April 29 update: Judge Grimm grants an extension to FDA
The FDA has asked for and received a two-week extension to deliver the first status report on the agency's progress reviewing PMTAs for mass-market vape manufacturers.
U.S. District Court Judge Paul Grimm received the FDA's motion requesting an extension this morning, and signed off on it almost immediately. The first report is now due on or before May 16.
Since Judge Grimm ordered the progress reports on April 15, the FDA has authorized the most popular product by one of the companies on the FDA's list. The agency granted marketing authorization three days ago for the NJOY Ace and three tobacco-flavored refill pods.
A federal court has ordered the FDA to provide status reports on its progress reviewing tens of thousands of remaining Premarket Tobacco Applications (PMTAs). The decision by U.S. District Court Judge Paul Grimm was issued last Friday, April 15.
The revised order from Judge Grimm grants the motion filed last fall by plaintiffs in the American Academy of Pediatrics, et al vs. FDA lawsuit. They asked Grimm to amend his original decision, which set a new deadline for PMTA submissions, to require that the FDA “provide regular status reports to the Court” estimating when the agency expects to complete review of PMTAs from the largest manufacturers.
The revised remedial order mandates that the FDA report the PMTA review status of all vaping products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar.” It also covers any other product with two percent or more market share (as measured in market reports issued by Nielson, which tracks mass-market sales in outlets like convenience stores and gas stations, but not vape shops and online sellers).
The FDA must issue its first progress report by April 29, and then every 90 days after that. The first report will estimate the percentage of applications by major brands the agency expects to have acted upon by June 22.
Closed-system, pod-based products and recently introduced disposable devices make up the vast majority of the c-store/gas station vaping market—and are the preferred products of adolescent users. The most popular devices, like Juul Labs’ JUUL and the Vuse Alto, remain on the market, protected by FDA enforcement discretion.
The FDA has authorized just three vaping products (and their tobacco-flavored refills), all sold by tobacco companies. But all of those devices—the Vuse Solo cigalike, and the Logic Power and Pro products—own less than one percent of the c-store market.
In early 2021, about five months after the Sept. 9, 2020 PMTA submission deadline, the FDA said it would prioritize PMTA decisions based on market share, completing review of applications for the most popular products first.
But that is not what the agency did. Instead, the FDA announced new criteria for authorization—nearly a year after PMTAs had already been submitted—and then issued form-letter MDOs for nearly all flavored products sold by small, independent manufacturers, using the new criteria.
The plaintiffs in the successful lawsuit against the FDA to change the PMTA deadline are the American Academy of Pediatrics (AAP), AAP’s Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
AAP and the other plaintiffs sued the FDA in 2018, claiming that the FDA violated the Administrative Procedure Act when the agency, in 2017, changed the PMTA submission deadline from 2018 to 2022 without following the usual notice-and-comment rulemaking process. (The agency later split the deadline to 2021 for non-tobacco flavored products and 2022 for tobacco flavors.)
In May 2019, Judge Grimm ruled for the plaintiffs and struck down the 2021/22 PMTA deadline. Soon after, he set a 10-month deadline (May 11, 2020) to submit PMTAs. (The deadline was later delayed because of coronavirus, and the final deadline became Sept. 9. 2021.) The vaping industry challenged the new deadline in court, but lost.
Last November, AAP and the other plaintiffs asked Judge Grimm to modify his original order to require progress reports from the FDA.