Right: Beste Ermaner, PMI Duty Free Vice President.

The U.S. Food and Drug Administration (FDA) has authorised the marketing of 20 ZYN nicotine pouch products following an extensive scientific review.

The decision, made on 16 January, covers all ZYN nicotine pouches currently marketed by Swedish Match in the US.

It permits those products on the list (see below) to be legally marketed in the US to adults aged 21 and over.

ZYN, available in duty free in markets around the world including in the US, falls within the multi-category portfolio of smoke-free products belonging to Philip Morris International and was recently named ‘Best Nicotine (non-combustible) Product 2024’ in the 2024 consumer-voted Global Travel Retail Awards.

“The U.S. Food and Drug Administration (FDA) decision to authorise the marketing of 20 ZYN products is very welcome news for PMI and will undoubtedly strengthen awareness of the product within the US region’s airport duty free stores,” commented Beste Ermaner, PMI Duty Free Vice President.

Swedish Match USA filed for FDA review and authorisation of the 20 ZYN nicotine pouch products back in March 2020.

PMI hopes the FDA’s decision will help to strengthen awareness of ZYN in airport duty free stores in the US.

The oral nicotine pouches present an option for legal age adults who are seeking a better alternative to conventional cigarettes and other traditional tobacco products.

Among several key considerations, the FDA’s evaluation showed that, ‘due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorised products pose lower risk of cancer and other serious health conditions than such products’.

The agency also referenced a study provided with the application showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorised nicotine pouch products.

ZYN has not been authorised to communicate this information to consumers but has submitted Modified Risk Tobacco Product applications seeking authorisation to communicate reduced risk messaging, which remain pending.

“To receive marketing authorisations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” commented Matthew Farrelly, Ph.D., Director of the Office of Science in the FDA’s Center for Tobacco Products.

“In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

The agency underlined that ‘it does not mean these tobacco products are safe’, or that they are ‘FDA approved’, also noting that ‘there is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start’.

While youth use of nicotine pouches remains low – 2024 National Youth Tobacco Survey showed that 1.8% of US middle and high school students reported currently using nicotine pouches – the FDA has said it will closely monitor youth use and company’s compliance with marketing restrictions.

PMI underlines that its marketing practices are focused only on existing legal age nicotine consumers.

The company states that PMI’s US affiliates do not use social media influencers in the US or people under the age of 35 in marketing materials.

More measures include employing independent age-verification systems such as ‘Double Verify’ to direct digital advertising to those over 21, and owned digital platforms are age-gated at the point of access and restricted to current nicotine users of legal age.

ZYN has been sold in the US since 2014.

The variants covered by the decision are: ZYN Cool Mint 3 mg; ZYN Cool Mint 6 mg; ZYN Peppermint 3 mg ; ZYN Peppermint 6 mg; ZYN Spearmint 3 mg; ZYN Spearmint 6 mg; ZYN Wintergreen 3 mg; ZYN Wintergreen 6 mg; ZYN Citrus 3 mg; ZYN Citrus 6 mg; ZYN Coffee 3 mg; ZYN Coffee 6 mg; ZYN Cinnamon 3 mg; ZYN Cinnamon 6 mg ; ZYN Smooth 3 mg; ZYN Smooth 6 mg; ZYN Chill 3 mg; ZYN Chill 6 mg; ZYN Menthol 3 mg; and ZYN Menthol 6 mg.

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