The ongoing legal battle over flavored vaping products took another significant turn this month as judges on the Ninth Circuit Court of Appeals sharply questioned the FDA’s approach to reviewing Premarket Tobacco Product Applications (PMTAs) for flavored vapor products. 

At the center of the case, MH Global LSC v. FDA, is a question the industry has been asking for years: did the FDA quietly create a brand-new approval standard for flavored products without formally telling anyone? 

During oral arguments, judges repeatedly pressed both the FDA and attorneys representing vape manufacturers on whether the agency’s so-called “comparative efficacy” requirement effectively became a rule without going through the required notice-and-comment rulemaking process. 

The Core Issue: Rulemaking or Case-by-Case Review? 

The FDA maintains that it never created a formal rule banning flavored products or requiring specific studies. Instead, government attorneys argued the agency was simply applying the Tobacco Control Act’s “appropriate for the protection of public health” standard on an individual basis as PMTAs were reviewed. 

Manufacturers challenging the agency see it very differently. 

Industry attorneys argued that the FDA effectively imposed a new requirement demanding flavored products prove they help adult smokers switch better than tobacco-flavored alternatives. According to the challengers, this standard emerged through internal FDA memoranda and was then broadly applied across thousands of applications with nearly identical denial language. 

One of the judges repeatedly questioned whether a standard applied universally across applications starts to look less like adjudication and more like rulemaking that should have required public input and transparency. 

That distinction could prove critical not only for this case, but for the future of the PMTA process itself. 

Why This Matters to the Industry 

For years, manufacturers have argued that the FDA shifted expectations after PMTAs were already submitted in 2020. Many companies say they were never clearly informed that they would need product-specific longitudinal or comparative efficacy studies showing flavored products outperform tobacco flavors for smoking cessation. 

Critics of the FDA’s approach argue that this created an impossible standard for many independent manufacturers, especially smaller companies without the resources of multinational tobacco corporations. 

The hearing also highlighted a growing legal debate over whether the FDA’s flavored vape review framework is being applied consistently. Several courts across the country have wrestled with similar questions surrounding the agency’s authority, evidentiary expectations, and procedural fairness. 

Glas Authorization Changes the Conversation 

One of the more notable moments during oral arguments involved discussion of recently authorized flavored products from Glas. 

FDA attorneys pointed to the Glas authorizations as evidence that flavored products are not categorically prohibited. According to the agency, the authorization demonstrated that companies can succeed if they sufficiently address youth-access concerns and provide appropriate supporting evidence. 

That point may become increasingly important moving forward. 

For years, many in the industry argued the PMTA process had effectively become a de facto flavor ban. The Glas authorization complicates that narrative and could signal that the FDA is at least willing to consider pathways for certain flavored products under specific conditions. 

At the same time, the broader industry concern remains unchanged: the standards continue to appear extraordinarily high, expensive, and often unclear, especially for independent companies trying to navigate the process without the resources of major tobacco-backed manufacturers. 

The Bigger Picture 

This case is about more than one company or one PMTA denial. 

It touches on one of the biggest unresolved questions in tobacco harm reduction regulation: how much discretion does the FDA have to reshape evidentiary expectations without formal rulemaking? 

The answer could have major implications for pending PMTAs, future flavored product applications, and ongoing legal challenges across the country. 

It also comes at a time when courts are increasingly scrutinizing FDA decision-making in the vaping space, particularly around comparative efficacy requirements and the agency’s handling of flavored product reviews. 

The Ninth Circuit panel did not indicate when it plans to issue a ruling, but the decision could become another pivotal moment in the ongoing fight over the future of flavored vapor products in the United States.