WASHINGTON – The Supreme Court On Monday, he will hear a dispute over the Food and Drug Administration’s refusal to approve flavored e-cigarettes due to 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, flood the market.
Manufacturers of flavored vapes have brought various cases across the country challenging the FDA rulings.
Although the FDA won most of those cases, it appealed to the Supreme Court after losing one of them at the 5th U.S. Circuit Court of Appeals in New Orleans.
The legal issue before the court is that the FDA failed to properly review the companies’ requests in violation of a federal law called the Administrative Procedure Act.
The case focuses on the challenges brought by Triton Distribution, which makes e-liquids with colorfully named flavors, including Mom’s Pistachio and Suicide Bunny Mom’s Milk and Cookies and Vapstasia, which is seeking approval for Iced Pineapple Express, Killer Custard. Blueberry and other flavors.
The FDA has repeatedly refused to approve flavored cigarettes, saying they could pose a health risk because they could encourage young people to use tobacco. Nevertheless, the products are widely available.
The companies, which face potential civil and criminal penalties for marketing the products without approval, say the FDA got it wrong, arguing that flavored vapes can be used to help people quit smoking.
Their attorneys argue that the FDA changed the standard for reviewing flavored vapes midway through the process without giving applicants adequate notice.
The agency states that it evaluates each application on its merits. General counsel Elizabeth Prelogar wrote in court filings that the two companies’ applications were rejected “because they failed to support their claims with any form of sufficient evidence.”
Under the Tobacco Control Act, the FDA has the authority to regulate tobacco products with a special focus on youth. But it only started regulating vape products in 2016, after they were already on the market. The FDA said at the time that it would not take enforcement action when companies seek approval.
It subsequently concluded that the potential benefits of helping adult smokers quit do not outweigh the potential health risks for youth, who are most drawn to non-tobacco flavored vapes.
There is an FDA approved menthol-flavored e-cigarettesalso some tobacco flavored.
The agency will be highly regarded when US President-elect Donald Trump takes office for a second term. Trump has vowed to shake up the health care system by nominating vaccine skeptic Robert F. Kennedy Jr. to lead the Department of Health and Human Services, of which the FDA is a part.