FDA Authorizes 4 New on! Nicotine Pouches

The U.S. Food and Drug Administration (FDA) has authorized the marketing of four new nicotine pouch products through the premarket tobacco product application (PMTA) pathway. The products are made by Helix Innovations LLC under the “on!” brand name, and include Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg and Autumn Spice 2 mg.

The products were approved under the FDA’s nicotine pouch pilot program, launched in September 2025, which the agency said “aims to increase efficiency and streamline the review process of nicotine pouches through the PMTA pathway. The pilot streamlined the FDA’s review processes, which has led to faster resolution of issues, decreased time needed for applicants to respond to deficiency letters and more efficient scientific reviews.”

At the time of the pilot launch, Anna Ready Blom, former director of government relations at NACS, said: “We hope this creates urgency within FDA to expedite all outstanding PMTAs and inform retailers which products can and cannot be sold.”

To date, the FDA has authorized 30 nicotine pouches, it said. These include 20 Zyn nicotine pouch products authorized in January 2025 through the PMTA pathway, marking the first time the agency authorized nicotine pouches, and six on! PLUS nicotine pouches approved in December 2025, the first products approved under the agency’s PMTA pilot program.

Last month, Altria reported its 2026 second quarter and first-half business results. “In smoke-free, Helix expanded on! PLUS to 120,000 stores nationwide, engaged in trial-generating activities and prepared for additional line extensions to come later this year,” the company said.

Read more about consumers changing tobacco preferences in the January 2026 NACS Magazine feature “Nicotine Pouches Pull Ahead.”

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