In 2009, the Family Smoking Prevention and Tobacco Control Act granted FDA, an agency within the Department of Health and Human Services (HHS), authority to regulate tobacco products such as cigarettes. The act requires that tobacco manufacturers submit information to be reviewed by FDA in order to market new tobacco products and established tobacco user fees to fund FDA's tobacco-related activities. The act represents the first time that FDA has had the authority to regulate tobacco products. Manufacturers have raised concerns about the progress of CTP, the FDA center established by the act to implement its provisions. GAO was asked to examine CTP's review of new tobacco product submissions, responses to meeting requests, and use of funds. This report examines (1) the status of CTP's reviews of new tobacco product submissions; (2) how CTP responded to manufacturers' and other entities' meeting requests, and the length of time CTP took to hold the meetings; and (3) the extent to which FDA has spent its tobacco user fee funds. GAO analyzed data regarding submissions received by FDA as of January 7, 2013; reviewed data on meeting requests, spending plans, and amounts obligated; and interviewed CTP and tobacco industry officials.

关键词：烟草制品；美国FDA；香烟；医药

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Tobacco is a highly addictive substance with well-documented health risks. Although great progress has been made in reducing and preventing tobacco use in the United States, the rates of cigarette use and dependence remain high in certain subpopulations, including those with substance use disorders. For example, 2011 data show that an estimated 22 percent of U.S. adults are current cigarette smokers, whereas smoking prevalence rates for those in substance abuse treatment exceeded 70 percent between 2005 and 2009. The negative health effects of tobacco use among alcohol- and drug dependent individuals can be substantial. Individuals in substance abuse treatment smoke more heavily than the general population, and consequently are more likely to suffer from tobacco-related morbidity, including cardiopulmonary problems, emphysema, and cancer, than are smokers in the general population. One study of substance abuse treatment clients found that tobacco use caused more deaths than the alcohol or drug use that brought them to treatment; specifically, the rate of death among tobacco users was nearly 1.5 times the rate of death from other addiction-related causes.

关键词：吸烟;卫生服务;癌;心肺疾病,肺气肿;健康影响;发病率;人口;预防医学;烟草;治疗项目;烟草戒烟

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