Fifth Circuit’s Latest Decision Affirms FDA’s Unlawful PMTA System

Published on August 24, 2026

FIFTH CIRCUIT’S LATEST DECISION CONFIRMS FDA’S UNLAWFUL PMTA SYSTEM IMPOSES “DE FACTO BAN” ON FLAVORED VAPES

The decision underscores years of advocacy from the independent vapor industry for the transparent, science-based regulation needed from the Trump Administration.

WASHINGTON, D.C. — August 24, 2026 — Last week the U.S. Court of Appeals for the Fifth Circuit reinforced the independent vapor industry’s advocacy for a complete reset of vapor regulation with its decision in NicQuid, LLC v. U.S. Food and Drug Administration. The court found that FDA used the PMTA regulation to impose a “de facto ban” on flavored vapor products based on sweeping regulatory decisions made “behind closed doors,” exposing the fundamentally unlawful manner in which FDA has repeatedly crushed American small businesses for years.

The Fifth Circuit indicted the FDA for creating a binding regulatory rule without any regulatory authority that its explanations of how it handled flavored vapes “cannot conceal or excuse the secretive development of a prospective policy…[t]his is not a close call.”

“This decision lays bare the fundamental problem with FDA’s entire approach to PMTA,” said Tony Abboud, Executive Director of VTA. “FDA did not merely make a technical mistake in reviewing one company’s applications. It built its vapor regulatory regime around standards that were never lawfully adopted, were developed behind closed doors, and were then used to suffocate an entire industry. That is not a system that can be repaired around the edges. It must be replaced.”

The decision confirms what the independent vapor industry has argued for years: FDA transformed a product-by-product authorization process into a mechanism for imposing sweeping market policy without first establishing clear, lawful rules governing what manufacturers must prove.

In light of this most recent 5^th Circuit decision, VTA is calling on President Trump, HHS Secretary Robert F. Kennedy Jr., and FDA Acting Commissioner Kyle Diamantas to use the NicQuid decision as the catalyst for a complete reset of vapor regulation. Specifically, the Administration should replace the current PMTA regulation with clear, transparent, and objective scientific guidance for ingredient purity, nicotine delivery, toxicology, product stability, device performance, and youth protections.

“This Administration inherited a regulatory system that is legally indefensible, scientifically incoherent, and practically unworkable. It should not spend another day trying to preserve it. You cannot tweak a system built on an unlawful foundation. You repeal it and replace it,” Abboud said. “American vapor companies that have suffered under the current unlawful regulation demand reform, certainty and science. American vaping voters deserve to be heard.”

The ruling comes just weeks after national polling released by VTA found overwhelming public support (71%) for repealing and replacing FDA’s current PMTA rules with clear, science-based guidelines for manufacturers.

“Americans have once again made it clear where they stand when it comes to vaping policy. More than 70% of voters want the current rules for vapor products repealed and replaced with clear scientific standards. They do not support the sweeping bans and threat to personal choice that defined the last administration,” said Kellyanne Conway.

The polling also found that a majority of voters (67%) support regulations that protect youth while recognizing adult demand for flavored vapor products and (77%) support allowing products with pending FDA applications that do not target youth to remain on the market while a new system is implemented.

“The legal case for change and the public case for change are now aligned,” Abboud said. “The Fifth Circuit has exposed the unlawful foundation of FDA’s approach, and voters overwhelmingly want that approach repealed and replaced. The time is now for the Trump Administration to keep its promise to save flavored vapes by dismantling the broken system which has crushed American small businesses, and replacing it with one that protects youth, preserves adult choice, and gives American manufacturers and small businesses a clear and lawful pathway to compete.”

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