The FDA’s flavored e-cigarette guidance could keep adult smokers from safer alternatives

A version of the following public comment was submitted to the U.S. Food and Drug Administration on Senate Bill 24 on May 11, 2026.

We appreciate that the draft guidance clarifies the FDA's position on the evidentiary burden for flavored ENDS products to receive marketing authorization. Nevertheless, the draft guidance suffers from several significant deficiencies that, if left unaddressed, will continue to undermine the agency's statutory obligation to protect the health of the population as a whole. These deficiencies center on an evidentiary burden that remains functionally prohibitive for most flavored ENDS products; an incomplete accounting of the youth risk landscape, including the agency's failure to engage its survey evidence on youth motivations for vaping; a failure to weigh the potential harms of the illicit ENDS market; and an insufficient recognition of the role flavored ENDS play in adult smoking cessation.

The recent authorization of two fruit-flavored pods is welcome, bringing the total number of authorized ENDS products to 45. But in a market dominated by tens of thousands of illicit products, the pathway remains too narrow to significantly reduce the illicit market and accelerate the reduction of death and disease from smoking.

The evidentiary burden functions as a de facto ban for the products most likely to help adult smokers

The draft guidance establishes a "sliding scale" under which flavored ENDS products with higher perceived youth appeal face a correspondingly higher evidentiary burden to demonstrate that their benefits to adult smokers outweigh the risks of youth initiation. In theory, this proportionate approach may appear reasonable. But in practice, the guidance sets evidentiary expectations for the most popular adult flavor categories, such as fruit and candy/dessert/sweet flavors, so high that they are unlikely to be met by the vast majority of applicants, regardless of the quality of their product or application.

The recent authorization of Glas products serves as a case in point. The authorization mandated device access restriction (DAR) technology that required government ID verification, Bluetooth pairing, and random biometric check-ins. These are innovative approaches to prevent youth e-cigarette use, but they also provide a significant barrier to adult smokers in terms of convenience, privacy, and cost. Furthermore, the Glas authorized products use abstract branding such as "Gold" and "Sapphire" instead of the more accurate and understandable descriptors of "mango" and "blueberry" suggesting that even when fruit flavors clear the bar, they must be marketed in ways that obscure what they are, limiting their effectiveness as switching tools for adult smokers who need to know what they're buying. The manner of the authorization has also called into question the transparency and fairness of the premarket review process, with these products recommended by FDA scientists but subsequently rejected by leadership, discovered only through freedom of information requests, and requiring guidance from outside the agency to adhere to recommendations.

The guidance states that applicants for products with flavors that are "highly appealing to youth" must demonstrate a magnitude of benefit "sufficient to overcome the risk to youth." So far, the FDA has found only two products from one company to meet this threshold. If only one applicant has ever successfully demonstrated that a fruit- or sweet-flavored ENDS product meets the "appropriate for the protection of the public health" (APPH) standard, and those products use DAR technology, competition will be extremely limited, and uptake by adult smokers will be minimal. Many companies whose products would provide a substantial benefit to adult smokers with negligible youth interest will continue to be shut out of the legal market. The current conditions necessary for a successful authorization cannot scale to create a functional legal market.

The practical result is that the only legally authorized ENDS products available to American consumers are products that, while beneficial for some smokers, do not reflect the preferences of the majority of adult vapers who have successfully switched from cigarettes. As the FDA itself acknowledges, emerging evidence indicates that many adult smokers who transition away from combusted cigarettes report a preference for non-tobacco flavors. The draft guidance's own citations include studies that find higher odds of quit attempts and quit success among adults who use non-tobacco-flavored ENDS.

The agency should provide concrete, achievable evidentiary benchmarks that applicants can realistically meet. Vague references to "robust and reliable evidence" and "well-controlled investigations" that fail to specify which study designs, sample sizes, or effect sizes would satisfy the standard leave applicants navigating a process with no clear endpoint. As the Cochrane Collaboration's living systematic review of 104 studies involving more than 30,000 participants has concluded, there is high-certainty evidence that nicotine e-cigarettes increase quit rates compared to nicotine replacement therapy. The agency should incorporate this body of evidence into its framework rather than requiring each applicant to independently replicate what the broader scientific literature has already established.

The draft guidance overstates the youth risk posed by flavored ENDS

The draft guidance devotes considerable attention to the role of flavors in youth ENDS initiation and use, citing data from the 2017-2019 period when youth e-cigarette use surged dramatically. While this historical context is relevant, the guidance fails to adequately account for the dramatic decline in youth vaping since that peak. This decline also coincided with a flood of illicit flavored products.

The 2025 National Youth Tobacco Survey (NYTS) data, released by the FDA in March 2026, show that past 30-day e-cigarette use among middle and high school students fell to 5.2 percent, down from 20 percent at its 2019 peak among high school students alone. This represents a roughly 74 percent decline in youth e-cigarette use in just six years. Cigarette smoking among youth remained at historic lows of 1.4 percent.

Critically, this decline occurred during a period when illicit flavored ENDS products were widely and increasingly available. If flavored products were the primary driver of youth uptake, one would expect youth use to remain elevated or increase as the illicit market expanded. Instead, youth use fell sharply. This strongly suggests that factors other than product flavoring, including raising the minimum purchase age to 21, public education campaigns, school-based prevention efforts, and changing social norms, have been the primary drivers of reduced youth vaping.

Furthermore, the guidance's reliance on survey data showing that youth who use e-cigarettes prefer fruit and sweet flavors conflates preference with causation. That youth users prefer certain flavors does not establish that those flavors caused their initiation. Adults also overwhelmingly prefer these same flavors when switching from cigarettes. A regulatory framework that treats shared preference as dispositive evidence of youth-specific risk fails to make the necessary distinctions between correlation and causation.

Youth themselves do not identify flavors as a primary reason for vaping

Beyond the prevalence trends discussed above, the NYTS provides another body of evidence that the draft guidance does not engage with, which is youth e-cigarette users' own stated reasons for first trying and continuing to use these products. Each year from 2021 through 2025, NYTS asked respondents who had ever used an e-cigarette why they first did so, and asked current users why they continue. Respondents could select any of fourteen reasons, including "they were available in flavors, such as menthol, mint, candy, fruit, or chocolate."

Across all five years, flavor availability ranks sixth or seventh among the fourteen reasons, well behind social and psychological motivations. For first use, the dominant reasons are consistently that "a friend used them", and either anxiety, stress, or depression, or family member use. For current use, the dominant reasons are anxiety, stress, or depression, getting a "high or buzz from nicotine," and friend use. Flavor availability falls into a substantially lower-magnitude class throughout.

The trend is also instructive. The share of youth ever-users citing flavor as a reason for first use declined significantly between 2022 and 2024 from 14.7 percent to 9.6 percent overall, and from 15.0 percent to 9.3 percent among high school students. The share citing flavor as a reason for current use has remained statistically stable throughout the 2021-2025 period. Even as the broader youth e-cigarette use rate fell by roughly 75 percent from its 2019 peak, the share of remaining users who say they vape because of flavor has not increased, and the share of new initiators who say flavors brought them in has decreased substantially.

We acknowledge the methodological limitation that stated-reasons data is self-reported and that respondents may not consciously attribute their behavior to all of its causes. Experimental appeal studies, including those FDA cites in the draft guidance, suggest that flavors may operate through mechanisms that survey respondents do not recognize or articulate. We do not claim that the NYTS reasons-for-use data alone disposes of the youth risk question. But two observations follow that the draft guidance should engage.

First, the agency relies heavily on other NYTS variables, such as the 2024 finding that 87.6 percent of youth current ENDS users use flavored products, with fruit at 62.8 percent and candy or sweets at 33.3 percent, as central evidence for the heightened evidentiary standard applied to fruit and candy/dessert/sweet flavors. Yet the agency does not cite or report the NYTS reasons-for-use battery, despite collecting it every year through 2025. The draft guidance's only footnote referencing youth "reasons for use" cites Rostron et al. 2020, which uses PATH Study data on flavored cigars rather than the directly applicable NYTS ENDS battery. The 2021 MMWR Surveillance Summary published these figures (Wang et al., Table 6); subsequent MMWR briefs have not done so. A genuine "totality of evidence" approach to APPH determinations should weigh the NYTS variables that complicate the youth-risk narrative alongside those that support it.

Second, the draft guidance preemptively dismisses survey-based counterevidence at page 12, observing that "many products that do not appear to be used (or are used very little) by youth in surveys may nevertheless be appealing to youth." This concern is reasonable as applied to obscure products with limited distribution, where low survey-measured use may reflect availability rather than appeal. But it does not extend to nationally representative measures of youth motivations for using widely available products. The NYTS reasons-for-use battery does not measure the appeal of any particular product; it measures across the full population of youth ENDS users, how those users themselves account for their behavior. If the agency intends to discount this measure, it should explain why and should also explain why the same survey instrument's other measures (flavored product prevalence, flavor type prevalence) remain authoritative.

The implication for the evidentiary framework is direct. The draft guidance treats fruit and candy/dessert/sweet flavors as imposing a youth-risk burden so substantial that no applicant has ever cleared it, and that DAR technology alone "might not, standing alone, satisfy" the burden. That framing rests heavily on the prevalence of flavored product use among youth current users (87.6 percent), which conflates what flavors users prefer, given that they are already using e-cigarettes, with what motivated them to use e-cigarettes in the first place. Adults who switch from cigarettes also overwhelmingly prefer non-tobacco flavors. But unlike current youth ENDS users, the stated main motivations for ENDS use among current adult users are to quit combustible cigarettes. Shared preferences among users are not, by themselves, evidence of youth-specific causation. The NYTS reasons-for-use data show flavors as a declining stated reason for initiation and as a stable stated reason for continued use. A risk-proportionate framework that takes the totality of evidence seriously should reflect this.

We urge the agency to revise the draft guidance to:

• Cite, report, and weigh the NYTS reasons-for-use data alongside the flavor prevalence data in its APPH framework, including the year-over-year trends through 2025.

• Lower the evidentiary burden for fruit, candy, and dessert/sweet flavors to a level that is achievable on the basis of the totality of evidence, including this NYTS data, the experimental appeal literature with its acknowledged limitations, and the longitudinal progression literature with its acknowledged confounders.

• Distinguish between preference (what flavors users select, given that they are using) and motivation (what brings users into and keeps them in the category), and apply each measure to the regulatory question it actually answers.

The draft guidance ignores the public health costs of the illicit ENDS market

Perhaps the most significant omission in the draft guidance is its failure to account for the illicit ENDS market, which exists largely because the FDA has failed to authorize a range of flavored products that meet adult consumer demand. The guidance does not mention the illicit market at all, despite its direct relevance to the APPH standard's requirement that the FDA consider the health of "the population as a whole."

According to estimates, between 54 and 86 percent of all ENDS products sold in the United States are unauthorized. Chinese vape exports to the United States rose to $4.1 billion in 2025, with an estimated 80 percent sold without FDA authorization. As of early 2026, only 45 e-cigarette products have received FDA marketing authorization, all in tobacco or menthol flavors. The market for the flavored products that tens of millions of American adults actually use is served almost entirely by unregulated, unauthorized products of unknown quality and composition.

Illicit products are not subject to manufacturing standards, ingredient disclosure requirements, or any of the quality controls that the PMTA process is designed to ensure. When the FDA sets evidentiary standards so high that no flavored products can be authorized, it does not eliminate consumer demand for them. It simply redirects that demand to the illicit market, where the agency has no oversight and consumers have no protection.

The APPH standard requires the FDA to weigh the risks and benefits to the population as a whole. A framework that ignores the health consequences of driving millions of adult consumers toward unregulated products is not protecting the population as a whole. It is protecting a regulatory abstraction at the expense of real-world public health outcomes. The draft guidance should be revised to explicitly incorporate the risks of the illicit market into the APPH calculus, and the evidentiary burden for flavored ENDS should reflect that the alternative to authorized flavored products is not the absence of flavored products but the continued dominance of illicit ones.

Flavor restrictions increase cigarette sales

A growing body of rigorous economic research demonstrates that restricting access to flavored e-cigarettes drives consumers back to combustible cigarettes. This evidence is directly relevant to the APPH determination and should inform the draft guidance's approach to the evidentiary burden for flavored ENDS.

A November 2025 study by economists Brad Davis, Abigail Friedman, and Michael Pesko, analyzing Canadian retail sales data from 2018 to 2023, found that provincial e-cigarette flavor restrictions increased cigarette sales by nearly 10 percent. This finding is particularly significant because Canada has among the world's most comprehensive tobacco control regimes, including a nationwide ban on menthol cigarettes, mandatory plain packaging, restrictions on tobacco advertising, and caps on nicotine levels in vaping products. If flavor restrictions were going to succeed without increasing cigarette use, Canada would have been a leading candidate, but it didn't.

Previous studies of U.S. sales data have reached consistent conclusions. Friedman, Liber, Crippen, and Pesko found that e-cigarette flavor restrictions in U.S. jurisdictions resulted in approximately 12 additional cigarettes sold for every e-cigarette pod no longer sold due to flavor bans. Research examining young adults aged 18 to 29 found that flavor bans reduced daily vaping by 3.6 percentage points while increasing daily cigarette smoking by 2.2 percentage points. Multiple studies using different methodologies and datasets have converged on the conclusion that when flavored e-cigarettes become less accessible, a substantial portion of consumers switch to combustible cigarettes.

The FDA and international health authorities recognize that e-cigarettes are substantially less harmful than combustible cigarettes. A regulatory framework that makes it functionally impossible to authorize the flavored ENDS products that help adults move away from cigarettes implicitly favors continued combustible cigarette use over reduced-risk alternatives.

Postmarket surveillance provides an essential safety net

The FDA's regulatory framework need not depend exclusively on premarket predictions about youth risk. The agency has substantial postmarket surveillance authority, including the ability to monitor youth use trends through the NYTS, impose additional marketing restrictions on authorized products, and withdraw marketing authorization if youth use of a particular product exceeds acceptable levels.

These tools provide a meaningful safety net that should inform the premarket evidentiary burden. If the agency authorizes a flavored ENDS product and subsequently observes an unacceptable increase in youth use attributable to that product, it may act swiftly. This dynamic oversight capacity should lower the premarket burden, not because youth protection is unimportant, but because the agency does not need to treat the premarket authorization decision as its sole opportunity to prevent youth harm. The draft guidance should explicitly account for the role of postmarket surveillance in mitigating the risks associated with the authorization of flavored ENDS.

Regarding the Glas authorization, the FDA stated that it may suspend or withdraw authorization if there is a notable increase in youth use of these products or evidence that their benefits no longer outweigh the risks. The agency itself recognizes that postmarket tools are available and appropriate. If the FDA trusts postmarket surveillance enough to authorize fruit-flavored products backed by DAR technology, it should extend that same trust more broadly, using postmarket monitoring as a safety net for a wider range of authorized products, rather than reserving it only for the rare applicant that can afford a biometric age-gating system.

Conclusion

The framework, as currently proposed, is likely to produce the same outcome as the agency's previous approach. The continued denial of marketing authorization for the flavored ENDS products that the majority of adult vapers use and that a substantial body of evidence suggests facilitate switching away from combustible cigarettes, thereby ensuring more cigarette sales than there otherwise would be.

More than 25 million American adults still smoke. Cigarettes remain the leading preventable cause of death, accounting for 480,000 deaths per year. Youth e-cigarette use has declined by roughly 74 percent from its 2019 peak. The illicit market for flavored ENDS continues to grow, serving millions of adult consumers with unregulated products of unknown safety. Youth themselves do not identify flavors as a primary reason for vaping, a finding consistent across five years of survey data. And the highest-certainty scientific evidence available shows that nicotine e-cigarettes are more effective than traditional nicotine replacement therapies in helping people quit smoking.

In light of these facts, the FDA should revise the draft guidance to:

1. Establish concrete, achievable evidentiary benchmarks for flavored ENDS applications, including clear guidance on acceptable study designs, sample sizes, and effect sizes.

2. Incorporate the dramatic decline in youth e-cigarette use into its risk assessment, rather than relying primarily on data from the 2017-2019 surge.

3. Cite, report, and weigh the NYTS reasons-for-use data, which consistently show flavor as a secondary motivator for youth vaping, alongside the flavor prevalence data the agency already relies upon, distinguishing between preference and motivation in its APPH analysis.

4. Account for the public health consequences of the illicit ENDS market in its APPH determinations, recognizing that the realistic alternative to authorized flavored products is not the absence of flavored products but the continued dominance of illicit ones.

5. Give appropriate weight to the substantial body of evidence, including the Cochrane systematic review and international experience, demonstrating the effectiveness of e-cigarettes, including flavored products, as smoking cessation tools.

6. Explicitly incorporate postmarket surveillance as a component of its risk-mitigation framework, reducing the premarket burden where robust postmarket monitoring can address emerging risks.