Fight over flavored vapes lands at Supreme Court
The e-cigarette makers have argued the FDA changed the rules for e-cigarette approval midstream in order to make sure their products did not make it to market
The latest battle in the fight over e-cigarettes has landed in the nation’s highest court.
The Supreme Court on Tuesday agreed to hear a case next session concerning the Food and Drug Administration’s approval process for the sale of e-cigarettes amid concerns about use among children and teenagers.
The Food and Drug Administration asked the Supreme Court to review a lower court’s decision overturning the agency’s denial of two companies’ flavored e-cigarette products, warning the ruling has “far-reaching consequences for public health.”
The decision comes just weeks after the agency authorized the marketing of four e-cigarette products in the United States — the first menthol-flavored vaping products to receive such approval.
But the agency has routinely denied applications for fruit-flavored products, arguing the risks of addicting children outweighs any potential benefits for the larger population.
“In many of those cases, as in this case, the agency has reasoned that the applicants have failed to show that the products’ benefits for adult smokers outweighs the risks they pose to youth,” Solicitor General Elizabeth Prelogar said in her petition to the court.
In the case, Food and Drug Administration v. Wages and White Lion Investments, LLC, the agency argued the Tobacco Control Act requires the agency to ensure new products do not result in “new generations of tobacco-dependent children and adults.”
The e-cigarette makers have argued the FDA changed the rules for e-cigarette approval midstream in order to make sure their products did not make it to the market.
FDA began reviewing marketing applications for e-cigarette products in 2016.
Under the review process, companies have to prove the marketing of their product would be “appropriate for the protection of public health.”
When deciding whether to approve a product, the FDA considers risks and benefits to the entire population, whether people who currently do not use tobacco products would be more or less likely to begin using if the new products were available, and other factors.
Of the e-cigarette products the FDA has approved so far, all are either tobacco or menthol flavored.
Tobacco-control groups have urged the agency to deny applications for products that could appeal to children, pointing to data showing 2.1 million youth said they currently used e-cigarettes in 2023.
“The Supreme Court should overturn the Fifth Circuit decision because it is misguided and, if left to stand, would cause significant harm to public health and especially to the health of our kids,” Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement Tuesday.
Richardson argued the flavors the companies were trying to get approved by the FDA — like “Jimmy the Juice Man Peachy Strawberry” and “Killer Kustard Blueberry” — are “intended to appeal to kids.”
Of the 2.1 million kids who used e-cigarettes, 9 out of 10 said they used flavored e-cigarettes, with fruit flavors being the most popular.
Cases concerning the FDA’s approval process for e-cigarettes have split lower courts, with seven others upholding the agency’s denial orders for flavored e-cigarettes.
The case will likely be argued in October or November and decided by the end of the court’s next term in June 2025.