Helix Innovations LLC, an Altria company, submitted its supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) for its On Plus oral nicotine pouch products. Helix submitted PMTAs for three distinct On Plus varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.
The Richmond, Virginia-based tobacco company said the pouch product is a spit-free, oral tobacco-derived nicotine (TDN) made from a proprietary “soft-feel” material. The On Plus packaging features a compartment to responsibly dispose of used product.
“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 for 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 for Altria Client Services LLC.
The tobacco company said it expects the products to be distributed by Altria Group Distribution Co. (AGDC), 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 United States. In first-quarter 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, the company said.
To date the FDA said it has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of these applications.
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