Plaintiffs in the lawsuit that changed the submission deadline for Premarket Tobacco Applications (PMTAs) have asked the federal judge in that case to demand the FDA regularly report on its PMTA review process.
A letter sent Nov. 15 to U.S. District Court Judge Paul Grimm from an attorney representing the plaintiffs requests Grimm reopen the case so the plaintiffs can file a motion to amend the judge’s order. They want Judge Grimm to force the FDA to explain its progress on PMTAs submitted by mass-market vaping brands.
“Specifically,” writes attorney Jeffrey Dubner, “Plaintiffs will seek a modification that would require FDA to provide regular status reports to the Court giving FDA’s estimate of the date(s) by which it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for all products for which PMTAs were filed by Juul, Vuse, NJOY, Blu, SMOK, Suorin, and any other brands that rank among the top 10 brands in market share, according to FDA.”
“Modification would be in the public interest because regular reporting by FDA would allow the Court to assess, on a continuing basis, the extent to which FDA is prolonging the unlawful regulatory holiday that contributed to the ongoing epidemic of youth e-cigarette use.”
The plaintiffs in the lawsuit against the FDA are the American Academy of Pediatrics (AAP) and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
On July 28, 2017, FDA Commissioner Scott Gottlieb announced the agency would push back the PMTA deadline from 2018 to 2022. The following year, AAP and the other plaintiffs listed above sued the agency, claiming that Gottlieb had changed the deadline without going through the usual agency process mandated by the Administrative Procedure Act.
In 2019, Judge Grimm ruled for the plaintiffs and gave manufacturers 10 months to submit PMTAs (the deadline was later postponed to Sept. 8, 2020). The FDA was expected to make decisions on most (or at least some) applications within a year, and manufacturers who submitted PMTAs on time were given a year to remain on the market without being subject to enforcement.
Five months after the submission deadline, the FDA announced it would prioritize its resources to complete assessments of the most popular products first. But when the agency’s self-imposed one-year review deadline rolled around, the FDA had made no decisions on the products with the greatest market share. Today, almost three months into its second year of reviews, the only PMTA from a mass-market vaping product the FDA has ruled on—to either authorize or deny—is the decidedly unpopular Vuse Solo.
In addition to asking Judge Grimm to monitor the FDA’s PMTA review progress on popular vape brands, AAP and the other plaintiffs complain that the agency has not taken any enforcement actions against companies still waiting for a PMTA decision. The companies haven’t been given formal extensions to remain on the market, and they haven’t been ordered off the market.
“FDA has issued marketing orders or marketing denial orders only for products with minimal market share, withholding decisions on any of the e-cigarette products sold in significant quantities, including the products most responsible for the youth vaping epidemic,” the plaintiffs’ attorney writes. “Second, FDA appears not to have enforced premarket review requirements against any companies awaiting PMTA decisions, suggesting they may have renewed their blanket extrastatutory exemption for such companies.”
The FDA is mired in legal actions challenging its cookie-cutter PMTA review process that has led to the vast majority of small, independent vape manufacturers receiving Marketing Denial Orders (MDOs). It has been forced to rescind some MDOs, and others have been stayed by federal courts while the courts review the denials.
It is unclear what Judge Grimm can or will do, but it’s certain that whatever action he takes (or doesn’t take) will make someone very unhappy.