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FDA Oversight of Tobacco Manufacturing Establishments


Smoking is the leading cause of preventable disease and death in the United States. In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, authorizing FDA to begin regulating tobacco products in the United States. It granted FDA comprehensive authority over domestic tobacco products and established the Center for Tobacco Products at FDA to oversee the manufacturing, distribution, and marketing of these products. Our work focuses on FDA's efforts to regulate and oversee domestic tobacco manufacturing establishments in the early years of implementing the Tobacco Control Act.


This data brief presents descriptive information about tobacco establishment registration and product listing, as well as FDA's inspections and enforcement actions related to tobacco manufacturing establishments, covering 2010 to 2015. We based this data brief on four data sources: (1) FDA Unified Registration and Listing System data from calendar years 2010 through 2015; (2) data on inspections of tobacco establishments from fiscal years 2011 through 2015; (3) enforcement action data from inspections and surveillance of tobacco marketing activity from fiscal years 2011 through 2015; (4) interviews with FDA officials.


In the first 6 years FDA has been authorized to regulate tobacco, 171 tobacco establishments registered. Tobacco establishments started registering with FDA slowly, and FDA acknowledged that the tobacco industry may have needed additional time to provide submissions. Of the consumer products listed by registrants, cigarettes account for two-thirds followed by moist snuff and roll-your-own products. FDA largely met its requirement to inspect tobacco manufacturing establishments biennially, and it concluded that no enforcement action was needed after those inspections. In addition to inspections, FDA conducts routine surveillance of marking activities for tobacco products and issued 14 warning letters to manufacturers for violations of advertising and labeling requirements.


Since the passage of the Tobacco Control Act, FDA has taken important steps in its oversight of tobacco products by implementing requirements for registration, listing, and inspection. Given establishments' slow start in registration and missed annual renewals, it is important for FDA to ensure that all registrants update annually and provide full product list information. Complete and accurate information on registrants will aid FDA in fulfilling its oversight role.