FDA Tells Court It Won’t Delay September Substantial Equivalence Deadline
The U.S. Food & Drug Administration (FDA) is not planning on delaying the current Sept. 9, 2020 deadline by which cigar companies will have to submit for product approval.
In a status report filed yesterday to the U.S. District Court for the District of Columbia, the agency said it does “not current plan to seek an extension of the September 9, 2020 premarket application deadline.” This is notable because Judge Amit P. Mehta, the federal judge overseeing the case between the cigar industry and FDA, has asked the agency to consider delaying the deadline.
FDA already delayed the deadline once this year due to the coronavirus COVID-19 pandemic. The deadline was previously scheduled for May 12, 2020 but was moved because of the ongoing pandemic. At the time, FDA said it received numerous requests for a delay from those in the cigar industry and others before settling on a 120-day delay. Any changes in regards to the deadline are likely to be more complicated as FDA might need to get approval from the Maryland-based federal court that forced the agency to move the deadline to May 12, 2020 due to a separate lawsuit.
The Sept. 9 deadline affects the premarket approval process for all tobacco products outside of cigarettes and smokeless tobacco, though for the cigar industry it’s mainly about substantial equivalence.
Substantial equivalence is expected to be the main approval process for cigars once FDA’s regulations are fully in effect. In short, a manufacturer would argue that its product is substantially equivalent to an already approved or grandfathered product, and as such poses no additional health risks and does not market towards children.
Cigar manufacturers are required to either file for substantial equivalence or grandfather status by the deadline—now Sept. 9, 2020—in order for their cigars to stay on the market. If they fail to do so, that product must be removed from sale in the U.S. and will not be able to be sold until FDA approves the report.
Charlie Minato
I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.
