[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.)
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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="">