FDA Regulation of Tobacco Products: A Powerful Tool for Tobacco Control

The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 opened the most far-reaching public-health intervention in recent decades. For the first time, the Food and Drug Administration (FDA) was fully authorized to use its regulatory powers against the leading preventable cause of death in the United States: tobacco. However, FDA regulation is not only a powerful new tool for reducing tobacco-related disease and death, but also brings new opportunities and challenges to public-health practitioners at all levels of government, academia, research institutions and advocacy agencies. The human and economic costs of tobacco use in the United States cannot be overemphasized. About 443,000 Americans die each year from smoking-related diseases, and another 8.6 million suffer from at least one serious disease as a result of smoking. What is more alarming is that 20% to 25% of high school students in the United States now use tobacco products, and about 4,000 adolescents under the age of 18 start smoking every day, with another 1,000 adolescents under 18 becoming long-term smokers. Since nine out of ten adult smokers start smoking as adolescents, these adolescents — to borrow the words of some tobacco-industry officials in the past — will become the “substitutes” for adult smokers after they quit smoking or die. There is no doubt that the Federal Government must take positive measures to respond to the avoidable loss of nearly 500,000 people a year from smoking. Prior to the FDA's regulation of tobacco products, the major components of the United States tobacco control strategy included public education, prevention programs, treatment services, epidemiology and monitoring, tax/price incentives, and air quality improvement measures. The combined effect of these measures was remarkable: between 1965 and 2001, the smoking rate among American adults fell from about 42% to nearly 23%. However, the downward trend in smoking rates over the past five years has stagnated. In 2009, the smoking rate among adults in the United States was 20.6%. The situation is similar in the adolescent population, where the smoking rate among students in grades 9 to 12 remains at 20%. Moreover, as state and local government measures (such as taxing cigarettes) have raised tobacco prices, the scope of banning smoking in public places has become wider, and the development and use of smoke-free and soluble tobacco products has increased accordingly. Now, with the FDA incorporating tobacco product regulation into the national tobacco control strategy, the public-health sector has an opportunity to relaunch and expand tobacco control efforts. Unlike other partners in tobacco control, the FDA has the power to regulate tobacco products, including the advertising, marketing, distribution and production of tobacco products. Regulation of the production of tobacco products includes setting product standards for the content of nicotine or other harmful ingredients, specifying the requirements for the sale of low-risk products, and setting good manufacturing practices for tobacco products. The American public has seen tobacco product regulation come into play in practice. Since President Barack Obama signed the Tobacco Control Law on June 22, 2009, the actions taken by the FDA to protect public health include: initiating and enforcing a ban on fruit- or candy-flavored cigarettes; prohibiting the use of misleading words such as “light,” “low” and “mild” on product labels; and enacting a wide range of laws restricting the supply and marketing of cigarettes and smokeless tobacco products to young people. These new laws aimed at reducing tobacco use by young people include: setting the minimum age for purchasing tobacco products at 18 years of age and enforcing it; prohibiting the distribution of free cigarette samples; terminating brand sponsorship by tobacco companies for sports events and concerts; and prohibiting all vending machines to which children may be exposed from selling cigarettes. In November 2010, the FDA proposed the use of new, specific graphic health warnings on cigarette packaging and advertising, and will decide how to formulate standards for the design and characteristics of tobacco products to protect public health. These and other elements of the FDA's tobacco product regulatory strategy are based on the “population health standard” adopted by the Tobacco Control Law. Under this standard, the FDA needs to assess the impact of tobacco products on the entire population, both users and non-users. The application of “population health standards” has always been the objective of tobacco control programs and policies. However, this is still a relatively new initiative for the FDA, which has traditionally judged the safety and effectiveness of regulated products mainly on the basis of their impact on users. Moreover, the FDA's strategy is based on a firm commitment to regulatory science. Regulatory science refers to the use of scientific knowledge gained through rigorous research to formulate effective regulations and identify new issues that may require regulatory action in the future. This process brings together public-health practitioners, academia and the wider research community with regulators to jointly develop new tools, standards and methods for assessing the performance of regulated products. In this sense, regulatory science is not only crucial to the work of the FDA and similar agencies, but is also becoming a fundamental component of public-health science itself. The FDA applies regulatory science in two areas: considering tobacco product standards, and tobacco product advertising and marketing programs. In these cases, assessing and expanding the scientific basis used to guide decision-makers will help adopt regulatory policies and practices consistent with the public-health goals of the Tobacco Control Law. In the area of tobacco product standards, the FDA will use regulatory science to: establish good manufacturing practices related to the manufacture, storage and distribution of tobacco products; review the impact of regulatory measures on the exposure of tobacco users and non-users; create innovative tools for measuring potentially harmful or potentially harmful ingredients in various tobacco products; develop surrogate markers or related predictive systems for measuring the development of disease related to human tobacco exposure. To implement effective regulatory actions related to tobacco product advertising and marketing programs, regulatory science is also used to: further understand the advertising and marketing factors related to how young people obtain tobacco; improve the effectiveness of health warnings and warnings that graphically present the health effects of tobacco use, focusing on at-risk groups/subgroups; improve the effectiveness of advertising restrictions to minimize young people's access to tobacco products; expand understanding of the role various tobacco products play in young people's access to tobacco. Clearly, building and expanding the scientific basis needed to carry out the above and other activities provides many opportunities for other agencies in the public-health community to cooperate with the FDA. In fact, cooperation with public-health partners is rapidly becoming a distinctive feature of the FDA's tobacco product regulation and related activities. For example: State and territorial authorities responsible for implementing traditional tobacco control programs have become, and will continue to be, part of the FDA's national enforcement system (through FDA contracts). The FDA's public education responsibilities include not only raising awareness of tobacco product regulation, but also promoting prevention among young people. The FDA's science programs — and many of its other activities — are rooted in the excellent work of agencies such as the Centers for Disease Control and Prevention, the Office of the Surgeon General, the National Institutes of Health and the Substance Abuse and Mental Health Services Administration. Deepening cooperation and expanding relationships with these agencies is one of the keys to supporting the FDA's responsibilities in tobacco product regulation.