Bryan Haynes of the Troutman Pepper Tobacco Team presented at the Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference on October 23, 2020. 

Bryan participated in a panel discussion entitled “The Post-PMTA Deadline Landscape:  What Happens After September 9th?”  The panelists discussed enforcement, compliance and the review of FDA requests for marketing authorization for “deemed” tobacco products submitted prior to September 9, 2020.  Bryan discussed his experience with PMTAs, substantial equivalence reports and requests for exemption from substantial experience for deemed tobacco products, including electronic nicotine delivery systems (ENDS), cigars, pipe tobacco and waterpipe tobacco, including FDA’s progress thus far and looming enforcement issues.