Fifth Circuit Upholds FDA’s 2021 PMTA Rule, Citing Statutory Health-Study Requirements
The Fifth Circuit Court affirmed the FDA’s 2021 rule requiring health-risk investigations for new tobacco products, upholding the agency's compliance with regulatory procedures.Summary
The Fifth Circuit Court of Appeals has upheld the U.S. Food and Drug Administration’s (FDA) 2021 rule mandating premarket authorization for new tobacco products to include information on health-risk investigations. The court found that the FDA satisfied the procedural requirements of the Regulatory Flexibility Act (RFA) and reasonably relied on a 2016 economic analysis to assess the impact on small businesses. Plaintiffs, including e-liquid manufacturers, argued the rule improperly relied on the older analysis and failed to consider less burdensome requirements. However, the court determined the FDA acted in good faith and that the disclosure of health-risk information is mandated by the Tobacco Control Act. The decision leaves the challenged rule intact, requiring companies to submit comprehensive health-risk data with their applications.
(Source：2Firsts)
