Regulation of Tobacco Products
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.
The Department of Homeland Security, National Protection and Programs Directorate, Office of Infrastructure Protection, Infrastructure Security Compliance Division (ISCD) will be submitting the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is a new information collection. The purpose of this notice is to solicit comments during a 60-day public comment period prior to the submission of this collection to OMB. The submission describes the nature of the information collection, the categories of respondents, the estimated burden and cost.
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