FDA Grants ZYN First-Ever Modified Risk Tobacco Product (MRTP) Authorizations
The FDA’s decision makes ZYN the first nicotine pouch to receive Modified Risk Tobacco Product (MRTP) authorizations, allowing it to communicate, in the United States and under the conditions specified by these authorizations, a reduction in certain risks compared to cigarettes.
Philip Morris International (PMI) announced today that the U.S. Food and Drug Administration (FDA) has granted Modified Risk Tobacco Product (MRTP) authorizations for 20 ZYN nicotine pouch varieties.
These are the first MRTP authorizations ever granted to nicotine pouches. They allow PMI U.S. to communicate, for the specific ZYN products covered and in accordance with the terms of the FDA’s authorizations, the following message:
“Using ZYN instead of cigarettes reduces the risk of mouth cancer, cardiovascular disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
“The FDA’s decision is a significant milestone for the more than 45 million adult nicotine consumers in the United States,” said Stacey Kennedy, President and CEO of PMI U.S.
“This decision ensures that affected adults have access to accurate, science-based information, including FDA-validated data indicating that switching from cigarettes to ZYN reduces the risk of certain smoking-related diseases, such as cardiovascular disease and lung cancer,” she added.
“More broadly, it confirms the agency’s scientific approach of evaluating products based on their risk profile and communicating its conclusions transparently.”
In January 2025, ZYN became the first nicotine pouch authorized for sale in the United States following a rigorous scientific review. With today’s announcement, PMI now holds MRTP authorizations for ZYN, certain versions of IQOS devices and consumables, and eight General snus products, reaffirming its status as a leader and innovator in the industry.
About Nicotine Pouches
Nicotine pouches, such as ZYN, deliver nicotine through oral absorption. They require no tobacco combustion or smoke inhalation, which can reduce exposure to certain harmful and potentially harmful substances compared to combustible tobacco products like cigarettes.
Philip Morris International: Committed to a Smoke-Free Future
Philip Morris International (PMI) is one of the world’s leading international consumer goods companies. The company is actively working to build a smoke-free future and is evolving its portfolio to include, over the long term, products beyond the tobacco and nicotine sectors.
Its current portfolio consists primarily of cigarettes and smoke-free products, including heated tobacco products, nicotine pouches, and vaping products. These products are marketed in more than 105 markets and were used by over 43 million adult consumers worldwide as of December 31, 2025, many of whom have quit smoking or significantly reduced their consumption.
Smoke-free activities accounted for 43% of PMI’s total net revenue in the first quarter of 2026. Since 2008, PMI has invested more than $16 billion in the development, scientific validation, and commercialization of innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of ending the sale of cigarettes.
These investments have helped develop world-class scientific capabilities in preclinical toxicology, clinical and behavioral research, and post-market studies.
Following a rigorous scientific review, the FDA authorized the marketing of Swedish Match’s General snus and ZYN nicotine pouches, as well as certain versions of PMI’s IQOS devices and consumables—a first in each of their respective categories.
Certain versions of IQOS, General Snus products, and ZYN have also received the first-ever MRTP authorizations in their respective categories from the FDA.
