In an important step forward for nicotine pouches in the US and internationally, the U.S. Food and Drug Administration (FDA) has reviewed and authorised for marketing Philip Morris International’s nicotine pouch brand, ZYN. The announcement marks a new stage for nicotine pouches in the US and is a clear signal to the world of the increasingly important role pouches play in the transition away from smoking cigarettes.
Growing in popularity with adult smokers in the UK looking for a discrete, convenient and reduced-risk smoke-free alternative, the pouches category has seen a 91 per cent rise in volume since 2019, with the potential for similar uptake as in Scandinavia and the US.
“This decision is an important step forward in the protection of public health in the US and resonates here in the UK," said Duncan Cunningham, External Affairs Director at Philip Morris Limited. "It affirms that ZYN nicotine pouches are a better alternative for legal age adults who smoke or use other traditional tobacco products and is a win for the consumer and for public health. Importantly, the decision was based on a comprehensive review of available science.”
The US Family Smoking Prevention and Tobacco Control Act requires new tobacco products (including non-medical nicotine products) to be authorised by FDA before they can be sold. The science-based review analyses factors including toxicological risk compared to cigarettes, risk of initiation by non-users and minors and overall benefit to public health.
After a stringent review, the FDA determined that the marketing of all 20 ZYN variants is appropriate as it has ‘the potential to provide a benefit to adults who smoke cigarettes’, and the benefits to legal-aged nicotine users were sufficient to outweigh any potential risk of the product, including youth access.
“The decision demonstrates the very real benefits of driving awareness of nicotine pouches to help switch adult smokers away from cigarettes," Cunningham said. "Clearly, if we are to succeed in realising the UK’s smoke-free ambition, we need to provide smokers with access to – and information about – the full range of smoke-free products.
“In the UK we’re seeing encouraging growth with products like ZYN as a reduced risk alternative, and the government should ensure that the Tobacco and Vapes Bill currently working its way through Parliament does not unintentionally harm the chances of the six million adult smokers in the UK today being able to switch to these and other less harmful alternatives.”
Philip Morris Limited’s brand, ZYN has grown +161 per cent in 2024 compared to 2023. UK retailers interested in stocking the product can find ZYN available in wholesalers nationwide.
