The Food and Drug Administration (FDA) set Sept. 9, 2020, as the deadline for manufacturers to submit a substantial equivalence application (SE) or a pre-market tobacco application (PMTA) for “deemed” tobacco products introduced into the marketplace between Feb. 15, 2007, and Aug. 8, 2016. Tobacco products subject to the PMTA requirements include cigars (except “premium…
Courts Extend FDA PMTA Application Deadline
As previously reported in CStore Decisions, the U.S. Department of Justice, on behalf of the Food and Drug Administration (FDA), submitted letters on March 30, 2020, to the U.S. District Court for the District of Maryland and the U.S. Circuit Court of Appeals for the Fourth Circuit with a request for a 120-day extension of…