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The FDA has authorized 11 new Zyn Ultra nicotine pouch products from Philip Morris, saying they contain lower levels of harmful constituents than other oral and smokeless tobacco products. This follows the agency's June approval of 20 Zyn variants as less harmful than cigarettes. Nicotine pouches are currently the fastest-growing nicotine category in the U.S.
The FDA has authorized 11 new nicotine pouch products from Philip Morris — specifically its higher-strength Zyn Ultra line — citing lower levels of harmful constituents compared with other oral and smokeless tobacco products. The newly approved products include 9 mg Zyn Ultra Citrus, Menthol, and Wintergreen variants, manufactured by Philip Morris subsidiary Swedish Match USA.
This latest authorization builds on the FDA's June 2026 approval of 20 Zyn variants, which were cleared to be marketed as less harmful than cigarettes. Philip Morris launched the Zyn Ultra line at lower price points to compete with British American Tobacco's Velo brand, and recently announced plans to increase investment in Zyn as competition in the category heats up.
By the Numbers:
Why it matters: Nicotine pouches are the fastest-growing nicotine category in the U.S., and back-to-back FDA authorizations signal a regulatory shift toward recognizing reduced-harm alternatives to cigarettes — a development with significant public health and clinical implications for tobacco cessation strategies.