The US Food and Drug Administration (FDA) has authorised ZYN brand nicotine pouches to be marketed as less harmful compared to cigarettes. Meanwhile, EU regulators continue to debate whether pouches should be banned altogether. 

The FDA has approved 20 varieties of ZYN brand nicotine pouches to be marketed with a Modified Risk Tobacco Product (MRTP) claim. 

The ruling allows the manufacturer, PMI, to inform adult consumers that completely switching from cigarettes to ZYN entails a lower risk of several serious diseases. 

The specific claim reads: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

It’s the first MRTP designation for nicotine pouches, and comes following a rigorous scientific review of the evidence submitted by the manufacturer.

At the same time, the agency emphasises that the products are not risk-free and should not be used by young people or by people who do not already use nicotine.

“The FDA’s decision shows it’s possible to combine strong consumer protection with scientifically grounded information,” says Patrik Strömer, Secretary General of the Association of Swedish Snus Manufacturers.

“While the US chooses to differentiate between the risks associated with cigarettes and nicotine pouches, Europe is instead discussing more bans and restrictions. These are two completely different approaches to public health.”

A clear recognition of harm reduction

The FDA’s decision is seen as one of the clearest regulatory recognitions to date of the principle of harm reduction for nicotine pouches. Back in 2019, the agency granted MRTP designation to eight varieties of General, a traditional Swedish snus smokeless tobacco product.

The ZYN ruling affirms US regulators’ view that adult smokers can make more informed decisions if they are given accurate information about the differences in risk between cigarettes and smoke-free products.

The designation stops short of describing nicotine pouches as harmless, but instead clarifies that the risks differ between different products.

Europe moving in the opposite direction

The decision comes at the same time as the EU is working on the third revision of the Tobacco Products Directive, TPD3.

Several European countries have been moving in the opposite direction in recent years.

Earlier this year, France enacted a complete ban on the possession of nicotine pouches. In Belgium, commercial sales have been outlawed since 2023. Meanwhile, several other member states are considering various restrictions on flavours, nicotine levels, marketing, and taxation. 

In parallel, negotiations are underway in Brussels on introducing common EU rules for nicotine pouches within the framework of TPD3 that could result in tighter rules heavily restricting or completely preventing adult nicotine consumers from having access to less harmful alternatives.

The latest FDA decision reveals a “growing transatlantic divide” over nicotine and harm reduction between two of the world’s largest regulatory actors, says Strömer.

“While the FDA is opening up for consumers to be informed about relative health risks, the discussion in Europe is largely focused on how access to the products should be restricted,” he says.

“This is an extremely troubling development for European consumers.”

Could the FDA impact debate in Europe?

While the FDA decision applies only to the US market, the agency is one of the world’s most influential regulators. 

As a result, the decision is expected to attract considerable international attention, not least when it comes to the ongoing debate on how nicotine products should be regulated in Europe

The question now is whether the EU will take note of the FDA’s scientific assessment or continue along the path of stricter rules and more restrictions.

Ahead of the upcoming TPD3 revision, the discussion about harm reduction, risk-proportionate regulation, and consumer information is therefore likely to become more relevant than ever.

“For me, this is not really a question of snus or nicotine pouches. It is about how political decisions should be made,” says Strömer.

“Should they be based on scientific assessments and actual results, or on something else? The FDA has now made its assessment. It will be interesting to see how the EU chooses to act.”