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FDA OKs Altria's On! Nicotine Pouches
20 Dec
Summary
- FDA authorized six Altria-owned on! PLUS nicotine pouch products.
- Authorization came via a pilot program for fast-tracked reviews.
- Products are considered lower risk than other smokeless tobacco.
The U.S. Food and Drug Administration announced on December 19, 2025, that it has authorized the marketing of six Altria-owned on! PLUS nicotine pouch products. This significant decision was made through a pilot program established in September 2025, specifically aimed at expediting reviews for these types of products.
These authorized on! PLUS nicotine pouches, manufactured by Helix Innovations LLC, are now legally available to adults in the United States. The approval covers mint, tobacco, and wintergreen flavors, offered in both 6 mg and 9 mg nicotine strengths. The FDA based its authorization on evidence indicating that these products contain lower levels of harmful chemicals, thus presenting a reduced risk of cancer and other serious health conditions when compared to traditional smokeless tobacco.
Nicotine pouches, inserted under the lip, represent the fastest-growing category within the U.S. tobacco market. They are widely regarded as among the lowest-risk alternatives to smoking because they do not involve inhalation and are tobacco-free. Altria announced that "on! PLUS will resume taking new orders for retail accounts in Florida, North Carolina and Texas and on e-commerce soon," indicating an immediate market push following the authorization.
