Fuente: Tobacco Reporter Lugar: FDA Today (Aug. 21), the U.S. Food and Drug Administration authorized 11 new nicotine pouch products from Swedish Match USA under the Zyn Ultra brand through the premarket tobacco product application pathway. The products include 10 9-milligram varieties and one 11-milligram variety, covering flavors such as Chill, Citrus, Cool Mint, Deep Freeze, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen.



The FDA said its review found the products contain lower levels of most harmful and potentially harmful constituents than other oral and smokeless tobacco products. The agency also said product-specific data indicated the pouches appeal primarily to adults who currently smoke cigarettes or use smokeless tobacco and could provide sufficient nicotine to reduce cravings and withdrawal symptoms, potentially supporting switching among adult tobacco users.



“We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.” 



The authorizations bring the number of FDA-authorized nicotine pouch products to 43, including 23 approved through the agency’s nicotine pouch pilot program. The FDA said the pilot has streamlined PMTA reviews and reduced the time needed to resolve deficiencies, with efficiencies now being applied to other tobacco-product applications.The post FDA authorizes 11 additional ZYN nicotine pouches first appeared on Tobacco Reporter.