5th Circuit Reviews FDA’s Compliance on Small-Business Impact of Vape Rule

Dec.03

A Fifth Circuit panel expressed doubts about whether the U.S. Food and Drug Administration complied with the Regulatory Flexibility Act when issuing its 2021 final rule on premarket tobacco product applications. Vape companies argued the FDA relied on outdated and inaccurate economic data, while the government said the challenged requirements stem from the Tobacco Control Act.

Key Points

Court examined whether FDA complied with the Regulatory Flexibility Act.
Vape companies said the FDA relied on outdated and inaccurate economic data.
Government argued the disputed requirements derived from the Tobacco Control Act.
Judges questioned FDA’s shift in stance between 2016 and 2021.
Debate centered on whether health risk information requirements were discretionary.

2Firsts, December 3, 2025 — According to Law360, a Fifth Circuit panel on Tuesday questioned whether the U.S. Food and Drug Administration met its obligations under the Regulatory Flexibility Act when it issued its 2021 final rule for premarket authorization of new tobacco products.

Jerad Wayne Najvar, representing the vaping companies, argued that the FDA used outdated and erroneous economic inputs and failed to consider regulatory alternatives for small businesses. He noted that the agency did not conduct an economic analysis when issuing its 2016 deeming rule.

Judge Edith H. Jones pressed the government on the FDA’s prior acknowledgment in 2016 that small businesses could face substantial compliance costs. Najvar said that even with the 2016 analysis, the FDA did not examine less burdensome alternatives as required by the RFA.

Government attorney Sophia Shams maintained that the contested elements of the 2021 rule were mandated by the Tobacco Control Act and had been addressed during the 2016 deeming rule. Judge Jones, however, questioned whether the FDA’s position was consistent with its earlier statements.

Najvar countered that the FDA had discretion regarding the challenged requirements and argued that the statute only requires health risk investigations “where appropriate,” a term not defined in the law.

The panel consisted of Judges Edith H. Jones, Kurt D. Engelhardt, and Robert R. Summerhays.

References:

[1] 5th Circ. Wary Of FDA Process Behind Rule For New Vapes

Also Read:

[1] U.S. FDA Unveils Next-Generation Agentic AI Tool to Boost Review and Regulatory Efficiency

[2] Vape Company Takes FDA to Court for Stalling Premarket Decision for Half a Decade

[3] AG Miyares Argues Vape Ban Consistent with Federal Law, Seeks Dismissal

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