Altria Files PMTA for New on! PLUS Oral Nicotine Pouch Products
Submission of PMTA Applications to the FDA
Altria Group, Inc. announced on June 26 that it has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration for its new on! PLUS oral nicotine pouch products. The applications were filed by Helix Innovations LLC, Altria’s wholly owned subsidiary.
Three New Flavors and Multiple Strength Options
Helix submitted PMTAs for three flavors — tobacco, menthol, and wintergreen — each offered in three different nicotine concentrations.
Company Leadership Highlights Commitment to Innovation
Helix Managing Director and General Manager Nick MacPhee emphasized that the on! PLUS submission reflects the company’s dedication to developing potentially reduced-risk products aligned with evolving adult consumer preferences.
Altria Reinforces Support for Smoke-Free Alternatives
Paige Magness, Senior Vice President at Altria Client Services LLC, stated that the company remains committed to offering adult smokers authorized smoke-free alternatives, positioning on! PLUS is a responsible and appealing option for the market.
FDA Authorization Required for Market Entry
To obtain marketing authorization through the PMTA pathway, manufacturers must demonstrate that the product protects public health—including its impact on users, non-users, and youth. Upon authorization, Altria expects the products to be distributed through the Altria Group Distribution Company network.
Strong Performance of Existing on! Products
Helix currently markets on! nicotine pouches in the United States. In Q1 2024, on! Shipments grew 32% year-over-year, securing a 7.1% retail market share in the U.S. oral nicotine category.
