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Maryland Judge Shortens Product Approval Deadline

Jul 18, 2019 | By Andrew Nagy
Maryland Judge Shortens Product Approval Deadline

A judge in Maryland has moved up the deadline for cigar manufacturers to submit certain product approval applications to the Food and Drug Administration.

Judge Paul Grimm, of U.S. District Court for the District of Maryland, issued an opinion last week that requires applications for “new tobacco products on the market as of the August 8, 2016” to be filed by May 12, 2020. The deadline for these applications, known as Substantial Equivalence reports, was extended two years ago by the FDA to August 2021.

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 files 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.

The order was the latest ruling in the case American Academy of Pediatrics, et al. v. Food and Drug Administration, a federal lawsuit filed three years ago that challenges the FDA’s decision to delay the review of e-cigarettes. While the lawsuit, and Judge Grimm’s decision, focuses on e-cigarettes, his order also affects premium, handmade cigars because both types of products are considered deemed tobacco by the FDA.

Judge Grimm’s order, however, may not be the final deadline, as the cigar industry recently filed a motion asking a Washington D.C. court to maintain the compliance deadlines that had been previously been set for handmade cigars. The industry’s motion seeks to keep the August 2021 deadline.

FDA

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