The U.S. FDA authorized the marketing of six nicotine pouch products from Helix Innovations LLC under the on! PLUS brand through the premarket tobacco product application (PMTA) pathway.
These authorizations mark the first decisions from a pilot program launched in September to streamline the review process for nicotine pouch applications while maintaining the agency’s rigorous scientific standards. Authorized products include mint, tobacco, and wintergreen flavors in 6 mg and 9 mg nicotine strengths. The FDA noted that these products contain lower levels of harmful constituents compared with other smokeless tobacco products and do not contain measurable levels of several carcinogens linked to oral cancer.
“While today’s actions permit these specific nicotine pouch products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved,’” FDA said in a statement.
All packaging will feature certified child-resistant cans.