FDA Authorizes Sale of ZYN Nicotine Pouches in All 20 Flavors
In a groundbreaking decision, the FDA has authorized the marketing and sale of all 20 varieties of ZYN nicotine pouches, produced by Swedish Match, a division of Philip Morris International (PMI). This long-awaited ruling comes over four years after Swedish Match submitted premarket tobacco applications (PMTAs) for the products.
Today, FDA authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. https://t.co/OcTXP7vCeX pic.twitter.com/58Hh4RODet
— U.S. FDA (@US_FDA) January 16, 2025
The Approved ZYN Flavors
The FDA’s Marketing Granted Order (MGO) applies to the following flavors, all available in both 3 mg and 6 mg nicotine strengths:
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Chill
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Cinnamon
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Citrus
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Coffee
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Cool Mint
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Menthol
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Peppermint
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Smooth
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Spearmint
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Wintergreen
These flavors represent the entire current ZYN lineup available in the U.S. market. Any future flavors or nicotine strengths would require separate PMTA submissions and FDA authorization.
A Milestone for Nicotine Pouches and Flavored Products
ZYN is the first nicotine pouch brand to receive FDA marketing authorization, and notably, the first nicotine product of any kind to gain approval in flavors beyond tobacco or menthol. In contrast, no vaping products with flavors other than tobacco or menthol have been authorized, highlighting the significance of this decision in the nicotine industry.
This ruling underscores the FDA’s position that ZYN products are “appropriate for the protection of public health,” a standard established under the 2009 Tobacco Control Act. The approval reflects the FDA’s assessment that ZYN products present a reduced harm potential for adult users compared to combustible tobacco products.
Youth Use and FDA Oversight
Despite the FDA’s endorsement, the agency issued a stern warning to PMI to prevent youth uptake. Youth use of nicotine pouches remains low—less than 2% of youth reported past-30-day use in the 2023 National Youth Tobacco Survey. However, the FDA emphasized that it is closely monitoring the marketplace and retains the authority to revoke the authorization if youth usage spikes.
“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said FDA Center for Tobacco Products (CTP) Director Brian King.
The Rapid Growth of ZYN and the Nicotine Pouch Market
ZYN has revolutionized the nicotine marketplace since its U.S. debut in test markets in 2016. By 2023, it held a dominant 70% share of the $8.6 billion U.S. nicotine pouch market. With its popularity growing rapidly, Swedish Match recently announced plans for a second production facility in Colorado to keep up with retail demand.
Nicotine pouches have become a preferred alternative for adult smokers seeking a less harmful option to traditional cigarettes. The absence of combustion and tobacco leaves makes these products a compelling choice for harm reduction, a factor contributing to their soaring popularity.
What This Means for the Industry
This FDA authorization marks a significant milestone in the evolution of nicotine products. ZYN’s approval not only solidifies nicotine pouches as a legitimate harm reduction tool but also sets a precedent for the FDA’s willingness to approve flavored products under the right circumstances.
However, the ruling also highlights disparities in the FDA’s approach to different nicotine categories. While nicotine pouches have received approval in a variety of flavors, the vaping industry continues to face significant regulatory hurdles, particularly for flavored products.
Looking Ahead
The ZYN authorization is a win for harm reduction advocates and adult consumers seeking less harmful alternatives to smoking. As the nicotine pouch market continues to grow, the industry must remain vigilant in ensuring responsible marketing practices and preventing youth access.
The FDA’s decision signals progress, but it also raises questions about consistency in the regulation of other harm reduction products, such as flavored e-cigarettes. For now, ZYN’s success reaffirms the potential of innovative nicotine products to transform the marketplace while protecting public health.
