Judge Critical of FDA’s Deferment Plan for Premium Cigars

Barring an immediate ruling in its favor, the cigar industry could not have had a much better day in court than the one it had today.

Judge Amit P. Mehta of the U.S. District Court for the District of Columbia used most of his words to criticize the legal strategy and regulatory plans of the U.S. Food & Drug Administration. And sometimes he was at a loss for words.

At stake today in Cigar Association of America et al. v. United States Food and Drug Administration et al. was whether this lawsuit should proceed in light of last week’s announcement that FDA plans on deferring the product approval process for premium cigars while the agency studies the issues. As Mehta made clear, it will.

Technically, he seems like he will look into the question of ripeness but Mehta made it clear that he plans on moving forward with issuing a decision about whether to throw out the premarket approval process for premium cigars—known as substantial equivalence—or perhaps an even larger part of the ruling. And solely based on today’s hearing, an outcome in the cigar industry’s favor looks increasingly likely.

Last week, the Department of Justice, acting on FDA’s behalf, told a different court that it was planning on delaying the product approval process for premium cigars before the current deadline of Sept. 8. It would do this by creating a deferment process where premium cigar companies could apply for deferment from the regulations until after FDA completes a thorough review of evidence to determine whether and how it should be regulating premium cigars, a process that will almost certainly take multiple years.

Even though product approval applications are due in less than a month, many of the details of how that would function remain up in the air. In fact, the other court won’t rule on the matter—whether it will allow FDA to enact the deferment process—until at least next Monday, leaving at most 22 days for cigar companies to figure out what to do before the Sept. 8 deadline.

Mehta’s court has been hearing arguments about the entire regulation of premium cigars, but more recently about whether the product approval process is fair for premium cigars. He had been poised to rule on that matter soon, but last week’s announcement threw a wrench into those plans.

Garrett Coyle, an attorney for the Department of Justice, argued that if FDA was allowed to move forward with its deferment plan, it’s the agency’s view that Mehta could dismiss this case because the plaintiff’s claims of harms would no longer be ripe, a legal term more or less for valid.

While Mehta didn’t rule on it today, he made it quite clear that he didn’t find that argument to be compelling.

Instead, Mehta attacked FDA’s process, starting with why the agency decided to announce this process—one cigar companies have been calling for since before the regulations took effect—now, roughly a month away from the most important regulatory deadline.

“(It is a) little bit surprising that the agency, here at the 11th hour, has now announced this alternative. I shouldn’t call it an ‘alternative.’ (A) delay (for) substantial equivalence for premium cigars,” said Mehta. “(FDA) has really provided no guidance about how long this study will take when all along the premium cigar folks, and cigar folks more generally, have been asking for relief either this time of relief or some other form. And here we are, this matter is ripe for decision, we’ve certainly been working on in terms of getting out a decision, and now the agency has thrown a wrench (in these proceedings.)”

At times, Mehta took long pauses and at other times he had to preface his comments to make it clear he was not attacking Coyle personally, but rather FDA and its decisions.

“On some level, it feels like the agency is trying to save itself from the (substantial equivalence) applications if I rule against the plaintiffs (and let the rule stand.)”

Today was yet another instance where the cigar industry argued, and Mehta seemed sympathetic, to the idea that FDA did not fully evaluate how to regulate premium cigars before announcing premium cigar regulations.

“From the very outset, what Mr. Edney (the lead attorney for the cigar industry) has been saying and I have articulated on a handful of occasions is that the agency… the claim that the agency didn’t do its homework before it subjected premium cigars to this regulatory scheme,” said Mehta. “The way that the FDA has treated the issue seems to underscore the lack of evidence that was considered that made these decisions.”

Mehta was also critical of the idea that there is more evidence regarding premium cigars for the FDA to study and also was critical that the agency didn’t provide more details about what the deferment process might look like.

For his part, it seemed Michael Edney’s main job was to avoid having Mehta change his mind. He made a variety of legal arguments about why Mehta should still rule, and still rule in the cigar industry’s favor.

He also pointed out that the deferment process could lead to a situation where a cigar company applies for a deferment but is not granted it by Sept. 8, presumably making that cigar illegal.

Coyle’s response to this opened a pandora’s box that likely only weakened the government’s position about the larger regulatory process regarding premium cigars. Coyle reiterated throughout the hearing, and again here, that earlier this year FDA said premium cigars are FDA’s lowest enforcement priority.

He seemed to suggest that even if a company didn’t get an approved deferral that they should trust that FDA won’t require the products to be removed from the market because premium cigars are the lowest priority.

Mehta didn’t understand what that meant in regards to Edney’s hypothetical.

Coyle then seemed to suggest that once the deeming regulations went into effect—on Aug. 8, 2016—that all products were subject to premarket approval requirements and illegal without them, though FDA used its discretion to give manufacturers a time period to keep those products on the market and wouldn’t start requiring their removal until that deadline, now Sept. 8, 2020.

That is technically correct. Previously, FDA has modified certain deadlines when it had felt a need to, i.e. when it moved up the deadlines for flavored vaping cartridges like Juul thus outlawing flavored pod or cartridge vaping systems until after those products gain premarket approval.

Edney, and more importantly Mehta, seemed somewhat taken aback by this position from FDA, specifically, that the advice from the government is that a company should knowingly violate the law by selling its products without an approved deferral or product approval because premium cigars are FDA’s lowest priority.

In the end, Mehta ended the hearing with the most important words, “so we’ll move forward…” A commitment that a decision from his court is coming, presumably before Sept. 8.

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.