[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.
    <bullet> 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)'').
    <bullet> 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