FDA Memos Reveal Its “Fatal Flaw” Rejection Plan for Flavored Vapes

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There’s an ongoing theory about the Food and Drug Administration (FDA) within the vaping community: The agency did not anticipate the onslaught of 6 million-plus premarket tobacco product applications (PMTAs) it received by a September 2020 deadline, and had to devise some way to try to sort through them all by the following year.

It would be no easy feat, but the bar for authorization would be set incredibly high—and that, in the FDA’s view, would help.

Documents obtained by Filter shed new light on how this murky process has looked from the heavily criticized agency’s perspective. For the first time, they also give an indication, from the agency itself, of something else the vaping community has long inferred: that the FDA—despite some protestations to the contrary—has taken a systemically different approach to PMTA applications for the flavored products on which so many former smokers depend.

Read full article here.

Alex Norcia – Filter – 2021-11-03.

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