Flavored e-cigarette company challenges FDA marketing denial

A customer vapes at a vape shop in Jakarta, Indonesia, October 23, 2020. REUTERS/Ajeng Dinar Ulfiana

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(Reuters) – A federal appeals court on Monday considered whether the U.S. Food and Drug Administration wrongly barred a maker of flavored e-cigarettes from marketing its products, in a case that could stall the regulator’s efforts to combat youth vaping.

A lawyer for Triton Distribution urged a three-judge panel at the 5th U.S. Circuit Court of Appeals in Houston to conclude that the FDA could not force manufacturers to prove that flavored vaping products could help adults quit smoking. smoking combustible cigarettes in order to obtain marketing approval from the agency. them.

The FDA saw e-cigarettes as promising to help adult smokers switch from conventional cigarettes, but faced pressure to restrict the sale of flavored e-cigarettes, which anti-tobacco groups said targeted children.

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In August, the FDA rejected marketing applications for 55,000 flavored e-cigarettes, including those from Triton, and said applicants would likely need to conduct long-term studies establishing the benefits of their products to gain approval.

The requirement for long-term studies differed from previous FDA guidelines and was a “surprise switcheroo,” a 5th Circuit panel concluded in October when it allowed Triton to continue selling e-cigarettes until so that another panel can hear his appeal.

During oral argument on Monday, Eric Heyer, Triton’s attorney at Thompson Hine, said the FDA’s requirement was “arbitrary and capricious, a position conservative U.S. Circuit Judge Edith Jones appeared to agree with. .

“It seems to me that it’s the height of arbitrariness and caprice, to say we’re the FDA, trust us, which I might say some of us are becoming skeptical of in light of recent experiences. vaccines,” she said, alluding to COVID-19. vaccines.

The other two judges questioned Triton’s case.

US Circuit Judge Gregg Costa asked if Triton’s products, like the one called Jimmy the Juiceman Strawberry Astronaut, were really meant for adults.

“Is that supposed to appeal to a 40-year-old man?” He asked.

And U.S. Circuit Judge Catharina Haynes questioned why companies like Triton haven’t had enough time to develop such support for the health benefits of their products for adults, given the years they’ve had to prepare for FDA regulations.

In 2016, the FDA considered e-cigarettes to be tobacco products like traditional cigarettes subject to review by the agency under the Tobacco Control Act. The manufacturers finally had until 2020 to apply for authorization to market them.

“All those years have passed with little detailed study,” Haynes said.

Noah Katzen, an FDA attorney at the US Department of Justice, said he hadn’t seen any evidence showing the benefits of flavored e-cigarettes outweighed their risks.

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

For Triton: Eric Heyer of Thompson Hine

For the FDA: Noah Katzen of the Civil Division of the United States Department of Justice

Read more:

Texas company can continue to sell flavored e-cigarettes, under 5th Circuit rules

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Nathalie Raymond

Nate Raymond reports on federal judiciary and litigation. He can be reached at [email protected]

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