[Federal Register Volume 64, Number 7 (Tuesday, January 12, 1999)]
[Proposed Rules]
[Pages 1765-1770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98P-0043]
Food Labeling: Nutrition Labeling of Dietary Supplements on a
``Per Day'' Basis
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its 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, if a recommendation
is made on the label that the dietary supplement be consumed more than
once per day. This proposal responds to a citizen petition requesting
that these regulations be modified to include this provision. FDA is
proposing this action to provide manufacturers of dietary supplements
flexibility to voluntarily present additional label information to
consumers.
DATES: Submit written comments by March 29, 1999. Submit written
comments on the information collection provisions by February 11, 1999.
See section IX of this document for the effective date of any final
rule that may issue based on this proposal.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written comments on the information
[[Page 1766]]
collection provisions to the Office of Information and Regulatory
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Washington,
DC 20503, ATTN: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Carole L. Adler, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5494.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 23, 1997 (62 FR 49826), FDA
published a final rule entitled ``Food Labeling; Statement of Identity,
Nutrition Labeling and Ingredient Labeling of Dietary Supplements;
Compliance Policy Guide, Revocation'' (hereinafter referred to as the
``September 23, 1997, final rule''). This document was published in
response to the Dietary Supplement Health and Education Act of 1994
(the DSHEA) and established requirements for the identification of
dietary supplements and for their nutrition labeling and ingredient
labeling. These regulations provide, in part, that quantitative
information be listed ``per serving'' and voluntarily ``per unit.'' The
effective date of the September 23, 1997, final rule is March 23, 1999.
In the November 27, 1991, proposed rule on nutrition labeling
entitled ``Food Labeling; Reference Daily Intakes and Daily Reference
Values; Mandatory Status of Nutrition Labeling and Nutrient Content
Revision'' (56 FR 60366 at 60382), the agency suggested that the
required nutrition information for dietary supplements be provided in
``units'' and ``units per day'' if label directions advise consumption
of more than one unit per day. The agency believed that, because more
than one unit of a supplement is often consumed per day, the daily
amount recommended by the manufacturer for consumption should be
clearly stated. As addressed in the January 6, 1993, final rule
entitled ``Food Labeling: Mandatory Status of Nutrition Labeling and
Nutrient Content Revision, Format for Nutrition Label'' (58 FR 2079 at
2168), the agency received several comments opposing dual labeling
(i.e., ``per unit'' and ``per day'') of nutrition information if more
than one unit is specified for consumption per day. Comments were
opposed for various reasons, including that dual declaration may create
consumer confusion, overcrowd labels, and discriminate against
supplements that do not provide ``units per day'' information. The
agency was persuaded that dual declaration may create a readability
problem for consumers, given the limited space available on most
dietary supplements, and that recommended daily consumption of other
than well-defined dosages (e.g., ``consume 1 to 3 tablets per day'')
would pose a problem in terms of labeling on a ``per day'' basis. The
agency tentatively concluded that labeling ``per unit'' would be more
useful in that the product would always be consumed ``per unit,'' and
that consumers may not always follow the manufacturer's recommendations
to consume a certain number of units per day of the product. The agency
planned to propose that nutrition information be provided ``per unit''
in its future rulemaking required by the Dietary Supplement Act (the DS
act) (see 58 FR 2079 at 2169).
In the interim, FDA reexamined this issue, and in its June 18,
1993, proposal entitled ``Food Labeling; General Requirements for
Nutrition Labeling for Dietary Supplements of Vitamins, Minerals,
Herbs, or Other Similar Nutritional Substances'' (58 FR 33715 at
33716), tentatively concluded that quantitative information should be
presented ``per serving'' rather than ``per unit.'' The agency
explained in this document that consumers might be confused by a ``per
unit'' declaration when more than one unit is to be consumed at one
time (e.g., two capsules with each meal) because they might assume that
the ``per unit'' information represents the amount specified for
consumption at one time (i.e., ``per serving'') similar to conventional
foods. The agency also noted that it preferred one consistent method of
labeling for the various forms of supplements and that ``per unit''
labeling was not as appropriate for supplements that do not come in
discrete units (e.g., liquid or powdered supplements). Therefore, the
agency proposed that quantitative information be provided on a ``per
serving'' basis consistent with Sec. 101.9 (21 CFR 101.9). The agency
maintained this requirement in the January 4, 1994, final rule entitled
``Food Labeling; General Requirements for Nutrition Labeling for
Dietary Supplements of Vitamins, Minerals, Herbs, or Other Similar
Nutritional Substances'' (59 FR 354 at 359).
The DSHEA added section 403(q)(5)(F)(ii) (21 U.S.C.
343(q)(5)(F)(ii)) to the Federal Food, Drug, and Cosmetic Act (the
act). This section specifies that the listing of dietary ingredients in
nutrition labeling shall include the quantity of each such ingredient
``per serving.'' Therefore, in its December 28, 1995, proposal entitled
``Food Labeling; Statement of Identity, Nutrition Labeling and
Ingredient Labeling of Dietary Supplements'' (60 FR 67194 at 67198),
FDA proposed in Sec. 101.36(b)(2)(ii) (21 CFR 101.36(b)(2)(ii)) that
quantitative information be listed on a ``per serving'' basis. This
requirement was unchanged in the September 23, 1997, final rule (62 FR
49826 at 49830). However, the agency was persuaded that there may be
some products in which the unit amount may be of interest to consumers,
and, therefore, added Sec. 101.36(b)(2)(iv) to provide for quantitative
information to be presented voluntarily on a ``per unit'' basis in
addition to the required ``per serving'' basis in Sec. 101.36(b)(2)(ii)
(62 FR 49826 at 49830).
II. Citizen Petition
The Nutrilite Division of Amway Corp., (hereinafter referred to as
``the petitioner''), submitted a citizen petition (filed January 23,
1998, Docket No. 98P-0043/CP1), requesting that FDA amend its nutrition
labeling regulations for dietary supplements to permit the option of
listing the quantitative amount and the percent of Daily Value of
dietary ingredients on a ``per day'' basis in addition to the required
``per serving'' basis if the label of the product advises that the
dietary supplement be consumed more than once per day.
Specifically, the petitioner requested that FDA redesignate
paragraphs (e)(9) and (e)(10) of Sec. 101.36 as (e)(10) and (e)(11). In
place of former paragraph (e)(9) of Sec. 101.36, the petitioner
requested that a new Sec. 101.36(e)(9) state:
If the labeling for a dietary supplement recommends that more
than one serving be consumed per day, the text of the ``Supplement
Facts'' may also declare the total quantitative amount and the total
percent of the Daily Value that will be consumed per day of each
dietary ingredient. This additional information shall be provided in
separate columns or other separate placement, but in the same type
size and same format employed for the rest of the ``Supplement
Facts'' information, and shall be introduced by the headings ``Total
Amount Per Day'' and ``Total % DV Per Day''.
The petitioner noted that the labels of some dietary supplements
recommend consumption of more than one per day, for instance, in the
morning and in the evening (i.e., two times a day), or with breakfast,
lunch, and dinner (i.e., three times a day). The petitioner asserted
that for safety reasons, the consumer should be provided with
information about the quantitative amount and the percent of the Daily
Value of each dietary ingredient to be consumed per day.
The petitioner stated that it recognizes that the DSHEA provides
that the listing of dietary ingredients be on a ``per
[[Page 1767]]
serving'' basis, but that does not prevent FDA from allowing
information about the quantity of each dietary ingredient consumed per
day to be declared voluntarily.
The petitioner maintained that providing additional columns of
information to augment the basic nutrition labeling information would
not be confusing or misleading, is consistent with the nutrition
labeling regulations for dietary supplements, and would not conflict in
any way with the required information. The petitioner noted that FDA
has already authorized additional columns of information in other
circumstances for dietary supplements (e.g., when a product contains
two or more separately packaged dietary supplements that differ from
each other (Sec. 101.36(e)(8) and (e)(10)(iii)), and dietary
information may be provided on a ``per unit'' basis in addition to a
``per serving'' basis (Sec. 101.36(b)(2)(iv)). The petitioner also
provided examples of situations when additional columns for
conventional foods may be used (e.g., two or more forms of the same
food, and food commonly combined with other ingredients or that is
cooked or otherwise prepared before eating may be presented ``as
purchased'' and ``as prepared'' (Sec. 101.9(e) and (h)(4)).
The petitioner noted that Sec. 101.9(b)(11) provides that if a
product is promoted on the label, or in labeling or advertising for a
use that differs in quantity by twofold or greater from the use upon
which the reference amount in Sec. 101.12(b) (21 CFR 101.12(b)) was
based, then the manufacturer shall provide a second column of nutrition
information based on the amount customarily consumed in the promoted
use, in addition to the nutrition information per serving derived from
the reference amount in Sec. 101.12(b). According to the petitioner,
this provision, which Sec. 101.36(b) references, includes the voluntary
declaration of nutrition information for dietary supplements on a ``per
day'' basis if the label recommends consumption more than once per day.
III. The Proposal
The agency acknowledges that it had previous concerns about
quantitative information for dietary supplements being presented on a
``per day'' basis, and has discussed them in section I of this
document. However, the agency is persuaded by the petitioner that this
additional information may be useful to impress upon consumers of
dietary supplement products the total daily intake of each dietary
ingredient they will receive from a product that is recommended for
consumption multiple times per day. Therefore, the agency tentatively
concludes that if the labeling of a dietary supplement recommends
consumption more than once per day, it would be acceptable to provide
quantitative information ``per day'' in addition to ``per serving''
when the product label has sufficient space available to present this
information in accordance with the format requirements specified in
Sec. 101.36(e) or the special labeling provisions for small and
intermediate-sized packages in Sec. 101.36(i)(2).
The agency does not agree that this provision is covered by
Sec. 101.9(b)(11). That paragraph refers to usage at one eating
occasion of a quantity that differs by twofold from the quantity upon
which the reference amount was based, not to the usage over a day's
time.
The agency agrees with the petitioner that it is appropriate to
place this provision in Sec. 101.36(e), which is the section pertaining
to the presentation of nutrition information. In doing so, the agency
is proposing to remove paragraph Sec. 101.36(b)(2)(iv), which provides
for the optional listing of quantitative information on a ``per unit''
basis and include this provision in a new Sec. 101.36(e)(9).
Accordingly, FDA is modifying the sample language provided by the
petitioner for a new Sec. 101.36(e)(9) and is proposing to provide in
that paragraph that quantitative information by weight (or volume, if
permitted) may be declared on either a ``per unit'' or ``per day''
basis in addition to the required ``per serving'' basis. The agency is
also proposing 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 to revise the reference in (e)(12) accordingly.
As is the case when nutrient information is given in additional
columns as shown in current Sec. 101.36(e)(10)(ii) and (e)(10)(iii),
FDA believes that it is critical that clearly labeled column headings
are provided to prevent consumer confusion about the information.
Therefore, FDA is also proposing to provide a sample label in new
Sec. 101.36(e)(11)(viii) of a suggested format for a dietary supplement
providing information on both a ``per serving'' and ``per day'' basis.
FDA requests comments on the proposed changes.
The regulation specifying nutrition labeling requirements for
dietary supplements will become effective March 23, 1999, and many
dietary supplement manufacturers are currently making label changes
necessary to come into compliance with those requirements. Although the
agency does not expect to complete this rulemaking in time for the
``per day'' information to be incorporated as part of the current
changes, it has considered whether the information should be allowed on
an interim basis prior to completion of the rulemaking so that firms
wishing to incorporate it now with the other changes may do so. Because
the agency believes that the proposed ``per day'' information would not
be misleading, FDA does not intend to object to manufacturers declaring
information on a ``per day'' basis prior to issuance of a final rule,
provided it is presented in a manner consistent with this proposal.
However, manufacturers should be aware that a final rule on this issue
may differ from this proposal and that they would then be required to
change their labels to conform to the final rule.
IV. Analysis of Impacts
A. Benefit/Cost Analysis
FDA has examined the impacts of this proposed rule under Executive
Order 12866. Executive Order 12866 directs agencies to assess the costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). According to
Executive Order 12866, a regulatory action is ``economically
significant'' if it meets any one of a number of specified conditions,
including having an annual effect on the economy of $100 million or
adversely affecting in a material way a sector of the economy,
competition, or jobs. A regulation is considered ``significant'' under
Executive Order 12866 if it raises novel legal or policy issues. FDA
finds that this proposed rule is neither an economically significant
nor a significant regulatory action as defined by Executive Order
12866.
In addition, FDA has determined that this rule does not constitute
a significant rule under the Unfunded Mandates Reform Act of 1995
requiring cost-benefit and other analyses. A significant rule is
defined in section 1531(a) of the Unfunded Mandates Reform Act of 1995
as ``a 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 (adjusted annually for inflation) in any 1
year.''
Finally, in accordance with the Small Business Regulatory
Enforcement Fairness Act of 1996, the administrator of the Office of
Information and
[[Page 1768]]
Regulatory Affairs of the Office of Management and Budget has
determined that this proposed rule is not a major rule for the purpose
of congressional review.
FDA is proposing to allow the nutrition labeling of dietary
supplements to present the quantitative amount by weight (or volume, if
permitted) and the percent of Daily Value of a dietary ingredient on a
``per day'' basis in addition to the required ``per serving'' basis.
This action provides manufacturers of dietary supplements flexibility
to voluntarily present additional label information to consumers. This
rule will result in 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 redesigning labels
unless it believes that the claim will result in increased sales of its
product.
B. Small Entity Analysis
FDA has examined the impacts of this proposed rule as required by
the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a
significant impact on a substantial number of small entities, the
Regulatory Flexibility Act requires agencies to analyze options that
would minimize the economic impact of that rule on small entities.
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the agency
certifies that this proposed rule will not have a significant impact on
a substantial number of small entities.
This proposed rule would provide for voluntary, ``per day''
labeling of dietary supplements. Because ``per day'' labeling would be
permitted and not required, a firm, including any small firm, will
change its labeling and incur costs only if the benefits to it (e.g.,
increased sales) exceed the costs. FDA further notes that small product
lines from certain small firms are exempt from the dietary supplement
nutrition labeling requirements provided no claims are made.
V. The Paperwork Reduction Act of 1995
This proposed 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). The
title, description, and respondent description of the information
collection provisions are shown in this section of this document with
an estimate of the annual reporting burden. 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.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology.
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 shall bear nutrition labeling in a manner that is
appropriate for the product and that is specified in regulations issued
by FDA. FDA issued regulations establishing the requirements for
nutrition labeling in Sec. 101.36 in the September 23, 1997, final
rule. FDA is proposing to amend its nutrition labeling regulations for
dietary supplements to provide that firms may voluntarily present the
quantitative amount and the percent of Daily Value of dietary
ingredients on a ``per day'' basis in addition to the required ``per
serving'' basis, if a recommendation is made on the label that the
dietary supplement be consumed more than once per day. These proposed
provisions are in response to a citizen petition submitted by a
manufacturer and marketer of dietary supplements. This proposed action
would provide suppliers of dietary supplements flexibility to present
additional label information voluntarily to consumers.
Respondent Description: Suppliers of dietary supplements.
Table 1.--Estimated Annual Reporting Burden1
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No. or Total
21 CFR Section No. of Responses per Total Annual Hours per Total Annual Operating
Respondents Respondent Responses Response Hours Costs
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101.36(e) 85 10 850 0.25 213 $83,000
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\1\ There are no capital or maintenance costs associated with this collection of information.
These estimates are based on agency communications with industry
(Refs. 1, 2, and 3) and FDA's knowledge of, and experience with, food
labeling. FDA estimated in the September 23, 1997, final rule (62 FR
49826 at 49846) that there were a maximum of 850 suppliers of dietary
supplements and that, on average, each supplier had 40 products whose
labels required revision. FDA estimates that only 10 percent, or 85, of
the dietary supplement suppliers would revise the labels of their
products to incorporate nutrition levels for the daily use of their
products. FDA also estimates that daily use levels for nutrition
information would generally be placed on at most 25 percent, or at most
10, of a firm's estimated 40 products, although this number would vary
by firm based on the types of products that it produces. FDA also
believes that the burden associated with the proposed disclosure of
nutrition information on a daily use basis for dietary supplements
would be a one-time burden for the small number of firms that would
decide voluntarily to add this additional information to the labels for
their products, separate from any other label changes for their
products. FDA estimates that at least 90 percent of firms would
coordinate addition of daily use nutrition information with other
changes in their labels, in which case the voluntary cost of
transmitting the information to consumers in labeling would be subsumed
almost entirely in the cost of these other voluntary or required
labeling changes. The incremental cost for these 76 firms would be
approximately $50 per label for 760 labels, or $38,000 total. For the
remaining 9 firms that would not coordinate changes with other labeling
changes, FDA estimates that the cost would be approximately $500 per
label
[[Page 1769]]
for 90 labels, or $45,000 total. The estimated total operating costs in
Table 1 are, therefore, $83,000 total. Respondents are already required
to disclose the quantitative amount and percent of Daily Value of
dietary ingredients per serving as part of the nutrition information
for dietary supplements. Respondents may also provide such information
on a per unit basis. The information provided for under the proposed
rule would be generated by simple extrapolation from that information.
In compliance with 44 U.S.C. 3507(d), the agency has submitted the
information collection provision of the proposed rule to OMB for
review. Interested persons are requested to send comments regarding
information collection by February 11, 1999, to the Office of
Information and Regulatory Affairs, OMB (address above), ATTN: Desk
Officer for FDA.
VI. Environmental Impact
The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum of telephone conversation of August 10, 1998,
between James C. Lassiter, Amway Corp., and Gerad L. McCowin, Office
of Food Labeling, FDA.
2. Memorandum of telephone conversation of August 20, 1998,
between Paul Bolar, Pharmavite Corp., and Gerad L. McCowin, Office
of Food Labeling, FDA.
3. Memorandum of telephone conversation of August 20, 1998,
between Mike Bradley and Bill Cochrane, Leiner, Inc., and Gerad L.
McCowin, Office of Food Labeling, FDA.
VIII. Comments
Interested persons may by March 29, 1999 submit to the Dockets
Management Branch (address above) written comments regarding this
proposal, except that comments regarding information collection are to
be submitted to the Office of Information and Regulatory Affairs, OMB
(address above), by February 11, 1999. Two copies of any comments are
to be submitted, except that individuals may submit one copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
IX. Effective Date
The agency is proposing that any final rule that may issue based
upon this proposed rule become effective 30 days after its date of
publication in the Federal Register.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
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 paragraph
(e)(9); by adding paragraph (e)(11)(viii) to newly redesignated
paragraph (e)(11); and by revising newly redesignated paragraph (e)(12)
to read as follows:
Sec. 101.36 Nutrition labeling of dietary supplements.
* * * * *
(e) * * *
(9) The quantitative amount by weight (or volume, if permitted) and
the percent of Daily Value may be presented on a ``per unit'' basis in
addition to on a ``per serving'' basis, as required in paragraph
(b)(2)(ii) and (b)(2)(iii) of this section. Alternatively, if a
recommendation is made on the label that a dietary supplement be
consumed more than once per day, the total quantitative amount and the
percent of the Daily Value that will be consumed per day of each
dietary ingredient may be presented. The ``per unit'' or ``per day''
information shall be presented in additional columns to the right of
the ``per serving'' information and shall be clearly identified by
appropriate headings as illustrated in paragraph (e)(11)(viii) of this
section.
* * * * *
(11) * * *
BILLING CODE 4160-01-F
[GRAPHIC] [TIFF OMITTED] TP12JA99.000
BILLING CODE 4160-01-C
[[Page 1770]]
(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 shall be set off by a line that
distinguishes it and sets it apart from the dietary ingredients and
percent of Daily Value information given to the left. The following
sample label illustrates this display:
* * * * *
Dated: January 4, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-564 Filed 1-11-99; 8:45 am]
BILLING CODE 4160-01-F
