Tobacco Regulatory Science

HPRC Tobacco Regulatory Science

Regulatory science focuses on ensuring that scientifically valid techniques, tools, and models are available to evaluate products and, subsequently, to inform regulatory actions that promote optimal health outcomes (Hamburg, 2010; Norman, 2012).

With the passage of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA acquired the authority to regulate the manufacturing, marketing, and distribution of tobacco products in order to protect public health. Within the framework of the Tobacco Control Act, the NIH and FDA formed a partnership to establish a comprehensive research agenda in tobacco regulatory science. Since 2009 the FDA has regulated the manufacturing, distribution, and marketing of tobacco products. Some of the FDA’s regulatory research priorities include:

  • The impact of marketing and communications on tobacco use behavior
  • Perceptions, knowledge, attitudes, and beliefs regarding tobacco products
  • Toxicity, oncogenicity, and other health risks of tobacco products
  • Varying nicotine levels and other constituents’ effects on initiation, dependence, and quitting
  • The effect of tobacco product characteristics on addiction and abuse liability across populations

Click the links below to learn more about current tobacco regulatory research at HPRC:

Dr. Amy Cohn examines the effects of menthol flavored tobacco products and low nicotine cigarettes on addiction outcomes.

Dr. Lurdes Queimado examines the health effects of traditional and emerging tobacco products using a broad combination of biological tools, including a novel DNA damage assay (q-PADDA) developed in her laboratory.

Dr. Evan Floyd examines product design characteristics and standards.

E-Cigarettes and Other Emerging Tobacco Products

While the prevalence of cigarette smoking has declined drastically, particularly in the last decade, studies show an increase in the use of e-cigarettes and other emerging tobacco products, like little cigars/cigarillos and hookah, particularly in younger age groups. The HPRC conducts groundbreaking research to help inform tobacco regulatory science on a broad range of issues related to the appeal, use and health effects of e-cigarettes and other emerging tobacco products among youth, young adults, and vulnerable populations including minorities and pregnant women.

Flavored Tobacco Products

Flavored tobacco use has become increasingly popular with the rising popularity of e-cigarettes and alternative tobacco products. While characterizing flavors have been banned from cigarettes, menthol flavoring is still available in cigarettes. Most recently, characterizing flavors have been banned in certain types of e-cigarettes, or electronic nicotine delivery devices; with the exception of menthol and tobacco flavoring. The HPRC is engaging in a variety of research studies and secondary analyses of data from the Population Assessment of Tobacco and Health study designed to understand reasons for appeal for flavored tobacco products, menthol cigarette smoking (particularly in youth and young adults), and smoking and tobacco use outcomes associated with flavored tobacco and menthol cigarette smoking.

Tobacco Industry Interference and Deception

The HPRC Tobacco Industry Interference and Deception Exposed, or "TIIDE" study, seeks to determine the extent and impact of efforts by tobacco companies to defeat effective tobacco control policy and promote ineffective policy of their own design.

Launched in 2016, the TIIDE study also examines changes in policy-related awareness and attitudes after exposure to court-ordered "corrective statements" now being published by major U.S. tobacco companies. The federal racketeering case that required publication of the statements remains active, with tobacco companies opposing publication at retail points-of-sale.

Key findings from the TIIDE study are presented in the following articles and reports: