This week the Food and Drug Administration (FDA) has finally released its long-awaited Premarket Tobacco Application (PMTA) guidance for e-cigarettes and vape juice, as the entire vaping industry scrambles to see what the changes might mean for them. Will the FDA kill vaping altogether? It seems unlikely, but the news is not good: The new FDA PMTA deadline and guidance, is no doubt, the FDA’s response to the American Pediatric Association’s (AAP) lawsuit alleging that the FDA was derelict in its responsibility to public health by dragging its feet to regulate e-cigarettes. The federal judge in that case, Hon. Paul Grimm, ruled last month that the FDA’s delay in reviewing vaping products was “so extreme as to amount to an abdication if its statutory responsibilities” and gave the FDA just thirty days to begin reviewing e-cigarette products.
The AAP filed a proposed remedial order in that case asking Judge Grimm to order the Agency to move the FDA PMTA deadline to 120 days — a mere four months from the judge’s order. The FDA filed a response to the APA’s proposed order this week including a statement from FDA Commissioner Mitchell Zeller, that a four-month deadline would “cause significant public health concerns as well as implementation challenges”. The FDA’s response states “It could suddenly clear the market of thousands of e-cigarette products, raising the risk that some former smokers addicted to nicotine might migrate back to conventional cigarettes, and is likely to flood the Agency with thousands of low-quality applications that would strain Agency resources and significantly delay processing… if the Court orders a deadline for the submission of premarket applications, it should set that deadline no sooner than 10 months.”
The FDA response went on to say that as of April 30, 2019 the Agency had received 401 PMTAs, 373 of which were for deemed products and of those “more than 99% (369/373) were closed as insufficient to accept or file, largely for failure to include an environmental assessment” and that only 4 products remained for deemed products, “none of them for e-cigarette products.” The remaining PMTAs are for “heat not burn” products, Big Tobacco’s brainchild.
Within days, the FDA finally released its PMTA guidelines for e-cigarette and vape juice manufacturers.
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