The Fight for Small Vape Companies Heads Back to Court

The battle between small, independent vapor businesses and the FDA is far from over. On September 30, a coalition of vape companies—including White Cloud, Vertigo Vapor, American Vapor, Elite Brothers, Vapermate, Breeze Smoke, and others—filed a consolidated opening brief in the U.S. Court of Appeals for the Fifth Circuit challenging the FDA’s recent Marketing Denial Orders (MDOs). 

At the heart of the case is whether the FDA acted unlawfully in how it handled applications (PMTAs) from these companies. The petitioners argue the FDA’s actions have not only ignored science but also threatened the survival of independent businesses that serve millions of adult consumers seeking alternatives to cigarettes. 

Key Issues Raised in the Challenge 

1. Failure to Conduct Full Scientific Review 
    The FDA is accused of issuing mass denials without giving these PMTAs the full scientific review required by law. Instead, the agency relied on a rigid “comparative efficacy” requirement, which petitioners argue served as a shortcut to deny applications en masse. 
2. A De Facto Flavor Ban 
    By demanding comparative efficacy studies—randomized trials proving flavored vapes help smokers quit more than tobacco flavors—the FDA effectively created a backdoor ban on flavored products. Petitioners argue this violates the Tobacco Control Act (TCA) and the Administrative Procedure Act (APA), since any real flavor restrictions must go through a formal rulemaking process. 
3. Arbitrary Treatment of Menthol Products 
    Internal FDA memos revealed that staff were directed to automatically deny menthol-flavored PMTAs without proper review. This contradicted earlier public guidance suggesting menthol would be treated differently from fruit and candy flavors. 
4. Zero-Nicotine Products 
    Several petitioners also had their 0% nicotine products denied. But under the TCA, zero-nicotine e-liquids not intended for mixing with tobacco-derived nicotine should fall outside FDA’s jurisdiction. These products are often used by adult consumers tapering off nicotine, and petitioners argue the FDA’s blanket denials were unlawful. 
5. Ignoring Real-World Data 
    Companies presented consumer surveys, health data, and FDA’s own youth tobacco surveys showing their products were not being used by minors. Petitioners argue the FDA ignored this evidence and instead applied one-size-fits-all reasoning. 

Why It Matters 

This case isn’t just about the companies listed—it’s about the future of the entire independent vapor industry. FDA has already denied authorization for over 1.2 million products, while granting only 39, almost exclusively tobacco or menthol flavors. Small manufacturers, who lack the resources of Big Tobacco, argue they’re being regulated out of existence. 

The Fifth Circuit will now decide whether FDA’s MDOs hold up under scrutiny. Petitioners are asking the court to vacate the denials and restore fairness to the PMTA process. 

The Bigger Picture 

With smoking still killing nearly half a million Americans annually, the stakes couldn’t be higher. If safer nicotine alternatives are pushed off the market through regulatory overreach, millions of adult smokers could lose access to the very products helping them quit. 

👉 You can read the full legal filing here: Consolidated Opening Brief (PDF).