The US Food and Drug Administration on June 30 gave Swedish Match permission to market 20 Zyn nicotine pouch products with a specific reduced-risk message aimed at adults who smoke.
The allowed claim is narrow. For those products, Zyn can tell US consumers that using the pouches instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis. That permission does not mean the FDA considers nicotine pouches safe. It also does not make Zyn an FDA-approved tool for quitting smoking, the way nicotine patches, gum and inhalers are used as nicotine-replacement therapies.
The decision came through the FDA’s modified risk tobacco product process, a regulatory lane for companies that want to make comparative health claims about tobacco products. In this case, the agency said it reviewed toxicology data, consumer research and public health modeling before issuing the order.
The authorization covers 10 Zyn flavors in two nicotine strengths, 3 milligrams and 6 milligrams. It does not cover every pouch Swedish Match sells, and it does not give the whole nicotine pouch category a regulatory halo, despite what the marketing department would presumably enjoy doing with it.
The catch is complete switching
The FDA’s finding applies to adults who stop smoking cigarettes and fully move to the covered Zyn products. People who keep smoking while using pouches, or who combine pouches with vapes, are outside the benefit the agency described.
The agency also said people who do not use tobacco should not start using nicotine pouches. Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said the review process is meant to give adult users “clear, science-based information about the relative harms of tobacco products” so they can make informed choices. He said the decision tells adults who smoke about the lower risks tied to the authorized products.
Swedish Match must monitor how the products are used in the real world and report that information to the FDA. The modified-risk order lasts five years unless the agency renews it or pulls it back.
A fast-growing category with youth concerns
The ruling lands after nicotine pouches had already become a major business. The World Health Organization reported that global retail sales of nicotine pouches reached 23.4 billion units in 2024, up more than 50 percent from the year before.
The WHO has also warned that regulation is lagging in many countries as pouches spread quickly. The organization has pointed to social media, influencers and youth-oriented marketing as promotional channels for the category. It has also warned that adolescents and young adults may be drawn to the products because of their youth appeal and addictive potential.
Zyn is one of the leading oral nicotine pouch brands, alongside products such as On! and Velo. The broader market for cigarette alternatives now includes nicotine-replacement therapies, disposable e-cigarettes, vapes and heated tobacco devices such as IQOS, which heat tobacco rather than burn it.
The FDA’s position is blunt once the label gloss is scraped off: some Zyn products may pose lower risk than cigarettes for adults who completely switch. The agency still says there is no safe tobacco product, and that fully quitting tobacco and nicotine remains the best health outcome.
This story draws on original reporting from WIRED.
