The US Food and Drug Administration (FDA) has for the first time authorised nicotine pouches to be marketed with a modified-risk claim, concluding that adult smokers who switch completely from cigarettes to ZYN nicotine pouches can substantially reduce their risk of developing several major smoking-related diseases.
The decision marks the first time a nicotine pouch has received such authorisation in the United States.
Under the order, Swedish Match may market 20 ZYN products with the 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 authorisation applies only to adults who completely replace cigarettes with the nicotine pouches and does not mean the products are safe or approved as smoking cessation aids.
“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products.
“Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”
The FDA said its decision followed an extensive scientific review under the Modified Risk Tobacco Product (MRTP) framework, concluding that allowing the claims was “appropriate to promote the public health”.
Because nicotine pouches do not involve combustion, users avoid exposure to many of the toxic chemicals created by burning tobacco that are responsible for the overwhelming majority of smoking-related diseases.
”FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” Stacey Kennedy, Philip Morris’s US chief executive, said in a statement.
“Today’s news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases.”
The FDA’s decision strengthens the case made by advocates of tobacco harm reduction, who argue that smokers who cannot or do not want to quit nicotine should be encouraged to switch to substantially less harmful alternatives rather than continue smoking.
They frequently point to Sweden, where widespread use of snus and, more recently, nicotine pouches has coincided with the EU’s lowest smoking prevalence and among the bloc’s lowest rates of tobacco-related cancer and mortality.
Sweden became the first EU country to achieve “smoke-free” status, with daily smoking falling below five per cent while outperforming the rest of Europe on smoking-related health outcomes.
The FDA’s decision comes as the European Commission is preparing a revision of the Tobacco Products Directive and broader tobacco legislation, with nicotine pouches expected to face stricter regulation rather than recognition as a lower-risk alternative.
Several member states have already introduced restrictions on nicotine strength, flavours and sales, while the Commission has indicated it is examining additional EU-wide measures covering novel nicotine products.
That approach has been criticised by Sweden and several public health experts, who argue that the EU risks undermining tobacco harm reduction by regulating smoke-free nicotine products in much the same way as combustible cigarettes.
Supporters of tighter regulation maintain that nicotine pouches require stricter controls to prevent uptake among young people and non-smokers, even if they are significantly less harmful than cigarettes.
The FDA echoed that concern, stressing that its decision was intended only for existing adult smokers.
“People who do not use tobacco products, especially youth, should not start using these products,” the agency said.
The modified-risk authorisation applies only to the 20 ZYN products reviewed by the FDA and does not automatically extend to other nicotine pouch brands.
Experts say that policies aimed at protecting the public against the negative effects of smoking have serious adverse effects, damaging public health. https://t.co/82mNHZxMMt
— Brussels Signal (@brusselssignal) March 24, 2026
