The Food & Drug Law Institute (FDLI) started its annual conference on October 6, 2020. The conference set out to explore advanced topics in Food & Drug Law. In this blog series, Perkins Coie reports on the three-day conference and meaningful takeaways for food litigation.

Day One of the 2020 FDLI Annual Conference featured significant representation from the FDA, including a keynote address from Dr. Stephen M. Hahn, FDA Commissioner, and Stacy Cline Amin, FDA’s Chief Counsel. Both keynote addresses emphasized the reaction of the agency in adapting quickly to the COVID-19 pandemic to meet emerging needs with regard to public health.

The conference also featured other senior FDA officials discussing regulatory topics within the age FDA Associate Commissioner for Regulatory Affairs Judy A. McMeekin discussed her regulatory and enforcement mechanisms the agency is using in responding to the COVID-19 pandemic, including “Operation Quack Hack” a multi-agency task force focusing on COVID-19 health fraud. According to McMeekin, online marketplaces have removed more than 500 product listings at FDA’s request and issued over 100 warning letters to products claiming to prevent or treat COVID-19, including one product “that when used as directed was equivalent to industrial bleach.”

Dr. Susan T. Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, joined by Douglas W. Stern, the agency’s Deputy Director of Regulatory Affairs, discussed FDA’s actions during COVID-19 to create temporary regulatory flexibility policies for food manufacturers. In addition, Mayne discussed the agency’s food safety priorities including the New Era of Smarter Food Safety and further action on the Food Safety Modernization Act and its suite of accompanying regulations. Mayne noted the agency’s Nutrition Innovation Strategy, which includes (i) updating the definition of the claim “healthy” on food packaging, (ii) “modernizing” food standards of identity, and (iii) conducting public education about the new Nutrition Facts label.   When asked about the potential regulatory pathway for products containing cannabidiol (CBD), Stern noted that there were gaps in existing data that the agency was working to address.

Overall, Day One of the FDLI Annual Conference provided an opportunity to hear from the FDA itself what it considered its top priority areas, biggest achievements over the past year, and issues on the horizon. On to Day Two.