In a First-of-Its-Kind Decision, FDA Will Allow Marketing of Nicotine Pouches

Late last week, the FDA handed down marketing authorization to ZYN, the brand from Swedish Match, a subsidiary of Philip Morris International, for 20 of its tobacco-free synthetic nicotine pouches.¹ The authorization covers the following 10 flavors of the pouches, each in a 3-mg and 6-mg nicotine strength: ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint, and ZYN Wintergreen.

Along with ZYN’s application, 27 million applications have been received through the FDA’s premarket tobacco product application pathway—and decisions made on more than 26 million of the applications—which requires extensive science-based review for all new tobacco products seeking authorization to be marketed in the US via an FDA marketing order.^1,2 According to the FDA, applications submitted for review under the pathway “must provide scientific data that demonstrates a product is appropriate for the protection of public health,” as well as data on the following from the Federal Food, Drug, and Cosmetic Act²:

• Risks and benefits to the population as a whole, encompassing users and nonusers
• Likelihood of use among current tobacco users if the product becomes available
• Likelihood of use among current nonusers of tobacco products if available
• Methods, facilities, and controls used to manufacture, process, and pack the new product

This marketing decision from the FDA covers 2 nicotine strengths, 3 mg and 6 mg, and 10 flavors of the small tobacco-free synthetic pouches. | Image Credit: © Liudmila-stock.adobe.com

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, PhD, director of the Office of Science in the FDA’s Center for Tobacco Products, said in a statement.¹ “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 first-of-its-kind authorization for the small pouches that are placed between the gum and lip only covers approval to market the products to adults in the US 21 years and older. It means that these pouches satisfy the public health standards that are required under the 2009 Family Smoking Prevention and Tobacco Control Act,¹ which include restricting marketing the products to youth, required scientific evidence on the products’ purported reduced risks, and disclosure of ingredients.³ It is not considered a simultaneous approval by the FDA, which reiterates in its release on the authorization that there are no safe tobacco products and youth and adult nonusers should not take up using them.¹

The authorization also involves ongoing monitoring of the marketing and use of the pouches, such as ensuring strict marketing restrictions are adhered to for ads disseminated via TV, radio, and digital means.¹ And ZYN has stated that it will implement measures beyond those that, among other claims, would see advertising actors and models used who are at least 35 years old, no mass-market advertising on radio or TV, and content that does not target a youth audience.

Tobacco use, according to the American Cancer Society, is the leading preventable cause of death in the US, with smoking alone also to blame for organ damage to the lungs, heart, blood vessels, reproductive organs, mouth, skin, eyes, and bones, with smokers having a 10-year shorter lifespan compared with nonsmokers.⁴ In youth (children and teens), the nicotine ingested through tobacco is also known to stunt brain development and has been linked to increased health problems, such as respiratory illness, greater headache frequency, wheezing or gasping, and worse cold and flu symptoms.

References

1. FDA authorizes marketing of 20 ZYN nicotine pouch products after extensive scientific review. FDA. January 16, 2025. Accessed January 20, 2025. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review

2. Premarket tobacco product applications. FDA. Updated March 28, 2024. Accessed January 20, 2025. https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications

3. Family smoking prevention and tobacco control act - an overview. FDA. Updated August 29, 2024. Accessed January 20, 2025. https://www.fda.gov/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/family-smoking-prevention-and-tobacco-control-act-overview

4. Health risks of smoking tobacco. American Cancer Society. Accessed January 20, 2025. https://www.cancer.org/cancer/risk-prevention/tobacco/health-risks-of-smoking-tobacco.html