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FDA Tobacco Product Regulation: A Powerful Tool for Tobacco Control
2026-02-27
The passage of the Family Smoking Prevention and Tobacco Control Act in 2009 initiated the most far-reaching public health interventions in recent decades.For the first time, the U.S. Food and Drug Administration (FDA) has been fully authorized to use its regulatory powers to combat tobacco as the leading preventable cause of death in the United States.However, FDA regulation is not only a powerful new tool for reducing tobacco-related illnesses and deaths, but also presents new opportunities and challenges for public health professionals at all levels of government, academia, research institutions, and advocacy organizations.
The human and economic losses caused by tobacco use in the United States cannot be overstated.Each year, approximately 443,000 Americans die from smoking-related diseases, and another 8.6 million develop at least one serious illness due to smoking.Even more alarming is that 20% to 25% of high school students in the United States currently use tobacco products, and approximately 4,000 teenagers under the age of 18 start smoking every day, with another 1,000 becoming long-term smokers.Since nine out of ten adult smokers started smoking during their teens, these teenagers—to borrow a phrase from some tobacco industry officials in the past—will become “replacements” for adult smokers who quit or die.Nearly 500,000 people die each year from smoking, which is preventable, so there is no doubt that the federal government must take proactive measures.
Before the FDA regulated tobacco products, the main components of the U.S. tobacco control strategy included public education, prevention programs, treatment services, epidemiology and surveillance, tax/price incentives, and air quality improvement measures.The combined effect of these measures was significant: between 1965 and 2001, the smoking rate among American adults dropped from about 42% to nearly 23%.However, the downward trend in smoking rates has stalled in the last five years.In 2009, the smoking rate among American adults was 20.6%.The situation is similar among teenagers, with the smoking rate among students in grades 9 to 12 remaining at 20%.Furthermore, as state and local governments have increased tobacco prices through measures such as cigarette taxes, smoking bans in public places have become more widespread, leading to an increase in the development and use of smokeless and soluble tobacco products.Now, with the U.S. Food and Drug Administration (FDA) incorporating tobacco product regulation into the national tobacco control strategy, the public health community has a renewed opportunity to relaunch and expand tobacco control efforts.
Unlike other partners in the tobacco control community, the FDA has the authority to regulate tobacco products, including their advertising, marketing, distribution, and production.Regulating tobacco product production includes setting product standards for the content of nicotine or other harmful ingredients, clarifying sales requirements for low-risk products, and establishing good manufacturing practices for tobacco products.
The American public has seen tobacco product regulation begin to take effect in practice.Since President Barack Obama signed the Tobacco Control Act on June 22, 2009, the U.S. Food and Drug Administration (FDA) has taken actions to protect public health, including initiating and enforcing bans on fruit-flavored or candy-flavored cigarettes.The use of misleading terms such as "mild," "low," and "mild" on product labels is prohibited;And a wide range of laws were enacted to restrict the supply of cigarettes and smokeless tobacco products to and from minors and their marketing.These new laws aimed at reducing tobacco use among teenagers include setting the minimum age for purchasing tobacco products at 18 and making it mandatory;Distributing free cigarette samples is prohibited;The tobacco company's brand sponsorship of sporting events and concerts will be terminated.And prohibit the sale of cigarettes from all vending machines that children may have access to.In November 2010, the U.S. Food and Drug Administration (FDA) proposed the use of new, specific graphic health warnings on cigarette packaging and advertising, and will decide how to develop design and characteristic standards for tobacco products to protect public health.
These elements, and others, of the FDA's tobacco product regulatory strategy are based on the "population health standards" adopted by the Tobacco Control Act.According to this standard, the FDA needs to assess the impact of tobacco products on the entire population (including users and non-users).Applying "population health standards" has always been a goal of tobacco control programs and policies.However, this is still a relatively new initiative for the U.S. Food and Drug Administration (FDA).The FDA traditionally assesses the safety and effectiveness of regulated products primarily based on their impact on users.
Furthermore, the FDA's strategy is based on a strong commitment to regulatory science.Regulatory science refers to the use of scientific knowledge obtained through rigorous research to develop effective regulations and identify new issues that may require future regulatory action.This process brings together public health professionals, academia, and the broader research community with regulatory agencies 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 gradually becoming a fundamental component of public health science itself.
The FDA utilizes regulatory science in two areas: first, in considering tobacco product standards, and second, in tobacco product advertising and marketing programs. In these cases, evaluating and expanding the scientific basis used to guide policymakers will help adopt regulatory policies and practices that align with the public health objectives of the Tobacco Control Act. 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 harmful components in various tobacco products.
Develop alternative biomarkers or related predictive systems for measuring the development of tobacco exposure-related diseases in humans.
Regulatory science is also used to implement effective regulatory actions related to tobacco product advertising and marketing programs:
To further understand how teenagers access tobacco-related advertising and marketing factors.
Enhance the effectiveness of health warnings and visually represent the health effects of tobacco use, with a focus on at-risk groups/subgroups.
Improve the effectiveness of advertising restrictions to minimize access to tobacco products for minors.
Expand our understanding of the roles that various tobacco products play in adolescents’ access to tobacco.
Clearly, building and expanding the scientific foundation required to conduct the above and other activities provides numerous opportunities for other public health agencies to collaborate with the FDA. In fact, collaboration with public health partners is rapidly becoming a prominent 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 regulations, but also promoting prevention efforts among young people.
The FDA's scientific programs—and many of its other activities—are rooted in the outstanding 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 Administration of Substance Abuse and Mental Health Services. Deepening cooperation and expanding relationships with these agencies is key to supporting the FDA's mandate in regulating tobacco products.