Dr. Jane Henney, a former commissioner of the U.S. Food & Drug Administration during the Clinton administration, will lead an external review of FDA’s Center for Tobacco Products (CTP) and food programs.

The review was requested last month by the current commissioner, Dr. Robert M. Califf, after a series of very public mishaps in two different areas of FDA’s purview. While Califf didn’t specify why CTP was included as part of the review, the agency has been in the news related to its handling of e-cigarette and vaping regulation, specifically the product authorization of JUUL.

In late June, FDA formally announced a marketing denial order to JUUL after concluding that JUUL had failed to produce “sufficient evidence regarding the toxicological profile of the products” as part of its premarket tobacco product applications (PMTA), the product approval process FDA uses for e-cigarettes and vaping products. That meant JUUL would soon be forced to remove its products from the market, though the very next day, JUUL went to a federal court and was granted an injunction that prevented FDA from enforcing the ban.

By July 5, FDA took an extraordinary step of announcing that it determined that there were “scientific issues unique to the JUUL application that warrant additional review.” As such, the agency issued its own administrative stay of its June 23 order, meaning the agency itself was pausing the sales ban after it determined it needed to do more work evaluating an application it had previously deemed “insufficient.”

The other area of FDA that will be included as part of the review is the agency’s work in food programs, which have been in the news because of the national baby formula shortage.

The Reagan-Udall Foundation, a 501(c)(3) non-profit dedicated to supporting FDA, is being tasked with leading the review, which is expected to produce a report “within 60 business days of initiation.”

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Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.