The U.S. Food and Drug Administration has granted marketing authorization for 20 Zyn nicotine pouch products through the premarket tobacco product application (PMTA) pathway, following a thorough scientific review, according to an FDA press release. This marks “the first time the agency has authorized products commonly known as nicotine pouches.”
The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole.
“As a public health scientist and former Director of the Office of Science at FDA’s Center for Tobacco Products [CTP], I couldn’t be more excited for public health with FDA’s decision today,” Matt Holman, vice president of U.S. Scientific Engagement and Regulatory Strategy at PMI said on X. “Authorizing products that can help the nearly 30 million smokers in the United States switch to a better form of nicotine has the potential to save countless lives.”
Among several key considerations, the agency’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 authorized products pose a lower risk of cancer and other serious health conditions than such products, according to the release.
Philip Morris International (PMI), which owns Zyn nicotine pouches, provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products, according to the FDA. PMI acquired Swedish Match, the manufacturer of Zyn, in November 2022 for $16 billion.
“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, director of the CTP’s Office of Science. “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.”
Additionally, the FDA found that the applicant showed these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth. As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. The 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches.
“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, director of CTP. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”
The FDA states that it will closely monitor the marketing and use of the ZYN products to reduce the potential for youth exposure to advertising. The authorizations impose stringent digital, television, and radio marketing restrictions, including measures to ensure ads are carefully targeted to adults ages 21 and older and the demographics of the audiences reached by the ads are tracked and measured by the manufacturer.
PMI stated that they intend to implement additional measures to restrict youth access, reduce youth appeal, and limit youth exposure to their labeling and advertising, such as: not using mass-market advertising on radio and TV; employing actors/models for marketing that are no younger than 35 years old, or styled to appear under 35; and avoiding any content designed to target youth, including characters, images or themes.
The agency may suspend or withdraw a marketing grant order issued under the PMTA pathway for various reasons if it determines that the continued marketing of a product no longer meets the necessary public health standard, such as if there is a notable increase in youth initiation.
The following products, each with two nicotine strengths (3 milligrams and 6 milligrams), were granted marketing orders by the FDA: ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint, and ZYN Wintergreen.
The FDA’s actions are only specific to these products; the authorizations do not apply to any other nicotine pouch or other ZYN products. Additionally, the authorization does not allow the company to make reduced-risk claims about the authorized products, which would require a modified-risk tobacco product (MRTP) application.
Critics are concerned about flavored nicotine pouches because they believe these products may appeal to young users. Yolonda Richardson from the Campaign for Tobacco-Free Kids argued, “The FDA should not be authorizing flavored tobacco products given their history of appealing to kids.”
