FDA announcements or company press releases

FDA Grants First Authorization to 20 Zyn Nicotine Pouches from Philip Morris, Citing Health Benefits

Jan 16, 2025, 04:18 PM

On Thursday, the U.S. Food and Drug Administration (FDA) authorized the marketing of 20 Zyn nicotine pouch products from Philip Morris International through the Premarket Tobacco Product Application (PMTA) pathway, following an extensive scientific review. This marks the first time the agency has authorized products commonly referred to as nicotine pouches, which are the fastest-growing segment of the U.S. tobacco market. The FDA stated that these products, which contain nicotine but no tobacco, can help adult smokers cut back or quit cigarettes. The decision was based on evidence showing that the pouches pose lower health risks compared to cigarettes and other smokeless tobacco products, including a reduced risk of cancer and other serious health conditions. The FDA emphasized that the benefits of these products as a safer alternative for adult cigarette smokers outweigh the potential risks to young people, providing 'greater benefits to population health than risks.' The agency will closely monitor youth use and compliance with marketing restrictions, as the authorized products include various flavors such as coffee, mint, and menthol.