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

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Jerad Wayne Najvar, representing the vaping companies, argued that the FDA used outdated and erroneous economic inputs and failed to consider regulatory alternatives for small businesses.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.