[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58346-58350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24960]


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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