Vape Company Triton Loses Its Appeal Against FDA Denial

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On July 18, the Fifth Circuit Court of Appeals denied Triton’s petition to review a marketing denial order (MDO) issued by the Food and Drug Administration (FDA) in September 2021.

The decision, which industry observers have been watching for nearly a year, could cap off one of the most significant legal battles between a notable vapor manufacturer and the FDA—one that has been viewed as something of a proxy for a wider struggle.

Dozens of other smaller vape companies have accused the agency of operating unfairly, and will likely be disheartened by this ruling.

Like all other vapor manufacturers, Triton had until September 2020 to file premarket tobacco product applications (PMTAs), which had to prove that their products would be “appropriate for the protection of public health.” It’s an intuitive threshold in theory: Triton had to show, in other words, that its vaping products were more likely to be used by adults looking to switch from cigarettes or stay on a safer alternative, as opposed to attracting a new generation to nicotine.

Read full article here.

Alex Norcia – Filter – 2022-07-19

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