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08/25/2022

FDA Ordered to Revisit PMTA Denials for Six Vapor Companies

A federal appeals panel ruled the agency did not consider plans to prevent underage use.
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SILVER SPRING, Md. — A federal appeals court directed the Food and Drug Administration (FDA) to reconsider its marketing denial orders (MDOs) for premarket tobacco product applications (PMTA) for six vapor companies.

On Aug. 23, the U.S. Court of Appeals for the Eleventh Circuit in Atlanta ruled the agency's decisions were arbitrary and capricious because it refused to consider the companies' plans to prevent their products from falling into the hands of minors, Reuters reported.

The ruling differs from previous decisions by the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of Appeals for the Fifth Circuit in New Orleans. Both upheld the FDA's authority to deny similar applications without considering the manufacturers' plans for avoiding underage use, the news outlet added.

The FDA declined to comment.

Keller & Heckman, which represents one of the companies, Bidi Vapor LLC, called the ruling "groundbreaking" and said that Bidi "has continued to supplement its comprehensive applications with additional science" as the case has progressed, according to Reuters.

The U.S. Court of Appeals for the Eleventh Circuit granted a judicial stay of the MDO previously issued by the FDA to Bidi Vapor in February, as Convenience Store News reported.

Jerad Najvar of Najvar Law Firm, who represents e-liquid makers Diamond Vapor, Union Street Brands, Vapor Unlimited LLC and Johnny Copper LLC, said the agency had wrongly assumed his clients' liquid products have the same youth appeal as pre-filled liquid cartridges.

A lawyer for the remaining company, Pop Vapor Co, did not immediately respond to the news outlet's request for comment.

Last fall, the six companies petitioned the 11th Circuit to review the FDA's denial of their applications to market various flavored e-cigarettes and liquids. They argued that the agency wrongly refused to consider their plans to avoid underage use, including marketing designed not to appeal to children and age verification on their websites, Reuters reported.

The FDA said that it declined to consider their specific plans because it had previously found similar measures to be ineffective.

Chief Judge William Pryor, joined by Circuit Judge Andrew Brasher, said the FDA's rationale was "akin to a federal district court judge refusing to hear a convicted criminal defendant at sentencing about his reformation plans or the impact on his family because, in the judge's experience, he found that those things do not matter."

Circuit Judge Robin Rosenbaum, dissenting, said remanding the case to the FDA was "futile" because evidence about the risks and benefits of electronic cigarettes would compel the FDA to reach the same result.

Tobacco and vapor companies faced a Sept. 9, 2020 deadline to submit PMTAs for electronic nicotine delivery systems. Companies that submitted PMTAs are generally allowed to continue to sell or distribute their products until the FDA completes its review, unless there is a negative action taken by the FDA on the application. 

The agency received applications for nearly 6.7 million ENDS products.

Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the tobacco product would be appropriate for the protection of public health. The FDA must approve PMTA bids for e-cigarette and vapor products to stay on the market.