Philip Morris International Urges FDA Advisory Committee to Recommend Authorizing ZYN as a Modified Risk Tobacco Product

Core Viewpoint - Philip Morris International (PMI) is seeking a Modified Risk Tobacco Product (MRTP) designation from the U.S. FDA for its ZYN nicotine pouch products, which would allow the company to communicate to adult smokers that switching to ZYN reduces the risk of smoking-related diseases [1][3][6] Group 1: Scientific Evidence and FDA Review - Experts from PMI presented scientific evidence to the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) regarding the health benefits of switching from cigarettes to ZYN [1][3] - The FDA indicated that the proposed modified risk claim regarding ZYN's lower risk of various health conditions is scientifically accurate [3][4] - Data presented showed that ZYN contains significantly lower levels of harmful chemicals compared to cigarettes, supporting its role in promoting complete switching from combustible products [5][11] Group 2: Market Authorization and Product Details - ZYN became the first nicotine pouch product to receive marketing authorization from the FDA through the Premarket Tobacco Product Authorization (PMTA) pathway in January 2025 [6] - The products submitted for MRTP designation include various flavors and strengths of ZYN, specifically 3 mg and 6 mg options across multiple flavors [6] - PMI has invested over $14 billion since 2008 in developing smoke-free products, with smoke-free products accounting for 41% of total net revenues in the first nine months of 2025 [8] Group 3: Consumer Impact and Usage Trends - The FDA's evaluation showed that a substantial proportion of adults who smoke have completely switched to ZYN, with over half reporting no cigarette consumption in the past 30 days [11] - Among those who continued to smoke after starting ZYN, 80.7% reduced their cigarette consumption, and 57.2% reduced their daily cigarette intake by more than 50% [11] - The TPSAC noted that youth usage of nicotine pouches is currently low, and exposure to the modified risk claim did not increase intentions to use ZYN among young adults [4][5]