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.
This story first appeared in the January/February 2022 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.
–Story by Tony Abboud, Executive Director, Vapor Technology Association (VTA)
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-science-06112021-06112021#4
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.
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.