Tobacco Business

[ 20 ] TOBACCO BUSINESS [ JANUARY / FEBRUARY | 22 ] OPINION / VAPOR PMTA RESPONSE products. Importantly, absent these studies, the FDA would just deny the application without reviewing any science submitted. On Aug. 17, 2021, the CTPOS tried to justify its new approach as necessary to overcome the FDA’s determination that all flavored ENDS are attractive to youth, a position the FDA had never before taken. 3 Then, from Sept. 3, 2021, to Sept. 17, 2021, the FDA leaned on its new fatal flaw strategy to reject virtually all flavored ENDS PMTAs—covering more than a million products—without actually reviewing them. There are so many problems with the FDA’s actions, many of which the VTA (Vapor Technology Association) raised in a letter to the FDA on Sept. 14, 2021, as the new plan came into focus. First, less than a month after declaring that long-term studies were not required and almost one year after the application deadline, the FDA implemented its fatal flaw analysis knowing companies had no chance to comply. Second, the FDA’s new claim that all flavored ENDS are attractive to youth contradicts, without science, the FDA’s position to date. Third, since the youth vaping rate was dropping, the denial of all flavors appears to be politically motivated after the acting commissioner’s haranguing by Congress. Importantly, the FDA’s July rationale for quick action on flavored ENDS PMTAs by Sept. 9, 2021, was a fiction since the FDA repeatedly stated that there was no such deadline, and since, as of this writing, the FDA still has not announced any decision on Juul or the majority of PMTAs from the largest manufacturers—the very decisions the FDA stated would have “the greatest public health impact.” In one case, the Fifth Circuit Court of Appeals has called the FDA’s regulatory whiplash a “surprise switcheroo” and a likely unlawful act. However, given the FDA’s tortured rationale and the FDA already knowing the targeted applications would fail the new requirements it was imposing retroactively, it is hard to deny that a political decision to rid the market of flavored e-cigarettes was imposed on the CTP from above. Surely the courts will sort out the legalities and what actual damage has been done to the regulatory process. However, in the meantime, the FDA’s abandonment of science to serve the whims of an acting commissioner is doing violence to those smokers and former smokers who are trying to quit or stay quit, whose flavored e-cigarettes are being ripped from their hands. TB 3 See, FDA Memorandum from Benjamin Appelberg, Deputy Director Office of Science, entitled PMTA Review: Evidence to Demonstrate Benefit of Flavored ENDS to Adult Smokers, August 17, 2021. 2 See, FDA Memorandum from Anne Radway, Associate Director Office of Science, entitled ENDS Containing Non-Tobacco Flavored E-Liquid: Approach to PMTAs not in Substantive Scientific Review (Phase III), July 9, 2021. 1 “Deemed Product Review: A Conversation with the Office of Science,” June 11, 2021, https://www.fda.gov/tobacco-products/ctp-newsroom/ deemed-product-review-conversation-center-tobacco-products-office-sci- ence-06112021-06112021#4 Less than a month after declaring that long-term studies were not required and almost one year after the application deadline, the FDA implemented its fatal flaw analysis knowing companies had no chance to comply. Contributed by Tony Abboud, Executive Director, Vapor Technology Association (VTA)