Commissioner Califf urged to allow small businesses trying to comply with the synthetic nicotine ban to remain on the market for longer than the 60 stipulated days, in order to have sufficient time to prepare their marketing applications.
The new FDA Commissioner Robert M. Califf M.D., has just received a letter in opposition to a new regulation signed into law by Congress, that would ban any vaping products containing synthetic nicotine. The substance is currently manufactured and sold legally across the US.

The groups are also urging Commissioner Califf to allow small businesses trying to comply with the new restriction, to remain on the market for longer than the 60 stipulated days as they prepare their marketing applications.

Dr. Robert Califf was confirmed by senate as the next commissioner of the Food and Drug Administration (FDA) with a 50-46 vote, last February. He is a cardiologist and 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.

FDA pressured to reject PMTAs

Meanwhile earlier this year, Attorneys General from 31 states signed a joint letter asking then FDA acting commissioner Janet Woodcock, to deny PMTAs for vaping products in a bid to prevent teen vaping.

“As the FDA reviews pending Premarket Tobacco Product Applications, the undersigned Attorneys General urge it to deny applications that will exacerbate America’s youth nicotine epidemic and jeopardize our children’s health,” notes the end of the letter, dated August 18, 2021. “In addition to addressing the explosion of high-nicotine, flavored e-cigarette products popular among youth, the FDA should be proactive—not reactive—in its approach to newer nicotine products, such as pouches, gums, and lozenges, to ensure they do not add to that epidemic. Now is the time to take decisive action to rein in all youth-appealing products before irreversible damage is done to the public health.”

Former acting FDA Commissioner Janet Woodcock was criticized for not doing much to address teen vaping rates during her time in the position. Meanwhile 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.”

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