FDA Recognition of IQOS Reignites Debate Over Tobacco Harm Reduction Policies

The recent re-issuance of Modified Risk Tobacco Product (MRTP) authorizations for a number of IQOS heated tobacco devices is yet another milestone in the international tobacco harm reduction dialogue by the U.S. Food and Drug Administration (FDA).

The FDA stated that Philip Morris International (PMI) can continue marketing IQOS, highlighting that switching completely from cigarettes “substantially reduces your body’s exposure to harmful or potentially harmful chemicals.”

Importantly, this was not a symbolic gesture or political compromise. MRTP authorization is among the most demanding public health pathways in the world, demanding comprehensive toxicological analysis, behavioural data, population modeling, and evidence demonstrating that the product benefits public health as a whole.

This is naturally considered a significant move by tobacco harm reduction experts, given a fact that has been known for decades: the smoker looks for nicotine; however, it is the smoke caused by combustion that causes harm. Heated tobacco products do not involve combustion at all; they heat rather than burn tobacco, reducing exposure to most toxicants associated with cancer, cardiovascular disease, and respiratory illness by several orders of magnitude.

This difference between heated tobacco products and cigarettes is everything. Public Health England (PHE), which has since been replaced by the UK Health Security Agency, has consistently highlighted that smoke-free nicotine products expose users to far fewer harmful compounds than combustible cigarettes. While countless other independent studies have concluded that exposure to carcinogens is primarily caused by burnt tobacco, not nicotine. Nicotine is addictive but not classified as carcinogenic by major international bodies (such as the International Agency for Research on Cancer, [IARC]). And the FDA’s renewed authorization, therefore, reinforces a broader harm-reduction principle already shaping global policy discussions: not all nicotine products carry the same level of risk.

Yet despite this, many health entities and lawmakers continue to frame heated tobacco products and other non-combustible nicotine products, such as vapes, as no different from cigarettes. If smokers are repeatedly told that all nicotine products are equally harmful, many will see little reason to switch away from cigarettes. That outcome directly conflicts with public health goals aimed at reducing smoking-related disease. The debate is not theoretical. The body of real-world evidence from countries that embraced harm reduction approaches continues to grow.

Japan may be the clearest case of how heated tobacco products can influence smoking prevalence. In Japan, cigarette sales have dropped at rates never seen before in the time since IQOS and other heated tobacco products were introduced. Independent analyses have attributed the rapid ongoing fall in cigarette consumption to widespread switching toward smoke-free alternatives (notably heated tobacco products).

Research published in BMJ Tobacco Control shows that after heated tobacco products entered the Japanese market late in 2014, cigarette sales fell off significantly faster than before. The introduction of heated tobacco led to a reduction in combustible cigarette sales, with some estimates showing declines of over 40% within 3 years. This is one of the largest reductions in smoking ever seen in a developed country without prohibitionist measures.

At the same time, consumer adoption continues to grow worldwide. A previous surveillance study (Global Heated Tobacco Product User Estimates, 2014-2024) estimated that the number of HTP users globally was around 49 million in 2024, based on a mean of parameter estimates from several models, which ranged from 79 million. The researchers concluded that heated tobacco products have proliferated around the world in just a single decade, indicating growing demand for less hazardous substitutes to cigarettes among adult smokers.

Importantly, the growth of heated tobacco products seems to be largely among current smokers looking for alternatives and not from nicotine-naive users. This is also seen in the UK vaping experience, with nearly all adult users being current or previous smokers.

Nonetheless, sizable segments of the public health community continue to demand that “more research is necessary” before regulators should recognize harm reduction. Although long-term monitoring is appropriate, critics say such a demand has increasingly become a political tool rather than a scientific benchmark. As if no public health intervention is ever launched with decades of epidemiological certainty already attached to it!

Unsurprisingly, the strategy of constantly calling for more evidence is reminiscent of tactics that were historically employed by the tobacco industry itself to put off acceptance of destructive evidence regarding the dangers associated with smoking. Today, though, several campaigners seem to be using similar arguments against products that could greatly lessen the overall harm of smoking.

Some harm reduction advocates are also questioning the role of institutional incentives in forming opposition to safer nicotine products. Large advocacy organizations dependent on anti-tobacco funding streams may find it hard to adjust to an environment in which nicotine use evolves away from combustible smoking. If smoking rates collapse because consumers adopt significantly lower-risk products, traditional abstinence-only approaches risk becoming increasingly disconnected from real-world outcomes.

Naturally, THR experts agree that heated tobacco products, like all nicotine products, require sensible regulation and should never be marketed to youth or non-smokers. However, refusing to acknowledge substantial risk differences between combustible and non-combustible products distorts public understanding and slows progress against smoking-related disease.

The FDA’s latest decision signals that regulatory science is moving toward a more balanced, evidence-based framework—one that recognizes the importance of relative risk in public health. The wider question is whether policymakers and public health institutions worldwide are willing to follow the evidence, or whether ideological resistance will continue to obstruct one of the most promising harm-reduction opportunities in modern tobacco control.

Beyond Combustion: The Role of Heated Tobacco Products in Harm Reduction