[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Rules and Regulations]
[Pages 74785-74792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9657]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 1998P-0043] (formerly Docket No. 98P-0043)
Food Labeling: Nutrition Labeling of Dietary Supplements on a
``Per Day'' Basis
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
nutrition labeling regulations for dietary supplements to provide that
the quantitative amount and the percent of Daily Value of a dietary
ingredient may be voluntarily presented on a ``per day'' basis in
addition to the required ``per serving'' basis when a recommendation is
made on the label that the dietary supplement be consumed more than
once per day. This final rule responds to a citizen petition requesting
that FDA amend our dietary supplement nutrition labeling regulations to
include this provision. FDA is taking this action to give manufacturers
of dietary supplements the option to present nutrition information on a
``per day'' basis to consumers.
[[Page 74786]]
DATES: The regulation is effective December 13, 2006.
FOR FURTHER INFORMATION CONTACT: Carole L. Adler, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2371.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 12, 1999 (64 FR 1765), FDA
published a proposed rule entitled ``Food Labeling: Nutrition Labeling
of Dietary Supplements on a `Per Day' Basis'' (the proposed rule). The
proposed rule was published in response to a citizen petition submitted
by the Nutrilite Division of the Amway Corporation (the petitioner)
(filed January 23, 1998, Docket No. 98P-0043/CP1). In the citizen
petition, the petitioner requested that we amend our nutrition labeling
regulations for dietary supplements to permit the option of listing the
quantitative amount and percent of Daily Value of dietary ingredients
on a ``per day'' basis in addition to the required ``per serving''
basis when the label of the product recommends or instructs that the
dietary supplement be consumed more than once per day. The proposed
rule described the petitioner's request for ``per day'' labeling,
including the petitioner's proposed language for amending Sec. 101.36
(21 CFR 101.36) (64 FR 1765 at 1766 through 1767).
In the proposed rule, FDA explained the relevant background and
history of Sec. 101.36, which governs the nutrition labeling of
dietary supplements (64 FR 1765 at 1766). Among other statutory
provisions, Sec. 101.36 implements section 403(q)(5)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
343(q)(5)(F)(ii)), which was added by the Dietary Supplement Health and
Education Act of 1994 (DSHEA). Section 403(q)(5)(F)(ii) states that the
listing of dietary ingredients in dietary supplement nutrition labeling
must include the quantity of each such ingredient (or of a proprietary
blend of such ingredients) ``per serving.''
In response to DSHEA, in its December 28, 1995, proposal entitled
``Food Labeling; Statement of Identity, Nutrition Labeling and
Ingredient Labeling of Dietary Supplements'' (the December 28, 1995,
proposed rule), FDA proposed that quantitative nutrition information
for a dietary supplement be listed on a ``per serving'' basis (60 FR
67194 at 67198 and 67201). This requirement remained unchanged in the
September 23, 1997, final rule (62 FR 49826 at 49830) entitled ``Food
Labeling; Statement of Identity, Nutrition Labeling and Ingredient
Labeling of Dietary Supplements; Compliance Policy Guide Revocation''
(the September 23, 1997, final rule). The September 23, 1997, final
rule established requirements for the nutrition labeling and ingredient
labeling of dietary supplements. These regulations state, in relevant
part, that, for ``(b)(2)-dietary ingredients'' (i.e., dietary
ingredients that have a Reference Daily Intake (RDI) or a Daily
Reference Value (DRV) as established in Sec. 101.9(c) (21 CFR
101.9(c))) and their subcomponents (see Sec. 101.36(b)(2)), the
declaration of nutrition information on the label and in the labeling
of dietary supplements must include the quantitative amount and percent
of Daily Value of each dietary ingredient ``per serving'' (Sec.
101.36(b)(2)(ii) through (b)(2)(iii)). For ``other dietary
ingredients'' (i.e., dietary ingredients for which RDIs and DRVs have
not been established (see Sec. 101.36(b)(3)), FDA's regulations
require a declaration of the quantitative amount of each dietary
ingredient ``per serving'' and a symbol (e.g., an asterisk) in the
column under the heading ``% Daily Value,'' or following the
quantitative amount when such a heading is not used, that refers to the
same symbol placed at the bottom of the Supplement Facts label and
followed by the statement ``Daily Value not established'' (Sec.
101.36(b)(3)(ii) and (b)(3)(iv)).
At the manufacturer's option, nutrition labeling for a dietary
supplement (i.e., the Supplement Facts label) may also include the
quantitative amount and percent of Daily Value of each dietary
ingredient on a ``per unit'' basis in addition to the required ``per
serving'' basis (Sec. 101.36(b)(2)(iv)). The petitioner requested that
Sec. 101.36 be amended to include a provision that the quantitative
amount and percent of Daily Value of a dietary ingredient may also be
listed on a ``per day'' basis in addition to the required ``per
serving'' basis when a recommendation is made on the label that the
dietary supplement be consumed more than once per day.
In response to the petitioner's request, we proposed to amend Sec.
101.36 by adding new paragraph (e)(9) to permit quantitative
information by weight (or volume, if permitted) to be declared on a
``per day'' basis in addition to the required ``per serving'' basis.
Accordingly, we proposed to remove Sec. 101.36(b)(2)(iv), which
provides for the optional listing of quantitative information on a
``per unit'' basis, and to include this provision with the new
provision for the optional listing of quantitative information on a
``per day'' basis in new Sec. 101.36(e)(9). These labeling provisions
would apply to all dietary ingredients (i.e., paragraph (b)(2) and
other dietary ingredients). We further proposed to redesignate existing
paragraphs (e)(9), (e)(10), and (e)(11) of Sec. 101.36 as (e)(10),
(e)(11), and (e)(12), respectively, and, accordingly, in redesignated
paragraph (e)(12), to change the reference to paragraph (e)(10) to
(e)(11). Finally, we proposed to provide an example in new Sec.
101.36(e)(11)(viii) of a suggested format for a Supplement Facts label
providing information on a ``per serving'' and ``per day'' basis.
Interested persons were given until March 29, 1999, to comment on the
proposed rule.
II. Summary of Comments and the Agency's Responses
FDA received six letters, each containing one or more comments, in
response to the proposed rule. Comments were received from industry
(including the petitioner), trade associations, and a consumer advocacy
group. All comments supported the proposed rule with two comments
requesting additional changes. The latter comments and the agency's
responses are discussed in the following paragraphs. Two other comments
raised issues regarding the ``Analysis of Impacts'' of the proposed
regulation; they are discussed in the ``Analysis of Impacts'' section
of this document.
Two comments responding to the proposed rule's inclusion
of a sample Supplement Facts label for ``per serving'' and ``per day''
information recommended additional options for the required format. One
comment requested that manufacturers have the option of providing a
statement such as ``Recommended Servings Per Day 3 Caplets (multiply
per caplet amounts by 3 for per day amount)'' below the ``Serving
Size'' declaration. The comment requested that we permit firms to
provide the ``per day'' information either in this format or in the
proposed rule's column format. The comment stated that the requested
optional format gives consumers instructions for calculating the total
amount of a dietary supplement and its dietary ingredients consumed per
day and that most consumers are able to do this simple calculation.
Also, the comment noted that the requested optional format would enable
companies to optimize the type size on dietary supplement labels to
improve label readability. The comment explained that using a column
format to provide ``per day'' information would increase the Supplement
Facts label by about 30 percent and that such an increase may drive the
choice of type
[[Page 74787]]
size to the minimum allowed, rather than larger type. The comment
contended that use of the minimum type size to offset the additional
space consumed by a larger Supplement Facts label is not necessarily in
the public interest.
The other comment requested that we allow a statement such as
``Recommended: Three (3) servings per day'' immediately following the
``Serving Size'' declaration in the Supplement Facts panel when
nutrition information is presented on a ``per day'' basis. The
comment's sample label provided this statement in conjunction with the
column format. The comment stated that the recommendation of a day's
consumption in the Supplement Facts label is not confusing and allows
for easy readability by the consumer so that the consumer understands
the concept of total daily consumption in one place on the label.
We have considered the comments requesting that the agency allow
these additional optional statements about servings ``per day''
recommended elsewhere on the label in the Supplement Facts label of a
dietary supplement. We believe that permitting a parenthetical
statement as part of the ``Serving Size'' declaration in lieu of an
additional column would promote larger print and would improve the
readability of the Supplement Facts label in some circumstances. We
also agree with the comment that permitting manufacturers to include a
parenthetical declaration of the servings per day recommended elsewhere
on the label after the listed serving size on the Supplement Facts
panel would be useful, and would not be confusing, to consumers.
Accordingly, we are permitting both types of parenthetical statements
with slight modifications.
We disagree with some of the language proposed by both comments.
Both comments proposed language for the optional parenthetical
statements, and both proposals included the word ``recommended.'' We
are not providing for use of the word ``recommended'' in new Sec.
101.36(e)(9) because we believe that the word may cause confusion among
consumers if used in the context of the Supplement Facts label. The
purpose of the Supplement Facts label is to set out the factual
nutritional information for the serving size of the product. To assure
that the relevant nutritional information is set out, section
403(q)(5)(F) of the act prescribes information that must be included on
the label of the dietary supplement. FDA's nutrition labeling
regulations for dietary supplements prescribe both the information in a
Supplement Facts label and its presentation, including the format
(Sec. 101.36(b)), the percent of Daily Value of certain dietary
ingredients (Sec. Sec. 101.9(c) and 101.36(b)(2)), the order in which
certain dietary ingredients are presented (Sec. 101.36(b)(2)(i)(B)),
the manner in which amounts are to be expressed (Sec.
101.36(b)(2)(ii)), and the manner in which dietary ingredients are to
be listed, even if no RDI or DRV has been established (Sec.
101.36(d)). Introducing the term ``recommended'' into the Supplement
Facts label could suggest to consumers that the recommendation for the
number of servings per day comes from some independent source, such as
an expert body. FDA believes that permitting the same information to be
conveyed without use of the word ``recommended'' would achieve the same
result sought by the comments without leading to the potential
confusion stemming from use of the word ``recommended'' in the context
of the Supplement Facts label. Moreover, manufacturers and distributors
remain free to use the term ``recommended'' elsewhere on the label of
their dietary supplements, so long as use of the term is not false or
misleading (e.g, if it suggests that the recommendation comes from a
source other than the manufacturer or distributor when, in fact, it
does not) or does not otherwise misbrand the dietary supplement under
section 403 of the act.
New Sec. 101.36(e)(9) will now permit a parenthetical statement in
the Supplement Facts label that provides directions for calculating the
``per day'' amount when there is a manufacturer's (or distributor's, if
the distributor labels the product) recommendation or directions for
use in other parts of the label that the dietary supplement be consumed
more than once per day. A manufacturer may use such a parenthetical
statement as an alternative to the column format for ``per day''
information described in the proposed rule and permitted in new Sec.
101.36(e)(9). For example, a manufacturer could provide a statement
such as ``Serving Size: 1 Caplet (Multiply amounts by 3 for total daily
amount).'' We are also incorporating a provision for a parenthetical
declaration of the servings per day recommended elsewhere on the label
into new Sec. 101.36(e)(9). The regulation will now permit such a
simple statement following the ``Serving Size'' declaration. FDA
believes that a simple declaration of the servings per day recommended
on other parts of the label, such as ``Total daily amount: 3 caplets
per day,'' on the Supplement Facts label would provide clarity for the
consumer when interpreting the column format, which provides the same
information in a different way (e.g., ``Per Day (3 Caplets)'').
One comment asked if continuous bars and lines would be
acceptable in place of the non-continuous bars and lines shown in the
sample Supplement Facts label in the proposed rule.\1\ Specifically,
concerning the sample Supplement Facts label, this comment was
referring to (1) the non-continuous heavy bar below the ``Serving
Size'' declaration, (2) the non-continuous light bar below the ``Per
Serving'' (``Per Caplet'' in the proposed sample label) and ``Per Day''
headings, (3) the non-continuous hairlines between the listed dietary
ingredients, and (4) the non-continuous heavy bar below the listing of
the (b)(2)-dietary ingredients.\2\
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\1\ This comment referred to proposed paragraph Sec.
101.36(e)(9)(vii) for the sample label. However, because there was
no Sec. 101.36(e)(9)(vii) in the proposed rule, we presume that the
comment intended to refer to the sample label in paragraph Sec.
101.36(e)(11)(viii) of the proposed rule.
\2\ This comment referred to the non-continuous nature of the
heavy bar below the listing of Sec. 101.36(b)(3) dietary
ingredients (i.e., ``other dietary ingredients'') in the proposed
sample label. However, because the sample label in the proposed rule
did not include other dietary ingredients, we presume that the
comment intended to inquire about the non-continuous heavy bar below
the listing of (b)(2)-dietary ingredients.
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The non-continuous lines and bars provided in the proposed sample
Supplement Facts label are a means of helping consumers distinguish
each column. However, the agency would like to clarify that the sample
labels presented in Sec. 101.36(e)(10) (now Sec. 101.36(e)(11)) are
included for the purpose of illustration. The non-continuous lines and
bars used in the sample Supplement Facts labels are one acceptable way
to comply with the regulations, but not the only way. As long as the
presentation otherwise complies with Sec. 101.36, deviations from the
sample Supplement Facts labels in new Sec. 101.36(e)(11) would not
violate the regulation. We believe that a Supplement Facts label using
continuous bars and lines to separate multiple pairs of quantitative
amounts and percents of Daily Value for dietary ingredients would be
acceptable when the information is clearly identified by appropriate
column headings.
To clarify the proposed provisions for ``per day'' and ``per unit''
information, and to make the codified language read more clearly and to
conform to plain language principles, we are making a number of
additional changes to the proposed codified language of new Sec.
101.36(e)(9), both in response to
[[Page 74788]]
comments, and after our own review of the proposal. We are providing
the codified language in two paragraphs: Sec. 101.36(e)(9)(i) and
Sec. 101.36(e)(9)(ii). The first two sentences, which pertain to ``per
unit'' information are included in Sec. 101.36(e)(9)(i). The remainder
of the codified section, which pertains to ``per day'' information is
included in Sec. 101.36(e)(9)(ii). In the first sentence of the
codified section, after ``Daily Value,'' we are adding ``of each
dietary ingredient'' and replacing the last clause of this sentence
(i.e., ``as required in paragraph (b)(2)(ii) and (b)(2)(iii) of this
section'') with the following: ``required by paragraphs (b)(2)(ii) and
(b)(2)(iii) of this section for (b)(2)-dietary ingredients and
(b)(3)(ii) and (b)(3)(iv) of this section for other dietary
ingredients.'' After the first sentence, we are adding the following
(second) sentence: ``If `per unit' information is provided, it must be
presented in additional columns to the right of the `per serving'
information and be clearly identified by appropriate headings.'' The
second sentence in the proposed codified language is now the third
sentence in this final rule (the first sentence of Sec.
101.36(e)(9)(ii)), and incorporates changes as follows: (1) We are
adding ``by weight (or volume, if permitted)'' following the words
``total quantitative amount'' and (2) following ``Daily Value,'' we are
adding ``of each dietary ingredient may be presented on a `per day'
basis in addition to the `per serving' basis required by paragraphs
(b)(2)(ii) and (b)(2)(iii) of this section for (b)(2)-dietary
ingredients and (b)(3)(ii) and (b)(3)(iv) of this section for other
dietary ingredients,'' to be consistent with the first sentence for
``per unit'' information and to avoid potential confusion.
In addition, to clarify the proposed provisions for ``per day''
information, we are adding the following sentences to Sec.
101.36(e)(9)(ii)):
If ``per day'' information is provided, it must be presented in
additional columns to the right of the ``per serving'' information
and be clearly identified by appropriate headings and/or be
presented in a parenthetical statement as part of the ``Serving
Size'' declaration. A sample illustration for ``per day''
information in a column format is provided in paragraph
(e)(11)(viii) of this section. As illustrated, the additional ``Per
Day'' column heading is followed parenthetically by the number of
servings recommended per day in other parts of the label (e.g.,
``Per Day (3 Caplets)''). When the parenthetical statement format
following the ``Serving Size'' declaration is used as an alternative
to the column format, the statement must provide no more than simple
instructions regarding how to calculate the ``per day'' amount for
the number of servings per day recommended in other parts of the
label (e.g., ``Serving Size: 1 Caplet (Multiply amounts by 3 for
total daily amount)''). When the parenthetical statement format
following the ``Serving Size'' declaration is used in addition to
the column format, the statement must provide no more than a simple
declaration of the number of servings recommended in other parts of
the label (e.g., ``Serving Size: 1 Caplet (Total daily amount: 3
caplets per day)'').
We are also changing the word ``shall'' to ``must'' in the second
sentence of new Sec. 101.36(e)(12). This change is meant to make the
codified language read more clearly and conform to plain language
principles.
In sum, we are finalizing the proposed rule as follows: We are
removing Sec. 101.36(b)(2)(iv), which provides for the optional
listing of quantitative information on a ``per unit'' basis, and
including this provision in a new Sec. 101.36(e)(9). We are,
therefore, continuing to provide for the optional presentation of the
quantitative amount by weight (or volume, if permitted) and the percent
of Daily Value on a ``per unit'' basis, in addition to the required
``per serving'' basis. We are also adding a new provision in the new
Sec. 101.36(e)(9) to provide for the optional presentation of the
quantitative amount by weight (or volume, if permitted) and the percent
of Daily Value on a ``per day'' basis, in addition to the required
``per serving'' basis, when the label recommends consumption of the
dietary supplement more than once per day.
As proposed, we are also redesignating existing paragraphs (e)(9),
(e)(10), and (e)(11) of Sec. 101.36 as (e)(10), (e)(11), and (e)(12),
respectively, and accordingly, in redesignated paragraph (e)(12)
changing the reference to paragraph (e)(10) to the newly redesignated
paragraph (e)(11). Lastly, in new Sec. 101.36(e)(11)(viii), we are
providing a sample label for the purpose of illustrating a column
format for a Supplement Facts label providing information on a ``per
serving'' and ``per day'' basis.
III. Legal Authority
In response to a citizen petition, FDA is amending its food
labeling regulations for dietary supplements to provide that the
quantitative amount and percent of Daily Value of a dietary ingredient
may be voluntarily presented on a ``per day'' basis in addition to the
required ``per serving'' basis when a recommendation is made on the
label that the dietary supplement be consumed more than once per day.
FDA has authority to take this action under sections 201(n), 403(a)(1)
and (q)(5)(F), and 701(a) of the act (21 U.S.C. 321(n), 343(a)(1) and
(q)(5)(F), 371(a)).
By delegation from the Secretary of Health and Human Services (the
Secretary), FDA has authority under section 701(a) of the act to issue
regulations for the efficient enforcement of the act. Further, section
403(q)(5)(F) provides that a dietary supplement product must comply
with the requirements of sections 403(q)(1) and (q)(2) in a manner
which is appropriate for the product and which is specified in
regulations of the Secretary (and by delegation, FDA). Sections
403(q)(1) and (q)(2) require that if a food, which includes a dietary
supplement, is intended for human consumption and is offered for sale,
its label or labeling must bear certain nutrition information. For
dietary supplements, this includes nutrition information ``per
serving'' about dietary ingredients that are present in significant
amounts (21 U.S.C. 343(q)(5)(F)(i)). Under these two sections, FDA has
authority to permit the voluntary presentation of ``per day'' nutrition
information on a dietary supplement label and provide requirements for
such labeling.
This final rule will give dietary supplement manufacturers the
option to present nutrition information of dietary supplements on a
``per day'' basis to consumers. When manufacturers choose to include
``per day'' information on a dietary supplement label, in addition to
the required ``per serving'' information, consumers will have more
information about the daily intake of dietary ingredients from a
dietary supplement that is recommended by the manufacturer to be
consumed more than once per day. When provided, ``per day'' information
about a dietary supplement can assist consumers in making dietary
choices about total consumption of dietary ingredients.
IV. Analysis of Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of this final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action as defined by
the Executive order.
1. The Need for This Regulation
Current regulations do not permit the voluntary declaration of
potentially
[[Page 74789]]
useful information on the labels of dietary supplements. Consumers may
want information on the amount of nutrition provided by dietary
supplements on a ``per day'' basis. Without this rule, manufacturers
are precluded from providing consumers with that information in the
Supplement Facts label of their dietary supplements.
2. Options
There are primarily four regulatory options available to us.
a. Option 1.--Take no new regulatory action. This option would
result in no change to the current situation. This option is the
baseline for comparison of options and entails no costs or benefits.
b. Option 2.--Take the regulatory actions as described in the
proposed rule. We proposed allowing the nutrition labeling of dietary
supplements to declare the quantitative amount and the percent of Daily
Value of a dietary ingredient on a ``per day'' basis in addition to the
required ``per serving'' basis when the label recommends that the
dietary supplement be consumed more than once per day as long as the
information was provided in a column format.
The proposed rule would have caused costs and benefits only to the
extent that firms elected to take advantage of the option of presenting
information on a ``per day'' basis. No firm would have borne the cost
of changing labels unless it believed that the claim would have
resulted in increased profits by virtue of increased sales of its
products or an increased willingness by consumers to pay more for the
product. Interested consumers would have benefited from the additional
``per day'' information.
In response to the proposal, we received one comment that agreed
with our analysis and stated that ``[t]he agency accurately notes that
the cost impact of this change is inconsequential.'' However, the
comment went on to say that, ``FDA should seek ways to balance the
potentially conflicting public health needs of the presentation of all
of the needed and required information and the limited label space of
dietary supplement product labels. * * * The use of a column format
would increase the Supplement Facts box by about 30%, thereby
potentially driving the choice of type size to the minimum required to
offset the additional space consumed by a larger Supplement Facts box.
This is not necessarily in the public interest.''
We still believe that finalizing the proposed rule would have been
of greater benefit to producers and consumers than continuing to
preclude the provision of this information in the Supplement Facts
label. However, that benefit would have been mitigated by the potential
cost to consumers of having to read the Supplement Facts label in a
smaller type size.
c. Option 3.--Take the regulatory actions described in this final
rule. In this final rule, we are allowing the nutrition labeling of
dietary supplements to declare the quantitative amount and the percent
of Daily Value of a dietary ingredient on a ``per day'' basis in
addition to the required ``per serving'' basis when the label
recommends that the dietary supplement be consumed more than once per
day. Based on comments (described in section II of this document) we
are also permitting this information to be provided in parenthetical
notations as an alternative to the column format described in the
proposed rule, as detailed in section II of this document. These
regulatory actions provide producers of dietary supplements the option
to present nutrition information on a ``per day'' basis in the
Supplement Facts label with greater flexibility than in the proposed
rule.
As under Option 2, the final rule will cause costs and benefits
only to the extent that firms elect to take advantage of the option of
presenting information on a ``per day'' basis. No firm will bear the
cost of changing labels unless it believes that the claim will result
in increased profits by virtue of increased sales of its products or an
increased willingness by consumers to pay more for the product.
However, this final rule is an improvement over the proposed rule.
It gives producers of dietary supplements greater flexibility in how
they provide consumers with the ``per day'' information. This
potentially decreases the costs to them (in comparison to Option 2) by
not requiring the information to be provided in a column format and
thereby reducing the potential need for extensive label redesigns.
The increased flexibility and decreased cost to producers of
providing the information increases the likelihood (compared to Option
2) that producers will voluntarily provide consumers with ``per day''
information. It also reduces the likelihood (compared to Option 2) that
the new ``per day'' information and all of the other information in the
Supplement Facts label would be provided in smaller and less legible
type.
Therefore, we conclude that this final rule will improve social
welfare compared with Options 1 and 2.
d. Option 4.--Require ``per day'' labeling of dietary supplements.
In response to the proposed rule, one comment stated that we should
monitor the costs for manufacturers who use the voluntary ``per day''
labeling and, if the costs are minimal, ``consider making per day
labeling mandatory in some future regulation.'' The comment stated the
belief ``that the informational benefits of the rule for consumers,
both at the time of purchase and of consumption, may be significant
enough to warrant a mandatory rule.''
We are not precluding that action in the future. There are at least
62,500 dietary supplement labels for products sold in the United
States. Requiring that all labels be changed could impose significant
costs on the industry. For example, if we were to require ``per day''
labeling within 2 years of the publication of this final rule, it could
cost between as little as $40 million and as much as $100 million,
based on data in our labeling cost model. Such significant costs would
warrant evidence of at least similarly sized benefits to consumers from
information on ``per day'' nutritional information. We currently do not
have enough information on the benefit to consumers of ``per day''
labeling to justify mandatory ``per day`` labeling for all dietary
supplements. Therefore, we have no evidence that this option is
superior for social welfare than this final rule (Option 3).
B. Small Entity Analysis
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies
to analyze regulatory options that would minimize any significant
impact of a rule on small entities. Because this final rule allows
voluntary ``per day'' labeling of dietary supplements, the agency
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities. Because ``per day''
labeling will be permitted and not required, a firm, including any
small firm, would change its labeling and incur costs only if the
expected benefits to it (e.g., increased sales) exceed the expected
costs. Therefore, under the Regulatory Flexibility Act, no further
analysis is required.
C. Unfunded Mandates
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and
[[Page 74790]]
benefits, before proposing ``any rule that includes any Federal mandate
that may result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $122
million, using the most current (2005) Implicit Price Deflator for the
Gross Domestic Product. FDA does not expect this final rule to result
in any 1-year expenditure that would meet or exceed this amount.
V. Federalism Analysis
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13132. FDA has determined that the rule has a
preemptive effect on State law. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal Statute to preempt
State law only where the statute contains an express preemption
provision, or there is some other clear evidence that Congress intended
preemption of State law, or where the exercise of State authority
conflicts with the exercise of Federal authority under the Federal
statute.'' Section 403A of the act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a)(4) of the act provides that: ``*
* * no State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as to
any food in interstate commerce--* * * (4) any requirement for
nutrition labeling of food that is not identical to the requirement of
section 403(q) * * *.''
Before the effective date of this rule, this provision operated to
preempt States from permitting ``per day'' nutrition labeling on
dietary supplements because no such requirements had been authorized by
FDA under section 403(q) of the act. Once this rule becomes effective,
States will be preempted from imposing any requirements about ``per
day'' nutrition labeling for dietary supplements that are not identical
to those permitted by this rule. This preemptive effect is consistent
with what Congress set forth in section 403A of the act. Section
403A(a)(4) of the act displaces both State and legislative requirements
and State common law duties (Medtronic v. Lohr, 518 U.S. 470, 503
(1996) (Breyer, J., concurring in part and concurring in the judgment);
id. at 510 (O'Connor, J., joined by Rehnquist, C.J., Scalia, J., and
Thomas, J., concurring in part and dissenting in part); Cippollone v.
Liggett Group, Inc., 505 U.S. 504, 521 (1992) (plurality op.); id. at
548-49 (Scalia, J., joined by Thomas, J., concurring in part in the
judgment and dissenting in part)).
FDA believes that the preemptive effect of the final rule is
consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that, ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' FDA
provided the States with an opportunity for appropriate participation
in this rulemaking when it sought input from all stakeholders through
publication of the proposed rule in the Federal Register on January 12,
1999 (64 FR 1765). FDA received no comments from any States on the
proposed rulemaking.
In conclusion, FDA believes that it has complied with all of the
applicable requirements of Executive Order 13132, and has determined
that the preemptive effects of this final rule are consistent with the
Executive order.
VI. The Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions with an estimate of the annual
reporting burden is given in the following paragraphs. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
Title: Food Labeling: Nutrition Labeling of Dietary Supplements on
a ``Per Day'' Basis.
Description: Section 403(q)(5)(F) of the act provides that dietary
supplements must bear nutrition labeling in a manner that is
appropriate for the product and that is specified in regulations issued
by FDA. We issued regulations establishing the requirements for
nutrition labeling of dietary supplements in Sec. 101.36 in the
September 23, 1997, final rule. We are now amending our nutrition
labeling regulations for dietary supplements to permit voluntary
declaration of the quantitative amount and the percent of Daily Value
of a dietary ingredient on a ``per day'' basis in addition to the
required ``per serving'' basis, if a dietary supplement label
recommends that the dietary supplement be consumed more than once per
day. These provisions respond to a citizen petition submitted by a
manufacturer and marketer of dietary supplements. This rule will
provide the option to present nutrition information on a ``per day''
basis to consumers.
Description of Respondents: Suppliers of dietary supplements.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses Total Annual Hours per Total Annual Total
21 CFR Section Respondents per Respondent Responses Response Hours Operating Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.36(e) 125 13 1,625 0.25 406 $151,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or maintenance costs associated with this collection.
The agency estimated in the March 13, 2003, proposed rule entitled
``Current Good Manufacturing Practice in Manufacturing, Packing, or
Holding Dietary Ingredients and Dietary Supplements'' that there were
about 1,250 manufacturers and relabelers of dietary supplements (68 FR
12157 at 12223). Based on data in our labeling cost model each producer
has, on average, roughly 50 products. We assume that only 10 percent,
or 125, of the dietary supplement suppliers would revise the labels of
their products to incorporate ``per day'' information for their
products. We also assume that ``per day'' information would generally
be placed on, at most, 25 percent, or, at most, 13 of a firm's
estimated 50 products, although this number would vary by firm based on
the types of products that it produces. The agency also believes that
the burden associated with providing nutrition information on a ``per
day'' basis for dietary supplements would be a one-time burden for the
small number of firms that decide voluntarily to add this additional
information to the labels of their products, separate from any other
label changes for their products. We estimate that at least 90 percent
of firms would coordinate adding ``per day''
[[Page 74791]]
information with other changes to their labels. In this case, the
voluntary cost of transmitting ``per day'' information to consumers
would be subsumed almost entirely in the cost of these other voluntary
or required labeling changes. The incremental cost for these 113 firms
would be approximately $50 (64 FR 1765 at 1768) per label for 1,469
labels, or about $73,000 total. For the remaining 12 firms that would
not coordinate adding ``per day'' information with other labeling
changes, we estimate that the cost would be approximately $500 per
label (64 FR 1765 at 1768 through 1769) for 156 labels, or $78,000
total. The estimated total operating costs in table 1 of this document
are, therefore, $151,000. Respondents are already required to list the
quantitative amount and percent of Daily Value of dietary ingredients
``per serving'' as part of the nutrition information for dietary
supplements. The ``per day'' information is generated by simple
extrapolation from the ``per serving'' information.
Individuals and organizations may submit comments on these burden
estimates or on any other aspect of these information collection
provisions, including suggestions for reducing the burden, and should
direct them to the Office of Nutritional Products, Labeling, and
Dietary Supplements (HFS-800), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740-3835.
The information collection provisions in the proposed rule were
approved under OMB control number 0910-0395. This approval was
discontinued in November 2004, but is now reinstated and expires on
October 31, 2009. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
VII. Environmental Impact
We have carefully considered the potential environmental effects of
this action. FDA has determined under 21 CFR 25.30(k) that this action
is of a type that does not have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required. No new information or
comments have been received that would affect this determination.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. Section 101.36 is amended by removing paragraph (b)(2)(iv); by
redesignating paragraphs (e)(9), (e)(10), and (e)(11) as paragraphs
(e)(10), (e)(11), and (e)(12), respectively; by adding new paragraphs
(e)(9)(i) and (e)(9)(ii); by adding new paragraph (e)(11)(viii) to
newly redesignated paragraph (e)(11); and by revising newly
redesignated paragraph (e)(12) to read as follows (The graphic to newly
redesignated (e)(12) remains unchanged.):
Sec. 101.36 Nutrition labeling of dietary supplements.
* * * * *
(e) * * *
(9)(i) The quantitative amount by weight (or volume, if permitted)
and the percent of Daily Value of each dietary ingredient may be
presented on a ``per unit'' basis in addition to the ``per serving''
basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section
for (b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this
section for other dietary ingredients. If ``per unit'' information is
provided, it must be presented in additional columns to the right of
the ``per serving'' information and be clearly identified by
appropriate headings.
(ii) Alternatively, if a recommendation is made in other parts of
the label that a dietary supplement be consumed more than once per day,
the total quantitative amount by weight (or volume, if permitted) and
the percent of Daily Value of each dietary ingredient may be presented
on a ``per day'' basis in addition to the ``per serving'' basis
required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section for
(b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this
section for other dietary ingredients. If ``per day'' information is
provided, it must be presented in additional columns to the right of
the ``per serving'' information and be clearly identified by
appropriate headings and/or be presented in a parenthetical statement
as part of the ``Serving Size'' declaration. A sample illustration for
``per day'' information in a column format is provided in paragraph
(e)(11)(viii) of this section. As illustrated, the additional ``Per
Day'' column heading is followed parenthetically by the number of
servings recommended per day in other parts of the label (e.g., ``Per
Day (3 Caplets)''). When the parenthetical statement format following
the ``Serving Size'' declaration is used as an alternative to the
column format, the statement must provide no more than simple
instructions regarding how to calculate the ``per day'' amount for the
number of servings per day recommended in other parts of the label
(e.g., ``Serving Size: 1 Caplet (Multiply amounts by 3 for total daily
amount)''). When the parenthetical statement format following the
``Serving Size'' declaration is used in addition to the column format,
the statement must provide no more than a simple declaration of the
number of servings recommended in other parts of the label (e.g.,
``Serving Size: 1 Caplet (Total daily amount: 3 caplets per day)'').
* * * * *
(11) * * *
(viii) Dietary supplement illustrating ``per serving'' and ``per
day'' information:
[[Page 74792]]
[GRAPHIC] [TIFF OMITTED] TR13DE06.001
(12) If space is not adequate to list the required information as
shown in the sample labels in paragraph (e)(11) of this section, the
list may be split and continued to the right as long as the headings
are repeated. The list to the right must be set off by a line that
distinguishes it and sets it apart from the dietary ingredients and
percent of Daily Value information given to the left. The following
sample label illustrates this display:
* * * * *
Dated: November 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-9657 Filed 12-12-06; 8:45 am]
BILLING CODE 4160-01-S