Philip Morris International Inc. (PMI) (NYSE: PM) announced that the U.S. Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of its ZYN nicotine pouch products.
The FDA authorization represents a significant milestone, as these are the first Modified Risk Tobacco Product (MRTP) orders granted for nicotine pouches. The authorization recognizes the role that smoke-free alternatives can play in tobacco harm reduction, supported by scientific evidence demonstrating that they expose users to substantially lower levels of harmful chemicals than cigarettes. In the United States, the orders allow PMI U.S. to market the following claim for theauthorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
This authorization marks another important step in PMI’s transformation toward a smoke-free future, as it continues to innovate, develop and scientifically substantiate smoke-free alternatives built on rigorous scientific assessment and transparent risk evaluation for adults who would otherwise smoke.
From the FDA Modified Risk Granted Order: “Based on our review of your MRTPAs, we determined that the proposed modified risk tobacco products, as described in your applications and specified in Appendix A, have satisfied the requirements of section 911(g)(1)(A) and (B), including that they, as actually used by consumers, would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products. Therefore, we authorize marketing of the tobacco products as modified risk tobacco products with the following modified risk information: ‘Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.’”
When reviewing the ZYN applications, the U.S. FDA considered extensive data showing that some adults who smoke and have started using ZYN products have reduced their cigarette use over time, with over half of those surveyed reporting no cigarette consumption in the past 30 days. Of those who continue to smoke cigarettes after starting to use ZYN products, the majority (80.7%) reduced their cigarette consumption, and over half (57.2%) reduced their cigarettes per day by more than 50%.
ZYN nicotine pouches, deliver nicotine through the oral absorption from the mucosa, unlike cigarettes where tobacco is burnt and smoke is inhaled. This significantly reduces exposure to harmful and potentially harmful chemicals compared to smoking cigarettes.
