In a significant regulatory decision for the tobacco harm reduction industry, the US Food and Drug Administration (FDA) has granted Modified Risk Tobacco Product (MRTP) orders to 20 variants of Philip Morris International’s (PMI) ZYN nicotine pouches, making them the first nicotine pouch products in the United States to receive such authorization.
The order allows PMI to market an FDA-authorised claim stating that “using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
The FDA’s decision follows an extensive scientific review under the agency’s Modified Risk Tobacco Product pathway, which evaluates whether a tobacco product, as actually used by consumers, significantly reduces harm and the risk of tobacco-related disease compared with conventional cigarettes while benefiting overall public health.
According to the FDA, evidence submitted by the company showed that adults who switched from cigarettes to ZYN substantially reduced or completely stopped cigarette consumption. The agency said more than half of surveyed users reported no cigarette smoking during the previous 30 days, while nearly 81% of dual users reduced their cigarette consumption. More than half of those continuing to smoke cut their daily cigarette intake by over 50%.
Nicotine pouches such as ZYN deliver nicotine through oral absorption without burning tobacco or producing smoke, resulting in substantially lower exposure to harmful chemicals than combustible cigarettes. The FDA had already authorized ZYN for sale in the United States in January 2025 through its Premarket Tobacco Product Application (PMTA) pathway after determining that the products posed lower health risks than cigarettes and many traditional smokeless tobacco products.
“This decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” said Stacey Kennedy, Chief Executive Officer of PMI U.S. “It ensures adult smokers have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases.”
The authorization covers 20 ZYN variants across multiple flavours, including Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill and Menthol, each available in 3 mg and 6 mg nicotine strengths.
The latest approval expands PMI’s portfolio of FDA-authorized modified-risk products, which already includes selected IQOS heated tobacco devices and General snus products. The decision is also expected to influence the broader regulatory debate around smoke-free nicotine alternatives, as policymakers in several countries continue to weigh stricter restrictions against evidence-based regulatory frameworks for reduced-risk products.