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Medical Daily
Medical Daily
Health
Cole Mercer

FDA Authorizes Eleven Stronger ZYN Pouches at Nine and Eleven Milligrams Under a Faster Review Pilot

The Food and Drug Administration has authorized 11 higher-strength nicotine pouch products for sale in the United States, with labeled strengths above those the agency had previously cleared for the brand.

The authorization of 11 ZYN ULTRA products by Swedish Match USA was announced on August 21. Ten contain 9 milligrams of nicotine per pouch. One, ZYN ULTRA Smooth, contains 11 milligrams. The agency's first pouch authorizations in January 2025, covering 20 ZYN products, were limited to 3-milligram and 6-milligram strengths.

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