Flavored e-cigarette company challenges FDA marketing denial

Date:

A federal appeals court on Monday weighed whether the U.S. Food and Drug Administration wrongly barred a flavored e-cigarette manufacturer from marketing its products, in a case that could curtail the regulator’s efforts to combat youth vaping.

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

The FDA had viewed e-cigarettes as having some promise to help adult smokers transition from conventional cigarettes, but faced pressure to restrict the sale of flavored e-cigarettes, which anti-smoking groups said targeted children.

In August, the FDA rejected applications to market 55,000 flavored e-cigarettes, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.

The requirement for long-term studies differed from earlier FDA guidance and was a “surprise switcheroo,” a 5th Circuit panel concluded in October when it allowed Triton to keep selling e-cigarettes until another panel could hear its appeal.

At Monday’s oral arguments, Eric Heyer, Triton’s lawyer 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’s the height of arbitrariness and capriciousness, to say we are the FDA, trust us, which I might say some of us are becoming skeptical about in light of recent vaccine experiences,” she said, alluding to COVID-19 vaccines.

The other two judges questioned Triton’s case.

U.S. Circuit Judge Gregg Costa asked whether Triton’s products, such as one called Jimmy the Juiceman Strawberry Astronaut, were really targeted to adults.

“That’s supposed to be appealing to a 40-year-old?” he asked.

And U.S. Circuit Judge Catharina Haynes questioned why companies like Triton did not have enough time to develop such support for their products’ health benefits for adults given the years they have had to prepare for FDA regulation.

The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act. Manufacturers were ultimately given until 2020 to seek approval to market them.

“All of these years have passed with little in the way of detailed studies,” Haynes said.

Noah Katzen, a lawyer for the FDA at the U.S. Justice Department, said it had seen no evidence showing the benefits of flavored e-cigarettes outweigh their risks.

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 – 2022-01-31.

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