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FDA under fire for failing to consider how manufacturers would tackle youth vaping when it denied their marketing applications

By Patrick Griffin 3rd December 2022 2 Mins


The US vape regulator has been branded ‘arbitrary and capricious’ over the marketing denial orders it issued to a number of vape manufacturers.

The Court of Appeals for the 11th Circuit found that, in the case of six vape companies, the Food and Drug Administration ‘failed to consider’ all the relevant evidence presented to it.

In a 2-1 majority decision, the court said that the FDA should look again at the denial orders and take into consideration how the companies in question planned to stop minors accessing their products.

The FDA had argued that it had not considered the specific plans because it had previously found similar measures to be ineffective.

Chief Judge William Pryor and Circuit Judge Andrew Brasher, said the FDA’s rationale was similar to a judge refusing to hear mitigation from a convicted criminal before sentencing ‘because, in the judge’s experience, he found that those things do not matter’.

Circuit Judge Robin Rosenbaum, dissenting, said the FDA was right to deny the marketing applications, adding that flavoured vape products played a ‘starring role in introducing a whole new generation to the dangers of vaping and smoking’.

Law firm Keller & Heckman, which represented Bidi Vapor, described the ruling as ‘ground-breaking’ and said its client had continued to ‘supplement its comprehensive applications with additional science’ as the case progressed. Lawyer Jerad Najvar, representing Diamond Vapor, Union Street Brands, Vapor Unlimited LLC and Johnny Copper

LLC, said the FDA had ‘wrongly assumed’ that his clients’ products had ‘the same youth appeal’ as pre-filled liquid cartridges.

He added:

“The FDA would be wrong to assume that it can simply paper up its review of the marketing plans and issue new denials.”

Previously two different appeals courts – the D.C. Circuit and 5th Circuit – held that the vape regulator did have authority to deny similar applications despite failing to consider how manufacturers planned to avoid underage use.

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Patrick Griffin