The founder explained that like other vape businesses, the brand is finding it impossible to meet the FDA’s unrealistic regulatory requirements. “Under this environment, we cannot operate a legitimate business,” Xu said. “Our biggest problem was we tried to believe in the FDA – that one day it would regulate this market with common sense.”
Of course this sentiment is echoed throughout the industry. Infact, while the FDA has rejected Premarket Tobacco Product Applications (PMTAs) for small to medium-sized businesses by the thousands, new documents reveal that PMTA reviewers have created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without reviewing their submitted documents.
The FDA’s strategy to quickly sift through and get rid of PMTAs
The uncovered memos reveal how the FDA planned to deal and quickly dismiss 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 recently 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.