The FDA’s first authorisation of fruit-flavoured vapes has been framed by critics as a dangerous break with past policy.

But the wider evidence points to a different problem. Regulators may have spent years demanding product-by-product proof in a way that made it harder for adult smokers to access the flavours many use to move away from cigarettes.

The immediate controversy centres on Glas, the Los Angeles-based vape company whose mango and blueberry pods were authorised by the Food and Drug Administration in May.

The FDA said the products use device access restrictions, including age and identity verification, phone pairing and biometric checks, to reduce the risk of youth use.

According to the Associated Press, a newly released six-page FDA memo found Glas’s fruit flavours were not statistically better than tobacco-flavoured vapes at helping smokers quit. Regulators reportedly said the products “did not have to demonstrate added adult benefit” because young people were unlikely to use them.

That memo deserves extra scrutiny. The FDA has previously said fruit and sweet flavours face a high evidentiary burden because of youth appeal, and that applicants for flavoured products generally need to show “added benefit compared to tobacco-flavored ENDS”.

But the public debate has quickly narrowed into the wrong argument. The issue is not whether one mango pod beat one tobacco pod in one company’s study. The bigger question is whether regulators have properly weighed the broad evidence that adult smokers use, prefer and often need non-tobacco flavours when switching from cigarettes.

The evidence that flavours help smokers switch

One of the most important recent studies comes from the US Population Assessment of Tobacco and Health study.

Published in Nicotine & Tobacco Research, the analysis led by Dr Karin Kasza tracked adult smokers who used vapes between 2014 and 2021.

It found that cigarette discontinuation rose among adults using menthol or mint flavours, fruit, sweet and other flavours, mixed flavours, disposables, cartridges and tanks. The authors concluded: “Increasing trends in cigarette discontinuation rates among adults who used ENDS was not specific to any ENDS flavor, ENDS device type, or age group examined here.”

The shift was substantial. In 2013/14, vapers and non-vapers had similar quit rates, at around 16 per cent. By 2018/19 to 2021, 31 per cent of smokers who vaped had quit cigarettes, compared with 20 per cent of smokers who did not vape.

The increase was not confined to one device or one flavour. Users of menthol or mint-flavoured vapes were around three times more likely to stop smoking at follow-up, while users of fruit or sweet flavours were around twice as likely. Quit rates also rose across device types, including disposables, cartridges and tank systems.

The study did not prove flavours alone caused the rise. The authors pointed to wider changes in the vape market, including nicotine salt products, which can deliver nicotine more effectively with a smoother inhale. But that is precisely why narrow regulatory comparisons can miss the point. Real-world switching is shaped by the full product experience- flavour, nicotine delivery, device design, affordability and availability.

Another 2025 analysis, published in Addictive Behaviours, looked at three US clinical trials involving more than 300 adult smokers from higher-risk groups, including people with mental health conditions, opioid use disorder and women of reproductive age with lower educational attainment.

Participants received very low nicotine cigarettes alongside either tobacco-flavoured vapes or a choice of preferred vape flavours, including mango, mint, fruit medley and crème brûlée.

Those given flavour choice used vapes more often, averaging 4.3 days a week compared with 3.4 days among those given tobacco-flavoured vapes. By week 16, the flavoured-vape group was smoking fewer cigarettes per day, 8.6 compared with 12.8.

The study also found lower levels of NNAL, a tobacco-specific carcinogen biomarker, among those using vapes more frequently. The authors concluded: “Greater frequency of e-cigarette use was a mechanism by which preferred-flavor e-cigarettes led to reductions in smoking and tobacco-toxicant exposure.”

That finding is highly relevant to flavour policy. If flavours make vapes more acceptable, and more regular vape use reduces smoking and toxicant exposure, then banning flavours is not a neutral move. It can reduce the appeal and effectiveness of the lower-risk alternative.

A 2023 US survey analysis by Mok and colleagues reached a similar conclusion at population level. Adults using non-tobacco flavoured vapes had higher odds of making a quit attempt and higher odds of quit success than non-users.

Current flavoured vape users had an adjusted odds ratio of 2.9 for quit attempts and 1.7 for quit success. Non-flavoured or tobacco-flavoured users did not show the same quit-success advantage.

A 2020 JAMA Network Open study using PATH data also found adults who began vaping non-tobacco flavours were more likely to quit smoking than those who used tobacco flavours. The adjusted odds ratio was 2.28.

None of this means every flavour should be approved automatically, but it does mean that flavour is not a cosmetic extra. For many smokers, it’s part of why vaping works.

What happens when flavours are banned

The evidence on flavour bans is increasingly difficult for policymakers to ignore. A JAMA Health Forum study of nearly 400,000 Americans aged 18 to 29 found that state restrictions on flavoured vape sales were associated with a 3.6 percentage point fall in daily vaping, but a 2.2 percentage point rise in daily cigarette smoking.

The researchers estimated that restrictions led to between 3.1 and 4.4 additional daily smokers for every five fewer daily vapers. They wrote that the findings “potentially offset” the public health benefits of the policies.

A separate Health Economics study found a similar substitution effect. Looking across several US states, researchers found that flavour bans reduced vaping among young adults by around two to three percentage points, while cigarette use rose.

That’s a serious trade-off. Cigarettes remain far more harmful than vapes because they burn tobacco and expose users to smoke toxicants. A policy that reduces vaping but increases smoking can look successful on a narrow youth-vaping metric while worsening the health risk for young adults.

Sales data point in the same direction. Research on US flavour restrictions has found increased cigarette purchases after flavoured vape sales were restricted. Another study by Abigail Friedman and colleagues found a trade-off of 12 additional cigarettes sold for every one fewer 0.7ml vape pod sold after flavour restrictions.

The Netherlands offers another warning. A study of more than 1,000 people who used vapes before the Dutch flavour ban found that vaping fell after non-tobacco flavours were removed. But six per cent of participants started smoking cigarettes and attributed this to the ban. Another 10.8 per cent reported increased use of alternative products, predominantly cigarettes.

Among those still using banned flavours, the largest group bought them abroad. That finding should be familiar to anyone watching the illicit vape trade. Prohibition rarely removes demand, it just changes where people shop.

This is the weakness in blanket bans. They assume people will respond by quitting nicotine. Some do, but others switch products, stockpile, buy illicit goods, cross borders, make liquids themselves or return to smoking.

A small US laboratory study of adults who both smoked and vaped gives a more granular view of the same behaviour. When participants could use their own vape and usual flavour, they were more likely to choose vaping. When only a tobacco-flavoured study vape was available, they chose cigarettes more often.

Even switching them to an unfamiliar non-tobacco vape increased cigarette choice compared with their own device.

The study was small and short-term, but it captured a simple behavioural reality. If the legal vape available to an adult smoker is less satisfying than the product they actually use, some will smoke more.

The youth question

Youth vaping remains a real concern. In 2024, the CDC reported that 1.63 million US middle and high school students currently used vapes, and 87.6 per cent of those users used flavoured products.

But youth protection and adult prohibition are not the same policy. A more proportionate route would focus on strict age verification, plain adult-focused packaging, enforcement against retailers selling to minors, penalties for youth-targeted branding and a legal route for products that help smokers switch.

That is where the FDA’s Glas decision becomes more important than its critics allow. The agency should publish fuller evidence on how well the age-gating system works in practice. But the principle is sound. It’s that regulation can target youth access and marketing rather than simply removing flavours from adults.

A better route than bans

The FDA’s historic demand that each flavoured product show added adult benefit over a tobacco-flavoured comparator may sound rigorous. In practice, it risks creating a legal market dominated by flavours that many smokers do not want.

A better framework would start from the evidence that non-tobacco flavours can support switching, while recognising that youth appeal differs by product design, branding, packaging and retail channel. It would allow adult-focused flavoured vapes through a clear, enforceable pathway, with strong post-market surveillance and fast removal if youth use rises.

The alternative is a regulatory system that makes cigarettes easy to buy while forcing safer nicotine products through years of uncertainty, litigation and denials.

The real test for regulators

The Glas memo may show that one fruit-flavoured product did not statistically outperform tobacco flavour in one study. It does not erase the broader evidence that flavours help many adults move away from smoking. Nor does it answer the growing evidence that flavour bans can backfire.

For smokers, the practical test is not whether tobacco flavour works in a regulatory comparison. It’s whether the product available on the shelf is appealing enough to replace a cigarette.

That is where flavours count.