Understanding the Tobacco Control Act: Efforts by the US Food and Drug Administration to Make Tobacco-Related Morbidity and Mortality Part of the USA’s Past, Not Its Future


The following are 10 points to remember about the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act):

1. Comprehensive tobacco-prevention programs, when implemented, are associated with significant reductions in smoking among both youth and adult smokers, along with reductions in smoking-related mortality. Such interventions include increasing the price of tobacco products, smoke-free policies, counter-marketing campaigns, advertising restrictions, increasing access to treatment for tobacco use through insurance coverage and telephone help lines, and comprehensive approaches to minimize access to tobacco products for children and adolescents. Although not expensive interventions per se, implementation of effective policy interventions can be challenging. With the passage of the Tobacco Control Act in June 2009, important new regulatory approaches were added to the US tobacco prevention and control arsenal.

2. The Tobacco Control Act gave the Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products to protect the public’s health. All operations and expenses of the FDA’s Center for Tobacco Products, which implements the law, are paid for by user fees imposed on particular tobacco manufacturers and importers on the basis of their market share in the USA.

3. An important provision of the Tobacco Control Act is that it directs the FDA to consider the effects on both users and nonusers of tobacco products when developing tobacco regulations (including effects on initiation and cessation). This standard differs substantially from the more familiar FDA standard of safe and effective, which is used for drugs, devices, and biological agents.

4. The FDA’s authorities and activities cover six major areas: regulation of tobacco products; regulation of the advertising, marketing, and promotion of tobacco products; regulation of the distribution and sales of tobacco products; enforcement of tobacco regulations; regulatory science research; and public education about the harms of tobacco products and to support the FDA’s regulatory actions. The FDA’s authority over tobacco products is quite broad, but has several limitations. For example, the FDA cannot ban specific classes of tobacco products, cannot require the total elimination of nicotine from tobacco products, cannot require a prescription to purchase tobacco products, cannot ban tobacco sales in any particular type of sales outlet, and cannot directly regulate tobacco farming.

5. The Tobacco Control Act gives the FDA authority over tobacco products—defined, in part, as products made or derived from tobacco and intended for human consumption including cigarettes, smokeless tobacco products, and roll-your-own tobacco.

6. The FDA has various authorities that directly regulate the manufacture of tobacco products and product characteristics. Tobacco companies must register with the FDA and provide a list of all products, including a list of ingredients in their products. Notification of any changes in those ingredients is required as well. An example of a tobacco product standard was the ban on characterizing flavors (other than menthol) in cigarettes, a product standard designed to reduce the appeal of cigarettes to children and adolescents.

7. The second set of authorities conferred to the FDA is the ability to regulate the advertising, marketing, and promotion of tobacco products. Many of the marketing restrictions are designed specifically to decrease the marketing and appeal of tobacco products to children and adolescents. Examples of marketing restrictions include prohibition of the use of tobacco brand names in sponsorship of sporting, entertainment, and cultural events, and prohibition of the use of tobacco brand names or logos on clothing, hats, and other nontobacco items.

8. The FDA has a large program devoted to ensuring adherence to the Tobacco Control Act and all tobacco regulations promulgated by the FDA. Legislation also gives the FDA a broad set of enforcement actions that it can take for violations of the law, including warning letters, civil money penalties (fines), no-tobacco sales orders, seizure of products, injunctions, and criminal penalties. The Tobacco Control Act included various provisions to restrict the distribution and sale of tobacco products to those under the age of 18 years.

9. The FDA also implements science and research programs designed to better understand the tobacco products, people’s exposure to harmful and potentially harmful constituents, the health effects of changes in these products, and the effect of tobacco product marketing and distribution practices. This research will inform regulatory decisions made by the FDA that help improve public health. Activities to date include funding research through the National Institutes of Health (the Population Assessment of Tobacco and Health [PATH], a large longitudinal study of tobacco users, funded through the National Institute on Drug Abuse). The FDA is also funding centers of excellence and a portfolio of investigator-initiated research, and it has enhanced several existing national surveys (National Youth Tobacco Survey, National Health Interview Survey, National Health and Nutrition Examination Survey, and National Adult Tobacco Survey) to include questions related to the FDA’s regulatory actions and activities or to expand analyses to meet the FDA’s needs.

10. An important component of the Tobacco Control Act is public education. This includes required health warnings on cigarettes and smokeless tobacco products. The FDA will also undertake media campaigns to educate the general public, particularly young people, about harms from tobacco use. Moreover, the FDA has been educating the retail community about how to comply with regulations including minors’ access to tobacco products.


This review provides an excellent summary of the FDA’s Tobacco Control Act, including details of the six major areas for tobacco regulations, with examples to highlight these areas.

Clinical Topics: Dyslipidemia, Prevention, Nonstatins, Smoking

Keywords: Seizures, Nicotine, Insurance Coverage, Telephone, Marketing, Smoke-Free Policy, Smoking, Public Health, Imidazoles, United States Food and Drug Administration, Niacin, Tobacco Use Disorder, National Institute on Drug Abuse (U.S.), Nutrition Surveys, Menthol

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