Altria’s Subsidiary, Helix Innovations, Submits PMTA for on! PLUS Nicotine Pouches
Helix Innovations, a wholly-owned subsidiary of Altria, has submitted premarket tobacco product applications (PMTAs) to the Food and Drug Administration (FDA) for its new on! PLUS oral nicotine pouches. These pouches are spit-free and made from a proprietary “soft-feel” material, targeting adults who dip and adult dual users (those who both smoke and dip).
Product Details and Varieties
The on! PLUS pouches are designed to provide a convenient and discreet alternative for adult tobacco consumers. Similar to the existing on! products, the on! PLUS packaging includes a compartment for the responsible disposal of used pouches. Helix Innovations has submitted PMTAs for three distinct varieties of on! PLUS: tobacco, mint, and wintergreen, each available in three different nicotine strength options.
On! Nicotine Pouches
Company Statements and Market Impact
Nick MacPhee, managing director and general manager of Helix, emphasized the significance of the submission, stating, “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.”
Paige Magness, senior vice president of regulatory affairs at Altria Client Services, added, “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.”
Regulatory Process and Distribution Plans
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. This requires the FDA to consider the risks and benefits to the population as a whole, including both users and non-users of tobacco products, and youth.
Altria anticipates that, upon authorization, the on! PLUS products will be distributed by Altria Group Distribution Co., which boasts significant U.S. retail coverage and decades of experience in supporting responsible retailing of tobacco products.
Current Market Performance
Helix currently sells on! nicotine pouches in the U.S. In the first quarter of 2024, on! reported a 32% growth in shipment volume compared to the previous year, achieving a 7.1% retail share of the total U.S. oral tobacco category.
