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JUDGE CRITICIZES FDA’S LEGAL STRATEGY & REGULATORY PLANS REGARDING DEFERMENT OF PREMIUM CIGAR APPROVAL PROCESS
August 12th, 2020WASHINGTON, D.C. – August 11, 2020 – Judge Amit P. Mehta of the U.S. District Court for the District of Columbia was highly critical of the Federal Drug Administration’s proposal last week which asked for a postponement of the premarket authorization requirement for premium cigar manufacturers and importers. This request comes several weeks before the September 9, 2020 deadline when cigar manufacturers are required to submit their premarket, “substantial equivalence” applications.
In an August 6, 2020 U.S. Justice Department letter to Judge Paul Grimm of the U.S. District Court for the District of Maryland, the FDA cited their reason for the deferral:
“The FDA intends to exercise its retained discretion by deferring enforcement of the premarket authorization requirement for premium cigar manufacturers and importers on a case-by-case basis. The deferrals are intended to help prioritize the use of the FDA’s limited enforcement resources while the agency undertakes a new research effort to evaluate the public health impact of premium cigars.”
This sudden turn of events comes as a result of an FDA finding that “youth smoke premium cigars comparatively less than most other deemed tobacco products, like e-cigarettes.” And since the FDA’s top priority is keeping youth from using products like e-cigarettes and vape products, premium cigars remain “the FDA’s lowest priority for premarket review.” Of course, a thorough review of the evidence to determine how the FDA should be regulating premium cigars could also take years to complete.
And therein lies the rub and the question for Judge Mehta: Should the Cigar Association of America et al. v. United States Food and Drug Administration et al. case proceed in light of last week’s proposal by FDA counsel? In any event, Mehta clearly indicated that he would move forward with a decision on whether to throw out the substantial equivalence process.
Moreover, Attorney for the Department of Justice, Garrett Coyle, argued that if the FDA was permitted to go ahead with its deferment plan, the FDA asserts that Judge Mehta could dismiss the case since the plaintiff’s claims of harm toward youth would no longer be valid.
Mehta was not convinced by that position. Rather, he took issue with the FDA’s decision to announce this process so close to the vital September 9 deadline.
“[It is a] little bit surprising that the agency, here at the 11th hour, has now announced this. . . delay [for] substantial equivalence for premium cigars,” said Judge Mehta. “[The 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 kind of relief or some other form. . .[W]e’ve certainly been working in terms of getting out a decision, and now the agency has thrown a wrench [in this case].”
As to whether he should let the rule stand, Mehta also stated that “it feels like the agency is trying to save itself from itself from the applications if I [were to] rule against the plaintiffs.”
Another point that seemed to irk the Judge was that the FDA should not have announced premium cigar regulations without fully evaluating how to regulate premium cigars.
Referring to Michael Edney, the lead attorney for the Cigar Industry, Judge Mehta added: “From the very outset, what Mr. Edney has been saying and I have articulated on a handful of occasions is that the agency. . .didn’t do its homework before it subjected premium cigars to this regulatory scheme. The way that the FDA has treated the issue seems to underscore the lack of evidence that was considered that made these decisions.”
Mehta also criticized the agency for not providing more details about what the deferment process might look like.
Mr. Edney continued to argue that Mehta should still rule in favor of the cigar industry while pointing out that the deferment process could be a problem for a company that applies for a deferment but doesn’t get it by the September 9 deadline. Such a situation could ostensibly make that company’s cigars illegal.
Coyle countered that by reminding the court that earlier this year the FDA had said that premium cigars were the FDA’s “lowest enforcement” priority. Coyle even suggested that premium cigar makers should “trust” that the FDA won’t require products removed from the market just because they missed the deadline. These statements may have even weakened the FDA’s case to some degree.
When the deeming regulations went into effect on August 8, 2016, all products were subject to premarket approval requirements and would be illegal without them. Coyle also appeared to suggest that even though the FDA did give premium cigar manufacturers additional time to keep their products on the market, they would still be required to remove them before September 9, 2020.
Mehta found the FDA’s position to be somewhat contradictory, in that, the government would advise a company to knowingly violate the law by selling its products without an approved deferral or product approval, lowest priority, or not.
“So, we’ll move forward,” added Mehta as he ended the hearing. His court is expected to have a commitment on a decision before September 9.