The U.S. Food and Drug Administration (FDA) faced intense scrutiny from a Fifth Circuit appellate panel on Tuesday over whether it violated federal law by implementing a heightened review standard to reject millions of flavored vape applications without public notice and comment.

The legal battle centers on the FDA’s “comparative efficacy standard.” Under this policy, manufacturers of non-tobacco-flavored e-liquids must prove their products are more effective at helping adult smokers quit than plain tobacco-flavored alternatives to gain marketing authorization.

The “Notice and Comment” Legal Battle

The plaintiffs, including Wages and White Lion Investments (doing business as Triton Distribution) and Vapetasia, argue that this comparative standard is a de facto regulatory rule. Under the Administrative Procedure Act (APA), the FDA is legally required to subject such rules to a public notice-and-comment period before implementation.

Eric Heyer, representing the vape companies, argued that the FDA applied this standard in the abstract, entirely divorced from the specific youth-use risk evidence presented in individual applications.

U.S. Circuit Judge Edith Jones, a Ronald Reagan appointee, expressed strong agreement with the plaintiffs. “Under the test of the Fifth Circuit, if it walks like a rule and it squawks like a rule, it’s subject to notice and comment,” Jones noted, adding that the FDA was “arbitrarily putting hundreds of thousands of small businesses out of business.”

FDA Defends Case-by-Case Adjudication

Justice Department lawyer Joshua Koppel, representing the FDA, countered that the agency did not engage in advance rulemaking. Instead, he argued the FDA simply “adjudicated a lot of applications in a similar way,” characterizing the consistent decisions as standard administrative practice.

Koppel asserted that the plaintiffs’ arguments relied on a rescinded internal FDA memo. However, Judge Jones remained skeptical, pointing out that 99% of subsequent marketing denials used identical language directly lifted from that supposedly discarded policy.

A History of Regulatory Friction

The dispute is part of a broader regulatory crackdown that began in 2016 when the FDA designated e-cigarettes as tobacco products under the Tobacco Control Act. In 2021, the agency issued mass denials for over a million flavored vape products, citing their high appeal to youth.

While the U.S. Supreme Court overturned a previous Fifth Circuit ruling in 2025 that deemed the FDA’s denials “arbitrary and capricious,” the high court explicitly declined to rule on the notice-and-comment issue, leaving the door open for the current challenge.

The three-judge panel, which also includes Judges Leslie Southwick and Catharina Haynes, has taken the case under submission. No timeline has been given for the final ruling.

• Source: FDA defends heightened review requirement for flavored vapes at Fifth Circuit