USA. In an important breakthrough for Philip Morris International (PMI), the US Food and Drug Administration (FDA) has yesterday (30 June) granted Modified Risk Tobacco Product (MRTP) status to 20 ZYN nicotine pouches, allowing the company to market them with reduced-risk claims.
The authorised claim states: ‘Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.’
ZYN is the smokeless nicotine pouch brand of Swedish Match, the Stockholm-based tobacco company owned by PMI since 2022.
Welcoming the regulatory milestone, PMI US CEO Stacey Kennedy described the decision as an important moment for the more than 45 million legal-age nicotine consumers in America.
She said, “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.
“More broadly, it reinforces the agency’s science-based approach to evaluating products across the continuum of risk and communicating those findings transparently.”
The FDA’s decision highlights the differing regulatory approaches to nicotine products globally, with the USA requiring extensive scientific study before authorisation, while many other countries have opted for prohibitions.
The MRTP orders apply to 20 ZYN nicotine pouch products across ten flavour variants: Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill and Menthol – each offered in 3mg and 6mg strengths.
The new orders follow FDA’s landmark January 2025 decision, when ZYN became the first nicotine pouch brand authorised for sale in the USA, following the agency’s scientific review.
The latest authorisation expands PMI’s portfolio of FDA-authorised Modified Risk Tobacco Products to include ZYN nicotine pouches, selected IQOS devices and consumables, and eight General snus products.
In a note, Goldman Sachs Research said: “We see this as a positive catalyst for the stock, as it should drive greater acceptance and adoption of the ZYN brand.
“Importantly, we see this as a competitive advantage for PM, but also believe it is positive for the entire nicotine pouch category as we believe consumers may now better appreciate the lower relative exposure to harm of these products (i.e., this could create a halo effect for the nic pouch category broadly).
“All in, we see today’s news as a significant step towards PM achieving its smoke-free future as it should accelerate the growth of ZYN globally.”
Goldman Sachs concluded that PMI remains well positioned for “strong top and bottom-line growth over the next several years”, driven by the continued momentum of IQOS and opportunities for ZYN. ✈
