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.”
Similarly, Durbin is now urging new Commissioner Califf to finally conclude the PMTA reviews, which are now eight months past the court-ordered deadline for the review. Under the Tobacco Control Act, e-cigarette manufacturers must prove to the FDA that entry on the market would be “appropriate for the protection of public health.”
No high hopes about Califf
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 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.
Former acting FDA Commissioner Janet Woodcock was criticized for not doing much to address teen vaping rates during her time in the position, while tobacco harm reduction experts were concerned she is not endorsing tobacco harm reduction. Sadly 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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