Philip Morris International (PMI) has become the first company to secure a modified risk authorisation for nicotine pouches in the US after the Food and Drug Administration (FDA) granted Modified Risk Tobacco Product (MRTP) orders covering 20 variants of its ZYN brand.
The decision allows PMI to market an FDA-authorised claim stating: "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 covers 20 ZYN nicotine pouch variants across 10 flavours, including Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill and Menthol, each available in 3mg and 6mg strengths.
Stacey Kennedy, chief executive of PMI U.S., described the decision as a significant milestone for adult nicotine consumers.
"Today's news ensures these adults have access to accurate, science-based information, including FDA-authorised evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer," she said.
She added that the decision reinforced the FDA's science-based approach to evaluating products across the continuum of risk.
The MRTP orders build on the FDA's January 2025 decision authorising ZYN for sale in the US through the premarket tobacco product application (PMTA) pathway, making it the first nicotine pouch approved for the US market following scientific review.
According to PMI, the latest authorisation means it now holds FDA modified risk orders for ZYN, IQOS heated tobacco products and eight General snus products.
In its modified risk order, the FDA said it had concluded that the authorised ZYN products "would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole," compared with continued cigarette smoking.
Nicotine pouches deliver nicotine orally without burning tobacco or producing smoke, resulting in substantially lower exposure to harmful chemicals than combustible cigarettes.
The FDA said evidence submitted by PMI showed that many adult smokers who began using ZYN reduced or completely stopped smoking cigarettes. More than half of those surveyed reported no cigarette consumption during the previous 30 days, while over 80 per cent of dual users reduced cigarette consumption and more than half cut their daily cigarette use by over 50 per cent.
The FDA's decision applies only to the authorised ZYN products marketed in the US and does not mean the products are risk-free or safe for non-users or young people. It also does not affect the regulatory status of nicotine pouches in other markets, including the UK.