[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Rules and Regulations]
[Page 58346-58350]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-4]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
[Docket No. 98N-0044]
RIN 0910-AB97
 
 
Regulations on Statements Made for Dietary Supplements Concerning
the Effect of the Product on the Structure or Function of the Body;
Partial Stay of Compliance
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Final rule; partial stay of compliance.
 
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SUMMARY: The Food and Drug Administration (FDA) is announcing a partial
stay of compliance for the final rule defining the types of statements
that can be made concerning the effect of a dietary supplement on the
structure or function of the body for certain dietary supplement
products. Dietary supplement products that were labeled, or for which
labeling had been printed, on or before January 6, 2000, the
publication date of the final rule, are eligible for the stay. This
action is in response to two petitions for stay and reconsideration.
 
DATES: This rule is effective October 30, 2000. Submit written comments
by October 30, 2000. Submit written comments on the information
collection provisions of this final rule by October 10, 2000.
Notifications of products that are eligible for the stay of compliance
may be submitted to FDA at any time following the effective date of
this rule; it is to manufacturers' advantage to submit such
notifications as soon as possible, as only products for which FDA has
received a notification qualify for the stay.
 
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
collection provisions of this final rule to the Office of Information
and Regulatory Affairs, Office of Management and Budget (OMB), 725 K
St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.
Send notifications of products that are eligible for the stay of
compliance to Food and Drug Administration, Office of Nutritional
Products, Labeling, and Dietary Supplements, Division of Compliance and
Enforcement (HFS-810), 200 C St. SW., Washington, DC 20204.
 
FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Office of Nutritional
Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4605.
 
SUPPLEMENTARY INFORMATION:
 
I. Introduction
 
    In the Federal Register of January 6, 2000 (65 FR 1000), FDA
published a final rule entitled ``Regulations on Statements Made for
Dietary Supplements Concerning the Effect of the Product on the
Structure or Function of the Body'' (hereinafter referred to as ``the
final rule''). In the final rule, FDA established regulations to define
the types of statements that may be made without prior FDA review about
the effects of dietary supplements on the structure or function of the
body (structure/function claims), and to distinguish these claims from
claims that a product treats, prevents, cures, diagnoses, or mitigates
disease (disease claims).
    In the preamble to the final rule, FDA stated that the final rule
would become effective on February 7, 2000, approximately 30 days after
publication. FDA also stated that any product that is marketed for the
first time after publication of the final rule, and any new claims made
for an existing product for the first time after the publication of the
final rule, would be expected to be in compliance as of the effective
date, February 7, 2000. However, small businesses that marketed a
product as of January 6, 2000, the date of publication of the final
rule, would have an additional 17 months (until July 7, 2001) to bring
existing claims (i.e., claims already in the product's labeling on
January 6, 2000) for those products into compliance. For all other
products that were on the market as of January 6, 2000, FDA allowed an
additional 11 months beyond the effective date (until January 7, 2001)
to bring existing claims for those products into compliance.
 
II. Petitions for Reconsideration and Stay of Action
 
    FDA received one petition under Sec. 10.35 (21 CFR 10.35) for stay
of the 30-day effective date and one petition under 21 CFR 10.33 for
stay and reconsideration of part of the implementation plan in the
final rule. A petition for stay submitted jointly by the Council for
Responsible Nutrition (CRN) and the Consumer Healthcare Products
Association (CHPA) (Docket No. 99N-0044/PSA1) (Ref. 1) (hereinafter
referred to as the ``joint petition'') requested that FDA stay its 30-
day effective date for ``pipeline'' products, i.e., products that were
labeled, or for which labeling had been printed, but that had not yet
been marketed when the final rule was published on January 6, 2000. The
joint petition requested that such products be given the 11 or 17
months for compliance afforded to products that were being marketed as
of the publication date of the final rule. The joint petition stated
that in the nearly 2 years between publication of the proposed and
final rules, dietary supplement manufacturers and distributors had
relied on the criteria and examples of acceptable structure/function
claims in the proposed rule to develop marketing strategies,
manufacture products, and design and produce labeling. The petition
stated that in many cases, this reliance had involved a significant
investment of resources.
    The joint petition further stated that the implementation of the
final rule will involve, among other things, package redesign, redesign
of websites and
 
[[Page 58347]]
 
promotional literature, and sometimes, new packaging equipment. The
joint petition argued that the short implementation period (30 days for
products not yet marketed) would not provide a long enough transition
period to enable ``pipeline'' products to be brought into compliance.
Moreover, the joint petition asserted that giving such products the
same transition compliance period as products that had actually been
marketed by January 6, 2000, would provide a fair and reasonable
implementation plan for firms that had invested energy and resources,
in good faith, developing a new product with labeling bearing claims
based on the proposed rule, but that narrowly missed marketing the
product by January 6, 2000.
    The petition for stay and reconsideration was submitted by the
American Herbal Products Association (Docket No. 98N-0044/PRC4) (Ref.
2) (hereinafter referred to as the ``AHPA petition''). The AHPA
petition requested that FDA reconsider two provisions of the final
rule, one of which was the implementation plan. This notice will
address only the request in the AHPA petition that concerns the
implementation plan in the final rule; the other part of the AHPA
petition will be addressed separately at a later time.
    The AHPA petition requested two actions by FDA concerning the
implementation plan. First, the AHPA petition requested that FDA treat
certain products labeled before the February 7, 2000, effective date
the same way as products marketed before the publication of the final
rule on January 6, 2000. Specifically, the petition requested that FDA
allow any product labeled before the February 7, 2000, effective date
to be marketed during the 11-month or 17-month transition compliance
period, provided that a notification has been submitted to FDA as
required by section 403 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 343(r)(6)), that FDA has not objected to the
notification, and that the product bears the required disclaimer.
Second, the AHPA petition requested that products subject to the
transition compliance period be allowed to be shipped after that period
has ended, provided that the label had been affixed to the product
prior to the applicable 11-month or 17-month compliance date.
    The AHPA petition stated that the requested relief is necessary for
two reasons. First, the AHPA petition asserted that the 30-day
effective date does not provide enough time to relabel products that
were in the pipeline, but were not marketed, before the publication of
the final rule. The AHPA petition also stated that products labeled at
any point during the 11-month or 17-month transition period should be
allowed to be marketed even after the applicable compliance date to
reduce the costs of the rule by eliminating the need to relabel or
destroy inventory not marketed by the end of the transition period. The
AHPA petition further stated that there is no basis to distinguish the
implementation scheme for the final rule from that used to implement
the dietary supplement nutrition labeling final regulations published
in the Federal Register of September 23, 1997 (62 FR 49826 at 49842),
which provided that any product labeled before the effective date did
not have to be relabeled to comply after the effective date.
 
III. Response to Petitions
 
    FDA has fully evaluated the two petitions for stay and
reconsideration of the implementation plan in the final rule. FDA
agrees that there may be manufacturers who, relying on the criteria and
examples of acceptable structure/function claims in the proposed rule,
produced labeling with claims that would have been considered
structure/function claims under the proposed rule, but that are
classified as disease claims under the final rule. We also agree that
the 30-day effective date of the final rule may not have provided a
long enough transition period to enable products close to being
marketed when the final rule was published to be brought into
compliance. Therefore, FDA is announcing a stay of compliance for a
limited class of products. Products that were labeled no later than the
publication date of the final rule, January 6, 2000, or for which
labeling had been printed by that date (hereinafter referred to as
``eligible products'') will be eligible for the stay.
    To prevent the partial stay from becoming effectively a blanket
stay of the 30-day effective date for all products, FDA is requiring
that any firm wishing to take advantage of the stay notify FDA of that
fact before it markets its eligible products. The notification must:
(1) Include the name and complete address of the firm submitting it;
(2) identify the eligible products; (3) provide documentation that the
eligible products were in fact labeled no later than January 6, 2000,
or that labeling for the products had been printed by that date; and
(4) include a certification, signed by a responsible individual, that
the products are eligible for the stay. The eligible products must be
described with sufficient specificity to enable FDA to identify them in
the marketplace and distinguish them from other products (including
other lots of the same product) that do not qualify for the stay. For
example, the identification might consist of the name of the product
and a unique identifier code, such as a product identification or lot
code that the manufacturer uses to track its products.
    FDA believes that the notification requirement is necessary for
effective enforcement of the final rule. Without the notification, the
agency would be unable to verify whether individual products are
eligible for the stay and therefore would not be able to determine
which products in the marketplace bear violative claims and are subject
to enforcement action.
    Firms must send the required notification to: Food and Drug
Administration, Office of Nutritional Products, Labeling, and Dietary
Supplements, Division of Compliance and Enforcement (HFS-810), 200 C
St. SW., Washington, DC 20204. Notifications may be submitted at any
time after the effective date of this final rule. It is to a
manufacturers' advantage to submit such notifications as soon as
possible, as only products for which FDA has received a notification
qualify for the partial stay of compliance.
    Small businesses that have eligible products and that submit the
required notification to FDA will have 17 months after the effective
date of the final rule (until July 7, 2001) to bring their eligible
products into compliance, and other firms will have 11 months after the
effective date of the final rule (until January 7, 2001) to bring their
eligible products into compliance. We believe that this action provides
a fair and reasonable implementation plan for firms that made a
substantial investment in products that narrowly missed being marketed
by the publication date of the final rule.
    We are not granting the request in the AHPA petition that FDA allow
products labeled before the 11-month or 17-month compliance date to be
shipped after that date. In the preamble to the final rule (65 FR 1000
at 1044), FDA concluded that the compliance periods of 11 and 17 months
following the effective date of the final rule were reasonable and
fair. The agency stated that these compliance periods, uniformly
applied, are sufficiently long and that an extension of the time to
comply is not needed. The purpose of the compliance period is to give
firms time to develop new labels that comply with the requirements of
the act and regulation and to ensure a level playing field for all
firms marketing dietary supplements. We find no basis to permit some
firms to continue to market
 
[[Page 58348]]
 
products with claims that violate the act and that may give them a
competitive advantage over products marketed by firms that have made
the investment in time and expense to meet the applicable compliance
dates.
    Moreover, granting AHPA's request would create an incentive for
manufacturers to perpetuate existing claims that are defined as disease
claims under the final rule and, in fact, to label as many products as
possible with such claims between now and the applicable compliance
date. FDA believes that creating such an incentive would be unwise and
that the agency should maintain the policy in the final rule, which was
designed to encourage manufacturers to change their labeling in
accordance with the final rule as quickly as possible, but no later
than the applicable compliance date. Having a date by which all
products must comply will reduce consumer confusion and greatly
simplify enforcement, as after that date the agency will be able to
take action against any product that bears unapproved disease claims,
without also having to determine when the product was labeled.
    We disagree that the basis for the effective date of the September
23, 1997, final rule implementing the nutrition labeling requirements
for dietary supplements is relevant to the current rulemaking. In
deciding to base the effective date of the September 23, 1997, final
rule on the date of labeling, rather than the date of marketing, FDA
relied on language in section 7 of the Dietary Supplement Health and
Education Act of 1994 (DSHEA). Section 7 of DSHEA states that dietary
supplements ``may be labeled after the date of the enactment of this
Act in accordance with the amendments made by this section, and shall
be labeled after December 31, 1996, in accordance with such
amendments.'' The final rule implements section 6 of DSHEA, which does
not contain the same language as section 7 and is not subject to
section 7. Therefore, the fact that FDA allowed products labeled before
the effective date of the September 23, 1997, final rule to be marketed
after the effective date of that rule does not compel that the same
approach be taken to implement the final rule. For the reasons
discussed above, namely, to encourage prompt implementation of the rule
and ensure a level playing field after the compliance date, the agency
is not staying the compliance dates in the implementation plan for
products labeled on or before the appropriate compliance date.
Consistent with the implementation plan in the final rule (65 FR 1000
at 1044), all products in interstate commerce that are subject to the
final rule must be in compliance with the act and regulations by July
7, 2001 (for products marketed by small businesses), or January 7, 2001
(for other products).
    Under Sec. 10.35(a) and (d)(1), FDA may stay the effective date of
a rule, or any other administrative action, upon a finding that the
stay is in the public interest. FDA finds that this partial stay of
compliance is in the public interest because it will allow a fair and
reasonable transition compliance period for firms that made a
substantial investment in dietary supplement products that were close
to marketing when the final rule was published.
    The Administrative Procedure Act and FDA regulations provide that
the agency may issue a regulation without notice and comment procedures
when the agency for good cause finds that such procedures are
impracticable, unnecessary, or contrary to the public interest (5
U.S.C. 553(b)(3)(B); 21 CFR 10.40(e)(1)). Because this final rule is a
stay of compliance, FDA finds that there is good cause to dispense with
notice and comment procedures. Notice and comment procedures are
unnecessary because this final rule does not change the substantive
requirements of the final rule, only the date on which compliance with
those requirements is expected for a limited class of products.
Further, notice and comment procedures are not in the public interest
because the final rule has already become effective, and therefore a
prompt response to the petitions for stay and reconsideration is
important.
 
IV. Analysis of Impacts
 
    The economic impact of the final rule was discussed in the Federal
Register (65 FR 1000 at 1044 through 1049). A partial stay of
compliance for the final rule will provide additional time for
companies to relabel products and will reduce label obsolescence, as
there will be additional time to use up more existing labeling.
Although this rule granting a partial stay of compliance will impose
some small administrative costs on those industry members that wish to
take advantage of it, these costs are expected to be much smaller than
the savings that will be realized from reduced inventory losses. Thus,
this final rule granting a partial stay of compliance should reduce the
economic impact on industry.
    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. 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 consistent
with the regulatory philosophy and principles identified in the
Executive Order. In addition, the final rule is not a significant
regulatory action as defined by the Executive Order and so is not
subject to review under the Executive Order.
    Under the Regulatory Flexibility Act, if a rule has a significant
economic impact on a substantial number of small entities, the agency
must analyze regulatory options that would minimize any significant
impact of the rule on small entities. This final rule provides a stay
of compliance, which will allow manufacturers additional time to use up
existing product labeling. Accordingly, the agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities. Therefore, under the Regulatory Flexibility
Act, no further analysis is required.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement of
anticipated costs and benefits before issuing any rule that may result
in an expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100 million in any one year
(adjusted annually for inflation).
    The Unfunded Mandates Reform Act does not require FDA to prepare a
statement of costs and benefits for this rule, because this rule is not
expected to result in expenditures that would exceed $100 million,
adjusted for inflation, in any one year. The current inflation-adjusted
statutory threshold is $110 million.
 
V. Paperwork Reduction Act of 1995
 
    This final rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501-3520). A description of these provisions is given
below 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.
    With respect to the following collection of information, FDA
invites
 
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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, when appropriate, and other forms of
information technology.
    Title: Notification of Products Eligible for a Stay of the
Effective Date of FDA's Regulations on Statements Made for Dietary
Supplements Concerning the Effect of the Product on the Structure or
Function of the Body.
    Description: Under sections 301, 403(r)(1)(B) and (r)(6), and
505(a) of the act (21 U.S.C. 331, 343(r)(1)(B) and (r)(6)), and 355(a))
FDA is responsible for preventing distribution in interstate commerce
of products marketed as dietary supplements with claims about the
effect of the product on a disease, unless the claim is an authorized
health claim. Section 701(a) of the act (21 U.S.C. 371(a)) gives FDA
the authority to issue regulations for the efficient enforcement of the
act. In the final rule (65 FR 1000), FDA published a regulation that
defined the types of statements that can be made concerning the effect
of a dietary supplement on the structure or function of the body. In
the preamble to the final rule, the agency stated that the final rule
would become effective on February 7, 2000, approximately 30 days after
the date of the final rule's publication in the Federal Register. The
final rule further provided that any product that is marketed for the
first time after publication of the final rule, and any new claims made
for an existing product for the first time after the publication of the
final rule, would have to be in compliance as of the effective date.
    In response to two petitions asking the agency to stay and/or
reconsider the 30-day effective date for the final rule, FDA is
granting a partial stay of compliance with the rule for those dietary
supplement products that were labeled or for which labeling had been
printed on or before January 6, 2000, the publication date of the final
rule. A manufacturer that wishes to market products that are eligible
for the stay would have to notify FDA of the identity of its eligible
products; provide documentation that the products were labeled by
January 6, 2000, or that labeling for the products had been printed by
that date; and certify that the products that are the subject of the
notification meet the eligibility criteria.
    Information that is required in the notification includes: (1) The
name and complete address of the firm submitting the notification; (2)
a description of the products that are the subject of the notification.
The description must be sufficient to enable FDA to identify the firm's
qualifying products in the marketplace and distinguish them from other
products (including other lots of the same product) that are not
eligible for the stay. For example, the description might consist of
the name of the product and a unique identifier code (such as a product
identification or lot code that the manufacturer uses to track its
products); (3) documentation that the products were labeled by January
6, 2000, or that the labeling for the products had been printed by that
date (for example, purchase records from a label manufacturer or
production records that showed that the products had been labeled by
January 6, 2000); and (4) a certification, signed by a responsible
individual, that the products are eligible for the stay.
    FDA estimates the burden of this collection of information as
follows:
 
                                 Table 1.--Estimated Annual Reporting Burden\1\
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                        Annual Frequency per       Total Annual
  No. of Respondents          Response              Responses          Hours per Response        Total Hours
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         48                      1                     48                      2                   96
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
 
    These estimates are based on the number of firms that may have
products that are eligible for the stay. In the final rule (65 FR 1000
at 1047), FDA estimated that 1,000 firms manufacture dietary supplement
products that would be covered by the final rule. FDA also estimated
that approximately 4.81 percent of the 17,400 dietary supplement
products currently being marketed with structure/function claims would
be required to change their labels because of the requirements in the
final rule (65 FR 1000 at 1046). Therefore, assuming that products
affected by the final rule are uniformly distributed throughout the
industry, approximately 48 firms (4.8 percent of 1,000 firms) may have
products affected by the partial stay of compliance.
    The notification burden would consist of the preparation of the
letter notifying FDA and accompanying documentation that the products
were labeled before January 6, 2000, or that the labeling had been
printed by that date. FDA believes this burden will be small since
firms already have the information needed to describe their own
products with specificity. With respect to the supporting
documentation, the firm would already have identified the relevant
documents as part of ascertaining which products are eligible for the
stay. Therefore, the firm would only need to reproduce the relevant
documents to accompany the notification. The notification is a one-time
action, and all of a firm's eligible products can be listed in a single
notification. Therefore, FDA anticipates receiving only one
notification per firm.
    The information collection provisions of this final rule have been
submitted to OMB for review. Interested persons may send comments
regarding information collection by October 10, 2000, to the Office of
Information and Regulatory Affairs, OMB, New Executive Office Bldg.,
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer
for FDA.
    FDA has requested expedited processing of this information
collection request under section 3507(j) of the PRA and 5 CFR 1320.13.
The information to be collected under this final rule is needed before
clearance could be obtained under the normal PRA clearance time
periods. Further, the use of normal PRA clearance procedures is
impracticable and would be likely to prevent or disrupt the collection
of information because the compliance periods during which products
that qualify for the partial stay may be marketed without relabeling
would have ended or would be close to ending.
    Prior to the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or
 
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disapprove the information collection provisions in this final rule. 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.
 
VI. Comments
 
    Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding the final rule by October
30, 2000, except that comments regarding information collection are to
submitted to OMB (address above) by October 10, 2000. 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
 
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. Council for Responsible Nutrition and Consumer Healthcare
Products Association, Petition for Stay of Action, February 7, 2000.
      2. American Herbal Products Association, Petition for
Reconsideration and Petition for Stay of Action, February 7, 2000.
 
    Dated: September 21, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24960 Filed 9-28-00; 8:45 am]
BILLING CODE 4160-01-F