[Federal Register Volume 76, Number 128 (Tuesday, July 5, 2011)]
[Notices]
[Pages 39111-39112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0376]


Draft Guidance for Industry; Dietary Supplements: New Dietary 
Ingredient Notifications and Related Issues; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Dietary 
Supplements: New Dietary Ingredient Notifications and Related Issues.'' 
The draft guidance, when finalized, will assist industry in deciding 
when a premarket safety notification for a dietary supplement 
containing a new dietary ingredient (NDI) is necessary and in preparing 
premarket safety notifications (also referred to as ``NDI 
notifications'').

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 3, 2011.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements, 
Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Corey Hilmas, Center for Food Safety 
and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2375.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Dietary Supplements: New Dietary Ingredient Notifications 
and Related Issues.'' This draft guidance is being issued consistent 
with FDA's good guidance practices regulation (21 CFR 10.115(g)(2)).
    This draft guidance is intended to assist industry in deciding when 
a premarket safety notification for a dietary supplement containing an 
NDI is necessary and in preparing NDI notifications. The draft guidance 
discusses in question and answer format FDA's views on what qualifies 
as an NDI, when an NDI notification is required, the procedures for 
submitting an NDI notification, the types of data and information that 
manufacturers and distributors should consider when they evaluate the 
safety of a dietary supplement containing an NDI, and what should be 
included in an NDI notification. In addition, the draft guidance 
contains questions and answers about parts of the dietary supplement 
definition that can affect whether a particular substance may be 
marketed as a dietary ingredient in a dietary supplement.
    On October 25, 1994, the Dietary Supplement Health and Education 
Act of 1994 (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA 
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding, 
among other provisions, (1) Section 201(ff) (21 U.S.C. 321(ff)), which 
defines the term ``dietary supplement'' and (2) section 413 (21 U.S.C. 
350b), which defines the term ``new dietary ingredient'' and requires 
the manufacturer or distributor of an NDI, or of the dietary supplement 
that contains the NDI, to submit a premarket notification to FDA at 
least 75 days before introducing the supplement into interstate 
commerce or delivering it for introduction into interstate commerce, 
unless the NDI and any other dietary ingredients in the dietary 
supplement ``have been present in the food supply as an article used 
for food in a form in which the food has not been chemically altered'' 
(section 413(a)(1)). The notification must contain the information, 
including any citation to published articles, which is the basis on 
which the manufacturer or distributor of the NDI or dietary supplement 
has concluded that the dietary supplement containing the NDI will 
reasonably be

[[Page 39112]]

expected to be safe. If the required premarket notification is not 
submitted to FDA, section 413(a) of the FD&C Act provides that the 
dietary supplement containing the NDI is deemed to be adulterated under 
section 402(f) of the FD&C Act (21 U.S.C. 342(f)). Even if the 
notification is submitted as required, the dietary supplement 
containing the NDI is adulterated under section 402(f) unless there is 
a history of use or other evidence of safety establishing that the NDI, 
when used under the conditions recommended or suggested in the labeling 
of the dietary supplement, will reasonably be expected to be safe.
    To assist industry in complying with DSHEA, FDA issued a 
regulation, Sec.  190.6 (21 CFR 190.6), to implement the FD&C Act's 
premarket notification requirements for dietary supplements that 
contain an NDI (62 FR 49886, September 23, 1997). The NDI regulation 
specifies the information the manufacturer or distributor must include 
in its premarket NDI notification (Sec.  190.6(b)) and establishes the 
administrative procedures for these notifications. FDA's goal in 
issuing the 1997 regulation was to ensure that NDI notifications 
contained the information that would enable FDA to evaluate whether a 
dietary supplement containing an NDI is reasonably expected to be safe.
    On January 4, 2011, the President signed into law the FDA Food 
Safety Modernization Act (FSMA) (Pub. L. 111-353). Section 113(b) of 
FSMA requires FDA to publish, not later than 180 days after the date of 
enactment, guidance that clarifies when a dietary supplement ingredient 
is an NDI, when the manufacturer or distributor of a dietary ingredient 
or dietary supplement should submit an NDI notification to FDA under 
section 413(a)(2) of the FD&C Act, the evidence needed to document the 
safety of an NDI, and appropriate methods for establishing the identity 
of an NDI. This draft guidance is being published to comply with 
section 113(b) of FSMA.
    The draft guidance, when finalized, will represent the Agency's 
current thinking on NDIs and dietary supplements that contain NDIs. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternate approach may be used if 
such approach satisfies the requirements of the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. This draft guidance contains proposed collections 
of information. ``Collection of information'' is defined in 44 U.S.C. 
3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a 
60-day notice in the Federal Register soliciting public comment on each 
proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, FDA will publish a 
60-day notice on the proposed collections of information in this draft 
guidance in a future issue of the Federal Register.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR Part 111 have been approved under OMB control 
number 0901-0606, and the collections of information in Sec.  190.6 
have been approved under OMB control number 0910-0330.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Always access an FDA 
guidance document by using FDA's Web site listed previously to find the 
most current version of the guidance.

    Dated: June 29, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16711 Filed 7-1-11; 8:45 am]
BILLING CODE 4160-01-P