The FDA Center for Tobacco Products will name current CTP Deputy Director Michele Mital as acting director when Mitch Zeller retires in April. The agency is conducting a search for a permanent director.
The news was first reported Wednesday afternoon in a tweet by FDA Tracker, and confirmed by Filter reporter Alex Norcia after speaking with FDA sources. No formal announcement has been made.
ECig Intelligence reported March 25 in a paywalled article that Mital is the most likely candidate to take over the permanent position, although other applications are still being reviewed. ECig Intelligence says she is considered to be “a safe pair of hands,” based on her 25-year history with the agency.
Whoever is chosen for the permanent director job will have to win the approval of new FDA Commissioner Robert Califf and Health and Human Services Secretary Xavier Becerra. Both men are somewhere between skeptical and antagonistic toward vaping. In recent years, both have advocated for outright bans of flavored products.
Mital joined the FDA in 1996, and has held various positions in the agency, including in the Office of Legislation. Since the CTP was formed in 2009, Mital has worked there in various capacities. She was named deputy director in 2018.
Mitch Zeller has been CTP director since 2013—just the second person to hold the position since the CTP was created in 2009. He led the agency as it granted itself regulatory authority over e-cigarettes with the 2016 Deeming Rule, and has presided over the chaotic implementation of the premarket review process.
After a year spent reviewing PMTAs, the agency issued millions of cookie-cutter Marketing Denial Orders (MDOs) to hundreds of small vaping manufacturers, wiping out more than 99 percent of the legal vaping market. Now the FDA faces dozens of legal challenges from independent vaping manufacturers, and has been forced to rescind some MDOs, while others have been stayed by federal courts.
The agency has authorized just three vaping devices (plus tobacco-flavored refills) since the PMTA submission deadline in September 2020.
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Because of declining cigarette sales, state governments in the U.S. and countries around the world are looking to vapor products as a new source of tax revenue.
The legal age to buy e-cigarettes and other vaping products varies around the world. The United States recently changed the legal minimum sales age to 21.
A list of vaping product flavor bans and online sales bans in the United States, and sales and possession bans in other countries.
