Document ID: FDA-2010-D-0281-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: "Harmful and Potentially Harmful Constituents in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act"
Posted Date: 2010-06-10T04:00Z

[Federal Register: June 10, 2010 (Volume 75, Number 111)]
[Notices]               
[Page 32952-32953]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn10-54]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0281]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; ```Harmful and Potentially Harmful Constituents' in Tobacco 
Products as Used in Section 904(e) of the Federal Food, Drug, and 
Cosmetic Act''; 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availability of a draft guidance for industry and FDA staff entitled 
```Harmful and Potentially Harmful Constituents' in Tobacco Products as 
Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' 
This draft guidance provides written guidance to industry and FDA staff 
on certain provisions of the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act).

DATES:  Although you can comment on any guidance at any time (see 21 
CFR

[[Page 32953]]

10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 8, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Center for Tobacco Products, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send 
one self-addressed adhesive label to assist that office in processing 
your requests or include a fax number to which the draft guidance 
document may be sent. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments on the draft guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Carol Drew, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 877-287-1373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ```Harmful and Potentially Harmful Constituents' 
in Tobacco Products as Used in Section 904(e) of the Federal Food, 
Drug, and Cosmetic Act.'' This draft guidance, when finalized, will 
discuss the meaning of the term ``harmful and potentially harmful 
constituent'' for use in implementing section 904(e) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387d(e)) as amended 
by the Tobacco Control Act.
    On June 22, 2009, the President signed the Tobacco Control Act 
(Public Law 111-310) into law. The Tobacco Control Act amended the act 
(21 U.S.C. 301 et seq.) by, among other things, adding a new chapter 
granting FDA important new authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect the public 
health generally and to reduce tobacco use by minors. Section 904(e) of 
the act, as added by the Tobacco Control Act, requires FDA to 
establish, and periodically revise as appropriate, ``a list of harmful 
and potentially harmful constituents, including smoke constituents, to 
health in each tobacco product by brand and by quantity in each brand 
and subbrand.'' The draft guidance discusses the meaning of the term 
``harmful and potentially harmful constituent'' in the context of 
implementing the listing requirements of section 904(e) of the act.

II. Significance of Guidance

    This draft guidance is being issued as a level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent the 
agency's current thinking on certain provisions of the Tobacco Control 
Act. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

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 document at 
either http://www.regulations.gov or http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14046 Filed 6-8-10; 4:15 pm]
BILLING CODE 4160-01-S