Ball in FDA’s Court as Official Review Cites Its Chaos, Opacity Over Vapes


On December 19, the Reagan-Udall Foundation, an independent nonprofit tasked by Congress to help modernize the Food and Drug Administration (FDA), released a commissioned report on the agency’s Center for Tobacco Products (CTP).

The expert panel—which mainly consisted of former agency higher-ups—concluded that the CTP has to pivot from “a reactive mode to proactive mode.”

It identified the lack of a coherent plan at the center charged with authorizing or rejecting vaping products, and called for transparency at an agency long characterized by its absence. Yet Reagan-Udall’s demand for an “operational roadmap” was accompanied by a call for more enforcement tools to be put at the FDA’s disposal.

The almost 40-page report highlighted that Reagan-Udall was “unable to identify a current comprehensive plan that clearly articulates CTP’s priorities, direction for the future, and its near-term and longer-term goals and objectives.” Its sweeping suggestions included improving communications and transparency, perhaps through a potential public meeting; adopting methods to allow more stakeholder input; developing clearer frameworks for “high-quality” marketing applications for nicotine products, and increasing “use of the Tobacco Products Scientific Advisory Committee (TPSAC),” an advisory panel that could help guide the center.

Read full article here.

Alex Norcia – Filter – 2022-12-20.

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