The U.S. Food and Drug Administration has issued Marketing Granted Orders to Swedish Match USA, Inc., a Philip Morris International affiliate, authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products. The authorization covers all 9mg variants and one 11mg variant, while additional 11mg variants remain under scientific review. PMI U.S. CEO Stacey Kennedy said the decision builds on ZYN's position as America's leading smoke-free product brand. ZYN ULTRA, which has higher moisture content than flagship ZYN pouches, is free of tobacco leaf. The FDA previously authorized ZYN in multiple flavors and both 3mg and 6mg variants, making it the first nicotine pouch authorized for sale in the United States.
Philip Morris International IncFDA authorization for 11 ZYN ULTRA products is a regulatory approval that supports PMI's smoke-free product growth.
Picard Medical, Inc.