Mitch Zeller, who had been the director of CTP for close to a decade, announced that he would retire in April.
The CTP is still reviewing the thousands of remaining premarket tobacco product applications (PMTAs) that companies had to file until September 2020. In fact the FDA is facing multiple lawsuits by a number of vape brands who have had their PMTAs rejected despite submitting all the required documentation.

In the midst of all this, Mitch Zeller, who had been the director of CTP for close to a decade, announced that he would retire in April, while former acting FDA Commissioner Janet Woodcock was criticized for not doing much to address teen vaping rates during her time in the position. While the FDA has not yet made an announcement about Mital’s promotion, it has been quoted by Filter as saying that she will assume the role once Zeller, retires in a few weeks.

“It’ll be status quo for a while, given her long career,” an industry insider, told Filter. However, “she’s probably the best option for permanent head of CTP, given possible alternatives”—by which they meant more prohibition-minded candidates. “To the extent that there are decisions that are ready to go out while she is there, I would expect they would go out,” added another. “I would not expect her to take any new initiatives.”

New Commissioner

Meanwhile last February, the Senate narrowly confirmed Dr. Robert Califf as the next commissioner of the Food and Drug Administration (FDA) with a 50-46 vote. Califf, is a cardiologist has already served as FDA commissioner under President Barack Obama’s administration. Following a bipartisan vote where six Republicans supported him and four Democrats opposed him, he will be taking over from acting commissioner Janet Woodcock.

Many in the vape industry are not too optimistic about Califf’s appointment and are concerned he will just pick up where Woodcock left off. “The FDA has become extremely politicized and his slim confirmation margin is a clear indication he does not have a policy mandate on anything,” said a vape industry insider to Filter. “For an agency that is embattled in PMTA litigation and unwilling to admit how flawed their regulation of the vapor industry has been, Califf needs to completely re-examine his agency’s approach to science and data actually guiding product approval decisions.”

The FDA Has Granted PMTAs to Several Tobacco Flavoured Vape Products 

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In-house journalist covering international vaping news.