Law360 (March 31, 2020, 4:29 PM EDT) -- The U.S. Food and Drug Administration has sought court approval to extend an approaching deadline for e-cigarette regulatory applications, saying the novel coronavirus pandemic has ground clinical testing to a halt and crippled vaping supply chains.
The FDA asked the Fourth Circuit on Monday to let a lower court extend the current May 12 deadline by 120 days, though the agency said the extension would not affect the merits of the appeal brought by industry groups trying to block their products from being regulated like tobacco.
"Defendants seek this extension solely because of the coronavirus outbreak and would not do so but for these highly unusual circumstances," the FDA said in a letter to the Maryland federal court.
The FDA said 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. Many FDA staffers have also 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. "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 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 last 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 that the district court's order on deadlines unfairly snared cigar and pipe tobacco manufacturers, as well.
Counsel for the parties did not immediately respond to requests for comment.
The vaping groups are represented by Eric P. Gotting of Keller & Heckman LLP.
The cigar groups are represented by Brian T. Burgess, Benjamin T. Hayes, Andrew Kim and Mark S. Raffman of Goodwin Procter LLP and Michael J. Edney of Steptoe & Johnson LLP.
The FDA is represented by Joshua Revesz, Joseph H. Hunt, David M. Morrell, Eric B. Beckenhauer and Garrett Coyle.
The cases are Cigar Association of America v. FDA, case number 19-2130, in the U.S. Court of Appeals for the Fourth Circuit, and Vapor Technology Association et al. v. FDA et al., case number 20-5199, in the U.S. Court of Appeals for the Sixth Circuit.
--Editing by Nicole Bleier.
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