The United States federal appeals court has ruled that the Food and Drug Administration (FDA) must reconsider its decision to deny six companies permission to sell e-cigarette products. The ruling has caused a conflict between the court and Washington, D.C. The FDA has declined to comment on the decision.
Attorney Jerad Najvar of the Najvar law firm, representing e-cigarette liquid manufacturers Diamond Vapor, Union Street Brands, Vapor Unlimited LLC, and Johnny Copper LLC, stated that the FDA's belief that it can simply dismiss marketing plan review reports is incorrect. He explained that the agency mistakenly believes that his clients' liquid products have the same youth appeal as pre-filled liquid cartridges. The lawyer for Pop Vapor Co, the remaining company, did not immediately respond.
Electronic cigarettes deliver nicotine through the vaporization of liquid rather than the combustion of tobacco. In 2016, the US Food and Drug Administration determined that electronic cigarettes are subject to their regulation, just like traditional tobacco products, and allowed manufacturers to apply for approval before 2020.
Last autumn, these six companies petitioned with the 11th Circuit Court to review the FDA's denial of their applications to market various flavored e-cigarettes and liquids. These were among the over 55,000 such products that the agency rejected last year.
Chief Justice William Pryor and Circuit Judge Andrew Brasher jointly stated that the FDA's reasoning was due to "a federal district court judge refusing to hear arguments from the defendant regarding their reform plans or their impact on their family, because the judge, based on their experience, found these things to be irrelevant.
Circuit judge Robin Rosenbaum, who holds a dissenting opinion, stated that sending the case back to the US Food and Drug Administration would be "futile".
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