A US federal appeals court has overturned a series of FDA decisions blocking vaping products from the market after ruling that the regulator used an unlawfully imposed standard that amounted to a “de facto ban”.
The US Court of Appeals for the Fifth Circuit on August 19 granted seven consolidated challenges brought by vape manufacturers and retailers, vacated the Food and Drug Administration’s marketing denial orders and sent the cases back to the agency.
At the heart of the dispute was the FDA’s “comparative-efficacy” standard, which required manufacturers seeking approval for non-tobacco-flavoured vapes to produce evidence showing their products offered greater benefits to adult smokers than tobacco-flavoured vapes.
The court found that the FDA had effectively created a substantive rule that applied across large numbers of applications without putting it through the public notice-and-comment process required by the Administrative Procedure Act.
It said the agency had “sidestepped the notice-and-comment rulemaking requirement of the APA”.
More than 1.2 million flavoured products denied
Under US law, manufacturers must obtain an FDA marketing order before a new vaping product can legally be sold.
The regulator must decide whether allowing a product onto the market would be appropriate for the protection of public health, weighing the potential benefits to existing smokers against risks including uptake among people who do not currently use tobacco.
For products in flavours other than tobacco, the FDA developed a more demanding test. Applicants were expected to demonstrate that their products could help adult smokers quit or switch more effectively than tobacco-flavoured vapes, offsetting what the agency considered the greater appeal of flavours to young people.
The Fifth Circuit said evidence presented in the litigation showed that FDA marketing denial orders had covered more than 1.2 million flavoured vaping products, following applications for more than six million ENDS products.
The judges said the scale and consistency of those decisions supported the conclusion that the comparative-efficacy test was binding FDA reviewers rather than being applied as a genuinely individual assessment.
The court described the approach as a “de facto ban”.
It said the standard had emerged through internal FDA policymaking before being applied to individual applications, rather than being developed openly through formal rulemaking.
The judges agreed with an earlier Fifth Circuit panel that the procedural issue was: “This is not a close call.”
FDA demanded stronger evidence of switching
The lead case involved NicQuid, which submitted premarket tobacco product applications in 2020 covering e-liquids including Menthol Blend, Strawberry-Peach, Spearmint and Sweet Leaf, alongside a zero-nicotine product.
The FDA rejected the applications in May 2024 after deciding there was insufficient evidence that the products would provide enough benefit to adult smokers to outweigh the potential risks to young people.
In particular, the agency said the applications did not contain a randomised controlled trial, longitudinal cohort study or other evidence robustly comparing switching or cigarette reduction among adults using flavoured products with those using tobacco-flavoured vapes.
The court did not rule that the FDA was wrong to consider youth vaping or to demand evidence of benefits to smokers.
Instead, it found that once the comparative-efficacy requirement became a rigid standard applied prospectively across applications, the FDA could not introduce it behind closed doors without following the procedural safeguards required for substantive rulemaking.
The judges said formal rulemaking would have given affected companies an opportunity to respond to the proposed requirements before they became binding.
Supreme Court had left question unresolved
The ruling follows years of litigation over the FDA’s handling of vaping applications.
In 2025, the US Supreme Court sided with the FDA in a separate case brought by flavoured vape manufacturers, rejecting arguments that the agency had acted unlawfully when assessing the evidence required from applicants.
But the Supreme Court specifically declined to decide whether the FDA’s standards should have been introduced through formal notice-and-comment rulemaking because that question was not properly before it.
The Fifth Circuit said the August case presented that unanswered question directly.
It also follows a June ruling involving VDX Distro, in which the same appeals court held that the comparative-efficacy approach was not technically a “tobacco product standard” requiring rulemaking under the Tobacco Control Act. However, that judgment left open the separate question of whether the policy amounted to a substantive rule under the Administrative Procedure Act.
The latest judgment answers that question in favour of the vape companies.
Products have not been authorised for sale
The decision does not mean the vaping products involved have now received FDA marketing authorisation.
Instead, the court vacated the challenged denial orders and sent the applications back to the agency for further proceedings.
FDA rules state that new tobacco products must have a written marketing order before they can legally be introduced into interstate commerce in the US.
The wider significance of the judgment could lie in the FDA’s future treatment of vaping applications. The court’s objection was directed at the way the comparative-efficacy standard was developed and applied across applicants, rather than solely at the evidence submitted by one manufacturer.
That could force the agency to reconsider how it sets evidential requirements for vaping products, or to establish any binding standard through a formal rulemaking process that allows manufacturers and other interested parties to comment before it takes effect.
