[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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
------------------------------------------------------------------------
             Annual No.      Annual        Average                      
  21 CFR         of         Frequency   Burden Hours     Annual Burden  
  Section    Respondents  per Response  per Response      Total Hours   
------------------------------------------------------------------------
101.93         Variable            20      0.5-1 hr         210-420 hrs 
Total                                                       210-420 hrs 
------------------------------------------------------------------------

    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