The FDA announced last Friday it has authorized U.S. sales of six on! PLUS nicotine pouch products. The authorizations are the first granted under a recently announced FDA Center for Tobacco Products (CTP) pilot program intended to speed review of select nicotine pouches.
The FDA authorized three flavors of on! PLUS pouches in two nicotine strengths—6 mg and 9 mg—but has not granted permission to sell the 12 mg strength. Altria submitted premarket tobacco applications (PMTAs) for all three nicotine strengths in June 2024.
The authorized on! PLUS flavors are Mint, Tobacco, and Wintergreen.
The on! products join 20 varieties of ZYN as the only nicotine pouches with marketing granted orders (MGOs) from the FDA. The ZYN products were authorized in January after a four-year FDA application review.
All the products included for review in the fast-track program are produced by tobacco companies or their affiliates. In addition to on! and on! PLUS, which are manufactured by Helix Innovations and sold by Altria Group, the pilot also includes Zyn Ultra (Swedish Match/Philip Morris International), Velo mini (R.J. Reynolds), and Fre and Alp (Turning Point Brands).
The FDA included no vaping products in the fast-track authorization program, despite the fact that many vape PMTAs have languished in review limbo for over five years.
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