Premium Cigar Regulation and Substantial Equivalence Reevaluated by FDA

Categories: News, TobaccoBy Published On: August 11th, 2020180 words

As the premium cigar industry barrels toward the Sept. 9, 2020 deadline to file Substantial Equivalence applications, many have been holding out hope for a last minute reprieve. Substantial Equivalence is part of the compliance process defined by the Deeming Rule that requires manufacturers of covered tobacco products–including premium cigars, pipe tobacco, vapor, e-cigarettes and hookah–to prove that tobacco products that do not have grandfathered/predicate status are “substantially equivalent” to a tobacco product that has predicate status. Substantial Equivalence has been a contentious part of the compliance requirements set forth by the U.S. Food and Drug Administration (FDA) due to a lack of clarity in how the process will be executed, the true costs associated with compiling the required reports and the length of time between submitting the reports and receiving approval or denial from the FDA.

On Aug. 5, 2020 in a letter penned by the U.S. Department of Justice’s (DOJ) trial attorney, Garrett Coyle, and sent to U.S. District Court for the District of Maryland Judge Paul W. Grimm…

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