[Federal Register Volume 61, Number 189 (Friday, September 27, 1996)]
[Proposed Rules]
[Pages 50771-50774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 96N-0240]
Food Labeling; Dietary Supplement; Nutritional Support Statement;
Notification Procedure
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
establish the procedure by which manufacturers, packers, and
distributors of dietary supplements who are marketing a dietary
supplement product that bears on its label or in its labeling one of
the types of statements provided for in the Federal Food, Drug, and
Cosmetic Act (the act) are to notify FDA of that fact. FDA is issuing
this proposal in response to the Dietary Supplement Health and
Education Act of 1994 (the DSHEA) and to inquiries from the dietary
supplement industry.
DATES: Written comments by December 26, 1996.
ADDRESSES: Written comments may be sent to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food
Safety and Applied Nutrition (HFS-456), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5372.
SUPPLEMENTARY INFORMATION:
I. Background
On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into
law. The DSHEA, among other things, amended the act by adding section
201(ff) (21 U.S.C. 321(ff)), which defines a ``dietary supplement,'' by
adding section 403(r)(6) (21 U.S.C. 343(r)(6)), which provides for the
use of certain types of statements on the labels and in the labeling of
dietary supplements, and by amending section 201(g)(1), which defines
``drug,'' to state: ``A food, dietary ingredient, or dietary supplement
for which a truthful and nonmisleading statement is made in accordance
with section 403(r)(6) is not a drug under clause (C) solely because
the label or the labeling contains such a statement.''
Section 403(r)(6) states that a statement for a dietary supplement
may be made if:
[T]he statement claims a benefit related to a classical nutrient
deficiency disease and
[[Page 50772]]
discloses the prevalence of such disease in the United States,
describes the role of a nutrient or dietary ingredient intended to
affect the structure or function in humans, characterizes the
documented mechanism by which a nutrient or dietary ingredient acts
to maintain such structure or function, or describes general well-
being from consumption of a nutrient or dietary ingredient * * *
(section 403(r)(6)(A) of the act) and certain other conditions are met.
These other conditions include that the manufacturer of the dietary
supplement have substantiation that the statement is truthful and not
misleading (section 403(r)(6)(B)); that the statement prominently
contain the disclaimer: ``This statement has not been evaluated by the
Food and Drug Administration. This product is not intended to diagnose,
treat, cure, or prevent any disease'' (section 403(r)(6)(C)); and that
the manufacturer notify FDA no later than 30 days after the first
marketing of a dietary supplement product that bears such a statement
on its label or in its labeling.
While section 403(r)(6) of the act became effective immediately
upon the signing of the DSHEA by the President, FDA has tentatively
concluded that certain elaborations and clarifications of its
provisions will facilitate implementation of this section. Although
some manufacturers have already submitted notifications to the agency
under section 403(r)(6), others have made inquiries that reflect
uncertainty about what must be done to notify the agency about a
statement of this type for a dietary supplement product. In addition,
the Nutritional Health Alliance, in a petition dated March 20, 1995
(petition number 95P-0079/CP 1), requested, among other things, that
FDA issue regulations implementing section 403(r)(6) of the act,
including regulations on the procedure to notify the agency about such
statements. Therefore, the agency is issuing this proposal to
facilitate manufacturers' preparation and submission of the notice
required under section 403(r)(6) of the act. In this proposal, FDA has
sought to set out those steps necessary to ensure that notification is
accomplished as efficiently as possible but with the least possible
burden on the industry.
FDA recommends that pending final action on this proposal,
manufacturers, packers, or distributors who file notices with FDA under
section 403(r)(6) of the act follow the procedures proposed below.
II. The Proposal
Proposed Sec. 101.93(a) provides that a manufacturer, packer, or
distributor of a dietary supplement who wishes to take advantage of
section 403(r)(6) of the act, notify the Office of Special Nutritionals
(HFS-450), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C. St. SW., Washington, DC 20204, within 30 days
after first marketing, that it is marketing a dietary supplement that
bears one of the statements listed in section 403(r)(6) of the act.
This provision reflects the basic requirement of the act. Proposed
Sec. 101.93(a) provides that the notification be submitted as an
original and two copies to ensure that the agency receives the number
of copies necessary for the maintenance of records to demonstrate that
the manufacturer has complied with the requirements of the act.
Proposed Sec. 101.93(b)(1) provides that the name and address of
the manufacturer, packer, or distributor of the dietary supplement
product that bears such a statement be included in the notification.
This information is necessary to identify the firm responsible for the
claim.
Proposed Sec. 101.93(b)(2) provides that the text of the statement
that is being made be included in the notification. FDA tentatively
finds that this information is necessary to enable the agency to
determine whether the statement is of the type that can appropriately
be made under section 403(r)(6) of the act. For example, FDA has
already received notifications for numerous statements that evidence an
intent to cure, treat, mitigate, diagnose, or prevent disease. FDA has
advised the submitters of these notices of this fact and of the fact
that such statements are not authorized under section 403(r)(6) of the
act, and that if the company continues to market the product, it risks
regulatory action by the agency.
Proposed Sec. 101.93(b)(3) provides that firms are to include in
the notification the name of the dietary ingredient or supplement that
is the subject of a statement if it is not provided in the text of the
statement. It would not be possible for FDA or the manufacturer to know
with certainty whether a notification has been submitted for a
statement on the labeling of a specific product or a product containing
a specific dietary ingredient, or whether the claim was being made in
compliance with the requirements of the act, without this information.
Proposed Sec. 101.93(b)(4) provides that firms are to include in
the notification the name of the dietary supplement (including the
brand name) if not provided in response to proposed Sec. 101.93(b)(3).
A claim may be made for a dietary ingredient, in which case the claim
that is the subject of the notification would likely not identify the
product labeled with the claim. If the notification did not include the
name of the dietary supplement product, FDA could not determine whether
a product whose label bears the claim is in compliance with section
403(r)(6). Therefore, the agency tentatively concludes that it is
necessary for the notification to contain the name of the dietary
supplement, as well as of the dietary ingredient.
Proposed Sec. 101.93(c) provides that the notice be signed by a
responsible individual or the person who can certify the accuracy of
the information presented and contained in the notice. This provision
will ensure that a responsible person at the firm, qualified to
determine that the statutory requirements have been met, has reviewed
and certified that the notification is complete and accurate. Proposed
Sec. 101.93(c) also requires that the individual certify that the
information contained in the notice is complete and accurate, and that
the notifying firm has substantiation that the statement is truthful
and not misleading. This certification is necessary to provide
assurance that the firm has fully complied with the requirements of
section 403(r)(6) of the act.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
IV. Economic Impact
FDA has examined the economic implications of the proposed rule as
required by Executive Order 12866 and the Regulatory Flexibility Act (5
U.S.C. 601-612). 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, safety, distributive, and equity effects). Executive Order
12866 classifies a rule as significant if it meets any one of a number
of specified conditions, including: Having an annual effect on the
economy of $100 million; adversely affecting some sector of the economy
in a material way; adversely affecting jobs
[[Page 50773]]
or competition; or raising novel legal or policy issues. If a rule has
a significant economic effect on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic impact of the rule on
small entities. FDA finds that the proposed rule does not constitute a
significant rule as defined by Executive Order 12866, and finds that
under the Regulatory Flexibility Act, the proposed rule will not have a
significant impact on a substantial number of small entities. Finally,
the agency, in conjunction with the Administrator of the Office of
Management and Budget (OMB), finds that this proposed rule is not a
major rule for the purpose of congressional review (Pub. L. 104-121).
The proposed rule deals only with notification of nutritional
support statements. The costs and benefits associated with the
nutritional support statements themselves were analyzed in the Federal
Register on December 28, 1995 (60 FR 67176). Because the proposed rule
covers only the procedures for notification, not the rules governing
the nutritional support statements themselves, this regulatory impact
analysis will be restricted to the costs and benefits of the
notification procedure.
The costs of this regulation are the costs of preparing and
submitting notification to FDA regarding statements of nutritional
support. The size of these costs will depend on the amount and type of
information contained in the support statements. The greater the amount
of information, the greater will be the cost of notification. Because
the information should already have been gathered in order to prepare
the nutritional support statement itself, the additional cost incurred
for notification will be small and in many instances negligible. The
benefits of this regulation are that the information will enable FDA to
enforce the rules governing the use of nutritional support statements
for dietary supplements.
Under the Regulatory Flexibility Act, FDA must consider the effects
of the proposed rule on small businesses. For purposes of defining
industry size standards, the Small Business Administration (SBA)
classifies industries according to four-digit Standard Industrial
Classification (SIC) codes. SBA does not define ``small'' for the
dietary supplement industry, because no SIC code corresponds to the
industry--dietary supplements encompass a wide range of products. The
industry's products, for the most part, come closest to the industry
groups Food Preparations N.E.C. (SIC code 2099) and Medicinal Chemicals
and Botanical Products (SIC code 2833). The SBA size standards for
small businesses are 500 or fewer employees for food preparations and
750 or fewer employees for medicinal and botanical products. Under
either employee-based size standard, virtually all firms in the dietary
supplement industry could be classified as small, including some firms
that are among the leaders in sales revenues.
For the dietary supplement industry, FDA proposes to base size
classifications on sales revenue rather than employees. According to
Nutrition Business Journal (August 1996), the industry includes 850
manufacturing companies and more than 100 large multilevel marketing
firms that sell mostly dietary supplements. The journal divides the 850
manufacturing firms into the following three groups: 11 firms with
total revenues over $100 million, accounting for 53 percent of total
sales; 30 firms with sales revenues between $20 and $100 million,
accounting for 28 percent of total sales; and 809 firms with sales
under $20 million, accounting for 19 percent of total sales. The 809
firms in the under $20 million category have an average sales revenue
of $800,000 and will be considered small businesses by FDA. The SBA
sales revenue standard for businesses that cannot be classified into a
specific industry is $5 million; the 29 independent firms (one
manufacturer in the category is a division of conglomerate) with sales
between $20 and $100 million will therefore not be classified as small.
FDA concludes that at least 809 firms in the dietary supplement
industry should be considered small businesses.
The number of small businesses affected by this proposed rule could
include all 809 small manufacturing firms in the industry, but the
additional costs imposed by the notification provisions will be
negligible to small. FDA therefore finds that this proposed rule will
not have a significant economic effect on a substantial number of small
businesses.
V. Paperwork Reduction Act
This proposed rule contains information collections which are
subject to review by OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3507). Therefore, in accordance with 5 CFR 1320, the title,
description, and respondent description of the proposed collection of
information requirements are shown below with an estimate of the annual
collection and information burden. Included in the estimate is the time
for assembling existing data sources, gathering necessary information,
and completing and submitting the notification.
Title: Food Labeling; Section 403(r)(6) Statements; Notification
Procedure.
Description: FDA is proposing a regulation requiring manufacturers,
packers, and distributors of dietary supplements to notify FDA that
they are marketing a dietary supplement product that bears on its label
or in its labeling a statement provided for in section 403(r)(6) of the
act. Section 403(r)(6) of the act requires that the agency be notified,
with a submission about such statements, no later than 30 days after
the first marketing of the dietary supplement. Information that is
required in the submission includes: (1) The name and address of the
manufacturer, packer, or distributor of the dietary supplement product;
(2) the text of the statement that is being made; (3) the name of the
dietary ingredient or supplement that is the subject of the statement;
(4) the name of the dietary supplement (including the brand name); and
(5) a signature of a responsible individual who can certify the
accuracy of the information presented.
The agency is proposing that Sec. 101.93 establish procedures for
submitting required information. Proposed Sec. 101.93 provides details
of the procedures associated with the submission and identifies the
information that must be included in the submission in order to meet
the requirements of section 403 of the act.
Description of Respondents: Businesses or other for-profit
organizations.
[[Page 50774]]
Description Of Respondents: Businesses Or Other For-Profit Organizations
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Annual No. Annual Average
21 CFR of Frequency Burden Hours Annual Burden
Section Respondents per Response per Response Total Hours
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101.93 Variable 20 0.5-1 hr 210-420 hrs
Total 210-420 hrs
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The agency believes that there will be minimal burden on the
industry to generate information to meet the requirements of section
403 of the act in submitting information regarding section 403(r)(6) of
the act statements on labels or labeling of dietary supplements. The
agency is requesting only information that is immediately available to
the manufacturer, packer, or distributor of the dietary supplement that
bears such a statement on its label or in its labeling. The agency
estimates that listing the information required by section 403 of the
act, and presenting it in a format that will meet the proposed
procedures of Sec. 101.93, will require a burden of approximately 0.5
to 1 hour of work per submission.
The agency has submitted to OMB copies of this proposed rule for
its review of this information collection requirement. Interested
persons are requested to submit comments regarding the collection of
information requirements to FDA's Dockets Management Branch (address
above), and to the Office of Information and Regulatory Affairs, OMB,
New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC
20503. Attn: FDA Desk Officer.
VI. Effective Date
FDA is proposing to make these regulations effective 30 days after
date of publication of a final rule in the Federal Register.
VII. Comments
Interested persons may, on or before December 26, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. 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.
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: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2.New Sec. 101.93 is added to subpart F to read as follows:
Sec. 101.93 Statements under section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act.
(a) No later than 30 days after the first marketing of a dietary
supplement that bears one of the statements listed in section 403(r)(6)
of the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer,
or distributor of the dietary supplement shall notify the Office of
Special Nutritionals (HFS-450), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC
20204, that it has included such a statement on the label or in the
labeling of its product. An original and two copies of this notice
shall be submitted.
(b) The notification shall include the following:
(1) The name and address of the manufacturer, packer, or
distributor of the dietary supplement product that bears the statement;
(2) The text of the statement that is being made;
(3) The name of the dietary ingredient or supplement that is the
subject of the statement, if not provided in the text of the statement;
and
(4) The name of the dietary supplement (including brand name), if
not provided in response to the preceding subparagraph, on whose label,
or in whose labeling, the statement appears.
(c) The notice shall be signed by a responsible individual or the
person who can certify the accuracy of the information presented and
contained in the notice. The individual shall certify that the
information contained in the notice is complete and accurate, and that
the notifying firm has substantiation that the statement is truthful
and not misleading.
Dated: September 19, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-24751 Filed 9-26-96; 8:45 am]
BILLING CODE 4160-01-F
