[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Rules and Regulations]
[Pages 49883-49886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24738]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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                                  
----------------------------------------------------------------------------------------------------------------
                             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