Regulators in the United States have moved a step closer to allowing Zyn brand nicotine pouches to be marketed as less-harmful alternatives to cigarettes.

At a recent public hearing convened by the U.S. Food and Drug Administration (FDA), experts reviewed evidence as to whether Philip Morris International (PMI) subsidiary Swedish Match USA can include “reduced risk” language when advertising 20 different varieties of Zyn brand nicotine pouches.

Specifically, the company wants to have authorisation to say that using Zyn instead of cigarettes puts consumers at a “lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

Youth pouch use ‘relatively low’

During the hearing, members of the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) confirmed that the modified risk claim for Zyn was “scientifically accurate”, despite the absence of long‑term studies on Zyn consumers and uncertainty around whether marketing the reduced‑risk language would actually prompt smokers to switch.

They also found that nicotine pouch use among young people was “relatively low”, adding that “among young adults, viewing the proposed claim did not increase intentions to use Zyn.”

US vs. EU nicotine regulation: a stark contrast

The language contrasts starkly with that heard from regulators and policymakers in Europe, where regulatory approaches have been trending in the opposite direction. 

In recent years, several European countries have introduced restrictions or outright bans on tobacco-free nicotine pouches over concerns about youth uptake.

“It’s encouraging that US regulators are willing to look at the evidence and adopt policies that will make it easier for American consumers to choose a less-harmful product,” says Patrik Strömer, Secretary General of the Association of Swedish Snus Manufacturers.

“At the same time, it makes the current situation in the EU even more maddening. Moralistic regulators seem hell-bent on depriving Europe’s smokers access to safer alternatives – despite the clear public health benefits of switching from combustible cigarettes to smokeless nicotine products.”

Zyn’s regulatory journey continues

The FDA hearing comes a year after the agency granted Zyn pre-market authorisation following a lengthy scientific review. 

The move marked the FDA’s first marketing authorisation for an oral nicotine product, finding that Zyn products are substantially less harmful than cigarettes.

The FDA’s comment period on the Zyn Modified Risk Tobacco Product (MRTP) application closes on March 4, 2026, after which the agency will consider all the evidence before issuing a final decision.

In 2019, the agency granted Swedish Match USA’s “General” brand of tobacco snus as an MRTP, marking the first time the agency designated any tobacco product as “less risky” than cigarettes.