FDA Regulation of Tobacco: A Comprehensive Guide - An FDLI Primer

October 2014

By Azim Chowdhury, Keller and Heckmann LLP, and J. Ben Haas and Natalie Sanders, Latham & Watkins LLP

This guide provides members of the tobacco manufacturing industry and other stakeholders with an overview of the key statutory provisions of the Tobacco Control Act of 2009 and FDA’s implementation of those provisions. In the context of the frenetic pace of FDA’s implementation activities, readers will gain an understanding of the regulatory landscape for new and current tobacco products in the United States.

In particular, FDA Regulation of Tobacco 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.

• The processes and requirements for FDA’s premarket review of new and modified tobacco products, including “modified risk” tobacco products.

• FDA’s authority over the labeling, marketing, and advertising of regulated tobacco products.

• 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.


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