Fifth Circuit Upholds FDA’s 2021 PMTA Rule, Citing Statutory Health-Study Requirements

Feb.27

A Fifth Circuit panel upheld the U.S. Food and Drug Administration’s 2021 final rule requiring companies seeking premarket authorization for new tobacco products to include information on health-risk investigations. In a published opinion, the court found FDA satisfied the Regulatory Flexibility Act’s procedural requirements and reasonably relied on the economic analysis from the 2016 “deeming rule” as a factual basis to certify limited impact on small businesses.

Key Takeaways

The Fifth Circuit upheld FDA’s 2021 PMTA rule on Feb. 26, 2026.
The court said FDA made a reasonable, good-faith effort to meet the RFA’s procedural requirements.
The panel found the 2016 “deeming rule” cost assessment supported FDA’s certification on small-entity impact.
The court said PMTA disclosure of health-risk investigation information is mandated by the Tobacco Control Act.
The case is Kealani Distribution LLC et al. v. Food & Drug Administration et al., No. 25-40135.

2Firsts, February 27, 2026

According to Law360, the U.S. Court of Appeals for the Fifth Circuit affirmed that the U.S. Food and Drug Administration complied with the law when it issued a 2021 rule requiring companies seeking premarket authorization of new tobacco products to investigate and disclose information about the product’s health effects.

In a published opinion, the three-judge panel held that FDA met its obligations under the Regulatory Flexibility Act (RFA) to certify that the 2021 final regulation would not have a significant economic impact on a substantial number of small entities. The unanimous decision concluded that FDA made a reasonable, good-faith effort to comply with the RFA’s procedural requirements and affirmed a trial court’s February 2025 grant of summary judgment to the agency.

The plaintiffs — a group of e-liquid manufacturers and the trade group United States Vaping Association — argued that the 2021 rule improperly relied on an economic analysis conducted for a prior 2016 “deeming rule” governing premarket tobacco product authorizations. The court found the 2016 cost assessment provided an adequate factual basis for FDA’s certification regarding the 2021 final PMTA rule.

The plaintiffs also contended FDA failed to consider less onerous requirements. The Fifth Circuit rejected that argument, finding that several requirements described as burdensome — including the obligation that applicants submit information about the potential dangers and benefits of their products — were mandated by the Tobacco Control Act. The court held that the requirement for an applicant to include all known information concerning health-risk investigations in a PMTA is imposed by statute, and FDA cannot dispense with a congressional mandate through regulation.

The lawsuit, filed in October 2022, alleged that many in the industry spent significant money attempting to comply with what they called FDA’s burdensome requirements, only to have applications rejected. The court’s decision left intact the challenged rule.

The case is Kealani Distribution LLC et al. v. Food & Drug Administration et al., case number 25-40135, in the U.S. Court of Appeals for the Fifth Circuit.

Image Source： Law360

References:

[1] 5th Circ. Affirms FDA's Vape Rule Despite Small Biz Concerns

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