On October 22, the Food and Drug Administration (FDA) put Fumizer’s flavored vaping products back under review—rescinding the denial it had issued in September. The reversal marks the second such rescission from the agency to date.
In early September, the FDA issued a marketing denial order (MDO) for Fumizer’s flavored vaping products. The company, like all others in the United States, had until September 2020 to file a premarket tobacco product application (PMTA) in order for its vapes and e-liquids to remain on the marketplace. The FDA, in turn, had until September 2021 to look over the PMTAs, which companies had to submit for every single product they wanted to keep selling.
The FDA’s rescission by no means ensures that Fumizer’s vapor products will eventually receive authorization. But the move, amid a flurry of lawsuits against the FDA from dozens of vapor companies, might be indicating a pattern: namely that the agency, in its rush to meet a court-imposed deadline, did not consider evidence that would indicate these products met the standard of being “appropriate for the protection of public health.” (This threshold has come to be understood as helping adult smokers switch to a less dangerous alternative while not introducing nicotine to a new generation of users.)
Many manufacturers have repeatedly complained of the FDA shifting its goal posts—and offering guidance on certain studies only after PMTAs had been filed.
“Upon further review … FDA found relevant information that was not adequately assessed previously.”
Filter reviewed a letter from the FDA to Eduard Kirakosyan, Fumizer’s chief executive officer, in which the agency indicated that “upon further review of the administrative record, FDA found relevant information that was not adequately assessed previously.”
“Specifically,” the letter continues, Fumizer’s “application did contain randomized controlled trials comparing tobacco flavored ENDS to flavored ENDS as well as several cross sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review.”
Consequently, “in light of the unusual circumstances,” the agency stated that it “does not intend to initiate an enforcement action,” allowing Fumizer to return to selling its flavored vaping products as the review restarts.
“On October 22, 2021, FDA issued a rescission of denial letter to Fumizer who submitted applications for their new tobacco products to FDA to obtain premarket authorization,” an FDA spokesperson told Filter. “With this rescission, the company’s tobacco products are placed back into the review process.”
Time will tell if the FDA rescinds other companies’ products with the same logic. Nonetheless, by putting Fumizer back under review—only weeks after doing the same for Turning Point Brands (TPB) for similar reasons—the criticisms that have plagued the agency look more and more justified.
Many producers have suspected that the FDA has used a rushed checklist-style method and not the comprehensive, substantive review it had promised. So far, the result of that strategy has forced the agency to admit it overlooked pertinent data.
“I reached out informally to the FDA and the Department of Justice,” Fumizer’s lawyer, George Jawlakian, told Filter. He added that, though initially the intention, the company did not officially file an injunction in a federal court of appeals. “This is the first private company to receive a rescission.” (TPB, which received a rescission first, is publicly traded.)
Now, with TPB and the California-based Fumizer once again under review, consumer advocates, manufacturers and industry observers are back on high alert, trying to suss out the likelihood of more rescissions and whether the existing two already indicate that the current regulatory procedure is a disaster.
“A rescission in California for Fumizer is evidence of the systemic failure of the agency.”
“It’s a demonstration that TPB’s petition for review and motion for a stay wasn’t simply treated like it was because of the jurisdiction TPB filed in,” an industry insider, who requested anonymity so as not to affect the PMTA process, told Filter.
“A rescission in California for Fumizer is evidence of the systemic failure of the agency to ‘adequately assess’ the science and data of a wide range of small- and mid-sized applicants, while giving all of their time and attention to the large companies like Juul and Reynolds.”
Despite a rocky few months for the industry, however, there might be cause for some optimism: On October 8, the FDA performed its initial backtracking, rescinding an MDO it had sent to TPB. The manufacturer, which had petitioned a federal court a few weeks ago to review the MDO, withdrew its appeal after the agency indicated it would reconsider the applications due to “relevant information that was not adequately assessed.” TPB and Fumizer, currently re-installed in the FDA’s PMTA review process, await an eventual and final decision from the agency.
Meanwhile, Triton, Bidi and Gripum have recently had some form of stay temporarily granted, meaning they can continue to sell products for the time being. Another vape company, My Vape Order, has also demanded a rescission, considering that the producer and TPB shared data and included some of the same studies in their respective PMTAs.
The tide, in other words, might slowly be turning. It had initially appeared bleak. Since the early fall, the agency has issued MDOs for most small- and medium-size manufacturers and stated that it needed more time to go through the applications of the industry’s largest players. In mid-October, the FDA authorized the first-ever vaping product to be legally sold and marketed in the US: the Vuse Solo, made by the R.J. Reynolds Vapor Company, and two of its “tobacco”-flavored cartridges.
Update, October 25: This article was updated to add the FDA’s comment.
Juul Labs, Inc has provided unrestricted grants to The Influence Foundation, which operates Filter. Filter’s Editorial Independence Policy applies.