The FDA’s first authorisation of fruit-flavoured vapes should be a turning point in America’s long-running battle over nicotine policy. Instead, it has exposed just how confused that policy has become.
The US Food and Drug Administration has authorised four vaping products from Los Angeles-based Glas Inc, including mango and blueberry pods. It marks the first time the agency has allowed non-tobacco and non-menthol vape flavours onto the legal US market.
The FDA said the products use device access restriction technology and will be subject to marketing restrictions intended to reduce youth use.
But the bigger story is not one company’s approval. It is what the decision reveals about a system that has spent years blocking legal flavoured vapes while cigarettes remain widely available.
For years, America’s approach to flavoured vaping has rested on the simple idea that flavours appeal to young people, so keeping them off the legal market protects youth.
But critics of the FDA’s approach argue the policy has failed to fully account for what happens when legal flavoured products are unavailable. What happens to adult smokers who prefer flavours? What happens when legal products disappear but demand does not? And what happens when the only widely available alternatives are cigarettes or illicit vapes?
The Glas decision appears to acknowledge that at least some fruit-flavoured vaping products can meet the FDA’s public health standard under certain conditions. Yet by approving only a tiny number of tightly controlled products, the agency has also highlighted the wider contradictions in the system.
The FDA has authorised just 45 vape products for legal sale in the US. Meanwhile, the agency previously denied more than a million flavoured vape applications during its crackdown on youth vaping, while illicit disposable products continued flooding the market.
Critics say that imbalance is not a technical detail but evidence of a regulatory system struggling to compete with real-world demand.
A policy built around fear of flavours
Flavours have become the centre of America’s vaping debate because they are easy to understand and easy to attack. Mango, blueberry, candy and dessert flavours sound youthful, while tobacco flavour sounds adult.
But real life is not that neat, as adults also like fruit flavours. Former smokers often say non-tobacco flavours help them move away from cigarettes because they break the sensory link with smoking. Critics argue that policies which severely restrict flavoured products risk making smoke-free alternatives less attractive to adult smokers.
Clive Bates and co-authors Stefanie Miller, Brad Rodu, Sally Satel and David Sweanor argue that the FDA’s current approach is fundamentally detached from the real world.
In a detailed comment on the FDA’s draft guidance, they say: “Despite the importance of these policies to millions of Americans, the Draft Guidance is untethered from reality and is not fit for purpose.”
That is a hard charge. But the FDA’s own market raises difficult questions. Despite years of restrictions, flavoured disposable vapes remain widely available through illicit channels, while only a small number of products have received FDA authorisation.
Bates and his co-authors argue that the policy has created a distorted market where legal manufacturers face enormous hurdles while illegal products continue to dominate demand.
And while flavoured vape applications have faced years of rejection and delay, combustible cigarettes remain widely available across the US market.
The legal market is too small to compete
The FDA’s latest decision was notable because it authorised mango and blueberry vape pods. But it was also notable because of how narrow the route to approval appears to be.
The agency highlighted Glas’s device access restriction technology, combined with FDA-required marketing restrictions. The FDA said: “The FDA’s rigorous, scientific review of these products found that the applicant sufficiently demonstrated that Glas’s device access restriction technology, combined with FDA-required marketing restrictions, is expected to effectively mitigate the ability of youth to use the product.”
That may be reasonable for these specific products. But if age-gated technology becomes the only realistic pathway for flavoured vapes, critics argue the legal market will remain too limited to compete with illicit supply.
That matters because the illicit market is already enormous.
Bates and his co-authors argue that the illegal market likely dominates US vape use, writing that the US vape market is “dominated (88 per cent) by products not authorised by the FDA”. They warn that a restrictive legal regime does not remove demand for flavoured products, it redirects it.
“The obvious problem with a highly restrictive regulatory approach to flavoured ENDS is that people (adults and youth) will source the flavoured products they want from illicit suppliers,” they write.
In 2021, the FDA issued denial orders for around 55,000 flavoured vaping products from just three applicants. Two years later, the agency issued further denial orders covering another 6,500 products.
The FDA’s crackdown did not eliminate flavoured vaping products from the market. Instead, disposable brands – many imported from China and lacking FDA authorisation – rapidly filled consumer demand.
Critics argue this raises a major contradiction at the centre of US policy. It’s that restrictions designed to control flavoured vaping may instead have helped drive consumers toward an unregulated market.
A regulated company can be required to follow packaging, marketing, manufacturing and age-verification rules, but an illegal supplier cannot. A legal product can be monitored, recalled or restricted, but illicit products sit outside that system entirely.
A regulatory imbalance in favour of cigarettes
One of the most controversial aspects of the FDA’s approach is the contrast between restrictions on vaping products and the continued availability of cigarettes.
Cigarettes remain legal, familiar and widely available. By contrast, smoke-free nicotine products face a slow, costly and uncertain authorisation process.
Bates and his co-authors call this a “perverse regulatory imbalance in favour of deadly combusted tobacco products”.
Their argument is that regulation should make it easier for smokers to move down the risk spectrum, not harder.
The FDA itself acknowledged in its announcement that smoking remains a major public health problem, saying more than 25 million Americans still smoke combustible cigarettes.
Critics say that should be the starting point for policy. Instead, the US system has spent years treating flavoured vaping products primarily as a youth-risk issue, rather than also assessing their potential role in helping adult smokers move away from cigarettes.
That does not mean youth use should be ignored, but critics argue the trade-offs need to be assessed honestly and transparently. A teenager who would otherwise never use nicotine is one concern. A middle-aged smoker facing serious smoking-related disease is another. A young person who vapes instead of smoking is another still.
Bates and his co-authors argue that the FDA’s public health framework has not adequately accounted for those competing realities.
The politics make the weakness clearer
The timing of the Glas authorisation has made the decision even more controversial. According to Reuters, the approval came amid political pressure on the agency, after reports that President Donald Trump had pushed FDA Commissioner Marty Makary to move faster on flavoured vapes and nicotine products.
Reuters also reported that the FDA would continue requiring “a heavy burden of evidence of benefits to smokers for vape flavors that also have strong appeal to youth, such as fruit or candy flavors.”
That political backdrop has intensified criticism of a regulatory process that many already viewed as opaque and unpredictable.
Critics argue that if the FDA had a clear, workable framework for flavoured products, individual authorisation decisions would be less vulnerable to political pressure and industry lobbying. Companies would know what evidence was required. Public health groups would know how youth risk was being assessed. Consumers would better understand why some products were authorised while others were rejected.
Instead, the process has often appeared inconsistent and difficult to navigate.
Bates and his co-authors argue that the FDA’s comparative-efficacy test for flavours is “so poorly specified as to be unworkable for most manufacturers”. They also say the agency has created “a poorly specified de facto product standard” without using the proper rulemaking process.
That critique matters because the stakes are not theoretical. A system that struggles to process legal applications efficiently creates space for illicit markets to grow.
Flavour policy cannot ignore behaviour
Critics of the FDA’s approach argue the agency has not adequately accounted for how consumers respond when legal flavoured products are unavailable.
People can switch products, buy illegally, share devices, use other nicotine products or return to cigarettes. Adults who cannot find the products they want may keep smoking. Young people determined to use nicotine may seek out illicit products instead.
Bates and his co-authors said: “FDA implicitly assumes they would remain nicotine-abstinent if flavoured ENDS were unavailable or if the FDA does not authorise flavoured vaping products.”
That assumption is at the centre of the debate. The real question is not simply whether fruit flavours appeal to youth. The broader question is what type of policy produces the lowest overall public health harm across the population.
Critics argue that if restrictions reduce legal vape sales but increase cigarette smoking or illicit trade, the policy may produce unintended consequences that undermine its stated goals.
Some economic research cited by Bates and his co-authors suggests flavour restrictions can increase cigarette sales, reinforcing concerns that cigarettes and vapes may function as substitute products for some consumers.
The decline in youth vaping in recent years has further complicated the debate. Teen vaping rates have fallen sharply from their 2019 peak despite the continued widespread availability of illicit flavoured disposable vapes across the US market.
The Glas approval is not enough
The FDA’s approval of Glas products marks a shift away from the agency’s earlier near-total resistance to fruit-flavoured vaping products. But critics argue it is far from enough to fix the wider system.
A handful of age-gated products cannot compete with a massive illicit market. Nor can they reflect the range of adult preferences in a country with millions of smokers.
Critics say the decision demonstrates that flavoured vapes can satisfy the FDA’s public health standard, but does not show that the agency has created a workable pathway for the wider category.
Bates and his co-authors argue for “non-marginal reform”, including a system capable of authorising thousands of ENDS products, reducing application costs, meeting statutory review timelines, and using post-market surveillance to monitor real-world outcomes.
They argue this would not mean an unregulated market, but a regulated legal market capable of competing with illicit supply.
Products could still be assessed for safety, quality, packaging and marketing. Youth-focused branding could still be restricted. Age controls could still be required. But critics argue adult smokers would have access to a wider range of regulated alternatives instead of being pushed toward cigarettes or illicit products.
The real test
The FDA’s first fruit-flavoured vape approval has been framed as a political victory, a regulatory shift and a test of new age-gating technology. It is all of those things, but it is also evidence of a deeper problem inside America’s nicotine policy.
For years, regulators have operated on the assumption that restricting legal flavoured products would protect public health. But the continued growth of illicit flavoured vape sales has exposed the limits of that approach.
The debate is no longer simply about whether flavours appeal to young people. It is about whether the current system has unintentionally strengthened the illegal market while leaving combustible cigarettes in a dominant position.
The Glas decision appears to acknowledge that fruit-flavoured vaping products can have a place in a regulated legal market under certain conditions. The question now is whether the FDA will build a broader system around that reality – or continue with an approach critics say has helped fuel illicit trade, restricted legal alternatives and left cigarettes largely untouched.
