SWT Global Supply, a maker of menthol-flavored e-cigarette liquids, has urged the 8th U.S. Circuit Court of Appeals to revive its rejected application with the U.S. Food and Drug Administration to continue selling its products, arguing that the FDA had not given the company fair notice of what would be required for approval, reports Reuters.
This latest appeal is one of many similar cases by e-cigarette companies following the FDA’s rule deeming e-cigarette products be subject to the same law as cigarettes and the FDA’s denial of millions of applications by manufacturers to sell their products. Federal appeals courts are split as to whether the FDA acted fairly.
SWT lawyer Jerad Najvar told a three-judge panel that SWT’s applications were denied because the company failed to present a controlled trial or study showing that menthol liquids can help adult smokers quit smoking compared to tobacco-flavored liquids. According to Najvar, the FDA’s guidance did not make it clear that such a study would be required.
“A client like mine doesn’t have a lot of arrows in its quiver when it’s trying to fight a decision by a federal agency,” said Navjar, referring to SWT being a small company with limited resources.
Comparing a product’s effectiveness to tobacco-flavored products is “a natural part of the risk benefit analysis,” according to Catherine Padhi, a lawyer for the FDA. She noted that SWT was free to submit additional information to support its application.
In 2021, the FDA denied SWT’s applications for liquids in various nonmenthol flavors, and in 2023, the FDA denied applications for menthol flavors. The nonmenthol denials are part of a separate, still-pending appeal in the 5th Circuit.
Most other appeals courts have sided with the FDA in similar cases.