FDA must reconsider rejection of flavored vapes - 11th Circuit

3 minute read

Flavored vape cartridges are pictured for sale at a shop in Atlanta, Georgia, U.S., September 26, 2019. Picture taken September 26, 2019. REUTERS/Elijah Nouvelage

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  • Decision creates split with 5th, D.C. Circuits over FDA's review of flavored vapes
  • Dissent says agency remand will "waste everyone's time and money"

(Reuters) - The U.S. Food and Drug Administration must reconsider its denial of six companies' applications to sell e-cigarette products, a federal appeals court has ruled.

A 2-1 panel of the 11th U.S. Circuit Court of Appeals ruled Tuesday that 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.

The decision puts the court at odds with the D.C. Circuit and 5th Circuit, which have upheld the FDA's authority to deny similar applications without considering the manufacturers' plans for avoiding underage use.

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The FDA declined to comment.

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

"FDA would be wrong to assume that it can simply paper up its review of the marketing plans and issue new denials," said Jerad Najvar of Najvar Law Firm, who represents e-cigarette liquid makers Diamond Vapor, Union Street Brands, Vapor Unlimited LLC and Johnny Copper LLC. He 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 a request for comment.

E-cigarettes deliver nicotine by vaporizing a liquid, rather than burning tobacco. In 2016, the FDA determined that e-cigarettes were subject to its regulation, like traditional tobacco products, and gave manufacturers until 2020 to apply for approval.

The six companies last fall petitioned the 11th Circuit to review the FDA's denial of their applications to market various flavored e-cigarettes and liquids, which were among the more than 55,000 such products the agency rejected last year.

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. 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 e-cigarettes would compel the FDA to reach the same result.

"I would not waste everyone's time and money with a remand," she said.

The case is Bidi Vapor LLC v. U.S. Food and Drug Administration et al, 11th U.S. Circuit Court of Appeals, No. 21-13340.

For the plaintiffs: Eric Gotting of Keller & Heckman for Bidi Vapor; Jerad Najvar of Najvar Law Firm for Diamond Vapor, Union Street Brands, Vapor Unlimited and Johnny Copper LLC; Eric Heyer of Thompson Hine for Pop Vapor Co

For the government: Kimberly Stephens, Zachary Cowan and Isaac Belfer of the U.S. Department of Justice

Read more:

Flavored e-cigarette companies lose challenge to FDA marketing denials

Flavored e-cigarette company challenges FDA marketing denial

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.