Supreme Court to decide whether FDA unfairly blocked marketing of flavored e-cigarettes

WASHINGTON − Jimmy The Juice Man Strawberry peach? Suicide Bunny Breast milk and cookies? Killer Kustard Blueberry?

The Supreme Court said Tuesday it will decide whether the federal government is unfairly blocking the marketing of flavored e-cigarettes.

The industry argues that the Food and Drug Administration has imposed a de facto ban on non-tobacco flavored products.

Rather than considering the likelihood that flavored e-cigarettes will help smokers switch to less harmful alternatives, manufacturers say, the FDA is focusing primarily on the risk that nonsmokers will be induced to use tobacco products.

“The FDA’s regulatory regime is anything but reasonable,” e-cigarette manufacturers, distributors and retailers told the court.

The FDA said it properly approved the marketing of some tobacco-flavored e-cigarette products, while denying the marketing of more than 1 million products in other flavors, including those purported to taste like candy, fruit and dessert.

These products “pose a serious and well-documented risk of attracting young people to tobacco use,” government lawyers told the Supreme Court.

“Although it is possible that an applicant could demonstrate that the benefits of a particular flavored product outweigh its harms, FDA has denied approval to applicants who have failed to provide this evidence,” they wrote.

Most courts have sided with the FDA when manufacturers challenged the agency’s decisions. But the U.S. Court of Appeals for the 5th Circuit said in January that the government had sent manufacturers “on a fruitless chase.”

After companies “spent untold millions” to comply with the approval process, the appeals court said, the FDA “imposed new testing requirements without any notice.”

“Worse still, after telling manufacturers that their marketing plans were ‘essential’ to their applications, the FDA candidly admitted that it had not read a single word of the million plans,” the court wrote.

The Supreme Court will hear oral arguments at its next session, which begins in October.

Eric Heyer, an attorney at Triton Distribution, said the vaping company “looks forward to the Supreme Court reviewing the FDA’s surprise, after-the-fact imposition of new study requirements and its failure to follow its own guidelines.”

Yolonda C. Richardson, who heads the Campaign for Tobacco-Free Kids, said that if the Supreme Court sided with the 5^th A circuit that would “significantly compromise the FDA’s efforts to protect children’s health from the dangers of flavored e-cigarettes.”

“We will not end the youth e-cigarette crisis if flavours like peach-strawberry, milk and cookies are allowed to remain on the market,” she said.

This article was originally published on USA TODAY: Supreme Court to review FDA’s handling of flavored e-cigarettes