On October 28, 2021, Womble Bond Dickinson attorney Mark J. Vaders moderated a panel discussion at the annual Tobacco and Nicotine Products Regulation and Policy Conference organized by the Food and Drug Law Institute (FDLI). The panel discussion, titled “Assessing the Modified Risk Tobacco Products (MRTPs) Pathway,” examined the successes and challenges of the MRTP pathway, as well as potential means the U.S. Food and Drug Administration (FDA) could use to improve the pathway going forward.

Modified Risk Tobacco Products, defined in Section 911 of the Federal Food, Drug, and Cosmetic Act as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products,” are a crucial component of leveraging federal regulation to reduce the harms caused by combusted tobacco products, as a “modified risk granted order” from FDA is the only avenue for industry to communicate differences in tobacco product risk to consumers.  Only two companies have obtained modified risk granted orders from FDA thus far—Swedish Match North America for its General Snus products, and Philip Morris S.A. for its iQOS heated tobacco products. Several other companies, including Reynolds American Inc., Altria Group, and 22nd Century Group, have Modified Risk Tobacco Product applications pending before the FDA.

Joining Mark in the discussion were:

  • Brian E. Erkkila, Director of Regulatory Science at Swedish Match North America
  • Aaron Williams, Senior Vice President – Scientific & Regulatory Affairs at RAI Services Company

The conference, typically held at the National Press Club in Washington, DC, was presented virtually this year. Participants in the FDLI conference include representatives from FDA’s Center for Tobacco Products, the tobacco and nicotine industry, public health organizations, and academics.