[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Rules and Regulations]
[Pages 49826-49858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24739]
[[Page 49825]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 101 Chapter I, and Part, 190
Food Labeling Regulation, Amendments; Food Regulation Uniform
Compliance Date; and New Dietary Ingredient Premarket Notification;
Final Rules
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 /
Rules and Regulations
[[Page 49826]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 95N-0245 and 94P-0110]
RIN 0910-AA59
Food Labeling; Statement of Identity, Nutrition Labeling and
Ingredient Labeling of Dietary Supplements; Compliance Policy Guide,
Revocation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations to establish requirements for the identification
of dietary supplements and for their nutrition labeling and ingredient
labeling in response to the Dietary Supplement Health and Education Act
of 1994 (the DSHEA). FDA is also responding to a citizen petition from
the Council for Responsible Nutrition on type size requirements for
these products. In addition, FDA is announcing the revocation of
Compliance Policy Guide 530.400 (CPG 7121.02) entitled ``Vitamin
Products for Human Use--Low Potency'' to eliminate inconsistencies with
the new labeling requirements.
DATES: The regulation is effective March 23, 1999. The Director of the
Office of the Federal Register approves the incorporations by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in 21 CFR 101.4(h), effective March 23, 1999.
FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-5587.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 28, 1995 (60 FR 67194), FDA
published a proposed rule entitled ``Food Labeling; Statement of
Identity, Nutrition Labeling and Ingredient Labeling of Dietary
Supplements'' (hereinafter identified as ``the December 1995
proposal''). This document, which specifically responds to the DSHEA,
superseded earlier documents responding to the Nutrition Labeling and
Education Act of 1990 (the 1990 amendments)(Pub. L. 101-535) and the
Dietary Supplement Act of 1992 (the DS act) (Pub. L. 102-571) with
respect to dietary supplements.
The 1990 amendments amended the Federal Food, Drug, and Cosmetic
Act (the act) in a number of important ways. One of the notable aspects
of the 1990 amendments is that they added section 403(q) to the act (21
U.S.C. 343(q)). This section provides that most foods are misbranded
unless they bear nutrition labeling.
In particular, section 403(q)(5)(F) (originally section
403(q)(5)(E)) of the act provided that separate regulations on the
nutrition labeling of dietary supplements of vitamins and minerals
could be established that are distinct from those for other foods. In
response to this section, FDA proposed a regulation in Sec. 101.36 (21
CFR 101.36) that was specifically on the nutrition labeling of dietary
supplements of vitamins and minerals, and a separate general regulation
that was on the nutrition labeling in Sec. 101.9 (21 CFR 101.9) of
conventional foods and of all other dietary supplements (those of herbs
and other nutritional substances) (56 FR 60366, November 27, 1991).
On October 6, 1992, the President signed into law the DS act. The
DS act established a moratorium until December 15, 1993, on the
implementation of the 1990 amendments with respect to dietary
supplements not in the form of conventional food. Also, it required
that a new proposed regulation on the nutrition labeling of dietary
supplements be issued by June 15, 1993, and a final rule by December
31, 1993.
In response to the DS act, FDA published a new proposed rule in the
Federal Register of June 18, 1993 (58 FR 33715), and a final rule on
January 4, 1994 (59 FR 354), on the nutrition labeling of dietary
supplements. As mandated in section 403(q)(5)(F) of the act, the final
rule established a regulation (Sec. 101.36) on the specific
requirements for nutrition labeling of dietary supplements of vitamins
and minerals.
On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into
law. The DSHEA amended the act by adding section 201(ff) (21 U.S.C.
321(ff)), which defines a ``dietary supplement,'' in part, as a
product, other than tobacco, intended to supplement the diet that
contains at least one or more of the following ingredients: A vitamin;
a mineral; an herb or other botanical; an amino acid; a dietary
substance for use to supplement the diet by increasing the total
dietary intake; or a concentrate, metabolite, constituent, extract, or
combination of any of the previously mentioned ingredients. This
section also states that the term ``dietary supplement'' means a
product that is labeled as a dietary supplement.
Furthermore, the DSHEA, among other things, amended section
403(q)(5)(F) of the act by adding specific requirements that relate to
the labeling of, and ingredient declaration on, dietary supplement
products. Previously, this section had applied only to dietary
supplements of vitamins and minerals and had not offered any
description of how the labeling of these products should differ from
the labeling of foods in general. As amended by the DSHEA, section
403(q)(5)(F) of the act provides that dietary ingredients that do not
have daily values (i.e., Reference Daily Intakes (RDI's) or Daily
Reference Values (DRV's)) must be listed within the nutrition
information, that the listing of dietary ingredients must include the
quantity of each dietary ingredient (or of a proprietary blend of such
dietary ingredients), and that the listing of dietary ingredients may
include the source of a dietary ingredient. It also provides that the
nutrition information must immediately precede the ingredient
information required under the act.
FDA received over 50 letters in response to the December 1995
proposal. Each of these letters contained one or more comments.
Responses were received from industry, trade associations, consumers,
consumer advocacy organizations, health care professionals,
professional societies, and city governments. Many comments supported
the proposal generally or supported aspects of the proposal. Other
comments objected to specific provisions of the proposal and requested
revisions. Some comments addressed issues outside the scope of the
proposal and will not be discussed here. A summary of the relevant
comments, the agency's responses to the comments, and a discussion of
the agency's conclusions follows.
II. The Term ``Dietary Supplement'' in the Statement of Identity
1. A number of comments objected to the proposed requirement in
Sec. 101.3(g) (21 CFR 101.3(g)) that the term ``dietary supplement''
appear as part of the statement of identity of dietary supplements.
Some of these comments requested the flexibility of allowing this term
either in the statement of identity or elsewhere on the label, such as
on the principal display panel or in the directions for use. A couple
of comments stated that, if the nutrition label was given the title
``Dietary Supplement Facts,'' a consumer could utilize the nutrition
label to identify the
[[Page 49827]]
product as a dietary supplement, making it unnecessary to include the
term as part of the statement of identity. Other comments requested
that FDA allow for reasonable flexibility in the use of synonyms or
modifiers for the term ``dietary supplement,'' such as ``Nutritional
Supplement,'' ``Herbal Supplement,'' ``Multivitamin/Multimineral
Supplement,'' or ``Amino Acid Blend.''
The comments presented a number of reasons for their disagreement
with the proposal. Several comments stated that the inclusion of the
term ``dietary supplement'' as part of the statement of identity on the
principal display panel overreaches the legislative intent of the
DSHEA. These comments stated that the DSHEA does not specify where the
term ``dietary supplement'' should be placed, and that, therefore,
flexibility of placement of the term is warranted. One comment stated
that it objected to FDA transforming an ``identify'' requirement in the
DSHEA into an ``identity'' requirement in the use of the term ``dietary
supplement.'' The comment asserted that the term ``identify'' in the
DSHEA is different from the requirement in 15 U.S.C. 1453(a)(1) (i.e.,
``the identity of the commodity''), upon which the identity labeling
provisions in Sec. 101.3 are based. Several comments stated that the
term ``dietary supplement'' by itself is inappropriate as a common
descriptor for dietary supplements because they include a wide range of
products, which meet vastly different consumer needs. These comments
stated that the term ``dietary'' does not add additional value to the
statement of identity, and that consumers might interpret the term
``dietary'' as part of the statement of identity to suggest that the
supplement is a weight loss or meal replacement product. These comments
stated that the statutory requirement that the term ``identify'' the
product could be satisfied with the use of the term ``supplement.'' One
comment submitted a market research study on consumer perception of the
term ``dietary supplement,'' which indicated that over 50 percent of
the subjects were confused by the term when used with the claim ``high
potency.'' One comment stated that the United States Pharmacopeia (USP)
has established a number of monographs of official names for specific
nutritional supplements but they do not include the term ``dietary
supplement.'' Several comments pointed out that use of the term
``dietary supplement'' is not part of their products' trademarked
terminology.
Several comments suggested that the agency provide alternate
requirements for dietary supplements in conventional food form to
distinguish them from conventional foods (e.g., cereals, snack bars,
drinks), requiring that the term ``dietary supplement'' appear on the
principal display panel, although not necessarily as part of the
statement of identity. These comments stated that dietary supplements
in capsule or tablet form are obviously dietary supplements, are easily
distinguished by consumers from conventional foods, and should not have
the same identity requirement. A few comments argued that there are
space limitations on the principal display panel of some dietary
supplements, and that the term ``dietary supplement'' uses up available
label space.
The agency has carefully reviewed these comments but concludes that
the best reading of the act, as well as the agency's longstanding
regulations that implement the act, require that the term ``dietary
supplement,'' or some form of this term, appear as part of the
statement of identity. Section 201(ff)(2)(C) of the act, in defining
the term ``dietary supplement,'' mandates that such a product must be
labeled as a dietary supplement. Section 403(s)(2)(B) of the act states
that a food shall be deemed to be misbranded if it is a dietary
supplement, and the label or labeling of the dietary supplement fails
to identify the product by using the term ``dietary supplement, which
term may be modified with the name of such an ingredient.'' Section
403(i)(1) of the act requires that a food label must bear the common or
usual name of the food, that is, a statement that identifies the food.
Dietary supplements are labeled subject to the provisions of section
403(i)(1) of the act (see the last sentence of section 201(ff) of the
act). Thus, when the act is read in its entirety, it is clear that
sections 201(ff)(2)(C), 403(s)(2)(B), and 403(i)(1) of the act require
that the statement of identity of a product that is marketed as a
dietary supplement identify the product as such.
FDA's longstanding regulations lead directly to this result.
Section 102.5 (21 CFR 102.5) sets out how the common or usual name of a
nonstandardized food is to be derived. Under this provision, the common
or usual name must accurately identify or describe, in as simple and
direct terms as possible, the basic nature of the food. The basic
nature of a dietary supplement is that it is a dietary supplement. This
is the point made in both sections 201(ff)(2)(C) and 403(s)(2)(B) of
the act. Thus, under Sec. 102.5(a), the common or usual name of these
products must, at least in part, identify them as a dietary supplement.
Section 101.3(b) of FDA's regulation states that the statement of
identity of a food shall be in terms of its common or usual name. Thus,
Sec. 101.3(g) derives directly from the act and FDA's longstanding
regulations that implement the act. Therefore, FDA is adopting
Sec. 101.3(g).
However, the agency is persuaded by the comments that flexibility
in the use of the term ``dietary'' as part of the name ``dietary
supplement''is warranted. The agency notes that section 403(s)(2)(B) of
the act states that the product shall be identified ``by using the term
`dietary supplement,' which term may be modified with the name of such
an ingredient.'' The agency interprets this provision to mean that the
term ``dietary supplement'' may be modified to include the name of a
dietary ingredient or ingredients (e.g., ``Vitamin C Supplement'').
Furthermore, to provide additional flexibility, an identifying term
that describes the types of dietary ingredients contained in the
product in appropriately descriptive terms (e.g., ``Multivitamin
Supplement,'' ``Herbal Supplement'') may be used. Generic terms that
are not descriptive (e.g., ``Food Supplement,'' ``Energy Bar'') would
not be appropriate because they do not identify or describe the dietary
ingredients (e.g., protein, folic acid, arrowroot) or combination of
ingredients that the product supplies.
Accordingly, FDA is revising Sec. 101.3(g) to provide that the term
``dietary supplement'' may be modified by replacing the term
``dietary'' with the name of a dietary ingredient or ingredients or an
appropriately descriptive term indicating the type of dietary
ingredients that are in the product. The agency notes that, with this
increased flexibility, several concerns expressed by the comments
(e.g., possible difficulties with space limitations, potential consumer
confusion, possible effects on established trademarked names) should be
alleviated.
2. One comment asked that the agency change the type size
requirements referred to in proposed Sec. 101.3(g), which stated that
``* * * the label shall bear the term `dietary supplement' as part of
the statement of identity in conformance with the provisions of
paragraph (d) of this section.'' The comment stated that the type size
requirements of Sec. 101.3(d) (i.e., that the statement of identity
``shall be in a size reasonably related to the most prominent printed
matter on such panel'') cross-referenced in proposed Sec. 101.3(g)
might be counterproductive or impracticable for products in small
packages with many dietary ingredients. The comment requested that the
agency require the same minimum type size as
[[Page 49828]]
that for the declaration of the net quantity of contents
(Sec. 101.105(i)(21 CFR 101.105(i))) because this would permit products
to bear the statement of identity in a type size that would be a
minimum of one-sixteenth of an inch.
FDA points out that Sec. 101.3(d) does not include minimum type
size requirements, but, as noted in the comment, it requires that the
size of the statement of identity be related to the size of the most
prominent printed matter on the label. Therefore, if the package size
is small, and there are many dietary ingredients to be listed, it is
reasonable to expect that even the most prominent printed matter will
be relatively small, permitting the statement of identity to be
proportionally smaller, in some cases as small as one-sixteenth of an
inch. Therefore, the agency is taking no action based on this comment.
However, because the reference in proposed Sec. 101.3(g) to paragraph
(d) of that section is redundant, inasmuch as all foods must meet all
regulatory requirements unless specific exceptions are noted, FDA has
deleted the reference to paragraph (d).
III. Nutrition Labeling of Dietary Supplements
A. Serving Size
3. Several comments stated that the term ``serving size'' is
inappropriate on dietary supplements. One comment stated that the term
``serving size'' should not appear in the nutrition label of dietary
supplements, except for products in the physical form of conventional
foods or for products with significant amounts of calories and
macronutrients, which should be covered by Sec. 101.9. This comment
recommended that the directions for use should provide the basis for
the quantitative statements contained in the nutrition label. Another
comment stated that the term ``serving size'' should not be used in the
nutrition label of herbal products and suggested the terms
``recommended use'' or ``suggested use.'' This comment suggested the
terms ``dose'' or ``dosage'' in the case of products marketed to health
professionals.
The agency is not persuaded by the comments objecting to the term
``serving size.'' As discussed in the final rule of January 4, 1994 (59
FR 354 at 358), information on serving size is as essential on the
nutrition label of dietary supplements as it is on that of conventional
foods. The agency points out that the directions for use provide the
basis for the serving size in the nutrition label of dietary
supplements in that serving sizes are derived by the manufacturer in
accordance with Sec. 101.12 (21 CFR 101.12). Section 101.12(b), Table
2, states that the reference amount customarily consumed for dietary
supplements is ``the maximum amount recommended, as appropriate, on the
label for consumption per eating occasion * * *.''
Section 403(q)(1)(A)(i) of the act states that a food is misbranded
unless its nutrition information specifies the serving size, and
nothing in the DSHEA directs the agency to eliminate the use of this
term in the nutrition label of dietary supplements. To the contrary,
section 403(q)(5)(F)(ii) of the act, which was added by the DSHEA,
states that the listing of dietary ingredients shall include the
quantity of each such ingredient per serving. This fact establishes
that Congress contemplated that serving size would be a part of the
nutrition labeling of dietary supplements.
With respect to using other terms in place of the term ``serving
size,'' the agency reiterates that the term ``serving size'' is
consistent with the act, and that it would be confusing to consumers if
the nutrition labels of dietary supplements used varied terms, such as
``recommended use'' or ``dose,'' in place of the term ``serving size.''
Use of the same term in the same place on all labels will help to avoid
confusion. Therefore, the agency has not made any changes in response
to these comments.
B. Information on Dietary Ingredients Having RDI's or DRV's
4. Several comments argued that some (sodium, vitamin A, vitamin C,
calcium, and iron) or all of the 14 nutrients required under
Sec. 101.9(c) should be required to be listed on the labels of dietary
supplements only when they are added to the supplement, or when a claim
is made about them. These comments argued that dietary supplements of
herbs or botanicals, for example, are not generally consumed for their
nutritional value, and that, thus, having to determine the levels of
the required nutrients would be unduly burdensome and of little use to
consumers who rely on the nutrition information to structure their
diets to maintain healthy dietary practices. One comment from an
independent analytical laboratory stated that mandatory requirements
for the listing of nutrients should not pertain to herbal products.
This comment stated that official methods of analysis do not apply to
herbal products and suggested that these products should be excluded
from labeling regulations requiring analysis until such time as
official methodology is published. Other comments specifically
supported the proposed rule in requiring that macronutrients be
declared whenever they are present.
FDA is not persuaded by the comments to modify Sec. 101.36(b)(2).
Section 403(q)(1) of the act specifies the nutrients that are to be
listed in the nutrition labeling of foods, and section 403(q)(2) of the
act gives the Secretary of Health and Human Services (the Secretary)
discretion to add to, or subtract from, this list for the purpose of
assisting consumers in maintaining healthy dietary practices. Section
403(q)(5)(F) of the act states that the labels of dietary supplements
shall comply with the requirements of subparagraphs (q)(1) and (q)(2)
in a manner that is appropriate.
In its final rule on nutrition labeling, the agency concluded that
information on the calorie, calories from fat, total fat, saturated
fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars,
protein, vitamin A, vitamin C, calcium, and iron content of foods was
necessary to assist consumers in maintaining healthy dietary practices
(58 FR 2079, January 6,1993). Accordingly, these nutrients are required
under Sec. 101.9(c) to be listed in nutrition labeling.
In its December 1995 proposal, the agency tentatively concluded
that these nutrients were equally as important to maintaining healthy
dietary practices when present in dietary supplements and, therefore,
should be mandatory on the labels of dietary supplement products as
well. However, to ease label crowding and to be consistent with the
DSHEA, FDA proposed that the 14 nutrients need only be listed on
dietary supplement labels when present in quantitative amounts by
weight that exceed the amount that can be declared as zero in
accordance with Sec. 101.9(c). FDA tentatively concluded that this
action would provide consumers with the information necessary to
determine how dietary supplement products fit into dietary regimens
that adhere to dietary recommendations.
Dietary supplements are foods under section 201(ff) of the act,
unless they are intended to be used as drugs. Moreover, under section
201(ff) of the act and some of the other changes made by the DSHEA,
dietary supplements may well be in conventional food form and contain
many of the 14 nutrients required to be listed in the nutrition label
under Sec. 101.9. Thus, as foods, it is appropriate to require that
their labeling bear the same nutrients as the nutrition labeling on
conventional foods, unless evidence is presented that justifies the
contrary conclusion.
[[Page 49829]]
The comments presented no evidence that would be a basis for the
agency to reach a conclusion different than it did for conventional
foods, i.e., that the listing of these nutrients will assist consumers
in maintaining healthy dietary practices. The agency is not convinced
that this requirement should be eliminated because of the argument that
herbs and botanicals are not generally consumed for their nutritional
value. The fact that a product is not generally consumed for its
nutritional value is immaterial under the act and its implementing
regulations. For example, certain spices, such as paprika, which are
consumed for their flavor-enhancing properties, not for nutritional
value, are not exempt from nutrition labeling under Sec. 101.9 if any
nutrient is present at more than insignificant levels
(Sec. 101.9(j)(4)). The agency concludes that it is appropriate for the
nutrients required in Sec. 101.9 to be mandatory on the labels of
dietary supplements. Thus, the agency is not modifying
Moreover, one of the principles underlying the agency's food
labeling initiative has been that, if nutrition labeling is to assist
consumers in making dietary choices, it should provide consistent
information for consumers to use (55 FR 29487 at 29490, July 19, 1990).
For example, fat is mandatory on the labels of conventional foods
because of scientific consensus that high dietary intakes of total fat
are associated with an increased risk of coronary heart disease, some
types of cancer, gallbladder disease, and obesity (55 FR 29487 at
29495). Thus, the listing of fat on the nutrition label, when it is
present, will assist consumers in meeting dietary recommendations to
limit fat intake to no more than 30 percent of calories, irrespective
of whether the nutrition labels are for conventional foods or dietary
supplements.
With respect to methodology issues, FDA is not persuaded that
herbal products should be exempt from labeling until analytical
methodology is validated for all herbal products. FDA is aware of the
difficulties in adapting analytical methods to different matrices and
specifically requested comment on this point in the proposal. The
agency received comments from industry groups actively working on the
development of official methodology, but these comments did not
indicate that problems with methodology necessitate exempting herbs
from nutrition labeling. Rather, FDA is aware that the adaptation of
existing methods to different matrices (e.g., herbs) is ongoing. In
addition, FDA has stated that analysis is not needed for nutrients
where reliable data bases or scientific knowledge establish that a
nutrient is not present in a serving of the product (58 FR 2079 at
2109). Therefore, it may not be necessary to analyze for several
nutrients in herbal products. For example, there is no need to analyze
for cholesterol because food composition studies have shown it to be
found only in animal products.
Thus, FDA concludes based upon these comments and on its own
experience that exempting herbs is unwarranted. Moreover, an exemption
would be inconsistent with section 403(q)(5)(F) of the act. Therefore,
the agency is not taking any action based on these comments.
5. Several comments requested more flexibility with the language
used in place of ``Amount Per Serving.'' The comments requested use of
phases such as ``Amount per 2 Tablets'' or ``Two Tablets Contain.''
The agency has no objection to the flexibility requested by these
comments. The agency proposed in Sec. 101.36(b)(2)(i)(A) that when the
serving size of the product is one unit, a heading consistent with the
declaration of the serving size, such as ``Amount Per Tablet'' or
``Each Tablet Contains,'' may be used in place of the heading ``Amount
Per Serving.'' In response to these comments, the agency agrees that
there is no reason to limit the language that can be used in this way.
Therefore, the agency is deleting the words ``when the serving size of
the product is one unit'' from Sec. 101.36(b)(2)(i)(A) and adding the
example ``Amount Per 2 Tablets.''
6. The agency received a couple of comments that recommended
changes in nomenclature for thiamin and riboflavin. These comments
requested that the name ``B1'' be used instead of
``thiamin,'' and that ``B2'' be used for ``riboflavin.'' One
comment stated that consumers do not know that these are B vitamins and
have been confused by the listing of thiamin and riboflavin on ``B-
complex'' products. The comment stated that the mandatory use of
``thiamin'' and ``riboflavin'' is inconsistent with the educational
purposes of the 1990 amendments and the DSHEA and recommended that the
use of these names be optional following the numerical names. The
comment recommended that this approach be followed on the labels of
conventional foods as well.
The agency has previously considered this issue. As discussed in
the proposal, the use of numerical terminology for these vitamins is
obsolete (29487 at 29502). ``The Handbook of Vitamins'' concurs with
this conclusion (Ref. 1, pp. 239 and 285). Also, the National Academy
of Sciences' National Research Council (NAS/NRC) publication on
``Recommended Dietary Allowances'' (Ref. 2, pp. 125 and 132) uses the
terminology ``thiamin'' and ``riboflavin,'' as does the nutrition
labeling of conventional foods. Consistent terminology is needed for
consumers to be able to calculate their total intake of these vitamins
from all food products.
To provide flexibility in the labeling of dietary supplements, the
agency proposed in the December 1995 proposal that the terms ``vitamin
B1'' and ``vitamin B2'' may be listed as synonyms
for thiamin and riboflavin. The agency is adopting this provision, so
manufacturers who wish to inform consumers that these nutrients are B
vitamins will be free to do so. Thus, they will be able to address any
consumer confusion as to why these nutrients are included in B-complex
products.
The agency concludes that the regulation it is adopting provides
the requisite flexibility and yet ensures that the nutrition label
conforms to up-to-date scientific views. Thus, FDA is not accepting the
recommendation of these comments.
7. One comment requested that ``folic acid'' be listed instead of
``folate,'' stating that the use of ``folic acid'' is consistent with
the final rule entitled ``Food Additives Permitted for Direct Addition
to Food for Human Consumption; Folic Acid (Folacin),'' published in the
Federal Register (61 FR 8797, March 5, 1996).
The agency agrees that the term ``folic acid'' can be listed in
place of ``folate.'' The December 1995 proposal stated in
Sec. 101.36(b)(2)(i)(B)(2) that ``folic acid'' and ``folacin'' may be
added in parentheses immediately following the listing of ``folate''
(60 FR 67194 at 67198). However, the health claims final rule on folate
and neural tube defects, amended the nutrition labeling regulations
that FDA had adopted for dietary supplements and conventional foods\1\
to allow the terms ``folic acid'' or ``folacin'' to be used
synonymously (61 FR 8752 at 8759, March 5, 1996)). In that final rule,
the agency acknowledged that the terms ``folic acid'' and ``folate''
are interchangeable in common usage, although technically ``folic
acid'' refers
[[Page 49830]]
to the synthetic form of this vitamin, and ``folate'' is a general term
that refers to both the synthetic and naturally-occurring forms.
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\1\ The regulations in place at that time were
Secs. 101.9(c)(8)(v) for conventional foods and Sec. 101.36(b)(3)(v)
for dietary supplements. Thus, FDA amended these regulations. FDA
had yet to implement Sec. 101.36(b)(3)(v), however (see 60 FR 7711,
February 9, 1995), and, as part of the changes included in the
December 1995 proposal, it renumbered this provision as
Sec. 101.36(b)(i)(B)(2).
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Thus, the agency agrees with the comment that it is appropriate for
``folic acid'' to be listed by itself in place of ``folate.'' For
clarity, the agency is modifying the language in
Secs. 101.36(b)(2)(i)(B)(2) and 101.9(c)(8)(v) to state
``alternatively, folic acid or folacin may be listed without
parentheses in place of folate.''
8. Several comments recommended that the agency require that
information on the quantitative amount by weight of each dietary
ingredient be placed immediately after the name of the dietary
ingredient, rather than in a separate column. The comments requested
this change because of space constraints on the label and the cost of
reformatting. One of these comments stated that consumers are already
familiar with a format in which amounts immediately follow names on
both dietary supplement and traditional food labels, and that there is
no evidence that they have difficulties understanding this information.
Other comments stated that the use of a single column should be
optional. At least one comment specifically supported the proposed two
columns because of readability.
The agency is persuaded that information on names and the
corresponding amounts of dietary ingredients should be allowed to
appear in one column to save space. In the January 4, 1994, final rule
on labeling of dietary supplements, the agency required that the name
of the nutrient and the quantitative amount by weight appear in a
single column despite several comments that argued for a separate
column for amounts. When the DSHEA amended the act to allow the source
of a dietary ingredient to be listed in the nutrition label following
the name, the agency's tentative view was that the additional
information added sufficient complexity to make it appropriate to have
the information on amount in a separate column. Some consumers buy
dietary supplements on the basis of quantitative amounts, and FDA
tentatively concluded that a separate column would help consumers to
locate this information more readily . However, based on the facts the
comments pointed out, that one column would make the dietary supplement
nutrition label consistent with that on conventional foods, and that
there are space and cost advantages to such a format, the agency has no
objection to the optional listing of the quantitative information by
weight immediately following the listing of names. The agency is
modifying Sec. 101.36(b)(2)(ii) accordingly.
9. A few comments stated that quantitative information should not
be declared on the basis of ``per serving.'' Some of these comments
requested that information be declared ``per day.'' These comments
argued that what is consumed per day is more important than per
serving. A couple of other comments preferred dual listing. One
suggested ``per unit and per day,'' and the other suggested ``per
serving and per day.'' Other comments specifically favored a ``per
serving'' basis and opposed dual listing.
The agency does not agree that quantitative information should be
declared on a ``per unit'' or a ``per day'' basis instead of ``per
serving.'' In its proposal on June 18, 1993 (58 FR 33715 at 33716), FDA
tentatively concluded that listing information on the basis of ``per
serving'' was preferable to ``per day'' because consumers might not
actually consume the amount indicated ``per day.'' With respect to
``per unit,'' FDA expressed concern that this basis alone could confuse
consumers when more that 1 unit is to be consumed at one time (e.g. two
capsules with each meal) because they might assume that the information
is on a ``per serving'' basis because the labels of conventional foods
are presented in this manner. For these reasons, the agency required a
``per serving'' basis in the final rule of January 4, 1994 (59 FR 354
at 359), and carried this forward in the December 1995 proposal (60 FR
67194 at 67198). More importantly, the act states in section
403(q)(5)(F)(ii) that the listing of dietary ingredients shall include
the quantity of each such ingredient ``per serving.'' Therefore, FDA is
not changing Sec. 101.36(b)(2)(ii), which requires that quantitative
information be listed on the basis of ``per serving.''
However, with respect to dual listing, the agency is persuaded that
there may be some products on which the unit amount may be of interest
to consumers, and, therefore, FDA is modifying the regulation to allow
the option of listing information on a ``per unit'' basis in addition
to a ``per serving'' basis. The agency notes that Sec. 101.9(b)(10)(ii)
permits the percent of Daily Value (DV) on the labels of conventional
foods to be listed in this manner when the product is in discrete
units, and a serving is more than 1 unit. Thus, the agency is adding
Sec. 101.36(b)(2)(iv) to provide for quantitative information to be
presented voluntarily on the basis of ``per unit'' in addition to the
required declaration ``per serving'' as noted in Sec. 101.36(b)(2)(ii).
When information is presented on a ``per unit'' basis, it must be
declared in additional columns to the right of the ``per serving''
information and must be clearly identified by appropriate headings, as
illustrated in Figure 1.
BILLING CODE 4190-01-F
[[Page 49831]]
[GRAPHIC] [TIFF OMITTED] TR23SE97.007
BILLING CODE 4190-01-C
10. One comment requested different rounding rules for sugars. The
comment wanted to be able to declare amounts under 2 grams (g) in
tenths of a g or to be able to declare 0, 0.5, 1.0, 1.5 and 2.0 g. This
comment stated that sugars are present in much smaller amounts in
dietary supplements than in conventional foods, and that the proposed
rounding rules are inappropriate.
The agency is not persuaded by the comment. Section 101.9(c)(6)(ii)
provides that sugars are expressed to the nearest g, except that if a
serving contains less than 1 g, the statement ``less than 1 gram'' may
be used, and if the serving contains less than 0.5 g, the content may
be expressed as zero. While sugars may be present in much smaller
amounts in dietary supplements than in conventional foods, FDA points
out that the comment did not justify why amounts of sugars that are
under 2 g should be listed any differently on the labels of dietary
supplements than on the labels of conventional foods. Moreover, given
that amounts under 0.5 g are considered nutritionally insignificant,
the agency is not convinced that being able to declare sugars in tenths
of a g or half-gram increments up to 2 g is useful in helping consumers
to maintain a healthy diet. Accordingly, the agency is not changing
Sec. 101.36 in response to this comment.
11. One comment requested clarification of the use of the word
``actual'' in proposed Sec. 101.36(b)(2)(ii)(B), which states ``The
amounts of vitamins and minerals, excluding sodium and potassium, shall
be the actual amount of the vitamin or mineral included in one serving
of the product * * *.'' This comment stated that overages of dietary
ingredients that are subject to degradation are added to dietary
supplement products to ensure that the products provide the labeled
quantities throughout their shelf life. The comment asked FDA to
acknowledge in the preamble of the final rule that the labeled amounts
of vitamins and minerals are not necessarily the actual amounts added
at the time of manufacture, and that the corresponding percent DV is
based on the labeled amount.
The agency agrees that the proposed language is not clear with
respect to what amount is to be declared. The agency does not intend
that the declared amount include any overages that a manufacturer
includes in anticipation of degradation. By use of the word ``actual,''
the agency was trying to draw a distinction between sodium and
potassium, which are required to be declared in the increments
prescribed in Sec. 101.9(c), and other vitamins and minerals, for which
increments are not prescribed in Sec. 101.9(c). (Section 101.9(c) does
not require declaration of the quantitative amounts by weight for these
other vitamins and minerals, only that they be declared as a percent of
the DV for the nutrient. Thus, the increments for declaration of the
quantitative amount of these nutrients are not specified in
Sec. 101.9(c).)
Given the reaction to Secs. 101.36(b)(2)(ii)(B) and
101.36(b)(2)(iii)(B) that is reflected in the comments, FDA concludes
that use of the word ``actual'' in these provisions is confusing.
Therefore, the agency is revising these paragraphs to delete this word.
12. Several comments agreed that the regulation should allow the
use of ``<1%'' in="" place="" of="" ``less="" than="" 1%''="" to="" save="" space.="" some="" of="" these="" comments="" supported="" the="" use="" of=""><1%'' on="" the="" labels="" of="" conventional="" foods="" as="" well="" as="" on="" the="" labels="" of="" dietary="" supplements.="" one="" of="" these="" comments="" stated="" that="" this="" symbol="" for="" ``less="" than''="" is="" taught="" in="" elementary="" math="" and="" science="" classes="" nationwide="" and="" is="" universally="" recognized.="" one="" comment="" from="" a="" trade="" association="" that="" represents="" manufacturers="" of="" conventional="" foods="" stated="" that="" the="" food="" industry="" has="" not="" been="" permitted="" the="" use="" of="" this="" symbol="" as="" there="" was="" no="" information="" demonstrating="" that="" consumers="" understand="" its="" meaning.="" this="" comment="" was="" opposed="" to="" the="" use="" of="" the="" symbol="" on="" the="" labels="" of="" dietary="" supplements="" until="" conventional="" foods="" are="" also="" able="" to="" use="" it.="" fda="" is="" persuaded="" by="" the="" comments="" to="" allow="" for="" the="" use="" of="" the="" symbol=""><'' for="" ``less="" than''="" on="" the="" labels="" of="" dietary="" supplements="" and="" conventional="" foods="" to="" provide="" more="" flexibility="" when="" space="" is="" limited="" on="" the="" label.="" while="" there="" is="" no="" consumer="" survey="" data="" to="" show="" the="" level="" of="" consumer="" understanding="" of="" the="" symbol,="" the="" agency="" acknowledges="" that="" elementary="" and="" secondary="" schools="" are="" teaching="" its="" use,="" so="" that="" a="" growing="" number="" of="" consumers="" can="" be="" expected="" to="" understand="" its="" meaning.="" in="" addition,="" the="" agency="" is="" aware="" that="" the="" symbol=""><'' is="" being="" used="" on="" the="" labels="" of="" some="" conventional="" foods,="" and="" fda="" has="" not="" received="" any="" consumer="" complaints="" about="" its="" use.="" given="" these="" unique="" circumstances,="" fda="" concludes="" that="" it="" is="" reasonable="" to="" allow="" use="" of="" the="" symbol,="" thereby="" reducing="" the="" possibility="" of="" overcrowding="" of="" information="" on="" some="" nutrition="" labels.="" accordingly,="" sec.="" 101.36(b)(2)(iii)(c)="" is="" finalized="" as="" proposed.="" the="" agency="" stated="" in="" the="" december="" 1995="" proposal="" (60="" fr="" 67194="" at="" 67200)="" [[page="" 49832]]="" that="" if="" it="" allowed="" the="" symbol="" on="" the="" nutrition="" labels="" of="" dietary="" supplements,="" it="" intended="" ``to="" provide="" for="" such="" use''="" on="" the="" nutrition="" labels="" of="" conventional="" foods="" as="" well.="" fda="" finds="" that="" it="" reasonably="" follows="" from="" this="" statement,="" and="" from="" the="" conclusions="" that="" it="" has="" reached="" with="" respect="" to="" dietary="" supplements,="" for="" it="" to="" take="" this="" action.="" accordingly,="" the="" agency="" is="" amending="" sec.="" 101.9(c)(8)(iii)="" and="" (d)(7)(i)="" to="" allow="" the="" use="" of="" the="" symbol=""><'' in="" place="" of="" the="" words="" ``less="" than.''="" 13.="" several="" comments="" supported="" the="" proposed="" use="" of="" the="" footnote="" ``daily="" value="" not="" established''(sec.="" 101.36(b)(2)(iii)(f)).="" however,="" three="" comments="" were="" against="" the="" use="" of="" this="" footnote="" in="" some="" cases.="" these="" comments="" stated="" that="" the="" footnote="" implied="" that="" a="" dv="" was="" not="" ``yet''="" established.="" consequently,="" they="" stated="" that="" it="" should="" only="" be="" permitted="" for="" components="" having="" some="" legitimate="" claim="" to="" nutritional="" value.="" one="" comment="" said="" that="" dietary="" ingredients="" such="" as="" choline="" should="" have="" an="" asterisk="" and="" a="" footnote,="" while="" dietary="" ingredients="" such="" as="" bee="" pollen="" should="" have="" no="" asterisk="" and="" no="" footnote.="" this="" comment="" said="" that="" a="" product="" composed="" solely="" of="" dietary="" ingredients="" such="" as="" bee="" pollen="" should="" have="" no="" ``%="" daily="" value''="" column,="" no="" asterisks,="" and="" no="" footnote.="" the="" agency="" does="" not="" agree="" with="" the="" comments="" that="" argued="" that="" the="" footnote="" apply="" only="" to="" dietary="" ingredients="" that="" ``have="" nutritional="" value.''="" the="" comments="" did="" not="" suggest="" a="" definition="" for="" dietary="" ingredients="" that="" have="" a="" ``claim="" to="" nutritional="" value,''="" or="" how="" to="" distinguish="" such="" dietary="" ingredients="" from="" the="" other="" dietary="" ingredients="" for="" which="" no="" dv="" has="" been="" established.="" thus,="" the="" agency="" does="" not="" know="" how="" it="" would="" implement="" the="" suggested="" change.="" the="" act="" makes="" it="" clear="" in="" section="" 403(q)(5)(f)(i)="" that="" dietary="" ingredients="" not="" having="" a="" recommendation="" for="" daily="" consumption="" established="" by="" the="" secretary="" are="" to="" be="" identified="" as="" ``having="" no="" such="" recommendation.''="" accordingly,="" fda="" is="" adopting="" sec.="" 101.36(b)(2)(iii)(f)="" unchanged="" from="" the="" proposal.="" c.="" other="" dietary="" ingredients="" 14.="" several="" comments="" recommended="" that="" ``other="" dietary="" ingredients''="" (those="" not="" having="" recommendations,="" i.e.,="" no="" rdi's="" or="" drv's)="" should="" be="" listed="" outside="" the="" ``box''="" format="" for="" nutrition="" information,="" and="" that="" products="" composed="" solely="" of="" these="" dietary="" ingredients,="" such="" as="" herbal="" supplements,="" should="" not="" be="" required="" to="" use="" the="" ``box''="" format.="" one="" of="" these="" comments="" suggested="" not="" requiring="" a="" ``box''="" format="" unless="" a="" claim="" is="" made.="" these="" comments="" stated="" that="" herbal="" supplements="" are="" not="" consumed="" for="" their="" nutritional="" value,="" and="" that="" it="" is="" not="" appropriate="" to="" use="" a="" format="" that="" mimics="" that="" of="" the="" nutrition="" facts="" panel.="" they="" said="" that="" the="" use="" of="" such="" a="" format="" would="" confuse="" consumers="" and="" would="" not="" convey="" any="" meaningful="" information.="" they="" argued="" that="" such="" a="" format="" goes="" beyond="" the="" intention="" of="" the="" dshea.="" one="" comment="" stated="" that="" simple="" ingredient="" listing="" should="" be="" an="" option="" in="" lieu="" of="" nutrition="" labeling.="" another="" comment,="" which="" requested="" more="" flexibility,="" said="" that="" the="" agency="" should="" allow="" the="" ``labeler="" to="" present="" the="" information="" to="" the="" consumer="" in="" the="" best="" way="" they="" see="" fit.''="" one="" other="" comment="" stated="" that="" flexibility="" in="" format="" was="" needed="" because="" of="" space="" constraints="" and="" recommended="" that="" the="" special="" labeling="" provisions="" in="" sec.="" 101.9(j)(13)="" should="" apply="" to="" dietary="" supplements.="" the="" agency="" is="" not="" persuaded="" by="" these="" comments="" that="" the="" format="" that="" it="" proposed="" goes="" beyond="" the="" intention="" of="" the="" dshea.="" to="" the="" contrary,="" the="" agency="" concludes="" that="" the="" format="" is="" consistent="" with="" the="" dshea.="" as="" a="" result="" of="" the="" dshea,="" the="" act="" requires="" that="" nutrition="" information="" immediately="" precede="" the="" ingredient="" information="" (section="" 403(q)(5)(f)(iv)),="" requires="" that="" the="" nutrition="" information="" list="" dietary="" ingredients="" not="" having="" recommendations="" (section="" 403(q)(5)(f)(i)),="" and="" defines="" herbs="" and="" other="" botanicals="" as="" dietary="" ingredients="" when="" present="" in="" dietary="" supplements="" (section="" 201(ff)(1)).="" taken="" together,="" the="" only="" logical="" reading="" of="" these="" provisions="" is="" that="" herbal="" dietary="" ingredients="" are="" to="" be="" listed="" in="" the="" nutrition="" information.="" accordingly,="" the="" agency="" is="" not="" making="" any="" change="" in="" sec.="" 101.36="" in="" response="" to="" these="" comments.="" the="" agency="" notes="" that="" sec.="" 101.36(i)(2)="" provides="" that="" dietary="" supplements="" are="" subject="" to="" the="" special="" labeling="" provisions="" specified="" for="" small="" and="" intermediate-sized="" packages="" in="" sec.="" 101.9(j)(13).="" 15.="" several="" comments="" requested="" that="" the="" ``other="" dietary="" ingredients,''="" those="" not="" having="" rdi's="" or="" drv's,="" including="" those="" in="" a="" proprietary="" blend,="" should="" be="" allowed="" to="" be="" declared="" in="" paragraph="" form="" beneath="" the="" bar="" required="" in="" sec.="" 101.36(e)(6)(ii)="" (i.e.,="" in="" a="" linear="" format="" with="" the="" quantity="" of="" each="" dietary="" ingredient="" immediately="" following="" the="" name="" of="" the="" ingredient="" itself)="" to="" save="" space.="" an="" example="" of="" such="" a="" label="" was="" included="" in="" one="" comment.="" one="" comment="" from="" a="" dietary="" supplement="" manufacturer="" stated="" that="" the="" majority="" of="" its="" products="" would="" qualify="" for="" an="" exemption="" or="" a="" linear="" layout="" under="" the="" special="" provisions="" for="" small="" or="" intermediate-sized="" packages="" in="" sec.="" 101.9(j)(13)="" if="" they="" were="" labeled="" as="" conventional="" foods.="" fda="" points="" out,="" as="" stated="" in="" response="" to="" the="" previous="" comment,="" that="" sec.="" 101.36(i)(2)="" provides="" that="" dietary="" supplements="" are="" subject="" to="" the="" special="" labeling="" provisions="" specified="" in="" sec.="" 101.9(j)(13)="" for="" foods="" in="" small="" or="" intermediate-sized="" packages,="" which="" includes="" the="" option="" of="" a="" linear="" layout="" when="" there="" is="" insufficient="" space="" for="" the="" vertical="" or="" tabular="" display.="" also,="" sec.="" 101.36(c)(2)="" provides="" that="" the="" ``other="" dietary="" ingredients''="" contained="" in="" a="" proprietary="" blend="" may="" be="" listed="" in="" linear="" fashion="" indented="" under="" the="" term="" ``proprietary="" blend.''="" in="" addition="" to="" the="" flexibility="" that="" these="" sections="" provide,="" fda="" has="" no="" objection="" if="" a="" linear="" display="" is="" used="" for="" the="" listing="" of="" all="" ``other="" dietary="" ingredients''="" on="" the="" labels="" of="" dietary="" supplement="" products,="" regardless="" of="" package="" size.="" however,="" as="" discussed="" in="" comment="" 18="" below,="" when="" constituents="" (i.e.,="" subcomponents)="" of="" ``other="" dietary="" ingredients''="" are="" listed,="" they="" must="" be="" indented="" under="" the="" listing="" of="" the="" dietary="" ingredient.="" thus,="" it="" is="" not="" possible="" to="" use="" a="" linear="" display="" for="" ``other="" dietary="" ingredients''="" when="" constituents="" are="" listed="" for="" any="" of="" them.="" therefore,="" the="" agency="" is="" revising="" sec.="" 101.36(b)(3)(i)="" and="" (b)(3)(ii)="" to="" provide="" explicitly="" that="" other="" dietary="" ingredients="" may="" be="" declared="" in="" a="" linear="" display="" as="" long="" as="" none="" of="" the="" dietary="" ingredients="" list="" constituents.="" figure="" 2="" illustrates="" the="" declaration="" of="" other="" dietary="" ingredients="" in="" a="" linear="" display.="" billing="" code="" 4190-01-f="" [[page="" 49833]]="" [graphic]="" [tiff="" omitted]="" tr23se97.008="" billing="" code="" 4190-01-c="" 16.="" one="" comment="" recommended="" that="" the="" listing="" of="" other="" dietary="" ingredients="" be="" alphabetical.="" the="" comment="" stated="" that="" this="" order="" would="" be="" user-friendly="" and="" assist="" consumers="" in="" making="" comparisons="" between="" various="" products.="" several="" other="" comments="" specifically="" stated="" that="" they="" agreed="" with="" the="" proposed="" rule,="" which="" would="" allow="" the="" manufacturer="" to="" determine="" the="" order="" of="" these="" dietary="" ingredients.="" one="" of="" these="" comments="" stated="" that="" there="" is="" no="" obvious="" benefit="" to="" alphabetical="" order="" or="" to="" descending="" order="" of="" predominance="" by="" weight="" because="" the="" quantity="" of="" each="" dietary="" ingredient="" is="" included.="" another="" comment="" stated="" that="" order="" based="" on="" predominance="" by="" weight="" could="" confuse="" consumers="" by="" incorrectly="" implying="" that="" the="" dietary="" ingredients="" that="" are="" present="" in="" greater="" predominance="" are="" of="" greater="" value.="" as="" discussed="" in="" the="" proposal="" (60="" fr="" 67194="" at="" 67210),="" the="" agency="" considered="" proposing="" to="" require="" alphabetical="" order="" but="" did="" not="" because="" it="" is="" not="" scientifically="" meaningful.="" the="" agency="" requested="" comments="" on="" this="" issue.="" because="" the="" majority="" of="" the="" comments="" supported="" the="" flexibility="" provided="" in="" the="" proposal,="" the="" agency="" is="" not="" persuaded="" that="" it="" is="" necessary="" to="" require="" that="" other="" dietary="" ingredients="" be="" listed="" in="" alphabetical="" order.="" manufacturers="" may,="" of="" course,="" do="" so="" if="" they="" choose.="" 17.="" several="" comments="" strongly="" opposed="" the="" statement="" in="" proposed="" sec.="" 101.36(b)(3)(ii)="" that="" ``or="" any="" dietary="" ingredients="" that="" are="" liquid="" extracts,="" the="" weight="" shall="" not="" include="" the="" weight="" of="" solvents.''="" the="" comments="" stated="" that="" the="" proposal="" is="" not="" practicable="" because="" in="" many="" cases="" there="" are="" no="" methods="" to="" determine="" the="" identity="" and="" quantity="" of="" entities="" dissolved="" in="" solvents.="" one="" comment="" from="" a="" trade="" association="" of="" manufacturers="" of="" natural="" food="" products="" stated="" that="" fda="" should="" allow="" a="" truthful="" and="" nonmisleading="" description="" of="" the="" content="" of="" an="" extract,="" such="" as="" the="" ratio="" of="" the="" weight="" of="" the="" starting="" material="" to="" the="" volume="" of="" the="" solvent="" used.="" this="" comment="" said="" that="" the="" association="" is="" working="" with="" other="" industry="" groups="" to="" develop="" a="" uniform="" method="" of="" reporting="" this="" information="" that="" is="" not="" false="" or="" misleading.="" another="" comment="" pointed="" out="" that="" the="" ratio="" method="" could="" be="" misleading="" in="" the="" absence="" of="" compendial="" standards="" because="" different="" supplies="" of="" the="" same="" herb="" can="" yield="" various="" strengths="" and="" potencies.="" for="" this="" reason,="" the="" comment="" discouraged="" the="" use="" of="" indicators="" of="" activity="" until="" compendial="" standards="" are="" established.="" another="" comment="" stated="" that="" fda="" should="" defer="" action="" on="" this="" issue="" until="" there="" is="" scientific="" agreement="" on="" appropriate="" methodology="" and,="" in="" the="" interim,="" require="" that="" extracts="" be="" listed="" with="" the="" weight="" of="" the="" entire="" extract.="" a="" comment="" from="" a="" trade="" association="" for="" herbal="" product="" manufacturers="" agreed="" that="" extracts="" should="" be="" listed="" with="" the="" weight="" of="" the="" entire="" extract,="" e.g.="" ``dandelion="" root="" extract="" (0.5="" fl="" oz).''="" this="" comment="" said="" that="" the="" identity="" of="" the="" dietary="" ingredients="" of="" botanical="" liquid="" extracts="" are="" the="" herbal="" extracts="" themselves.="" the="" agency="" is="" persuaded="" by="" the="" comments="" that="" the="" proposed="" manner="" of="" declaring="" extracts="" is="" not="" appropriate.="" the="" agency="" acknowledged="" in="" the="" proposal="" that="" this="" matter="" is="" a="" difficult="" one="" and="" specifically="" requested="" comment="" on="" how="" these="" provisions="" should="" be="" implemented.="" the="" comments="" pointed="" out="" that="" the="" dietary="" supplement="" industry="" and="" others="" are="" developing="" methods="" that="" will="" result="" in="" better="" information="" on="" the="" composition="" of="" such="" extracts.="" however,="" fda="" does="" not="" agree="" that="" it="" should="" defer="" action="" until="" validated="" methods="" are="" available="" or,="" in="" the="" meantime,="" require="" only="" that="" manufacturers="" list="" the="" weight="" of="" the="" entire="" extract.="" the="" agency="" is="" persuaded="" by="" the="" comment="" that="" recommended="" that="" extracts="" should="" be="" described="" by="" a="" ratio="" of="" the="" weight="" of="" the="" starting="" material="" to="" the="" volume="" of="" the="" solvent="" or="" a="" description="" of="" these="" values,="" which="" would="" indicate="" the="" concentration="" of="" the="" extract.="" the="" agency="" notes="" that="" the="" label="" must="" state="" whether="" the="" starting="" material="" is="" fresh="" or="" dry.="" because="" fresh="" botanicals="" contain="" water,="" it="" is="" important="" that="" the="" label="" have="" this="" information="" so="" that="" consumers="" can="" determine="" whether="" the="" weight="" listed="" includes="" the="" weight="" of="" any="" water.="" fda="" has="" subdivided="" proposed="" sec.="" 101.36(b)(3)(ii)="" to="" address="" the="" listing="" of="" liquid="" extracts="" in="" sec.="" 101.36(b)(3)(ii)(b)="" and="" of="" dried="" extracts="" in="" (b)(3)(ii)(c).="" the="" agency="" is="" requiring="" in="" sec.="" 101.36(b)(3)(ii)(b)="" that="" the="" label="" of="" liquid="" extracts="" clearly="" state="" whether="" the="" [[page="" 49834]]="" starting="" material="" is="" fresh="" or="" dry,="" what="" solvent="" is="" used,="" and="" the="" concentration="" of="" the="" botanical="" in="" the="" solvent,="" e.g.,="" ``fresh="" dandelion="" root="" extract,="" x="" mg="" (y:z)="" in="" 70%="" ethanol''="" where="" ``x''="" is="" the="" number="" of="" mg="" of="" the="" entire="" extract,="" ``y''="" is="" the="" number="" of="" mg="" of="" the="" starting="" material="" and="" ``z''="" is="" the="" number="" of="" milliliters="" of="" solvent.="" where="" the="" solvent="" has="" been="" partially="" removed="" (not="" to="" dryness),="" the="" final="" concentration="" should="" be="" stated="" (e.g.,="" if="" the="" original="" extract="" had="" a="" ratio="" of="" 1:5,="" and="" 50="" percent="" of="" the="" solvent="" were="" removed,="" the="" concentration="" listed="" would="" be="" 1:2.5).="" section="" 101.36(b)(3)(ii)(c)="" of="" this="" final="" rule="" states="" that="" where="" the="" solvent="" is="" removed="" to="" dryness,="" the="" weight="" of="" the="" dried="" extract="" must="" be="" listed.="" also,="" the="" dried="" extract="" must="" be="" described="" in="" a="" manner="" that="" includes="" the="" identity="" of="" the="" solvent="" because="" the="" solvent="" used="" determines="" the="" composition="" of="" an="" extract.="" for="" example,="" hexane="" as="" a="" solvent="" would="" concentrate="" nonpolar="" constituents,="" and="" water="" would="" concentrate="" polar="" constituents.="" these="" two="" dried="" extracts="" could="" have="" very="" different="" compositions.="" thus,="" the="" type="" of="" extract="" (e.g.,="" ``dried="" hexane="" extract="" of="" ________''="" or="" ``________,="" dried="" hexane="" extract'')="" is="" a="" material="" fact="" under="" sections="" 201(n)="" and="" 403(a)="" of="" the="" act="" and="" must="" be="" specified="" on="" the="" label,="" even="" when="" the="" solvent="" is="" removed="" during="" processing.="" the="" agency="" points="" out="" that="" solvents="" removed="" during="" processing="" that="" do="" not="" have="" any="" technical="" or="" functional="" effect="" in="" a="" food="" are="" exempt="" from="" being="" listed="" in="" ingredient="" labeling="" in="" accordance="" with="" sec.="" 101.100(a)(3)(ii)(a)="" (21="" cfr="" 101.100(a)(3)(ii)(a).="" however,="" solvent="" information="" is="" needed="" in="" the="" nutrition="" label="" of="" dietary="" supplements="" to="" appropriately="" describe="" extracts="" because="" dietary="" ingredients="" do="" not="" have="" individual="" regulations,="" like="" the="" regulations="" for="" food="" additives,="" that="" specify="" how="" they="" are="" to="" be="" made,="" and,="" when="" needed="" for="" identity="" or="" safety="" reasons,="" what="" solvent="" can="" be="" used="" in="" the="" processing.="" for="" example,="" sec.="" 172.580(b)="" (21="" cfr="" 172.580(b))="" states="" that="" safrole-free="" extract="" of="" sassafras="" is="" to="" be="" obtained="" by="" extracting="" the="" bark="" specified="" with="" dilute="" alcohol.="" there="" is="" no="" parallel="" provision="" for,="" nor="" is="" sec.="" 172.580(b)="" applicable="" to,="" the="" use="" of="" this="" substance="" in="" a="" dietary="" supplement.="" therefore,="" in="" the="" absence="" of="" individual="" regulations="" on="" dietary="" ingredients,="" the="" agency="" is="" requiring="" in="" sec.="" 101.36(b)(3)(ii)="" that="" a="" dried="" extract="" be="" described="" by="" an="" appropriately="" descriptive="" term="" that="" identifies="" the="" solvent="" used.="" 18.="" several="" comments="" requested="" the="" flexibility="" of="" listing="" both="" a="" dietary="" ingredient="" and="" one="" or="" more="" of="" its="" constituents="" (i.e.,="" subcomponents)="" to="" provide="" consumers="" with="" more="" information.="" one="" of="" the="" comments="" favoring="" this="" approach="" stated="" that,="" while="" two="" different="" supplements="" may="" both="" contain="" the="" same="" amount="" of="" a="" botanical,="" one="" product="" may="" yield="" twice="" as="" much="" of="" a="" particular="" constituent="" as="" the="" other="" brand.="" most="" of="" these="" comments="" suggested="" that="" constituents="" of="" a="" dietary="" ingredient="" should="" be="" indented="" under="" the="" listing="" of="" the="" dietary="" ingredient="" because="" consumers="" are="" familiar="" with="" this="" format,="" as="" it="" is="" comparable="" to="" the="" format="" used="" for="" certain="" drv="" nutrients="" and="" their="" subcomponents="" in="" the="" nutrition="" labeling="" of="" conventional="" foods.="" alternatively,="" a="" couple="" of="" comments="" suggested="" that="" constituent="" information="" immediately="" follow="" the="" listing="" of="" the="" dietary="" ingredient="" within="" parentheses.="" most="" of="" the="" comments="" gave="" examples="" where="" both="" the="" constituents="" and="" the="" dietary="" ingredients="" do="" not="" have="" rdi's="" or="" drv's,="" but="" one="" comment="" suggested="" that="" vitamin="" a="" and="" vitamin="" c="" should="" be="" indented="" under="" fish="" oil.="" one="" comment="" stated="" that="" if="" fda="" does="" not="" allow="" information="" about="" constituents="" inside="" the="" ``supplement="" facts''="" box,="" it="" should="" clarify="" that="" such="" information="" is="" allowed="" elsewhere="" on="" the="" label.="" the="" agency="" is="" persuaded="" by="" the="" comments="" to="" allow="" more="" flexibility="" with="" respect="" to="" the="" listing="" of="" constituents="" of="" dietary="" ingredients="" that="" do="" not="" have="" rdi's="" or="" drv's,="" as="" long="" as="" the="" resultant="" labels="" are="" not="" inconsistent="" with="" the="" act="" and="" are="" not="" confusing="" to="" consumers.="" the="" agency="" is="" requiring="" that="" constituents,="" when="" they="" are="" listed,="" be="" indented="" under="" the="" listing="" of="" the="" dietary="" ingredient="" in="" either="" a="" column="" or,="" to="" save="" space,="" in="" a="" horizontal="" linear="" display.="" quantitative="" amounts="" of="" the="" constituents="" must="" be="" listed="" and="" also="" must="" be="" included="" in="" the="" total="" quantitative="" amount="" listed="" for="" the="" dietary="" ingredient.="" the="" agency="" is="" requiring="" that="" the="" dietary="" ingredient="" and="" its="" weight="" be="" presented="" on="" one="" line,="" and="" that="" any="" information="" on="" constituents="" be="" indented="" under="" the="" declaration="" of="" the="" dietary="" ingredient="" to="" help="" clarify="" to="" consumers="" that="" the="" constituents="" are="" contained="" in="" the="" dietary="" ingredient.="" accordingly,="" the="" agency="" is="" adding="" new="" sec.="" 101.36(b)(3)(iii)="" to="" provide="" that="" the="" constituents="" of="" dietary="" ingredients="" not="" having="" rdi's="" or="" drv's="" may="" be="" listed.="" proposed="" sec.="" 101.36(b)(3)(iii)="" is="" redesignated="" as="" sec.="" 101.36(b)(3)(iv).="" when="" constituents="" of="" other="" dietary="" ingredients="" are="" dietary="" ingredients="" described="" in="" sec.="" 101.36(b)(2),="" they="" are="" to="" be="" listed="" in="" accordance="" with="" sec.="" 101.36(b)(2).="" section="" 403(q)(5)(f)(i)="" of="" the="" act="" provides="" that="" dietary="" ingredients="" having="" recognized="" dietary="" recommendations="" are="" to="" be="" listed="" first="" to="" be="" followed="" by="" the="" dietary="" ingredients="" not="" having="" recommendations.="" accordingly,="" with="" respect="" to="" the="" fish="" oil="" example,="" sec.="" 101.36(b)(2)="" requires="" that="" vitamin="" a="" and="" vitamin="" c="" be="" listed="" in="" the="" top="" half="" of="" the="" nutrition="" label,="" and="" that="" source="" information="" may="" be="" included="" following="" the="" listing="" of="" each="" in="" accordance="" with="" section="" 403(q)(5)(f)(iii)="" of="" the="" act="" ,="" e.g.,="" ``vitamin="" a="" (from="" fish="" oil).''="" listing="" vitamin="" a="" and="" vitamin="" c="" as="" constituents="" under="" the="" listing="" of="" fish="" oil="" is="" inconsistent="" with="" section="" 403(q)(5)(f)="" of="" the="" act.="" d.="" proprietary="" blends="" 19.="" one="" comment="" stated="" that="" there="" is="" no="" need="" to="" require="" a="" dietary="" supplement="" that="" is="" a="" proprietary="" blend="" to="" be="" identified="" specifically="" as="" a="" ``proprietary="" blend.''="" this="" comment="" gave="" an="" example="" that="" used="" the="" word="" ``blend''="" in="" place="" of="" ``proprietary="" blend''="" and="" noted="" that="" there="" are="" synonyms="" of="" ``blend''="" that="" would="" also="" accurately="" describe="" these="" products.="" however="" the="" comment="" did="" not="" list="" specific="" synonyms.="" the="" comment="" stated="" that="" there="" is="" no="" reason="" to="" limit="" label="" flexibility="" in="" this="" regard.="" other="" comments="" supported="" the="" use="" of="" the="" term="" ``proprietary="" blend.''="" one="" comment="" stated="" that,="" while="" a="" company="" has="" the="" obligation="" to="" identify="" such="" blends,="" most="" users="" of="" these="" blends="" have="" devised="" fanciful="" or="" trademarked="" names="" for="" them,="" and="" the="" term="" ``proprietary="" blend''="" should="" not="" have="" to="" be="" repeated="" in="" the="" top="" half="" of="" the="" nutrition="" label="" when="" source="" information="" is="" included="" in="" parentheses,="" and="" the="" blend="" is="" a="" source="" of="" one="" or="" more="" of="" the="" 14="" mandatory="" nutrients.="" fda="" is="" persuaded="" by="" the="" comment="" that="" it="" is="" not="" necessary="" to="" include="" the="" term="" ``proprietary="" blend''="" when="" the="" blend="" is="" identified="" by="" another="" term="" or="" fanciful="" or="" trademarked="" name.="" inasmuch="" as="" the="" act="" does="" not="" require="" use="" of="" the="" term="" ``proprietary="" blend,''="" and="" the="" formatting="" requirements="" (i.e.,="" declaration="" of="" total="" weight="" of="" blend="" followed="" by="" listing="" of="" dietary="" ingredients="" in="" the="" blend)="" will="" make="" the="" presence="" of="" a="" proprietary="" blend="" apparent,="" the="" agency="" is="" modifying="" sec.="" 101.36(c),="" (c)(2),="" and="" (c)(3)="" to="" state="" that="" the="" blend="" may="" be="" identified="" by="" the="" term="" ``proprietary="" blend''="" or="" another="" appropriately="" descriptive="" term="" or="" fanciful="" name.="" regarding="" the="" comment="" that="" stated="" that="" the="" name="" of="" a="" proprietary="" blend="" should="" not="" have="" to="" be="" repeated="" each="" time="" it="" is="" a="" source="" of="" a="" nutrient,="" the="" agency="" points="" out="" that="" this="" would="" not="" happen.="" firms="" are="" to="" list="" the="" specific="" ingredient="" in="" a="" proprietary="" blend="" that="" supplies="" a="" nutrient,="" rather="" than="" list="" the="" name="" of="" the="" proprietary="" blend.="" [[page="" 49835]]="" 20.="" another="" comment="" requested="" that="" the="" words="" ``proprietary="" blend''="" be="" allowed="" in="" bold="" type.="" the="" comment="" stated="" that="" in="" some="" instances,="" a="" bold="" type="" heading="" may="" be="" easier="" to="" see="" and="" to="" understand="" than="" an="" indented="" list="" of="" ingredients="" below="" the="" heading.="" the="" comment="" did="" not="" include="" a="" sample="" label="" illustrating="" its="" recommendation.="" the="" agency="" is="" not="" persuaded="" that="" bolding="" the="" term="" ``proprietary="" blend''="" is="" preferable="" to="" indenting="" the="" dietary="" ingredients="" in="" the="" blend="" under="" the="" term="" to="" show="" that="" these="" ingredients="" are="" included="" in="" the="" blend.="" indentation="" is="" used="" in="" other="" situations="" to="" convey="" the="" concept="" of="" inclusion="" (e.g.,="" in="" the="" listing="" of="" subcomponents="" of="" nutrients="" in="" nutrition="" labels="" on="" conventional="" foods="" in="" sec.="" 101.9(c)="" and="" on="" dietary="" supplements="" in="" sec.="" 101.36(b)(2)(i)(b)).="" as="" an="" example,="" sec.="" 101.9(c)(2)(i)="" provides="" that="" ``saturated="" fat''="" be="" indented="" under="" the="" listing="" of="" ``total="" fat.''="" at="" the="" same="" time,="" sec.="" 101.9(d)(1)(iv)="" provides="" that="" nutrients="" that="" are="" not="" indented,="" such="" as="" ``total="" fat''="" and="" ``total="" carbohydrate,''="" are="" to="" be="" bolded.="" consequently,="" while="" the="" agency="" has="" decided="" to="" retain="" the="" requirement="" in="" sec.="" 101.36(c)(2)="" that="" dietary="" ingredients="" contained="" in="" a="" proprietary="" blend="" be="" indented="" under="" the="" term="" ``proprietary="" blend''="" or="" descriptive="" term="" or="" fanciful="" name="" used="" in="" its="" place,="" fda="" does="" not="" object="" to="" the="" voluntary="" bolding="" of="" this="" term.="" accordingly,="" the="" agency="" is="" changing="" sec.="" 101.36(c)="" to="" permit="" bolding.="" 21.="" one="" comment="" objected="" to="" the="" requirement="" that="" a="" proprietary="" blend="" list="" its="" dietary="" ingredients="" in="" descending="" order="" of="" predominance="" by="" weight.="" this="" comment="" requested="" that="" the="" agency="" permit="" the="" listing="" of="" a="" ``lesser="" ingredient''="" first="" when="" the="" weight="" of="" the="" ingredient="" is="" specified.="" the="" comment="" did="" not="" give="" a="" reason="" for="" this="" request.="" fda="" is="" rejecting="" this="" request.="" to="" allow="" a="" dietary="" ingredient="" in="" a="" proprietary="" blend="" to="" be="" listed="" first="" when="" its="" weight="" is="" voluntarily="" declared="" would="" create="" an="" implication="" that="" there="" is="" less="" of="" the="" other="" dietary="" ingredients="" in="" the="" blend="" than="" the="" ingredient="" that="" is="" listed="" first.="" the="" only="" way="" to="" avoid="" creating="" this="" impression="" would="" be="" to="" list="" the="" weight="" of="" each="" of="" the="" other="" ingredients.="" yet,="" by="" definition,="" the="" amounts="" of="" the="" ingredients="" in="" the="" blend="" are="" proprietary.="" thus,="" the="" agency="" concludes="" that,="" when="" a="" proprietary="" blend="" is="" involved,="" the="" only="" way="" to="" avoid="" misleading="" consumers="" is="" to="" require="" that="" the="" ingredients="" of="" the="" blend="" be="" listed="" in="" descending="" order="" of="" predominance.="" if="" a="" manufacturer="" wishes="" to="" voluntarily="" list="" the="" weights="" of="" ingredients,="" it="" is="" free="" to="" do="" so,="" but="" fda="" is="" not="" requiring="" such="" a="" disclosure="" for="" other="" dietary="" ingredients="" in="" a="" proprietary="" blend.="" therefore,="" fda="" is="" not="" changing="" sec.="" 101.36(c)(2)="" in="" response="" to="" this="" comment.="" e.="" sources="" 22.="" several="" comments="" requested="" that="" dietary="" ingredient="" sources="" be="" permitted="" to="" be="" declared="" in="" the="" nutrition="" label="" without="" parentheses="" or="" without="" the="" word="" ``as''="" or="" ``from.''="" one="" of="" these="" comments="" stated="" that="" these="" points="" should="" be="" left="" up="" to="" the="" judgment="" of="" the="" manufacturer.="" this="" comment="" stated="" that="" the="" meaning="" of="" ``calcium="" from="" calcium="" carbonate''="" is="" clear="" without="" the="" use="" of="" parentheses,="" and="" that="" flexibility="" is="" needed="" to="" save="" space.="" one="" comment="" expressed="" support="" for="" the="" proposal="" and="" stated="" that="" the="" format="" proposed="" will="" help="" consumers="" to="" understand="" the="" relationship="" between="" the="" dietary="" ingredient="" and="" its="" source.="" the="" agency="" is="" not="" persuaded="" that="" space="" constraints="" justify="" making="" the="" use="" of="" parentheses,="" or="" of="" the="" words="" ``as''="" or="" ``from,''="" optional.="" in="" fact,="" some="" dietary="" supplements="" in="" small="" or="" intermediate-sized="" containers="" currently="" use="" the="" words="" ``as''="" or="" ``from''="" to="" help="" consumers="" understand="" that="" such="" compounds="" are="" the="" source="" of="" the="" dietary="" ingredients.="" the="" agency="" continues="" to="" be="" concerned="" that="" allowing="" flexibility="" in="" the="" manner="" in="" which="" dietary="" ingredient="" sources="" are="" listed="" in="" the="" nutrition="" label="" could="" lead="" to="" consumer="" confusion.="" fda="" has="" received="" many="" inquiries="" over="" the="" years="" that="" questioned="" whether="" amounts="" specified="" on="" labels="" refer="" to="" the="" weight="" of="" a="" particular="" nutrient="" or="" to="" the="" salt="" of="" that="" nutrient="" used="" to="" make="" the="" supplement.="" having="" parentheses="" around="" the="" source="" compound="" makes="" it="" clear="" that="" the="" quantitative="" amount="" and="" %="" dv="" pertain="" to="" the="" dietary="" ingredient="" listed="" and="" not="" to="" the="" source.="" thus,="" fda="" concludes="" that="" the="" format="" that="" it="" proposed="" is="" the="" most="" clear="" and="" should="" not="" be="" optional.="" accordingly,="" fda="" is="" not="" changing="" sec.="" 101.36(d)="" in="" response="" to="" these="" comments.="" 23.="" the="" agency="" received="" a="" comment="" on="" the="" proposed="" requirement="" (see="" proposed="" secs.="" 101.4(g)="" and="" 101.36(d))="" that="" the="" ingredient="" list="" on="" dietary="" supplements="" be="" preceded="" by="" the="" word="" ``ingredients''="" or,="" when="" some="" ingredients="" (i.e.,="" sources)="" are="" identified="" within="" the="" nutrition="" label,="" by="" the="" words="" ``other="" ingredients.''="" the="" comment,="" which="" was="" from="" a="" trade="" association="" for="" conventional="" foods,="" noted="" that="" the="" term="" ``ingredients''="" is="" in="" common="" usage="" in="" the="" labeling="" of="" conventional="" foods="" to="" denote="" the="" ingredient="" declaration="" but="" is="" not="" required.="" the="" comment="" stated="" that="" this="" requirement="" would="" set="" an="" adverse="" precedent="" for="" the="" labeling="" of="" conventional="" foods="" and="" requested="" that="" the="" use="" of="" these="" identifying="" terms="" be="" optional.="" the="" agency="" acknowledges="" that="" the="" ingredient="" declaration="" on="" the="" labels="" of="" conventional="" foods="" are="" not="" required="" to="" be="" preceded="" by="" the="" word="" ``ingredient.''="" however,="" the="" labels="" of="" conventional="" foods="" do="" not="" allow="" ingredient="" information="" in="" the="" nutrition="" label,="" so="" the="" potential="" for="" consumer="" confusion="" is="" not="" an="" issue.="" given="" the="" fact="" that="" the="" dshea="" requires="" dietary="" ingredients="" not="" having="" rdi's="" or="" drv's="" to="" be="" listed="" in="" the="" nutrition="" label="" of="" dietary="" supplements="" along="" with="" their="" amounts="" and="" also="" permits="" the="" sources="" of="" these="" dietary="" ingredients="" to="" be="" included="" in="" the="" nutrition="" label,="" the="" agency="" concludes="" that="" it="" is="" important="" that="" the="" nutrition="" information="" and="" the="" ingredient="" information="" on="" labels="" of="" dietary="" supplements="" be="" clearly="" identified.="" inasmuch="" as="" no="" comments="" from="" the="" dietary="" supplement="" industry="" objected="" on="" this="" point,="" and="" as="" the="" situation="" presented="" by="" dietary="" supplements="" is="" distinguishable="" from="" that="" presented="" by="" conventional="" foods,="" fda="" does="" not="" view="" this="" regulatory="" action="" as="" setting="" a="" precedent="" for="" conventional="" foods.="" thus,="" the="" agency="" is="" not="" making="" any="" changes="" in="" sec.="" 101.36(d)="" or="" sec.="" 101.4(g)="" on="" the="" designation="" of="" ingredients="" in="" response="" to="" this="" comment.="" 24.="" one="" comment="" urged="" the="" agency="" to="" abandon="" the="" requirement="" in="" proposed="" secs.="" 101.36(d)="" and="" 101.4(h)="" that="" the="" common="" or="" usual="" name="" of="" ingredients="" that="" are="" botanicals="" be="" followed="" by="" the="" latin="" binomial="" name="" of="" the="" plant.="" this="" comment="" stated="" that="" latin="" binomials="" are="" generally="" meaningless="" to="" consumers="" and="" take="" up="" valuable="" label="" space.="" another="" comment="" stated="" that="" latin="" binomials="" should="" only="" be="" used="" on="" dietary="" supplements="" sold="" to="" health="" professionals="" because="" they="" have="" the="" training="" to="" understand="" them.="" several="" other="" comments="" pointed="" out="" that="" the="" book="" herbs="" of="" commerce="" (ref.="" 11)="" establishes="" individual="" common="" names="" for="" over="" 600="" of="" the="" most="" prominent="" botanical="" ingredients="" in="" trade="" and="" gives="" the="" corresponding="" latin="" name="" for="" each="" common="" name.="" these="" comments="" recommended="" that="" the="" agency="" require="" the="" use="" of="" these="" standardized="" common="" names="" in="" labeling="" and="" not="" require="" the="" listing="" of="" latin="" names="" when="" they="" are="" available="" in="" this="" reference.="" other="" comments="" did="" not="" object="" to="" listing="" latin="" binomials="" but="" did="" object="" to="" including="" the="" designation="" of="" the="" author="" who="" published="" the="" name.="" another="" comment="" requested="" that="" abbreviations="" of="" latin="" binomials="" be="" allowed="" to="" save="" space.="" the="" agency="" is="" persuaded="" by="" the="" comments="" that="" the="" common="" names="" for="" botanicals="" standardized="" in="" the="" book="" [[page="" 49836]]="" herbs="" of="" commerce="" (ref.="" 11)="" should="" be="" used="" in="" labeling.="" because="" this="" reference="" lists="" the="" latin="" binomial="" for="" each="" standardized="" common="" name,="" the="" agency="" is="" persuaded="" that="" a="" latin="" binomial="" need="" not="" be="" included="" on="" labels="" when="" this="" information="" is="" available="" in="" herbs="" of="" commerce="" (ref.="" 11).="" thus,="" the="" agency="" is="" changing="" secs.="" 101.36(d)(1)="" and="" 101.4(h)="" accordingly.="" latin="" binomials="" will="" be="" required="" except="" when="" the="" common="" or="" usual="" name="" of="" the="" botanical="" is="" available="" in="" this="" reference,="" and="" the="" designation="" of="" the="" author="" will="" be="" needed="" when="" a="" positive="" identification="" can="" not="" be="" made="" in="" its="" absence="" (sec.="" 101.4(h)(2)).="" the="" agency="" reiterates="" that="" when="" a="" latin="" binomial="" is="" required,="" the="" complete="" binomial="" is="" required="" for="" each="" botanical="" present,="" even="" when="" multiple="" species="" of="" the="" same="" genus="" are="" present.="" with="" respect="" to="" the="" use="" of="" abbreviations="" of="" latin="" binomials,="" the="" agency="" proposed="" that="" any="" name="" in="" latin="" form="" shall="" be="" in="" accordance="" with="" internationally="" accepted="" rules="" on="" nomenclature,="" such="" as="" those="" found="" in="" the="" international="" code="" of="" botanical="" nomenclature,="" which="" does="" not="" include="" rules="" for="" the="" use="" of="" abbreviations="" (ref.="" 12).="" the="" comment="" that="" requested="" that="" abbreviations="" be="" permitted="" did="" not="" address="" why="" they="" should="" be="" permitted="" when="" they="" are="" not="" included="" in="" the="" international="" code="" of="" botanical="" nomenclature="" (ref.="" 12).="" in="" the="" absence="" of="" clearly="" defined="" rules,="" the="" agency="" is="" concerned="" that="" allowing="" abbreviations="" would="" cause="" a="" great="" deal="" of="" confusion.="" for="" example,="" there="" are="" 66="" plant="" names="" that="" could="" be="" represented="" by="" the="" abbreviation="" ``a.="" alba.''="" for="" this="" reason,="" the="" agency="" is="" not="" changing="" the="" regulation="" to="" allow="" for="" latin="" binomials="" to="" be="" abbreviated.="" 25.="" one="" comment="" requested="" that="" fda="" not="" require="" the="" declaration="" of="" the="" part="" of="" the="" plant="" for="" botanical="" ingredients="" that="" are="" used="" as="" a="" source="" material="" for="" other="" dietary="" ingredients.="" this="" comment="" stated="" that="" section="" 403(s)(2)(c)="" of="" the="" act="" requires="" that="" the="" labeling="" identify="" the="" part="" of="" the="" plant="" from="" which="" an="" herb="" or="" other="" botanical="" dietary="" ingredient="" is="" derived.="" thus,="" the="" comment="" contends="" that="" this="" information="" should="" not="" be="" required="" when="" an="" herb="" or="" other="" botanical="" is="" the="" source="" of="" a="" dietary="" ingredient.="" the="" agency="" agrees="" with="" this="" comment.="" as="" stated,="" the="" act,="" as="" a="" result="" of="" the="" dshea,="" requires="" identification="" of="" the="" part="" of="" a="" plant="" when="" a="" supplement="" contains="" a="" dietary="" ingredient="" that="" is="" an="" herb="" or="" other="" botanical.="" however,="" a="" constituent="" (i.e.,="" a="" chemical="" component)="" of="" a="" botanical="" may="" be="" a="" dietary="" ingredient="" under="" section="" 201(ff)(1)(f)="" of="" the="" act.="" when="" a="" constituent="" is="" listed,="" the="" agency="" agrees="" that="" information="" on="" the="" part="" of="" the="" plant="" is="" not="" required="" by="" the="" act.="" 26.="" several="" comments="" objected="" to="" the="" requirement="" that="" the="" part="" of="" the="" plant="" be="" listed="" in="" parentheses="" after="" the="" listing="" of="" the="" latin="" binomial.="" these="" comments="" requested="" that,="" as="" an="" alternative="" to="" allow="" flexibility="" and="" to="" save="" space,="" the="" listing="" of="" the="" part="" of="" the="" plant="" be="" permitted="" without="" parentheses="" following="" the="" common="" name="" of="" the="" plant.="" one="" of="" these="" comments="" stated="" that="" listing="" the="" part="" of="" the="" plant="" in="" this="" manner="" was="" more="" comprehensible.="" the="" agency="" points="" out="" that="" these="" final="" regulations="" do="" not="" require="" that="" latin="" binomial="" names="" be="" included="" when="" they="" are="" available="" in="" herbs="" of="" commerce="" (ref.="" 11)="" (see="" comment="" 24="" in="" section="" iii.e.="" of="" this="" document).="" in="" these="" cases,="" the="" part="" of="" a="" plant="" would="" immediately="" follow="" the="" listing="" of="" the="" common="" name.="" when="" a="" latin="" binomial="" name="" is="" required,="" the="" agency="" has="" no="" objection="" to="" having="" it="" be="" listed="" after="" the="" part="" of="" the="" plant.="" furthermore,="" fda="" is="" persuaded="" that,="" to="" save="" space,="" the="" listing="" of="" the="" part="" of="" the="" plant="" should="" be="" permitted="" to="" follow="" the="" common="" name="" of="" the="" plant="" without="" parentheses.="" therefore,="" the="" agency="" is="" reversing="" the="" order="" of="" proposed="" sec.="" 101.4(h)(1)="" and="" (h)(2)="" to="" reflect="" the="" order="" in="" which="" the="" information="" is="" to="" be="" provided="" and="" is="" revising="" the="" paragraph="" renumbered="" as="" sec.="" 101.4(h)(2)="" in="" response="" to="" these="" comments.="" the="" agency="" notes="" that="" sec.="" 101.36(d)(1)="" does="" not="" need="" to="" be="" changed="" in="" response="" to="" these="" comments="" as="" it="" cross="" references="" sec.="" 101.4="" and="" does="" not="" provide="" specific="" information="" on="" how="" to="" list="" the="" part="" of="" a="" plant.="" 27.="" one="" comment="" requested="" the="" option="" of="" listing="" each="" of="" the="" separate="" parts="" of="" a="" plant="" instead="" of="" the="" words="" entire="" ``plant,''="" when="" all="" parts="" of="" a="" plant="" are="" used.="" the="" comment="" stated="" that="" it="" is="" quite="" rare="" to="" actually="" use="" all="" parts="" of="" a="" plant.="" this="" comment="" also="" requested="" that="" the="" word="" ``herb''="" be="" permitted="" to="" refer="" to="" the="" above="" ground="" parts="" of="" a="" plant.="" the="" comment="" said="" that="" webster's="" new="" universal="" dictionary="" (2d="" ed.,="" 1983)="" gives="" ``herbage''="" as="" a="" definition="" of="" ``herb,''="" and="" that="" ``herbage''="" is="" defined="" as="" ``the="" green="" foliage="" and="" juicy="" stem="" of="" herbs.''="" the="" agency="" does="" not="" object="" to="" the="" listing="" of="" each="" of="" the="" separate="" parts="" of="" a="" plant="" instead="" of="" the="" words="" ``entire="" plant.''="" while="" this="" point="" was="" not="" addressed="" in="" the="" codified="" section="" of="" the="" proposal,="" the="" agency="" did="" make="" the="" statement="" in="" the="" preamble="" that="" when="" an="" entire="" plant="" is="" used,="" the="" label="" should="" specify="" ``entire="" plant''="" to="" meet="" the="" requirements="" of="" the="" act.="" the="" agency="" made="" this="" statement="" assuming="" that="" manufacturers="" would="" not="" want="" to="" list="" all="" the="" parts="" of="" a="" plant.="" however,="" the="" agency="" would="" not="" object="" if="" a="" manufacturer="" listed="" all="" the="" individual="" parts="" of="" a="" plant="" because="" such="" a="" listing="" is="" consistent="" with="" the="" dshea.="" regarding="" the="" request="" that="" the="" word="" ``herb''="" be="" permitted="" to="" describe="" the="" above="" ground="" parts="" of="" a="" plant,="" the="" agency="" is="" not="" convinced="" that="" this="" usage="" is="" appropriate.="" fda="" notes="" that="" the="" primary="" definition="" of="" the="" word="" ``herb''="" in="" many="" dictionaries="" refers="" to="" a="" type="" of="" a="" plant,="" i.e.,="" a="" nonwoody="" plant="" whose="" aerial="" portion="" is="" relatively="" short="" lived="" (only="" a="" single="" growing="" season="" in="" the="" temperate="" zone),="" rather="" than="" a="" part="" of="" a="" plant.="" accordingly,="" the="" agency="" is="" not="" persuaded="" by="" the="" comment="" that="" consumers="" would="" understand="" the="" term="" ``herb''="" to="" mean="" that="" part="" of="" the="" plant="" grown="" above="" ground="" and="" is="" denying="" this="" request.="" however,="" the="" agency="" has="" no="" objection="" to="" the="" use="" of="" the="" term="" ``aerial="" part''="" to="" describe="" the="" above="" ground="" parts="" of="" a="" part.="" f.="" format="" 28.="" several="" comments="" requested="" that="" the="" nutrition="" label="" be="" entitled="" ``nutrition="" facts''="" for="" all="" dietary="" supplements.="" these="" comments="" stated="" that="" ``nutrition="" facts''="" should="" be="" used="" for="" a="" variety="" of="" reasons,="" including="" that:="" (1)="" these="" products="" are="" marketed="" for="" their="" nutritional="" value,="" (2)="" the="" information="" presented="" is="" about="" nutrition,="" (3)="" the="" dshea="" uses="" the="" term="" ``nutrition="" information''="" (see="" section="" 403(q)(5)(f)(i)="" of="" the="" act),="" (4)="" the="" heading="" should="" be="" consistent="" with="" the="" heading="" used="" for="" conventional="" foods,="" (5)="" some="" conventional="" foods="" do="" not="" have="" nutritional="" value;="" thus,="" ``nutrition="" facts''="" on="" dietary="" supplements="" is="" acceptable,="" and="" (6)="" consumers="" would="" be="" confused="" by="" the="" heading="" ``supplement="" facts''="" and="" think="" that="" the="" products="" are="" of="" lesser="" value="" than="" conventional="" foods.="" one="" of="" these="" comments="" said="" that="" the="" heading="" ``supplement="" facts''="" is="" a="" misnomer="" because="" it="" implies="" that="" the="" information="" is="" supplemental="" and="" not="" complete.="" another="" comment="" stated="" that="" the="" heading="" ``supplement="" facts''="" would="" be="" a="" violation="" of="" sec.="" 101.9(k)(6),="" which="" provides="" that="" a="" food="" is="" misbranded="" if="" its="" label="" differentiates="" in="" any="" way="" between="" vitamins="" that="" are="" naturally="" present="" and="" those="" that="" are="" added.="" other="" comments="" recommended="" that="" the="" use="" of="" the="" heading="" ``nutrition="" facts''="" or="" ``supplement="" facts''="" should="" depend="" on="" the="" composition="" of="" a="" particular="" dietary="" supplement.="" some="" of="" these="" comments="" stated="" that="" a="" product="" containing="" even="" one="" vitamin="" or="" mineral="" having="" a="" dv-nutrient="" should="" be="" able="" to="" use="" the="" heading="" ``nutrition="" facts''="" because="" the="" product="" would="" have="" nutritional="" value.="" another="" comment="" [[page="" 49837]]="" wanted="" products="" containing="" only="" dv-nutrients="" to="" use="" the="" heading="" ``nutrition="" facts''="" and="" had="" no="" opinion="" on="" other="" products.="" other="" comments="" said="" that="" products="" that="" were="" mostly="" dv-nutrients="" should="" use="" the="" heading="" ``nutrition="" facts,''="" and="" products="" that="" were="" mostly="" herbals="" should="" use="" the="" heading="" ``supplement="" facts.''="" one="" comment="" wanted="" the="" option="" of="" using="" both="" headings="" in="" one="" nutrition="" label,="" listing="" dv-="" nutrients="" under="" the="" heading="" of="" ``nutrition="" facts''="" and="" other="" dietary="" ingredients="" under="" a="" secondary="" heading="" of="" ``supplement="" facts.''="" some="" of="" these="" comments="" recommended="" that="" the="" use="" of="" ``nutrition="" facts''="" or="" ``supplement="" facts''="" for="" combination="" products="" should="" depend="" upon="" how="" a="" product="" is="" marketed="" (i.e,="" the="" focus="" of="" the="" claims).="" a="" couple="" of="" these="" comments="" wanted="" the="" option="" of="" using="" ``dietary="" supplement="" facts''="" or="" ``herbal="" facts''="" in="" place="" of="" ``supplement="" facts.''="" additionally,="" at="" least="" one="" of="" these="" comments="" said="" that="" all="" dietary="" supplements="" in="" conventional="" food="" form="" should="" use="" the="" heading="" ``nutrition="" facts.''="" several="" other="" comments="" supported="" the="" proposed="" heading="" of="" ``supplement="" facts''="" for="" all="" dietary="" supplements.="" one="" of="" these="" comments="" said="" that="" this="" heading="" is="" consistent="" with="" the="" dshea,="" and="" another="" said="" that="" it="" will="" help="" consumers="" recognize="" the="" differences="" between="" dietary="" supplements="" and="" conventional="" foods.="" fda="" is="" not="" persuaded="" that="" the="" heading="" should="" be="" ``nutrition="" facts''="" because="" the="" dshea="" uses="" the="" term="" ``nutrition="" information,''="" because="" the="" information="" presented,="" at="" least="" in="" part,="" is="" about="" nutrition,="" or="" because="" these="" products="" are="" marketed="" for="" their="" nutritional="" value.="" the="" nutritional="" value="" of="" a="" particular="" product="" does="" not="" determine="" whether="" it="" is="" a="" dietary="" supplement="" or="" a="" conventional="" food.="" many="" dietary="" supplements="" contain="" many="" dv-nutrients;="" many="" contain="" none.="" additionally,="" the="" agency="" is="" not="" persuaded="" by="" the="" argument="" that="" consumers="" will="" be="" confused="" by="" the="" heading="" ``supplement="" facts''="" and="" think="" that="" products="" labeled="" in="" this="" manner="" are="" of="" lesser="" value.="" ``supplement''="" is="" the="" single="" word="" that="" must="" be="" used="" in="" the="" statement="" of="" identity="" for="" all="" dietary="" supplements="" (see="" comment="" 1="" in="" section="" ii.="" of="" this="" document),="" so="" use="" of="" the="" term="" in="" the="" title="" of="" the="" nutrition="" label="" can="" assist="" consumers="" in="" identifying="" dietary="" supplement="" products.="" the="" agency="" is="" not="" convinced="" that="" the="" name="" ``supplement="" facts''="" will="" result="" in="" any="" consumer="" judgment="" of="" the="" value="" of="" the="" product.="" dietary="" supplements="" have="" been="" known="" as="" ``supplements''="" for="" years,="" and="" fda="" is="" not="" aware="" of="" any="" confusion="" caused="" by="" this="" term.="" also,="" the="" supplemental="" nature="" of="" these="" products="" is="" supported="" by="" the="" new="" definition="" in="" section="" 201(ff)(2)(b)="" of="" the="" act,="" which="" states="" that="" a="" dietary="" supplement="" can="" not="" be="" ``represented="" for="" use="" as="" the="" sole="" item="" of="" a="" meal="" or="" the="" diet.''="" the="" agency="" does="" not="" agree="" that="" use="" of="" the="" title="" ``supplement="" facts''="" is="" a="" violation="" of="" sec.="" 101.9(k)(6).="" the="" distinguishing="" characteristic="" between="" products="" bearing="" nutrition="" labeling="" entitled="" ``supplement="" facts''="" and="" those="" bearing="" nutrition="" labeling="" entitled="" ``nutrition="" facts''is="" whether="" the="" products="" are="" dietary="" supplements="" or="" conventional="" foods,="" not="" whether="" the="" vitamins="" are="" natural="" or="" synthetic.="" both="" conventional="" foods="" and="" dietary="" supplements="" can="" include="" natural="" and="" synthetic="" vitamins.="" furthermore,="" the="" agency="" does="" not="" accept="" the="" suggestion="" that="" some="" dietary="" supplement="" products="" should="" have="" the="" heading="" ``nutrition="" facts,''="" while="" others="" have="" various="" headings="" (``supplements="" facts,''="" ``herbal="" facts,''="" and="" ``dietary="" supplements="" facts'')="" or="" even="" two="" headings="" (``nutrition="" facts''="" for="" the="" top="" half="" and="" ``supplement="" facts''="" for="" the="" bottom="" half).="" the="" act="" does="" not="" support="" treating="" supplements="" of="" vitamins="" and="" minerals="" any="" differently="" than="" other="" types="" of="" supplements.="" therefore,="" the="" agency="" is="" not="" doing="" so.="" in="" addition,="" if="" the="" agency="" consented="" to="" these="" recommendations,="" it="" would="" be="" possible="" for="" some="" chemically="" identical="" products="" to="" use="" up="" to="" four="" different="" headings.="" the="" agency="" concludes="" that="" so="" many="" different="" headings="" would="" only="" serve="" to="" confuse="" consumers.="" fda="" agrees="" with="" the="" comments="" that="" said="" that="" the="" heading="" of="" the="" nutrition="" label="" for="" all="" dietary="" supplements="" should="" be="" entitled="" ``supplement="" facts.''="" while="" dietary="" supplements="" are="" a="" category="" of="" foods,="" the="" act="" distinguishes="" dietary="" supplements="" from="" conventional="" foods="" in="" many="" important="" ways,="" e.g.,="" different="" requirements="" with="" respect="" to="" safety,="" to="" the="" types="" of="" claims="" that="" can="" be="" made,="" and="" to="" the="" kind="" of="" information="" that="" must="" be="" provided="" in="" the="" nutrition="" label.="" as="" stated="" in="" the="" preamble="" of="" the="" proposal="" and="" in="" one="" of="" the="" comments,="" the="" heading="" ``supplement="" facts''="" will="" help="" consumers="" to="" clearly="" distinguish="" between="" dietary="" supplements="" and="" conventional="" foods.="" nothing="" in="" the="" comments="" has="" persuaded="" fda="" that="" the="" heading="" ``supplement="" facts''="" would="" not="" help="" consumers="" to="" readily="" identify="" these="" products="" as="" dietary="" supplements.="" therefore,="" the="" agency="" is="" not="" changing="" sec.="" 101.36(e)(1)="" in="" response="" to="" the="" comments.="" however,="" the="" agency="" does="" advise="" that="" the="" decision="" whether="" a="" product="" is="" sold="" as="" a="" dietary="" supplement="" is="" made="" by="" the="" manufacturer.="" under="" the="" act,="" as="" amended="" by="" the="" dshea,="" the="" term="" ``dietary="" supplement''="" is="" defined="" as="" a="" product="" (other="" than="" tobacco)="" intended="" to="" supplement="" the="" diet="" that="" bears="" or="" contains="" a="" vitamin,="" a="" mineral,="" an="" herb="" or="" other="" botanical,="" an="" amino="" acid,="" a="" dietary="" substance="" for="" use="" by="" man="" to="" supplement="" the="" diet="" by="" increasing="" the="" total="" dietary="" intake,="" or="" a="" concentrate,="" metabolite,="" constituent,="" extract,="" or="" combination="" of="" any="" of="" the="" above="" ingredients="" (section="" 201(ff)(1)="" of="" the="" act).="" section="" 201(ff)(2)="" of="" the="" act="" further="" states="" that="" dietary="" supplements="" are="" intended="" for="" ingestion="" in="" a="" form="" described="" in="" section="" 411(c)(1)(b)(i)="" of="" the="" act="" (21="" u.s.c.="" 350="" (c)(1)(b)(i))="" or="" in="" compliance="" with="" section="" 411(c)(1)(b)(ii)="" of="" the="" act,="" are="" not="" represented="" as="" conventional="" food="" or="" as="" a="" sole="" item="" of="" a="" meal="" or="" the="" diet,="" and="" are="" labeled="" as="" a="" dietary="" supplement.="" thus,="" dietary="" supplements="" may="" be="" similar="" to="" conventional="" foods="" in="" composition="" and="" form.="" whether="" a="" product="" is="" a="" dietary="" supplement="" or="" a="" conventional="" food,="" however,="" will="" depend="" on="" how="" it="" is="" represented.="" to="" be="" a="" dietary="" supplement,="" a="" product="" must="" bear="" the="" term="" ``dietary="" supplement''="" as="" part="" of="" its="" common="" or="" usual="" name.="" (as="" stated="" in="" comment="" 1="" in="" section="" ii.="" of="" this="" document,="" this="" term="" may="" be="" modified="" to="" include="" the="" name="" of="" the="" dietary="" ingredient="" or="" type="" of="" dietary="" ingredient,="" such="" as="" ``vitamin="" c="" supplement''="" or="" ``multivitamin="" supplement.'')="" products="" that="" are="" not="" represented="" as="" dietary="" supplements="" will="" be="" subject="" to="" regulation="" as="" conventional="" foods.="" for="" example,="" the="" manufacturer="" of="" a="" product="" that="" is="" in="" the="" form="" of="" a="" tablet="" or="" capsule="" that="" has="" nutritive="" value="" or="" a="" powdered="" herbal="" product="" with="" no="" nutritive="" value="" may="" choose="" to="" market="" the="" product="" as="" a="" conventional="" food="" that="" bears="" nutrition="" labeling="" in="" accordance="" with="" sec.="" 101.9.="" in="" that="" situation,="" the="" nutrition="" labeling="" on="" the="" package="" of="" tablets="" with="" nutritive="" value="" would="" use="" the="" title="" ``nutrition="" facts,''="" while="" the="" herbal="" product="" with="" no="" nutritive="" value="" would="" be="" exempt="" from="" nutrition="" labeling="" under="" sec.="" 101.9(j)(4).="" should="" the="" manufacturer="" choose="" to="" do="" this,="" however,="" the="" label="" or="" labeling="" could="" not="" represent="" the="" food="" as="" a="" ``dietary="" supplement,''="" and="" the="" product="" could="" not="" rely="" on="" any="" of="" the="" special="" provisions="" for="" dietary="" supplements="" that="" were="" added="" by="" the="" dshea.="" thus,="" for="" example,="" the="" ingredients="" of="" the="" product="" would="" not="" be="" eligible="" for="" the="" exception="" for="" dietary="" ingredients="" from="" the="" definition="" of="" a="" ``food="" additive,''="" and="" the="" product="" could="" not="" bear="" statements="" under="" the="" authority="" of="" section="" 403(r)(6)="" of="" the="" act.="" [[page="" 49838]]="" 29.="" several="" comments="" objected="" to="" the="" use="" of="" hairlines="" in="" the="" nutrition="" label="" for="" space="" and="" readability="" reasons.="" one="" of="" these="" comments="" said="" that="" the="" use="" of="" hairlines="" should="" be="" optional,="" and="" another="" said="" that="" hairlines="" should="" not="" be="" required="" if="" there="" are="" more="" than="" eight="" dietary="" ingredients="" to="" be="" declared.="" another="" comment="" requested="" that="" dots="" be="" allowed="" instead="" of="" hairlines="" when="" the="" use="" of="" hairlines="" would="" cause="" the="" type="" size="" to="" fall="" under="" 4.5="" points.="" this="" comment="" sent="" sample="" labels="" with="" hairlines,="" without="" hairlines,="" and="" with="" dots.="" the="" dots="" connected="" the="" name="" of="" a="" dietary="" ingredient="" to="" the="" quantitative="" amount="" and="" the="" amount="" to="" the="" percent="" dv="" (see="" sample="" label="" in="" figure="" 3).="" billing="" code="" 4190-01-f="" [graphic]="" [tiff="" omitted]="" tr23se97.009="" billing="" code="" 4190-01-c="" the="" comments="" did="" not="" provide="" information="" to="" show="" that="" the="" legibility="" of="" the="" nutrition="" label="" is="" maintained="" if="" hairlines="" are="" allowed="" to="" be="" used="" optionally.="" section="" 2(b)(1)(a)="" of="" the="" 1990="" amendments="" directed="" the="" secretary="" (and="" by="" delegation="" fda)="" to="" require="" that="" the="" information="" required="" in="" nutrition="" labeling="" be="" conveyed="" in="" a="" manner="" that="" enables="" the="" public="" to="" readily="" observe="" and="" comprehend="" such="" information.="" to="" implement="" this="" provision="" of="" the="" 1990="" amendments,="" fda="" issued="" a="" rule="" that="" required="" hairlines="" in="" the="" nutrition="" label.="" hairlines="" make="" the="" nutrition="" label="" easier="" to="" read="" by="" aiding="" consumers'="" eye="" movement="" from="" the="" name="" of="" the="" nutrient="" to="" the="" percent="" dv.="" consumer="" surveys="" have="" shown="" that="" the="" graphic="" requirements="" in="" the="" nutrition="" labeling="" in="" sec.="" 101.9="" were="" successful="" in="" that="" the="" majority="" of="" shoppers="" who="" are="" aware="" of="" the="" new="" label="" think="" it="" is="" clear="" and="" understandable="" (ref.="" 3).="" therefore,="" fda="" is="" not="" willing="" to="" remove="" the="" requirement="" for="" hairlines="" without="" evidence="" that="" the="" legibility="" and="" readability="" of="" the="" nutrition="" label="" will="" be="" maintained="" on="" dietary="" supplement="" products,="" particularly="" when="" the="" product="" contains="" a="" large="" number="" of="" dietary="" ingredients.="" however,="" the="" agency="" finds="" that="" the="" sample="" label="" submitted="" that="" uses="" dots="" to="" connect="" the="" nutrient="" name="" to="" the="" weight="" and="" percent="" dv="" is="" a="" satisfactory="" substitute="" to="" assist="" eye="" movement="" when="" the="" only="" other="" option="" would="" be="" to="" reduce="" type="" size="" below="" 4.5="" points,="" the="" minimum="" type="" size="" consistent="" with="" the="" nonprescription="" drug="" manufacturers="" association="" (ndma)="" label="" readability="" guidelines="" used="" for="" over-the-counter="" drugs="" (ref.="" 4).="" this="" suggested="" flexibility="" appears="" to="" offer="" a="" reasonable="" balance="" between="" the="" competing="" needs="" for="" label="" space="" and="" readability="" on="" small="" and="" intermediate-sized="" packages.="" accordingly,="" the="" agency="" is="" adding="" sec.="" 101.36(i)(2)(v)="" to="" provide="" that="" dots="" connecting="" columns="" of="" nutrient="" names="" and="" quantitative="" amounts="" are="" allowed="" in="" place="" of="" hairlines="" between="" rows="" of="" type="" on="" small="" and="" intermediate-sized="" packages="" when="" it="" is="" not="" possible="" to="" meet="" the="" minimum="" type="" size="" requirements="" of="" 4.5="" points="" if="" hairlines="" are="" used.="" 30.="" several="" comments="" objected="" to="" the="" bar="" that="" separates="" the="" dietary="" ingredients="" having="" rdi's="" or="" drv's="" from="" other="" dietary="" ingredients="" because="" it="" may="" imply="" to="" consumers="" that="" other="" dietary="" ingredients="" are="" of="" lesser="" importance="" and="" it="" takes="" up="" space.="" one="" comment="" said="" that="" the="" bar="" should="" be="" optional="" because="" the="" asterisk="" and="" footnote="" ``daily="" value="" not="" established''="" are="" sufficient="" to="" distinguish="" other="" dietary="" ingredients.="" one="" trade="" association="" said="" that="" some="" of="" their="" members="" disliked="" this="" bar="" because="" it="" creates="" an="" artificial="" and="" illogical="" separation="" in="" some="" cases,="" e.g.,="" for="" a="" product="" containing="" only="" vitamins="" and="" minerals,="" but="" with="" some="" minerals="" for="" which="" an="" rdi="" has="" not="" been="" established.="" this="" comment="" said="" that="" other="" members="" liked="" the="" bar="" because="" it="" highlights="" the="" second="" portion="" of="" the="" list="" of="" dietary="" ingredients.="" other="" comments="" supported="" the="" proposed="" use="" of="" the="" bar.="" the="" agency="" is="" not="" persuaded="" by="" the="" comments="" that="" the="" bar="" should="" be="" eliminated="" because="" it="" may="" imply="" that="" the="" dietary="" ingredients="" below="" it="" are="" of="" lesser="" importance.="" while="" the="" agency="" acknowledges="" that="" the="" use="" of="" a="" bar="" is="" not="" expressly="" required="" by="" the="" act,="" section="" 403(q)(5)(f)(i)="" of="" the="" act="" states="" that="" ``nutrition="" information="" shall="" first="" list="" those="" dietary="" ingredients="" *="" *="" *="" for="" which="" a="" recommendation="" for="" daily="" consumption="" has="" been="" established="" by="" the="" secretary="" *="" *="" *="" and="" shall="" list="" any="" other="" dietary="" ingredient="" present="" and="" identified="" as="" having="" no="" such="" recommendation.''="" as="" discussed="" in="" the="" december="" 1995="" proposal="" (60="" fr="" 67194="" at="" 67206),="" the="" bar="" helps="" consumers="" to="" readily="" distinguish="" these="" two="" types="" of="" dietary="" ingredients,="" just="" as="" a="" bar="" differentiates="" between="" macronutrients="" and="" vitamins="" or="" minerals="" in="" the="" nutrition="" labeling="" of="" conventional="" foods.="" the="" agency="" does="" not="" agree="" that="" the="" asterisk="" and="" the="" footnote="" are="" sufficient="" for="" consumers="" to="" readily="" distinguish="" between="" these="" two="" groups="" because="" there="" are="" some="" cases="" where="" the="" asterisk="" and="" the="" footnote="" would="" be="" required="" for="" dietary="" ingredients="" listed="" above="" the="" bar="" (e.g.,="" sugars).="" for="" these="" reasons,="" the="" agency="" is="" not="" willing="" to="" eliminate="" the="" bar="" to="" conserve="" space.="" the="" agency="" points="" out="" that="" it="" has="" made="" a="" number="" of="" changes="" to="" save="" space,="" such="" as="" allowing="" the="" names="" of="" dietary="" ingredients="" and="" the="" corresponding="" amounts="" to="" appear="" in="" one="" column.="" thus,="" the="" agency="" is="" not="" making="" any="" change="" in="" sec.="" 101.36(e)(6)(ii)="" in="" response="" to="" these="" comments.="" g.="" compliance="" 31.="" several="" comments="" objected="" to="" the="" statement="" in="" proposed="" sec.="" 101.36(f)(1)="" that="" compliance="" will="" be="" determined="" in="" accordance="" with="" sec.="" 101.9(g)(1)="" through="" (g)(8).="" in="" particular,="" the="" comments="" objected="" to="" the="" application="" of="" sec.="" 101.9(g)(4)(i),="" which="" provides="" that="" the="" content="" of="" added="" nutrients="" should="" be="" at="" least="" 100="" percent="" of="" the="" value="" declared="" in="" the="" nutrition="" label,="" except="" for="" variability="" because="" of="" analytical="" methods.="" one="" comment="" supported="" the="" proposal="" and="" said="" that="" products="" should="" contain="" the="" levels="" that="" are="" declared.="" many="" of="" the="" comments="" in="" opposition="" requested="" that="" sec.="" 101.36(f)(1)="" be="" revised="" to="" state="" that="" supplements="" claiming="" to="" comply="" with="" compendial="" standards="" shall="" be="" judged="" ``based="" on="" compliance="" procedures="" specified="" or="" incorporated="" by="" reference="" in="" the="" compendial="" specifications.''="" specifically,="" these="" comments="" requested="" that="" the="" compliance="" level="" be="" a="" fixed="" minimum="" of="" 90="" percent="" that="" does="" not="" allow="" for="" variability="" because="" of="" methods,="" in="" accordance="" with="" standards="" in="" the="" usp.="" [[page="" 49839]]="" a="" comment="" from="" usp="" stated="" that="" its="" lower="" limit="" is="" not="" a="" moving="" target="" depending="" on="" analytical="" precision="" or="" on="" whose="" laboratory="" is="" performing="" the="" test.="" another="" comment="" explained="" that="" some="" nutrients="" are="" subject="" to="" degradation.="" this="" comment="" said="" that="" overages="" of="" these="" nutrients="" are="" added="" to="" dietary="" supplement="" products="" to="" ensure="" that="" the="" products="" provide="" the="" labeled="" amounts="" throughout="" their="" shelf="" life.="" to="" avoid="" excessive="" overages,="" the="" usp="" has="" required="" that="" at="" any="" time="" that="" a="" product="" is="" analyzed="" during="" its="" shelf="" life,="" the="" product="" must="" be="" shown="" to="" supply="" at="" least="" 90="" percent="" of="" the="" labeled="" amount="" of="" any="" ingredient.="" these="" comments="" argued="" that="" congress="" called="" for="" compendial="" products="" to="" meet="" compendial="" specifications="" (see="" section="" 403(s)(2)(d)="" of="" the="" act),="" and="" that="" fda="" should="" not="" alter="" those="" requirements.="" the="" agency="" is="" not="" persuaded="" that="" a="" fixed="" minimum="" of="" 90="" percent="" of="" the="" labeled="" amount="" should="" be="" acceptable="" for="" the="" nutrition="" panel="" of="" dietary="" supplements.="" fda="" agrees="" that="" section="" 403(s)(2)(d)="" of="" the="" act="" provides="" that="" a="" dietary="" supplement="" is="" misbranded="" if="" it="" is="" covered="" by="" the="" specifications="" of="" an="" official="" compendium,="" is="" represented="" as="" conforming="" to="" those="" specifications,="" but="" fails="" to="" do="" so.="" thus,="" dietary="" supplement="" products="" that="" are="" represented="" to="" meet="" the="" specifications="" of="" an="" official="" compendium,="" such="" as="" the="" usp,="" and="" fail="" to="" do="" so="" are="" misbranded="" under="" this="" section.="" however,="" the="" agency="" points="" out="" that="" products="" not="" misbranded="" under="" this="" section="" may="" be="" misbranded="" under="" other="" sections="" of="" the="" act.="" the="" issue="" of="" the="" acceptable="" amount="" of="" an="" added="" vitamin="" or="" mineral="" in="" a="" dietary="" supplement="" has="" been="" raised="" in="" earlier="" final="" rules="" (58="" fr="" 2079="" at="" 2171,="" january="" 6,="" 1993;="" and="" 59="" fr="" 354="" at="" 369,="" january="" 4,="" 1994).="" as="" discussed="" in="" those="" final="" rules,="" the="" agency="" informed="" usp="" in="" 1991="" that="" anything="" less="" that="" 100="" percent="" of="" the="" value="" declared="" on="" the="" label="" was="" not="" acceptable="" with="" the="" exception="" of="" a="" deviation="" that="" is="" attributable="" to="" the="" analytical="" method="" (ref.="" 5).="" fda="" finds="" nothing="" in="" the="" comments="" that="" would="" justify="" accepting="" less="" than="" 100="" percent="" of="" the="" value="" declared="" as="" compliance="" for="" added="" nutrients="" in="" dietary="" supplements.="" the="" argument="" that="" 90="" percent="" is="" appropriate="" because="" some="" nutrients="" degrade="" is="" not="" sufficient="" justification="" for="" the="" agency="" to="" change="" its="" position.="" because="" the="" degradation="" is="" foreseeable,="" fda="" expects="" that="" manufacturers="" will="" take="" it="" into="" account="" when="" fabricating="" dietary="" supplements.="" manufacturers="" have="" complete="" control="" over="" the="" level="" of="" dietary="" ingredients="" added="" to="" their="" products.="" thus,="" the="" manufacturers="" are="" appropriately="" charged="" with="" ensuring="" that="" the="" amounts="" present="" are="" at="" least="" 100="" percent="" of="" the="" amounts="" declared="" throughout="" the="" shelf="" life="" of="" their="" products,="" except="" for="" any="" variability="" that="" is="" attributable="" to="" methods.="" the="" agency="" concludes="" that="" a="" dietary="" supplement="" not="" meeting="" this="" requirement="" is="" misbranded="" under="" section="" 403(a)(1)="" of="" the="" act.="" therefore,="" the="" agency="" is="" not="" modifying="" sec.="" 101.36(f)(1)="" in="" response="" to="" these="" comments.="" furthermore,="" fda="" advises="" that="" it="" is="" aware="" that="" compliance="" policy="" guide="" 530.400="" (cpg="" 7121.02),="" entitled="" ``vitamin="" products="" for="" human="" use--low="" potency,''="" is="" inconsistent="" with="" sec.="" 101.36(f)(1).="" cpg="" 530.400="" sets="" forth="" the="" criteria="" for="" multivitamin="" products="" and="" states="" that="" legal="" action="" is="" recommended="" when="" a="" deficiency="" is="" found="" in="" excess="" of="" 20="" percent="" in="" one="" or="" more="" nutrients.="" because="" this="" position="" is="" contrary="" to="" sec.="" 101.36(f)(1),="" fda="" is="" revoking="" cpg="" 530.400.="" additionally,="" based="" on="" its="" review="" of="" the="" proposed="" regulations="" in="" preparation="" of="" this="" final="" rule,="" fda="" has="" come="" to="" recognize="" that="" the="" requirement="" in="" sec.="" 101.9(g)(2)="" that="" a="" sample="" for="" analysis="" shall="" consist="" of="" a="" composite="" of="" 12="" subsamples="" (consumer="" units)="" taken="" 1="" from="" each="" of="" 12="" different="" shipping="" cases="" is="" impractical="" for="" many="" dietary="" supplement="" products.="" the="" agency="" has="" found="" that="" it="" is="" not="" always="" possible="" to="" locate="" 12="" different="" shipping="" cases="" of="" dietary="" supplement="" products.="" inventories="" of="" dietary="" supplement="" products="" are="" often="" smaller="" than="" those="" of="" conventional="" foods,="" particularly="" at="" distribution="" and="" retail="" sites.="" accordingly,="" when="" 12="" shipping="" cases="" are="" not="" available,="" it="" is="" not="" possible="" for="" fda="" to="" collect="" a="" compliance="" sample="" that="" complies="" with="" sec.="" 101.9(g)(2).="" to="" provide="" for="" greater="" flexibility,="" the="" agency="" is="" modifying="" sec.="" 101.36(f)(1)="" to="" eliminate="" the="" requirement="" that="" consumer="" units="" come="" from="" 12="" different="" shipping="" cases.="" the="" agency="" is="" requiring="" only="" that="" the="" consumer="" units="" come="" from="" the="" same="" inspection="" lot="" (that="" is,="" the="" product="" available="" for="" inspection="" at="" a="" specific="" location)="" and="" be="" randomly="" selected="" to="" be="" representative="" of="" that="" lot.="" furthermore,="" the="" agency="" is="" providing="" flexibility="" with="" respect="" to="" the="" number="" of="" consumer="" units="" that="" are="" to="" be="" collected.="" fda="" is="" requiring="" in="" sec.="" 101.36(f)(1)="" that="" the="" ``sample="" for="" analysis="" shall="" consist="" of="" a="" composite="" of="" 12="" subsamples="" (consumer="" packages)="" or="" 10="" percent="" of="" the="" number="" of="" packages="" in="" the="" same="" inspection="" lot,="" whichever="" is="" smaller''.="" in="" other="" words,="" the="" entire="" contents="" of="" 12="" packages="" would="" be="" needed="" when="" there="" are="" over="" 120="" packages="" available.="" fewer="" packages="" would="" be="" needed="" when="" the="" total="" number="" of="" consumer="" units="" available="" is="" less="" than="" 120.="" in="" this="" case,="" the="" agency="" concludes="" that="" a="" 10="" percent="" sample="" is="" sufficiently="" representative="" for="" compliance="" purposes.="" while="" not="" statistically="" based,="" the="" 10="" percent="" sample="" has="" been="" well="" accepted="" in="" enforcement="" proceedings="" (ref.="" 6,="" pp.="" 818="" through="" 821).="" this="" approach="" allows="" the="" agency="" to="" take="" compliance="" actions="" as="" necessary,="" without="" being="" impeded="" by="" the="" low="" availability="" of="" the="" product="" in="" question.="" at="" the="" same="" time,="" fda="" is="" introducing="" the="" term="" ``packages''="" to="" clarify="" that="" this="" section="" pertains="" to="" packages="" labeled="" for="" retail="" sale="" rather="" than="" individual="" units="" of="" the="" product,="" e.g.,="" tablets="" or="" capsules,="" as="" the="" term="" ``unit''="" is="" defined="" in="" other="" parts="" of="" this="" document.="" this="" provision="" is="" a="" logical="" outgrowth="" of="" the="" proposal="" because="" by="" cross-referencing="" sec.="" 101.9(g)(1)="" through="" (g)(8)="" in="" the="" proposal,="" fda="" raised="" the="" question="" of="" whether="" these="" provisions="" appropriately="" apply="" to="" dietary="" supplements.="" based="" on="" the="" factors="" discussed="" above,="" fda="" concludes="" that="" the="" requirements="" regarding="" the="" number="" of="" consumer="" units="" in="" sec.="" 101.9(g)(2)="" should="" not="" apply="" to="" dietary="" supplements="" and="" is="" modifying="" sec.="" 101.36(f)(1)="" accordingly.="" h.="" special="" provisions="" and="" misbranding="" 32.="" one="" comment="" stated="" that="" small-sized="" packages="" (i.e.,="" those="" having="" a="" total="" surface="" area="" available="" to="" bear="" labeling="" of="" less="" than="" 12="" square="" inches)="" should="" be="" allowed="" to="" use="" a="" minimum="" type="" size="" of="" 4.0="" point="" when="" there="" are="" more="" than="" eight="" dietary="" ingredients="" to="" be="" listed="" in="" the="" nutrition="" label.="" the="" comment="" stated="" that="" the="" proposed="" minimum="" of="" 4.5="" point="" is="" impractical="" for="" certain="" dietary="" supplements="" products,="" and="" that="" a="" type="" size="" of="" 4.0="" point="" is="" still="" legible.="" the="" comment="" included="" sample="" labels="" using="" a="" type="" size="" of="" 4.0="" point.="" another="" comment="" requested="" that="" small-sized="" packages="" be="" allowed="" to="" use="" a="" minimum="" type="" size="" of="" 3="" point.="" this="" comment="" did="" not="" include="" sample="" labels.="" fda="" is="" not="" persuaded="" by="" these="" comments.="" as="" discussed="" in="" the="" final="" rule="" of="" january="" 4,="" 1994,="" fda="" set="" the="" minimum="" type="" size="" at="" 4.5="" point="" in="" response="" to="" the="" majority="" of="" the="" comments,="" which="" stated="" that="" this="" minimum="" is="" consistent="" with="" the="" ndma's="" label="" readability="" guidelines="" used="" for="" over-the-counter="" drugs="" (ref.="" 4).="" fda="" has="" received="" information="" from="" ndma="" that="" shows="" that="" it="" did="" not="" set="" this="" minimum="" arbitrarily="" or="" subjectively,="" but="" that="" it="" arrived="" at="" this="" minimum="" type="" size="" based="" on="" studies="" of="" visual="" acuity="" and="" demographics="" (ref.="" 7).="" while="" one="" of="" the="" comments="" that="" objected="" included="" sample="" labels="" using="" a="" type="" size="" of="" 4.0="" [[page="" 49840]]="" point,="" it="" did="" not="" present="" any="" visual="" acuity="" studies="" in="" support="" of="" its="" contention="" that="" a="" type="" size="" of="" 4.0="" point="" is="" legible.="" fda="" has="" been="" persuaded="" by="" ndma's="" data="" and="" points="" out="" that="" the="" vast="" majority="" of="" comments="" did="" not="" object="" to="" a="" minimum="" type="" size="" of="" 4.5="" point.="" moreover,="" firms="" in="" need="" of="" special="" allowances="" may="" seek="" alternative="" means="" of="" compliance="" or="" an="" exemption="" under="" sec.="" 101.36(f)(2).="" therefore,="" fda="" is="" not="" modifying="" sec.="" 101.36(i)(2)(i)="" in="" response="" to="" this="" comment.="" 33.="" several="" comments="" requested="" that="" sec.="" 101.2(c)="" be="" amended="" to="" include="" sec.="" 101.36.="" this="" amendment="" would="" allow="" type="" size="" smaller="" than="" 1/16th="" inch="" in="" certain="" instances.="" one="" of="" these="" comments="" said="" that="" this="" request="" is="" reasonable="" because="" the="" labels="" of="" dietary="" supplements="" commonly="" include="" information="" not="" found="" on="" the="" labels="" of="" conventional="" foods,="" e.g.,="" the="" iron="" warning="" statement.="" the="" agency="" is="" not="" persuaded="" by="" these="" comments.="" as="" discussed="" in="" the="" december="" 1995="" proposal,="" the="" request="" to="" amend="" several="" paragraphs="" in="" sec.="" 101.2(c)="" to="" include="" sec.="" 101.36="" was="" included="" in="" a="" citizen="" petition="" (docket="" no.="" 94p-0110/cp1)="" submitted="" to="" fda="" by="" the="" council="" for="" responsible="" nutrition="" in="" 1994.="" the="" agency="" denied="" this="" request="" because="" sec.="" 101.36="" addresses="" the="" type="" size="" requirements="" for="" information="" in="" the="" nutrition="" label="" of="" dietary="" supplements="" (60="" fr="" 67194="" at="" 67208).="" the="" agency="" noted="" that="" sec.="" 101.9="" covers="" the="" corresponding="" requirements="" for="" conventional="" foods.="" the="" purpose="" of="" sec.="" 101.2(c)(1)="" through="" (c)(3)="" was="" to="" encourage="" voluntary="" declaration="" of="" nutrition="" information="" and="" complete="" ingredient="" listing="" on="" all="" foods="" before="" declaration="" became="" mandatory="" under="" the="" 1990="" amendments.="" fda="" gave="" notice="" of="" its="" intention="" to="" revoke="" the="" exemptions="" in="" sec.="" 101.2(c)(1),="" (c)(2),="" and="" (c)(3)="" in="" its="" december="" 1995="" proposal="" (60="" fr="" 67194="" at="" 67208),="" and="" proposed="" to="" do="" so="" in="" the="" federal="" register="" of="" june="" 12,="" 1996="" (61="" fr="" 29708),="" because="" they="" are="" obsolete.="" therefore,="" fda="" is="" not="" accepting="" these="" comments.="" 34.="" at="" least="" one="" comment="" recommended="" that="" a="" minimum="" type="" size="" of="" 4.5="" point="" be="" allowed="" for="" dietary="" supplement="" packages="" that="" have="" a="" total="" surface="" area="" available="" to="" bear="" labeling="" of="" less="" than="" 40="" square="" inches="" and="" have="" more="" than="" 8="" dietary="" ingredients="" to="" be="" listed="" in="" the="" nutrition="" label.="" the="" comment="" said="" that="" it="" is="" impracticable="" to="" comply="" with="" the="" proposed="" type="" size="" requirements="" for="" dietary="" supplement="" products="" that="" contain="" many="" dietary="" ingredients.="" fda="" is="" not="" persuaded="" by="" the="" comment="" that="" a="" minimum="" type="" size="" of="" 4.5="" point="" should="" be="" allowed="" on="" dietary="" supplement="" packages="" with="" 20="" to="" less="" than="" 40="" square="" inches="" of="" total="" surface="" area="" available="" to="" bear="" labeling="" that="" have="" more="" than="" 8="" dietary="" ingredients="" to="" be="" listed.="" the="" agency="" proposed="" to="" require="" a="" minimum="" type="" size="" of="" 4.5="" point="" for="" packages="" of="" less="" than="" 12="" square="" inches="" and="" 6="" point="" for="" packages="" of="" 12="" to="" 40="" square="" inches,="" except="" that="" it="" proposed="" that="" 4.5="" point="" may="" be="" used="" on="" packages="" of="" less="" than="" 20="" square="" inches="" that="" have="" more="" than="" 8="" dietary="" ingredients="" to="" be="" listed="" in="" the="" nutrition="" label.="" this="" exception="" for="" packages="" of="" less="" than="" 20="" square="" inches="" was="" in="" response="" to="" a="" citizen="" petition="" filed="" by="" the="" council="" for="" responsible="" nutrition="" (docket="" no.="" 94p-0110/cp1).="" in="" its="" proposal="" (60="" fr="" 67194="" at="" 67208),="" fda="" explained="" how="" it="" arrived="" at="" its="" tentative="" determination="" that="" a="" minimum="" of="" 4.5="" point="" should="" be="" allowed="" only="" on="" packages="" of="" less="" than="" 20="" square="" inches="" that="" have="" more="" than="" 8="" dietary="" ingredients.="" agency="" precedent="" provided="" that="" not="" more="" than="" 30="" percent="" of="" the="" total="" surface="" area="" of="" a="" package="" should="" be="" required="" to="" be="" devoted="" to="" fda-required="" information="" that="" is="" not="" on="" the="" principal="" display="" panel.="" the="" agency="" calculated="" that="" this="" 30="" percent="" level="" would="" likely="" be="" exceeded="" on="" packages="" of="" 12="" to="" 20="" square="" inches="" of="" surface="" area="" available="" to="" bear="" labeling="" if="" more="" than="" 8="" dietary="" ingredients="" were="" listed="" using="" 6="" point="" type="" size.="" accordingly,="" fda="" proposed="" to="" allow="" those="" packages="" to="" bear="" nutrition="" labeling="" that="" uses="" the="" smaller="" type.="" applying="" the="" same="" calculations="" as="" discussed="" in="" the="" preamble="" of="" the="" proposed="" rule,="" the="" agency="" estimates="" that="" listing="" 24="" dietary="" ingredients="" in="" 6="" point="" type="" size="" plus="" 1="" point="" leading="" between="" each="" line="" of="" type="" could="" use="" up="" to="" 6="" square="" inches="" of="" label="" space.="" this="" would="" be="" equivalent="" to="" 30="" percent="" of="" the="" total="" surface="" area="" of="" a="" package="" having="" 20="" square="" inches="" of="" surface="" area="" available="" to="" bear="" labeling="" (i.e.,="" 20="" x="" 0.3).="" accordingly,="" in="" response="" to="" the="" comment,="" the="" agency="" will="" allow="" for="" the="" use="" of="" a="" minimum="" 4.5="" type="" size="" in="" such="" situations.="" in="" addition,="" based="" on="" the="" agency's="" observation="" that="" about="" 20="" percent="" of="" dietary="" ingredients="" listed="" in="" sample="" labels="" submitted="" with="" comments="" that="" include="" ingredient="" information="" require="" two="" lines="" of="" type,="" the="" agency="" concludes="" that="" it="" is="" reasonable="" to="" allow="" the="" minimum="" type="" size="" of="" 4.5="" point="" for="" packages="" with="" 20="" to="" 40="" square="" inches="" of="" label="" space="" available="" to="" bear="" labeling="" having="" more="" than="" 16="" dietary="" ingredients.="" section="" 101.36(i)(2)(ii)="" is="" revised="" accordingly.="" this="" final="" rule="" represents="" a="" full="" response="" to="" the="" council="" for="" responsible="" nutrition's="" citizen="" petition="" referred="" to="" above="" (docket="" no.="" 94p-0110/cp1),="" in="" accordance="" with="" 21="" cfr="" 10.30(e).="" 35.="" several="" comments="" supported="" the="" proposed="" deletion="" of="" sec.="" 101.9(k)(2)="" and="" (k)(5).="" some="" of="" these="" comments="" recommended="" that="" all="" of="" sec.="" 101.9(k)="" be="" deleted,="" asserting="" that="" it="" is="" not="" scientifically="" defensible,="" and="" that="" it="" is="" not="" consistent="" with="" the="" protection="" of="" free="" speech="" provided="" in="" the="" first="" amendment="" and="" the="" supreme="" court="" decision="" of="" rubin="" v.="" coors="" brewing="" co.,="" 517="" u.s.____,="" 115="" s.="" ct.="" 1585="" (1995).="" while="" these="" comments="" specifically="" addressed="" the="" deletion="" of="" sec.="" 101.9(k)(3),="" (k)(4),="" and="" (k)(6),="" none="" addressed="" sec.="" 101.9(k)(1).="" two="" comments="" addressed="" sec.="" 101.9(k)(3)="" and="" (k)(4),="" which="" prohibit="" statements="" that="" represent,="" suggest,="" or="" imply="" that="" the="" suboptimal="" nutritional="" quality="" of="" a="" food="" because="" of="" soil="" conditions="" or="" storage,="" transportation,="" or="" processing="" methods="" may="" be="" responsible="" for="" an="" inadequacy="" in="" the="" quality="" of="" the="" daily="" diet.="" one="" comment="" argued="" that="" these="" paragraphs="" should="" be="" deleted="" because="" any="" conditions="" that="" adversely="" affect="" the="" nutritional="" quality="" of="" foods="" will="" ultimately="" affect="" the="" nutritional="" quality="" of="" diets,="" even="" if="" such="" effects="" are="" not="" so="" extensive="" as="" to="" lead="" to="" widespread="" nutritional="" deficiencies.="" two="" other="" comments="" addressed="" sec.="" 101.9(k)(4)="" specifically,="" citing="" evidence="" to="" show="" that="" various="" food="" processing="" techniques="" do="" cause="" nutrient="" losses="" and="" stating="" that="" national="" food="" consumption="" patterns="" are="" changing,="" leading="" to="" reduced="" consumption="" of="" fresh="" foods="" and="" increased="" use="" of="" processed="" convenience="" foods.="" a="" few="" comments="" recommended="" deletion="" of="" sec.="" 101.9(k)(6),="" which="" prohibits="" any="" representation="" that="" naturally-occurring="" vitamins="" are="" superior="" to="" added="" or="" synthetic="" vitamins="" or="" any="" differentiation="" between="" added="" and="" naturally="" occurring="" vitamins.="" the="" comments="" argued="" that="" fda="" should="" not="" forbid="" truthful="" representations="" on="" the="" label="" of="" the="" composition="" and="" biochemical="" forms="" of="" natural="" and="" synthetic="" vitamins,="" citing="" biochemical="" distinctions="" between="" naturally="" occurring="" and="" synthetic="" vitamins="" and="" stating="" that="" this="" information="" enables="" consumers="" to="" make="" more="" informed="" purchasing="" decisions.="" fda="" has="" considered="" the="" comments="" pertaining="" to="" sec.="" 101.9(k)(3)="" and="" (k)(4)="" and="" is="" not="" persuaded="" that="" they="" are="" no="" longer="" supportable.="" the="" agency="" agrees="" with="" the="" comments="" that="" stated="" that="" the="" nutritional="" quality="" of="" a="" diet="" is="" affected="" by="" the="" nutritional="" quality="" of="" the="" foods="" contained="" in="" that="" diet.="" however,="" when="" diets="" are="" inadequate,="" many="" factors="" must="" [[page="" 49841]]="" be="" considered="" as="" causal,="" and="" it="" would="" be="" misleading="" to="" attribute="" such="" a="" result="" only="" to="" soil="" conditions="" and="" storage,="" transportation,="" and="" processing="" methods.="" for="" example,="" the="" food="" choices="" a="" person="" makes="" are="" a="" major="" determinant="" of="" the="" quality="" of="" his/her="" diet.="" recent="" research="" has="" shown="" that="" the="" more="" a="" diet="" adheres="" to="" the="" food="" guide="" pyramid="" (ref.="" 8)="" and="" to="" dietary="" recommendations="" to="" eat="" a="" variety="" of="" foods="" and="" to="" moderate="" the="" consumption="" of="" fat,="" saturated="" fat,="" cholesterol,="" and="" sodium,="" the="" greater="" the="" likelihood="" that="" nutrient="" requirements="" will="" be="" met="" (ref.="" 9).="" the="" comment="" that="" suggested="" that="" the="" consumption="" of="" fresh="" fruits="" and="" vegetables="" is="" decreasing="" is="" not="" supported="" by="" recent="" research="" on="" the="" u.s.="" food="" supply="" by="" the="" u.s.="" department="" of="" agriculture="" economic="" research="" service.="" this="" research="" found="" that="" the="" per="" capita="" consumption="" of="" fresh="" fruits="" rose="" 25="" percent="" from="" 1970="" to="" 1994,="" while="" the="" per="" capita="" consumption="" of="" fresh="" vegetables="" rose="" 33="" percent="" from="" 1970="" to="" 1994="" (ref.="" 10,="" pp.="" 18-19).="" accordingly,="" fda="" concludes="" that="" it="" is="" still="" appropriate="" to="" prohibit="" misleading="" and="" unsubstantiated="" generalizations="" on="" the="" label="" or="" in="" labeling="" about="" dietary="" inadequacies="" because="" of="" nutrient="" losses="" resulting="" from="" poor="" soil="" conditions="" or="" storage,="" transportation,="" or="" processing="" methods.="" nothing="" in="" rubin="" v.="" coors="" brewing="" co.,="" supra,="" prevents="" the="" government="" from="" regulating="" misleading="" speech.="" (see="" 115="" s.="" ct.="" at="" 1589.)="" as="" stated="" earlier,="" current="" sec.="" 101.9(k)(3)="" and="" (k)(4)="" (redesignated="" as="" sec.="" 101.9(k)(2)="" and="" (k)(3))="" do="" not="" preclude="" a="" producer,="" manufacturer,="" or="" vendor="" from="" indicating="" a="" higher="" nutrient="" retention="" in="" a="" particular="" product="" as="" compared="" to="" other="" similar="" products.="" nor="" do="" they="" preclude="" an="" indication="" that="" such="" retention="" results="" from="" special="" handling="" of="" the="" product,="" provided="" that="" such="" indications="" are="" factual="" and="" is="" not="" misleading="" (58="" fr="" 2079="" at="" 2167).="" in="" regard="" to="" sec.="" 101.9(k)(6),="" fda="" has="" stated="" in="" the="" past="" that="" this="" section="" permitted="" truthful="" designation="" of="" any="" nutrient="" as="" natural="" in="" origin="" (38="" fr="" 6950="" at="" 6958,="" march="" 14,="" 1973;="" and="" 58="" fr="" 2079="" at="" 2167).="" however,="" the="" agency="" is="" persuaded="" by="" the="" comments="" that="" the="" phrase="" ``differentiate="" in="" any="" way="" between="" vitamins="" naturally="" present="" from="" those="" added''="" in="" sec.="" 101.9(k)(6)="" is="" easily="" misinterpreted="" to="" mean="" that="" labels="" cannot="" identify="" nutrients="" as="" naturally-occurring="" or="" synthetic.="" accordingly,="" fda="" is="" modifying="" that="" paragraph="" (renumbered="" as="" sec.="" 101.9(k)(4))="" to="" remove="" the="" prohibition="" on="" differentiating="" between="" naturally-occurring="" and="" synthetic="" vitamins.="" it="" should="" be="" noted="" that="" fda="" addressed="" the="" use="" of="" the="" term="" ``natural''="" in="" rulemaking="" implementing="" the="" 1990="" amendments="" (58="" fr="" 2302="" at="" 2407,="" january="" 6,="" 1993).="" at="" that="" time,="" the="" agency="" said="" it="" was="" not="" establishing="" a="" definition="" for="" ``natural,''="" but="" that="" it="" would="" maintain="" its="" policy="" not="" to="" restrict="" truthful="" and="" non-misleading="" use="" of="" the="" term,="" except="" for="" products="" with="" added="" color,="" synthetic="" substances,="" or="" artificial="" flavors="" as="" provided="" in="" sec.="" 101.22,="" for="" which="" use="" of="" the="" term="" ``natural''="" on="" the="" label="" would="" be="" considered="" misleading.="" however,="" the="" agency="" advises="" that="" the="" term="" ``natural''="" should="" not="" be="" used="" when="" referring="" to="" a="" vitamin="" that="" is="" only="" obtained="" through="" chemical="" synthesis="" (e.g.,="" use="" of="" ``natural="" vitamin="" e''="" for="" a="" product="" containing="" dl-alpha="" tocopheryl="" acetate).="" comments="" did="" not="" specifically="" address="" that="" part="" of="" current="" sec.="" 101.9(k)(6)="" that="" prohibits="" any="" suggestion="" that="" a="" natural="" vitamin="" is="" superior="" to="" an="" added="" vitamin.="" comments="" pointed="" out,="" and="" fda="" is="" in="" agreement,="" that="" differences="" between="" natural="" and="" synthetic="" vitamins="" are="" often="" really="" differences="" in="" the="" form="" of="" the="" nutrient.="" for="" example,="" comments="" pointed="" out="" that="" vitamin="" e="" occurs="" in="" natural="" oils="" in="" the="" d-="" alpha="" form="" and="" exists="" in="" synthetic="" products="" as="" a="" racemic="" mixture,="" with="" less="" biological="" activity.="" comments="" did="" not,="" however,="" provide="" information="" to="" support="" any="" difference="" between="" a="" natural="" or="" synthetic="" version="" of="" the="" same="" form="" of="" a="" nutrient.="" thus,="" the="" agency="" is="" aware="" of="" nothing="" that="" establishes="" that="" a="" claim="" of="" difference="" between="" the="" natural="" and="" synthetic="" version="" of="" the="" same="" form="" of="" a="" nutrient="" is="" not="" misleading.="" therefore,="" fda="" is="" maintaining="" the="" prohibition="" against="" statements="" that="" a="" natural="" vitamin="" is="" superior="" to="" an="" added="" one="" in="" sec.="" 101.9(k)(4).="" however,="" the="" agency="" advises="" that="" there="" are="" no="" restrictions="" in="" the="" regulations="" on="" identification="" of="" the="" chemical="" form="" of="" the="" nutrient.="" in="" fact,="" such="" identification="" is="" helpful="" on="" certain="" nutrients,="" such="" as="" carotene,="" whose="" biological="" activity="" varies="" according="" to="" its="" isomeric="" composition.="" fda="" notes="" that="" when="" the="" chemical="" form="" of="" the="" vitamin="" is="" identified="" on="" the="" label="" or="" in="" labeling,="" manufacturers="" are="" free="" to="" use="" statements="" that="" characterize="" the="" structure="" and="" function="" of="" that="" stereoisomer.="" label="" statements="" may="" thus="" differentiate="" between="" the="" different="" forms="" of="" a="" vitamin.="" i.="" miscellaneous="" issues="" 36.="" one="" comment="" asked="" whether="" nutrition="" labeling="" is="" required="" on="" samples="" of="" dietary="" supplements="" that="" are="" distributed="" free="" of="" charge,="" such="" as="" at="" trade="" shows.="" the="" nutrition="" labeling="" requirements="" of="" the="" 1990="" amendments="" apply="" to="" foods="" offered="" for="" sale="" (section="" 403(q)(1)="" of="" the="" act).="" nutrition="" labeling="" would="" not="" be="" required="" on="" dietary="" supplements="" that="" are="" not="" offered="" for="" sale="" because="" there="" is="" nothing="" in="" the="" dshea="" that="" requires="" dietary="" supplements="" to="" be="" treated="" any="" differently="" than="" conventional="" foods="" in="" this="" respect.="" fda="" inadvertently="" did="" not="" make="" this="" clear="" in="" the="" december="" 1995="" proposal.="" accordingly,="" fda="" is="" revising="" sec.="" 101.36(a)="" to="" state="" ``the="" label="" of="" a="" dietary="" supplement="" that="" is="" offered="" for="" sale="" shall="" bear="" nutrition="" labeling="" in="" accordance="" with="" this="" regulation="" unless="" an="" exemption="" is="" provided="" for="" the="" product="" in="" paragraph="" (h)="" of="" this="" section.''="" 37.="" one="" comment="" stated="" that="" products="" composed="" only="" of="" mixtures="" of="" free="" amino="" acids="" should="" be="" able="" to="" declare="" ``protein''="" in="" the="" nutrition="" label="" and="" list="" the="" total="" weight="" of="" the="" amino="" acids="" as="" the="" amount="" of="" protein="" in="" the="" product.="" the="" comment="" said="" that="" the="" only="" difference="" between="" free="" amino="" acids="" and="" protein="" is="" that="" the="" amino="" acids="" in="" protein="" are="" connected="" to="" each="" other="" by="" peptide="" bonds.="" another="" comment="" stated="" that="" amino="" acids="" that="" are="" essential="" should="" be="" distinguished="" from="" those="" that="" are="" nonessential.="" this="" comment="" also="" stated="" that="" the="" dangers="" of="" using="" single="" amino="" acids="" should="" also="" be="" listed="" with="" a="" warning="" that="" many="" of="" the="" uses="" are="" unproven.="" with="" respect="" to="" protein="" supplements,="" the="" comment="" said="" that="" such="" products="" should="" indicate="" their="" sources="" of="" protein,="" and="" ``when="" collagen="" with="" a="" little="" tryptophan="" added="" is="" called="" a="" protein="" supplement="" it="" should="" be="" stated="" that="" this="" is="" not="" a="" complete="" protein="" and="" cannot="" support="" life="" or="" tissue="" building="" on="" its="" own.''="" the="" comment="" recommended="" that="" protein="" supplements="" used="" for="" body="" building="" should="" contain="" a="" statement="" that="" muscle="" building="" requires="" not="" only="" protein,="" but="" calories="" and="" especially="" carbohydrates.="" fda="" agrees="" that="" protein="" differs="" from="" free="" amino="" acids="" in="" that="" protein="" is="" composed="" of="" amino="" acids="" connected="" to="" each="" other="" by="" peptide="" bonds="" (60="" fr="" 67194="" at="" 67198).="" in="" recognition="" of="" this="" difference,="" fda="" proposed="" that="" the="" nutrition="" label="" of="" dietary="" supplements="" list="" whatever="" is="" actually="" present,="" i.e.,="" protein="" or="" individual="" amino="" acids.="" the="" comment="" did="" not="" justify="" why="" it="" was="" not="" misleading="" to="" declare="" protein="" content="" in="" the="" nutrition="" label="" of="" a="" dietary="" supplement="" that="" contains="" only="" free="" amino="" acids.="" therefore,="" fda="" concludes="" that="" this="" requirement="" is="" appropriate="" and="" consistent="" with="" section="" 201(ff)(1)="" of="" the="" act,="" which="" lists="" amino="" acids="" in="" [[page="" 49842]]="" subparagraph="" (d)="" as="" a="" separate="" entity="" from="" protein,="" which="" would="" be="" covered="" in="" subparagraph="" (e)="" as="" a="" dietary="" substance.="" furthermore,="" fda="" is="" not="" persuaded="" to="" require="" that="" amino="" acids="" be="" identified="" as="" essential="" or="" nonessential="" in="" the="" nutrition="" label="" of="" dietary="" supplements="" because="" the="" act="" does="" not="" require="" this="" information="" in="" the="" nutrition="" label,="" and="" the="" comment="" did="" not="" provide="" any="" reason="" for="" this="" approach.="" in="" fact,="" the="" comment="" in="" question="" did="" not="" state="" clearly="" where="" this="" information="" should="" be="" presented.="" fda="" points="" out="" that="" such="" information="" may="" be="" stated="" outside="" of="" the="" nutrition="" label="" on="" the="" labels="" of="" dietary="" supplements="" and="" conventional="" foods="" as="" well.="" in="" response="" to="" the="" comment="" that="" requested="" that="" the="" source="" of="" protein="" supplements="" should="" be="" identified,="" the="" agency="" points="" out="" that,="" under="" the="" act,="" manufacturers="" of="" dietary="" supplements,="" including="" protein="" supplements,="" may="" choose="" either="" to="" list="" the="" source="" of="" any="" dietary="" ingredient="" in="" the="" nutrition="" label="" or="" in="" the="" ingredient="" statement="" that="" appears="" below="" the="" nutrition="" label.="" while="" the="" concerns="" of="" the="" comment="" would="" apparently="" be="" better="" addressed="" by="" the="" former="" approach,="" fda="" is="" not="" aware="" of="" any="" reason="" to="" require="" it.="" the="" other="" points="" in="" this="" comment="" about="" warning="" or="" other="" statements="" are="" beyond="" the="" scope="" of="" this="" rulemaking.="" 38.="" one="" comment="" recommended="" that="" herbal="" products="" be="" required="" to="" declare="" any="" possible="" drug="" interactions.="" the="" comment="" stated="" that="" herbs="" were="" the="" first="" medicines="" and="" should="" be="" treated="" as="" such.="" fda="" disagrees="" with="" this="" comment.="" the="" herbal="" products="" that="" are="" the="" subject="" of="" this="" rulemaking="" are="" foods="" and="" not="" drugs.="" to="" the="" extent="" that="" herbal="" products="" are="" intended="" for="" use="" as="" medicines,="" they="" are="" drugs="" under="" the="" act="" and="" subject="" to="" regulation="" under="" chapter="" v="" of="" the="" act,="" not="" chapter="" iv="" (the="" food="" provisions).="" as="" for="" possible="" drug="" interactions,="" fda="" will="" consider="" the="" need="" for="" warnings="" under="" sections="" 201(a),="" 403(a),="" and="" 701(a)="" of="" the="" act="" (21="" u.s.c.="" 371(a)),="" but="" warnings="" about="" drug="" interactions="" are="" not="" typically="" the="" subject="" of="" food="" labeling="" requirements.="" iv.="" other="" provisions="" fda="" has="" made="" a="" few="" editorial="" changes="" in="" certain="" provisions="" of="" sec.="" 101.36.="" specifically,="" sec.="" 101.36(h)(2)="" (designated="" as="" sec.="" 101.36(f)(2)="" in="" the="" final="" rule="" on="" small="" business="" exemptions="" in="" the="" federal="" register="" of="" august="" 7,="" 1996="" (61="" fr="" 40963),="" has="" been="" revised="" to="" make="" it="" clear="" that="" either="" a="" manufacturer,="" packer,="" or="" distributor="" may="" file="" a="" claim="" for="" an="" exemption.="" this="" change="" is="" consistent="" with="" the="" language="" in="" sec.="" 101.9(j)(18).="" also,="" to="" avoid="" confusion,="" the="" first="" sentence="" in="" sec.="" 101.36(h)(1)="" through="" (h)(3)="" reads="" ``foods''="" instead="" of="" ``dietary="" supplements.''="" fda="" did="" not="" receive="" any="" comments="" that="" dealt="" specifically="" with="" the="" other="" provisions="" of="" the="" proposal.="" in="" the="" absence="" of="" any="" basis="" for="" doing="" otherwise,="" fda="" is="" adopting="" those="" provisions="" as="" proposed.="" v.="" effective="" date="" 39.="" several="" comments="" recommended="" that="" the="" compliance="" date="" of="" this="" final="" rule="" be="" coordinated="" with="" other="" final="" rules="" on="" dietary="" supplements.="" most="" of="" these="" comments="" requested="" that="" a="" uniform="" effective="" date="" be="" set="" at="" 18="" months="" after="" the="" publication="" of="" the="" last="" final="" rule="" concerning="" dietary="" supplements="" based="" on="" any="" pending="" proposals,="" although="" 3="" comments="" requested="" 12="" months,="" and="" 1="" comment="" requested="" 24="" months.="" one="" comment="" stated="" that="" multiple="" effective="" dates="" will="" balloon="" the="" cost="" of="" all="" label="" changes="" to="" the="" industry="" and="" to="" consumers,="" who="" ultimately="" will="" bear="" the="" cost="" of="" multiple="" revisions.="" other="" comments="" stated="" that="" an="" 18-="" month="" extension="" is="" needed="" because="" of="" the="" great="" number="" of="" labels="" to="" be="" redesigned.="" one="" comment="" said="" that="" they="" may="" manufacture="" an="" identical="" multivitamin="" product="" for="" more="" than="" 100="" different="" retail="" customers="" that="" sell="" the="" product="" under="" their="" own="" private="" label="" name,="" e.g.,="" store="" brand="" names.="" thus,="" this="" manufacturer="" has="" to="" make="" new="" labels="" for="" each="" customer,="" not="" for="" each="" product.="" another="" comment="" stated="" that="" a="" manufacturer="" of="" ``private="" label''="" products="" may="" have="" over="" 10,000="" labels="" to="" redesign.="" fda="" is="" persuaded="" by="" the="" majority="" of="" the="" comments="" that="" it="" is="" appropriate="" to="" have="" the="" effective="" date="" of="" this="" final="" rule="" be="" 18="" months="" after="" its="" publication,="" consistent="" with="" the="" time="" period="" allowed="" for="" the="" labels="" of="" conventional="" foods="" to="" comply="" with="" the="" final="" rules="" implementing="" the="" 1990="" amendments.="" as="" discussed="" in="" section="" vi.="" of="" this="" document,="" an="" 18-month="" compliance="" period="" will="" minimize="" the="" cost="" of="" the="" changeover="" compared="" to="" a="" 12-month="" compliance="" period.="" the="" agency="" does="" not="" agree="" with="" the="" comment="" that="" requested="" a="" 24-month="" compliance="" period="" because="" the="" majority="" of="" the="" comments="" stated="" that="" an="" 18-month="" compliance="" period="" is="" sufficient.="" moreover,="" the="" agency="" agrees="" that="" it="" is="" reasonable="" and="" practical="" to="" have="" the="" same="" date="" apply="" to="" the="" other="" final="" rules="" on="" dietary="" supplement="" labeling="" that="" are="" published="" elsewhere="" in="" this="" issue="" of="" the="" federal="" register,="" as="" multiple="" effective="" dates="" will="" increase="" costs="" and="" are="" unjustified.="" therefore,="" the="" agency="" concludes="" that="" the="" effective="" date="" of="" this="" final="" rule="" is="" 18="" months="" from="" the="" date="" of="" its="" publication="" and="" that="" this="" date="" shall="" apply="" to="" the="" other="" final="" rules="" on="" dietary="" supplements="" that="" are="" published="" in="" this="" issue="" of="" the="" federal="" register.="" the="" same="" will="" also="" apply="" to="" the="" enforcement="" of="" prescribed="" iron="" statements="" on="" products="" that="" currently="" bear="" voluntary="" iron="" warning="" statements,="" as="" discussed="" in="" the="" final="" rule="" on="" iron="" statements="" (62="" fr="" 2218,="" january="" 15,="" 1997).="" in="" that="" final="" rule,="" the="" agency="" stated="" that="" it="" intended="" to="" use="" enforcement="" discretion="" for="" these="" products="" that="" bear="" a="" voluntary="" warning="" until="" the="" date="" for="" label="" changes="" made="" in="" response="" to="" the="" dshea="" (62="" fr="" 2218="" at="" 2246).="" the="" agency="" notes="" that="" this="" effective="" date="" is="" not="" in="" accordance="" with="" the="" uniform="" compliance="" date="" of="" january="" 1,="" 2000,="" established="" by="" regulation="" on="" december="" 27,="" 1996="" (61="" fr="" 68145).="" as="" stated="" in="" that="" document,="" ``if="" any="" food="" labeling="" regulation="" involves="" special="" circumstances="" that="" justify="" a="" compliance="" date="" other="" than="" january="" 1,="" 2000,="" the="" agency="" will="" determine="" for="" that="" regulation="" an="" appropriate="" compliance="" date,="" which="" will="" be="" specified="" when="" the="" final="" regulation="" is="" published''="" (61="" fr="" 68145="" at="" 68146).="" the="" dshea="" states="" that="" dietary="" supplement="" products="" shall="" be="" labeled="" in="" accordance="" with="" its="" amendments="" after="" december="" 31,="" 1996.="" because="" final="" rules="" were="" not="" published="" in="" sufficient="" time="" for="" the="" industry="" to="" be="" in="" compliance="" with="" them="" by="" january="" 1,="" 1997,="" fda="" stated="" on="" april="" 15,="" 1996,="" that="" it="" would="" exercise="" its="" enforcement="" discretion="" such="" that="" it="" would="" not="" enforce="" the="" provisions="" of="" the="" dshea="" until="" january="" 1,="" 1998="" (61="" fr="" 16423).="" at="" this="" time,="" fda="" is="" extending="" this="" period="" of="" nonenforcement="" until="" march="" 23,="" 1999.="" any="" further="" extension="" (i.e.,="" to="" january="" 1,="" 2000)="" would="" be="" unresponsive="" to="" the="" directives="" of="" the="" statute,="" as="" well="" as="" unnecessary="" based="" on="" comments="" received.="" in="" addition,="" in="" response="" to="" the="" directive="" in="" the="" dshea="" that="" dietary="" supplements="" ``be="" labeled''="" after="" december="" 31,="" 1996,="" and="" consistent="" with="" the="" approach="" taken="" by="" congress="" in="" the="" 1990="" amendments,="" the="" agency="" advises="" that="" the="" effective="" date="" of="" this="" regulation,="" the="" other="" dietary="" supplement="" regulations="" published="" in="" this="" issue="" of="" the="" federal="" register,="" and="" the="" final="" rule="" on="" iron="" statements,="" will="" apply="" to="" the="" attachment="" of="" labels="" to="" dietary="" supplement="" products="" rather="" than="" to="" the="" introduction="" of="" products="" into="" interstate="" commerce="" as="" specified="" in="" the="" agency's="" final="" rule="" on="" uniform="" compliance="" dates="" for="" food="" labeling="" regulations="" (61="" fr="" [[page="" 49843]]="" 68145).="" in="" other="" words,="" products="" bearing="" labels="" that="" are="" affixed="" prior="" to="" march="" 23,="" 1999="" do="" not="" have="" to="" be="" in="" compliance="" with="" these="" final="" rules,="" and="" products="" labeled="" after="" march="" 23,="" 1999="" do.="" although="" the="" effective="" date="" is="" 18="" months="" hence,="" fda="" encourages="" manufacturers="" to="" have="" new="" labels="" that="" are="" in="" compliance="" with="" these="" final="" rules="" printed="" as="" soon="" as="" current="" inventories="" are="" exhausted="" to="" assure="" a="" smooth="" and="" timely="" changeover.="" the="" agency="" does="" not="" anticipate="" extending="" its="" use="" of="" enforcement="" discretion="" any="" further.="" vi.="" analysis="" of="" impacts="" fda="" has="" examined="" the="" economic="" implications="" of="" the="" final="" rule="" as="" required="" by="" executive="" order="" 12866="" and="" the="" regulatory="" flexibility="" act="" (5="" u.s.c.="" 601-612).="" executive="" order="" 12866="" directs="" agencies="" to="" assess="" all="" costs="" and="" benefits="" of="" available="" regulatory="" alternatives="" and,="" when="" regulation="" is="" necessary,="" to="" select="" the="" regulatory="" approach="" which="" maximizes="" net="" benefits="" (including="" potential="" economic,="" environmental,="" public="" health="" and="" safety="" effects;="" distributive="" impacts;="" and="" equity).="" executive="" order="" 12866="" classifies="" a="" rule="" as="" significant="" if="" it="" meets="" any="" one="" of="" a="" number="" of="" specified="" conditions,="" including="" having="" an="" annual="" effect="" on="" the="" economy="" of="" $100="" million="" or="" adversely="" affecting="" in="" a="" material="" way="" a="" sector="" of="" the="" economy,="" competition,="" or="" jobs,="" or="" if="" it="" raises="" novel="" legal="" or="" policy="" issues.="" if="" a="" rule="" has="" a="" significant="" impact="" on="" a="" substantial="" number="" of="" small="" entities,="" the="" regulatory="" flexibility="" act="" requires="" agencies="" to="" analyze="" options="" that="" would="" minimize="" the="" economic="" impact="" of="" that="" rule="" on="" small="" entities.="" fda="" finds="" that="" this="" final="" rule="" is="" not="" an="" economically="" significant="" rule="" as="" defined="" by="" executive="" order="" 12866="" and="" finds="" under="" the="" regulatory="" flexibility="" act,="" that="" the="" final="" rule="" will="" have="" a="" significant="" impact="" on="" a="" substantial="" number="" of="" small="" entities.="" there="" are="" several="" different="" types="" of="" products="" that="" may="" be="" considered="" to="" be="" dietary="" supplements.="" these="" products="" include="" but="" are="" not="" limited="" to="" vitamin="" or="" mineral="" supplements,="" herbal="" products,="" and="" products="" that="" contain="" other="" similar="" nutritional="" substances.="" an="" estimate="" of="" the="" number="" of="" such="" products="" is="" approximately="" 29,000.="" the="" number="" of="" stockkeeping="" units,="" a="" more="" accurate="" count="" of="" the="" number="" of="" labels,="" is="" approximately="" 75,000.="" estimates="" of="" the="" number="" of="" dietary="" supplements="" are="" approximate="" because="" no="" one="" source="" collects="" information="" on="" all="" types="" of="" dietary="" supplements.="" in="" fact,="" until="" the="" dshea,="" there="" was="" no="" agreed="" upon="" definition="" of="" a="" dietary="" supplement.="" some="" sources="" include="" only="" dietary="" supplements="" of="" vitamin="" or="" minerals,="" others="" include="" herbals="" or="" botanicals,="" and="" still="" others="" include="" other="" types="" of="" products="" that="" may="" or="" may="" not="" be="" dietary="" supplements,="" such="" as="" sports="" nutrition="" products="" and="" ``functional="" foods,''="" a="" term="" for="" which="" there="" is="" no="" recognized="" definition.="" in="" its="" proposed="" analysis,="" fda="" estimated="" the="" number="" of="" dietary="" supplement="" firms="" to="" be="" between="" 150="" and="" 650="" firms.="" according="" to="" duns="" market="" identifiers,="" there="" are="" approximately="" 250="" manufacturers="" of="" vitamin="" and="" mineral="" products.="" according="" to="" nutrition="" business="" journal="" (august="" 1996),="" the="" dietary="" supplement="" industry="" includes="" 850="" supplement="" manufacturing="" companies.="" the="" journal="" reports="" 1995="" industry="" revenues="" at="" $4.5="" billion.="" although="" fda="" concludes="" that="" there="" are="" clearly="" at="" least="" 250="" firms,="" the="" journal's="" estimate="" of="" 850="" is="" most="" likely="" an="" overestimate="" of="" the="" dietary="" supplement="" industry="" because="" it="" includes="" homeopathic="" products,="" which="" are="" drugs="" by="" statutory="" definition,="" and="" ``functional="" foods''="" and="" sports="" nutrition="" products,="" which="" may="" be="" either="" conventional="" foods="" or="" dietary="" supplements="" depending="" on="" how="" they="" are="" marketed="" and="" used.="" although="" the="" journal="" does="" not="" break="" down="" the="" number="" of="" firms="" by="" the="" type="" of="" dietary="" supplement="" produced,="" it="" does="" specify="" that="" 250="" firms="" produce="" herbal="" or="" botanical="" products.="" fda="" received="" one="" comment="" on="" its="" proposed="" analysis="" that="" suggested="" that="" estimates="" of="" the="" number="" of="" firms="" should="" include="" the="" product="" manufacturer,="" label="" printer,="" product="" packager,="" label/brand="" owner,="" and="" brand="" wholesaler.="" fda="" notes="" that,="" with="" the="" exception="" of="" administrative="" costs,="" costs="" of="" labeling="" regulations="" are="" calculated="" on="" a="" per="" product="" or="" per="" label="" basis,="" not="" on="" a="" per="" firm="" basis.="" administrative="" costs,="" which="" are="" typically="" calculated="" on="" a="" per="" firm="" basis,="" include="" the="" cost="" of="" reading="" and="" interpreting="" the="" regulation="" and="" formulating="" a="" compliance="" policy="" which="" must="" be="" done="" once="" for="" each="" regulation,="" not="" for="" each="" product.="" for="" purposes="" of="" determining="" the="" costs="" of="" this="" regulation,="" fda="" will="" use="" 850="" as="" an="" upper="" bound="" estimate="" of="" the="" number="" of="" firms.="" as="" a="" lower="" bound="" estimate,="" fda="" will="" use="" 500="" (250="" vitamin/mineral="" firms="" +="" 250="" herbal/botanical="" firms).="" a.="" costs="" categories="" of="" costs="" for="" relabeling="" include="" administrative,="" analytical,="" printing,="" and="" inventory="" disposal.="" the="" administrative="" costs="" associated="" with="" a="" labeling="" regulation="" result="" from="" the="" incremental="" administrative="" labor="" expended="" in="" order="" to="" comply="" with="" a="" regulation.="" fda="" received="" one="" comment="" objecting="" to="" the="" estimated="" administrative="" costs.="" the="" comment="" stated="" that="" administrative="" costs="" fail="" to="" include="" both="" scientific="" and="" legal="" review,="" but="" the="" comment="" did="" not="" provide="" any="" information="" to="" help="" fda="" modify="" its="" previous="" estimate.="" therefore,="" fda="" will="" continue="" to="" estimate="" administrative="" costs="" at="" $425="" per="" firm="" for="" a="" 1-year="" compliance="" period="" and="" approximately="" $320="" for="" an="" 18-month="" compliance="" period.="" longer="" compliance="" periods="" decrease="" administrative="" effort="" because="" firm="" executives="" often="" delegate="" downward="" decisions="" that="" are="" less="" immediate.="" total="" administrative="" costs="" are="" estimated="" to="" be="" between="" $160,000="" ($320="" x="" 500="" firms)="" and="" $272,000="" ($320="" x="" 850="" firms)="" with="" an="" 18-month="" compliance="" period.="" fda="" received="" one="" comment="" stating="" that="" its="" estimate="" of="" analytical="" costs="" substantially="" underestimated="" the="" true="" costs.="" the="" comment="" estimated="" analytical="" costs="" at="" $340="" per="" product.="" fda="" notes,="" however,="" that="" although="" the="" comment="" stated="" that="" fda's="" estimates="" were="" too="" low,="" the="" comment's="" per="" product="" estimate="" is="" lower="" than="" fda's="" estimate="" of="" $615="" per="" product.="" therefore,="" fda="" will="" continue="" to="" estimate="" costs="" at="" $615="" per="" product="" for="" each="" of="" 29,000="" products.="" all="" products="" will="" be="" tested="" once="" during="" the="" 18-month="" compliance="" period="" in="" order="" to="" determine="" initial="" compliance.="" in="" the="" proposed="" rule,="" fda="" assumed="" that="" products="" would="" undergo="" retesting="" once="" every="" 5="" years.="" fda="" received="" no="" objections="" to="" that="" assumption.="" therefore,="" fda="" estimates="" total="" discounted="" analytical="" costs="" of="" $75="" million="" (discounted="" to="" infinity="" at="" 7="" percent),="" of="" which="" $17.8="" million="" ($615="" x="" 29,000="" products)="" will="" occur="" during="" the="" 18-month="" compliance="" period.="" fda="" received="" several="" comments="" that="" its="" estimates="" of="" printing/="" redesign="" costs="" were="" too="" low.="" one="" comment="" suggested="" that="" costs="" would="" be="" $1,370="" for="" each="" printed="" label="" and="" $3,870="" for="" each="" direct-printed="" package="" label.="" estimates="" from="" other="" comments="" ranged="" from="" $50="" to="" $3,500="" per="" label.="" based="" on="" an="" average="" of="" the="" estimates="" provided="" by="" the="" comments,="" fda="" estimates="" that="" the="" average="" per="" label="" redesign="" cost="" for="" a="" 1-year="" compliance="" period="" is="" $1,700.="" however,="" because="" fda="" is="" allowing="" a="" compliance="" period="" of="" 18="" months,="" firms="" will="" be="" able="" to="" combine="" planned="" label="" changes="" with="" mandated="" changes,="" thus="" lowering="" redesign="" costs.="" redesign="" costs="" associated="" with="" an="" 18-month="" compliance="" are="" typically="" 3/4="" of="" those="" for="" a="" 1-year="" compliance="" period.="" therefore,="" fda="" estimates="" redesign="" costs="" to="" be="" $1,300="" for="" each="" of="" 75,000="" labels,="" or="" a="" total="" $97.5="" million.="" fda="" received="" one="" comment="" indicating="" that="" inventory="" disposal="" costs="" would="" range="" between="" $8="" and="" $15="" [[page="" 49844]]="" million="" depending="" on="" the="" length="" of="" the="" compliance="" period.="" in="" the="" analysis="" to="" the="" proposed="" rule,="" fda="" estimated="" inventory="" disposal="" costs="" at="" $6.5="" million="" assuming="" the="" rules="" would="" become="" effective="" 12="" months="" after="" publication="" of="" the="" final="" regulations.="" fda="" will="" not="" alter="" its="" previous="" estimates="" based="" on="" the="" comment="" because="" dietary="" supplement="" firms="" have="" known="" about="" these="" label="" changes="" since="" at="" least="" january="" 1994,="" and="" the="" majority="" of="" firms="" have="" been="" taking="" the="" necessary="" steps="" to="" reduce="" their="" label="" inventories.="" however,="" because="" fda="" is="" providing="" firms="" with="" 18="" months="" to="" comply,="" firms="" will="" have="" an="" additional="" 6="" months="" to="" dispose="" of="" label="" inventory.="" as="" with="" redesign="" costs,="" inventory="" disposal="" costs="" associated="" with="" an="" 18-month="" compliance="" period="" are="" approximately="" 3/4="" of="" the="" costs="" associated="" with="" a="" 1-year="" compliance="" period.="" therefore,="" disposal="" costs="" for="" this="" rule="" are="" estimated="" at="" $4.8="" million.="" fda="" has="" estimated="" the="" impact="" of="" the="" final="" regulations="" and="" has="" determined="" that="" administrative="" costs="" would="" be="" between="" $160,000="" and="" $272,000,="" discounted="" analytical="" costs="" would="" be="" $75="" million="" (discounted="" to="" infinity="" at="" 7="" percent),="" redesign="" costs="" would="" be="" $97.5="" million,="" and="" inventory="" disposal="" costs="" would="" be="" $4.8="" million.="" therefore,="" total="" discounted="" costs="" are="" estimated="" to="" be="" $177.8="" million="" (discounted="" to="" infinity="" at="" 7="" percent).="" costs="" during="" the="" 18-month="" compliance="" period="" are="" estimated="" to="" be="" $120="" million.="" if="" we="" assume="" that="" the="" rate="" at="" which="" firms="" comply="" is="" evenly="" distributed="" throughout="" the="" compliance="" period,="" then="" costs="" during="" the="" most="" expensive="" 12-month="" period,="" the="" first="" year,="" would="" be="" $80.3="" million.="" costs="" in="" the="" second="" year="" would="" be="" $39.7="" million.="" recurring="" costs="" would="" be="" $17.8="" million="" every="" 5="" years.="" according="" to="" basic="" economic="" principles,="" firms="" are="" profit="" maximizers.="" therefore,="" it="" is="" logical="" to="" assume="" that="" firms="" will="" select="" the="" least="" costly="" alternative.="" the="" supply="" of="" label="" redesign="" and="" analytical="" laboratory="" services="" is="" limited="" in="" the="" short="" run.="" when="" demand="" for="" those="" services="" increases="" as="" a="" result="" of="" regulatory="" requirements,="" the="" cost="" of="" those="" services="" also="" increases.="" if="" compliance="" were="" skewed="" toward="" one="" end="" of="" the="" compliance="" period,="" then="" the="" demands="" places="" on="" those="" services="" would="" cause="" prices="" to="" increase="" more="" than="" if="" the="" demand="" were="" more="" evenly="" distributed.="" firms="" are="" aware="" of="" this="" phenomenon="" and="" will,="" therefore,="" attempt="" to="" spread="" out="" the="" demands="" on="" the="" redesign="" and="" laboratory="" services.="" also,="" because="" the="" capacity="" for="" these="" services="" is="" fixed="" in="" the="" short="" run,="" the="" suppliers="" of="" redesign="" and="" laboratory="" services="" will="" force="" firms="" to="" space="" out="" their="" demand.="" because="" it="" is="" unlikely="" that="" the="" rate="" at="" which="" firms="" comply="" is="" heavily="" skewed="" toward="" one="" end="" of="" the="" compliance="" period,="" it="" is="" unlikely="" that="" costs="" will="" exceed="" $100="" million="" during="" any="" single="" year.="" therefore,="" fda="" concludes="" that="" this="" rule="" is="" not="" economically="" significant="" as="" defined="" by="" executive="" order="" 12866.="" b.="" benefits="" although="" almost="" all="" dietary="" supplements="" of="" vitamins="" and="" minerals="" currently="" contain="" substantial="" nutrition="" information,="" many="" other="" dietary="" supplements="" do="" not.="" this="" regulation="" will="" benefit="" consumers="" by="" assuring="" that="" adequate="" and="" complete="" nutrition="" information="" is="" provided="" accurately="" and="" consistently="" to="" aid="" consumers="" in="" their="" choices.="" c.="" regulatory="" flexibility="" according="" to="" the="" regulatory="" flexibility="" act,="" the="" definition="" of="" a="" small="" entity="" is="" a="" business="" independently="" owned="" and="" operated="" and="" not="" dominant="" in="" its="" field.="" the="" small="" business="" administration="" (sba)="" has="" set="" size="" standards="" for="" most="" business="" categories="" through="" use="" of="" four-digit="" standard="" industrial="" classification="" codes.="" for="" dietary="" supplements="" of="" vitamins="" and="" minerals,="" a="" business="" is="" considered="" small="" if="" it="" has="" fewer="" than="" 750="" employees.="" according="" to="" duns="" market="" identifiers,="" there="" are="" approximately="" 250="" producers="" of="" vitamin="" and="" mineral="" supplements,="" of="" which="" 200="" have="" fewer="" than="" 750="" employees.="" the="" remaining="" dietary="" supplement="" products="" come="" closest="" to="" the="" industry="" groups="" food="" preparations="" n.e.c.="" (sic="" 2099)="" and="" medicinal="" chemicals="" and="" botanical="" products="" (sic="" 2834).="" the="" sba="" size="" standards="" are="" 500="" or="" fewer="" employees="" for="" food="" preparations="" and="" 750="" or="" fewer="" employees="" for="" medicinal="" and="" botanical="" products.="" under="" either="" employee-based="" size="" standard,="" virtually="" all="" firms="" could="" be="" classified="" as="" small,="" including="" some="" firms="" that="" are="" among="" the="" leaders="" in="" sales="" revenues.="" therefore,="" fda="" is="" basing="" size="" classifications="" on="" sales="" revenue="" rather="" than="" employees.="" according="" to="" nutrition="" business="" journal,="" of="" the="" 850="" dietary="" supplement="" manufacturing="" firms,="" 11="" have="" total="" revenues="" over="" $100="" million,="" accounting="" for="" 53="" percent="" of="" total="" sales;="" 30="" firms="" have="" sales="" revenues="" between="" $20="" and="" $100="" million,="" accounting="" for="" 28="" percent="" of="" industry="" sales;="" and="" 809="" firms="" have="" sales="" under="" $20="" million,="" accounting="" for="" 19="" percent="" of="" industry="" sales.="" the="" 809="" firms="" in="" the="" under="" $20="" million="" category="" have="" an="" average="" sales="" revenue="" of="" $800,000="" and="" will="" be="" considered="" small="" by="" fda.="" the="" sba="" sales="" revenue="" standard="" for="" businesses="" that="" cannot="" be="" classified="" into="" a="" specific="" industry="" is="" $5="" million.="" fda="" concludes="" therefore="" that="" as="" many="" as="" 809="" firms="" in="" the="" dietary="" supplement="" industry,="" or="" 95="" percent="" of="" firms,="" could="" be="" considered="" small="" (sales="" under="" $20="" million).="" as="" stated="" previously="" in="" this="" analysis,="" this="" may="" be="" an="" overestimate="" because="" it="" counts="" firms="" that="" produce="" homeopathic="" products,="" which="" are="" drugs,="" and="" sports="" nutrition="" products="" and="" ``functional="" foods,''="" which="" may="" be="" foods="" or="" dietary="" supplements.="" if="" there="" are="" as="" few="" as="" 500="" dietary="" supplement="" firms,="" there="" may="" be="" 475="" small="" dietary="" supplement="" firms.="" the="" agency="" has="" published="" an="" exemption="" from="" mandatory="" nutrition="" labeling="" for="" small="" businesses="" in="" sec.="" 101.9(j)(1)="" and="" has="" proposed="" an="" exemption="" for="" low-volume="" food="" products="" of="" small="" businesses="" in="" sec.="" 101.9(j)(18)="" (59="" fr="" 11872,="" march="" 14,="" 1994).="" these="" regulations="" are="" cross-referenced="" in="" this="" final="" rule="" on="" labeling="" of="" dietary="" supplements,="" in="" sec.="" 101.36(h)(1)="" and="" (h)(2),="" respectively.="" as="" of="" january="" 1,="" 1997,="" sec.="" 101.9(j)(1)="" will="" only="" apply="" to="" retailers.="" as="" of="" may="" 1997,="" sec.="" 101.9(j)(18)="" will="" apply="" to="" manufacturers,="" packers,="" distributors,="" or="" retailers="" of="" low="" volume="" products,="" defined="" as="" fewer="" than="" 100,000="" units,="" produced="" by="" firms="" with="" fewer="" than="" 100="" employees.="" fda="" does="" not="" have="" information="" to="" show="" how="" many="" dietary="" supplement="" products="" would="" be="" exempted="" under="" this="" provision.="" comments="" to="" the="" proposed="" analysis="" suggested="" that="" very="" few="" products="" will="" qualify="" for="" exemptions="" for="" low="" volume="" products.="" according="" to="" the="" limited="" information="" available="" to="" the="" fda,="" approximately="" 72="" percent="" of="" vitamin/mineral="" producers="" and="" 86="" percent="" of="" herbal/botanical="" producers="" have="" fewer="" than="" 100="" employees.="" even="" if="" every="" firm="" with="" fewer="" than="" 100="" employees="" produced="" low="" volume="" products,="" between="" 9="" and="" 13="" percent="" of="" the="" firms="" with="" annual="" sales="" less="" than="" $20="" million="" would="" still="" not="" meet="" the="" definition.="" therefore,="" although="" it="" is="" likely="" that="" many="" firms="" will="" be="" able="" to="" take="" advantage="" of="" the="" small="" business="" exemption,="" fda="" concludes="" that="" this="" rule="" will="" impact="" on="" a="" substantial="" number="" of="" small="" entities.="" dietary="" supplement="" firms="" each="" produce="" between="" 3="" and="" over="" 50="" distinct="" products.="" a="" firm="" that="" produces="" three="" products="" will="" incur="" costs="" of="" $14,000="" during="" the="" compliance="" period.="" a="" firm="" that="" produces="" 50="" products="" will="" incur="" costs="" of="" $236,000="" during="" the="" compliance="" period.="" if="" the="" average="" small="" firm="" incurs="" costs="" of="" $125,000="" ((14,000="" +="" 236,000)/2),="" using="" an="" average="" annual="" sales="" of="" $800,000,="" the="" increase="" in="" costs="" due="" to="" this="" regulation="" will="" be="" 16="" percent="" of="" [[page="" 49845]]="" sales="" for="" the="" average="" small="" firm.="" therefore,="" fda="" concludes="" this="" rule="" will="" result="" in="" a="" significant="" economic="" impact="" on="" a="" substantial="" number="" of="" small="" entities.="" the="" regulatory="" flexibility="" act="" requires="" agencies="" to="" examine="" regulatory="" alternatives="" that="" would="" minimize="" the="" impact="" on="" small="" entities.="" because="" the="" dshea="" mandates="" nutrition="" labeling="" for="" all="" dietary="" supplement="" products,="" except="" low-volume="" products="" as="" described="" above,="" there="" are="" very="" few="" alternatives="" available="" to="" the="" agency.="" however,="" as="" discussed="" elsewhere="" in="" this="" document,="" fda="" received="" many="" comments="" requesting="" that="" firms="" be="" given="" 18="" months="" to="" comply="" with="" these="" regulations.="" fda="" has="" examined="" the="" impact="" of="" different="" compliance="" periods="" and="" has="" determined="" that="" extending="" the="" compliance="" to="" 18="" months="" reduces="" the="" burden="" on="" small="" entities.="" with="" a="" 12-month="" compliance="" period,="" first="" year="" costs="" for="" an="" average="" small="" entity="" would="" be="" $158,500,="" or="" 20="" percent="" of="" sales.="" extending="" the="" compliance="" period="" to="" 18="" months="" reduces="" first="" year="" costs="" to="" the="" average="" small="" firm="" by="" $33,500.="" if="" fda="" did="" not="" extend="" the="" compliance="" period,="" the="" total="" discounted="" costs="" of="" this="" regulation="" would="" be="" $209.5="" million,="" of="" which="" $152="" million="" would="" occur="" in="" the="" first="" year.="" the="" longer="" compliance="" period="" reduces="" total="" discounted="" costs="" of="" the="" regulation="" by="" $31.2="" million.="" d.="" summary="" total="" discounted="" costs="" of="" this="" regulation="" are="" estimated="" to="" be="" between="" $177.8="" million="" (discounted="" to="" infinity="" at="" 7="" percent).="" these="" costs="" include="" administrative,="" analytical,="" printing,="" and="" inventory="" disposal="" costs.="" the="" benefits="" are="" improved="" and="" more="" consistent="" information="" with="" which="" consumers="" can="" refine="" their="" choices="" for="" health="" or="" other="" reasons.="" fda="" is="" unable="" to="" quantify="" this="" benefit.="" fda="" has="" analyzed="" the="" costs="" and="" benefits="" of="" this="" proposed="" rule="" and="" has="" determined="" that,="" because="" neither="" costs="" nor="" benefits="" are="" likely="" to="" exceed="" $100="" million="" in="" any="" single="" year,="" it="" does="" not="" constitute="" an="" economically="" significant="" rule="" as="" defined="" by="" executive="" order="" 12866.="" fda="" has="" also="" analyzed="" the="" impacts="" on="" small="" firms="" according="" to="" the="" regulatory="" flexibility="" act="" and="" has="" determined="" that="" these="" rules="" will="" have="" a="" significant="" impact="" on="" a="" substantial="" number="" of="" small="" entities.="" fda="" has="" reviewed="" alternatives="" to="" reduce="" the="" burden="" on="" small="" entities="" and="" has="" concluded="" that="" providing="" for="" a="" compliance="" period="" of="" 18="" months="" will="" alleviate="" that="" burden.="" e.="" public="" outreach="" fda="" has="" conducted="" extensive="" outreach="" to="" a="" wide="" audience,="" including="" small="" businesses,="" on="" the="" labeling="" of="" dietary="" supplements.="" this="" outreach="" included="" independent="" fda="" activities="" as="" well="" as="" cooperative="" efforts="" between="" fda="" and="" professional="" trade="" organizations.="" fda="" has="" informed="" small="" businesses="" of="" the="" requirements="" in="" the="" dshea="" regarding="" dietary="" supplements="" and="" of="" fda's="" implementation="" of="" these="" requirements="" in="" a="" number="" of="" ways.="" since="" passage="" of="" the="" dshea,="" fda="" representatives="" have="" responded="" on="" a="" daily="" basis="" to="" numerous="" inquiries="" on="" supplements,="" including="" inquiries="" from="" small="" businesses.="" in="" addition,="" fda="" has="" had="" meetings="" on="" the="" regulation="" of="" dietary="" supplements="" with="" representatives="" of="" at="" least="" four="" trade="" organizations="" that="" include="" small="" businesses="" in="" their="" membership.="" furthermore,="" fda="" has="" participated="" in="" a="" number="" of="" trade="" organization="" conferences="" on="" dietary="" supplements="" and="" has="" cooperated="" with="" the="" drug="" information="" association,="" which="" has="" sponsored="" conferences="" on="" botanicals.="" fda="" has="" issued="" a="" number="" of="" publications="" on="" dietary="" supplements="" that="" have="" been="" available="" to="" small="" businesses,="" including="" an="" article="" in="" the="" fda="" consumer="" of="" november="" 1993="" and="" an="" ``fda="" backgrounder''="" of="" august="" 1995,="" which="" described="" the="" dshea.="" fda="" has="" distributed="" about="" 500="" reprints="" of="" its="" december="" 1995="" proposals="" on="" the="" labeling="" of="" dietary="" supplements="" to="" various="" interested="" parties,="" including="" small="" businesses.="" fda="" has="" also="" placed="" information="" on="" these="" proposed="" rules="" in="" the="" fda="" news="" section="" of="" the="" agency's="" home="" page="" on="" the="" world="" wide="" web.="" in="" response="" to="" these="" proposals,="" fda="" has="" received="" numerous="" comments="" from="" small="" businesses.="" fda="" concludes="" that="" its="" efforts="" to="" inform="" small="" businesses="" of="" activity="" in="" this="" area="" have="" been="" successful.="" vii.="" environmental="" impact="" the="" agency="" has="" previously="" considered="" the="" environmental="" effects="" of="" this="" rule="" as="" announced="" in="" the="" proposed="" rule="" (60="" fr="" 67194,="" december="" 28,="" 1995).="" no="" new="" information="" or="" comments="" have="" been="" received="" that="" would="" affect="" the="" agency's="" previous="" determination="" that="" there="" is="" no="" significant="" impact="" on="" the="" human="" environment="" and="" that="" an="" environmental="" impact="" statement="" is="" not="" required.="" viii.="" paperwork="" reduction="" act="" this="" rule="" contains="" information="" collection="" requirements="" that="" are="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget="" (omb)="" under="" the="" paperwork="" reduction="" act="" of="" 1995="" (pub.="" l.="" 104-13).="" the="" title,="" description,="" and="" respondent="" description="" of="" the="" information="" collection="" are="" shown="" below="" with="" an="" estimate="" of="" the="" annual="" reporting="" and="" recordkeeping="" burden.="" included="" in="" the="" estimate="" is="" the="" time="" for="" reviewing="" procedures,="" searching="" existing="" data="" sources,="" gathering="" and="" maintaining="" the="" data="" needed,="" and="" completing="" and="" reviewing="" the="" collection="" of="" information.="" title:="" requirements="" for="" nutrition="" and="" ingredient="" labeling="" of="" dietary="" supplements.="" description:="" in="" a="" final="" rule,="" fda="" is="" amending="" sec.="" 101.36="" to="" require="" that="" most="" dietary="" supplements="" provide="" on="" their="" labels,="" and="" in="" their="" labeling,="" information="" on="" the="" quantity="" of="" specific="" nutrients="" present="" in="" them,="" along="" with="" the="" daily="" value="" for="" each,="" and="" the="" quantity="" of="" other="" dietary="" ingredients.="" this="" requirement="" implements="" the="" requirements="" of="" the="" 1990="" amendments="" and="" the="" dshea.="" the="" agency="" is="" also="" providing="" a="" mechanism="" by="" which="" firms="" may="" request="" an="" alternative="" approach="" to="" providing="" the="" necessary="" nutrition="" information.="" section="" 101.36(b)(2)="" specifies="" the="" nutrients="" for="" which="" the="" amount="" must="" be="" present="" on="" the="" labels="" of="" dietary="" supplements="" and="" sec.="" 101.36(b)(3)="" provides="" for="" the="" listing="" of="" the="" quantity="" of="" other="" dietary="" ingredients,="" respectively.="" other="" paragraphs="" of="" sec.="" 101.36="" provide="" information="" to="" assist="" manufacturers="" and="" distributors="" of="" dietary="" supplements="" in="" determining="" how="" the="" amount="" of="" nutrients="" that="" their="" products="" contain="" should="" be="" disclosed="" on="" the="" labels="" of="" the="" products.="" section="" 101.36(f)(2)="" provides="" a="" mechanism="" whereby="" firms="" may="" request="" in="" writing="" from="" fda="" alternative="" means="" of="" compliance="" or="" additional="" exemptions="" when="" it="" is="" not="" technologically="" feasible,="" or="" some="" other="" circumstance="" makes="" it="" impracticable,="" for="" the="" firm="" to="" comply="" with="" the="" requirements="" of="" sec.="" 101.36.="" fda="" had="" submitted="" these="" information="" collection="" requirements="" to="" omb="" for="" review="" under="" section="" 3504(h)="" of="" the="" paperwork="" reduction="" act="" (44="" u.s.c.="" 3501="" et="" seq.)="" at="" the="" time="" the="" december="" 1995="" proposal="" was="" published.="" in="" response,="" omb="" disapproved="" the="" information="" collection="" but="" gave="" an="" omb="" control="" number,="" 0910-0314,="" and="" requested="" that="" fda="" respond="" to="" the="" following="" concerns="" at="" the="" time="" of="" resubmission="" for="" omb="" approval="" of="" the="" information="" collection="" package="" at="" the="" final="" rule="" stage:="" omb="" does="" not="" approve="" this="" package.="" omb="" is="" concerned="" about="" the="" accuracy="" of="" the="" cost="" and="" hour="" burden="" estimates,="" as="" well="" as="" the="" utility="" of="" the="" nutrition="" info.="" required="" to="" be="" disclosed="" on="" the="" labels="" of="" dietary="" supplements="" and="" whether="" the="" labels="" are="" sufficiently="" clear="" to="" the="" third="" party="" recipients="" [[page="" 49846]]="" of="" this="" information.="" when="" the="" package="" is="" resubmitted="" to="" omb="" for="" approval="" at="" the="" final="" stage,="" the="" agency="" will="" address="" omb's="" concerns="" and="" the="" public="" comments="" received="" on="" these="" issues="" in="" the="" preamble="" of="" the="" final="" rule="" and="" in="" the="" paperwork="" submission="" package.="" fda="" estimates="" the="" total="" annual="" disclosure="" and="" reporting="" hour="" burden="" for="" the="" information="" collection="" requirements="" contained="" in="" this="" final="" rule="" to="" be="" 136,040="" hours,="" as="" follows:="" table="" 1.--estimated="" annual="" reporting="" burden="" ----------------------------------------------------------------------------------------------------------------="" no.="" of="" 21="" cfr="" no.="" of="" responses="" per="" total="" annual="" hours="" per="" total="" annual="" total="" operating="" &="" section="" respondents="" respondent="" hours="" response="" hours="" maintenance="" costs="" ----------------------------------------------------------------------------------------------------------------="" 101.36="" (b)(2)="" and="" (b)(3)="" (disclosu="" re)="" 850="" 40="" 34,000="" 4="" 136,000="" 40,000,000="" 101.36(f)(="" 2)="" (reportin="" g)="" 20="" 1="" 20="" 2="" 40="" 0="" totals="" 34,020="" 136,040="" 40,000,000="" ----------------------------------------------------------------------------------------------------------------="" fda="" estimates="" that="" each="" supplier="" of="" dietary="" supplements="" will="" revise="" the="" labels="" for="" each="" product="" that="" is="" not="" otherwise="" exempt="" to="" comply="" with="" the="" requirements="" for="" nutrition="" labeling="" within="" the="" first="" 18="" months="" after="" publication="" of="" the="" final="" rule.="" the="" agency="" estimates="" that,="" on="" average,="" each="" supplier="" will="" have="" 40="" products="" whose="" labels="" will="" require="" revision.="" the="" agency="" expects="" that="" the="" number="" of="" respondents="" and="" corresponding="" annual="" burden="" hours="" will="" decrease="" over="" succeeding="" years="" because="" it="" does="" not="" believe="" that="" firms="" will="" modify="" the="" composition="" of="" each="" of="" their="" products="" and="" revise="" the="" labeling="" for="" each="" of="" their="" products="" each="" year.="" similarly="" requests="" for="" alternative="" approaches="" for="" providing="" nutrition="" information="" are="" most="" likely="" to="" be="" submitted="" within="" the="" first="" 18="" months.="" the="" agency="" estimated="" the="" number="" of="" such="" requests="" based="" on="" its="" experience="" with="" the="" similar="" requirement="" that="" is="" provided="" in="" sec.="" 101.9(g)(9)="" for="" conventional="" foods.="" thus,="" there="" will="" be="" a="" significant="" decrease="" in="" the="" number="" of="" respondents="" and="" product="" labels="" requiring="" revision="" in="" succeeding="" years="" with="" a="" corresponding="" decrease="" in="" annual="" burden="" hour="" cost.="" the="" hour="" burden="" estimates="" contained="" above="" are="" for="" the="" information="" collection="" requirements="" established="" by="" regulation="" alone="" and="" do="" not="" include="" those="" that="" stem="" solely="" from="" the="" act="" or="" the="" dshea.="" fda="" has="" estimated="" that="" the="" total="" annualized="" operating="" and="" maintenance="" costs="" will="" approximate="" $40,000,000="" over="" the="" next="" 3="" to="" 4="" years.="" this="" is="" based="" on="" annualized="" estimated="" relabeling="" costs="" of="" $32.5="" million,="" analytical="" costs="" of="" $6="" million,="" and="" labor="" and="" overhead="" costs="" of="" $1.5="" million="" over="" the="" next="" 3="" to="" 4="" years.="" the="" agency="" believes="" that="" these="" costs="" will="" decrease="" significantly="" over="" succeeding="" years.="" fda="" will="" reexamine="" these="" estimates="" at="" the="" end="" of="" 3="" to="" 4="" years.="" the="" agency="" has="" determined="" that="" the="" requirements="" in="" sec.="" 101.36="" do="" not="" require="" capital="" costs="" on="" the="" part="" of="" respondents.="" the="" first="" concern="" expressed="" by="" omb="" was="" about="" the="" accuracy="" of="" the="" cost="" and="" hour="" burden="" estimates="" for="" the="" information="" collection="" requirements.="" fda="" received="" one="" comment="" in="" response="" to="" the="" proposal="" that="" estimates="" of="" the="" number="" of="" firms="" should="" include="" the="" product="" manufacturer,="" label="" printer,="" product="" packager,="" label/brand="" owner,="" and="" the="" brand="" wholesaler.="" fda="" received="" no="" comments="" that="" suggested="" alternative="" costs="" or="" hour="" burdens="" from="" the="" agency's="" estimates.="" as="" discussed="" in="" more="" detail="" in="" section="" v.="" of="" this="" document="" and="" as="" indicated="" in="" the="" preceding="" table="" ``estimated="" annual="" reporting="" burden,''="" the="" agency="" has="" modified="" the="" number="" of="" respondents="" that="" will="" be="" affected="" by="" the="" information="" collection="" requirements="" from="" 600="" to="" 850="" but="" has="" retained="" the="" estimates="" of="" hour="" burden="" per="" response="" that="" was="" contained="" in="" the="" december="" 1995="" proposal.="" omb="" also="" expressed="" its="" concern="" about="" the="" utility="" of="" the="" nutrition="" information="" required="" to="" be="" disclosed="" on="" the="" labels="" of="" dietary="" supplements="" and="" whether="" the="" labels="" are="" sufficiently="" clear="" to="" the="" third-="" party="" recipients="" of="" this="" information.="" several="" comments="" to="" the="" december="" 1995="" proposal="" recommended="" that="" nutrients="" should="" be="" listed="" on="" dietary="" supplements="" only="" when="" they="" are="" added.="" other="" comments="" expressed="" concerns="" about="" the="" format="" requirements="" for="" the="" nutrition="" facts="" panel.="" as="" discussed="" in="" more="" detail="" above,="" fda="" is="" not="" persuaded="" by="" the="" comments="" that="" it="" should="" change="" the="" requirements="" for="" the="" listing="" of="" nutrients="" on="" dietary="" supplements.="" as="" also="" noted="" above,="" the="" agency="" points="" out="" that,="" except="" for="" certain="" specified="" exceptions,="" section="" 403(q)="" of="" the="" act="" requires="" nutrition="" labeling="" on="" most="" foods.="" with="" respect="" to="" dietary="" supplements,="" section="" 403(q)(5)(f)="" of="" the="" act,="" as="" amended="" by="" the="" dshea,="" specifies="" that="" the="" labels="" of="" dietary="" supplements="" shall="" comply="" with="" the="" requirements="" for="" nutrition="" labeling="" contained="" in="" subparagraphs="" (q)(1)="" and="" (q)(2)="" in="" a="" manner="" which="" is="" appropriate.="" furthermore,="" the="" agency="" believes="" that="" nutrition="" information="" on="" dietary="" supplements="" is="" essential="" for="" those="" that="" are="" interested="" to="" be="" able="" to="" calculate="" their="" daily="" intakes="" of="" nutrients.="" as="" to="" omb's="" concern="" that="" the="" information="" will="" be="" sufficiently="" clear="" to="" the="" third-party="" recipients,="" fda="" notes="" that="" consumer="" surveys="" have="" indicated="" that="" the="" graphic="" requirements="" in="" the="" nutrition="" labeling="" rules="" for="" food="" (i.e.,="" sec.="" 101.9)="" were="" successful="" in="" that="" the="" majority="" of="" shoppers="" who="" are="" aware="" of="" the="" new="" label="" think="" it="" is="" clear="" and="" understandable.="" fda="" has="" no="" reason="" to="" believe="" that="" the="" requirements="" for="" nutrition="" labeling="" of="" dietary="" supplements="" will="" be="" any="" less="" clear.="" fda="" has="" resubmitted="" the="" information="" collection="" requirements="" contained="" in="" this="" rule="" to="" omb="" for="" its="" review="" under="" the="" paperwork="" reduction="" act="" of="" 1995.="" interested="" persons="" are="" requested="" to="" send="" comments="" regarding="" information="" collection="" by="" october="" 23,="" 1997="" to="" the="" office="" of="" information="" and="" regulatory="" affairs,="" omb,="" new="" executive="" office="" bldg.,="" rm.="" 10235,="" washington,="" dc="" 20503,="" attn:="" desk="" officer="" for="" fda.="" no="" person="" may="" be="" required="" to="" respond="" to,="" or="" may="" be="" subjected="" a="" penalty="" for="" failure="" to="" comply="" with,="" these="" information="" collection="" requirements="" until="" they="" have="" been="" approved="" by="" omb="" and="" fda="" has="" displayed="" the="" assigned="" omb="" control="" number.="" the="" omb="" control="" number,="" when="" assigned,="" will="" be="" announced="" by="" separate="" notice="" in="" the="" federal="" register.="" ix.="" references="" the="" following="" references="" have="" been="" placed="" on="" display="" in="" the="" dockets="" management="" branch="" (address="" above)="" and="" may="" be="" seen="" by="" interested="" persons="" between="" 9="" a.m.="" and="" 4="" p.m.,="" monday="" through="" friday.="" 1.="" machlin,="" l.="" j.,="" editor,="" handbook="" of="" vitamins,="" 2d="" ed.,="" pp.="" 239="" and="" 285,="" dekker,="" ny,="" 1991.="" 2.="" subcommittee="" on="" the="" 10th="" edition="" of="" the="" rda's,="" food="" and="" nutrition="" board,="" commission="" of="" life="" sciences,="" national="" research="" council,="" ``recommended="" dietary="" allowances,="" 10th="" ed.,''="" pp.="" 125="" and="" 132,="" washington,="" dc,="" national="" academy="" press,="" 1989.="" [[page="" 49847]]="" 3.="" food="" marketing="" institute="" prevention="" magazine="" report,="" ``shopping="" for="" health="" 1995,''="" food="" marketing="" institute,="" washington,="" dc,="" and="" prevention="" magazine,="" emmaus,="" pa,="" 1995.="" 4.="" nonprescription="" drug="" manufacturers="" association's="" special="" task="" force="" on="" label="" readability,="" ``label="" readability="" guidelines,''="" washington,="" dc,="" 1991.="" 5.="" tanner,="" j.="" t.,="" letter="" to="" v.="" srinivasan,="" u.s.="" pharmacopeial="" convention,="" inc.,="" may="" 7,="" 1991.="" 6.="" deming,="" w.="" e.,="" ``on="" the="" presentation="" of="" the="" results="" of="" sample="" surveys="" as="" legal="" evidence,''="" the="" journal="" of="" the="" american="" statistical="" association,="" 49:818-821,="" december="" 1954.="" 7.="" memorandum="" between="" bill="" bradley,="" nonprescription="" drug="" manufacturers="" association,="" and="" susan="" thompson,="" cfsan,="" fda,="" october="" 15,="" 1993.="" 8.="" u.s.="" department="" of="" agriculture,="" human="" nutrition="" information="" service,="" ``the="" food="" guide="" pyramid,''="" home="" and="" garden="" bulletin="" number="" 252,="" august="" 1992.="" 9.="" u.s.="" department="" of="" agriculture,="" center="" for="" nutrition="" policy="" and="" promotion,="" ``the="" healthy="" eating="" index,''="" october="" 1995.="" 10.="" u.s.="" department="" of="" agriculture,="" economic="" research="" service,="" ``food="" consumption,="" prices,="" and="" expenditures,="" 1996,''="" statistical="" bulletin="" number="" 928,="" pp.="" 18-19.="" 11.="" foster,="" s.,="" editor,="" herbs="" of="" commerce,="" amercian="" herbal="" products="" association,="" bethesda,="" md,="" 1992.="" 12.="" greuter,="" w.,="" editor="" (chairperson),="" international="" code="" of="" botanical="" nomenclature="" (tokyo="" code),="" adopted="" by="" the="" 15th="" international="" botanical="" congress,="" koeltz="" scientific="" books,="" d-61453="" konigstein,="" germany,="" 1994.="" list="" of="" subjects="" in="" 21="" cfr="" part="" 101="" food="" labeling,="" incorporation="" by="" reference,="" nutrition,="" reporting="" and="" recordkeeping="" requirements.="" therefore,="" under="" the="" federal="" food,="" drug,="" and="" cosmetic="" act="" and="" under="" authority="" delegated="" to="" the="" commissioner="" of="" food="" and="" drugs,="" 21="" cfr="" part="" 101="" is="" amended="" as="" follows:="" part="" 101--food="" labeling="" 1.="" the="" authority="" citation="" for="" 21="" cfr="" part="" 101="" continues="" to="" read="" as="" follows:="" authority:="" secs.="" 4,="" 5,="" 6="" of="" the="" fair="" packaging="" and="" labeling="" act="" (15="" u.s.c.="" 1453,="" 1454,="" 1455);="" secs.="" 201,="" 301,="" 402,="" 403,="" 409,="" 701="" of="" the="" federal="" food,="" drug,="" and="" cosmetic="" act="" (21="" u.s.c.="" 321,="" 331,="" 342,="" 343,="" 348,="" 371).="" 2.="" section="" 101.2="" is="" amended="" by="" revising="" paragraphs="" (b),="" (d)(1),="" and="" (f)="" to="" read="" as="" follows:="" sec.="" 101.2="" information="" panel="" of="" package="" form="" food.="" *="" *="" *="" *="" *="" (b)="" all="" information="" required="" to="" appear="" on="" the="" label="" of="" any="" package="" of="" food="" under="" secs.="" 101.4,="" 101.5,="" 101.8,="" 101.9,="" 101.13,="" 101.17,="" 101.36,="" subpart="" d="" of="" part="" 101,="" and="" part="" 105="" of="" this="" chapter="" shall="" appear="" either="" on="" the="" principal="" display="" panel="" or="" on="" the="" information="" panel,="" unless="" otherwise="" specified="" by="" regulations="" in="" this="" chapter.="" *="" *="" *="" *="" *="" (d)(1)="" except="" as="" provided="" by="" secs.="" 101.9(j)(13)="" and="" (j)(17)="" and="" 101.36(i)(2)="" and="" (i)(5),="" all="" information="" required="" to="" appear="" on="" the="" principal="" display="" panel="" or="" on="" the="" information="" panel="" under="" this="" section="" shall="" appear="" on="" the="" same="" panel="" unless="" there="" is="" insufficient="" space.="" in="" determining="" the="" sufficiency="" of="" the="" available="" space,="" except="" as="" provided="" by="" secs.="" 101.9(j)(17)="" and="" 101.36(i)(5),="" any="" vignettes,="" designs,="" and="" other="" nonmandatory="" label="" information="" shall="" not="" be="" considered.="" if="" there="" is="" insufficient="" space="" for="" all="" of="" this="" information="" to="" appear="" on="" a="" single="" panel,="" it="" may="" be="" divided="" between="" these="" two="" panels,="" except="" that="" the="" information="" required="" under="" any="" given="" section="" or="" part="" shall="" all="" appear="" on="" the="" same="" panel.="" a="" food="" whose="" label="" is="" required="" to="" bear="" the="" ingredient="" statement="" on="" the="" principal="" display="" panel="" may="" bear="" all="" other="" information="" specified="" in="" paragraph="" (b)="" of="" this="" section="" on="" the="" information="" panel.="" *="" *="" *="" *="" *="" (f)="" if="" the="" label="" of="" any="" package="" of="" food="" is="" too="" small="" to="" accommodate="" all="" of="" the="" information="" required="" by="" secs.="" 101.4,="" 101.5,="" 101.8,="" 101.9,="" 101.13,="" 101.17,="" 101.36,="" subpart="" d="" of="" part="" 101,="" and="" part="" 105="" of="" this="" chapter,="" the="" commissioner="" may="" establish="" by="" regulation="" an="" acceptable="" alternative="" method="" of="" disseminating="" such="" information="" to="" the="" public,="" e.g.,="" a="" type="" size="" smaller="" than="" one-sixteenth="" inch="" in="" height,="" or="" labeling="" attached="" to="" or="" inserted="" in="" the="" package="" or="" available="" at="" the="" point="" of="" purchase.="" a="" petition="" requesting="" such="" a="" regulation,="" as="" an="" amendment="" to="" this="" paragraph,="" shall="" be="" submitted="" under="" part="" 10="" of="" this="" chapter.="" 3.="" section="" 101.3="" is="" amended="" by="" adding="" new="" paragraph="" (g)="" to="" read="" as="" follows:="" sec.="" 101.3="" identity="" labeling="" of="" food="" in="" packaged="" form.="" *="" *="" *="" *="" *="" (g)="" dietary="" supplements="" shall="" be="" identified="" by="" the="" term="" ``dietary="" supplement''="" as="" a="" part="" of="" the="" statement="" of="" identity,="" except="" that="" the="" word="" ``dietary''="" may="" be="" deleted="" and="" replaced="" by="" the="" name="" of="" the="" dietary="" ingredients="" in="" the="" product="" (e.g.,="" calcium="" supplement)="" or="" an="" appropriately="" descriptive="" term="" indicating="" the="" type="" of="" dietary="" ingredients="" that="" are="" in="" the="" product="" (e.g.,="" herbal="" supplement="" with="" vitamins).="" 4.="" section="" 101.4="" is="" amended="" by="" revising="" paragraph="" (a)(1)="" and="" adding="" new="" paragraphs="" (g)="" and="" (h)="" to="" read="" as="" follows:="" sec.="" 101.4="" food;="" designation="" of="" ingredients.="" (a)(1)="" ingredients="" required="" to="" be="" declared="" on="" the="" label="" or="" labeling="" of="" a="" food,="" including="" foods="" that="" comply="" with="" standards="" of="" identity,="" except="" those="" ingredients="" exempted="" by="" sec.="" 101.100,="" shall="" be="" listed="" by="" common="" or="" usual="" name="" in="" descending="" order="" of="" predominance="" by="" weight="" on="" either="" the="" principal="" display="" panel="" or="" the="" information="" panel="" in="" accordance="" with="" the="" provisions="" of="" sec.="" 101.2,="" except="" that="" ingredients="" in="" dietary="" supplements="" that="" are="" listed="" in="" the="" nutrition="" label="" in="" accordance="" with="" sec.="" 101.36="" need="" not="" be="" repeated="" in="" the="" ingredient="" list.="" paragraph="" (g)="" of="" this="" section="" describes="" the="" ingredient="" list="" on="" dietary="" supplement="" products.="" *="" *="" *="" *="" *="" (g)="" when="" present,="" the="" ingredient="" list="" on="" dietary="" supplement="" products="" shall="" be="" located="" immediately="" below="" the="" nutrition="" label,="" or,="" if="" there="" is="" insufficient="" space="" below="" the="" nutrition="" label,="" immediately="" contiguous="" and="" to="" the="" right="" of="" the="" nutrition="" label="" and="" shall="" be="" preceded="" by="" the="" word="" ``ingredients,''="" unless="" some="" ingredients="" (i.e.,="" sources)="" are="" identified="" within="" the="" nutrition="" label="" in="" accordance="" with="" sec.="" 101.36(d),="" in="" which="" case="" the="" ingredients="" listed="" outside="" the="" nutrition="" label="" shall="" be="" in="" a="" list="" preceded="" by="" the="" words="" ``other="" ingredients.''="" ingredients="" in="" dietary="" supplements="" that="" are="" not="" dietary="" ingredients="" or="" that="" do="" not="" contain="" dietary="" ingredients,="" such="" as="" excipients,="" fillers,="" artificial="" colors,="" artificial="" sweeteners,="" flavors,="" or="" binders,="" shall="" be="" included="" in="" the="" ingredient="" list.="" (h)="" the="" common="" or="" usual="" name="" of="" ingredients="" of="" dietary="" supplements="" that="" are="" botanicals="" (including="" fungi="" and="" algae)="" shall="" be="" consistent="" with="" the="" names="" standardized="" in="" herbs="" of="" commerce,="" 1992="" edition,="" which="" is="" incorporated="" by="" reference="" in="" accordance="" with="" 5="" u.s.c.="" 552(a)="" and="" 1="" cfr="" part="" 51.="" copies="" may="" be="" obtained="" from="" the="" american="" herbal="" products="" association,="" 4733="" bethesda="" ave.,="" suite="" 345,="" bethesda,="" md="" 20814,="" or="" may="" be="" examined="" at="" the="" center="" for="" food="" safety="" and="" applied="" nutrition's="" library,="" 200="" c="" st.="" sw.,="" rm.="" 3321,="" washington,="" dc,="" or="" at="" the="" office="" of="" the="" federal="" register,="" 800="" capital="" st.="" nw.,="" suite="" 700,="" washington,="" dc.="" the="" listing="" of="" these="" names="" on="" the="" label="" shall="" be="" followed="" by="" statements="" of:="" (1)="" the="" part="" of="" the="" plant="" (e.g.,="" root,="" leaves)="" from="" which="" the="" dietary="" ingredient="" is="" derived="" (e.g.,="" ``garlic="" bulb''="" or="" ``garlic="" (bulb)''),="" except="" that="" this="" designation="" is="" not="" required="" for="" algae.="" the="" name="" of="" the="" part="" of="" the="" plant="" shall="" [[page="" 49848]]="" pressed="" in="" english="" (e.g.,="" ``flower''="" rather="" than="" ``flos'');="" (2)="" the="" latin="" binomial="" name="" of="" the="" plant,="" in="" parentheses,="" except="" that="" this="" name="" is="" not="" required="" when="" it="" is="" available="" in="" the="" reference="" entitled:="" herbs="" of="" commerce="" for="" the="" common="" or="" usual="" name="" listed="" on="" the="" label,="" and,="" when="" required,="" the="" latin="" binomial="" name="" may="" be="" listed="" before="" the="" part="" of="" the="" plant.="" any="" name="" in="" latin="" form="" shall="" be="" in="" accordance="" with="" internationally="" accepted="" rules="" on="" nomenclature,="" such="" as="" those="" found="" in="" the="" international="" code="" of="" botanical="" nomenclature="" and="" shall="" include="" the="" designation="" of="" the="" author="" or="" authors="" who="" published="" the="" latin="" name,="" when="" a="" positive="" identification="" cannot="" be="" made="" in="" its="" absence.="" the="" international="" code="" of="" botanical="" nomenclature="" (tokyo="" code),="" 1994="" edition,="" a="" publication="" of="" the="" international="" association="" for="" plant="" taxonomy,="" is="" incorporated="" by="" reference="" in="" accordance="" with="" 5="" u.s.c.="" 552(a)="" and="" 1="" cfr="" part="" 51.="" copies="" of="" the="" international="" code="" of="" botanical="" nomenclature="" may="" be="" obtained="" from="" koeltz="" scientific="" books,="" d-61453="" konigstein,="" germany,="" and="" university="" bookstore,="" southern="" illinois="" university,="" carbondale,="" il="" 62901-4422,="" 618-536-3321,="" fax="" 618-453-5207,="" or="" may="" be="" examined="" at="" the="" center="" for="" food="" safety="" and="" applied="" nutrition's="" library,="" 200="" c="" st.="" sw.,="" rm.="" 3321,="" washington="" dc,="" or="" at="" the="" office="" of="" the="" federal="" register,="" 800="" north="" capitol="" st.="" nw.,="" suite="" 700,="" washington="" dc.="" (3)="" on="" labels="" of="" single-ingredient="" dietary="" supplements="" that="" do="" not="" include="" an="" ingredient="" list,="" the="" identification="" of="" the="" latin="" binomial="" name,="" when="" needed,="" and="" the="" part="" of="" the="" plant="" may="" be="" prominently="" placed="" on="" the="" principal="" display="" panel="" or="" information="" panel,="" or="" included="" in="" the="" nutrition="" label.="" 5.="" section="" 101.9="" is="" amended="" by="" removing="" paragraphs="" (k)(2)="" and="" (k)(5),="" by="" redesignating="" paragraphs="" (k)(3),="" (k)(4),="" and="" (k)(6)="" as="" paragraphs="" (k)(2),="" (k)(3),="" and="" (k)(4),="" respectively,="" and="" by="" revising="" paragraphs="" (c)(8)(iii),="" (c)(8)(v),="" (d)(7)(i),="" (j)(6),="" and="" newly="" redesignated="" (k)(4)="" to="" read="" as="" follows:="" sec.="" 101.9="" nutrition="" labeling="" of="" food.="" *="" *="" *="" *="" *="" (c)="" *="" *="" *="" (8)="" *="" *="" *="" (iii)="" the="" percentages="" for="" vitamins="" and="" minerals="" shall="" be="" expressed="" to="" the="" nearest="" 2-percent="" increment="" up="" to="" and="" including="" the="" 10-percent="" level,="" the="" nearest="" 5-percent="" increment="" above="" 10="" percent="" and="" up="" to="" and="" including="" the="" 50-percent="" level,="" and="" the="" nearest="" 10-percent="" increment="" above="" the="" 50-percent="" level.="" amounts="" of="" vitamins="" and="" minerals="" present="" at="" less="" than="" 2="" percent="" of="" the="" rdi="" are="" not="" required="" to="" be="" declared="" in="" nutrition="" labeling="" but="" may="" be="" declared="" by="" a="" zero="" or="" by="" the="" use="" of="" an="" asterisk="" (or="" other="" symbol)="" that="" refers="" to="" another="" asterisk="" (or="" symbol)="" that="" is="" placed="" at="" the="" bottom="" of="" the="" table="" and="" that="" is="" followed="" by="" the="" statement="" ``contains="" less="" than="" 2="" percent="" of="" the="" daily="" value="" of="" this="" (these)="" nutrient="" (nutrients)''="" or="" ``contains="">< 2="" percent="" of="" the="" daily="" value="" of="" this="" (these)="" nutrient="" (nutrients).''="" alternatively,="" except="" as="" provided="" for="" in="" paragraph="" (f)="" of="" this="" section,="" if="" vitamin="" a,="" vitamin="" c,="" calcium,="" or="" iron="" is="" present="" in="" amounts="" less="" than="" 2="" percent="" of="" the="" rdi,="" label="" declaration="" of="" the="" nutrient(s)="" is="" not="" required="" if="" the="" statement="" ``not="" a="" significant="" source="" of="" ______="" (listing="" the="" vitamins="" or="" minerals="" omitted)''="" is="" placed="" at="" the="" bottom="" of="" the="" table="" of="" nutrient="" values.="" either="" statement="" shall="" be="" in="" the="" same="" type="" size="" as="" nutrients="" that="" are="" indented.="" *="" *="" *="" *="" *="" (v)="" the="" following="" synonyms="" may="" be="" added="" in="" parentheses="" immediately="" following="" the="" name="" of="" the="" nutrient="" or="" dietary="" component:="" calories--energy,="" vitamin="" c--ascorbic="" acid,="" thiamin--vitamin="">1,
Riboflavin--Vitamin B2,
Folate--Folic acid or Folacin. Alternatively, folic acid or folacin may
be listed without parentheses in place of folate.
* * * * *
(d) * * *
(7) * * *
(i) The name of each nutrient, as specified in paragraph (c) of
this section, shall be given in a column and followed immediately by
the quantitative amount by weight for that nutrient appended with a
``g'' for grams or a ``mg'' for milligrams as shown in paragraph
(d)(12) of this section. The symbol ``<'' may="" be="" used="" in="" place="" of="" ``less="" than.''="" *="" *="" *="" *="" *="" (j)="" *="" *="" *="" (6)="" dietary="" supplements,="" except="" that="" such="" foods="" shall="" be="" labeled="" in="" compliance="" with="" sec.="" 101.36.="" *="" *="" *="" *="" *="" (k)="" *="" *="" *="" (4)="" that="" a="" natural="" vitamin="" in="" a="" food="" is="" superior="" to="" an="" added="" or="" synthetic="" vitamin.="" 6.="" section="" 101.12="" is="" amended="" in="" paragraph="" (b),="" table="" 2,="" under="" the="" subheading="" ``miscellaneous="" category''="" by="" revising="" the="" entry="" ``dietary="" supplements="" not="" in="" conventional="" food="" form''="" to="" read="" as="" follows:="" sec.="" 101.12="" reference="" amounts="" customarily="" consumed="" per="" eating="" occasion.="" *="" *="" *="" *="" *="" (b)="" *="" *="" *="" table="" 2.--reference="" amounts="" customarily="" consumed="" per="" eating="" occasion:="" general="" food="">1,2,3,4
----------------------------------------------------------------------------------------------------------------
Product category Reference amount Label statement5
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Miscellaneous category:
Dietary supplements The maximum amount ______tablet(s), ______capsule(s), ______packet(s),
recommended, as ______tsp(s), (______g), etc
appropriate, on the
label for consumption
per eating occasion, or,
in the absence of
recommendations, 1 unit,
e.g., tablet, capsule,
packet, teaspoonsful,
etc.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
primarily derived from the 1977-78 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or
almost ready-to-serve form of the product (i.e, heat and serve, brown and serve). If not listed separately,
the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; fresh and frozen
pasta) is the amount required to make the reference amount of the prepared form. Prepared means prepared for
consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the label serving size in a household measure
most appropriate to their specific product using the procedures in 21 CFR 101.9(b).
[[Page 49849]]
\4\ Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington,
DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers on the presentation of serving size
information on the label, but they are not required. The term ``piece'' is used as a generic description of a
discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific
product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided
is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not
apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless
specifically stated in the product category, reference amount, or label statement column that it is for these
forms of the product. For products that require further preparation, manufacturers must determine the label
statement following the rules in Sec. 101.9(b) using the reference amount determined according to Sec.
101.12(c).
* * * * *
7. Section 101.36 is revised to read as follows:
Sec. 101.36 Nutrition labeling of dietary supplements.
(a) The label of a dietary supplement that is offered for sale
shall bear nutrition labeling in accordance with this regulation unless
an exemption is provided for the product in paragraph (h) of this
section.
(b) The declaration of nutrition information on the label and in
labeling shall contain the following information, using the subheadings
and the format specified in paragraph (e) of this section.
(1) Serving size--(i) The subheading ``Serving Size'' shall be
placed under the heading ``Supplement Facts'' and aligned on the left
side of the nutrition label. The serving size shall be determined in
accordance with Secs. 101.9(b) and 101.12(b), Table 2. Serving size for
dietary supplements shall be expressed using a term that is appropriate
for the form of the supplement, such as ``tablets,'' ``capsules,''
``packets,'' or ``teaspoonfuls.''
(ii) The subheading ``Servings Per Container'' shall be placed
under the subheading ``Serving Size'' and aligned on the left side of
the nutrition label, except that this information need not be provided
when it is stated in the net quantity of contents declaration.
(2) Information on dietary ingredients that have a Reference Daily
Intake (RDI) or a Daily Reference Value (DRV) as established in
Sec. 101.9(c) and their subcomponents (hereinafter referred to as
``(b)(2)-dietary ingredients'')--(i) The (b)(2)-dietary ingredients to
be declared, that is, total calories, calories from fat, total fat,
saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber,
sugars, protein, vitamin A, vitamin C, calcium and iron, shall be
declared when they are present in a dietary supplement in quantitative
amounts by weight that exceed the amount that can be declared as zero
in nutrition labeling of foods in accordance with Sec. 101.9(c).
Calories from saturated fat and polyunsaturated fat, monounsaturated
fat, soluble fiber, insoluble fiber, sugar alcohol, and other
carbohydrate may be declared, but they shall be declared when a claim
is made about them. Any other vitamins or minerals listed in
Sec. 101.9(c)(8)(iv) or (c)(9) may be declared, but they shall be
declared when they are added to the product for purposes of
supplementation, or when a claim is made about them. Any (b)(2)-dietary
ingredients that are not present, or that are present in amounts that
can be declared as zero in Sec. 101.9(c), shall not be declared (e.g.,
amounts corresponding to less than 2 percent of the RDI for vitamins
and minerals). Protein shall not be declared on labels of products
that, other than ingredients added solely for technological reasons,
contain only individual amino acids.
(A) The names and the quantitative amounts by weight of each
(b)(2)-dietary ingredient shall be presented under the heading ``Amount
Per Serving.'' When the quantitative amounts by weight are presented in
a separate column, the heading may be centered over a column of
quantitative amounts, described by paragraph (b)(2)(ii) of this
section, if space permits. A heading consistent with the declaration of
the serving size, such as ``Each Tablet Contains,'' or ``Amount Per 2
Tablets'' may be used in place of the heading ``Amount Per Serving.''
Other appropriate terms, such as capsule, packet, or teaspoonful, also
may be used in place of the term ``Serving.''
(B) The names of dietary ingredients that are declared under
paragraph (b)(2)(i) of this section shall be presented in a column
aligned on the left side of the nutrition label in the order and manner
of indentation specified in Sec. 101.9(c), except that calcium and iron
shall follow pantothenic acid, and sodium and potassium shall follow
chloride. This results in the following order for vitamins and
minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K,
thiamin, riboflavin, niacin, vitamin 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 or in paragraph (b)(2)(i)(B)(2) of this section.
(1) When ``Calories'' are declared, they shall be listed first in
the column of names, beneath a light bar separating the heading
``Amount Per Serving'' from the list of names. When ``Calories from
fat'' or ``Calories from saturated fat'' are declared, they shall be
indented beneath ``Calories.''
(2) The following synonyms may be added in parentheses immediately
following the name of these (b)(2)-dietary ingredients: Vitamin C
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin
B2), folate (folacin or folic acid), and calories (energy).
Alternatively, the term ``folic acid'' or ``folacin'' may be listed
without parentheses in place of ``folate.'' Energy content per serving
may be expressed in kilojoules units, added in parentheses immediately
following the statement of caloric content.
(3) Beta-carotene may be declared as the percent of vitamin A that
is present as beta-carotene, except that the declaration is required
when a claim is made about beta-carotene. When declared, the percent
shall be declared to the nearest whole percent, immediately adjacent to
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of international
units (IU) may be included in parentheses following the percent
statement (e.g., ``Vitamin A (90% (4500 IU) as beta-carotene)'').
(ii) The number of calories, if declared, and the quantitative
amount by weight per serving of each dietary ingredient required to be
listed under paragraph (b)(2)(i) of this section shall be presented
either in a separate column aligned to the right of the column of names
or immediately following the listing of names within the same column.
The quantitative amounts by weight shall represent the weight of the
dietary ingredient rather than the weight of the source of the dietary
ingredient (e.g., the weight of calcium rather than that of calcium
carbonate).
(A) These amounts shall be expressed in the increments specified in
Sec. 101.9(c)(1) through (c)(7), which includes increments for sodium
and potassium.
[[Page 49850]]
(B) The amounts of vitamins and minerals, excluding sodium and
potassium, shall be the amount of the vitamin or mineral included in
one serving of the product, using the units of measurement and the
levels of significance given in Sec. 101.9(c)(8)(iv), except that zeros
following decimal points may be dropped, and additional levels of
significance may be used when the number of decimal places indicated is
not sufficient to express lower amounts (e.g., the RDI for zinc is
given in whole milligrams (mg), but the quantitative amount may be
declared in tenths of a mg).
(iii) The percent of the Daily Value of all dietary ingredients
declared under paragraph (b)(2)(i) of this section shall be listed,
except that the percent for protein may be omitted as provided in
Sec. 101.9(c)(7); no percent shall be given for subcomponents for which
DRV's have not been established (e.g., sugars); and, for labels of
dietary supplements of vitamins and minerals that are represented or
purported to be for use by infants, children less than 4 years of age,
or pregnant or lactating women, no percent shall be given for total
fat, saturated fat, cholesterol, total carbohydrate, dietary fiber,
vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium,
or potassium.
(A) When information on the percent of Daily Values is listed, this
information shall be presented in one column aligned under the heading
of ``% Daily Value'' and to the right of the column of amounts. The
headings ``% Daily Value (DV),'' ``% DV,'' ``Percent Daily Value,'' or
``Percent DV'' may be substituted for ``% Daily Value.'' The heading
``% Daily Value'' shall be placed on the same line as the heading
``Amount Per Serving.'' When the acronym ``DV'' is unexplained in the
heading and a footnote is required under (b)(2)(iii)(D),
(b)(2)(iii)(F), or (b)(3)(iv) of this section, the footnote shall
explain the acronym (e.g. ``Daily Value (DV) not established'').
(B) The percent of Daily Value shall be calculated by dividing the
quantitative amount by weight of each (b)(2)-dietary ingredient by the
RDI as established in Sec. 101.9(c)(8)(iv) or the DRV as established in
Sec. 101.9(c)(9) for the specified dietary ingredient and multiplying
by 100, except that the percent of Daily Value for protein, when
present, shall be calculated as specified in Sec. 101.9(c)(7)(ii). The
quantitative amount by weight of each dietary ingredient in this
calculation shall be the unrounded amount, except that for total fat,
saturated fat, cholesterol, sodium, potassium, total carbohydrate, and
dietary fiber, the quantitative amount by weight declared on the label
(i.e, rounded amount) may be used. The numerical value shall be
followed by the symbol for percent (i.e., %).
(C) The percentages based on RDI's and on DRV's shall be expressed
to the nearest whole percent, except that for dietary ingredients for
which DRV's have been established, ``Less than 1%'' or ``<1%'' shall="" be="" used="" to="" declare="" the="" ``%="" daily="" value''="" when="" the="" quantitative="" amount="" of="" the="" dietary="" ingredient="" by="" weight="" is="" great="" enough="" to="" require="" that="" the="" dietary="" ingredient="" be="" listed,="" but="" the="" amount="" is="" so="" small="" that="" the="" ``%="" daily="" value''="" when="" rounded="" to="" the="" nearest="" percent="" is="" zero="" (e.g.,="" a="" product="" that="" contains="" 1="" gram="" of="" total="" carbohydrate="" would="" list="" the="" percent="" daily="" value="" as="" ``less="" than="" 1%''="" or=""><1%''). (d)="" if="" the="" percent="" of="" daily="" value="" is="" declared="" for="" total="" fat,="" saturated="" fat,="" total="" carbohydrate,="" dietary="" fiber,="" or="" protein,="" a="" symbol="" shall="" follow="" the="" value="" listed="" for="" those="" nutrients="" that="" refers="" to="" the="" same="" symbol="" that="" is="" placed="" at="" the="" bottom="" of="" the="" nutrition="" label,="" below="" the="" bar="" required="" under="" paragraph="" (e)(6)="" of="" this="" section="" and="" inside="" the="" box,="" that="" is="" followed="" by="" the="" statement="" ``percent="" daily="" values="" are="" based="" on="" a="" 2,000="" calorie="" diet.''="" (e)="" the="" percent="" of="" daily="" value="" shall="" be="" based="" on="" rdi="" and="" drv="" values="" for="" adults="" and="" children="" 4="" or="" more="" years="" of="" age,="" unless="" the="" product="" is="" represented="" or="" purported="" to="" be="" for="" use="" by="" infants,="" children="" less="" than="" 4="" years="" of="" age,="" pregnant="" women,="" or="" lactating="" women,="" in="" which="" case="" the="" column="" heading="" shall="" clearly="" state="" the="" intended="" group.="" if="" the="" product="" is="" for="" persons="" within="" more="" than="" one="" group,="" the="" percent="" of="" daily="" value="" for="" each="" group="" shall="" be="" presented="" in="" separate="" columns="" as="" shown="" in="" paragraph="" (e)(10)(ii)="" of="" this="" section.="" (f)="" for="" declared="" subcomponents="" that="" have="" no="" drv's="" and,="" on="" the="" labels="" of="" dietary="" supplements="" of="" vitamins="" and="" minerals="" that="" are="" represented="" or="" purported="" to="" be="" for="" use="" by="" infants,="" children="" less="" that="" 4="" years="" of="" age,="" or="" pregnant="" or="" lactating="" women,="" for="" total="" fat,="" saturated="" fat,="" cholesterol,="" total="" carbohydrate,="" dietary="" fiber,="" vitamin="" k,="" selenium,="" manganese,="" chromium,="" molybdenum,="" chloride,="" sodium,="" or="" potassium,="" a="" symbol="" (e.g.,="" an="" asterisk)="" shall="" be="" placed="" in="" the="" ``percent="" daily="" value''="" column="" that="" shall="" refer="" to="" the="" same="" symbol="" that="" is="" placed="" at="" the="" bottom="" of="" the="" nutrition="" label,="" below="" the="" last="" heavy="" bar="" and="" inside="" the="" box,="" and="" followed="" by="" the="" statement="" ``daily="" value="" not="" established.''="" (g)="" when="" calories,="" calories="" from="" fat,="" or="" calories="" from="" saturated="" fat="" are="" declared,="" the="" space="" under="" the="" ``%="" daily="" value''="" column="" shall="" be="" left="" blank="" for="" these="" items.="" when="" there="" are="" no="" other="" (b)(2)-dietary="" ingredients="" listed="" for="" which="" a="" value="" must="" be="" declared="" in="" the="" ``%="" daily="" value''="" column,="" the="" column="" may="" be="" omitted="" as="" shown="" in="" paragraph="" (e)(10)(vii)="" of="" this="" section.="" when="" the="" ``%="" daily="" value''="" column="" is="" not="" required,="" but="" the="" dietary="" ingredients="" listed="" are="" subject="" to="" paragraph="" (b)(2)(iii)(f)="" of="" this="" section,="" the="" symbol="" required="" in="" that="" paragraph="" shall="" immediately="" follow="" the="" quantitative="" amount="" by="" weight="" for="" each="" dietary="" ingredient="" listed="" under="" ``amount="" per="" serving.''="" (iv)="" the="" quantitative="" amount="" by="" weight="" and="" the="" percent="" of="" daily="" value="" may="" be="" presented="" on="" a="" ``per="" unit''="" basis="" in="" addition="" to="" on="" a="" ``per="" serving''="" basis,="" as="" required="" in="" paragraph="" (b)(2)(ii)="" of="" this="" section.="" this="" information="" shall="" be="" presented="" in="" additional="" columns="" and="" clearly="" identified="" by="" appropriate="" headings.="" (3)="" information="" on="" dietary="" ingredients="" for="" which="" rdi's="" and="" drv's="" have="" not="" been="" established--(i)="" dietary="" ingredients="" for="" which="" fda="" has="" not="" established="" rdi's="" or="" drv's="" and="" that="" are="" not="" subject="" to="" regulation="" under="" paragraph="" (b)(2)="" of="" this="" section="" (hereinafter="" referred="" to="" as="" ``other="" dietary="" ingredients'')="" shall="" be="" declared="" by="" their="" common="" or="" usual="" name="" when="" they="" are="" present="" in="" a="" dietary="" supplement,="" in="" a="" column="" that="" is="" under="" the="" column="" of="" names="" described="" in="" paragraph="" (b)(2)(i)(b)="" of="" this="" section="" or,="" as="" long="" as="" the="" constituents="" of="" an="" other="" dietary="" ingredient="" are="" not="" listed,="" in="" a="" linear="" display,="" under="" the="" heavy="" bar="" described="" in="" paragraph="" (e)(6)="" of="" this="" section,="" except="" that="" if="" no="" (b)(2)-dietary="" ingredients="" are="" declared,="" other="" dietary="" ingredients="" shall="" be="" declared="" directly="" beneath="" the="" heading="" ``amount="" per="" serving''="" described="" in="" paragraph="" (b)(2)(i)(a)="" of="" this="" section.="" (ii)="" the="" quantitative="" amount="" by="" weight="" per="" serving="" of="" other="" dietary="" ingredients="" shall="" be="" presented="" in="" the="" same="" manner="" as="" the="" corresponding="" information="" required="" in="" paragraph="" (b)(2)(ii)="" of="" this="" section="" or,="" when="" a="" linear="" display="" is="" used,="" shall="" be="" presented="" immediately="" following="" the="" name="" of="" the="" other="" dietary="" ingredient.="" the="" quantitative="" amount="" by="" weight="" shall="" be="" the="" weight="" of="" the="" other="" dietary="" ingredient="" listed="" and="" not="" the="" weight="" of="" any="" component,="" or="" the="" source,="" of="" that="" dietary="" ingredient.="" (a)="" these="" amounts="" shall="" be="" expressed="" using="" metric="" measures="" in="" appropriate="" units="" (i.e.,="" 1,000="" or="" more="" units="" shall="" be="" declared="" in="" the="" next="" higher="" set="" of="" units,="" e.g.,="" 1,100="" mg="" shall="" be="" declared="" as="" 1.1="" g).="" (b)="" for="" any="" dietary="" ingredient="" that="" is="" a="" liquid="" extract="" from="" which="" the="" solvent="" [[page="" 49851]]="" has="" not="" been="" removed,="" the="" quantity="" listed="" shall="" be="" the="" weight="" of="" the="" total="" extract="" with="" information="" on="" the="" concentration="" of="" the="" dietary="" ingredient,="" the="" solvent="" used,="" and="" the="" condition="" of="" the="" starting="" material="" (i.e.,="" whether="" it="" is="" fresh="" or="" dried),="" e.g.,="" ``fresh="" dandelion="" root="" extract,="" x="" mg="" (y:z)="" in="" 70%="" ethanol,''="" where="" x="" is="" the="" number="" of="" mg="" of="" the="" entire="" extract,="" y="" is="" the="" weight="" of="" the="" starting="" material="" and="" z="" is="" the="" volume="" (milliliters)="" of="" solvent.="" where="" the="" solvent="" has="" been="" partially="" removed="" (not="" to="" dryness),="" the="" final="" concentration="" shall="" be="" stated="" (e.g.,="" if="" the="" original="" extract="" was="" 1:5="" and="" 50="" percent="" of="" the="" solvent="" was="" removed,="" then="" the="" final="" concentration="" shall="" be="" stated="" as="" 1:2.5).="" (c)="" for="" a="" dietary="" ingredient="" that="" is="" an="" extract="" from="" which="" the="" solvent="" has="" been="" removed,="" the="" weight="" of="" the="" ingredient="" shall="" be="" the="" weight="" of="" the="" dried="" extract.="" the="" dried="" extract="" shall="" be="" described="" by="" an="" appropriately="" descriptive="" term="" that="" identifies="" the="" solvent="" used,="" e.g.,="" ``dried="" hexane="" extract="" of="" ________''="" or="" ``________,="" dried="" hexane="" extract.''="" (iii)="" the="" constituents="" of="" a="" dietary="" ingredient="" described="" in="" paragraph="" (b)(3)(i)="" of="" this="" section="" may="" be="" listed="" indented="" under="" the="" dietary="" ingredient="" and="" followed="" by="" their="" quantitative="" amounts="" by="" weight,="" except="" that="" dietary="" ingredients="" described="" in="" paragraph="" (b)(2)="" of="" this="" section="" shall="" be="" listed="" in="" accordance="" with="" that="" section.="" when="" the="" constituents="" of="" a="" dietary="" ingredient="" described="" in="" paragraph="" (b)(3)(i)="" of="" this="" section="" are="" listed,="" all="" other="" dietary="" ingredients="" shall="" be="" declared="" in="" a="" column;="" however,="" the="" constituents="" themselves="" may="" be="" declared="" in="" a="" column="" or="" in="" a="" linear="" display.="" (iv)="" other="" dietary="" ingredients="" shall="" bear="" a="" symbol="" (e.g.,="" an="" asterisk)="" in="" the="" column="" under="" the="" heading="" of="" ``%="" daily="" value''="" that="" refers="" to="" the="" same="" symbol="" placed="" at="" the="" bottom="" of="" the="" nutrition="" label="" and="" followed="" by="" the="" statement="" ``daily="" value="" not="" established,''="" except="" that="" when="" the="" heading="" ``%="" daily="" value''="" is="" not="" used,="" the="" symbol="" shall="" follow="" the="" quantitative="" amount="" by="" weight="" for="" each="" dietary="" ingredient="" listed.="" (c)="" a="" proprietary="" blend="" of="" dietary="" ingredients="" shall="" be="" included="" in="" the="" list="" of="" dietary="" ingredients="" described="" in="" paragraph="" (b)(3)(i)="" of="" this="" section="" and="" identified="" by="" the="" term="" ``proprietary="" blend''="" or="" other="" appropriately="" descriptive="" term="" or="" fanciful="" name="" and="" may="" be="" highlighted="" by="" bold="" type.="" except="" as="" specified="" in="" this="" paragraph,="" all="" other="" requirements="" for="" the="" listing="" of="" dietary="" ingredients="" in="" dietary="" supplements="" are="" applicable.="" (1)="" dietary="" ingredients="" contained="" in="" the="" proprietary="" blend="" that="" are="" listed="" under="" paragraph="" (b)(2)="" of="" this="" section="" shall="" be="" declared="" in="" accordance="" with="" paragraph="" (b)(2)="" of="" this="" section.="" (2)="" dietary="" ingredients="" contained="" in="" the="" proprietary="" blend="" that="" are="" listed="" under="" paragraph="" (b)(3)="" of="" this="" section="" (i.e.,="" ``other="" dietary="" ingredients'')="" shall="" be="" declared="" in="" descending="" order="" of="" predominance="" by="" weight,="" in="" a="" column="" or="" linear="" fashion,="" and="" indented="" under="" the="" term="" ``proprietary="" blend''="" or="" other="" appropriately="" descriptive="" term="" or="" fanciful="" name.="" (3)="" the="" quantitative="" amount="" by="" weight="" specified="" for="" the="" proprietary="" blend="" shall="" be="" the="" total="" weight="" of="" all="" other="" dietary="" ingredients="" contained="" in="" the="" proprietary="" blend="" and="" shall="" be="" placed="" on="" the="" same="" line="" to="" the="" right="" of="" the="" term="" ``proprietary="" blend''="" or="" other="" appropriately="" descriptive="" term="" or="" fanciful="" name="" underneath="" the="" column="" of="" amounts="" described="" in="" paragraph="" (b)(2)(ii)="" of="" this="" section.="" a="" symbol="" (e.g.,="" asterisk),="" which="" refers="" to="" the="" same="" symbol="" placed="" at="" the="" bottom="" of="" the="" nutrition="" label="" that="" is="" followed="" by="" the="" statement="" ``daily="" value="" not="" established,''="" shall="" be="" placed="" under="" the="" heading="" ``%="" daily="" value,''="" if="" present,="" or="" immediately="" following="" the="" quantitative="" amount="" by="" weight="" for="" the="" proprietary="" blend.="" (4)="" the="" sample="" label="" shown="" in="" paragraph="" (e)(10)(v)="" of="" this="" section="" illustrates="" one="" method="" of="" nutrition="" labeling="" a="" proprietary="" blend="" of="" dietary="" ingredients.="" (d)="" the="" source="" ingredient="" that="" supplies="" a="" dietary="" ingredient="" may="" be="" identified="" within="" the="" nutrition="" label="" in="" parentheses="" immediately="" following="" or="" indented="" beneath="" the="" name="" of="" a="" dietary="" ingredient="" and="" preceded="" by="" the="" words="" ``as''="" or="" ``from'',="" e.g.,="" ``calcium="" (as="" calcium="" carbonate),''="" except="" that="" manner="" of="" presentation="" is="" unnecessary="" when="" the="" name="" of="" the="" dietary="" ingredient="" (e.g.,="" oriental="" ginseng)="" or="" its="" synonym="" (e.g.,="" ascorbic="" acid)="" is="" itself="" the="" source="" ingredient.="" when="" a="" source="" ingredient="" is="" identified="" in="" parentheses="" within="" the="" nutrition="" label,="" or="" when="" the="" name="" of="" the="" dietary="" ingredient="" or="" its="" synonym="" is="" the="" source="" ingredient,="" it="" shall="" not="" be="" required="" to="" be="" listed="" again="" in="" the="" ingredient="" statement="" that="" appears="" outside="" of="" the="" nutrition="" label.="" when="" a="" source="" ingredient="" is="" not="" identified="" within="" the="" nutrition="" label,="" it="" shall="" be="" listed="" in="" an="" ingredient="" statement="" in="" accordance="" with="" sec.="" 101.4(g),="" which="" shall="" appear="" outside="" and="" immediately="" below="" the="" nutrition="" label="" or,="" if="" there="" is="" insufficient="" space="" below="" the="" nutrition="" label,="" immediately="" contiguous="" and="" to="" the="" right="" of="" the="" nutrition="" label.="" (1)="" source="" ingredients="" shall="" be="" identified="" in="" accordance="" with="" sec.="" 101.4="" (i.e.,="" shall="" be="" listed="" by="" common="" or="" usual="" name,="" and="" the="" listing="" of="" botanicals="" shall="" specify="" the="" part="" of="" the="" plant="" from="" which="" the="" ingredient="" is="" derived)="" regardless="" of="" whether="" they="" are="" listed="" in="" an="" ingredient="" statement="" or="" in="" the="" nutrition="" label.="" (2)="" when="" source="" ingredients="" are="" listed="" within="" the="" nutrition="" label,="" and="" two="" or="" more="" are="" used="" to="" provide="" a="" single="" dietary="" ingredient,="" all="" of="" the="" sources="" shall="" be="" listed="" within="" the="" parentheses="" in="" descending="" order="" by="" weight.="" (3)="" representations="" that="" the="" source="" ingredient="" conforms="" to="" an="" official="" compendium="" may="" be="" included="" either="" in="" the="" nutrition="" label="" or="" in="" the="" ingredient="" list="" (e.g.,="" ``calcium="" (as="" calcium="" carbonate="" usp)'').="" (e)="" nutrition="" information="" specified="" in="" this="" section="" shall="" be="" presented="" as="" follows:="" (1)="" the="" title,="" ``supplement="" facts,''="" shall="" be="" set="" in="" a="" type="" size="" larger="" than="" all="" other="" print="" size="" in="" the="" nutrition="" label="" and,="" unless="" impractical,="" shall="" be="" set="" full="" width="" of="" the="" nutrition="" label.="" the="" title="" and="" all="" headings="" shall="" be="" bolded="" to="" distinguish="" them="" from="" other="" information.="" (2)="" the="" nutrition="" information="" shall="" be="" enclosed="" in="" a="" box="" by="" using="" hairlines.="" (3)="" all="" information="" within="" the="" nutrition="" label="" shall="" utilize:="" (i)="" a="" single="" easy-to-read="" type="" style,="" (ii)="" all="" black="" or="" one="" color="" type,="" printed="" on="" a="" white="" or="" other="" neutral="" contrasting="" background="" whenever="" practical,="" (iii)="" upper-="" and="" lowercase="" letters,="" except="" that="" all="" uppercase="" lettering="" may="" be="" utilized="" for="" packages="" that="" have="" a="" total="" surface="" area="" available="" to="" bear="" labeling="" of="" less="" than="" 12="" square="" inches,="" (iv)="" at="" least="" one="" point="" leading="" (i.e.,="" space="" between="" lines="" of="" text),="" and="" (v)="" letters="" that="" do="" not="" touch.="" (4)="" except="" as="" provided="" for="" small="" and="" intermediate-sized="" packages="" under="" paragraph="" (i)(2)="" of="" this="" section,="" information="" other="" than="" the="" title,="" headings,="" and="" footnotes="" shall="" be="" in="" uniform="" type="" size="" no="" smaller="" than="" 8="" point.="" type="" size="" no="" smaller="" than="" 6="" point="" may="" be="" used="" for="" column="" headings="" (e.g.,="" ``amount="" per="" serving''="" and="" ``%="" daily="" value'')="" and="" for="" footnotes="" (e.g.,="" ``percent="" daily="" values="" are="" based="" on="" a="" 2,000="" calorie="" diet'').="" (5)="" a="" hairline="" rule="" that="" is="" centered="" between="" the="" lines="" of="" text="" shall="" separate="" each="" dietary="" ingredient="" required="" in="" paragraph="" (b)(2)="" and="" (b)(3)="" of="" this="" section="" from="" the="" dietary="" ingredient="" above="" and="" beneath="" it,="" as="" shown="" in="" paragraph="" (e)(10)="" of="" this="" section.="" (6)="" a="" heavy="" bar="" shall="" be="" placed:="" (i)="" beneath="" the="" subheading="" ``servings="" per="" container''="" except="" that="" if="" ``servings="" per="" container''="" is="" not="" required="" and,="" as="" a="" result,="" not="" declared,="" the="" bar="" shall="" be="" [[page="" 49852]]="" placed="" beneath="" the="" subheading="" ``serving="" size,''="" (ii)="" beneath="" the="" last="" dietary="" ingredient="" to="" be="" listed="" under="" paragraph="" (b)(2)(i)="" of="" this="" section,="" if="" any,="" and="" (iii)="" beneath="" the="" last="" other="" dietary="" ingredient="" to="" be="" listed="" under="" paragraph="" (b)(3)="" of="" this="" section,="" if="" any.="" (7)="" a="" light="" bar="" shall="" be="" placed="" beneath="" the="" headings="" ``amount="" per="" serving''="" and="" ``%="" daily="" value.''="" (8)="" if="" the="" product="" contains="" two="" or="" more="" separately="" packaged="" dietary="" supplements="" that="" differ="" from="" each="" other="" (e.g.,="" the="" product="" has="" a="" packet="" of="" supplements="" to="" be="" taken="" in="" the="" morning="" and="" a="" different="" packet="" to="" be="" taken="" in="" the="" afternoon),="" the="" quantitative="" amounts="" and="" percent="" of="" daily="" value="" may="" be="" presented="" as="" specified="" in="" this="" paragraph="" in="" individual="" nutrition="" labels="" or="" in="" one="" aggregate="" nutrition="" label="" as="" illustrated="" in="" paragraph="" (e)(10)(iii)="" of="" this="" section.="" (9)="" in="" the="" interest="" of="" uniformity="" of="" presentation,="" fda="" urges="" that="" the="" information="" be="" presented="" using="" the="" graphic="" specifications="" set="" forth="" in="" appendix="" b="" to="" part="" 101,="" as="" applicable.="" (10)="" the="" following="" sample="" labels="" are="" presented="" for="" the="" purpose="" of="" illustration:="" billing="" code="" 4190-01-f="" [[page="" 49853]]="" [graphic]="" [tiff="" omitted]="" tr23se97.010="" [[page="" 49854]]="" [graphic]="" [tiff="" omitted]="" tr23se97.011="" [[page="" 49855]]="" [graphic]="" [tiff="" omitted]="" tr23se97.012="" [[page="" 49856]]="" [graphic]="" [tiff="" omitted]="" tr23se97.013="" billing="" code="" 4190-01-c="" (11)="" if="" space="" is="" not="" adequate="" to="" list="" the="" required="" information="" as="" shown="" in="" the="" sample="" labels="" in="" paragraph="" (e)(10)="" of="" this="" section,="" the="" list="" may="" be="" split="" and="" continued="" to="" the="" right="" as="" long="" as="" the="" headings="" are="" repeated.="" the="" list="" to="" the="" right="" shall="" be="" set="" off="" by="" a="" line="" that="" distinguishes="" it="" and="" sets="" it="" apart="" from="" the="" dietary="" ingredients="" and="" percent="" of="" daily="" value="" information="" given="" to="" the="" left.="" the="" following="" sample="" label="" illustrates="" this="" display:="" [[page="" 49857]]="" [graphic]="" [tiff="" omitted]="" tr23se97.014="" billing="" code="" 4190-01-c="" [[page="" 49858]]="" (f)(1)="" compliance="" with="" this="" section="" will="" be="" determined="" in="" accordance="" with="" sec.="" 101.9(g)(1)="" through="" (g)(8),="" except="" that="" the="" sample="" for="" analysis="" shall="" consist="" of="" a="" composite="" of="" 12="" subsamples="" (consumer="" packages)="" or="" 10="" percent="" of="" the="" number="" of="" packages="" in="" the="" same="" inspection="" lot,="" whichever="" is="" smaller,="" randomly="" selected="" to="" be="" representative="" of="" the="" lot.="" the="" criteria="" on="" class="" i="" and="" class="" ii="" nutrients="" given="" in="" sec.="" 101.9(g)(3)="" and="" (g)(4)="" also="" are="" applicable="" to="" other="" dietary="" ingredients="" described="" in="" paragraph="" (b)(3)(i)="" of="" this="" section.="" reasonable="" excesses="" of="" these="" other="" dietary="" ingredients="" over="" labeled="" amounts="" are="" acceptable="" within="" current="" good="" manufacturing="" practice.="" (2)="" when="" it="" is="" not="" technologically="" feasible,="" or="" some="" other="" circumstance="" makes="" it="" impracticable,="" for="" firms="" to="" comply="" with="" the="" requirements="" of="" this="" section,="" fda="" may="" permit="" alternative="" means="" of="" compliance="" or="" additional="" exemptions="" to="" deal="" with="" the="" situation="" in="" accordance="" with="" sec.="" 101.9(g)(9).="" firms="" in="" need="" of="" such="" special="" allowances="" shall="" make="" their="" request="" in="" writing="" to="" the="" office="" of="" food="" labeling="" (hfs-150),="" food="" and="" drug="" administration,="" 200="" c="" st.="" sw.,="" washington,="" dc="" 20204.="" (g)="" except="" as="" provided="" in="" paragraphs="" (i)(2)="" and="" (i)(5)="" of="" this="" section,="" the="" location="" of="" nutrition="" information="" on="" a="" label="" shall="" be="" in="" compliance="" with="" sec.="" 101.2.="" (h)="" dietary="" supplements="" are="" subject="" to="" the="" exemptions="" specified="" as="" follows="" in:="" (1)="" section="" 101.9(j)(1)="" for="" foods="" that="" are="" offered="" for="" sale="" by="" a="" person="" who="" makes="" direct="" sales="" to="" consumers="" (i.e.,="" a="" retailer)="" who="" has="" annual="" gross="" sales="" or="" business="" done="" in="" sales="" to="" consumers="" that="" is="" not="" more="" than="" $500,000="" or="" has="" annual="" gross="" sales="" made="" or="" business="" done="" in="" sales="" of="" food="" to="" consumers="" of="" not="" more="" than="" $50,000,="" and="" whose="" labels,="" labeling,="" and="" advertising="" do="" not="" provide="" nutrition="" information="" or="" make="" a="" nutrient="" content="" or="" health="" claim;="" (2)="" section="" 101.9(j)(18)="" for="" foods="" that="" are="" low-volume="" products="" (that="" is,="" they="" meet="" the="" requirements="" for="" units="" sold="" in="" sec.="" 101.9(j)(18)(i)="" or="" (j)(18)(ii));="" that,="" except="" as="" provided="" in="" sec.="" 101.9(j)(18)(iv),="" are="" the="" subject="" of="" a="" claim="" for="" an="" exemption="" that="" provides="" the="" information="" required="" under="" sec.="" 101.9(j)(18)(iv),="" that="" is="" filed="" before="" the="" beginning="" of="" the="" time="" period="" for="" which="" the="" exemption="" is="" claimed,="" and="" that="" is="" filed="" by="" a="" person,="" whether="" it="" is="" the="" manufacturer,="" packer,="" or="" distributor,="" that="" qualifies="" to="" claim="" the="" exemption="" under="" the="" requirements="" for="" average="" full-time="" equivalent="" employees="" in="" sec.="" 101.9(j)(18)(i)="" or="" (j)(18)(ii),="" and="" whose="" labels,="" labeling,="" and="" advertising="" do="" not="" provide="" nutrition="" information="" or="" make="" a="" nutrient="" content="" or="" health="" claim;="" (3)="" section="" 101.9(j)(9)="" for="" foods="" shipped="" in="" bulk="" form="" that="" are="" not="" for="" distribution="" to="" consumers="" in="" such="" form="" and="" that="" are="" for="" use="" solely="" in="" the="" manufacture="" of="" other="" dietary="" supplements="" or="" that="" are="" to="" be="" processed,="" labeled,="" or="" repacked="" at="" a="" site="" other="" than="" where="" originally="" processed="" or="" packed.="" (i)="" dietary="" supplements="" are="" subject="" to="" the="" special="" labeling="" provisions="" specified="" in:="" (1)="" section="" 101.9(j)(5)(i)="" for="" foods,="" other="" than="" infant="" formula,="" represented="" or="" purported="" to="" be="" specifically="" for="" infants="" and="" children="" less="" than="" 2="" years="" of="" age,="" in="" that="" nutrition="" labels="" on="" such="" foods="" shall="" not="" include="" calories="" from="" fat,="" calories="" from="" saturated="" fat,="" saturated="" fat,="" polyunsaturated="" fat,="" monounsaturated="" fat,="" and="" cholesterol;="" (2)="" section="" 101.9(j)(13)="" for="" foods="" in="" small="" or="" intermediate-sized="" packages,="" except="" that:="" (i)="" all="" information="" within="" the="" nutrition="" label="" on="" small-sized="" packages,="" which="" have="" a="" total="" surface="" area="" available="" to="" labeling="" of="" less="" than="" 12="" square="" inches,="" shall="" be="" in="" type="" size="" no="" smaller="" than="" 4.5="" point;="" (ii)="" all="" information="" within="" the="" nutrition="" label="" on="" intermediate-="" sized="" packages,="" which="" have="" from="" 12="" to="" 40="" square="" inches="" of="" surface="" area="" available="" to="" bear="" labeling,="" shall="" be="" in="" type="" size="" no="" smaller="" than="" 6="" point,="" except="" that="" type="" size="" no="" smaller="" than="" 4.5="" point="" may="" be="" used="" on="" packages="" that="" have="" less="" than="" 20="" square="" inches="" available="" for="" labeling="" and="" more="" than="" 8="" dietary="" ingredients="" to="" be="" listed="" and="" on="" packages="" that="" have="" 20="" to="" 40="" square="" inches="" available="" for="" labeling="" and="" more="" than="" 16="" dietary="" ingredients="" to="" be="" listed.="" (iii)="" when="" the="" nutrition="" information="" is="" presented="" on="" any="" panel="" under="" sec.="" 101.9(j)(13)(ii)(d),="" the="" ingredient="" list="" shall="" continue="" to="" be="" located="" immediately="" below="" the="" nutrition="" label,="" or,="" if="" there="" is="" insufficient="" space="" below="" the="" nutrition="" label,="" immediately="" contiguous="" and="" to="" the="" right="" of="" the="" nutrition="" label="" as="" specified="" in="" sec.="" 101.4(g).="" (iv)="" when="" it="" is="" not="" possible="" for="" a="" small="" or="" intermediate-sized="" package="" that="" is="" enclosed="" in="" an="" outer="" package="" to="" comply="" with="" these="" type="" size="" requirements,="" the="" type="" size="" of="" the="" nutrition="" label="" on="" the="" primary="" (inner)="" container="" may="" be="" as="" small="" as="" needed="" to="" accommodate="" all="" of="" the="" required="" label="" information="" provided="" that="" the="" primary="" container="" is="" securely="" enclosed="" in="" outer="" packaging,="" the="" nutrition="" labeling="" on="" the="" outer="" packaging="" meets="" the="" applicable="" type="" size="" requirements,="" and="" such="" outer="" packaging="" is="" not="" intended="" to="" be="" separated="" from="" the="" primary="" container="" under="" conditions="" of="" retail="" sale.="" (v)="" where="" there="" is="" not="" sufficient="" space="" on="" a="" small="" or="" intermediate-="" sized="" package="" for="" a="" nutrition="" label="" that="" meets="" minimum="" type="" size="" requirements="" of="" 4.5="" points="" if="" hairlines="" are="" used="" in="" accordance="" with="" paragraph="" (e)(5)="" of="" this="" section,="" the="" hairlines="" may="" be="" omitted="" and="" replaced="" by="" a="" row="" of="" dots="" connecting="" the="" columns="" containing="" the="" name="" of="" each="" dietary="" ingredient="" and="" the="" quantitative="" amounts="" (by="" weight="" and="" as="" a="" percent="" of="" daily="" value).="" (3)="" section="" 101.9(j)(15)="" for="" foods="" in="" multiunit="" food="" containers;="" (4)="" section="" 101.9(j)(16)="" for="" foods="" sold="" in="" bulk="" containers;="" and="" (5)="" section="" 101.9(j)(17)="" for="" foods="" in="" packages="" that="" have="" a="" total="" surface="" area="" available="" to="" bear="" labeling="" greater="" than="" 40="" square="" inches="" but="" whose="" principal="" display="" panel="" and="" information="" panel="" do="" not="" provide="" sufficient="" space="" to="" accommodate="" all="" required="" label="" information,="" except="" that="" the="" ingredient="" list="" shall="" continue="" to="" be="" located="" immediately="" below="" the="" nutrition="" label,="" or,="" if="" there="" is="" insufficient="" space="" below="" the="" nutrition="" label,="" immediately="" contiguous="" and="" to="" the="" right="" of="" the="" nutrition="" label="" as="" specified="" in="" sec.="" 101.4(g).="" (j)="" dietary="" supplements="" shall="" be="" subject="" to="" the="" misbranding="" provisions="" of="" sec.="" 101.9(k).="" 7.="" section="" 101.65="" is="" amended="" by="" revising="" paragraph="" (b)(4)="" to="" read="" as="" follows:="" sec.="" 101.65="" implied="" nutrient="" content="" claims="" and="" related="" label="" statements.="" *="" *="" *="" *="" *="" (b)="" *="" *="" *="" (4)="" a="" statement="" of="" identity="" for="" a="" food="" in="" which="" an="" ingredient="" constitutes="" essentially="" 100="" percent="" of="" a="" food="" (e.g.,="" ``corn="" oil,''="" ``oat="" bran,''="" ``dietary="" supplement="" of="" vitamin="" c="" 60="" mg="" tablet'').="" *="" *="" *="" *="" *="" dated:="" september="" 11,="" 1997.="" william="" b.="" schultz,="" deputy="" commissioner="" for="" policy.="" [fr="" doc.="" 97-24739="" filed="" 9-22-97;="" 8:45="" am]="" billing="" code="" 4160-01-f="">