By Kerry Roche
FDA has just announced that its Tobacco Products Scientific Advisory Committee will hold a 3-day public meeting in Rockville, MD (April 16-18, 2014). The purpose of this Ad Com is to provide advice and recommendations to the Agency on tobacco regulatory issues. During the April meeting, the committee will address the following:
- April 16: Scientific issues pertaining to dependence and addiction, including the development of addiction, measurement of dependence and addiction, and concepts concerning the assessment of addiction in the review of product submissions.
- April 17: Information on population modeling in the assessment of tobacco product applications and discuss the ways modeling can inform decisions critical to population health.
- April 18: Possible approaches for evaluating information on the risks and potential benefits of a proposed modified risk tobacco product to the health of individual tobacco users and to the population as a whole.
Established in 2010, TPSAC is tasked with evaluating the safety, dependence and health issues relating to tobacco products and providing advice, information and recommendations to the Commissioner of Food and Drugs. Past TPSAC meetings have discussed the impact of the use of menthol in cigarettes on public health; the impact of the use of dissolvable tobacco products on public health; the effects of the alteration of nicotine yields from tobacco products; and modified risk tobacco products.
These past meetings have had differing outcomes so it is hard to tell what FDA aims to achieve following the April meeting. The three sessions should provide a closer look at the tools that the FDA intends to use and the contexts in which they will use them to define risks and benefits of modified tobacco products.
Kerry Roche is a Senior Consultant at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.
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