FDA’s Final Rule for Premium Cigars Delayed by Judge Mehta

The premium cigar industry has scored a victory–albeit a temporary one–against the U.S. Food and Drug Administration’s (FDA) Deeming Rule. In an Aug. 19, 2020 ruling issued by Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, the court has remanded the Final Deeming Rule and temporarily prohibited the premarket review requirements for premium cigars. Due to the ruling, premium cigar manufacturers will no longer have to file Substantial Equivalence (SE) applications with the FDA by Sept. 9, 2020, as originally required by the Deeming Rule.

On May 10, 2016, the FDA published the Deeming Rule that applied to cigars, pipe tobacco, e-cigarettes and other covered tobacco products. The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the power to regulate these products but much of the Deeming Rule has been met with more questions and confusion than answers. The PMTA and SE requirements for premium cigars…

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