FDA announcements or major news outlets reporting on FDA decisions

FDA Authorizes 20 ZYN Nicotine Pouches by Philip Morris International as Safer Alternative

Jan 16, 2025, 05:39 PM

The U.S. Food and Drug Administration (FDA) has authorized the marketing of 20 ZYN nicotine pouch products, marking the first time the agency has approved such products. Following an extensive scientific review, the FDA determined that these products pose a lower risk of cancer and other serious health conditions compared to cigarettes and most smokeless tobacco products. The authorization was granted through the premarket tobacco product application (PMTA) pathway, and the products, including 10 flavors such as coffee, mint, and menthol, are intended for adults who smoke cigarettes or use other smokeless tobacco products. Philip Morris International, through its Swedish Match unit, will market these products. The FDA will closely monitor youth use and the company's compliance with marketing restrictions to prevent underage use. Philip Morris International has agreed to implement measures to restrict youth access and appeal, such as not using mass-market advertising on radio and TV and employing actors/models no younger than 35 years old for marketing.