By Timothy S. Donahue
Top Takeaways:
- Fifth Circuit judges questioned whether the FDA fulfilled its duty under the Regulatory Flexibility Act when finalizing the 2021 PMTA rule.
- Vaping companies claim the FDA used flawed economic data and ignored less burdensome options for small businesses.
- Government attorneys state that the disputed requirements were mandated by the Tobacco Control Act, but judges pressed the agency on earlier acknowledgments regarding compliance burdens.
A Fifth Circuit panel on Tuesday expressed doubt about whether the U.S. Food and Drug Administration followed the Regulatory Flexibility Act (RFA) when issuing its 2021 final rule that details premarket tobacco product application (PMTA) procedures — a rule that vaping companies say places significant and improperly assessed burdens on small manufacturers.
According to reporting from Law360, attorney Jerad Wayne Najvar, who is representing a group of vape companies challenging the rule, told the panel that FDA relied on outdated and inaccurate economic inputs and failed to consider less burdensome regulatory alternatives, as required under the RFA when an agency action is expected to impose substantial costs on small entities.
Najvar also stressed that the agency did not conduct an economic analysis when it issued the 2016 deeming rule, which first expanded FDA’s tobacco authority to include e-cigarettes and vaping products.
Judge Edith H. Jones questioned the government about FDA’s earlier acknowledgments — including those made in 2016 — that the compliance requirements could create significant financial strain on small businesses. Najvar argued that even if the 2016 analysis were accepted, the FDA still did not fulfill its obligation to evaluate other feasible regulatory options that could reduce the impact on small firms.
Department of Justice attorney Sophia Shams argued that the contested parts of the 2021 rule were required by the Tobacco Control Act and had already been addressed during the 2016 deeming process. However, Judge Jones inquired whether FDA’s position was consistent with its previous statements acknowledging the significant burdens on small businesses and whether that history necessitated a more thorough reassessment under the RFA.
Najvar argued that the statute grants the FDA discretion over several of the challenged requirements and that the Tobacco Control Act only requires additional health-risk investigations “where appropriate”—a phrase he stressed is undefined in the statute and therefore does not automatically obligate the steps that FDA now claims are mandatory.
Judges Edith H. Jones, Kurt D. Engelhardt, and Robert R. Summerhays heard the case. A ruling has not yet been issued.
