Azim Chowdhury Co-Authors FDLI Tobacco Primer

Azim Chowdhury co-authored “FDA Regulation of Tobacco:  A Comprehensive Guide – An FDLI Primer”.  The purpose of this Primer is to provide members of the tobacco manufacturing industry and other stakeholders with an overview of the key statutory provisions of the Tobacco Control Act and FDA’s implementation of those provisions to date. While certain information provided in this Primer may change due to the frenetic pace of FDA’s implementation activities, the Primer should nonetheless provide readers with an understanding of the regulatory landscape for new and current tobacco products in the United States. In particular, this Primer addresses the statutory definition of “tobacco product” and the scope of FDA’s enforcement authority over entities engaged in the manufacture, distribution, and sale of regulated tobacco products. Additionally, this primer addresses the processes and requirements for FDA’s premarket review of new and modified tobacco products, including “modified risk” tobacco products as well as FDA’s authority over the labeling, marketing, and advertising of regulated tobacco products. Lastly, this primer will cover key issues in the regulation of tobacco products that remain open, including the potential regulation of menthol in cigarettes and tobacco products, the composition of the Tobacco Products Scientific Advisory Committee, Good Manufacturing Practices and, of course, FDA’s Deeming Regulation, which proposes to capture currently unregulated tobacco products within the agency’s authority.  To view a preview of the Primer, see here.