Bryan Haynes, Agustin Rodriguez, Michael Jordan, and Zie Alere of the Troutman Pepper Locke Tobacco + Nicotine team will sponsor and attend the Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference in Washington, D.C., on October 6 and 7.

This is a key annual conference on regulating tobacco and nicotine products in the United States. It will feature influential stakeholders from a diverse range of backgrounds—public health leaders, researchers, manufacturers, attorneys, consumer advocates, entrepreneurs, and federal and state regulators.

Bryan will moderate a panel entitled “Modifications & Market Survival: Mastering SEs, EX REQs, and sPMTAs.” The panel’s discussion will cover the U.S. Food and Drug Administration’s (FDA) regulatory pathways to market beyond traditional premarket tobacco product applications (PMTAs), including substantial equivalence (SE) reports, exemption from substantial equivalence requests (EX REQs), and supplemental PMTAs (sPMTAs).

Agustin will participate in a panel entitled “Regulating the Illicit Market—Enforcement, Registration & Product Listing, Registries, and Retail Ramifications.” Panelists will discuss FDA’s latest efforts to combat the illicit market, including the recent proposed rule on “Establishment Registration and Product Listing for Tobacco Products” for imported products (which we previously covered here), recent product authorizations, and upcoming enforcement discretion lists for electronic nicotine delivery systems (ENDS) and nicotine pouches.

We look forward to seeing clients and friends at the conference.