The U.S. Food and Drug Administration has authorized Philip Morris International to market its Zyn nicotine pouches with a modified risk claim stating they pose a lower risk of tobacco-related disease than cigarettes. The decision covers 20 Zyn products made by Swedish Match, a wholly owned subsidiary of Philip Morris, and allows marketing that highlights reduced risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The authorization is valid for five years, after which Swedish Match may seek renewal. Zyn contains nicotine but not tobacco, and the FDA noted that the modified risk pathway represents a meaningful harm reduction opportunity. Philip Morris shares surrendered earlier gains and were down 0.85% on the day.
Philip Morris International IncFDA authorized Zyn as lower-risk, allowing modified risk marketing for 5 years.