FDA’s PMTA Process May Finally Have More Transparency

April 15, 2022

On April 15, a federal court judge said that the Food and Drug Administration (FDA) will have to report when it expects to take action on the vaping products with the largest market share.

Paul W. Grimm, a judge in the United States District Court for the District of Maryland, granted a motion filed by American Academy of Pediatrics (AAP) and other plaintiffs—many of them public health groups hostile to vaping—that requires the FDA to “forecast the percentages of such products for which it expects to have taken ‘action’ by June 2022 and quarterly thereafter.” The first report must be sent to the court and plaintiffs in two weeks, and every 90 days after that.

The decision is something of a rarity in tobacco control—transparency about a process that has been decidedly opaque, and from which all parties could now potentially stand to benefit.

“When the FDA began issuing product denials and removing millions of products from the market last year, it did so for the businesses representing the smallest market share,” an industry insider, who requested anonymity because their own premarket tobacco product applications (PMTAs) are still pending, told Filter. “That was to the benefit of Big Tobacco and the biggest vapor companies, who were given extra time to have their applications considered.”

“Small businesses will likely be moved to the bottom of the pile while the big guys get their due. I’d consider this a win.”

Now that the agency will be occupied reviewing and providing updates on the PMTAs from the biggest tobacco and vapor companies, the smaller manufacturers still under review may actually benefit by being able to continue selling for longer.

“Small- and medium-sized businesses [have borne] the burden of reckless agency denials caused by the prior bad acts and youth use numbers brought about by only the largest players,” the insider said. “Small businesses will likely have their applications moved to the bottom of the pile while the big guys get their due. I’d consider this a win.”

In July 2017, then-FDA Commissioner Scott Gottlieb pushed the PMTA deadline from 2018 to 2022. In 2018, AAP and the other plaintiffs—including the American Heart Association, the Campaign for Tobacco-Free Kids and the Truth Initiative—sued the agency, arguing that Gottlieb had violated the Administrative Procedure Act.

Then, in July 2019, Judge Grimm gave manufacturers 10 months to submit their PMTAs—which had to prove, as many manufacturers have learned by now, that a given vaping product would be more likely to help an adult smoker switch to a safer alternative than introduce a new generation to nicotine. That deadline was later extended to September 2020 because of COVID-related delays.

The FDA, which had a year to review the PMTAs but did not seem equipped to handle the avalanche of 6.5 million applications, said that it would prioritize the biggest players in the industry. That has not been the case.

So far, the agency has denied millions of those submissions, many from smaller manufacturers. The handful vaping products from tobacco companies that it has authorized are barely used.

 


 

Photograph by Ecig Click via Flickr/Creative Commons 2.0

Alex Norcia

Alex is Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism Review, The Los Angeles Times and The New Republic, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. He is currently based in Los Angeles.

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