Flavored e-cigarette companies lose challenge to FDA marketing denials

Date:

A federal appeals court has concluded that the U.S. Food and Drug Administration did not act unreasonably in barring two makers of flavored liquid for e-cigarettes from marketing their products as the regulator combated a spike in youth vaping.

A 5th U.S. Circuit Court of Appeals panel on Monday on a 2-1 vote ruled that the FDA did not act arbitrarily or capriciously when it rejected premarket tobacco product applications by Triton Distribution and Vapetasia LLC.

  • 5th Circuit on 2-1 vote rules FDA did not wrongly deny applications
  • FDA denials came amid rise in youth vaping nationally

The companies had applied to market products with flavors like sour grape, pink lemonade, crème brulee and milk and cookies and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act, a law U.S. Circuit Judge Catharina Haynes said Congress passed to protect public health.

“In serving that purpose, we cannot say that FDA acted arbitrarily and capriciously by disagreeing with Petitioners as to the significance of the evidence they presented” about their products’ benefits, Haynes wrote.

Eric Heyer, a lawyer for the companies at Thompson Hine, said they will “promptly” ask the entire 5th Circuit to rehear the case.

The FDA had no immediate comment. The agency recently moved to block sales of Juul Labs Inc’s e-cigarettes but put those plans on hold for further review of its application.

The FDA initially considered e-cigarettes as having some promise in helping adult smokers transition from conventional cigarettes, but faced pressure from anti-smoking groups to restrict flavored e-cigarettes amid a rise in youth vaping.

In August 2021, the FDA rejected applications to market 55,000 flavored e-cigarette products from various companies and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.

It soon after denied the applications by Triton Distribution and Vapetasia, citing a lack of scientific evidence demonstrating their products’ benefits to adult smokers that outweighed risks to youths.

A different 5th Circuit panel in October allowed Texas-based Triton to keep selling its products pending its appeal, saying requiring long-term studies was a “surprise switcheroo” following earlier FDA guidance saying they were not needed.

But in Monday’s ruling, Haynes said the FDA had not required studies of how e-cigarettes could help with smoking cessation, only suggesting they would be helpful, and was within its rights to reject the companies’ studies as unreliable.

U.S. Circuit Judge Edith Jones dissented, noting that three other 5th Circuit judges from October’s ruling would have agreed with her that the FDA’s actions were “a “mockery of ‘reasoned’ administrative decision-making.”

The case is Wages and White Lion Investments LLC dba Triton Distribution v. FDA, 5th U.S. Circuit Court of Appeals, No. 21-60766.

For Triton: Eric Heyer of Thompson Hine

For FDA: Noah Katzen of the U.S. Department of Justice Civil Division

Read full article here.

Nate Raymond – Reuters – 2022-07-19.

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