For The First Time FDA Authorises Modified Risk Claims for Nicotine Pouches: A Milestone for International Public Health

For the first time, the U.S. Food and Drug Administration (FDA) has authorised nicotine pouch products to be marketed with modified risk claims, marking a significant development in tobacco harm reduction (THR). 

The decision applies to 20 specific ZYN nicotine pouch products, owned by Philip Morris International (PMI), that underwent the FDA’s extensive Modified Risk Tobacco Product (MRTP) scientific review. These products are now authorised to communicate that completely switching from cigarettes to them reduces the risk of several serious smoking-related diseases. 

Nicotine pouches are tobacco-free oral products similar to traditional Swedish snus, but they do not contain tobacco and are designed to deliver nicotine without combustion. Placed under the upper lip, they release nicotine through the oral mucosa. Because they do not involve burning tobacco, they expose users to substantially lower levels of harmful chemicals than cigarettes and are intended for adults. 

The U.S. Food and Drug Administration (FDA), the federal agency responsible for regulating medicines, food, medical devices and tobacco products, requires manufacturers to submit extensive scientific evidence before any tobacco or nicotine product can be marketed. Products seeking to communicate reduced-risk or reduced-exposure information are subject to an even more rigorous review through the Modified Risk Tobacco Product (MRTP) pathway.

Following its extensive scientific review, the FDA concluded that authorising these modified risk claims is appropriate for the protection of public health. The agency found sufficient scientific evidence that adult smokers who completely switch from cigarettes to the authorised products reduce their risk of diseases such as mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis. As a result, the authorised products may now carry the claim: “Using ZYN instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

Bret Koplow, Acting Director of the FDA’s Center for Tobacco Products, said: “FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices.”

Why is this important for international public health?

For many years, tobacco harm reduction advocates have argued that public health policies should distinguish between combustible tobacco products, which are responsible for the overwhelming majority of tobacco-related disease, and significantly lower-risk nicotine products. 

The FDA’s decision reinforces this principle by acknowledging that not all nicotine products present the same level of risk. It also demonstrates that regulators can evaluate these products using rigorous scientific standards and authorise factual communications when supported by evidence.

Providing accurate information about relative risk helps adult smokers make informed decisions and may encourage more smokers who would otherwise continue smoking to switch to less harmful alternatives.

Sweden’s experience

Long before nicotine pouches became popular internationally, Sweden had already adopted a regulatory approach that allowed adult access to smoke-free nicotine products under clear rules.

For decades, Swedish consumers have had legal access to snus, and more recently to nicotine pouches. Rather than replacing tobacco control measures, these products complemented existing policies and enabled millions of smokers to transition away from cigarettes.

Today, Sweden has the world’s lowest smoking prevalence and correspondingly low rates of smoking-related disease. The Swedish experience has become one of the most frequently cited real-world examples of tobacco harm reduction, demonstrating how regulated access to lower-risk alternatives can accelerate the decline of cigarette smoking while maintaining strong protections for young people. This experience has attracted increasing attention from researchers and policymakers around the world.

At Quit Like Sweden, we believe that successful tobacco harm reduction depends on more than simply making lower-risk products available. It requires what we call the Three A’s:

Acceptability means that products must be attractive enough for adult smokers to choose them instead of cigarettes, while also being recognised by society, healthcare professionals and policymakers as legitimate tools for reducing smoking-related harm.

Accessibility means that adults who smoke should have legal, regulated access to products that have been shown to present substantially lower risks than combustible cigarettes.

Affordability means that these alternatives should remain economically attractive compared with cigarettes. If lower-risk products become more expensive or more difficult to obtain than smoking, many smokers will simply continue smoking.

The FDA’s decision regarding ZYN represents more than an authorisation for a single product. It reflects an evidence-based regulatory approach that recognises the importance of providing adult smokers with accurate information about relative risk. Combined with appropriate regulation, youth protections and ongoing scientific evaluation, this approach has the potential to contribute meaningfully to reducing the global burden of smoking-related disease.