[Federal Register Volume 75, Number 111 (Thursday, June 10, 2010)]
[Notices]
[Pages 32952-32953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14046]
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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Draft Guidance for Industry and Food and Drug Administration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availability of a draft guidance for industry and FDA staff entitled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This draft guidance provides written guidance to industry and FDA staff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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 8, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Center for Tobacco Products, Food and Drug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your requests or include a fax number to which the draft guidance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electronic access to the draft guidance document.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written comments on the draft guidance to the Division of Dockets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FDA is announcing the availability of a draft guidance for industry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]
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