
Sec. 101.36), and the symbol (e.g., asterisk) referring to the 
statement ``Daily Value not established'' must be placed in the column 
under the heading of ``% Daily Value,'' if present, or immediately 
following the quantitative amount by weight for the proprietary blend.
    In addition, the agency is proposing to require that a dietary 
supplement containing a proprietary blend comply with Sec. 101.36(b)(2) 
(Sec. 101.36(c)(1)). If the proprietary blend furnishes more than 
insignificant amounts of any required (b)(2)-dietary ingredients (i.e., 
calories, calories from fat, total fat, saturated fat, cholesterol, 
sodium, total carbohydrate, sugars, dietary fiber, protein, vitamin A, 
vitamin C, calcium, iron, or any other dietary ingredient listed in 
proposed Sec. 101.36(b)(2)(i) that is added for purposes of 
supplementation or about which claims are made), that dietary 
ingredient must be declared, as well as the amount of the ingredient 
and the percent of the Daily Value that the supplement supplies. While 
FDA recognizes some ambiguity in the language of section 403 
(q)(5)(F)(ii) and (s)(2)(ii)(II) of the act, the agency tentatively 
concludes that an interpretation of these provisions of the act to mean 
that amounts of (b)(2)-dietary ingredients need not be listed 
individually, but rather be included in the total weight of the 
proprietary blend, would be inconsistent with section 403(q)(5)(F) of 
the act, which states that dietary supplement products ``shall comply 
with the requirements of subparagraphs (1) and (2),'' albeit in a 
manner which is appropriate for the product. Section 403(q)(1) and 
(q)(2) of the act require the listing of the individual nutrients 
determined by the Secretary to assist consumers in maintaining healthy 
dietary practices. FDA tentatively concludes that it would be contrary 
to the intent of the 1990 amendments to fail to list nutrients such as 
calories, total fat, sodium, or vitamin C, when present, in the 
nutrition labeling of dietary supplements containing proprietary 
blends.
    Inasmuch as FDA is proposing that any (b)(2)-dietary ingredients 
present in the proprietary blend be listed in accordance with 
Sec. 101.36(b)(2) (e.g., above the heavy bar separating (b)(2)-dietary 
ingredients and other dietary ingredients), these (b)(2)-dietary 
ingredients in the blend would not need to be listed a second time 
under the term ``Proprietary Blend'' and, if not listed, would not be 
included in the weight specified for such blend.

G. Information on the Source of a Dietary Ingredient and Other 
Ingredient Labeling Issues

    In response to sections 403 (q)(5)(F)(iii) and (q)(5)(F)(iv) of the 
act, which were added by the DSHEA, FDA is proposing in new 
Sec. 101.36(d) to allow the source of a dietary ingredient to be 
declared in the nutrition label. Section 403(q)(5)(F)(iii) of the act 
states that ``the listing of dietary ingredients may include the source 
of a dietary ingredient,'' and subclause (iv) states that ``the 
nutrition information shall immediately precede the ingredient 
information required under subclause (i), except that no ingredient 
identified pursuant to subclause (i) shall be required to be identified 
a second time.'' With respect to subclause (iv), the agency observes 
that it has received questions regarding the intent of the phrase 
``except that no ingredient identified pursuant to subclause (i) shall 
be required to be identified a second time.'' The agency acknowledges 
that the meaning of this phrase is not clear and has speculated whether 
the reference to ``subclause (i)'' is intended to refer to section 
403(i) of the act. Given this ambiguity, the agency is interpreting 
subclause (iv) to mean that any ingredient listed in the nutrition 
label need not be listed a second time in the ingredient statement 
required in Sec. 101.4. For example, under the agency's proposal, if an 
ingredient such as calcium carbonate is listed as the source of 
``calcium'' in the nutrition information, it would not need to be 
listed again in the ingredient statement. Accordingly, the agency is 
proposing to revise Sec. 101.4(a)(1) to provide that any ingredient of 
a dietary supplement that is listed in the nutrition label in 
accordance with proposed Sec. 101.36(d) (i.e., inside the box) need not 
be repeated in the ingredient list.
    The agency notes that one of the analyses of the DSHEA that it has 
received addressed section 403(q)(5)(F)(iv) of the act in detail (Ref. 
4). The analysis stated: ``The listing [of dietary ingredients] can 
also include the source ingredient of the dietary ingredient, and the 
traditional ingredient declaration need not repeat those ingredients 
(although a technical correction is needed so that the first cross 
reference in section 403(q)(5)(F)(iv) of the act is to `subsection (i)' 
rather than to `subclause(i)').'' Hence, this analysis is suggesting 
the first cross reference is to section 403(i) of the act that deals 
with the ingredient statement that is required in Sec. 101.4. This 
analysis is consistent with FDA's interpretation that: (1) A source 
ingredient may be included in the nutrition information, (2) the 
nutrition information must immediately precede the ingredient statement 
required in Sec. 101.4, and (3) no ingredient listed in the nutrition 
label is required to be declared a second time in the ingredient 
statement.
    Accordingly, the agency is proposing in Sec. 101.36(d) that the 
source of any dietary ingredient (i.e., the ingredient supplying the 
dietary ingredient) may be added in parentheses immediately following 
or indented beneath the name of the dietary ingredient, and that the 
words ``as'' or ``from'' must precede the name of the source 
ingredient, e.g., ``calcium (as calcium carbonate)'' or ``calcium (from 
oyster shell powder).'' By way of exception, the agency is proposing 
that, if the name of the dietary ingredient (e.g., Siberian ginseng) or 
its synonym (e.g., ascorbic acid as a synonym for vitamin C) is itself 
the source ingredient, the listing of the dietary ingredient will 
fulfill the requirement for the listing of the ingredient. In regard to 
the use of the words ``as'' or ``from,'' many dietary supplements in 
the marketplace currently use such terminology. The agency tentatively 
concludes that these words will help to convey to consumers the 
understanding that such compounds are the source of the dietary 
ingredients.
    If this proposal becomes final, when a source is disclosed in 
parentheses in the nutrition label, or when the name of a dietary 
ingredient or its synonym (e.g., ascorbic acid) is itself the source 
ingredient, the ingredient need not be listed in the ingredient 
statement that is required under section 403(i)(2) of the act. When a 
source is not identified within the nutrition label, proposed 
Sec. 101.36(d) provides that it shall be listed in the ingredient 
statement in accordance with proposed Sec. 101.4(g).
    Under proposed Sec. 101.4(g), the ingredient statement on a dietary 
supplement 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. This 
provision is in accordance with section 403(q)(5)(F)(iv) of the act, 
which was added by the DSHEA. It requires that the nutrition 
information immediately precede the ingredient information. The agency 
tentatively concludes that when there is insufficient space below the 
nutrition label, it is appropriate to allow the 

[[Page 67204]]
flexibility indicated and have the nutrition label precede the 
ingredient statement horizontally.
    FDA is proposing in Sec. 101.4(g) to require that the ingredient 
list be preceded by the word ``Ingredients,'' unless some ingredients 
(i.e., dietary ingredients or sources of dietary ingredients) are 
identified within the nutrition label, in which case the ingredients 
listed outside the nutrition label shall be in a list preceded by the 
words ``Other Ingredients.'' FDA is proposing that the word 
``Ingredients'' precede the list of ingredients so that the appearance 
of this aspect of the label is as consistent as possible with the 
labeling of other foods. As stated above, consistency in the 
presentation of food labeling information enhances consumer 
understanding. FDA is proposing that the term ``Other Ingredients'' be 
used to indicate to consumers that some ingredient information appears 
in the nutrition information that precedes the ingredient list.
    Proposed Sec. 101.4(g) also requires that ingredients that are not, 
or do not contain, dietary ingredients, such as excipients, fillers, 
artificial colors, artificial sweeteners, flavors, or binders, be 
listed in the ingredient statement. The agency acknowledges that a 1942 
Trade Correspondence identified as TC- 387 (Ref. 5) exempted 
``excipients, fillers, binders, and other fabricating ingredients'' 
from complete ingredient declaration when used in manufacturing dietary 
supplements (i.e., labels could list ``excipients'' rather than listing 
excipients by name). As explained in the final rule on ingredient 
labeling (58 FR 2850 at 2869, January 6, 1993), however, although TC-
387 has not been officially revoked, its position has been overturned 
by more recent agency statements of policy on this subject, as 
expressed in the Federal Register of August 2, 1973 (38 FR 20730), the 
Federal Register of March 16, 1979 (44 FR 16005), and in subsequent 
correspondence with industry (Refs. 6 and 7). These more recent 
statements of policy make it clear that the label for dietary 
supplements must contain a list of nutrients and a full statement of 
ingredients (except those exempted under section 403(i)(2) of the act), 
declared by their common or usual name. At this time, because TC-387 
expresses a position contrary to the agency's policy since 1973, the 
agency is revoking TC-387.
    In proposed Sec. 101.36(d)(1), the agency is providing that source 
ingredients in dietary supplements be identified in accordance with 
Sec. 101.4 that addresses ingredient labeling for all food products. A 
basic requirement of this section is that ingredients be listed by 
common or usual name (see Sec. 101.4(a)). To help ensure correct 
identification of herbs or other botanicals, including algae and fungi, 
the agency is proposing in Sec. 101.4(h)(1) that the botanical name in 
Latin binomial form be included in parentheses following the common or 
usual name. Proper scientific reference to a species is done with its 
Latin binomial, representing the genus in which the species has been 
placed and the species epithet, followed by the designation of the 
author or authors who published the name. When an author has moved a 
species from one genus to another, the name of the original author is 
enclosed in parentheses followed by the author who made the transfer. 
To ensure that there is consistency and clarity in declaration, the 
agency is proposing that any botanical name declared should be in 
accordance with internationally accepted rules on nomenclature, such as 
those found in the International Code of Botanical Nomenclature (Ref. 
8). The agency requests comments on this issue.
    FDA recognizes that it is possible to have more than one acceptable 
botanical name in Latin form (i.e., a synonym). FDA advises 
manufacturers to choose the name that is most currently used in 
commerce and in appropriate references and, in cases of confusion, to 
consult with the agency.
    Section 403(s)(2)(C) of the act, which was added by the DSHEA, 
provides that a dietary supplement is misbranded if it contains an herb 
or other botanical, and the label or labeling of the supplement fails 
to identify any part of the plant from which the dietary ingredient is 
derived. Accordingly, FDA is proposing in Sec. 101.4(h)(2) that this 
information be provided as part of the required ingredient information. 
While nothing in the act requires that information on the part of the 
plant from which a botanical is derived be in a particular place on the 
label, FDA tentatively finds that it would be in the interest of 
consumers if the information were presented as part of the ingredient 
information because it would ensure that all the identifying 
information about the herb or other botanical (i.e., common or usual 
name, Latin binomial, and part of plant from which it is derived) is 
presented in one place.
    FDA is proposing in Sec. 101.4(h)(2) to require that the part or 
parts of the plant (e.g., leaf, flower, root, fruit, seed, or bark) be 
presented in parentheses immediately following the Latin binomial name 
of the botanical ingredient. This manner of presentation is consistent 
with the way other clarifying information is presented in ingredient 
statements (see Sec. 101.4(d) and (e)). Whenever information on the 
part of the plant is presented on the label or in labeling, FDA is 
proposing to require that the name of the part of the plant be 
expressed in English. FDA tentatively concludes that pharmaceutical 
names such as ``flos'' for flower, ``radix'' for root, or ``fructus'' 
for fruit should not be used because they are not recognized in 
botanical nomenclature, and their meanings would not be commonly 
understood by American consumers. When an entire plant is used, the 
label should specify ``entire plant'' to meet the requirements of the 
act.
    The requirements of proposed Sec. 101.4(h)(1) and (2) apply whether 
the botanical ingredient is listed in an ingredient statement or in the 
nutrition label as provided by proposed Sec. 101.36(d). However, 
inasmuch as section 403(i) of the act does not require ingredients to 
be listed when the food contains only one ingredient, FDA is proposing 
in Sec. 101.36(h)(3) that for single-ingredient dietary supplements, 
the Latin binomial name and the part of the plant from which the 
dietary ingredient is derived may be prominently placed on the 
principal display panel or the information panel, or included in the 
nutrition label.
    In proposed Sec. 101.36(d)(2), the agency is requiring that when 
two or more sources are listed within a parentheses, they be listed in 
descending order by weight, which is consistent with the way 
ingredients are to be listed in Sec. 101.4. This listing of ingredients 
in descending order by weight will provide consumers with an indication 
of the relative amount of each ingredient in the absence of information 
on their actual amounts. As discussed elsewhere in this preamble, the 
agency is not proposing that other dietary ingredients be listed in 
descending order by weight because the amounts of these dietary 
ingredients are required to be listed.
    In proposed Sec. 101.36(d)(3), the agency is providing that 
representations that a source ingredient conforms to an official 
compendium may be included such as by a reference to the compendium 
(e.g., ``Calcium (from calcium carbonate USP)''). This provision is 
consistent with the discussion in the preamble of the 1994 dietary 
supplement final rule that explained that the agency would not object 
to the use of the U.S.P. symbol in the ingredient list to identify 
those ingredients that are U.S.P. grade (59 FR 354 at 369), as long as 
the ingredients meet FDA's compliance requirements in Sec. 101.9(g)(4), 
which are discussed below under Compliance and 

[[Page 67205]]
Location Requirements. The agency recognizes that in some cases 
individual dietary ingredients may conform to compendial specifications 
even though the entire product does not. Thus, the agency is proposing 
in Sec. 101.36(d)(3) to allow individual dietary ingredients to be so 
represented.
    If such a representation is made, and the ingredient does not 
comply with the specifications of the official compendium, the 
supplement would be misbranded under 403(a) of the act. The agency 
notes that section 403(s)(2)(D) of the act provides that a dietary 
supplement is misbranded if it is represented as complying with an 
official compendium and fails to do so. Proposed Sec. 101.36(d)(3) 
applies to representations about a particular ingredient and not the 
entire supplement, as does section 403(s)(2)(D) of the act.

H. Format Requirements

    As stated above, the agency continues to believe that consistency 
in the presentation of nutrition information on all foods will help 
consumers observe and comprehend such information, as required by 
section 2(b)(1)(A) of the 1990 amendments. Accordingly, FDA is 
proposing in Sec. 101.36(e) that the information required in proposed 
Sec. 101.36 (b) and (c) be presented in a manner that is similar to the 
requirements listed in Sec. 101.9(d) for conventional foods, as well as 
those in current Sec. 101.36 for dietary supplements of vitamins and 
minerals. In this rulemaking, the agency is proposing to alter slightly 
the organization in current Sec. 101.36 to combine all format 
requirements in proposed Sec. 101.36(e), all exemptions in 
Sec. 101.36(h), and all special labeling provisions (such as those for 
small or intermediate-sized containers) in Sec. 101.36(i), 
respectively.
    Despite the desire for consistency in the appearance of nutrition 
information on dietary supplements and conventional foods, the 
requirements adopted in the DSHEA, such as the listing of the names and 
amounts of other dietary ingredients and the optional listing of source 
information, necessitate that there be some differences in format. 
Accordingly, to signal to consumers that nutrition labeling on dietary 
supplements differs in several significant respects from that on 
conventional foods, FDA is proposing in Sec. 101.36(e)(1) that the 
title for the nutrition information on packages of dietary supplements 
be ``Supplement Facts.'' The agency tentatively concludes that the 
title ``Supplement Facts'' and the proposed format structure are 
sufficiently similar to the title ``Nutrition Facts'' and the format 
requirements used in nutrition labeling of conventional foods for the 
consumer to immediately recognize that the information in the two boxes 
is related. However, by the use of a different name, the consumer can 
be taught to recognize the basic structural differences in nutrition 
information on the two different types of food products. For example, 
the nutrition information on dietary supplements will have the 
quantitative amounts by weight located in a separate column; may 
include source ingredients; and may not have a ``% Daily Value'' column 
if no dietary ingredients having RDI's or DRV's are present in the 
product. Comments are requested on the appropriateness of the title 
``Supplement Facts.''
    FDA is proposing in Sec. 101.36 (e)(1) through (e)(3) to maintain 
the graphic requirements in current Sec. 101.36(b) and (c)(1) through 
(c)(5). These sections require the use of the largest type size within 
the nutrition label for the title; bolding of the title and column 
headings; a hairline box around the nutrition label; a single easy-to-
read type style; all black or one color type on a white or other 
neutral contrasting background, whenever practical; upper and lower 
case letters, except on very small packages; at least one point 
leading; and letters that do not touch. The agency is retaining these 
requirements because they are responsible, in large measure, for the 
appearance of the nutrition label and are designed to maximize the 
legibility of the label.
    The agency is addressing type size requirements in proposed 
Sec. 101.36(e)(4). Current Sec. 101.36(c)(6) requires that: (1) 
packages with less than 12 square inches of total surface area 
available to bear labeling (i.e., small-sized packages) use a type size 
no smaller than 4.5 point for the nutrition label, (2) packages with 12 
to 40 square inches of total surface area available to bear labeling 
(i.e., intermediate-sized packages) use a type size no smaller than 6 
point, and (3) packages with more than 40 square inches of total 
surface area available to bear labeling use type size no smaller than 8 
point, except that these larger packages could use 6 point type for 
column headings, footnotes, and information on beta-carotene, when 
present. Because the DSHEA does not necessitate any changes in type 
size, the agency is proposing in Sec. 101.36(e)(4) to carry forward the 
requirement for larger-sized packages of 8 point type with 6 point type 
for column headings and footnotes. (The agency is not proposing to 
carry forward 6 point type for the information on beta-carotene because 
the agency tentatively concludes that the type size for all dietary 
ingredients should be uniform.) To be more consistent with the 
organization of Sec. 101.9, FDA is proposing to move the exceptions in 
type size for small and intermediate-sized packages to 
Sec. 101.36(i)(2). The agency will discuss these exceptions under 
section III.J. of this document.
    Proposed Sec. 101.36(e)(5) requires a hairline rule between the 
listing of each dietary ingredient. This requirement is identical to 
that in current Sec. 101.36(c)(7). Following publication of the 1994 
dietary supplement final rule, the agency received comment on this 
requirement and on the effect that the multiple hairlines could have on 
the legibility of labels of products with large numbers of dietary 
ingredients, where labels have severe space constraints, and where the 
minimum type size (i.e., 4.5 point type) is used. FDA requests comments 
on the use of hairlines to separate the dietary ingredients listed. 
Such comments will be particularly helpful if actual sample labels are 
included as well as suggestions for when relief from such a requirement 
should be provided, e.g., should hairlines be omitted when more than 8 
(or some other number) dietary ingredients that qualify to use 4.5 
point type are listed? Comments should set out in detail the basis for 
their recommendations.
    Comments received by the agency since publication of the 1994 
dietary supplement final rule suggest that there is some confusion 
about the relative size of bars used to separate parts of the nutrition 
label, and whether the bars are required by regulation. It appears that 
many persons were unable to find the regulatory references to the bars 
in current Sec. 101.36 (b)(3), (b)(3)(ii), and (b)(4). Therefore, FDA 
is proposing to focus two paragraphs, Sec. 101.36 (e)(6) and (e)(7), 
specifically on bars, rather than addressing them as ancillary issues 
in broader provisions. These paragraphs identify the points in the 
label format where bars are required and differentiate the thickness of 
the bars (i.e., ``heavy bars'' versus ``light bars'').
    In proposed Sec. 101.36(e)(6), the agency is requiring that a heavy 
bar be placed beneath the subheading ``Serving Size'' or the subheading 
``Servings Per Container'' when it is required, beneath the last 
dietary ingredient to be listed in proposed Sec. 101.36(b)(2)(i), and 
beneath the last other dietary ingredient to be listed in proposed 
Sec. 101.36(b)(3). Also, in proposed Sec. 101.36(e)(7), the agency is 
proposing that a light bar be placed beneath the headings ``Amount Per 
Serving'' and ``% Daily Value,'' which 

[[Page 67206]]
will be above the listing of ``Calories,'' when the latter is required.
    Except for the introduction in this rulemaking of a bar above, 
rather than below, the listing of ``Calories'' and of a bar to separate 
(b)(2)-dietary ingredients from other dietary ingredients, FDA is 
proposing no change from the bars as currently required above and 
beneath the ``Amount Per Serving'' heading in current Sec. 101.36(b)(3) 
and at the bottom of the nutrition label in current 
Sec. 101.36(b)(3)(ii). The use of the bars and their respective 
thickness is illustrated in sample labels under proposed 
Sec. 101.36(e)(10).
    For products that contain both (b)(2)-dietary ingredients and other 
dietary ingredients, the heavy bar that FDA is proposing to require in 
Sec. 101.36(e)(6)(ii) beneath the last (b)(2)-dietary ingredient will 
result in a bar separating the list of (b)(2)-dietary ingredients from 
that of other dietary ingredients. FDA has tentatively concluded that 
this visual separation will assist consumers to differentiate dietary 
ingredients for which RDI's and DRV's have been established from other 
dietary ingredients for which such daily values have not been 
established.
    The agency interprets the direction given in section 
403(q)(5)(F)(i) of the act that ``nutrition information shall first 
list those dietary ingredients * * * for which a recommendation for 
daily consumption has been established * * * and shall list any other 
dietary ingredient present and identified as having no such 
recommendation'' as evidencing that such a differentiation should be 
made. FDA has tentatively concluded that the use of a heavy bar, 
similar to that which is used in Sec. 101.9 to differentiate vitamins 
and minerals from preceding nutrients, will distinguish the two groups 
of dietary ingredients while helping to maintain some consistency in 
the appearance between nutrition labels on dietary supplements and 
products represented as conventional foods.
    Proposed Sec. 101.36(e)(8) addresses how nutrition information is 
to be presented on products that contain two or more separately 
packaged dietary supplements that differ from each other. This section, 
which allows manufacturers to choose between separate nutrition labels 
for each product or one aggregate nutrition label, is analogous to 
Sec. 101.9(d)(13) for conventional foods and maintains the provisions 
of current Sec. 101.36(b)(3)(iii), except that there is no longer a 
need to specify that separate columns be used to list quantitative 
amounts because the agency is proposing to require that the 
quantitative amounts on all dietary supplements be listed in separate 
columns.
    Proposed Sec. 101.36(e)(9), which encourages uniformity in 
presentation, and proposed Sec. 101.36(e)(11), which allows for 
flexibility when there is insufficient continuous vertical space to 
accommodate the required components of the nutrition label, are 
identical to current Sec. 101.36(c)(8) and (c)(10).
    Proposed Sec. 101.36(e)(10) provides sample labels to illustrate 
the format requirements of Sec. 101.36.

I. Compliance and Location Requirements

    FDA is proposing in Sec. 101.36(f)(1) to provide that compliance 
with Sec. 101.36 will be determined using the procedures outlined in 
Sec. 101.9(g)(1) through (g)(8) for conventional foods. These 
regulations, which are cited in current Sec. 101.36(d)(1), describe how 
FDA will collect samples for compliance reviews and the types of 
analytical methods that it will use, set quantitative criteria (e.g., 
allowable margins of error) for added and naturally occurring 
nutrients, and provide for the use of FDA-approved data bases.
    An issue addressed in the preamble to the 1994 dietary supplement 
final rule was the requirement in Sec. 101.9(g)(4)(i) for added 
vitamins, minerals, protein, dietary fiber, or potassium to be present 
in amounts ``at least equal to the value for that nutrient declared on 
the label'' (59 FR 354 at 369). A comment pointed out that U.S.P. 
monographs for several nutritional products require a minimum nutrient 
content of 90 percent of the label declaration, and that this 
specification was in conflict with FDA's requirement that added 
nutrients be present at 100 percent of declared value when tested 
during the shelf life of the product. In responding, the agency noted 
an inconsistency in U.S.P. directives in that the General Notices of 
the U.S.P. state that a dosage should be formulated to provide 100 
percent of the labeled amount (Ref. 9).
    In light of new section 403(s)(2)(D) of the act, the agency 
questioned whether it should alter its long-standing compliance 
criterion in Sec. 101.9(g)(4)(i). The agency reviewed its response to 
the comment mentioned above and earlier correspondence from the agency 
to U.S.P. informing that organization that anything less than 100 
percent of the value declared on the label for vitamin and mineral 
products is not acceptable, and that the only permissible deviation 
from this requirement would be a deviation that is attributable to the 
variability of the analytical method (Ref. 10).
    The agency tentatively concludes that any deviation from the 
criterion in Sec. 101.9(g)(4)(i) that is attributable to reasons other 
than variability of analytical methods would be a material fact and 
would need to be disclosed on the label if the agency were to allow 
less than 100 percent of the value declared. Accordingly, FDA has 
considered proposing that, on labels of products where U.S.P. 
specifications are met but less than 100 percent of the labeled amount 
is present, the U.S.P. designation would be allowed with a disclosure 
of the lack of the declared amount (e.g., a symbol by the U.S.P. 
designation that refers to a footnote that states ``May contain only --
--% of the amount listed''). However, the agency is concerned that such 
a message could diminish consumer confidence in the values declared in 
nutrition labeling for all foods. Therefore, FDA tentatively concludes 
that its previous position is the better course of action (i.e., that, 
other than deviations that are attributable to the variability of the 
analytical method, anything less than 100 percent of the value declared 
on the label is not acceptable for added nutrients). Consequently, FDA 
is not proposing any change in its position that the requirements for 
the nutrients listed in Sec. 101.9(g)(4) should pertain regardless of 
whether these nutrients are present in conventional foods or in dietary 
supplements.
    Likewise, the agency is proposing in Sec. 101.36(f)(1) that the 
criteria in Sec. 101.9(g)(3) and (g)(4) are applicable to other dietary 
ingredients described in proposed Sec. 101.36(b)(3)(i). The agency is 
unaware of any reason why these criteria that pertain to dietary 
ingredients that are nutrients should not apply to other dietary 
ingredients. Hence, the agency tentatively concludes that other dietary 
ingredients, when they are added, be present in amounts at least equal 
to the values declared in the nutrition label and, when they occur 
naturally, be present in amounts at least equal to 80 percent of the 
value declared. The agency is also proposing that reasonable excesses 
of other dietary ingredients over labeled amounts are acceptable within 
current good manufacturing practice, which is consistent with 
Sec. 101.9(g)(6). The agency is unaware of any reason at this time for 
applying the approach in Sec. 101.9(g)(5) to any other dietary 
ingredients. This section provides that food with a label declaration 
of calories, sugars, total fat, saturated fat, cholesterol, or sodium 
shall be deemed to be misbranded under section 403(a) of the act if a 
composite of the product 

[[Page 67207]]
is found to contain more than 20 percent in excess of the amount 
declared for one of these nutrients. FDA is not aware of any other 
dietary ingredient that should be singled out in this way. The agency 
requests comments on the proposed criteria for other dietary 
ingredients.
    In recognition of the fact that the exemptive provisions referenced 
in proposed Sec. 101.36(f)(1) may not include all situations in which 
nutrition information is technologically infeasible or impracticable on 
a particular package, the agency is proposing in Sec. 101.36(f)(2) to 
carry forward current Sec. 101.36(d)(2), which provides the opportunity 
in such a situation for firms to write to the Office of Food Labeling, 
FDA, to request additional exemptions or alternative means of 
compliance. This provision is identical to that in Sec. 101.9(g)(9) for 
conventional foods. In such a situation, the firm should state why it 
is technologically infeasible or impracticable for the specified 
products to comply with the nutrition labeling regulations, identify 
alternative means of compliance that would be used to provide nutrition 
information for the product (e.g., specify type size variations 
needed), and explain why this mode of compliance would be consistent 
with the intent of the 1990 amendments and the DSHEA.
    With respect to analytical procedures for compliance programs, 
Sec. 101.9(g)(2) states that FDA will use methods as given in the 
``Official Methods of Analysis of the AOAC [Association of Official 
Analytical Chemists] International'' unless no AOAC method is available 
or appropriate, in which case other reliable and appropriate analytical 
procedures will be used. AOAC methods and other reliable analytical 
methods exist for most vitamins and minerals used as, or as a component 
of, dietary supplements. However, AOAC methods do not exist for most 
other dietary ingredients, including many botanicals. Accordingly, the 
agency is interested in identifying a variety of analytical procedures 
and sources of information that can be used for other dietary 
ingredients. FDA requests comments on appropriate analytical procedures 
or other alternative approaches for determining whether the dietary 
supplement provides the quantity of dietary ingredient listed in the 
nutrition label for the supplement. Additionally, FDA is requesting 
information on organizations that establish such procedures.
    The agency is proposing in Sec. 101.36(g) to require that the 
location of nutrition information on a label be in compliance with 
Sec. 101.2, except as provided in proposed paragraphs (i)(2) and (i)(5) 
of Sec. 101.36. Proposed (i)(2) states 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. 
Section 101.9(j)(13)(ii)(D) provides that foods in packages that have a 
total surface area available to bear labeling of 40 or less square 
inches may present the required nutrition information on any label 
panel. In addition, proposed (i)(5) states that dietary supplements are 
subject to the special labeling provision specified in 
Sec. 101.9(j)(17) for foods in packages that have a total surface area 
available to bear labeling greater than 40 square inches but whose 
principal display panel and information panel do not provide sufficient 
space to accommodate all required label information (see 50 FR 17202, 
April 5, 1995). Section 101.9(j)(17) allows the nutrition label on such 
packages to be moved to any other label panel that is readily seen by 
consumers. However, because of the requirement in section 
403(q)(5)(F)(iv) of the act that the ingredient list immediately follow 
the nutrition label, proposed Sec. 101.36(i)(5) states 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), which FDA has proposed to adopt in this 
document.

J. Exemptions and Special Labeling Provisions

    FDA is proposing in Sec. 101.36(h)(1) and (h)(2) to provide for 
small business exemptions in accordance with the 1990 amendments and 
the Nutrition Labeling and Education Act Amendments of 1993 (the 1993 
amendments) (Pub. L. 103-80), which (1) stated that, after May 8, 1995, 
section 403(q)(5)(D) of the act, which provides an exemption based on 
total gross annual sales, shall apply to food from retailers only, and 
(2) established a new exemption for low-volume food products from 
manufacturers, packers, distributors, and retailers that are small 
businesses. A proposed rule to implement this change in Sec. 101.9(j) 
and current Sec. 101.36(f) was published on March 14, 1994 (59 FR 
11872). A final rule has not yet been published.
    To streamline the regulations and be consistent with the manner in 
which other exemptions and special labeling provisions are listed in 
current Sec. 101.36(f) and (g) (proposed Sec. 101.36(h) and (i)), FDA 
is proposing in Sec. 101.36(h)(1) and (2) to cross reference the small 
business exemption in Sec. 101.9(j)(1) and the exemption for low-volume 
food products of small businesses in proposed Sec. 101.9(j)(18), 
respectively, rather than to independently codify those exemptions 
under Sec. 101.36.
    Proposed Sec. 101.36(h)(3) incorporates the exemption in 
Sec. 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 foods or that are to be processed, labeled, or 
repacked at a site other than where originally processed or packed. 
This exemption was incorrectly listed in current Sec. 101.36(g) and 
identified as a special labeling condition. Inasmuch as nutrition 
labeling is not required on products shipped in bulk form that are not 
intended to be seen by consumers (section 403(q)(5)(A)(v)) of the act, 
it is being redesignated as an exemption under proposed 
Sec. 101.36(h)(3).
    Special labeling provisions (or conditions) are provided for 
specific situations in which the product is not exempt from nutrition 
labeling requirements, but deviations from the general nutrition 
labeling requirements are necessary for a variety of reasons. For 
example, proposed Sec. 101.36(i)(1), which was carried forward from 
current Sec. 101.36(g), references Sec. 101.9(j)(5)(i) which describes 
a special labeling provision that pertains to the nutrition labeling of 
foods represented or purported to be for children less the 2 years of 
age. In the nutrition labeling of these foods, other than infant 
formula, the listing of calories from fat, calories from saturated fat, 
saturated fat, polysaturated fat, monounsaturated fat, and cholesterol 
is prohibited. FDA included this special labeling provision in its 
regulations to discourage the inappropriate application of adult 
dietary guidelines to infants and toddlers (55 FR 29487 at 29506, July 
19, 1990, as modified in 58 FR 2079 at 2150). While current 
Sec. 101.36(g) also cross references Sec. 101.9(j)(5)(ii), which 
addresses broader issues of the format of nutrition labeling on foods 
intended for children less than 4 years of ages, these format issues 
are addressed elsewhere in this proposed regulation (e.g., the 
exclusion of percent Daily Value in proposed Sec. 101.36(b)(2)(iii)(F) 
for total fat, saturated fat, cholesterol, sodium, potassium, total 
carbohydrate, and dietary fiber because DRV's have not been established 
for this age group). Accordingly, proposed Sec. 101.36(i)(1) references 
only that portion of Sec. 101.9(j)(5)(i) that prohibits the inclusion 
of calories from fat, calories from saturated fat, saturated fat, 

[[Page 67208]]
polyunsaturated fat, monounsaturated fat, and cholesterol in the 
nutrition label of foods, other than infant formula, represented or 
purported to be for children less than 2 years of age.
    Proposed Sec. 101.36(i)(2) describes special labeling provisions 
for small and intermediate-sized containers. Special labeling 
provisions are provided for these containers in current Sec. 101.36(g) 
which cross references Sec. 101.9(j)(13). Section 101.9(j)(13)(i) 
allows small packages with less than 12 square inches of space 
available to bear labeling to supply an address or telephone number for 
the consumer's use in obtaining nutrition information in lieu of 
nutrition labeling when no claims or other nutrition information are 
present on the label or in labeling or advertising, or, if they are 
present, to provide the required nutrition information in 6 point type 
or in all upper case type of 1/16 inches minimum height. Section 
101.9(j)(13)(ii) allows packages with 40 or less square inches of space 
available to bear labeling to present the nutrition label in a tabular 
format when the package shape and size cannot accommodate a standard 
vertical display and in a linear display if the label will not 
accommodate a tabular display; to use specified abbreviations; to 
shorten the required footnotes; and to place the required nutrition 
information on any label panel.
    In addition to cross referencing these special labeling provisions, 
current Sec. 101.36(c)(6) provides for smaller type size requirements 
for dietary supplements in small and intermediate- sized containers. 
That provision allows labels of dietary supplements in packages with 
less than 12 square inches of total surface area available to bear 
labeling to use a type size no smaller than 4.5 point in the nutrition 
label, in packages with 12 to 40 square inches of total surface area 
available to bear labeling to use a type size no smaller than 6 point, 
and in packages with more than 40 square inches of total surface area 
available to bear labeling to use type size no smaller than 8 point, 
except that these larger packages can use 6 point type for column 
headings, footnotes, and information on beta-carotene, when present.
    In proposed Sec. 101.36(i)(2), FDA is continuing to cross reference 
the special provisions in Sec. 101.9(j)(13) and to allow the use of 4.5 
point type on packages with less than 12 square inches of available 
label space and the use of 6 point type on packages with 12 to 40 
square inches of available label space. However, in response to a 
citizen petition (Docket No. 94P-0110/CP1) (Ref. 11) from a trade 
association, the agency is proposing to provide additional flexibility 
for multi-ingredient dietary supplements in packages with less than 20 
square inches of available label space. The petition stated that the 
majority of dietary supplement products on the market have labels that 
are 12 to 20 square inches in size, and that, while 6 point type in the 
nutrition label is feasible on single-nutrient products with this size 
label, there is insufficient space for all the required information on 
multinutrient products. The petitioner submitted sample labels in 
support of their position.
    FDA is persuaded by this citizen petition that it is infeasible to 
use 6 point type on many products containing multiple dietary 
ingredients in packages with less than 20 square inches of space 
available to bear labeling. However, the agency tentatively finds that 
6 point type is feasible on products with a limited number of dietary 
ingredients based on the following calculations. The agency calculates 
that a listing of 8 dietary ingredients in 6 point type plus one point 
leading between each name would take less than 1 inch of vertical 
space. Adding another inch to this for the title, headings, bars, and 
footnote would result in a nutrition label for a product declaring up 
to 8 dietary ingredients of no more, and possibly less, than 2 inches 
in height. Assuming a 1\1/2\ inch width, such a nutrition label would 
take no more than 3 square inches of surface area.
    In the preamble to the final rule implementing the 1990 amendments, 
FDA based decisions on small package sizes on the assumption 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 (58 FR 2079 at 2155). On a package with 12 
square inches of available label space, 30 percent of the total surface 
area is 3.6 square inches. Inasmuch as the ingredient list can be 
included in the nutrition label and based on the above calculations, 
the agency tentatively concludes that it is reasonable to require that 
6 point type be used on a package with 12 to 20 square inches of space 
available to bear labeling when 8 or fewer dietary ingredients are 
listed. However, when a dietary supplement is in a package that has 
from 12 to 20 square inches of surface area available to bear labeling, 
and the nutrition label lists more than 8 dietary ingredients, the use 
of 6 point type would likely mean that more than 30 percent of the 
total surface area of the package would have to be devoted to FDA 
required information. Therefore, FDA is proposing in 
Sec. 101.36(i)(2)(ii) to provide for the use of a smaller type size 
(i.e., a minimum of 4.5 point type) in such circumstances.
    It should be noted that the dimensions used by the agency are 
inclusive of ``space available to bear labeling,'' not merely the 
dimensions of the current label. When there is space on the container 
to enlarge the current label (i.e., unused surface area available to 
bear labeling), and the current label is not large enough to provide 
the required information in accordance with format and type size 
specifications, FDA considers it is reasonable to expect that the 
manufacturer, packer, or distributor will increase the size of the 
label.
    This action (i.e., proposing to allow only those products with more 
than eight dietary ingredients to use the smaller type size) is 
supported by the petitioner referred to above (Ref. 11), who stated in 
followup correspondence that, in a survey of its membership, 
``responding companies agreed that eight or ten would be an appropriate 
cutoff number, triggering the smaller type size for multinutrient 
products,'' and that the responding companies believed that the cutoff 
should be set at eight nutrients (Ref. 12).
    The aforementioned citizen petition (Ref. 11) also requested that 
Sec. 101.2(c) be amended to allow the type size requirements in 
Sec. 101.2 (c)(1) through (c)(3) to apply to the labeling of dietary 
supplements of vitamins and minerals. Current Sec. 101.36 and proposed 
Sec. 101.36 include type size requirements for varying sizes of 
packages of dietary supplements. Therefore, the agency is denying the 
request to have the type size requirements in Sec. 101.2(c) pertain to 
the nutrition labeling of dietary supplements.
    The agency notes that Sec. 101.2 (c)(1) through (c)(3) were added 
to the regulations in 1974 (39 FR 15268), in part, in an effort to 
encourage manufacturers, packers, and distributors to include nutrition 
labeling on conventional foods. However, because the final rule on 
nutrition labeling (58 FR 2079) includes type size requirements, the 
agency believes there is no longer a need for Sec. 101.2 (c)(1) through 
(c)(3) to address the type size of information in the nutrition label. 
The agency plans to amend Sec. 101.2 (c)(1) through (c)(3) accordingly 
in a later document dealing with the labeling of conventional foods, as 
well as dietary supplements, so that the rulemaking will be seen by the 
greatest number of persons who may be affected by such action. 

[[Page 67209]]

    The agency is proposing, however, to amend Sec. 101.2 (b) and (f) 
to include Sec. 101.36 among the list of sections noted. Section 
101.2(b) states that the information required to appear under the 
sections noted shall appear either on the principal display panel or 
the information panel unless otherwise specified by regulation. Section 
101.2(f) provides that when the label of any package is too small to 
accommodate all of the information required under the sections noted, 
FDA may establish by regulation an acceptable alternative method of 
disseminating such information to the public (e.g., by the use of 
smaller type size).
    FDA is proposing a special labeling provision in proposed 
Sec. 101.36(i)(2)(iii) for dietary supplements in packages that have a 
surface area available to bear labeling of 40 or less square inches. 
Under this provision, when the nutrition label on packages of this size 
is presented on a label panel other than the principal display or 
information panels, as allowed in Sec. 101.9(j)(13)(ii)(D), the 
ingredient information must move in conjunction with the nutrition 
label. This provision is in response to section 403(q)(5)(F)(iv) of the 
act as added by the DSHEA, which states that nutrition information 
shall immediately precede the ingredient information.
    In proposed Sec. 101.36(i)(2)(iv), the agency is providing 
additional flexibility for dietary supplements in packages that have a 
surface area available to bear labeling of 40 or less square inches. 
When it is not possible for primary (inner) containers of this size to 
comply with the type size requirements, the agency is proposing that 
type as small as needed may be used in the nutrition label as long as 
the primary container is securely enclosed in outer packaging that 
bears nutrition labeling in required type size. In the preamble of the 
1994 dietary supplement final rule (59 FR 354 at 367), the agency 
erroneously advised that it considered outer packaging that securely 
encloses a primary container and that is not intended to be separated 
from the primary container under conditions of retail sale to be the 
equivalent of the product label. In these situations, the agency stated 
that manufacturers did not have to repeat the nutrition information on 
the primary container, although it encouraged them to do so to give 
consumers easy access to the information once the container is removed 
from the outer packaging. These statements were inconsistent with 
section 201(k) of the act which defines the term ``label'' as ``* * * a 
display of written, printed, or graphic matter upon the immediate 
container of any article * * *'' as well as with previous agency policy 
that requires that other required information appear on the primary 
container (e.g., statement of identity, quantity of contents, name and 
place of business of the manufacturer, packer, or distributor). 
Therefore, nutrition labeling is required to appear on the label of the 
primary container. However, consistent with FDA's intent in the 
preamble of the 1994 dietary supplement final rule to allow 
flexibility, the agency is proposing in Sec. 101.36(i)(2)(iv) that when 
nutrition labeling is presented in required type size on outer 
packaging that securely encloses a primary container and is not 
intended to be separated from the primary container under conditions of 
retail sale, the nutrition labeling on the primary container may use 
type size as small as needed to accommodate all of the required 
information on the label.
    FDA is proposing to carry forward the special labeling provisions 
in current Sec. 101.36(g) for foods in multiunit containers in proposed 
Sec. 101.36(i)(3) and for foods sold in bulk containers in proposed 
Sec. 101.36(i)(4).
    FDA is proposing to add a special labeling provision in proposed 
Sec. 101.36(i)(5) 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. This provision 
cross references Sec. 101.9(j)(17), which was recently added to the 
regulations (60 FR 17202, April 5, 1995) and allows the nutrition label 
on such packages to be placed on any alternate panel that can be 
readily seen by consumers. However, as previously discussed, ingredient 
information must move in conjunction with the nutrition label. 
Accordingly, proposed Sec. 101.36(i)(5) includes an exception to 
Sec. 101.9(j)(17) whereby the ingredient list would continue to be 
located immediately beneath the nutrition label, or, if there is 
insufficient space below the nutrition label, immediately contiguous 
and to the right of the nutrition label as proposed in Sec. 101.4(g).

K. Misbranding Provisions

    Current Sec. 101.36(h), redesignated as Sec. 101.36(j) in this 
proposed rulemaking, cross references the misbranding provisions of 
Sec. 101.9(k) that were first proposed in the Federal Register of March 
30, 1972 (37 FR 6493) and that were issued and published in the Federal 
Register of January 19, 1973 (38 FR 2125). These provisions were based 
on findings of fact and conclusions of law resulting from 1968-1970 
Special Dietary Hearings (38 FR 2143). Following a comment period, 
these regulations were modified and published as final regulations in 
Sec. 1.17 (i)(2) through (i)(6) on March 14, 1973 (38 FR 6961). In the 
reorganization and republication of Title 21 of the Code of Federal 
Regulations that appeared in the Federal Register of March 15, 1977 (42 
FR 14308), Sec. 1.17(i) was recodified as Sec. 101.9(i).
    No changes were made to the original codified language of the 
subject paragraphs until regulations implementing the 1990 amendments 
were published on January 6, 1993, at which time FDA redesignated the 
paragraphs as Sec. 101.9(k) and modified Sec. 101.9(k)(1) to 
incorporate a reference to the general requirements for health claims 
in Secs. 101.14 and 101.9(k)(5) in response to requests to remove 
restrictions about the incorporation of substances such as rutin, 
inositol, and other similar substances to conventional foods or dietary 
supplements (38 FR 2478 at 2502 and 38 FR 2079 at 2166, respectively).
    The current misbranding provisions in Sec. 101.9(k) state that a 
food will be considered to be misbranded under sections 201(n) and 
403(a) of the act if its label or labeling represents, suggests, or 
implies: (1) That the food, because of the presence or absence of 
certain dietary properties, is adequate or effective in the prevention, 
cure, mitigation, or treatment of any disease or symptom except as 
provided for in health claim regulations; (2) that a balanced diet of 
ordinary foods cannot supply adequate amounts of nutrients; (3) that 
the lack of optimum nutritive quality of a food, by reason of the soil 
on which the food was grown, is or may be responsible for an inadequacy 
or deficiency in the quality of the diet; (4) that the storage, 
transportation, processing, or cooking of a food is or may be 
responsible for an inadequacy or deficiency in the quality of the diet; 
(5) that the food has special dietary properties when such properties 
are of no significant value or need in human nutrition; and (6) that a 
natural vitamin in a food is superior to an added or synthetic vitamin 
or to differentiate in any way between vitamins naturally present from 
those added.
    FDA has reviewed these misbranding provisions in light of the DSHEA 
and current scientific knowledge. As a result of its review, the agency 
is proposing to delete current Sec. 101.9 (k)(2) and (k)(5). Section 
101.9(k)(2) states that a food is misbranded if its label or labeling 
represents, suggests, or implies that a 

[[Page 67210]]
balanced diet of ordinary foods cannot supply adequate amounts of 
nutrients. The agency is deleting this provision based on the 
acknowledgment by scientific and consensus groups that there are 
certain situations in which the use of dietary supplements may be 
needed for persons to obtain adequate nutrient intakes. For example, 
the National Academy of Sciences has stated in the 10th edition of 
``Recommended Dietary Allowances'' that ``In a few cases where 
deficiency is commonly observed (e.g., iron deficiency in women), food 
fortification and individual supplementation are appropriate'' (Ref. 
13, p. 14). Also, the ``Dietary Guidelines for Americans'' states that 
supplements may be needed by pregnant or lactating women; other women 
in their childbearing years; people who are unable to be active and eat 
little food; and people, especially older people, who take medicines 
that interact with nutrients (Ref. 14). These conclusions are supported 
by other documents such as ``Diet and Health, Implications for Reducing 
Chronic Disease Risk'' (Ref. 15, pp. 509-525) and a task force 
representing the American Dietetic Association, National Council 
Against Health Fraud, Inc., Society for Nutrition Education, American 
Society for Clinical Nutrition, and the American Institute of Nutrition 
(Ref. 16).
    Section 101.9(k)(5) states that a food is misbranded if its label 
or labeling represents, suggests, or implies that ``the food has 
dietary properties when such properties are of no significant value or 
need in human nutrition.'' New section 403(r)(6) of the act, which was 
added by the DSHEA, provides for statements that, in part, describe the 
role of a nutrient or dietary ingredient intended to affect the 
structure or function in humans or which describe general well-being 
from consumption of a nutrient or dietary ingredient. There is no 
requirement in this new section that the subject of the statement be of 
significant value or need in human nutrition. Therefore, to eliminate 
any inconsistency between section 403(r)(6) of the act and the agency's 
regulations, FDA is proposing to delete Sec. 101.9(k)(5). If it adopts 
the proposed deletion of Sec. 101.9 (k)(2) and (k)(5), the agency will 
redesignate current Sec. 101.9(k)(3) as (k)(2), Sec. 101.9(k)(4) as 
(k)(3), and Sec. 101.9(k)(6) as (k)(4).
    FDA is not aware of grounds for eliminating the other provisions 
under Sec. 101.9(k). However, if information is provided in comments to 
this proposed rule that persuades the agency that the findings of fact 
and conclusions of law resulting from 1968-1970 special dietary 
hearings (38 FR 2143) that underlie the other provisions in 
Sec. 101.9(k) are no longer supportable, FDA will consider deleting the 
subject provisions in the final rule.

IV. Conforming Amendments

    As previously discussed (in section III.J. of this document), FDA 
is proposing to amend Sec. 101.2 (b) and (f) to include Sec. 101.36 in 
the lists of sections noted. The agency is also proposing to amend 
Sec. 101.2(d)(1), which states that all required label information 
shall appear on the principal display panel or the information panel. 
This paragraph was recently amended in a document entitled ``Food 
Labeling; Placement of the Nutrition Label on Food Packages'' (60 FR 
17202, April 5, 1995) to exclude from its coverage products that are 
exempt under Sec. 101.9(j)(13), which allows flexibility in the 
placement of the nutrition label on packages that have less than 40 
square inches of space available to bear labeling, and 
Sec. 101.9(j)(17), which allows the nutrition label on 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 information 
to be placed on any alternate panel that can be readily seen by 
consumers. Inasmuch as proposed Sec. 101.36 (i)(2) and (i)(5) cross 
reference Sec. 101.9 (j)(13) and (j)(17), respectively, and therefore 
similarly exclude dietary supplements that meet the criteria in 
Sec. 101.9 (j)(13) and (j)(17) from coverage of Sec. 101.2(d)(1), FDA 
is proposing to amend that paragraph to cite Sec. 101.36 (i)(2) and 
(i)(5) as exceptions.
    Section 101.9(j)(6) of the nutrition labeling regulations lists as 
an exemption: Dietary supplements of vitamins and minerals that have an 
RDI as established in Sec. 101.9(c)(8)(iv) of this section or a DRV as 
established in Sec. 101.9(c)(9) of this section shall be labeled in 
compliance with Sec. 101.36, except that dietary supplements of 
vitamins and minerals in food in conventional form (e.g., a breakfast 
cereals), of herbs, and of other similar nutritional substances shall 
conform to the labeling of this section.
    As discussed previously (in section III. of this document), the 
definition of dietary supplements in new section 201(ff) of the act 
broadens the coverage of proposed Sec. 101.36 and eliminates 
differentiation based on the form of the food. Therefore, FDA is 
proposing to amend Sec. 101.9(j)(6) to exempt all dietary supplements 
from coverage under Sec. 101.9, noting that such foods must be labeled 
in compliance with Sec. 101.36.
    The agency is also proposing to amend Sec. 101.65(b)(4) to modify 
the example given of the statement of identity of a dietary supplement 
of vitamin C to incorporate the term ``dietary supplement'' in 
accordance with proposed Sec. 101.3(g). The amended paragraph will 
state:

    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'').

V. Regulatory Review Under Executive Order 12866

    This proposed rule has been deemed by the Office of Information and 
Regulatory Affairs (OIRA) of the Office of Management and Budget to be 
a significant regulatory action pursuant to Section 3(f)(4) of 
Executive Order 12866 because it raises novel legal and/or policy 
issues arising out of a legal mandate, namely the DSHEA, or principles 
set forth in Executive Order 12866. Accordingly, this proposed rule has 
been formally reviewed by OIRA pursuant to the provisions of Executive 
Order 12866.

VI. Economic Impact

    FDA has examined the economic implications of the proposed rule as 
required by Executive Order 12866 and the Regulatory Flexibility Act 
(Pub. Law 96-354). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects; distributive impacts; and equity). The 
Regulatory Flexibility Act requires analyzing options for regulatory 
relief for small businesses. FDA finds that this proposed rule is not 
an economically significant rule as defined by Executive Order 12866. 
In accordance with the Regulatory Flexibility Act, the agency certifies 
that the proposed rule will not have a significant impact on a 
substantial number of small businesses.
    There are several different types of products that may be 
considered to be dietary supplements. These products include, but are 
not limited to, vitamin and mineral supplements, herbal products, and 
products that contain other similar nutritional substances. Estimates 
of the number of such products range from 4,000 to over 25,000 such 
products. Similarly, estimates of the number of dietary supplement 
manufacturers range from 150 to 600. 

[[Page 67211]]


A. Costs

    Categories of costs for relabeling include administrative, 
analytical, printing, inventory disposal, and reformulation. The 
administrative costs associated with a labeling regulation result from 
the incremental administrative labor expended in order to comply with 
it. The administrative activities that FDA anticipates will be 
undertaken in response to a change in regulation include: Identifying 
the underlying policy of the regulation, interpreting that policy 
relative to a firm's products, determining the scope and coverage 
related to product labels, establishing a corporate position, 
formulating a method for compliance, and managing the compliance 
method. Longer compliance periods decrease administrative costs because 
firm executives often delegate downward decisions that are less 
immediate. Many firms estimate that administrative effort would be 
twice as high for a 6-month compliance period as for a 12- month 
compliance period (Ref. 17). FDA is proposing that any final rule that 
may issue based upon this proposal become effective January 1, 1997. 
This effective date leads to a compliance period of approximately 1 
year. FDA estimates that for a 1-year compliance period, manufacturers 
of dietary supplements will incur administrative costs of $425 per firm 
for each of between 150 and 600 firms, or a total of between 
approximately $65,000 and $300,000.
    FDA requests comments on whether dietary supplement products will 
undergo analytical testing as a result of these regulations if 
implemented as proposed. Dietary supplement products need only list 
those nutrients present in significant amounts. The agency assumes that 
manufacturers of vitamin and mineral supplements are already aware of 
the nutritional content of their products, and that those products will 
not undergo any additional testing. However, it is possible that herbal 
and other botanical products may undergo additional testing for their 
nutritional content. The agency estimates that between 4,000 and 20,000 
products may undergo testing once every 5 years for a total discounted 
analytical cost over the next 20 years of between $8.3 and $41 million 
(7 percent discount rate).
    However, many herbs do not contain significant amounts of the 
nutrients that must be listed in the nutrition label, and this fact may 
be determinable from reference works without testing. Thus, some herbal 
and botanical products may not require nutrient testing at all. FDA 
requests comments on this issue.
    FDA estimates that printing/redesign costs for dietary supplement 
manufacturers would be approximately $1,000 per label for each of 
75,000 labels with a 6-month compliance period, or a total of $75 
million. However, the length of the compliance period determines a 
firm's ability to combine planned label changes with mandated changes. 
Therefore, incremental labeling and redesign activities are less costly 
with lengthier compliance periods. With the proposed compliance period 
of 1 year, printing and redesign costs would be approximately half that 
of a 6-month compliance period, or approximately $37.5 million.
    FDA estimates the cost of inventory disposal associated with a 1-
year compliance period to be approximately $13 million. However, 
manufacturers of these products have been aware of the potential for 
regulated labeling changes due to recent regulatory and legal 
activities. FDA assumes that the majority of these manufacturers have 
been taking the necessary steps to reduce their label inventories since 
January of 1994, the date of publication of FDA's previous regulations 
regarding the labeling of dietary supplements. Therefore, the cost of 
inventory disposal is more accurately calculated on a compliance period 
of 2 years, or approximately $6.5 million.
    FDA has examined the impact of the proposed regulations on dietary 
supplement manufacturers and has determined that administrative costs 
would be between $65,000 and $300,000, discounted analytical testing 
costs would be between $8.3 and $41 million over the next 20 years (7 
percent discount rate), printing and redesign costs would be $37.5 
million, and inventory disposal costs would be $6.5 million. Therefore, 
total discounted costs are estimated to be between $52 and $85 million.

B. Benefits

    According to Congress as stated in the DSHEA, almost 50 percent of 
the 260,000,000 Americans regularly consume dietary supplements of 
vitamins, minerals, or herbs as a means of improving their nutrition. 
Although almost all dietary supplements of vitamins and minerals 
currently contain substantial nutrition information, many other dietary 
supplements do not typically provide such information. Moreover, the 
information that is presented is not presented in any particular order 
or following any particular format.
    This proposed regulation will benefit consumers by ensuring that 
adequate and complete nutrition information is provided accurately and 
consistently in order to aid consumers in their dietary choices. As 
consumers are given more informative labeling in an improved format, 
uncertainty and ignorance concerning the ingredient and nutrient 
content of the products they consume will decrease, and some consumers 
may select more nutritious, healthier products. Moreover, since FDA 
began its food labeling initiative in 1989, a theme that has been 
consistently sounded is that consumers will benefit from nutrition 
labeling that is presented in a consistent manner, not only within a 
particular product class but also across all foods. Such a consistent 
manner will not only help to make the information presented more 
comprehensible but will facilitate comparisons among food products. 
This proposed rule, if adopted, will help to ensure that dietary 
supplements are nutrition labeled in a manner that is as consistent as 
possible with other foods, yet, with such features as the listing of 
substances for which no daily reference amount has been established, in 
a manner that is fully tailored to the special nature of those 
products.
    All told, this action, if adopted, will benefit consumers by 
ensuring that nutrition labeling is provided on dietary supplements in 
a manner that will help consumers to follow healthy dietary practices.

C. Regulatory Flexibility

    According to the Regulatory Flexibility Act, the definition of 
small business 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 most food processing 
industries, a business is considered small if it has fewer than 500 
employees. For dietary supplements, a business is considered small if 
it has fewer than 750 employees. FDA estimates that the majority of 
manufacturers of dietary supplements meet the SBA definition of a small 
business.
    The agency has published an exemption from mandatory nutrition 
labeling for small businesses in Sec. 101.9(j)(1) (incorporated in this 
proposed rule in Sec. 101.36(h)(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) (incorporated in this proposed rule in 
Sec. 101.36(h)(2)). As of the date this subject rulemaking is proposed 
to become effective, January 1, 1997, 

[[Page 67212]]
Sec. 101.9(j)(1) (and proposed Sec. 101.36(h)(1)) will only apply to 
retailers. Proposed Sec. 101.9(j)(18) (and proposed Sec. 101.36(h)(2)) 
will apply to manufacturers, packers, distributors, or retailers of low 
volume products, defined as fewer than 200,000 units, produced by firms 
with fewer than 200 employees. As of May 1997, criteria for meeting the 
definition of low volume product will be reduced to 100,000 units and 
100 employees. FDA does not have information to show how many dietary 
supplement products would be exempted under this provision. The agency 
believes that several herbal and botanical products will have unit 
sales and firm size low enough to meet this definition. Therefore, many 
of the products produced by businesses defined as small by the SBA will 
not be subject to the rules if issued as proposed.
    The agency requests information regarding the impact of this 
regulation on small firms. Most of the costs associated with labeling 
regulations are fixed costs which are typically more burdensome for 
small firms than for large firms because of the smaller sales base on 
which to spread costs. Estimates of annual sales for the dietary 
supplement industry range from $2.9 billion to over $4 billion. The 
estimated cost of between $52 and $85 million is approximately one to 
three percent of industry annual sales. In relation to the volume of 
sales, this amount does not appear to represent a significant cost.

D. Summary

    Total discounted costs of this regulation is estimated to be 
between $52 and $85 million over the next 20 years (7 percent discount 
rate). 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 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 the proposed rules 
will probably not have an adverse impact on a substantial number of 
small businesses. Nonetheless, the agency requests comments on the 
impact on small businesses and any burden-reducing options.

VII. Environmental Impact

    The agency has determined under Sec. 25.24(a)(11) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environment assessment nor an environmental impact statement is 
required.

VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collections that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). In particular, 
the proposed regulations would require that manufacturers and 
distributors of dietary supplements disclose information on the levels 
of specific nutrients on the label or in labeling of their products 
with some exceptions. Additionally, the proposed regulations would 
require that these firms disclose the quantity of other dietary 
ingredients in their dietary supplements. Therefore, in accordance with 
5 CFR Part 1320, FDA is providing below the title, description, and 
respondent descriptions for the information collection requirements 
that will be submitted to OMB along with an estimate of the annual 
collection of information burden. Included in the estimate is the time 
for reviewing instructions, searching existing data sources, gathering 
necessary information, and disclosure of the information.
    FDA is soliciting comments to: (1) Evaluate whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information will 
have practical utility; (2) evaluate the accuracy of the agency's 
estimate of the burden of the proposed collection of information; (3) 
evaluate the quality, utility, and clarity of the information to be 
collected; and (4) minimize the burden of the collection of information 
on those who are to respond, including through the use of automated 
collection techniques or other forms of information technology, when 
appropriate.
    Title: Requirements for Nutrition and Ingredient Labeling of 
Dietary Supplements.
    Description: The proposed rule, Sec. 101.36, would 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 daily value for each, and the quantity of other dietary 
ingredients. This requirement is being proposed to implement the 
requirements of the 1990 amendments and the DSHEA.
    The DSHEA requires that dietary supplements provide information on 
their labels as to the level of nutrients and other dietary ingredients 
present in them. The DSHEA requires that FDA issue regulations to 
implement these requirements within specific timeframes. Section 
101.36(b)(2) specifies the nutrients for which 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 to determine the 
amount of nutrient that their products contain and that should be 
disclosed on the labels of the products.
    Description of Respondents: Persons and businesses, including small 
businesses.

----------------------------------------------------------------------------------------------------------------
                                                    No. of                                              Total   
                                       No. of     responses      Total      Hours per      Total      operating 
             Title 21               respondents      per         annual      response      annual    maintenance
                                                  respondent   responses                   hours        costs   
----------------------------------------------------------------------------------------------------------------
101.36............................          600           40       24,000            4       96,000  $51,616,000
----------------------------------------------------------------------------------------------------------------

    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 year after 
publication of a final rule. 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. FDA has estimated the total annual 
operating and 

[[Page 67213]]
maintenance costs of $51,616,000 based on maximum estimated relabeling 
costs of $34 million, all of which will be incurred in the first year; 
annualized analytical costs of $13.2 million; and labor and overhead 
costs of $4.616 million for the first year. The agency believes that 
these costs will decrease significantly over succeeding years. The 
agency does not believe that this proposed regulation requires capital 
costs on the part of respondents.
    The agency has submitted copies of the proposed rule to OMB for its 
review of these requirements. Interested persons are requested to send 
comments regarding information collection by Janaury 29, 1996, but not 
later than February 26, 1996 to the Office of Information and 
Regulatory Affairs, OMB, New Executive Office Building, rm. 10235, 
Washington, DC 20503, ATTN: Desk Officer for FDA.

IX. Effective Date

    FDA is proposing to make this regulation effective on January 1, 
1997. This date is consistent with section 7(e) of the DSHEA, which 
states that dietary supplements must be labeled in accordance with its 
provisions after December 31, 1996.

X. Comments

    Interested persons may, on or before March 13, 1996 submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

XI. 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. Lehninger, A. L., ``Biochemistry,'' Second Edition, pp. 57-
58, Worth Publishers, Inc., New York, NY, 1977.
    2. Memorandum of telephone conversation between Mr. Mark 
Blumenthal, American Botanical Council, and Susan Thompson, FDA, 
March 16, 1995.
    3. Bass, I. S., A. L. Young, and S. C. Stolzer, Piper & Marbury, 
letter to F. E. Scarbrough, January 31, 1995.
    4. Covington & Burling, ``Dietary Supplement Health and 
Education Act of 1994,'' October 12, 1994.
    5. FDA trade correspondence letter (387), June 23, 1942.
    6. FDA opinion letter, Taylor M. Quinn, Office of Compliance, 
Bureau of Foods, to Stanley Skelskie, March 30, 1979.
    7. FDA opinion letter, Taylor M. Quinn, Office of Compliance, 
Bureau of Foods, to Stanley Skelskie, January 25, 1980.
    8. 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.
    9. U. S. Pharmacopeial Convention, Inc. USP XXII, NF XVII, The 
United States Pharmacopeia, The National Formulary, General Notices 
and Requirements Applying to Standards, Test, Assays, and Other 
Specifications of the United States Pharmacopeia, pp. 1 to 3, 
January 1, 1990.
    10. Tanner, J. T., letter to V. Srinivasan, U.S. Pharmacopeial 
Convention, Inc., May 7, 1991.
    11. Citizen Petition, Docket No. 94P-0110/CP1.
    12. Dickinson, Annette, Council for Responsible Nutrition, 
Letter to Susan Thompson, FDA, February 28, 1995.
    13. 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.,'' p. 14, 
Washington, DC, National Academy Press, 1989.
    14. U.S. Department of Agriculture and U.S. Department of Health 
and Human Services, ``Nutrition and Your Health, Dietary Guidelines 
for Americans,'' Home and Garden Bulletin No. 232, U.S. Government 
Printing Office, Washington DC, 1990.
    15. Committee on Diet and Health, Food and Nutrition Board, 
Commission of Life Sciences, National Research Council, ``Diet and 
Health, Implications for Reducing Chronic Disease Risk,'' Chapter 
18, Dietary Supplements, National Academy Press, Washington, DC, 
1989.
    16. ``Recommendations concerning supplement usage: ADA 
statement,'' Journal of the American Dietetic Association, 87:1742-
3, 1987.
    17. Center for Economics Research, ``Compliance Costs of Food 
Labeling Regulations Final Report,'' prepared under FDA Contract No. 
223-87-2097, Washington, DC, FDA, DHHS, 1991.

List of Subjects in 21 CFR Part 101

    Food labeling, 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, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 is revised 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, 501, 
502, 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321, 331, 342, 343, 348, 351, 352, 355, 371).

    1. 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 pursuant to 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 Sec. 101.9(j)(13) and (j)(17) and 
Sec. 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 Sec. 101.9(j)(17) and Sec. 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.
    2. 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) When a food is marketed as a dietary supplement, the label 
shall bear the term ``dietary supplement'' as a part of the statement 
of identity in 

[[Page 67214]]
conformance with the provisions of paragraph (d) of this section.
    3. 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 immediately 
followed by parenthetical statements of:
    (1) The Latin binomial name 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 appropriate; and
    (2) The part of the plant (e.g., root, leaves) from which the 
dietary ingredient is derived (e.g., ``Garlic (Allium sativum L.) 
(bulb)''), except that this designation is not required for algae. The 
name of the part of the plant shall be expressed in English (e.g., 
``flower'' rather than ``flos'').
    (3) On labels of single-ingredient dietary supplements that do not 
include an ingredient list, the required identification of the Latin 
binomial name and the part of the plant may be prominently placed on 
the principal display panel or information panel, or included in the 
nutrition label.
    4. Section 101.9 is amended by revising paragraph (j)(6), by 
removing paragraphs (k)(2) and (k)(5), and by redesignating paragraphs 
(k)(3), (k)(4), and (k)(6) as (k)(2), (k)(3), and (k)(4), respectively, 
to read as follows:


Sec. 101.9  Nutrition labeling of food.

* * * * *
    (j) * * *
    (6) Dietary supplements, except that such foods shall be labeled in 
compliance with Sec. 101.36.
* * * * *
    5. Section 101.12 is amended in paragraph (b), Table 2, by revising 
the entry ``Dietary supplements not in conventional food form'' under 
the subheading ``Miscellaneous category'' 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 \5\      
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
Miscellaneous Category--                                                                                        
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
Dietary supplements..........................  The maximum amount recommended,   ______ tablet(s) ______        
                                                as appropriate, on the label      capsule(s), ____ packet(s),   
                                                for consumption per eating        tsp(s) (______g), etc.        
                                                occasion, or, in the absence of                                 
                                                recommendations, 1 unit, e.g.,                                  
                                                tablet, capsule, packet,                                        
                                                teaspoonsful, etc.                                              
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
  primarily derived from the 1977-78 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.                                                                                    
\2\ Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or  
  almost ready-to-serve form of the product (i.e, heat and serve, brown and serve). If not listed separately,   
  the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; dry, fresh, and   
  frozen pasta) is the amount required to make the reference amount of the prepared form. Prepared means        
  prepared for consumption (e.g., cooked).                                                                      
\3\ Manufacturers are required to convert the reference amount to the label serving size in a household measure 
  most appropriate to their specific product using the procedures in 21 CFR 101.9(b).                           
\4\ Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-
  150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington,  
  DC 20204.                                                                                                     
\5\ The label statements are meant to provide guidance to manufacturers on the presentation of serving size     
  information on the label, but they are not required. The term ``piece'' is used as a generic description of a 
  discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific   
  product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided
  is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not 
  apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless
  specifically stated in the product category, reference amount, or label statement column that it is for these 
  forms of the product. For products that require further preparation, manufacturers must determine the label   
  statement following the rules in Sec.  101.9(b) using the reference amount determined according to Sec.       
  101.12(c).                                                                                                    


[[Page 67215]]

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


Sec. 101.36  Nutrition labeling of dietary supplements.

    (a) The label of a dietary supplement shall bear nutrition labeling 
in accordance with this regulation unless an exemption is provided for 
the product in paragraph (h) of this section.
    (b) The declaration of nutrition information on the label and in 
labeling shall contain the following information, using the subheadings 
and the format specified in paragraph (e) of this section.
    (1) Serving size. (i) The subheading ``Serving Size'' shall be 
placed under the heading ``Supplement Facts'' and aligned on the left 
side of the nutrition label. The serving size shall be determined in 
accordance with Secs. 101.9(b) and 101.12(b), Table 2. Serving size for 
dietary supplements shall be expressed using a term that is appropriate 
for the form of the supplement, such as ``tablets,'' ``capsules,'' 
``packets,'' or ``teaspoonfuls.''
    (ii) The subheading ``Servings Per Container'' shall be placed 
under the subheading ``Serving Size'' and aligned on the left side of 
the nutrition label, except that this information need not be provided 
when it is stated in the net quantity of contents declaration.
    (2) Information on dietary ingredients that have a Reference Daily 
Intake (RDI) or a Daily Reference Value (DRV) as established in 
Sec. 101.9(c) and their subcomponents (hereinafter referred to as 
``(b)(2)-dietary ingredients'').
    (i) The (b)(2)-dietary ingredients to be declared, that is, total 
calories, calories from fat, total fat, saturated fat, cholesterol, 
sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, 
vitamin C, calcium and iron, shall be declared when they are present in 
a dietary supplement in quantitative amounts by weight that exceed the 
amount that can be declared as zero in nutrition labeling of foods in 
accordance with Sec. 101.9(c). Calories from saturated fat and 
polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble 
fiber, sugar alcohol, and other carbohydrate may be declared, but they 
shall be declared when a claim is made about them. Any other vitamins 
or minerals listed in Sec. 101.9(c)(8)(iv) or in Sec. 101.9(c)(9) may 
be declared, but they shall be declared when they are added to the 
product for purposes of supplementation, or when a claim is made about 
them. Any (b)(2)-dietary ingredients that are not present, or that are 
present in amounts that can be declared as zero in Sec. 101.9(c), shall 
not be declared (e.g., amounts corresponding to less than 2 percent of 
the RDI for vitamins and minerals). Protein shall not be declared on 
labels of products that, other than ingredients added solely for 
technological reasons, contain only individual amino acids.
    (A) The names and the quantitative amounts by weight of each 
(b)(2)-dietary ingredient shall be presented under the heading ``Amount 
Per Serving.'' The heading may be centered over the column of 
quantitative amounts, described by paragraph (b)(2)(ii) of this 
section, if space permits. When the serving size of the product is one 
unit (e.g., one tablet), a heading consistent with the declaration of 
the serving size, such as ``Amount Per Tablet'' or ``Each Tablet 
Contains,'' may be used in place of the heading ``Amount Per Serving.'' 
Other appropriate terms, such as capsule, packet, or teaspoonful, also 
may be used in place of the term ``Serving.''
    (B) The names of dietary ingredients that are declared under 
paragraph (b)(2)(i) of this section shall be presented in a column 
aligned on the left side of the nutrition label in the order and manner 
of indentation specified in Sec. 101.9(c) except that calcium and iron 
shall follow pantothenic acid, and sodium and potassium shall follow 
chloride. This results in the following order for vitamins and 
minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, 
thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, 
pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, chloride, sodium, 
and potassium. The (b)(2)-dietary ingredients shall be listed according 
to the nomenclature specified in Sec. 101.9.
    (1) When ``Calories'' are declared, they shall be listed first in 
the column of names, beneath a light bar separating the heading 
``Amount Per Serving'' from the list of names. When ``Calories from 
fat'' or ``Calories from saturated fat'' are declared, they shall be 
indented beneath ``Calories.''
    (2) The following synonyms may be added in parentheses immediately 
following the name of these (b)(2)-dietary ingredients: Vitamin C 
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2), folate 
(folacin or folic acid), and calories (energy). Energy content per 
serving may be expressed in kilojoules units, added in parentheses 
immediately following the statement of caloric content.
    (3) Beta-carotene may be declared as the percent of vitamin A that 
is present as beta-carotene, except that the declaration is required 
when a claim is made about beta-carotene. When declared, the percent 
shall be declared to the nearest whole percent, immediately adjacent to 
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of international 
units (IU) may be included in parentheses following the percent 
statement (e.g., ``Vitamin A (90% (4500 IU) as beta-carotene)'').
    (ii) The number of calories, if declared, and the quantitative 
amount by weight per serving of each dietary ingredient required to be 
listed under paragraph (b)(2)(i) of this section shall be presented in 
a separate column aligned to the right of the column of names. The 
quantitative amounts by weight shall represent the weight of the 
dietary ingredient rather than the weight of the source of the dietary 
ingredient (e.g., the weight of calcium rather than that of calcium 
carbonate).
    (A) These amounts shall be expressed in the increments specified in 
Sec. 101.9 (c)(1) through (c)(7), which includes increments for sodium 
and potassium.
    (B) The amounts of vitamins and minerals, excluding sodium and 
potassium, shall be the actual amount of the vitamin or mineral 
included in one serving of the product, using the units of measurement 
and the levels of significance given in Sec. 101.9(c)(8)(iv), except 
that zeros following decimal points may be dropped, and additional 
levels of significance may be used when the number of decimal places 
indicated is not sufficient to express lower amounts (e.g., the RDI for 
zinc is given in whole milligrams (mg), but the quantitative amount may 
be declared in tenths of a mg).
    (iii) The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed 
except that the percent for protein may be omitted as provided in 
Sec. 101.9(c)(7), no percent shall be given for subcomponents for which 
DRV's have not been established (e.g., sugars), and, for labels of 
dietary supplements of vitamins and minerals that are represented or 
purported to be for use by infants, children less than 4 years of age, 
or pregnant or lactating women, no percent shall be given for total 
fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, 
sodium, potassium, vitamin K, chloride, chromium, manganese, 
molybdenum, or selenium.
    (A) When information on the percent of Daily Values is listed, this 


[[Page 67216]]
information shall be presented in one column aligned under the heading 
of ``% Daily Value'' and to the right of the column of amounts. The 
headings ``% Daily Value (DV),'' ``% DV,'' ``Percent Daily Value,'' or 
``Percent DV'' may be substituted for ``% Daily Value.'' The heading 
``% Daily Value'' shall be placed on the same line as the heading 
``Amount Per Serving.''
    (B) The percent of Daily Value shall be calculated by dividing the 
quantitative amount by weight of each (b)(2)-dietary ingredient by the 
RDI as established in Sec. 101.9(c)(8)(iv) or the DRV as established in 
Sec. 101.9(c)(9) for the specified dietary ingredient and multiplying 
by 100, except that the percent of Daily Value for protein, when 
present, shall be calculated as specified in Sec. 101.9(c)(7)(ii). The 
actual quantitative amount by weight of each dietary ingredient shall 
be used in this calculation, except that for total fat, saturated fat, 
cholesterol, sodium, potassium, total carbohydrate, and dietary fiber, 
the percent shall be calculated by dividing either the quantitative 
amount by weight declared on the label or the actual amount (i.e., 
before rounding) by the DRV for the dietary ingredient. The numerical 
value shall be followed by the symbol for percent (i.e., %).
    (C) The percentages based on RDI's and on DRV's shall be expressed 
to the nearest whole percent, except that for dietary ingredients for 
which DRV's have been established, ``Less than 1%'' or ``<1%'' shall be 
used to declare the ``% Daily Value'' when the quantitative amount of 
the dietary ingredient by weight is great enough to require that the 
dietary ingredient be listed, but the amount is so small that the ``% 
Daily Value'' when rounded to the nearest percent is zero (e.g., the 
percent Daily Value for 1 gram of total carbohydrate is to be listed as 
``Less than 1%'' or ``<1%'').
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, a symbol 
shall follow the value listed for those nutrients that refers to the 
same symbol that is placed at the bottom of the nutrition label, below 
the bar required under paragraph (e)(6) of this section and inside the 
box, that is followed by the statement ``Percent Daily Values are based 
on a 2,000 calorie diet.''
    (E) The percent of Daily Value shall be based on RDI and DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women, in which case the 
column heading shall clearly state the intended group. If the product 
is for persons within more than one group, the percent of Daily Value 
for each group shall be presented in separate columns as shown in 
paragraph (e)(10)(ii) of this section.
    (F) For declared subcomponents that have no DRV's and, on the 
labels of dietary supplements of vitamins and minerals that are 
represented or purported to be for use by infants, children less that 4 
years of age, or pregnant or lactating women, for total fat, saturated 
fat, cholesterol, total carbohydrate, dietary fiber, sodium, potassium, 
vitamin K, chloride, chromium, manganese, molybdenum, or selenium, a 
symbol (e.g., an asterisk) shall be placed in the ``Percent Daily 
Value'' column that shall refer to the same symbol that is placed at 
the bottom of the nutrition label, below the last heavy bar and inside 
the box, and followed by the statement ``Daily Value not established.''
    (G) When calories, calories from fat, or calories from saturated 
fat are declared, the space under the ``% Daily Value'' column shall be 
left blank for these items. When there are no other (b)(2)-dietary 
ingredients listed for which a value must be declared in the ``% Daily 
Value'' column, the column may be omitted as shown in paragraph 
(e)(10)(vii) of this section. When the ``% Daily Value'' column is not 
required, but the dietary ingredients listed are subject to paragraph 
(b)(2)(iii)(F) of this section, the symbol required in that paragraph 
shall immediately follow the quantitative amount by weight for each 
dietary ingredient listed under ``Amount Per Serving.''
    (3) Information on dietary ingredients for which RDI's and DRV's 
have not been established. (i) Dietary ingredients for which FDA has 
not established an RDI or DRV and that are not subject to regulation 
under paragraph (b)(2) of this section (hereinafter referred to as 
``other dietary ingredients'') shall be declared by their common or 
usual name when they are present in a dietary supplement, in a column 
that is under the column of names described in paragraph (b)(2)(i)(B) 
of this section and under the heavy bar described in paragraph (e)(6) 
of this section, except that if no (b)(2)-dietary ingredients are 
declared, other dietary ingredients shall be listed directly beneath 
the heading ``Amount Per Serving'' described in paragraph (b)(2)(i)(A).
    (ii) The quantitative amount by weight per serving of other dietary 
ingredients shall be presented in a separate column aligned to the 
right of the column of names and underneath the column of amounts 
described in paragraph (b)(2)(ii) of this section. The quantitative 
amount by weight shall be the weight of the other dietary ingredient 
listed and not the weight of any component, or the source, of that 
dietary ingredient. These amounts shall be expressed using metric 
measures in appropriate units (i.e., 1,000 or more units shall be 
declared in the next higher set of units, e.g., 1,100 mg shall be 
declared as 1.1 g). For any dietary ingredients that are liquid 
extracts, the weight shall not include the weight of solvents.
    (iii) Other dietary ingredients shall bear a symbol (e.g., an 
asterisk) in the column under the heading of ``% Daily Value'' that 
refers to the same symbol placed at the bottom of the nutrition label 
and followed by the statement ``Daily Value not established,'' except 
that when the heading ``% Daily Value'' is not used, the symbol shall 
follow the quantitative amount by weight for each dietary ingredient 
listed.
    (c) A proprietary blend of dietary ingredients shall be included in 
the list of dietary ingredients described in paragraph (b)(3)(i) of 
this section and identified by the term ``Proprietary Blend,'' which 
may be modified by an appropriate descriptive term or fanciful name. 
Except as specified in this paragraph, all other requirements for the 
listing of dietary ingredients in dietary supplements are applicable.
    (1) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(2) of this section shall be declared in 
accordance with paragraph (b)(2) of this section.
    (2) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(3) of this section (i.e., ``other dietary 
ingredients'') shall be declared in descending order of predominance by 
weight, in a column or linear fashion, and indented under the term 
``Proprietary Blend.''
    (3) The quantitative amount by weight specified for the proprietary 
blend shall be the total weight of all other dietary ingredients 
contained in the proprietary blend and shall be placed on the same line 
to the right of the term ``Proprietary Blend'' underneath the column of 
amounts described in paragraph (b)(2)(ii) of this section. A symbol 
(e.g., asterisk), which refers to the same symbol placed at the bottom 
of the nutrition label that is followed by the statement ``Daily Value 
not established,'' shall be placed under the heading ``% Daily Value,'' 
if present, or immediately following the quantitative amount by weight 
for the proprietary blend.

[[Page 67217]]

    (4) The sample label shown in paragraph (e)(10)(v) of this section 
illustrates one method of nutrition labeling a proprietary blend of 
dietary ingredients.
    (d) The source ingredient that supplies a dietary ingredient may be 
identified within the nutrition label in parentheses immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the words ``as'' or ``from'', e.g., ``Calcium (as calcium 
carbonate),'' except that manner of presentation is unnecessary when 
the name of the dietary ingredient (e.g., Siberian ginseng) or its 
synonym (e.g., ascorbic acid) is itself the source ingredient. When a 
source ingredient is identified in parentheses within the nutrition 
label, or when the name of the dietary ingredient or its synonym is the 
source ingredient, it shall not be required to be listed again in the 
ingredient statement that appears outside of the nutrition label. When 
a source ingredient is not identified within the nutrition label, it 
shall be listed in an ingredient statement in accordance with 
Sec. 101.4(g), which shall appear outside and immediately below the 
nutrition label or, if there is insufficient space below the nutrition 
label, immediately contiguous and to the right of the nutrition label.
    (1) Source ingredients shall be identified in accordance with 
Sec. 101.4 (i.e., shall be listed by common or usual name, and the 
listing of botanicals shall specify the Latin binomial name and the 
part of the plant from which the ingredient is derived) regardless of 
whether they are listed in an ingredient statement or in the nutrition 
label.
    (2) When source ingredients are listed within the nutrition label, 
and two or more are used to provide a single dietary ingredient, all of 
the sources shall be listed within the parentheses in descending order 
by weight.
    (3) Representations that the source ingredient conforms to an 
official compendium may be included either in the nutrition label or in 
the ingredient list (e.g., ``Calcium (as calcium carbonate USP)'').
    (e) Nutrition information specified in this section shall be 
presented as follows:
    (1) The title, ``Supplement Facts,'' shall be set in a type size 
larger than all other print size in the nutrition label and, unless 
impractical, shall be set full width of the nutrition label. The title 
and all headings shall be bolded to distinguish them from other 
information.
    (2) The nutrition information shall be enclosed in a box by using 
hairlines.
    (3) All information within the nutrition label shall utilize:
    (i) A single easy-to-read type style,
    (ii) All black or one color type, printed on a white or other 
neutral contrasting background whenever practical,
    (iii) Upper and lower case letters, except that all uppercase 
lettering may be utilized for packages that have a total surface area 
available to bear labeling of less than 12 square inches,
    (iv) At least one point leading (i.e., space between lines of 
text), and
    (v) Letters that do not touch.
    (4) Except as provided for small and intermediate-sized packages 
under paragraph (i)(2) of this section, information other than the 
title, headings, and footnotes shall be in uniform type size no smaller 
than 8 point. Type size no smaller than 6 point may be used for column 
headings (e.g., ``Amount Per Serving'' and ``% Daily Value'') and for 
footnotes (e.g., ``Percent Daily Values are based on a 2,000 calorie 
diet'').
    (5) A hairline rule that is centered between the lines of text 
shall separate each dietary ingredient required in paragraph (b)(2) and 
(b)(3) of this section from the dietary ingredient above and beneath 
it, as shown in paragraph (e)(10) of this section.
    (6) A heavy bar shall be placed:
    (i) Beneath the subheading ``Servings Per Container'' except that 
if ``Servings Per Container'' is not required and, as a result, not 
declared, the bar shall be placed beneath the subheading ``Serving 
Size,''
    (ii) Beneath the last dietary ingredient to be listed under 
paragraph (b)(2)(i) of this section, if any, and
    (iii) Beneath the last other dietary ingredient to be listed under 
paragraph (b)(3) of this section, if any.
    (7) A light bar shall be placed beneath the headings ``Amount Per 
Serving'' and ``% Daily Value.''
    (8) If the product contains two or more separately packaged dietary 
supplements that differ from each other (e.g., the product has a packet 
of supplements to be taken in the morning and a different packet to be 
taken in the afternoon), the quantitative amounts and percent of Daily 
Value may be presented as specified in this paragraph in individual 
nutrition labels or in one aggregate nutrition label as illustrated in 
paragraph (e)(10)(iii) of this section.
    (9) In the interest of uniformity of presentation, FDA urges that 
the information be presented using the graphic specifications set forth 
in Appendix B to part 101, as applicable.
    (10) The following sample labels are presented for the purpose of 
illustration:

BILLING CODE 4160-01-P

[[Page 67218]]
[GRAPHIC][TIFF OMITTED]TP28DE95.000



[[Page 67219]]
[GRAPHIC][TIFF OMITTED]TP28DE95.001



[[Page 67220]]
[GRAPHIC][TIFF OMITTED]TP28DE95.002



[[Page 67221]]
[GRAPHIC][TIFF OMITTED]TP28DE95.003



BILLING CODE 4160-01-C

[[Page 67222]]

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

BILLING CODE 4160-01-P

[[Page 67223]]
[GRAPHIC][TIFF OMITTED]TP28DE95.004


BILLING CODE 4160-01-C

[[Page 67224]]

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


Sec. 101.65  Implied Nutrient Content Claims and Related Label 
Statements.

* * * * *
    (b) * * *
    (4) A statement of identity for a food in which an ingredient 
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' 
``oat bran,'' ``dietary supplement of vitamin C 60 mg tablet'').
* * * * *
    Dated: October 11, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 95-31196 Filed 12-27-95; 8:45 am]
BILLING CODE 4160-01-P