[Federal Register: September 23, 1997 (Volume 62, Number 184)]
[Rules and Regulations]
[Page 49825-49858]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se97-15]
[[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
[[Page 49826]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 95N-0245 and 94P-0110]
RIN 0910-AA59
Food Labeling; Statement of Identity, Nutrition Labeling and
Ingredient Labeling of Dietary Supplements; Compliance Policy Guide,
Revocation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations to establish requirements for the identification
of dietary supplements and for their nutrition labeling and ingredient
labeling in response to the Dietary Supplement Health and Education Act
of 1994 (the DSHEA). FDA is also responding to a citizen petition from
the Council for Responsible Nutrition on type size requirements for
these products. In addition, FDA is announcing the revocation of
Compliance Policy Guide 530.400 (CPG 7121.02) entitled ``Vitamin
Products for Human Use--Low Potency'' to eliminate inconsistencies with
the new labeling requirements.
DATES: The regulation is effective March 23, 1999. The Director of the
Office of the Federal Register approves the incorporations by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in 21 CFR 101.4(h), effective March 23, 1999.
FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-5587.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 28, 1995 (60 FR 67194), FDA
published a proposed rule entitled ``Food Labeling; Statement of
Identity, Nutrition Labeling and Ingredient Labeling of Dietary
Supplements'' (hereinafter identified as ``the December 1995
proposal''). This document, which specifically responds to the DSHEA,
superseded earlier documents responding to the Nutrition Labeling and
Education Act of 1990 (the 1990 amendments)(Pub. L. 101-535) and the
Dietary Supplement Act of 1992 (the DS act) (Pub. L. 102-571) with
respect to dietary supplements.
The 1990 amendments amended the Federal Food, Drug, and Cosmetic
Act (the act) in a number of important ways. One of the notable aspects
of the 1990 amendments is that they added section 403(q) to the act (21
U.S.C. 343(q)). This section provides that most foods are misbranded
unless they bear nutrition labeling.
In particular, section 403(q)(5)(F) (originally section
403(q)(5)(E)) of the act provided that separate regulations on the
nutrition labeling of dietary supplements of vitamins and minerals
could be established that are distinct from those for other foods. In
response to this section, FDA proposed a regulation in Sec. 101.36 (21
CFR 101.36) that was specifically on the nutrition labeling of dietary
supplements of vitamins and minerals, and a separate general regulation
that was on the nutrition labeling in Sec. 101.9 (21 CFR 101.9) of
conventional foods and of all other dietary supplements (those of herbs
and other nutritional substances) (56 FR 60366, November 27, 1991).
On October 6, 1992, the President signed into law the DS act. The
DS act established a moratorium until December 15, 1993, on the
implementation of the 1990 amendments with respect to dietary
supplements not in the form of conventional food. Also, it required
that a new proposed regulation on the nutrition labeling of dietary
supplements be issued by June 15, 1993, and a final rule by December
31, 1993.
In response to the DS act, FDA published a new proposed rule in the
Federal Register of June 18, 1993 (58 FR 33715), and a final rule on
January 4, 1994 (59 FR 354), on the nutrition labeling of dietary
supplements. As mandated in section 403(q)(5)(F) of the act, the final
rule established a regulation (Sec. 101.36) on the specific
requirements for nutrition labeling of dietary supplements of vitamins
and minerals.
On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into
law. The DSHEA amended the act by adding section 201(ff) (21 U.S.C.
321(ff)), which defines a ``dietary supplement,'' in part, as a
product, other than tobacco, intended to supplement the diet that
contains at least one or more of the following ingredients: A vitamin;
a mineral; an herb or other botanical; an amino acid; a dietary
substance for use to supplement the diet by increasing the total
dietary intake; or a concentrate, metabolite, constituent, extract, or
combination of any of the previously mentioned ingredients. This
section also states that the term ``dietary supplement'' means a
product that is labeled as a dietary supplement.
Furthermore, the DSHEA, among other things, amended section
403(q)(5)(F) of the act by adding specific requirements that relate to
the labeling of, and ingredient declaration on, dietary supplement
products. Previously, this section had applied only to dietary
supplements of vitamins and minerals and had not offered any
description of how the labeling of these products should differ from
the labeling of foods in general. As amended by the DSHEA, section
403(q)(5)(F) of the act provides that dietary ingredients that do not
have daily values (i.e., Reference Daily Intakes (RDI's) or Daily
Reference Values (DRV's)) must be listed within the nutrition
information, that the listing of dietary ingredients must include the
quantity of each dietary ingredient (or of a proprietary blend of such
dietary ingredients), and that the listing of dietary ingredients may
include the source of a dietary ingredient. It also provides that the
nutrition information must immediately precede the ingredient
information required under the act.
FDA received over 50 letters in response to the December 1995
proposal. Each of these letters contained one or more comments.
Responses were received from industry, trade associations, consumers,
consumer advocacy organizations, health care professionals,
professional societies, and city governments. Many comments supported
the proposal generally or supported aspects of the proposal. Other
comments objected to specific provisions of the proposal and requested
revisions. Some comments addressed issues outside the scope of the
proposal and will not be discussed here. A summary of the relevant
comments, the agency's responses to the comments, and a discussion of
the agency's conclusions follows.
II. The Term ``Dietary Supplement'' in the Statement of Identity
1. A number of comments objected to the proposed requirement in
Sec. 101.3(g) (21 CFR 101.3(g)) that the term ``dietary supplement''
appear as part of the statement of identity of dietary supplements.
Some of these comments requested the flexibility of allowing this term
either in the statement of identity or elsewhere on the label, such as
on the principal display panel or in the directions for use. A couple
of comments stated that, if the nutrition label was given the title
``Dietary Supplement Facts,'' a consumer could utilize the nutrition
label to identify the
[[Page 49827]]
product as a dietary supplement, making it unnecessary to include the
term as part of the statement of identity. Other comments requested
that FDA allow for reasonable flexibility in the use of synonyms or
modifiers for the term ``dietary supplement,'' such as ``Nutritional
Supplement,'' ``Herbal Supplement,'' ``Multivitamin/Multimineral
Supplement,'' or ``Amino Acid Blend.''
The comments presented a number of reasons for their disagreement
with the proposal. Several comments stated that the inclusion of the
term ``dietary supplement'' as part of the statement of identity on the
principal display panel overreaches the legislative intent of the
DSHEA. These comments stated that the DSHEA does not specify where the
term ``dietary supplement'' should be placed, and that, therefore,
flexibility of placement of the term is warranted. One comment stated
that it objected to FDA transforming an ``identify'' requirement in the
DSHEA into an ``identity'' requirement in the use of the term ``dietary
supplement.'' The comment asserted that the term ``identify'' in the
DSHEA is different from the requirement in 15 U.S.C. 1453(a)(1) (i.e.,
``the identity of the commodity''), upon which the identity labeling
provisions in Sec. 101.3 are based. Several comments stated that the
term ``dietary supplement'' by itself is inappropriate as a common
descriptor for dietary supplements because they include a wide range of
products, which meet vastly different consumer needs. These comments
stated that the term ``dietary'' does not add additional value to the
statement of identity, and that consumers might interpret the term
``dietary'' as part of the statement of identity to suggest that the
supplement is a weight loss or meal replacement product. These comments
stated that the statutory requirement that the term ``identify'' the
product could be satisfied with the use of the term ``supplement.'' One
comment submitted a market research study on consumer perception of the
term ``dietary supplement,'' which indicated that over 50 percent of
the subjects were confused by the term when used with the claim ``high
potency.'' One comment stated that the United States Pharmacopeia (USP)
has established a number of monographs of official names for specific
nutritional supplements but they do not include the term ``dietary
supplement.'' Several comments pointed out that use of the term
``dietary supplement'' is not part of their products' trademarked
terminology.
Several comments suggested that the agency provide alternate
requirements for dietary supplements in conventional food form to
distinguish them from conventional foods (e.g., cereals, snack bars,
drinks), requiring that the term ``dietary supplement'' appear on the
principal display panel, although not necessarily as part of the
statement of identity. These comments stated that dietary supplements
in capsule or tablet form are obviously dietary supplements, are easily
distinguished by consumers from conventional foods, and should not have
the same identity requirement. A few comments argued that there are
space limitations on the principal display panel of some dietary
supplements, and that the term ``dietary supplement'' uses up available
label space.
The agency has carefully reviewed these comments but concludes that
the best reading of the act, as well as the agency's longstanding
regulations that implement the act, require that the term ``dietary
supplement,'' or some form of this term, appear as part of the
statement of identity. Section 201(ff)(2)(C) of the act, in defining
the term ``dietary supplement,'' mandates that such a product must be
labeled as a dietary supplement. Section 403(s)(2)(B) of the act states
that a food shall be deemed to be misbranded if it is a dietary
supplement, and the label or labeling of the dietary supplement fails
to identify the product by using the term ``dietary supplement, which
term may be modified with the name of such an ingredient.'' Section
403(i)(1) of the act requires that a food label must bear the common or
usual name of the food, that is, a statement that identifies the food.
Dietary supplements are labeled subject to the provisions of section
403(i)(1) of the act (see the last sentence of section 201(ff) of the
act). Thus, when the act is read in its entirety, it is clear that
sections 201(ff)(2)(C), 403(s)(2)(B), and 403(i)(1) of the act require
that the statement of identity of a product that is marketed as a
dietary supplement identify the product as such.
FDA's longstanding regulations lead directly to this result.
Section 102.5 (21 CFR 102.5) sets out how the common or usual name of a
nonstandardized food is to be derived. Under this provision, the common
or usual name must accurately identify or describe, in as simple and
direct terms as possible, the basic nature of the food. The basic
nature of a dietary supplement is that it is a dietary supplement. This
is the point made in both sections 201(ff)(2)(C) and 403(s)(2)(B) of
the act. Thus, under Sec. 102.5(a), the common or usual name of these
products must, at least in part, identify them as a dietary supplement.
Section 101.3(b) of FDA's regulation states that the statement of
identity of a food shall be in terms of its common or usual name. Thus,
Sec. 101.3(g) derives directly from the act and FDA's longstanding
regulations that implement the act. Therefore, FDA is adopting
Sec. 101.3(g).
However, the agency is persuaded by the comments that flexibility
in the use of the term ``dietary'' as part of the name ``dietary
supplement''is warranted. The agency notes that section 403(s)(2)(B) of
the act states that the product shall be identified ``by using the term
`dietary supplement,' which term may be modified with the name of such
an ingredient.'' The agency interprets this provision to mean that the
term ``dietary supplement'' may be modified to include the name of a
dietary ingredient or ingredients (e.g., ``Vitamin C Supplement'').
Furthermore, to provide additional flexibility, an identifying term
that describes the types of dietary ingredients contained in the
product in appropriately descriptive terms (e.g., ``Multivitamin
Supplement,'' ``Herbal Supplement'') may be used. Generic terms that
are not descriptive (e.g., ``Food Supplement,'' ``Energy Bar'') would
not be appropriate because they do not identify or describe the dietary
ingredients (e.g., protein, folic acid, arrowroot) or combination of
ingredients that the product supplies.
Accordingly, FDA is revising Sec. 101.3(g) to provide that the term
``dietary supplement'' may be modified by replacing the term
``dietary'' with the name of a dietary ingredient or ingredients or an
appropriately descriptive term indicating the type of dietary
ingredients that are in the product. The agency notes that, with this
increased flexibility, several concerns expressed by the comments
(e.g., possible difficulties with space limitations, potential consumer
confusion, possible effects on established trademarked names) should be
alleviated.
2. One comment asked that the agency change the type size
requirements referred to in proposed Sec. 101.3(g), which stated that
``* * * the label shall bear the term `dietary supplement' as part of
the statement of identity in conformance with the provisions of
paragraph (d) of this section.'' The comment stated that the type size
requirements of Sec. 101.3(d) (i.e., that the statement of identity
``shall be in a size reasonably related to the most prominent printed
matter on such panel'') cross-referenced in proposed Sec. 101.3(g)
might be counterproductive or impracticable for products in small
packages with many dietary ingredients. The comment requested that the
agency require the same minimum type size as
[[Page 49828]]
that for the declaration of the net quantity of contents
(Sec. 101.105(i)(21 CFR 101.105(i))) because this would permit products
to bear the statement of identity in a type size that would be a
minimum of one-sixteenth of an inch.
FDA points out that Sec. 101.3(d) does not include minimum type
size requirements, but, as noted in the comment, it requires that the
size of the statement of identity be related to the size of the most
prominent printed matter on the label. Therefore, if the package size
is small, and there are many dietary ingredients to be listed, it is
reasonable to expect that even the most prominent printed matter will
be relatively small, permitting the statement of identity to be
proportionally smaller, in some cases as small as one-sixteenth of an
inch. Therefore, the agency is taking no action based on this comment.
However, because the reference in proposed Sec. 101.3(g) to paragraph
(d) of that section is redundant, inasmuch as all foods must meet all
regulatory requirements unless specific exceptions are noted, FDA has
deleted the reference to paragraph (d).
III. Nutrition Labeling of Dietary Supplements
A. Serving Size
3. Several comments stated that the term ``serving size'' is
inappropriate on dietary supplements. One comment stated that the term
``serving size'' should not appear in the nutrition label of dietary
supplements, except for products in the physical form of conventional
foods or for products with significant amounts of calories and
macronutrients, which should be covered by Sec. 101.9. This comment
recommended that the directions for use should provide the basis for
the quantitative statements contained in the nutrition label. Another
comment stated that the term ``serving size'' should not be used in the
nutrition label of herbal products and suggested the terms
``recommended use'' or ``suggested use.'' This comment suggested the
terms ``dose'' or ``dosage'' in the case of products marketed to health
professionals.
The agency is not persuaded by the comments objecting to the term
``serving size.'' As discussed in the final rule of January 4, 1994 (59
FR 354 at 358), information on serving size is as essential on the
nutrition label of dietary supplements as it is on that of conventional
foods. The agency points out that the directions for use provide the
basis for the serving size in the nutrition label of dietary
supplements in that serving sizes are derived by the manufacturer in
accordance with Sec. 101.12 (21 CFR 101.12). Section 101.12(b), Table
2, states that the reference amount customarily consumed for dietary
supplements is ``the maximum amount recommended, as appropriate, on the
label for consumption per eating occasion * * *.''
Section 403(q)(1)(A)(i) of the act states that a food is misbranded
unless its nutrition information specifies the serving size, and
nothing in the DSHEA directs the agency to eliminate the use of this
term in the nutrition label of dietary supplements. To the contrary,
section 403(q)(5)(F)(ii) of the act, which was added by the DSHEA,
states that the listing of dietary ingredients shall include the
quantity of each such ingredient per serving. This fact establishes
that Congress contemplated that serving size would be a part of the
nutrition labeling of dietary supplements.
With respect to using other terms in place of the term ``serving
size,'' the agency reiterates that the term ``serving size'' is
consistent with the act, and that it would be confusing to consumers if
the nutrition labels of dietary supplements used varied terms, such as
``recommended use'' or ``dose,'' in place of the term ``serving size.''
Use of the same term in the same place on all labels will help to avoid
confusion. Therefore, the agency has not made any changes in response
to these comments.
B. Information on Dietary Ingredients Having RDI's or DRV's
4. Several comments argued that some (sodium, vitamin A, vitamin C,
calcium, and iron) or all of the 14 nutrients required under
Sec. 101.9(c) should be required to be listed on the labels of dietary
supplements only when they are added to the supplement, or when a claim
is made about them. These comments argued that dietary supplements of
herbs or botanicals, for example, are not generally consumed for their
nutritional value, and that, thus, having to determine the levels of
the required nutrients would be unduly burdensome and of little use to
consumers who rely on the nutrition information to structure their
diets to maintain healthy dietary practices. One comment from an
independent analytical laboratory stated that mandatory requirements
for the listing of nutrients should not pertain to herbal products.
This comment stated that official methods of analysis do not apply to
herbal products and suggested that these products should be excluded
from labeling regulations requiring analysis until such time as
official methodology is published. Other comments specifically
supported the proposed rule in requiring that macronutrients be
declared whenever they are present.
FDA is not persuaded by the comments to modify Sec. 101.36(b)(2).
Section 403(q)(1) of the act specifies the nutrients that are to be
listed in the nutrition labeling of foods, and section 403(q)(2) of the
act gives the Secretary of Health and Human Services (the Secretary)
discretion to add to, or subtract from, this list for the purpose of
assisting consumers in maintaining healthy dietary practices. Section
403(q)(5)(F) of the act states that the labels of dietary supplements
shall comply with the requirements of subparagraphs (q)(1) and (q)(2)
in a manner that is appropriate.
In its final rule on nutrition labeling, the agency concluded that
information on the calorie, calories from fat, total fat, saturated
fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars,
protein, vitamin A, vitamin C, calcium, and iron content of foods was
necessary to assist consumers in maintaining healthy dietary practices
(58 FR 2079, January 6,1993). Accordingly, these nutrients are required
under Sec. 101.9(c) to be listed in nutrition labeling.
In its December 1995 proposal, the agency tentatively concluded
that these nutrients were equally as important to maintaining healthy
dietary practices when present in dietary supplements and, therefore,
should be mandatory on the labels of dietary supplement products as
well. However, to ease label crowding and to be consistent with the
DSHEA, FDA proposed that the 14 nutrients need only be listed on
dietary supplement labels when present in quantitative amounts by
weight that exceed the amount that can be declared as zero in
accordance with Sec. 101.9(c). FDA tentatively concluded that this
action would provide consumers with the information necessary to
determine how dietary supplement products fit into dietary regimens
that adhere to dietary recommendations.
Dietary supplements are foods under section 201(ff) of the act,
unless they are intended to be used as drugs. Moreover, under section
201(ff) of the act and some of the other changes made by the DSHEA,
dietary supplements may well be in conventional food form and contain
many of the 14 nutrients required to be listed in the nutrition label
under Sec. 101.9. Thus, as foods, it is appropriate to require that
their labeling bear the same nutrients as the nutrition labeling on
conventional foods, unless evidence is presented that justifies the
contrary conclusion.
[[Page 49829]]
The comments presented no evidence that would be a basis for the
agency to reach a conclusion different than it did for conventional
foods, i.e., that the listing of these nutrients will assist consumers
in maintaining healthy dietary practices. The agency is not convinced
that this requirement should be eliminated because of the argument that
herbs and botanicals are not generally consumed for their nutritional
value. The fact that a product is not generally consumed for its
nutritional value is immaterial under the act and its implementing
regulations. For example, certain spices, such as paprika, which are
consumed for their flavor-enhancing properties, not for nutritional
value, are not exempt from nutrition labeling under Sec. 101.9 if any
nutrient is present at more than insignificant levels
(Sec. 101.9(j)(4)). The agency concludes that it is appropriate for the
nutrients required in Sec. 101.9 to be mandatory on the labels of
dietary supplements. Thus, the agency is not modifying
Moreover, one of the principles underlying the agency's food
labeling initiative has been that, if nutrition labeling is to assist
consumers in making dietary choices, it should provide consistent
information for consumers to use (55 FR 29487 at 29490, July 19, 1990).
For example, fat is mandatory on the labels of conventional foods
because of scientific consensus that high dietary intakes of total fat
are associated with an increased risk of coronary heart disease, some
types of cancer, gallbladder disease, and obesity (55 FR 29487 at
29495). Thus, the listing of fat on the nutrition label, when it is
present, will assist consumers in meeting dietary recommendations to
limit fat intake to no more than 30 percent of calories, irrespective
of whether the nutrition labels are for conventional foods or dietary
supplements.
With respect to methodology issues, FDA is not persuaded that
herbal products should be exempt from labeling until analytical
methodology is validated for all herbal products. FDA is aware of the
difficulties in adapting analytical methods to different matrices and
specifically requested comment on this point in the proposal. The
agency received comments from industry groups actively working on the
development of official methodology, but these comments did not
indicate that problems with methodology necessitate exempting herbs
from nutrition labeling. Rather, FDA is aware that the adaptation of
existing methods to different matrices (e.g., herbs) is ongoing. In
addition, FDA has stated that analysis is not needed for nutrients
where reliable data bases or scientific knowledge establish that a
nutrient is not present in a serving of the product (58 FR 2079 at
2109). Therefore, it may not be necessary to analyze for several
nutrients in herbal products. For example, there is no need to analyze
for cholesterol because food composition studies have shown it to be
found only in animal products.
Thus, FDA concludes based upon these comments and on its own
experience that exempting herbs is unwarranted. Moreover, an exemption
would be inconsistent with section 403(q)(5)(F) of the act. Therefore,
the agency is not taking any action based on these comments.
5. Several comments requested more flexibility with the language
used in place of ``Amount Per Serving.'' The comments requested use of
phases such as ``Amount per 2 Tablets'' or ``Two Tablets Contain.''
The agency has no objection to the flexibility requested by these
comments. The agency proposed in Sec. 101.36(b)(2)(i)(A) that when the
serving size of the product is one unit, a heading consistent with the
declaration of the serving size, such as ``Amount Per Tablet'' or
``Each Tablet Contains,'' may be used in place of the heading ``Amount
Per Serving.'' In response to these comments, the agency agrees that
there is no reason to limit the language that can be used in this way.
Therefore, the agency is deleting the words ``when the serving size of
the product is one unit'' from Sec. 101.36(b)(2)(i)(A) and adding the
example ``Amount Per 2 Tablets.''
6. The agency received a couple of comments that recommended
changes in nomenclature for thiamin and riboflavin. These comments
requested that the name ``B<INF>1</INF>'' be used instead of
``thiamin,'' and that ``B<INF>2</INF>'' be used for ``riboflavin.'' One
comment stated that consumers do not know that these are B vitamins and
have been confused by the listing of thiamin and riboflavin on ``B-
complex'' products. The comment stated that the mandatory use of
``thiamin'' and ``riboflavin'' is inconsistent with the educational
purposes of the 1990 amendments and the DSHEA and recommended that the
use of these names be optional following the numerical names. The
comment recommended that this approach be followed on the labels of
conventional foods as well.
The agency has previously considered this issue. As discussed in
the proposal, the use of numerical terminology for these vitamins is
obsolete (29487 at 29502). ``The Handbook of Vitamins'' concurs with
this conclusion (Ref. 1, pp. 239 and 285). Also, the National Academy
of Sciences' National Research Council (NAS/NRC) publication on
``Recommended Dietary Allowances'' (Ref. 2, pp. 125 and 132) uses the
terminology ``thiamin'' and ``riboflavin,'' as does the nutrition
labeling of conventional foods. Consistent terminology is needed for
consumers to be able to calculate their total intake of these vitamins
from all food products.
To provide flexibility in the labeling of dietary supplements, the
agency proposed in the December 1995 proposal that the terms ``vitamin
B<INF>1</INF>'' and ``vitamin B<INF>2</INF>'' may be listed as synonyms
for thiamin and riboflavin. The agency is adopting this provision, so
manufacturers who wish to inform consumers that these nutrients are B
vitamins will be free to do so. Thus, they will be able to address any
consumer confusion as to why these nutrients are included in B-complex
products.
The agency concludes that the regulation it is adopting provides
the requisite flexibility and yet ensures that the nutrition label
conforms to up-to-date scientific views. Thus, FDA is not accepting the
recommendation of these comments.
7. One comment requested that ``folic acid'' be listed instead of
``folate,'' stating that the use of ``folic acid'' is consistent with
the final rule entitled ``Food Additives Permitted for Direct Addition
to Food for Human Consumption; Folic Acid (Folacin),'' published in the
Federal Register (61 FR 8797, March 5, 1996).
The agency agrees that the term ``folic acid'' can be listed in
place of ``folate.'' The December 1995 proposal stated in
Sec. 101.36(b)(2)(i)(B)(2) that ``folic acid'' and ``folacin'' may be
added in parentheses immediately following the listing of ``folate''
(60 FR 67194 at 67198). However, the health claims final rule on folate
and neural tube defects, amended the nutrition labeling regulations
that FDA had adopted for dietary supplements and conventional foods\1\
to allow the terms ``folic acid'' or ``folacin'' to be used
synonymously (61 FR 8752 at 8759, March 5, 1996)). In that final rule,
the agency acknowledged that the terms ``folic acid'' and ``folate''
are interchangeable in common usage, although technically ``folic
acid'' refers
[[Page 49830]]
to the synthetic form of this vitamin, and ``folate'' is a general term
that refers to both the synthetic and naturally-occurring forms.
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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).
---------------------------------------------------------------------------
Thus, the agency agrees with the comment that it is appropriate for
``folic acid'' to be listed by itself in place of ``folate.'' For
clarity, the agency is modifying the language in
Secs. 101.36(b)(2)(i)(B)(2) and 101.9(c)(8)(v) to state
``alternatively, folic acid or folacin may be listed without
parentheses in place of folate.''
8. Several comments recommended that the agency require that
information on the quantitative amount by weight of each dietary
ingredient be placed immediately after the name of the dietary
ingredient, rather than in a separate column. The comments requested
this change because of space constraints on the label and the cost of
reformatting. One of these comments stated that consumers are already
familiar with a format in which amounts immediately follow names on
both dietary supplement and traditional food labels, and that there is
no evidence that they have difficulties understanding this information.
Other comments stated that the use of a single column should be
optional. At least one comment specifically supported the proposed two
columns because of readability.
The agency is persuaded that information on names and the
corresponding amounts of dietary ingredients should be allowed to
appear in one column to save space. In the January 4, 1994, final rule
on labeling of dietary supplements, the agency required that the name
of the nutrient and the quantitative amount by weight appear in a
single column despite several comments that argued for a separate
column for amounts. When the DSHEA amended the act to allow the source
of a dietary ingredient to be listed in the nutrition label following
the name, the agency's tentative view was that the additional
information added sufficient complexity to make it appropriate to have
the information on amount in a separate column. Some consumers buy
dietary supplements on the basis of quantitative amounts, and FDA
tentatively concluded that a separate column would help consumers to
locate this information more readily . However, based on the facts the
comments pointed out, that one column would make the dietary supplement
nutrition label consistent with that on conventional foods, and that
there are space and cost advantages to such a format, the agency has no
objection to the optional listing of the quantitative information by
weight immediately following the listing of names. The agency is
modifying Sec. 101.36(b)(2)(ii) accordingly.
9. A few comments stated that quantitative information should not
be declared on the basis of ``per serving.'' Some of these comments
requested that information be declared ``per day.'' These comments
argued that what is consumed per day is more important than per
serving. A couple of other comments preferred dual listing. One
suggested ``per unit and per day,'' and the other suggested ``per
serving and per day.'' Other comments specifically favored a ``per
serving'' basis and opposed dual listing.
The agency does not agree that quantitative information should be
declared on a ``per unit'' or a ``per day'' basis instead of ``per
serving.'' In its proposal on June 18, 1993 (58 FR 33715 at 33716), FDA
tentatively concluded that listing information on the basis of ``per
serving'' was preferable to ``per day'' because consumers might not
actually consume the amount indicated ``per day.'' With respect to
``per unit,'' FDA expressed concern that this basis alone could confuse
consumers when more that 1 unit is to be consumed at one time (e.g. two
capsules with each meal) because they might assume that the information
is on a ``per serving'' basis because the labels of conventional foods
are presented in this manner. For these reasons, the agency required a
``per serving'' basis in the final rule of January 4, 1994 (59 FR 354
at 359), and carried this forward in the December 1995 proposal (60 FR
67194 at 67198). More importantly, the act states in section
403(q)(5)(F)(ii) that the listing of dietary ingredients shall include
the quantity of each such ingredient ``per serving.'' Therefore, FDA is
not changing Sec. 101.36(b)(2)(ii), which requires that quantitative
information be listed on the basis of ``per serving.''
However, with respect to dual listing, the agency is persuaded that
there may be some products on which the unit amount may be of interest
to consumers, and, therefore, FDA is modifying the regulation to allow
the option of listing information on a ``per unit'' basis in addition
to a ``per serving'' basis. The agency notes that Sec. 101.9(b)(10)(ii)
permits the percent of Daily Value (DV) on the labels of conventional
foods to be listed in this manner when the product is in discrete
units, and a serving is more than 1 unit. Thus, the agency is adding
Sec. 101.36(b)(2)(iv) to provide for quantitative information to be
presented voluntarily on the basis of ``per unit'' in addition to the
required declaration ``per serving'' as noted in Sec. 101.36(b)(2)(ii).
When information is presented on a ``per unit'' basis, it must be
declared in additional columns to the right of the ``per serving''
information and must be clearly identified by appropriate headings, as
illustrated in Figure 1.
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10. One comment requested different rounding rules for sugars. The
comment wanted to be able to declare amounts under 2 grams (g) in
tenths of a g or to be able to declare 0, 0.5, 1.0, 1.5 and 2.0 g. This
comment stated that sugars are present in much smaller amounts in
dietary supplements than in conventional foods, and that the proposed
rounding rules are inappropriate.
The agency is not persuaded by the comment. Section 101.9(c)(6)(ii)
provides that sugars are expressed to the nearest g, except that if a
serving contains less than 1 g, the statement ``less than 1 gram'' may
be used, and if the serving contains less than 0.5 g, the content may
be expressed as zero. While sugars may be present in much smaller
amounts in dietary supplements than in conventional foods, FDA points
out that the comment did not justify why amounts of sugars that are
under 2 g should be listed any differently on the labels of dietary
supplements than on the labels of conventional foods. Moreover, given
that amounts under 0.5 g are considered nutritionally insignificant,
the agency is not convinced that being able to declare sugars in tenths
of a g or half-gram increments up to 2 g is useful in helping consumers
to maintain a healthy diet. Accordingly, the agency is not changing
Sec. 101.36 in response to this comment.
11. One comment requested clarification of the use of the word
``actual'' in proposed Sec. 101.36(b)(2)(ii)(B), which states ``The
amounts of vitamins and minerals, excluding sodium and potassium, shall
be the actual amount of the vitamin or mineral included in one serving
of the product * * *.'' This comment stated that overages of dietary
ingredients that are subject to degradation are added to dietary
supplement products to ensure that the products provide the labeled
quantities throughout their shelf life. The comment asked FDA to
acknowledge in the preamble of the final rule that the labeled amounts
of vitamins and minerals are not necessarily the actual amounts added
at the time of manufacture, and that the corresponding percent DV is
based on the labeled amount.
The agency agrees that the proposed language is not clear with
respect to what amount is to be declared. The agency does not intend
that the declared amount include any overages that a manufacturer
includes in anticipation of degradation. By use of the word ``actual,''
the agency was trying to draw a distinction between sodium and
potassium, which are required to be declared in the increments
prescribed in Sec. 101.9(c), and other vitamins and minerals, for which
increments are not prescribed in Sec. 101.9(c). (Section 101.9(c) does
not require declaration of the quantitative amounts by weight for these
other vitamins and minerals, only that they be declared as a percent of
the DV for the nutrient. Thus, the increments for declaration of the
quantitative amount of these nutrients are not specified in
Sec. 101.9(c).)
Given the reaction to Secs. 101.36(b)(2)(ii)(B) and
101.36(b)(2)(iii)(B) that is reflected in the comments, FDA concludes
that use of the word ``actual'' in these provisions is confusing.
Therefore, the agency is revising these paragraphs to delete this word.
12. Several comments agreed that the regulation should allow the
use of ``<1%'' in place of ``less than 1%'' to save space. Some of
these comments supported the use of ``<1%'' on the labels of
conventional foods as well as on the labels of dietary supplements. One
of these comments stated that this symbol for ``less than'' is taught
in elementary math and science classes nationwide and is universally
recognized. One comment from a trade association that represents
manufacturers of conventional foods stated that the food industry has
not been permitted the use of this symbol as there was no information
demonstrating that consumers understand its meaning. This comment was
opposed to the use of the symbol on the labels of dietary supplements
until conventional foods are also able to use it.
FDA is persuaded by the comments to allow for the use of the symbol
``<'' for ``less than'' on the labels of dietary supplements and
conventional foods to provide more flexibility when space is limited on
the label. While there is no consumer survey data to show the level of
consumer understanding of the symbol, the agency acknowledges that
elementary and secondary schools are teaching its use, so that a
growing number of consumers can be expected to understand its meaning.
In addition, the agency is aware that the symbol ``<'' is being used on
the labels of some conventional foods, and FDA has not received any
consumer complaints about its use. Given these unique circumstances,
FDA concludes that it is reasonable to allow use of the symbol, thereby
reducing the possibility of overcrowding of information on some
nutrition labels. Accordingly, Sec. 101.36(b)(2)(iii)(C) is finalized
as proposed.
The agency stated in the December 1995 proposal (60 FR 67194 at
67200)
[[Page 49832]]
that if it allowed the symbol on the nutrition labels of dietary
supplements, it intended ``to provide for such use'' on the nutrition
labels of conventional foods as well. FDA finds that it reasonably
follows from this statement, and from the conclusions that it has
reached with respect to dietary supplements, for it to take this
action. Accordingly, the agency is amending Sec. 101.9(c)(8)(iii) and
(d)(7)(i) to allow the use of the symbol ``<'' in place of the words
``less than.''
13. Several comments supported the proposed use of the footnote
``Daily Value not established''(Sec. 101.36(b)(2)(iii)(F)). However,
three comments were against the use of this footnote in some cases.
These comments stated that the footnote implied that a DV was not
``yet'' established. Consequently, they stated that it should only be
permitted for components having some legitimate claim to nutritional
value. One comment said that dietary ingredients such as choline should
have an asterisk and a footnote, while dietary ingredients such as bee
pollen should have no asterisk and no footnote. This comment said that
a product composed solely of dietary ingredients such as bee pollen
should have no ``% Daily Value'' column, no asterisks, and no footnote.
The agency does not agree with the comments that argued that the
footnote apply only to dietary ingredients that ``have nutritional
value.'' The comments did not suggest a definition for dietary
ingredients that have a ``claim to nutritional value,'' or how to
distinguish such dietary ingredients from the other dietary ingredients
for which no DV has been established. Thus, the agency does not know
how it would implement the suggested change. The act makes it clear in
section 403(q)(5)(F)(i) that dietary ingredients not having a
recommendation for daily consumption established by the Secretary are
to be identified as ``having no such recommendation.'' Accordingly, FDA
is adopting Sec. 101.36(b)(2)(iii)(F) unchanged from the proposal.
C. Other Dietary Ingredients
14. Several comments recommended that ``other dietary ingredients''
(those not having recommendations, i.e., no RDI's or DRV's) should be
listed outside the ``box'' format for nutrition information, and that
products composed solely of these dietary ingredients, such as herbal
supplements, should not be required to use the ``box'' format. One of
these comments suggested not requiring a ``box'' format unless a claim
is made. These comments stated that herbal supplements are not consumed
for their nutritional value, and that it is not appropriate to use a
format that mimics that of the Nutrition Facts panel. They said that
the use of such a format would confuse consumers and would not convey
any meaningful information. They argued that such a format goes beyond
the intention of the DSHEA.
One comment stated that simple ingredient listing should be an
option in lieu of nutrition labeling. Another comment, which requested
more flexibility, said that the agency should allow the ``labeler to
present the information to the consumer in the best way they see fit.''
One other comment stated that flexibility in format was needed because
of space constraints and recommended that the special labeling
provisions in Sec. 101.9(j)(13) should apply to dietary supplements.
The agency is not persuaded by these comments that the format that
it proposed goes beyond the intention of the DSHEA. To the contrary,
the agency concludes that the format is consistent with the DSHEA.
As a result of the DSHEA, the act requires that nutrition
information immediately precede the ingredient information (section
403(q)(5)(F)(iv)), requires that the nutrition information list dietary
ingredients not having recommendations (section 403(q)(5)(F)(i)), and
defines herbs and other botanicals as dietary ingredients when present
in dietary supplements (section 201(ff)(1)). Taken together, the only
logical reading of these provisions is that herbal dietary ingredients
are to be listed in the nutrition information. Accordingly, the agency
is not making any change in Sec. 101.36 in response to these comments.
The agency notes that Sec. 101.36(i)(2) provides that dietary
supplements are subject to the special labeling provisions specified
for small and intermediate-sized packages in Sec. 101.9(j)(13).
15. Several comments requested that the ``other dietary
ingredients,'' those not having RDI's or DRV's, including those in a
proprietary blend, should be allowed to be declared in paragraph form
beneath the bar required in Sec. 101.36(e)(6)(ii) (i.e., in a linear
format with the quantity of each dietary ingredient immediately
following the name of the ingredient itself) to save space. An example
of such a label was included in one comment. One comment from a dietary
supplement manufacturer stated that the majority of its products would
qualify for an exemption or a linear layout under the special
provisions for small or intermediate-sized packages in
Sec. 101.9(j)(13) if they were labeled as conventional foods.
FDA points out, as stated in response to the previous comment, that
Sec. 101.36(i)(2) provides that dietary supplements are subject to the
special labeling provisions specified in Sec. 101.9(j)(13) for foods in
small or intermediate-sized packages, which includes the option of a
linear layout when there is insufficient space for the vertical or
tabular display. Also, Sec. 101.36(c)(2) provides that the ``other
dietary ingredients'' contained in a proprietary blend may be listed in
linear fashion indented under the term ``Proprietary Blend.'' In
addition to the flexibility that these sections provide, FDA has no
objection if a linear display is used for the listing of all ``other
dietary ingredients'' on the labels of dietary supplement products,
regardless of package size. However, as discussed in comment 18 below,
when constituents (i.e., subcomponents) of ``other dietary
ingredients'' are listed, they must be indented under the listing of
the dietary ingredient. Thus, it is not possible to use a linear
display for ``other dietary ingredients'' when constituents are listed
for any of them.
Therefore, the agency is revising Sec. 101.36(b)(3)(i) and
(b)(3)(ii) to provide explicitly that other dietary ingredients may be
declared in a linear display as long as none of the dietary ingredients
list constituents. Figure 2 illustrates the declaration of other
dietary ingredients in a linear display.
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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 se