Memos Show FDA Overruled Science-Office Call to OK Menthol Vapes

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New evidence provides the clearest signal yet that the Food and Drug Administration (FDA) is opposed categorically to authorizing non-tobacco flavored vapes—something indicated by reams of rejections under its premarket tobacco product applications (PMTA) process, but never explicitly stated.

Two memos reviewed by Filter indicate that the office of Brian King, director of the FDA’s Center for Tobacco Products (CTP), intervened to push back against the CTP Office of Science’s recommendation to authorize menthol vaping products for the first time.

These documents appear to reveal substantial disagreement within CTP, one that could be framed as the agency’s scientists battling against its bureaucratic upper ranks, who have the FDA commissioner, and ultimately Congress, to answer to.

It can all be viewed, in other words, as a fight between science and politics. The news has angered tobacco harm reduction proponents, who point out that most adults who switch from cigarettes to vapes find flavors, in general, helpful—and sometimes even critical to their doing so. No non-tobacco flavored vapes have yet been authorized.

At the end of October, the CTP denied the PMTAs for Logic’s menthol-flavored e-cigarettes.

Read full article here.

Alex Norcia – Filter – 2022-12-14.

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