Fifth Circuit Affirms FDA’s Vape Rule - Tobacco Reporter
The Fifth Circuit Court upheld the FDA's 2021 rule requiring vape manufacturers to disclose health effects data.Summary
The U.S. Court of Appeals for the Fifth Circuit has affirmed a 2021 rule by the Food and Drug Administration (FDA) concerning premarket tobacco product authorization. The rule mandates that manufacturers investigate and disclose data regarding the health effects of their products. A unanimous three-judge panel ruled that the FDA had properly assessed the rule’s economic impact, finding it would not significantly affect a substantial number of small businesses. Plaintiffs, including e-liquid manufacturers and the United States Vaping Association, had argued the FDA improperly relied on a 2016 economic analysis and failed to consider less burdensome alternatives. However, the court disagreed, stating the 2016 assessment was sufficient and that the rule’s requirements are mandated by the Tobacco Control Act. The ruling, in the case of Kealani Distribution LLC et al. v. FDA, leaves the 2021 PMTA rule in effect.
(Source：Tobacco Reporter)
