FDA Authorizes ZYN ULTRA Nicotine Pouches Following Scientific Review
Authorizations add selection of ZYN ULTRA products to PMI U.S.'s growing portfolio of better alternatives for legal-age adults who smoke or use traditional oral tobacco products
STAMFORD, CT, August 21, 2026--Philip Morris International Inc. (NYSE: PM) today announces that the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders to PMI's U.S. affiliate, Swedish Match USA, Inc., authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, including all 9mg variants and one 11mg variant. Additional 11mg variants remain under scientific review.
Today's action further enhances PMI's leadership role in the smoke-free category.
"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."
ZYN ULTRA positions the brand to further extend its category leadership among legal-age consumers of nicotine products. Like the flagship FDA-authorized ZYN pouches, ZYN ULTRA, with its higher moisture content, is free of tobacco-leaf.
Today's decisions build on the FDA's earlier authorizations of ZYN in multiple flavors and both 3mg and 6 mg variants. ZYN was the first nicotine pouch authorized for sale in the United States following rigorous scientific review. PMI leads the industry in securing FDA authorizations, reinforcing its commitment to transparency and science-based regulation.
These authorizations underscore PMI U.S.'s commitment to innovation and responsible marketing practices to adults aged 21+, as the company works to offer alternatives that are a much better choice than continuing to smoke.
The FDA authorized the following products in 9 mg nicotine concentrations:
ZYN ULTRA Smooth (commercialized as Signature Smooth)
ZYN ULTRA Cool Mint (commercialized as Arctic Mint)
ZYN ULTRA Spearmint (commercialized as Fresh Spearmint)
ZYN ULTRA Wintergreen (commercialized as Wintergreen Blast)
ZYN ULTRA Peppermint (commercialized as Peppermint Frost)
ZYN ULTRA Citrus (commercialized as Citrus Zest)
ZYN ULTRA Chill (commercialized as Chill Mist)
ZYN ULTRA Menthol (commercialized as Menthol Ice)
ZYN ULTRA Deep Freeze
ZYN ULTRA Wintergreen Chill
The FDA authorized the following product in 11mg nicotine concentration:
ZYN ULTRA Smooth (commercialized as Signature Smooth)
EDITOR'S NOTE
From the FDA Granted Order: "Based on our review of your PMTAs, we determined that permitting the marketing of the new tobacco products, as described in your applications and specified in Appendix A, are appropriate for the protection of public health."
Pre-market applications for other ZYN ULTRA 11mg variants remain under scientific review at FDA.
Today's news follows a series of recent FDA actions involving PMI's smoke-free portfolio, including modified risk tobacco product orders for certain previously authorized ZYN nicotine pouches. PMI U.S. began commercialization of ZYN ULTRA in June 2026 under recent FDA guidance.