Court Ruling Ends Chances of 2021 Deadline for FDA Product Reports
The FDA’s pre-market application deadline for cigars will remain September 9 after a trio of judges yesterday rejected the cigar industry’s appeal to extend the deadline for nearly one year.
The ruling, filed in the U.S. Court of Appeals for the Fourth Circuit, essentially eliminates any chance that the deadline will be moved to August 2021, a date that the FDA announced three years ago when it said it would be reconsidering how it regulates premium cigars.
The deadline concerns only cigars that need to be filed with the FDA using either Substantial Equivalent reports or Premarket Tobacco Applications (PMTAs). Cigars that were commercially marketed before February 15, 2007, are considered “grandfathered” and therefore do not require FDA review.
While the cigar industry viewed that 2017 announcement in a positive light, health groups disagreed and shortly after filed a lawsuit in Maryland challenging the agency’s new deadlines. Last year, the presiding judge sided with the health groups and shortened the deadline to May 12, 2020.
Then just last week, the deadline was officially extended to September 9 due to the Coronavirus outbreak.
