The World Health Organisation estimates that more than 100 million people worldwide use smoke-free tobacco products like vapes, snus, and other smokeless tobacco in 2025, with each segment showing rapid growth and significant geographic variation. This includes at least 86 million adults and 15 million adolescents. Estimates from other market sources suggest 82 million or more vape users worldwide in 2025, with regional increases in North America, Europe, and Asia-Pacific.
Independent studies have shown that countries that adopted smoke-free products as aids for switching and Tobacco Harm Reduction have greatly reduced tobacco-related mortality and the disease burden on healthcare systems.
Yet, despite evidence of growing use of novel nicotine products, global health decision-making bodies continue to block the use of scientifically proven Tobacco Harm Reduction products. Organisations such as the Food and Drug Administration and the WHO remain sceptical of fully accepting smoke-free tobacco products like vapes, snus, and nicotine pouches. They cite major public health concerns, especially around youth usage, long-term risks, and insufficient independent research on harm reduction. Data shows that 99 percent of harm reduction products have either been denied by the FDA or are gathering dust somewhere on an FDA shelf.
However, Tobacco Harm Reduction advocates and scientists believe the FDA and WHO could be working in bad faith.
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“If you have not heard, the U.S. has a new president. The new head of the FDA, Marty Makary, has not spoken much about harm reduction, and there is not much indication that things will change one way or the other,” said Jeff Smith, a Resident Senior Fellow at Integrated Harm Reduction, during a panel discussion titled ‘THR in the Americas: Fury, Failure and the FDA.’
“More than 99 percent of harm reduction products have either been denied by the FDA or are sitting in limbo. If, as a professor, more than 99 percent of my students failed, I would ask what I was doing wrong.”
He added that there is some hope as 20 applications have been approved, including flavours. A resolution that was passed recently mandated that 200 million dollars go toward enforcement in America.
“America has also announced a fast-track program for four different products to see if they can move through the regulatory pathway much more efficiently. We have not seen anything come out of that yet, but in terms of moving products to the marketplace there has been more effort than keeping products out of the marketplace,” added Smith.
Most experts and evidence suggest that delays in approving Tobacco Harm Reduction products like vapes and snus are damaging to public health since these slow policy actions block adult smokers from switching to far safer alternatives that can dramatically reduce risk and save lives.
“There were more than 2.5 million perfectly reasonable THR product applications submitted to the FDA, and the number approved can only be counted in the dozens,” said Jacob Grier, a THR blogger.
Leading experts argue that regulatory delays perpetuate cigarette-related disease and death by protecting combustible tobacco, stalling innovation, and denying adult smokers access to proven reduced-risk choices.
Canada and the Copy Paste Syndrome from the FDA
In Canada, the government has taken steps to restrict the sale of nicotine pouches, with Health Canada announcing that these products can now only be sold in pharmacies as of early 2025. This decision follows concerns about youth access and marketing that could make nicotine pouches attractive to children and teenagers, especially flavoured varieties. By limiting sales to pharmacies and strengthening labelling and packaging rules, including mandatory warnings and prohibitions on youth-oriented branding, officials aim to ensure these products are used strictly as smoking cessation aids for adults rather than as recreational nicotine devices.
However, the biggest challenge Canada faces is the copy-and-paste formula adopted from the FDA, which, according to experts, has been detrimental to public health and Tobacco Harm Reduction.
“Canada is still reliant on what the FDA says. We do not have the same sophisticated program and often for most of our medicines the FDA is our default regulator. We have not created our own. Maybe that should change now,” said Mark Tyndall, a vaping advocate from Canada.
He also said provinces in Canada were competing to implement heavy restrictive policies toward Tobacco Harm Reduction, and this was having a negative effect on public health.
“The topic is a real winner for politics because they talk about protecting the young and pushing back against big corporations. Most of the population are in agreement, saying they are doing us a favour, but we can talk all day about regulatory processes. Consumers will ultimately do what they want to do. We are on the cusp of handing the entire market over to illegal operations.”
Canada currently has about 3.7 million adult smokers, roughly 10 to 11 percent of the population, with prevalence varying by province and age group. The market is largely driven by illicit trade. Despite pioneering Tobacco Harm Reduction strategies such as legalising vaping products and supporting reduced-risk alternatives, the pace of progress has slowed in recent years. The country now risks falling behind world leaders like Sweden and New Zealand, which have pushed prevalence rates much lower. Public health experts note that while innovative tobacco policies helped Canada slash smoking rates in the past, increasing regulatory restrictions on alternatives like nicotine pouches could jeopardise further reductions, especially among vulnerable and hard-to-reach groups.
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How Smoke-Free Misinformation Is Hindering THR in Mexico
Data shows that Mexico is currently one of the most restrictive countries in the region regarding Tobacco Harm Reduction and alternative nicotine products. Over the past several years, the government has implemented and expanded strict bans on e-cigarettes, nicotine pouches, and other smoke-free products, even as traditional cigarette smoking continues to cause more than 65,000 deaths annually.
“The Mexican government is continuing bans on everything right now. The new president is basically the same as the old one and answers to no one. The government is faking information, and there is no accountability,” said Juan Jose Cirion, a Mexican author of the book ‘The Harm Reduction Concept and Human Rights.’
These policies, initiated under President López Obrador and apparently continued by the current leadership, are described by harm reduction advocates and some civil society voices as lacking transparency and accountability. According to critics like Juan Jose Cirion, there is widespread concern that the government’s regulatory process is opaque, ignores independent scientific evidence, and relies on misinformation while stifling meaningful debate or public input.
