Earlier this month, a court case which had been brought about by anti-tobacco and health groups, after the FDA had announced the premarket tobacco product application (PMTA) delay, has resulted in a ruling requiring e-cig manufacturers to submit their PMTAs by May 2020.
“Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry’s recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary,” U.S. District Judge Paul Grimm wrote in his order.
The FDA welcomes the court order
“The judge’s decision sets a rapid pace for the agency to receive and review applications to evaluate the public health benefits and harms of a product and ensure that any product authorized for marketing is appropriate for the protection of public health.”
In response to this ruling, acting FDA Commissioner Ned Sharpless issued a statement saying that given the current concern about teen vaping, this court order is welcomed by the agency. Hence, said Sharpless, the FDA is happy to accelerate the PMTA processes.
“The FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products. And we remain committed to tackling the epidemic of youth vaping using all available regulatory tools at our disposal. We will continue to take vigorous enforcement actions aimed at ensuring e-cigarettes and other tobacco products aren’t being marketed to, or sold to, kids.”
“The judge’s decision sets a rapid pace for the agency to receive and review applications to evaluate the public health benefits and harms of a product and ensure that any product authorized for marketing is appropriate for the protection of public health. Importantly, the judge recognized the agency’s work to provide a framework and clear guidance for companies seeking to market e-cigarette and ENDS products as they prepare their product applications,” added Sharpless.
New PMTA Process
Meanwhile last month, the FDA had issued the finalized guidance for manufacturers submitting new tobacco product applications through the PMTA pathway for electronic nicotine delivery systems (ENDS).
Under the new PMTA pathway, manufacturers and importers must demonstrate to the agency, amongst other things, that marketing of the new tobacco product would be appropriate for the protection of public health. The agency’s evaluation also includes reviewing a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.
Following an extensive review of input from the public on the previous draft guidance, the recently issued guidance further clarified the PMTA process for ENDS products and points out information the agency recommends applicants include in a submission. Importantly, it also includes recommendations for how applicants should address public health issues in the design and manufacture of their products, such as accidental nicotine exposure and battery safety.