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 U.S. government asking for a six-month stay from the deadline for Substantial Equivalence reports.
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 of the FDA. 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.
Substantial Equivalence is one of the three pathways to product approval that the 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.
“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 the FDA’s decision to extend the Substantial Equivalence deadline to 2021, shortening it instead to May 12, 2020. The cigar industry last week actually argued for relief in an appeals court.
"Even during these complex and trying times, it is important to note that the wheels of the unelected bureaucracy continue to churn and threaten the premium cigar industry,” said Glynn Loope, executive director of CRA, stated. “Although the government is rightfully consumed with addressing the COVID-19 crisis, CRA and PCA continue to work the appropriate channels to convey the message of regulatory relief with Congress, the courts, and the Trump administration.”
Additionally, the PCA and CRA said they plan to amend their complaint in the U.S. District Court for the District of Columbia to request that Judge Amit Mehta, who has been overseeing the cigar industry’s lawsuit against the FDA, provide relief from the Substantial Equivalence deadline.