Philip Morris International Inc. (PMI) has 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. This marks the first time the FDA has granted MRTP orders specifically for nicotine pouches. The historic authorization allows PMI U.S. to market a specific reduced-risk claim for these products, explicitly stating that using ZYN instead of traditional cigarettes puts the consumer at a lower risk of developing mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
Stacey Kennedy, CEO of PMI U.S., described the FDA’s decision as an important moment for the more than 45 million legal-age nicotine consumers in America. She emphasized that the authorization ensures adult consumers have direct access to accurate, science-based information and FDA-authorized evidence showing that switching from cigarettes to ZYN reduces the risk of smoking-related diseases. Furthermore, the move highlights a stark contrast in global regulatory strategies; while the U.S. subjects nicotine products to detailed, transparent scientific reviews across a continuum of risk, policymakers in many other countries opt for flat product bans rather than careful evaluation.
