Proceedings in a US appeal court could demonstrate how judges are likely to perceive arguments from vaping companies contesting US Food and Drug Administration (FDA) decisions on pre-market tobacco applications (PMTAs).
A three-judge panel with the 11th Circuit Court of Appeals in Miami, Florida has been hearing arguments on three vaping cases: one by Bidi Vapor challenging the denial of its PMTA – which the FDA later rescinded; one by Pop Vapor on its marketing denial order (MDO); and a third combined case consolidating appeals against MDOs issued to Bidi Vapor, Diamond Vapor, Johnny Cooper and Vapor Unlimited.
The court has not yet issued a ruling and it is unclear how the panel will eventually decide, but the comments, questions and arguments from the judges and lawyers offer a hint of what legal rulings could lie ahead.
Bidi’s lawyer Eric Gotting focused on an argument many other lawyers for vape companies, including Juul, are putting forward: that the FDA’s rejection of PMTAs is based partly on requirements for scientific studies that were never properly notified to the companies before PMTAs were submitted.
Gotting told the judges that Bidi asked the FDA “in writing” what the requirement were for PMTAs, and the FDA responded in May 2020 that there were “point blank no specific requirements for comparator products”.
“The FDA left it up to Bidi” which comparators to use, Gotting said. “But four months later, without warning, the FDA did a 180-degree turn.”
ECigIntelligence – 2022-07-19
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