Despite shifting the PMTA deadline back and forth numerous times, leaving the smaller vape companies unprepared, over 500 businesses (most of which are small) managed to meet the deadline. In total, over 6.5 million Premarket Tobacco Applications were submitted, one for each product from every brand and any slight variation of it.
The FDA was expecting less applications
The CTP used “a database query to identify the top twelve manufacturers with the largest number of pending PMTAs not in Phase III for non-tobacco flavored e-liquid products,” and put them through the “Fatal Flaw” review.
A recent blog on the Competitive Enterprise Institute’s website highlighted that this was way over the 25 applications a year that the FDA initially expected. “Perhaps that explains why the FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle,” reads the blog.
The first batch of rejections came in early August 2021, when the FDA announced that it would not even review the 4.5 million applications from the same company, JD Nova, on grounds that they did not include an adequate Environmental Assessment. At the end of the same month, the agency issued marketing denial orders, or MDOs, for applications related to flavoured vaping products (55,000 from one company and 800 from another), based on the excuse that these failed to provide “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”
The agency added that such evidence, “would likely be in the form of a randomized controlled trial or longitudinal cohort study,” though it leaves room for other types of evidence “if sufficiently robust and reliable.”
And now, documents obtained by Filter sadly seem to confirm the above, whilst also indicating a bias towards flavoured products. The FDA had previously indicated that the threshold to be met would largely involve a balancing act between the products facilitating smoking cessation for adults whilst not being attractive to minors. The agency had also made it clear that it would likely require at least one of two studies: a longitudinal cohort study or a randomized controlled trial (RCT), in order to prove the above.
However, in later announcement about the PMTA process, the agency’s director of the Center for Tobacco Products, Mitch Zeller had stated that the FDA “does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.” The agency never really expanded on what kind of other evidence that would be.
The “Fatal Flaw”
Meanwhile, the uncovered memos reveal how the FDA planned to deal with the heavy volume of applications. “Office of Science has been tasked with developing a new plan to effectively manage the remaining non-tobacco flavored ENDS PMTAs not in Phase III, substantive scientific review,” reads a memorandum signed on July 9 by Matthew Holman, the director of CTP’s Office of Science.
“This task has been assigned by the Acting Commissioner given the likely impact on the marketplace on September 10, 2021 (the end of the enforcement discretion period for deemed tobacco products) and in order to take final action on as many applications as possible by September 10, 2021.”
“Considering the large number of applications that remain to be reviewed by the September 9, 2021 deadline, OS [Office of Science] will conduct a Fatal Flaw review of PMTAs not in Phase III for non-tobacco-flavored ENDS products,” the memo goes on. “The Fatal Flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies.”
The memo actually states that the studies’ content will not hold any weight. “The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies.”
Quoting the memo, Filter explained that the CTP used “a database query to identify the top twelve manufacturers with the largest number of pending PMTAs not in Phase III for non-tobacco flavored e-liquid products,” which then represented 85% of all pending PMTA applications. The agency pulled these applications “out of their respective place in the PMTA priority list,” and once “Phase II filing was initiated,” they underwent the “Fatal Flaw” review. A former CTP employee said that they had never heard of the “Fatal Flaw” standard until now.
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