We attended the two-day Food & Drug Law Institute Conference this week. Three panels focused on FDA regulation of tobacco products, including a deeming regulations panel at which Bryan Haynes presented.
The first day included an FDA Center for Tobacco Products “Center Director” panel featuring CTP Director Mitch Zeller. He discussed recent developoments at CTP, including its effort to improve processing of substantial equivalence reports, CTP’s consideration of menthol and the rulemaking on FDA user fees.
The deeming regulations panel addressed various scenarios regarding the deeming regulations that coincidentally were issued the next day. Haynes and RAI Services Counsel Mitch Neuhauser discussed their almost five years of experience representing clients with respect to the FDA’s current regulations, and how that experience might impact the FDA’s regulation of additional tobacco products. They noted particular concern with respect to scenarios involving FDA review of the newly “deemed” products.
There was also a panel that discussed the FDA’s successes and challenges at the five-year anniversary of the passage of the Tobacco Control Act.