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U.S. Department of Health and Human Services

Science & Research

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VII. Meeting the Challenges for Regulating Tobacco

Table of Contents: Advancing Regulatory Science for Public Health

The recently passed Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products. The Center for Tobacco Products (CTP) was created to lead this effort by harnessing the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.

The Tobacco Control Act gives the CTP important authorities, including restricting the marketing of tobacco products to children and youth, requiring new warning labels, and prohibiting marketing measures that are misleading to consumers. It also requires CTP to:

  • Require industry reporting of tobacco product ingredient and constituent data, including a description of the nicotine content and delivery mechanisms.
  • Establish tobacco product standards.
  • Require good manufacturing practice standards for tobacco product manufacturing facilities.

What can FDA do with increased investment in regulatory science?

There are several ways in which advances in regulatory science can enhance CTP’s success in regulating tobacco products and protecting the American people from their dangers:

• Biomarkers for tobacco-associated pathogenesis and disease
Tobacco products contain thousands of toxic constituents, but knowledge about the link between specific constituents and specific diseases is still evolving. CTP will need to be able to evaluate the relative contribution of each of these toxic constituents and their potential to cause disease. Since tobacco-related diseases are caused by chronic exposures that occur over years, even decades, CTP will have to work with the research community to develop and test biomarkers that can be linked to specific tobacco-related disease risks. This, in turn, will enable CTP to determine scientific bases for guidelines and review criteria for tobacco products, including industry claims of substantial equivalence, applications for non-equivalent new products, and applications for products claiming to provide reduced risk of harm.

• Tobacco product standards
The law gives FDA authority to set performance standards for tobacco products, standards that may help make entire classes of products less addictive or less harmful. Successful development and implementation of these standards will depend on the development of a strong science base.

• Tobacco product advertising and marketing
FDA can propose and implement targeted restrictions on advertising and marketing — particularly those targeted to children and youth — to reduce initiation of tobacco use. Recognizing which industry activities have the greatest effect on youth smoking can help the agency design regulatory efforts to block them. Measuring the effects of these actions on initiation will ensure that FDA is able to meet its goals.

FDA will work with a broad range of experts and engage the academic community to move this field forward. In these and other areas, progress in regulatory science can enhance CTP’s ability to attract, recruit, and retain the review, laboratory, and population scientists needed to achieve its mission and, ultimately, mean the difference between actions that are ineffective and actions that save lives. 

Next Section: A Collaborative Implementation Framework