E9-15549. Regulation of Tobacco Products; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

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: [phone], [e-mail].

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 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.