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Vapes: Supreme Court will decide if FDA unfairly blocked marketing of flavored e-cigarettes
By Maureen Groppe, USA TODAY,
7 hours ago
WASHINGTON −Jimmy The Juice Man Peachy Strawberry? Suicide Bunny Mother's Milk and Cookies? Killer Kustard Blueberry?
The Supreme Court said Tuesday it will decide if the federal government is unfairly blocking the marketing of flavored e-cigarettes.
The industry contends the Food and Drug Administration has imposed a de facto ban on non-tobacco flavored products.
Supreme Hypp Max Flow flavored vaping e-cigarette products are displayed in a convenience store on June 23, 2022 in El Segundo, California. PATRICK T. FALLON, AFP via Getty Images
Instead of considering the likelihood that flavored e-cigarettes will help smokers switch to less dangerous alternatives, the manufacturers argue, the FDA is focusing primarily on the risk that non-smokers will be enticed into using tobacco products.
"FDA’s regulatory regime has been anything but reasonable," the manufacturers, distributors and retailers of e-cigarettes told the court.
The FDA says that it's properly approved the marketing of certain tobacco-flavored e-cigarette products while denying the marketing of more than a million products with other flavors, including those meant to taste like candy, fruit, and desserts.
Those products "pose a serious, well- documented risk of attracting young people to the use of tobacco," the government's attorneys told the Supreme Court.
"Although it is possible that an applicant could show that the benefits of a particular flavored product outweigh its harms, FDA has denied authorization to applicants that have failed to make that showing," they wrote.
Most courts have sided with the FDA as manufacturers have challenged the agency's decisions. But the 5th U.S. Circuit Court of Appeals , in January, said the government sent manufacturers "on a wild goose chase."
After the companies "spent untold millions" to comply with the approval process, the appeals court said, the FDA "imposed new testing requirements without any notice."
"Worse, after telling manufacturers that their marketing plans were `critical' to their applications, FDA candidly admitted that it did not read a single word of the one million plans," the court wrote.
The Supreme Court will hear oral arguments in its next term, which begins in October.
Eric Heyer, an attorney with Triton Distribution, said the vaping company "looks forward to having the Supreme Court review FDA's surprise, after-the-fact imposition of new study requirements and failure to follow its own guidance."
Yolonda C. Richardson, who heads the Campaign for Tobacco-Free Kids, said if the Supreme Court sides with the 5 th Circuit that would “significantly undermine FDA’s efforts to protect the health of children from the harms of flavored e-cigarettes.”
“We will not end the youth e-cigarette crisis if flavors like peachy strawberry and milk and cookies are allowed to remain on the market,” she said.
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