[Federal Register Volume 74, Number 125 (Wednesday, July 1, 2009)]
[Notices]
[Pages 31457-31458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0294]


Regulation of Tobacco Products; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.

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SUMMARY:  The Food and Drug Administration (FDA) is establishing a 
public docket to obtain information on the implementation of the Family 
Smoking Prevention and Tobacco Control Act. FDA is establishing this 
docket in order to provide an opportunity for all interested parties to 
provide information and share views on the implementation of the new 
law.

DATES: Submit written or electronic comments by September 29, 2009.

ADDRESSES: Submit electronic comments 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:  Erik Mettler, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., WO1, rm. 4300, 
Silver Spring, MD 20993, 301-796-4830, FAX: 301-847-3541, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Tobacco products are responsible for more than 430,000 deaths each 
year. The Centers for Disease Control and Prevention (CDC) report an 
estimated 60

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million adults smoke cigarettes in the United States, even though this 
behavior will result in death or disability for half of all regular 
users. Paralleling this enormous health burden is the economic burden 
of tobacco use, which is estimated to total $193 billion annually in 
medical expenditures and lost productivity. Curbing the significant 
adverse consequences of tobacco use is one of the most important public 
health goals of our time.
    On June 22, 2009, the President signed H.R. 1256, the Family 
Smoking Prevention and Tobacco Control Act, into law. The Family 
Smoking Prevention and Tobacco Control Act grants 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. The Family Smoking Prevention and Tobacco 
Control Act authorizes FDA to require disclosure of tobacco product 
ingredients and additives; regulate ``modified risk'' tobacco products; 
create standards for tobacco products, including standards for the 
reduction or elimination of certain constituents; restrict sales, 
distribution, advertising, and promotion of tobacco products; and 
require stronger health warnings on packaging. The Family Smoking 
Prevention and Tobacco Control Act also requires FDA to issue its 1996 
final regulation restricting the sale and distribution of nicotine-
containing cigarettes and smokeless tobacco products. The rule contains 
provisions designed to limit young people's access to tobacco products, 
as well as restrictions on marketing to curb the appeal of these 
products to minors.
    We are requesting comments that will inform strategies to protect 
the public health as we implement this new authority. A copy of the 
Family Smoking Prevention and Tobacco Control Act is available on the 
agency's Web site at http://www.fda.gov/tobacco.

II. Request for Comments and Information

    We are particularly interested in comments on the approaches and 
actions the agency should consider initially to increase the likelihood 
of reducing the incidence and prevalence of tobacco product use and 
protecting the public health. Although the agency will not respond to 
specific suggestions, we will consider them in establishing the new 
Center for Tobacco Products and in implementing the Family Smoking 
Prevention and Tobacco Control Act. In the future, we intend to solicit 
public input on specific issues. Please organize any comments you have 
in response to this notice using these general categories:

    Federal, State, and local government collaboration;
    New product submission and approval;
    Product ingredient disclosure;
    Prevention;
    Tobacco use by specific groups including minors, women, and racial 
and ethnic minority populations;
    Tobacco addiction;
    Smoking cessation;
    Data collection;
    Products with ``reduced harm/risk'' claims;
    Enforcement;
    Research and testing;
    Advertising and marketing of tobacco products;
    Label statements and warnings (including graphic warnings);
    Tobacco product standards (including flavors, ingredients, etc.);
    Sale and distribution of tobacco products;
    Manufacturing restrictions and facilities controls; and
    Other.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: June 25, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-15549 Filed 6-30-09; 8:45 am]
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