US
Due to the impact of the coronavirus pandemic on handmade cigar manufacturers, the leading lobbying groups for the handmade cigar industry have filed a joint petition with the US government asking for a six-month stay from the deadline for substantial equivalence reports.
Substantial equivalence is one of the three pathways to product approval that FDA outlined in its Final Deeming Rule of 2016. It allows a cigar manufacturer to file a report showing that a new tobacco product has similar characteristics to a grandfathered (or predicate) tobacco product, or has different characteristics, but doesn’t raise any new questions of public health.
The petition was filed by the Premium Cigar Association and the Cigar Rights of America with Alex Azar, secretary of Health and Human Services, and Stephen Hahn, the newly appointed commissioner. The petition seeks to extend the looming May 12 deadline for Substantial Equivalence filings. Both Azar and Hahn have the power to stay any regulatory deadline during a public health emergency.
“These substantial equivalence reports are required to continue to sell the thousands of premium cigars introduced to the market between February 15, 2007, and August 8, 2016, and each report requires time, considerable cost, and effort,” said the Premium Cigar Association in a press release.
Last July, a Maryland judge ruled against FDA’s decision to extend the substantial equivalence deadline to 2021, shortening it instead to May 12, 2020. The cigar industry recently actually argued for relief in an appeals court.