United States Food and Drug Administration (FDA) has opened a full scientific review of Swedish Match USA’s bid to have its Zyn nicotine pouches carry a health statement, “Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The application moves the popular nicotine pouch brand into the FDA’s Modified Risk Tobacco Product (MRTP) track, a legal pathway that can grant companies permission to advertise reduced harm claims.
Zyn cleared the agency’s pre-market hurdles in January, but a separate order is required before any health language appears on packages sold in the US.
Twenty Zyn flavours and strengths, from Cool Mint to Coffee, in 3 mg and 6 mg formats, are bundled into the request.
FDA accepted the files on June 17, triggering a rigorous evidence review and a public comment period that opened on June 18.
FDA will not set a closing date until every redacted document is posted online, a process expected to take months.
Under US law, regulators must decide whether the proposed claim would “significantly reduce harm” for individual users and “benefit the health of the population as a whole,” including people who have never used nicotine.
An independent Tobacco Product Scientific Advisory Committee (TPSAC) will examine the data and make a recommendation before the FDA issues its verdict.
Philip Morris International (PMI), which owns Swedish Match, says US smokers deserve clear information.
“It is a positive development that FDA is progressing the MRTP applications and we hope for an expeditious review,” a PMI spokesperson told the media.
“Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health. Providing accurate information on the relative risk of different nicotine products to America’s 45 million legal-age nicotine consumers will help accelerate switching to better alternatives than continued cigarette use—the most harmful form of nicotine consumption.”
PMI argues its laboratory, clinical, and behavioural studies show pouches deliver nicotine without the combustion that creates tar and thousands of toxic chemicals.
Early public feedback, however, shows a split.
John Benner, a former smoker who switched to Zyn last year, called the pouch “life-changing” and dismissed worries about youth uptake.
“To be blunt, I still get my nicotine, but not the cancer,” wrote Benner.
In contrast, an anonymous commenter warned that touting reduced disease risk is “misleading and dangerous,” pointing to nicotine’s effect on teen brain development and limited long term data on nicotine pouches.
Health advocates are watching closely.
If the FDA grants the order, Zyn would become the first nicotine pouch sold in the US with a government sanctioned lower risk label.
Only a handful of smokeless products, including Swedish Match’s General Snus, have ever received an MRTP order, and most came with tight marketing controls to limit youth appeal.
The FDA stresses that an MRTP decision is product specific.
Even if the claim is approved, other pouch makers would need their own evidence packages.
In the meantime, the FDA urges interested parties, from doctors and parents to industry rivals, to submit comments through Regulations.gov website.
A final ruling could come in 2026, though timelines often shift if reviewers demand more studies.
For Canadian observers, the outcome may foreshadow future debates at home.
While Zyn is not yet sold nationally in Canada, Imperial Tobacco’s Zonnic is available at pharmacies across Canada.
Any new US labeling is likely to spread northward, sparking renewed discussions on the most effective strategies to guide smokers towards less harmful options while preventing nicotine from reaching teenagers.