Bryan Haynes of the Troutman Pepper Tobacco Team will be presenting on FDA Tobacco Enforcement in a Post-Compliance Policy World: Current Status and Future Implications, as part of the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10.
Now past the September 9, 2021 deadline for Premarket Tobacco Applications (PMTAs) and other requests for marketing authorization for tobacco and nicotine products not on the market prior to February 15, 2007, FDA has issued Refuse to File (RTF) and Marketing Denial Orders (MDOs) in response to PMTAs that cover millions of products. Any product with a RTF or MDO may no longer be legally sold on the market, but questions abound about enforcing these decisions in light of FDA’s limited resources and the lack of publicly available information regarding the specific products covered. Panelists will review recent FDA enforcement activities, discuss potential approaches such as better collaboration with state and local governments, and address current and looming concerns including the frequent appearance of synthetic nicotine products that arguably fall outside of FDA’s regulatory authority.
As we move out of the COVID-19 pandemic, come hear from your peers about how they are staying compliant and inspection ready as FDA ramps back up inspections, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year. Sign up with the discount code SAVE15 for 15% off registration and learn more at fdli.org/enforcement21
We look forward to seeing our clients and friends at the conference.