关键词：烟草制品；美国FDA；香烟；医药
摘 要：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.