Federal Register: September 23, 1997 (Volume 62, Number 184)
Rules and Regulations
Page 49883-49886
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr23se97-19
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
Docket No. 96N-0240
 
 
Food Labeling; Notification Procedures for Statements on Dietary
Supplements
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Final rule.
 
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to establish the notification procedures for manufacturers,
packers, or distributors of dietary supplements who are marketing
dietary supplement products that bear statements under a provision of
the Federal Food, Drug, and Cosmetic Act (the act). The agency is
adopting this procedure to ensure that notification is accomplished
efficiently. FDA instituted this proceeding to help the industry comply
with the Dietary Supplement Health and Education Act of 1994 (the
DSHEA).
 
EFFECTIVE DATE: October 23, 1997.
 
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, 202-205-4605.
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
    In the Federal Register of September 27, 1996 (61 FR 50771), FDA
published a proposed rule entitled ``Food Labeling; Dietary Supplement;
Nutritional Support Statement; Notification Procedure'' (hereinafter
referred to as ``the September 1996 proposal''). FDA issued this
proposal in response to section 6 of the DSHEA (Pub. L. 103-417). This
section of the DSHEA amended the act by adding section 403(r)(6) (21
U.S.C. 343(r)(6)). This section of the act allows for statements to be
made on the label or in the labeling of a dietary supplement that does
the following:
    (1) Claims a benefit related to a classical nutrient deficiency
disease and discloses the prevalence of such disease in the United
States,
    (2) describes the role of a nutrient or dietary ingredient intended
to affect the structure or function in humans,
    (3) characterizes the documented mechanism by which a nutrient or
dietary ingredient acts to maintain such structure or function, or
    (4) describes general well-being from consumption of a nutrient or
dietary ingredient if the statements are made in accordance with
certain requirements.
The manufacturer of the dietary supplement must:
    (1) Substantiate that the statement is truthful and not misleading;
    (2) Include, prominently displayed and in boldface type, the
following: ``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;'' and
    (3) Notify the Secretary of Health and Human Services (the
Secretary) (and by delegation FDA) no later than 30 days after the
first marketing of a dietary supplement bearing such a statement that
the statement is being made.
The statement may not claim to diagnose, mitigate, treat, cure, or
prevent a disease or class of diseases.
    In the September 1996 proposal, FDA outlined the procedure by which
manufacturers would comply with the requirements that they notify the
Secretary when they make a claim under section 403(r)(6) of the act.
FDA received eight responses to the proposal. Each response contained
one or more comments. Some comments supported the proposal generally or
supported aspects of the proposal. Other comments addressed issues
outside the scope of the proposal (e.g., guidelines differentiating
health claims from structure/function claims, health information to
consumers, types of claims that can be made, the form and amount of
substantiation FDA will require, when the disclaimer should or should
not be required, and the use of classical nutrient deficiency claims)
and will not be addressed in this document. Several comments suggested
modifications or revisions of various aspects of the proposal. A
summary of the comments and the agency's responses to the comments
follow.
 
II. Notification of ``Products'' or ``Brands''
 
    1. One comment objected to proposed Sec. 101.93(b)(4) (redesignated
as Sec. 101.93(a)(2)(iv)) requiring that the brand name of the product
be included in the notification. The comment argued that providing this
information would be unnecessarily burdensome, and that the DSHEA did
not require this information. The comment cited the fact that a dietary
supplement product, such as vitamin C 500 milligrams (mg), may be
marketed under a variety of brand names, but that the product (i.e.,
the dietary supplement) could be the same from brand ABC to brand XYZ.
The comment argued that if a notification has been made for a claim on
one brand of this dietary supplement, it should not be necessary for
every manufacturer of this type of supplement to file a notification.
    FDA is not persuaded to modify the regulation in response to this
comment. If a manufacturer makes a type of dietary supplement, such as
a vitamin C supplement, under a number of different brand names, under
Sec. 101.93(a)(2)(iv), a manufacturer may list all of the brands on
which the claim is to appear, and thus for which it is providing
notification, in a single submission. The regulation does not require
that a separate notice be submitted for each individual product or
brand.
    FDA finds that the brand name of a dietary supplement is a
necessary part of the notification that a statement of nutritional
support is being made on the label or in the labeling of the dietary
supplement. Including the brand is necessary to efficiently enforce the
act. If the notification does not include the relevant brand name, FDA
will not know which products are in compliance with the notification
requirement of section 403(r)(6) of the act. This is particularly
important because there is no requirement that a manufacturer submit to
FDA its substantiation that establishes that its claim is truthful and
not misleading (section 403(r)(6)(B) of the act). Thus, it cannot be
assumed that the first submission for a claim under section 403(r)(6)
of the act establishes that adequate substantiation exists to support
that claim for all products that may contain that substance. Each
manufacturer must have its own substantiation that any statement it
makes in the labeling of a dietary supplement product under section
403(r)(6) of the act is truthful and not misleading, and the
manufacturer must submit a notice to FDA that attests to this fact.
 
III. Signature of Person Who Can Certify that Firm has
Substantiation
 
    2. Several comments objected to proposed Sec. 101.93(c)
(redesignated as
 
Page 49884
 
Sec. 101.93(a)(3)), which requires that the notice be signed by a
responsible individual or by the person authorized to certify that the
information presented and contained in the notice is accurate. Other
comments objected to proposed Sec. 101.93(c) (redesignated as
Sec. 101.93(a)(3)) which 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. These comments argued that the DSHEA does not
require that the notification be signed by anyone, and that it does not
require that an individual certify that the information contained in
the notice is complete and accurate, or that the notifying firm have
substantiation that the statement is truthful and not misleading.
    One comment agreed that the company must have substantiation that
statements made in accordance with section 403(r)(6)(B) of the act are
truthful and not misleading. However, this comment maintained that
section 403(r)(6)(B) of the act does not require, or provide any basis
for requiring, signature and certification as part of the notification.
Another comment stated that the DSHEA's requirement that manufacturers
of dietary supplements have substantiation that such statements are
truthful and not misleading is independent of the notification
requirement.
    Several comments also disagreed with FDA's explanation that the
requirement for a signature will ensure that the statutory requirements
have been met, and that the certification is necessary to provide
assurance that a notifying firm has fully complied with the requirement
of section 403(r)(6) of the act.
    Several comments contended that neither the courts nor FDA have
established procedures, guidelines, or standards for identifying the
type and amount of evidence needed to support substantiation, and
therefore, the manufacturer who is giving notification cannot know
whether the evidence it has meets FDA's expectations and has no basis
to provide certification. One comment stated that general dictionary
definitions for ``substantiation'' are of no help because, in the
relevant legal context, the question requires detailed legal analysis,
which at best can only identify possible interpretations and does not
even begin to predict what the agency's ultimate interpretation of
``substantiation'' might be. One comment stated that ``substantiation''
under the DSHEA might be interpreted by regulated supplement companies
to mean a number of different things (e.g., near scientific certainty,
significant scientific agreement, or reasonable basis). The comment
requested that FDA acknowledge that it will not attempt to set a
substantiation standard under the DSHEA comparable to new drug or
health claims requirements, and that it will not adopt the Federal
Trade Commission's ``reasonable basis'' standard that is currently
applied in dietary supplement advertising cases.
    Several comments maintained that the requirement that manufacturers
certify that the notifying firm has substantiation that the statement
is truthful and not misleading goes beyond the authority of the act
because it imposes potential liability under the False Statements Act
(18 U.S.C. 1001) if FDA does not agree that the substantiation relied
upon by the person making the notification meets the requirements of
the act. Another comment contended that the objective of
Sec. 101.93(a)(3) is accomplished by existing Federal statutes (i.e.,
18 U.S.C. 1001) that prohibit the knowing and willful false
representation of any statement to a Government agency. Another comment
objected to the agency subjecting both a manufacturer and the person
representing the company to potential criminal sanctions for making
false statements, and this comment argued that, in doing so, FDA would
be acting in a manner that is inconsistent with the intent of Congress.
    FDA disagrees with these comments and finds that they are without
merit. First, FDA does not agree that the requirement that
manufacturers have substantiation that statements made in accordance
with section 403(r)(6) of the act are truthful and not misleading is
independent of the notification requirement. The last sentence of
section 403(r)(6) of the act states that if a manufacturer of a dietary
supplement proposes to make a ``statement described in the first
sentence of this subparagraph,'' it is to notify the Secretary (that
is, FDA). A ``statement described in the first sentence of section
403(r)(6)'' is one for which (among other things) ``the manufacturer
of the dietary supplement has substantiation that such statement is
truthful and not misleading.'' In section 403(r)(6) of the act, thus,
contrary to the assertion in the comment, there is a direct connection
between the substantiation requirement and the notification requirement
in section 403(r)(6) of the act.
    Second, FDA also finds no merit to the argument made with respect
to 18 U.S.C. 1001. Because the act on its face connects the
notification requirement to the substantiation requirement, a
manufacturer who submits a notification under section 402(r)(6) of the
act without being in possession of substantiation that the claim that
it intends to make, or is making, is truthful and not misleading is
making a false statement to the Government, in violation of 18 U.S.C.
1001. This is true without regard to whether a responsible individual
has signed a certification or not.
    FDA is requiring that the notification be signed by a responsible
individual, and that individual certify the accuracy of the information
presented in the notice, for efficient enforcement of the act under
sections 403(r)(6) and 701(a) of the act (21 U.S.C. 371(a)). The person
signing the notice, and the company on whose behalf he or she signs it,
must recognize that there are significant consequences to their action,
including potential liability under 18 U.S.C. 1001. Signing a
certification that the information in the notice is accurate will
likely cause the person who is doing so to check the information in the
notice. Such a check should minimize any problems under this section of
the act and thus will contribute to its efficient enforcement.
    Third, FDA finds no merit to the comments that claim that firms
have no basis to determine what level of substantiation is necessary.
In this regard, the act is clear on its face: The manufacturer must
have substantiation that the statement is truthful and not misleading.
If the manufacturer has any doubts as to whether it has substantiation
to meet this standard, it should not make the statement in question on
its label or in its labeling. Claims that manufacturers are unable to
interpret this standard are belied by the fact that since the passage
of the DSHEA, FDA has received literally hundreds of notices under
section 403(r)(6) of the act. FDA assumes that these notifications have
been made in good faith, and the submitters were confident that they
were in possession of adequate substantiation. Thus, FDA finds no need
for it to elaborate on the substantiation standard that appears in the
act.
 
IV. Recommended Compliance With the Proposed Rule
 
    3. One comment stated that FDA indicated in the preamble to the
September 1996 proposal that it ``recommends'' that manufacturers
follow the proposed regulation immediately. The comment requested that
FDA make clear that failure to follow ``recommendations'' that are not
final rules carries no penalty or sanction and generates no prejudice.
 
Page 49885
 
    FDA made this recommendation in the September 1996 proposal because
of the many requests from manufacturers to FDA asking for guidance on
how to make a statement of nutritional support notification. However,
the comment is correct that no penalty or sanction applies to
manufacturers who do not make their notification according to these
rules until the effective date of this regulation. It should, however,
be noted that dietary supplement manufacturers do not have the option
of not notifying FDA if they are making statements of nutritional
support on the label or in the labeling of their products. The
requirement to make the notification to FDA no later than 30 days after
the first marketing of the dietary supplement that bears such a
statement became effective with the signing into law of the DSHEA on
October 25, 1994.
 
V. 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.
 
VI. Analysis of Impacts
 
A. Benefit-Cost Analysis
 
    FDA has examined the economic implications of this final rule as
required by Executive Order 12866. 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). 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 or competition; or raising novel legal or
policy issues.
    In the economic analysis of the proposed rule, FDA stated that the
costs of this regulation consisted of the costs of preparing and
submitting notification to FDA regarding statements of nutritional
support. FDA concluded that because the information should already have
been gathered in order to prepare the nutritional support statement
itself, the additional cost incurred for notification would be small
and in many instances negligible. One comment said that the costs of
notification could be burdensome for a manufacturer producing many
different brands and products. FDA is not persuaded that this
additional burden would be large, for the same reasons as stated in the
economic analysis of the proposed rule--the notification cost will be
negligible to manufacturers who have borne the labeling costs
associated with nutritional support statements for several different
brands or products. This final rule is procedural and implements the
statutory notification requirement at minimal cost. Other requirements
associated with nutritional support statements will be dealt with by
other rules.
    FDA finds that this final rule does not constitute a significant
rule as defined by Executive Order 12866. Furthermore, it has been
determined that this rule is not a major rule for the purpose of
congressional review (Pub. L. 104-121).
 
B. Small Business Analysis
 
    FDA has examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities.
    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 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 is basing size
classifications on sales revenue rather than employees. According to
the Nutrition Business Journal, of the 850 firms manufacturing dietary
supplements, 11 firms have total revenues over $100 million, accounting
for 53 percent of total sales; 30 firms have sales revenues between $20
and $100 million, accounting for 28 percent of total sales; and 809
firms have 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. Because the total includes some firms making functional foods that
are not dietary supplements and other products, such as sports
nutrition products, that are not considered dietary supplements, the
estimate may overstate the number of small firms affected by this final
rule.
    The number of small businesses affected by this final rule could
include all small businesses in the dietary supplement industry, if
they choose to use nutritional support statements. As FDA concluded in
the benefit-cost analysis, the additional costs imposed by the
notification provisions will be negligible to small firms once the
labeling provisions have been carried out. This final rule requires
only that the manufacturer notify FDA within 30 days of marketing a
supplement that bears a nutritional support statement on its label. The
information required in the notification is either on the label itself
(e.g., the text of the statement) or readily available (e.g., the name
of the ingredient that is the subject of the statement).
    FDA finds that this final rule will not have a significant economic
impact on a substantial number of small entities. Accordingly, under
the Regulatory Flexibility Act (5 U.S.C. 605(b)), the agency certifies
that this final rule will not have a significant impact on a
substantial number of small entities.
 
VII. The Paperwork Reduction Act of 1995
 
    This final rule contains information collection requirements 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 below with an estimate of the annual
reporting and recordkeeping 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.
    Title: Food Labeling; Notification Procedures for Statements on
Dietary Supplements.
    Description: FDA is, by regulation, requiring manufacturers,
packers, and distributors of dietary supplements to
 
Page 49886
 
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.
    In Sec. 101.93, the agency is establishing procedures for
submitting required information. Section 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.
 
                                   Table 1.--Estimated Annual Reporting Burden
 
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--------------------------------
                             No. of       Annual Frequency    Total Annual
  Hours per
    21 CFR Section         Respondents      per Response        Responses
  Response         Total Hours
--------------------------------------------------------------------------------
--------------------------------
101.93                        420                 1               420
      0.5-1       210-420
--------------------------------------------------------------------------------
--------------------------------
 
(Through inadvertent error, the agency misreported the number of
respondents and the annual frequency per response and omitted the total
annual response in the proposal. Hours per response and total hours
were reported correctly. In this final rule, FDA is correcting the
inadvertent errors that it made in the proposal).
    Individuals and organizations may submit comments on these burden
estimates or on any other aspect of these information collection
provisions, including suggestions for reducing the burden, and should
direct them to the Office of Special Nutritionals (HFS-450), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C
St. SW., Washington, DC 20204.
    The information collection provisions in this final rule have been
approved under OMB control number 0910-0331. This approval expires on
October 31, 1999. 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.
 
List of Subjects in 21 CFR Part 101
 
    Food labeling, Nutrition, Reporting and recordkeeping requirements.
 
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. Section 101.93 is added to subpart F to read as follows:
 
Sec. 101.93  Notification procedures for certain types of statements on
dietary supplements.
 
    (a)(1) 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)
or 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
notification shall be submitted.
    (2) The notification shall include the following:
    (i) The name and address of the manufacturer, packer, or
distributor of the dietary supplement that bears the statement;
    (ii) The text of the statement that is being made;
    (iii) 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
    (iv) The name of the dietary supplement (including brand name), if
not provided in response to paragraph (a)(2)(iii) on whose label, or in
whose labeling, the statement appears.
    (3) 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.
    (b) through (e) Reserved
 
    Dated: August 20, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
FR Doc. 97-24738 Filed 9-22-97; 8:45 am
BILLING CODE 4160-01-F