A Maryland federal judge on Friday said that he would grant a 120-day extension to the deadline for e-cigarette regulatory applications in light of the novel coronavirus outbreak that has strained U.S. Food and Drug Administration resources and disrupted supply chains.
Last week, the FDA asked the Fourth Circuit to extend the current May 12 deadline in light of the coronavirus outbreak, saying that many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted in-person testing in light of the COVID-19 pandemic.
In a one-page indicative ruling, U.S. District Judge Paul W. Grimm said he would agree to extend the deadline for e-cigarette premarket tobacco applications to Sept. 9.
The FDA told the Fourth Circuit on March 31 that many of its staff have been enlisted by the U.S. Public Health Service to help fight the pandemic, limiting the agency’s ability to review applications.
“Also, virtually the entire FDA staff responsible for reviewing premarket applications will be teleworking until further notice,” the agency said in the letter. “While the FDA has taken steps to enable work to be performed remotely as much as possible, the agency anticipates that it will take additional time for a remote workforce to receive and process applications and conduct scientific review of those applications.”
Travel restrictions around the world have also limited the FDA’s ability to gather information about vape manufacturers in countries including Italy, China, Honduras, the Dominican Republic, Nicaragua and Mexico, according to the letter.
On the industry side, the pandemic has disrupted supply chains, including shuttering factories abroad that manufacture vape products. The FDA said it has received 15 letters from groups representing thousands of market players requesting a 180-day deadline extension in light of COVID-19 disruptions.
“At this point, we do not believe that an extension at the upper end of that range is appropriate given FDA’s countervailing critical public health priority in promptly requiring submission of applications,” the agency said, though it acknowledged a 120-day extension was necessary to fight the pandemic’s spread and protect vaping industry workers.
The vaping industry is challenging the FDA’s deadline in both the Fourth and Sixth Circuits.
The pair of appeals stem from an effort by public health groups to accelerate the FDA’s regulation of vaping products under the Tobacco Control Act, citing vaping-related lung injuries that sickened thousands of people and left nearly 70 dead in 2019. Those groups partially succeeded but also landed the FDA in a scrum with vape shops and e-cigarette manufacturers, who intervened in the case and are now fighting the new regulatory timeline in federal appeals courts.
The lawsuit stems from health organizations and anti-vaping groups’ bid to speed up so-called pre-market approval applications for vaping companies, which have proceeded slowly since the FDA first determined vapes should be regulated like tobacco products.
The court imposed the May deadline in July, but the vaping groups that intervened in the case are now challenging the regulations. They say the FDA flouted the formal rulemaking process and imposed a one-size-fits-all application process, contrary to the case-by-case approach called for by the Tobacco Control Act.
Cigar industry groups have teamed up with the vaping groups and filed joint briefs on appeal. Those groups argue the district court’s order on deadlines unfairly ensnared cigar and pipe tobacco manufacturers, as well.
Representatives for the parties didn’t immediately respond to requests for comment on Monday.
The public health groups are represented by Dennis A. Henigan and Mark E. Greenwold of the Campaign for Tobacco-Free Kids, Javier M. Guzman and Jeffrey B. Dubner of the Democracy Forward Foundation and Eve L. Hill of Brown Goldstein & Levy.
The FDA is represented by Mark B. Stern, Lindsey Powell and Joshua Revesz of the U.S. Department of Justice‘s Civil Division, general counsel for the Department of Health and Human Services, Robert P. Charrow, and Stacy Cline Amin, Wendy S. Vicente, Samantha Hong and Peter G. Dickos of the FDA chief counsel’s office.
The vape trade associations are represented by Eric P. Gotting of Keller & Heckman LLP.