Following an extensive scientific review, the US Food and Drug Administration (FDA) has concluded that 20 varieties of nicotine pouches are less harmful than cigarettes and an effective alternative for adult smokers who want to quit. 

The finding lies behind the US agency’s decision to grant marketing authorisation to 20 ZYN-brand nicotine pouches produced by Swedish Match. 

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Dr. Matthew Farrelly of the FDA’s Center for Tobacco Products said in a statement.  

“The data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.” 

FDA’s first nicotine pouch authorisation 

The decision marks the FDA’s first marketing authorisation for an oral nicotine product and allows the products to remain on the market in the US. 

Nicotine pouches have been available in the US for nearly a decade while the FDA has conducted an extensive scientific review to determine whether they should be formally authorised. 

The products have become increasingly popular in recent years, including among young people, sparking fears among anti-smoking groups that pouches could become a gateway to smoking. 

However, after assessing the available evidence, the FDA found that “the potential of the new products to benefit adults who smoke or use smokeless tobacco outweighs the risk to youth”.  

The agency cited the 2024 National Youth Tobacco Survey which revealed that only 1.8 percent of US middle and high school students reported currently using nicotine pouches.  

Harm reduction as a strategy  

Patrik Strömer, Secretary General of the Association of Swedish Snus Manufacturers, describes the FDA authorisation for ZYN as a “major boost” for harm reduction advocates who have long argued that nicotine pouches are an important tool to help adult smokers quit. 

“The FDA’s decision strengthens the argument for harm reduction as a strategy,” he says. 

“It’s a signal to policymakers in the rest of the world that alternative nicotine products have an important role in reducing tobacco-related diseases.” 

‘Foolish’ to villainize nicotine  

Strömer contrasts the FDA finding with nicotine “fear-mongering” among public health officials in the EU, where several countries are considering outright bans on nicotine pouches. 

“Villanizing nicotine through claims that cigarettes and alternative products are equally dangerous looks even more foolish in light of the FDA decision,” he says. 

“It’s high time that anti-nicotine organizations stop spreading myths that nicotine itself is the cause of tobacco-related diseases. The science is clear: combustion is the problem, not nicotine.” 

He hopes policymakers and public health groups in Europe can take inspiration from the FDA and create regulations “based on facts rather than outdated attitudes towards nicotine”.  

‘Smokers need alternatives, not bans’ 

“The FDA decision is a victory for both consumers and public health. Now is the time for more countries to follow suit and make harm reduction a central part of their tobacco policies,” he says. 

“We need to shift the focus from ideology to science. Europe’s smokers need alternatives – not bans.”  

The January 2025 authorisation for ZYN marks the second time the Swedish Match – which since 2022 has been owned by Phillip Morris International – has been the subject of a history FDA decision. 

In 2019, the agency granted the company’s “General” brand of tobacco snus a Modified Risk Tobacco Product (MRTP). It was the first time the agency had designated any kind of tobacco product as “less risky” than cigarettes.