Fifth Circuit Signals Growing Frustration with FDA’s PMTA Process for Flavored Vapes

The vaping industry may have just witnessed one of the most important court hearings since the FDA began denying millions of flavored vaping product applications in 2021. 

During recent oral arguments before the U.S. Court of Appeals for the Fifth Circuit, multiple judges appeared openly skeptical of how the FDA handled its review process for flavored vape products — particularly whether the agency quietly changed the rules without properly informing manufacturers beforehand. 

At the center of the case is a major question that has frustrated the independent vaping industry for years: 

Did the FDA create a brand-new approval standard for flavored vape products without ever formally announcing it? 

For many manufacturers and vape businesses, the answer has always been yes. 

 

The Core Issue: “Comparative Efficacy” 

 

The dispute focuses on the FDA’s requirement that flavored vape manufacturers prove their products are more effective than tobacco-flavored vapes at helping adult smokers switch away from cigarettes. 

This became known as the FDA’s “comparative efficacy” standard. 

The problem, according to manufacturers, is that this requirement was never clearly communicated before the FDA began issuing mass marketing denial orders (MDOs) in 2021. 

Thousands of companies spent years and millions of dollars preparing PMTA applications under one understanding of the rules, only to later discover the FDA expected an entirely different level of evidence. 

For many small and mid-sized companies, that realization came only after receiving denial letters. 

And according to the judges hearing this case, that may be exactly where the FDA has a problem. 

 

Judges Question FDA’s Actions 

 

During oral arguments, Judge Edith Jones repeatedly challenged the FDA’s position that it was simply reviewing applications individually rather than creating a new industry-wide rule. 

At one point, she criticized the agency for using nearly identical denial language across massive numbers of applications. 

“A million denials use essentially the same language,” she noted during the hearing. 

That observation cuts directly to one of the vaping industry’s biggest criticisms of the PMTA process — that companies were never truly evaluated as individuals despite repeated FDA claims that every application received a case-by-case scientific review. 

Judge Jones also questioned whether the FDA effectively bypassed the Administrative Procedure Act (APA), which normally requires agencies to publicly propose major new rules and allow public comment before enforcing them. 

Her comments suggested concern that the FDA may have imposed a sweeping new standard without ever formally admitting it was doing so. 

And perhaps most notably, she openly acknowledged the devastating impact the agency’s actions had on independent businesses. 

“I’m not saying vaping is a good thing,” Jones stated. “But they were arbitrarily putting hundreds of thousands of small businesses out of business.” 

That level of direct judicial recognition is something the vaping industry has rarely heard from federal courts. 

 

Why This Case Matters So Much 

 

This case involves companies including Wages and White Lion Investments and Vapetasia, but the implications stretch far beyond just a few manufacturers. 

If the Fifth Circuit ultimately rules that the FDA improperly imposed a new regulatory standard without notice-and-comment rulemaking, it could reopen challenges to countless flavored vape denials issued over the past several years. 

That would be a massive development for the industry. 

Many PMTA denials were based on the FDA’s position that flavored products needed to demonstrate benefits beyond what tobacco-flavored vaping products already offered. 

But manufacturers have consistently argued they were never warned this specific comparative standard would become the deciding factor. 

Instead, companies say they followed earlier FDA guidance that emphasized broader scientific review, toxicology, ingredient disclosures, and general evidence regarding adult smokers switching away from cigarettes. 

The feeling across much of the industry has been that the target moved mid-process. 

 

FDA’s Defense 

 

The FDA continues arguing that it did nothing improper. 

Government attorneys claimed during the hearing that the agency was simply applying the Tobacco Control Act’s public health standard during individual application reviews. 

According to the FDA, the law already requires balancing: 

• Potential benefits to adult smokers 
• Risks of youth uptake 
• Population-level public health impact 

 

From the agency’s perspective, requiring stronger evidence for flavored products was simply part of applying those statutory obligations. 

But the judges appeared unconvinced that the FDA’s actions were truly just “individual adjudications,” given how standardized the denial language became across the industry. 

 

The Industry’s Longstanding Frustration 

 

For independent manufacturers, vape shops, and advocacy groups, the hearing reinforced concerns that have existed since the earliest PMTA denials. 

Many businesses believe the FDA: 

• Shifted standards midstream 
• Failed to provide clear guidance 
• Created impossible evidentiary hurdles 
• Applied inconsistent expectations 
• Treated flavored products differently without formal rulemaking 

 

The frustration has only intensified as products from multinational tobacco companies received authorization while thousands of independent applications were denied. 

This is also why many in the industry continue asking a broader question: 

Why are lower-risk smoke-free alternatives being forced to meet evidentiary standards that combustible cigarettes themselves were never required to satisfy? 

That question continues hanging over nearly every major PMTA battle. 

 

A Potential Turning Point 

 

Importantly, the Supreme Court already ruled earlier this year that the FDA’s denials themselves were not “arbitrary and capricious.” 

However, the Court deliberately avoided deciding on the separate notice-and-comment issue now being argued before the Fifth Circuit. 

That leaves this case potentially far more important than many initially realized. 

If the Fifth Circuit rules against the FDA, it could reshape how future PMTA reviews are conducted and potentially reopen litigation involving flavored product denials across the country. 

For the vaping industry, this case is no longer just about a handful of denied applications. 

It has become a broader test of whether federal agencies can fundamentally reshape entire industries without clearly announcing the rules first. 

And based on the judges’ questions during oral arguments, the FDA may finally be facing serious scrutiny over how the PMTA process unfolded.