On Monday, the U.S. Supreme Court will hear a case challenging the FDA’s decision to ban two e-cigarette companies from selling flavored vape products due to health risks for young people. The FDA’s appeal comes after a lower court ruled that the agency did not follow proper legal procedures when rejecting applications from Triton Distribution and Vapetasia to sell their nicotine products.
Background on the Case The FDA has broadly denied applications for flavored vape products, which Triton and Vapetasia have challenged. A lower court found that the FDA violated proper procedures under the Administrative Procedure Act.
Impact on Regulatory Agencies This case gives the Supreme Court a chance to limit the power of federal regulatory agencies. If the court overrules the FDA, it could allow thousands of potentially harmful e-cigarettes back onto the market.
FDA’s Role and Regulations Since a 2016 rule deemed e-cigarettes as tobacco products, they require FDA approval under the Tobacco Control Act. Triton and Vapetasia applied in 2020 to sell flavors like sour grape and pink lemonade, which critics argue appeal to children. The FDA has approved only 34 flavored e-cigarette varieties, mainly tobacco and menthol, rejecting over a million other products.
Current Situation and Concerns Despite being illegal, many flavored e-cigarettes are still available. The FDA lacks its own litigating power and relies on the U.S. Justice Department to enforce regulations, which has been reluctant to crack down on unauthorized products.
Public Health Risks The FDA argues that flavored e-cigarettes pose significant risks to youths. Studies show high usage rates among high school and middle school students, with flavors being a major attraction. The FDA’s stringent approval process requires proving that any health benefits outweigh the risks.
Legal Arguments The case has seen differing opinions, with the FDA maintaining it followed laws to protect minors, while manufacturers claim the agency imposed shifting and confusing requirements. The 5th U.S. Circuit Court of Appeals sided with Triton and Vapetasia, prompting the FDA to seek a Supreme Court ruling.
