[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]
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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.
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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.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.''
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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.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 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