US FDA issues 'Modified Risk Tobacco Product Orders' for 20 ZYN Nicotine pouch products

New Delhi [India], July 3 : Philip Morris International Inc. (PMI) (NYSE: PM) announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized 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."
"FDA's decision is an important moment for the more than 45 million legal-age nicotine consumers in America," said Stacey Kennedy, PMI U.S. CEO. "Today's news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer," she added. "More broadly, it reinforces the agency's science-based approach to evaluating products across the continuum of risk and communicating those findings transparently."
The FDA's action highlights a stark contrast: in the U.S., nicotine products undergo detailed scientific review before being authorized, while in many countries policymakers opt for bans rather than careful evaluation.
Products covered by the FDA's MRTP orders include: ZYN Cool Mint 3 mg, ZYN Cool Mint 6 mg, ZYN Peppermint 3 mg, ZYN Peppermint 6 mg, ZYN Spearmint 3 mg, ZYN Spearmint 6 mg, ZYN Wintergreen 3 mg, ZYN Wintergreen 6 mg, ZYN Citrus 3 mg, ZYN Citrus 6 mg, ZYN Coffee 3 mg, ZYN Coffee 6 mg, ZYN Cinnamon 3 mg, ZYN Cinnamon 6 mg, ZYN Smooth 3 mg, ZYN Smooth 6 mg, ZYN Chill 3 mg, ZYN Chill 6 mg, ZYN Menthol 3 mg, ZYN Menthol 6 mg
In January 2025, ZYN was the first nicotine pouch authorized for sale in the United States following rigorous scientific review. With today's decision, PMI holds MRTP authorizations for ZYN, the first nicotine pouch authorized by the FDA, versions of IQOS devices and consumables and eight General snus products, underscoring the company's position as an industry leader and innovator.
Nicotine pouches, like ZYN, deliver nicotine through oral absorption and do not require the burning of tobacco, or inhaling of smoke. This significantly reduces exposure to harmful and potentially harmful chemicals compared to the use of combustible tobacco, such as cigarettes.
In authorizing ZYN through the premarket tobacco product application (PMTA) pathway in January 2025, the FDA noted, "The agency's evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products [ZYN] pose lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products."
When reviewing the ZYN applications, US 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%.