Court Denies Injunction Seeking to Delay FDA Substantial Equivalence Deadline Pending Appeal

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An appeal filed by the Cigar Association of America (CAA) to suspend enforcement of certain upcoming FDA deadlines pending an appeal has been denied.

Judge Amit P. Mehta of the U.S. District Court for the District of Columbia denied CAA’s motion to suspend FDA’s enforcement of the Sept. 9 substantial equivalence deadline for all cigars and pipes tobacco pending an appeal.

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Last month, Mehta ruled that certain cigars—those that meet a definition of being a  premium cigar—will not be subject to the Sept. 9 deadline until after FDA completes a review of whether it should create a streamlined process for premium cigars.

For all other cigars—which mostly consist of flavored or machine-made cigars—the Sept. 9 deadline remains in effect.

CAA had filed a request for an injunction as it appeals four counts of Mehta’s Aug. 19 ruling. The group had requested Mehta suspend the Sept. 9 deadline until after the appeals process has finished, a request Mehta rejected yesterday.


First and foremost, Mehta rules that an injunction would “upset” the ruling in American Academy of Pediatrics v. Food and Drug Administration, a separate lawsuit filed in Maryland where a group of pediatricians and anti-tobacco groups successfully sued FDA arguing the agency had no authority to delay certain parts of the deeming regulations.

That decision moved up the deadline for premarket approval for tobacco products from August 2021 to May 2020, though the May deadline was later delayed to Sept. 9 due to the coronavirus COVID-19 pandemic.

Mehta writes:

The injunctive relief requested here ould upset the AAP court’s judgment without justification. It would, in the short term, exempt from the AAP court’s order all newly deemed cigar and pipe tobacco products. Such collateral relief from another court’s order is generally unwarranted.

Abstaining from such collateral relief is particularly apt in this case, where Plaintiff had ample opportunity to participate in the AAP litigation but simply delayed in doing so.

In its filing, CAA argued that the upcoming deadline will cause manufacturers to incur substantial costs associated with filing the Sept. 9 reports, though Mehta rejects the claim and says the plaintiffs failed to show “irreparable harm.”

His reasoning is largely based on the idea that manufacturers will have to apply for some form of product approval regardless of his decision:

Thus, cigar and pipe tobacco product manufacturers, if not now, eventually will have to file for premarket approval with the FDA. How much additional cost cigar and pipe tobacco manufacturers face from the impending deadline is difficult to quantify—Plaintiff offers no evidence to this effect—but those manufacturers cannot escape incurring any costs altogether.

Mehta says the arguments that he had previously granted injunctive relief pending appeal aren’t applicable here because when he did that it was because First Amendment rights were at stake, something that is not affected by the Sept. 9 deadline.

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Charlie Minato
About the author

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 handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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