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Philip Morris International (PMI) announced that the U.S. Food and Drug Administration (FDA) has authorized the commercialization of its ZYN smoke-free nicotine pouches as modified risk tobacco products (MRTPs).
The authorization marks a significant milestone, making ZYN the first and only nicotine pouch brand to receive this designation from the FDA. The agency’s decision recognizes that, based on the available scientific evidence, switching completely from cigarettes to ZYN significantly reduces exposure to harmful chemicals. This reduction is expected to lower the risk of developing several smoking-related diseases, including oral and lung cancer, heart disease, stroke, emphysema, and chronic bronchitis.
The authorization represents another step forward in PMI’s commitment to advancing smoke-free alternatives. The company continues to invest in the research, development, and commercialization of scientifically substantiated products within regulatory frameworks that prioritize rigorous scientific evaluation and transparent risk assessment.
Earlier this year, PMI presented its scientific evidence to the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) as part of its application to market ZYN as a modified risk tobacco product. The application was intended to ensure that adult smokers have access to accurate, science-based information about the benefits of switching completely from cigarettes to these products. This follows the FDA’s authorization in January 2025 allowing ZYN products to be marketed in the United States.
ZYN nicotine pouches contain nicotine derived from the tobacco plant. While nicotine is addictive, it is not the primary cause of smoking-related diseases. The pouches are made from plant-based fibers and are placed between the gum and upper lip, where nicotine is absorbed through the oral mucosa.
As part of its vision for a smoke-free future, PMI continues to invest in developing better alternatives for adults who would otherwise continue smoking cigarettes. Its smoke-free portfolio includes heated tobacco products, nicotine pouches, and e-vapor products, which are now available in markets around the world.