FDA oversight of tobacco manufacturing establishments
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Data brief (United States Department of Health and Human Services, Office of Inspector General)
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Government Regulation Tobacco Industry Tobacco Products Advertising as Topic Product Labeling Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- Smoking is the leading cause of preventable disease and death in the United States, responsible for more than 480,000 deaths annually. Until 2009, tobacco products were largely exempt from Federal oversight. That year, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which authorized the Food and Drug Administration (FDA) to begin regulating tobacco products in the United States. The Tobacco Control Act granted FDA comprehensive authority over domestic tobacco products and established the Center for Tobacco Products (CTP) at FDA to oversee the manufacturing, distribution, and marketing of these products. User fees from tobacco manufacturers and importers are the sole source of funding for FDA's regulation of tobacco products. CTP's goal is to reduce harm from all regulated tobacco products by preventing people from starting to use tobacco products, encouraging tobacco users to quit, and reducing the adverse health impacts for those who continue to use tobacco products. Toward this goal, CTP and FDA's Office of Regulatory Affairs (ORA) collaborate in the oversight of tobacco manufacturers. FDA has a wide range of tools to meet its goals, including the ability to set policy and issue guidance; to regulate the production and distribution of tobacco products; to conduct research; and to educate the public on the effects of regulated tobacco products. On August 8, 2016, FDA's jurisdiction expanded to include additional tobacco products such as electronic nicotine delivery systems (e.g., e-cigarettes and vape pens), cigars, hookah tobacco, and nicotine gels. 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 (see Exhibit 1). This data brief presents descriptive information about how tobacco establishments register and provide product listings, as well as FDA's inspections and enforcement actions related to tobacco manufacturing establishments, spanning 2010 to 2015. During this timeframe, FDA required only manufacturers of cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco to register and list their products.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (15 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101737904 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101737904