FDA's Tobacco Products Scientific Advisory Committee meets to discuss Modified Risk Tobacco Products
On April 30, the Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) met to discuss a range of issues related to Modified Risk Tobacco Products (MRTP). In order to qualify as an MRTP, a product must significantly reduce the harm and the risk of tobacco related disease to individual users and benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products, patterns of actual use behavior, uptake, continued use and cessation.
Much of the meeting was devoted to how TPSAC would review MRTP applications including what action FDA would take to trigger TPSAC’s 60 day review of an application, what information TPSAC would need to complete its review and the format of TPSAC’s post-review recommendations to FDA. Joining the committee for his first meeting was APA Fellow Warren Bickel, PhD, who was among several psychological scientists APA had nominated for TPSAC membership.
During an open comment period, APA Fellow David Abrams, PhD, director of the Schroeder Institute For Tobacco Research and Policy Studies at the Legacy Foundation, gave a presentation (PDF, 255KB) on the need for rigorous pre-market population level studies as well as extended post-market surveillance research to determine if a MRTP should be removed from the market.
For more information on this issue contact Geoff Mumford.