	Introduction

On April 2, 2009, the House passed the Family Smoking Prevention and Tobacco Control Act ( H.R. 1256 ; H.Rept. 111-58 , part 1 and 2) by a vote of 298-112. H.R. 1256 , introduced by Representative Waxman (D-CA), would give the Food and Drug Administration (FDA) broad new statutory authority under the Federal Food, Drug, and Cosmetic Act (FFDCA) to regulate the manufacture, distribution, advertising, promotion, sale, and use of cigarettes and smokeless tobacco (e.g., snuff and chewing tobacco). S. 982 , which is almost identical to the House-passed measure, was approved with amendments by the Committee on Health, Education, Labor and Pensions on May 20 and now awaits Senate floor action. The Family Smoking Prevention and Tobacco Control Act would create a new FFDCA Chapter IX solely for the purpose of regulating tobacco products. Among its many provisions, the legislation would:
require all tobacco product manufacturers to register with the FDA and provide the agency with a detailed product list; mandate biennial inspection of all registered establishments; replace the existing health warning labels with more explicit health warnings in bold type occupying at least 30% of the front and back of the product package; require the manufacturer of a new tobacco product to submit a marketing application for FDA approval before entering the market, unless the new product is determined to be substantially equivalent to a tobacco product already on the market or it represents a minor modification of an existing product; require manufacturers seeking FDA approval, in order to market a product with a reduced-risk or reduced-exposure claim (including the use of descriptors such as "light," "mild," and "low"), to provide scientific evidence substantiating that claim and agree to conduct postmarket surveillance; give FDA the authority to regulate the sale, distribution, advertising and promotion of tobacco products in order to protect public health; require FDA to regulate Internet tobacco sales; authorize FDA to establish tobacco product standards requiring changes to the design and characteristics of tobacco products in order to protect public health (e.g., reducing nicotine yields and eliminating other harmful constituents); require FDA to establish good manufacturing practices for tobacco product manufacturers; require FDA to develop new regulations for the testing, reporting, and public disclosure of tobacco product ingredients and smoke constituents; preserve the authority of states and localities to take additional measures to restrict the distribution, advertising, promotion, sale, access to, and use of tobacco products; instruct FDA to issue new recordkeeping requirements to help counter the illicit trade of tobacco products; and assess user fees on manufacturers to pay for the cost of FDA tobacco regulation. 1256 / S. 982 would require FDA to reissue its 1996 tobacco rule, which the U.S. Supreme Court struck down. The language drew extensively on the FFDCA's existing drug and device provisions, but with modifications. Under the new language, FDA would have to demonstrate that any proposed tobacco regulation was appropriate for the protection of public health. Table 1 provides a detailed summary of all the provisions in H.R. A companion report, CRS Report R40196, FDA Tobacco Regulation: History of the 1996 Rule and Related Legislative Activity, 1998-2008 , by [author name scrubbed] and [author name scrubbed], provides some analysis of the 1996 FDA tobacco rule and the industry's successful legal challenge that overturned it. 1256 / S. 982 . Tobacco Product Regulation under H.R. 1256/S. That would place new restrictions on youth access to tobacco products and on tobacco advertising, beyond those included in the MSA (see Appendix ). For example, all remaining brand-name sponsorship of sporting and other entertainment events would come to an end, and advertising in publications with a significant youth readership would be limited to black-on-white text. H.R. 1256 / S. 982 also would give FDA the authority to develop regulations restricting the sale, distribution, advertising, and promotion of tobacco products, to the full extent permitted by the First Amendment. That standard would require FDA to demonstrate that the proposal was appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole, including users and nonusers of tobacco products. In addition, FDA would have the authority to require changes in the design and characteristics of current and future tobacco products, such as the reduction or elimination of harmful ingredients and additives. Under the legislation, manufacturers would have to obtain FDA approval in order to market a new product. 1256 / S. 982 would prohibit the use of descriptors such as "light" and "mild." H.R. H.R. H.R. H.R.
The 111th Congress is considering legislation that would give the Food and Drug Administration (FDA) broad new statutory authority to regulate the manufacture and marketing of cigarettes and smokeless tobacco products under the Federal Food, Drug, and Cosmetic Act (FFDCA). On April 2, 2009, the House passed the Family Smoking Prevention and Tobacco Control Act (H.R. 1256; H.Rept. 111-58, part 1 and 2). On May 20, the Senate Committee on Health, Education, Labor and Pensions approved an almost identical bill (S. 982). Similar legislation was first introduced in the 108th Congress and passed the Senate in 2004 and the House in 2008 with strong bipartisan support. The Administration strongly supports H.R. 1256/S. 982.
H.R. 1256/S. 982 would create a new FFDCA Chapter IX solely for the regulation of tobacco products. While the bill's language draws extensively on the FFDCA's existing provisions for regulating pharmaceutical products and medical devices, tobacco products would be regulated under new legal authority based on a public health standard rather than the safety and effectiveness standard by which the FDA regulates drugs and devices. Under the new language, FDA would have to demonstrate that any proposed tobacco product regulation was appropriate for the protection of public health, taking into consideration the risks and benefits to the population as a whole.
Among its many provisions, H.R. 1256/S. 982 would require all tobacco product manufacturers to register with FDA. All registered facilities would be inspected every two years. H.R. 1256/S. 982 would require the FDA to reissue its 1996 tobacco rule, which was struck down by the U.S. Supreme Court in 2000. The rule would place new restrictions on youth access to tobacco products, end all remaining brand-name sponsorship of sporting and other entertainment events, and limit tobacco advertising in publications with a significant youth readership to black-on-white text only. In addition, the existing health warnings on tobacco product packaging and advertising would be replaced with more explicit and conspicuous health warnings. H.R. 1256/S. 982 would give FDA the authority to develop regulations restricting the sale, distribution, advertising, and promotion of tobacco products, to the extent permitted by the First Amendment. The agency also would have the authority to require changes in the design and characteristics of current and future tobacco products, such as the reduction or elimination of harmful ingredients and additives. FDA would not have the authority to reduce nicotine yields to zero or ban tobacco products.
Under H.R. 1256/S. 982, manufacturers would have to obtain FDA approval in order to market a new tobacco product, unless FDA determined that it was substantially equivalent to a product already on the market, or a minor modification of an existing product. The bill would prohibit the use of descriptors such as "light" and "mild" and require manufacturers seeking FDA approval to market a product for which they intend to make a reduced-risk claim to provide evidence substantiating that claim. H.R. 1256/S. 982 would require FDA to develop new requirements for testing and reporting tobacco product ingredients and smoke constituents, and to issue new recordkeeping requirements to help counter the illicit trade of tobacco products. FDA's new regulatory activities would be paid for by user fees assessed on the manufacturers. This report provides a detailed summary of the provisions in H.R. 1256/S. 982 and discusses some of the public health and legal issues it raises. A companion report, CRS Report R40196, FDA Tobacco Regulation: History of the 1996 Rule and Related Legislative Activity, 1998-2008, by [author name scrubbed] and [author name scrubbed], provides more background on the FDA rule and past efforts to give the agency the authority to regulate tobacco products.