WASHINGTON — The Supreme Court on Monday will hear a dispute over the Food and Drug Administration’s refusal to approve flavored e-cigarettes over public health concerns.
The case puts the FDA’s role in approving new tobacco products under the microscope at a time when e-cigarettes, or vapes, have flooded the market.
Makers of flavored vapes have brought various cases around the country challenging FDA decisions.
Although the FDA won most of those cases, it appealed to the Supreme Court after it lost one of them in the New Orleans-based 5th U.S. Circuit Court of Appeals.
The legal issue before the justices is whether the FDA failed to correctly consider the companies’ requests, in violation of a federal law called the Administrative Procedure Act.
The case focuses on challenges brought by Triton Distribution, which makes e-liquids for vape pens with colorfully named flavors, including Signature Series Mom’s Pistachio and Suicide Bunny Mother’s Milk and Cookies, and Vapestasia, which has sought approval for Iced Pineapple Express, Killer Kustard Blueberry and other flavors.
The FDA has repeatedly declined to approve flavored vapes, saying they might pose a health risk because they could encourage young people to use tobacco. The products nevertheless remain widely available.
The companies, which face potential civil and criminal penalties for marketing products without approval, say the FDA got it wrong, arguing that flavored vapes can be used to help people stop smoking.
Their lawyers argue that the FDA changed its standard for considering flavored vapes in the middle of the process without giving applicants adequate warning.
The agency says it evaluates each application on its merits. The two companies’ applications were rejected because “they failed to support their claims with sufficient evidence in any form,” Solicitor General Elizabeth Prelogar wrote in court papers.
Under the Tobacco Control Act, the FDA has the power to regulate tobacco products, with a special focus on young people. But it began regulating vape products only in 2016, after they were already on the market. The FDA said at the time that it would not take enforcement actions while companies sought approval.
It subsequently concluded that the potential benefits of helping adult smokers quit do not outweigh the potential health risks to young people, who are most attracted to non-tobacco flavored vapes.
The FDA has approved menthol-flavored e-cigarettes, as well as some that are tobacco-flavored.
The agency will have a high profile when President-elect Donald Trump takes office for his second term. Trump has pledged to shake up the health care system, pledging to nominate vaccine skeptic Robert F. Kennedy Jr. to run the Department of Health and Human Services, of which the FDA is part.
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