Wholly-owned Altria subsidiary Helix Innovations has submitted PMTAs to the Food and Drug Administration for its on! PLUS oral nicotine pouches.
The product is a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary “soft-feel” material. The on! PLUS pouch is designed for adults who dip and adult dual users (i.e., adults who smoke and dip).
Similar to the currently marketed on! products, on! PLUS packaging features a compartment to responsibly dispose of used product. Helix submitted PMTAs for three distinct on! PLUS varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.
“Helix’s submission of the on! PLUS applications underscores Altria’s commitment to addressing consumers’ evolving preferences through innovation in potentially reduced risk products. We firmly believe that on! PLUS is a transformative product that will meaningfully contribute to Helix’s growth in the U.S. market, upon timely FDA authorization,” said Nick MacPhee, managing director and general manager, Helix.
“We’ve long believed in the value of a robust marketplace of authorized smoke-free products for adult tobacco consumers. We believe that these PMTAs demonstrate that responsibly marketed on! PLUS pouches can provide a compelling alternative in the marketplace,” said Paige Magness, senior vice president of regulatory affairs, Altria Client Services.
To secure market authorization under a PMTA, manufacturers must demonstrate that the marketing of a new tobacco product is appropriate for the protection of public health, according to the FDA. This requires the agency to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products, and youth.
Altria expects that, upon authorization, the products will be distributed by Altria Group Distribution Co., which has significant U.S. retail coverage and decades of experience supporting the responsible retailing of tobacco products.
Helix currently sells on! nicotine pouches in the U.S. In the first quarter of 2024, on! reported shipment volume grew 32% versus the prior year and the brand achieved a 7.1% retail share of the total U.S. oral tobacco category.
