In a major escalation of frustration within the American vaping industry, USA Vape Lab, the manufacturer behind the well-known Naked 100 e-liquid line, has filed a federal lawsuit accusing the U.S. Food and Drug Administration of unlawful and unreasonable delays in the PMTA (Premarket Tobacco Application) process. 

The legal action, filed on Nov. 21 in the U.S. District Court for the District of Columbia, argues that FDA’s years-long inaction not only violates federal law but has now placed compliant U.S. manufacturers at direct risk of enforcement—including product seizures—despite companies having followed every instruction the agency has issued since 2016. 

The defendants named in the suit include the FDA, Commissioner Martin Makary, the Department of Health and Human Services (HHS), and HHS Secretary Robert F. Kennedy, Jr. 

Five Years of Waiting for a 180-Day Decision 

Under the Tobacco Control Act, companies submitting PMTAs are entitled to a marketing decision within 180 days. USA Vape Lab submitted its applications before the September 2020 deadline and, like many responsible manufacturers, continued operating during the FDA’s review period. 

But “review period” has turned into something far more troubling. 

Despite filing its applications more than five years ago, USA Vape Lab has received no decision—a delay nearly ten times longer than the statute allows. 

In the meantime, the regulatory environment has shifted dramatically. FDA had previously indicated that companies with timely-filed PMTAs could continue selling their products while awaiting decisions. However, according to the lawsuit, federal agents recently seized USA Vape Lab’s products during the September 10 enforcement raids, treating long-pending PMTAs as though they were equivalent to marketing denials. 

This sudden reversal, the lawsuit argues, is both arbitrary and unlawful. 

“We Had No Choice”: A Manufacturer Reaches Its Breaking Point 

USA Vape Lab founder Huy Nguyen said the decision to sue the FDA was not taken lightly: 

“We cannot continue to live in a world where the FDA ignores for years the statutory requirement to decide PMTAs in 180 days and then threatens American manufacturers with seizures of their products because they lack a marketing order. We had no choice but to initiate this lawsuit.” 

For many small and mid-sized vape manufacturers, this sentiment will feel painfully familiar. PMTA reviews have dragged on for years, leaving companies in limbo while larger competitors with greater resources have been able to navigate uncertainty more easily. 

What USA Vape Lab Is Asking the Court to Do 

The lawsuit seeks two primary outcomes: 

1. Compel FDA to Render a Decision Within 90 Days 

Under the Administrative Procedure Act, courts can order agencies to act when they unlawfully withhold or unreasonably delay required decisions. USA Vape Lab argues that FDA’s five-year delay is the definition of unreasonable. 

2. Require FDA to Properly Evaluate Evidence on Flavored E-Liquids 

The company is asking the court to ensure the FDA weighs: 

The actual popularity of flavored nicotine products among adult consumers 

The comparative benefits of flavored vs. tobacco-flavored products 

Scientific evidence from USA Vape Lab’s PMTAs—including a randomized controlled trial (RCT) showing that one-third of its product users achieved complete cigarette abstinence 

This is important because FDA’s past decisions have often assumed that flavored products inherently pose greater population-level risks, even when adult-focused evidence contradicts that conclusion. 

Why This Lawsuit Matters Beyond Naked 100 

This is not an isolated incident—it is part of a growing rebellion against PMTA inaction. 

Earlier this year, NJOY, the Altria-owned vapor company with the only FDA-authorized closed-system vapes on the market, filed a similar lawsuit alleging unlawful delays and mismanagement within the PMTA process. 

Industry lawyers warn that another wave of lawsuits could be coming as patience runs out. 

For smaller manufacturers without tobacco-industry backing, a five-year delay isn’t just an inconvenience—it threatens their survival. 

What Happens If FDA Denies the Applications? 

Should the FDA ultimately issue a Marketing Denial Order (MDO) against USA Vape Lab, the Tobacco Control Act allows the company to appeal directly to a federal circuit court. Dozens of manufacturers have already taken this path, challenging MDOs on procedural, scientific, and constitutional grounds. 

But this lawsuit seeks to prevent the need for that fight by demanding FDA finally complete the review it was required to finish years ago. 

A Pivotal Moment for Vapor Regulation 

USA Vape Lab’s legal challenge marks a potential turning point in the decade-long battle over how the U.S. regulates smoke-free nicotine products. 

Whether this lawsuit succeeds or not, it underscores a broader truth: 

The FDA’s PMTA backlog is no longer just a bureaucratic delay—it is actively reshaping the American vapor market, determining winners and losers, and jeopardizing companies that followed the rules. 

If courts step in, it may finally force transparency and accountability into a process that millions of consumers and thousands of businesses depend on. 

For now, the industry is watching closely.