Tuesday, June 14

Premarket Tobacco Applications: Legal Challenges to FDA’s Process and Outcomes (2:00 pm - 3:00 pm)

Since enactment of the “Deeming Rule,” Electronic Nicotine Delivery System (ENDS) products have been regulated as “tobacco products,” subject to the requirements of the Tobacco Control Act. Thus, in order to stay on the market, they were required to submit a Premarket Tobacco Application (PMTA) by September 9, 2020 and receive a marketing order from the FDA. The Agency did not anticipate the nearly 6 million applications it received and ended up issuing Marketing Denial Orders arguably not in accordance with the rule and guidance it set forth outlining PMTA requirements. As a result, multiple companies brought legal action against the FDA for acting in an arbitrary and capricious manner. This panel will explore key cases, including any active litigation challenging FDA denial of PMTAs.

Micah L. Berman, Associate Professor of Public Health and Law, The Ohio State University
Paul Blair, Vice President, Government Affairs, Turning Point Brands, Inc.
Eric Heyer, Partner, Thomson Hine LLP
Moderated by Barry Schaevitz, Partner, Fox Rothschild LLP

Wednesday, June 15

Menthol and Other Tobacco Product Standards (1:00 pm - 2:00 pm)

In April 2022, FDA proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit all characterizing flavors–other than tobacco–in cigars. This panel will provide an overview of these proposed rules, discuss the definition of “characterizing flavor,” and address the potential intended and unintended impacts these product standards may have on public health. Speakers will also discuss how these standards fit into broader harm reduction efforts, considering the impact this may have on health equity, as well as vis-à-vis menthol- and mint-flavored ENDS.

Bryan M. Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Nicole L. Nollen, Professor, University of Kansas School of Medicine, Department of Population Health
John Pritchard, Vice President of Regulatory Science, 22^nd Century Group, Inc.
Moderated by Beth G. Oliva, Partner, Fox Rothschild LLP