Legislation

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

More in Legislation

See all
Florida Lawmaker Files Measure Urging Members to Support Cigar-Exemption Bills

Florida Lawmaker Files Measure Urging Members to Support Cigar-Exemption Bills

Rep. Anthony Sabatini (R-32) introduced a memorial bill yesterday in the Florida House that encourage…

Jan 15, 2020
Tobacco 21: Retailers Respond

Tobacco 21: Retailers Respond

With the stroke of a pen, the legal age to buy tobacco anywhere in the U.S. became 21 immediately …

Jan 7, 2020
FDA Says Premium, Handmade Cigars Are ‘Lowest Priority’

FDA Says Premium, Handmade Cigars Are ‘Lowest Priority’

The U.S. Food and Drug Administration issued a new guidance last week citing handmade cigars as the …

Jan 6, 2020
Congress Raises Tobacco-Purchase Age to 21

Congress Raises Tobacco-Purchase Age to 21

The legal age to purchase tobacco products, including handmade cigars, in the United States will be …

Dec 20, 2019
Senate Confirms Hahn as New FDA Head

Senate Confirms Hahn as New FDA Head

The Senate today confirmed by a vote of 72 to 18 that Dr. Stephen Hahn will be the new commissioner …

Dec 12, 2019
FDA Extends Comment Period for Cigar Approval Rule Proposal

FDA Extends Comment Period for Cigar Approval Rule Proposal

Originally set to end today, the FDA says it will continue accepting public feedback until December …

Nov 25, 2019