There are 20 ZYN variants (“Zyns”) currently sold in the USA: 10 flavors x 2 nicotine strengths (3mg, 6mg). ZYN flavors include Smooth, Chill, Menthol, Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee and Cinnamon. Read more: ZYN Flavors.
Zyns are sold in a polypropylene can of 15 pouches. Each ZYN pouch weighs 0.40 grams and contains 3mg or 6mg of nicotine. A ZYN pouch is 28 millimeters in length, 14 millimeters in width and 4.5mm in thickness – in dimensions that can be comfortably placed between the gum and lips for “a smooth flow of nicotine and flavors”. And, more than 2 millions of Americans do that on a daily basis – to the extent that ZYN is now the fourth largest nicotine brand in the USA, after Marlboro, Newport and Camel. Read more: USA: ZYN Pouches. Some famous & controversial peple also feature among the Zyn-lovers, or “Zynners” (- as opposed to Sinners as ZYN is not a sin). Read more: ZYN & People and ZYN Sayings & Puns.
But, what does the U.S. Food and Drug Administration (FDA) tell us about Zyns? In January 2025, US FDA authorized the marketing of all 20 Zyns sold in the US through the premarket tobacco product application (PMTA) pathway following an extensive scientific review1. This is the first and, so far, the only nicotine pouch authorization by the US FDA.
Let’s summarize what US FDA’s scientific review of Zyns found:
– Zyns are granted marketing authorization because US FDA concluded that permitting Zyns to be marketed in the US is appropriate for the protection of the public health (APPH) when the risks and benefits to the population as a whole, including users and nonusers of tobacco products, are taken into account.
– FDA assesses that ZYN would have a net benefit to public health as the potential positive public health impact (e.g. benefit from current tobacco users switching to Zyns) outweighs the potential negative public health impacts (e.g., harm from initiation and use among nonusers, particularly youth). In simple terms, US FDA is not overly worried about the likelihood of nonusers (especially, the youth) to start using Zyns.
– There is sufficient information to conclude that Zyns are manufactured consistently and have an abuse liability (i.e. propensity to be abused and produce adverse public health consequences) lower than combusted cigarettes and similar to smokeless tobacco products.
– The overall toxicological risk to the ZYN users is lower compared to smokers due to the significantly lower Harmful & Potentially Harmful Constituent (HPHC) levels. Risk is also reduced compared to smokeless tobacco products, including General Snus, and as evidenced by low levels of HPHC exposure and results of nonclinical studies.
– US FDA does not expect substantial uptake of Zyns by smokers even if ZYN-owner, Philip Morris International (PMI) claims that a substantial portion of dual users (cigarettes & Zyns) may switch to Zyns over time.
– US FDA is convinced that risk of ZYN initiation by youth is limited: according to PMI’s study findings, more than 90% of 18-24 years-old never users reported that their likelihood of buying Zyns in the future was less than 1%, nearly 75% said Zyns were not at all appealing, and 62% said the Zyns’ variety of flavors were not at all or slightly appealing.
– ZYN marketing authorization is subject to PMI following the post-marketing requirements aimed at reducing youth exposure and access to the products and may be withdrawn if ZYN marketing leads to significant youth uptake.
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