US FDA approval of nicotine pouches is a landmark moment for Harm Reduction

STOCKHOLM – The United States Food and Drug Administration (FDA) has taken a major step forward in tobacco harm reduction by authorising the marketing of nicotine pouch products through its Premarket Tobacco Product Application (PMTA) pathway. This decision establishes a global benchmark for evidence-based public health policy.

Nicotine pouches, which are smoke-free and significantly less harmful than cigarettes, have been recognised by the FDA for helping smokers transition to other nicotine alternatives. The agency’s evaluation highlighted dramatically lower risks of cancer and other severe health conditions among users, compared to cigarettes. This aligns with Sweden’s success in achieving the lowest smoking rates in Europe and an associated reduction in smoking-related diseases through the widespread availability of reduced-risk alternatives.

Dr. Delon Human, leader of Smoke Free Sweden, said:

The FDA’s decision is a turning point for harm reduction worldwide, showing how science-based policies can lead to healthier outcomes for millions, By approving nicotine pouches based on a robust evaluation of scientific evidence, the FDA has shown how regulatory frameworks can actively improve public health. Europe must take notice and follow this example.”

Sweden’s strategy, built on accessibility, acceptability, and affordability of smoke-free products, has been transformative. Smoking rates in Sweden dropped to just 5.3% of the population last year, compared to the EU average of 24%. 

While the FDA’s decision underscores the importance of innovation in tobacco control, several European countries are moving in the opposite direction. Denmark, Poland and Luxembourg are pushing to ban nicotine pouches due to concerns over youth uptake, despite limited evidence. Belgium has already banned them. Such prohibitive measures risk eliminating effective tools for smokers who want to quit, ultimately undermining public health goals.

As the European Union revisits its Tobacco Products Directive (TPD), policymakers face a critical choice: maintain restrictive measures or adopt a harm reduction approach inspired by Sweden’s success and validated by the FDA’s scientific review. The evidence clearly supports the latter.

Matthew Farrelly, Ph.D., of the FDA’s Center for Tobacco Products, stated in the agency’s announcement: “The data show these nicotine pouch products offer more public health benefits than risks by helping adults switch from cigarettes.”

Smoke Free Sweden urges European lawmakers to prioritise evidence-based policies that promote harm reduction. By ensuring the availability of smoke-free alternatives, providing accurate risk communication, and implementing proportionate taxation, Europe can replicate Sweden’s public health success on a wider scale.

“The evidence is clear,” said Dr. Human. “Harm reduction is a proven method in optimising tobacco control. Preventing smoking-related disease and premature death should be the priority for European policymakers, to save lives. Sweden has shown the way – now it’s time for the rest of the world to follow.”

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Notes to editors

Contact

Smoke Free Sweden

Jessica Perkins 

info@smokefreesweden.org

www.smokefreesweden.org

About Smoke Free Sweden

Smoke Free Sweden is a movement which encourages other countries to follow the Swedish model when it comes to Tobacco Harm Reduction. Sweden’s smoke free success can be attributed to its open attitude towards regulated alternative nicotine products.

For more information on Sweden’s successful approach to becoming a smoke free nation, please visit www.smokefreesweden.org.