A Fifth Circuit panel questioned the U.S. Food and Drug Administration this week, raising doubts about whether it properly considered the impact of its 2021 rule requiring premarket authorization for new tobacco products on small businesses. According to Law 360, the judges questioned whether the agency complied with the Regulatory Flexibility Act, which mandates that regulators assess how new rules affect smaller firms. Vape companies argue the FDA relied on outdated economic data and imposed disproportionate costs that could drive many small manufacturers out of the market.
During oral arguments in New Orleans, the panel pressed the FDA on its shift in position between 2016 and 2021, when the agency moved from a more flexible approach to requiring extensive scientific evidence for new products. The judges also asked whether the health risk information requirements were discretionary or mandated by the Tobacco Control Act. The skepticism suggests the court is weighing whether the FDA’s rulemaking process adequately accounted for the realities faced by small vape businesses.
The case comes amid broader challenges to the FDA’s handling of Premarket Tobacco Product Applications (PMTAs), including disputes over flavored e-cigarette denials. If the Fifth Circuit finds the FDA violated the Regulatory Flexibility Act, the agency could be forced to revisit its rulemaking, potentially easing compliance burdens for smaller companies.
