The FDA’s ability to require premium cigar companies to seek product approval for its cigars has been delayed indefinitely by a federal court.
Judge Amit P. Mehta of the U.S. District Court for the District of Columbia has ruled in the cigar industry’s favor in an ongoing lawsuit against the U.S. Food & Drug Administration. He has granted the cigar industry’s request for relief and delayed FDA’s ability to enforce its premarket approval process for premium cigars until after the agency completes a thorough review and considers a “streamlined” process specifically for premium cigars.
As such, premium cigar companies will not have to file for product approval on the Sept. 9, 2020 deadline.
The ruling will apply to almost all cigars found in humidors across the country with the notable exception of flavored and infused cigars, which are not considered premium by FDA.
Companies will also not need to file paperwork with the agency to prove that their products are premium, rather, any company selling a cigar that does not meet the definition of “premium cigar” will be subject to the Sept. 9 premarket approval deadline and will need to file for substantial equivalence or another approval pathway.
Mehta’s ruling does not require FDA to enact a “streamlined substantial equivalence” process for premium cigars, only that the agency must study the issue and cannot require premium cigars to go through substantial equivalence or another process until after that study is complete. Given the nature of FDA, it is likely—though not guaranteed—that this process will take multiple years.