On June 30, the U.S. Food and Drug Administration (FDA) granted Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch products. This decision allows Philip Morris International U.S. (PMI U.S.) to market these products in the United States with a specific modified risk claim, following a thorough scientific review.
The MRTP orders enable the marketing of certain tobacco or nicotine products with FDA-approved modified-risk claims. However, this authorization is limited to the specific products reviewed and does not extend to all tobacco or nicotine products. The FDA’s decision reflects its commitment to ensuring that consumers have access to accurate information regarding the risks associated with tobacco use.
Details of the FDA’s Decision
The FDA’s MRTP orders were issued after a comprehensive scientific evaluation of the applications submitted by Swedish Match USA, Inc. This evaluation included:
- Assessment of the relative health risks of the ZYN nicotine pouches for tobacco users.
- Consumer understanding and perception of the modified risk claims.
- Data concerning youth risk and the potential impact on the broader population.
Based on these factors, the FDA concluded that Swedish Match demonstrated that the modified risk claim is scientifically accurate for these 20 ZYN products. Furthermore, it was determined that consumers could understand the claim, and marketing these products with the authorized claim would benefit public health.
Authorized Modified Risk Claim
The FDA has authorized the following modified risk claim for the ZYN nicotine pouches: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” This claim is significant as it provides adult smokers with information about the relative risks of using ZYN compared to traditional cigarettes.
Implications for Tobacco Product Marketing
This decision marks a pivotal moment in the regulation of nicotine products, as it is the first time the FDA has granted MRTP orders specifically for nicotine pouches. The FDA’s acting director of the Centre for Tobacco Products, Bret Koplow, emphasized that the review process for modified risk products aims to provide adult users with clear, science-based information about the relative harms of tobacco products. This transparency is intended to help consumers make informed choices regarding their tobacco use.
Future of ZYN Nicotine Pouches in the Market
The ZYN nicotine pouches were previously authorized for sale in the U.S. through the Premarket Tobacco Product Application (PMTA) pathway in January 2025. With the recent MRTP orders, these products can now be marketed with the FDA-approved modified risk claims. This development is expected to influence consumer behavior and potentially shift market dynamics in the tobacco industry.
Public Health Considerations
While the FDA’s decision aims to provide smokers with lower-risk alternatives, it also raises questions about youth access and the long-term health implications of nicotine pouch use. The FDA’s ongoing monitoring and reporting requirements will be crucial in assessing the impact of these products on public health, particularly among younger demographics.
For more detailed information regarding the FDA’s modified risk orders, interested parties can visit the FDA’s official website. Additionally, further insights about Philip Morris International can be found on their corporate website.
