Document ID: FDA-2010-D-0281-0014
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Availability: Harmful and Potentially Harmful Constituents in Tobacco Products, etc.
Posted Date: 2011-01-31T05:00Z

[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5387-5388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1990]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 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 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: Submit either electronic or written comments on this guidance at 
any time.

ADDRESSES: Submit written requests for single copies of this 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 guidance document may be sent. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the 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. Identify comments with the docket number 
found in brackets in the heading of this document.

[[Page 5388]]

FOR FURTHER INFORMATION CONTACT: Carol Drew, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 301-796-3505.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 10, 2010 (75 FR 32952), FDA 
announced the availability of a draft guidance entitled ```Harmful and 
Potentially Harmful Constituents' in Tobacco Products as Used in 
Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' The 
Agency considered received comments as it finalized this guidance. The 
guidance document 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 Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 387d(e)).
    On June 22, 2009, the President signed the Tobacco Control Act 
(Pub. L. 111-310) into law. The Tobacco Control Act amended the FD&C 
Act 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 FD&C 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 
guidance discusses the meaning of the term ``harmful and potentially 
harmful constituent'' in the context of implementing the listing 
requirements of section 904(e).

II. Significance of Guidance

    This guidance is being issued as a level 1 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The guidance 
represents the Agency's current thinking on the meaning of the term 
``harmful and potentially harmful constituents'' in the context of 
section 904(e) of the FD&C 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:[sol][sol]www.regulations.gov or 
http:[sol][sol]www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: January 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1990 Filed 1-28-11; 8:45 am]
BILLING CODE 4160-01-P