Challenge

To exercise its authority to regulate the manufacture, marketing, and distribution of tobacco products, the Food and Drug Administration (FDA) requires rigorous and timely scientific evidence to inform its regulatory activities. 

The Center for Tobacco Products (CTP) at FDA funds tobacco regulatory science (TRS) research through various mechanisms, including a partnership with the Tobacco Regulatory Science Program (TRSP) at the National Institutes of Health (NIH). The TRSP, within the Office of the NIH Director, oversees the administration of CTP-funded grants throughout various institutes and centers at NIH. Multiple scientific disciplines contribute to developing an extensive knowledge base for the field of TRS. Key areas for research are:

• Chemical constituents in tobacco products and the methods for measuring them across products
• Toxicity and carcinogenicity of tobacco products
• Potential for dependence and addiction of different tobacco products
• Health effects of tobacco product use
• Communications about the risks and harms posed by tobacco product use
• Impact of marketing techniques on susceptibility to tobacco product use
• Potential impact of FDA regulatory actions

Through a cooperative agreement funded by the FDA’s CTP and administered by the National Institute on Drug Abuse, Westat provides support for CTP-funded investigators through the Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science.

Solution

CASEL is engaged in the following key activities:

• Acting as a central hub for communications with researchers in the TRS community
• Creating forums and venues for dissemination of research findings (e.g., through scientific meetings, webinars, and themed special journal issues)
• Leading initiatives that promote synergies and organized collaborations among researchers in the TRS community (e.g., through topical special interest and working groups)
• Providing professional development and networking opportunities for TRS trainees and early career scientists
• Promoting common measures and providing analytical and technical expertise, guidance, and tools

Results

Tobacco regulatory research has contributed to many FDA activities. One example is informing the additional provisions that were in the 2016 “Deeming Rule” that extended FDA’s authority to include the regulation of electronic nicotine delivery systems, all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels. 

Research results also informed 2 Advance Notices of Proposed Rulemaking (ANPRMs):

• Lowering nicotine in cigarettes to a minimally or non-addictive level
• Regulating flavors in tobacco products, including menthol

The research supported by CASEL will continue to generate new evidence that informs FDA’s tobacco regulatory activities and decisionmaking to positively impact public health.