FDA Greenlights ZYN Nicotine Pouches: A Milestone for Harm Reduction and PMTA Pathway Insights

On January 16, 2025, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway. This marks the first instance of the FDA authorizing nicotine pouches, which are smokeless, tobacco-free products designed to deliver nicotine when placed between the gum and lip.

The FDA’s decision was based on an extensive scientific review demonstrating that these products contain substantially lower levels of harmful constituents compared to traditional cigarettes and most smokeless tobacco products, such as moist snuff and snus. Consequently, the authorized ZYN pouches pose a reduced risk of cancer and other serious health conditions. Additionally, studies indicated that a significant number of adult smokers and smokeless tobacco users completely transitioned to these nicotine pouches, highlighting their potential as a harm reduction tool.

Despite the growing popularity of nicotine pouches, youth usage remains relatively low. The 2024 National Youth Tobacco Survey reported that only 1.8% of U.S. middle and high school students currently use nicotine pouches. To maintain this low prevalence, the FDA emphasizes the importance of responsible marketing practices and will closely monitor youth usage trends and the company’s adherence to marketing restrictions.

Implications for Other PMTAs

This authorization sets a significant precedent for future PMTAs involving nicotine pouches and similar products. It underscores the FDA’s commitment to a rigorous, science-based evaluation process, focusing on the overall public health impact. Applicants seeking marketing authorization for new tobacco products should be prepared to provide comprehensive scientific data demonstrating that their products offer a net benefit to public health, particularly by aiding adult smokers in reducing or quitting traditional tobacco use.

Moreover, this decision highlights the FDA’s vigilance regarding youth exposure to nicotine products. Companies must implement robust measures to prevent youth access and appeal, as the FDA will continue to monitor compliance and take necessary actions to protect public health.

The FDA’s authorization of ZYN nicotine pouches reflects a balanced approach to tobacco product regulation, aiming to reduce harm among adult users while safeguarding youth. This development provides valuable insights for stakeholders navigating the PMTA process and emphasizes the importance of thorough scientific evidence and responsible marketing practices.