The U.S. Food and Drug Administration announced the authorization of four additional on! nicotine pouch products through the premarket tobacco product application (PMTA) pathway: Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg. Manufactured by Helix Innovations LLC, the products were reviewed under the FDA’s nicotine pouch pilot program, which is designed to streamline PMTA reviews and improve review efficiency. The agency said lessons from the pilot are now being applied to other PMTA reviews.
The FDA concluded that the newly authorized products contain lower levels of most harmful and potentially harmful constituents than traditional oral and smokeless tobacco products. The agency said adults 21 and older who completely switch from cigarettes or smokeless tobacco to FDA-authorized nicotine pouches may reduce their exposure to harmful chemicals, while noting that dual use does not provide the same level of risk reduction. With the latest authorizations, the FDA has now authorized 30 nicotine pouch products through the PMTA pathway.
