The Supreme Court heard a case on Monday regarding the Food and Drug Administration’s decision to block several flavored vaping products from the market. The court’s decision next year could change the way the agency regulates tobacco and other products under its purview.
The FDA was sued by two e-cigarette manufacturers after the agency denied their marketing applications in 2021. The manufacturers, Triton Distribution and Vapetasia, argued that the FDA unfairly changed its standards in the middle of the application process by adding a requirement for long-term studies. The FDA, meanwhile, maintains that it was right to deny the companies based on a lack of evidence of public health benefit.
The 5th U.S. Circuit Court of Appeals ruled against the FDA in January, taking issue with the agency saying it is not bound to statements made in its guidance documents. If the Supreme Court upholds this decision, the FDA may release fewer guidance documents in areas beyond tobacco regulation. Guidance documents give companies insight into the agency’s broader thinking on various regulatory issues.
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