How do you develop a knowledge base for tobacco regulatory science?

Challenge

The 2009 Family Smoking Prevention and Tobacco Control Act (TCA, Public Law 111-31) established the Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA), investing it with the authority to regulate the manufacture, marketing, and distribution of tobacco products. CTP promotes the development of regulatory science to ensure that a strong evidence base informs its activities.

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

Solution

CASEL is engaged in the following key activities:

• Administering a $1.5M Opportunity Fund for rapid response research projects
• Serving as the communications hub for the TRS research community
• Creating forums and venues for dissemination of research findings (e.g., through the CASEL TRS Knowledge Center website, 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

TRS research has contributed significant rigorous scientific evidence to support FDA CTPs regulatory actions. Among these are proposed rules to establish tobacco product standards aimed to ban menthol as a characterizing flavor in cigarettes, and to ban characterizing flavors other than tobacco in cigars. The research supported by CASEL will continue to generate new evidence that informs FDA CTP’s tobacco regulatory activities and decisionmaking to positively impact public health.