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Judge Declines to Extend Substantial Equivalence Deadline to Cigar Industry

Oct 21, 2019 | By Andrew Nagy
Judge Declines to Extend Substantial Equivalence Deadline to Cigar Industry

A judge in Washington D.C. has denied the cigar industry’s request to extend the deadline for a key product approval rule known as Substantial Equivalence.

Substantial Equivalence is one of the three pathways to product approval that the FDA established when it published its Final Deeming Rule in May 2016. According to the FDA, a cigar manufacturer must file an SE report to show that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn't raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.

Judge Amit P. Mehta of United States District Court for the District of Columbia filed his ruling on Friday, saying that the cigar industry failed to establish that the new Substantial Equivalence deadline is unfair to cigar manufacturers. The motion was filed in July on behalf of the Cigar Rights of America, Cigar Association of America and Premium Cigar Association.

“That is because the predicament in which Plaintiffs find themselves—facing an earlier deadline to comply with a new statutory substantial equivalence requirement—was caused not by any action or inaction by the Food and Drug Administration; rather, it is entirely a function of a judicial ruling,” wrote Judge Mehta in his ruling.

Earlier this year, the Substantial Equivalence deadline was moved up to May 2020 by a judge’s ruling in a Maryland court case called American Academy of Pediatrics v. FDA.

Back in July 2017, then-FDA commissioner Dr. Scott Gottlieb extended the SE report deadline to August 2021, and this deadline was recognized by Judge Mehta.

FDA

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