According to a press release on the official website of Altria Group, Inc. on June 26th, Altria has announced that it has submitted a Pre-Market Tobacco Product Application (PMTA) to the Food and Drug Administration (FDA) for its on! PLUS oral nicotine pouch product. The application was submitted by Altria's wholly-owned subsidiary, Helix Innovations LLC (Helix).
Helix has submitted PMTA for three different flavors of on! PLUS: tobacco, mint, and wintergreen. Each flavor has three different nicotine strength options.
The CEO and General Manager of Helix, Nick MacPhee, stated that...
Helix's submission of the on! PLUS application demonstrates Ochia's commitment to meeting consumers' ever-changing preferences through innovative products that have the potential to reduce risks. We believe that on! PLUS is a groundbreaking product and, once authorized by the FDA, will make a significant contribution to Helix's growth in the US market.
Paige Magness, Senior Vice President of Ochia Client Services LLC, stated that...
We have long believed that providing authorized smoke-free products for adult tobacco consumers is beneficial. We believe that these PMTAs demonstrate that responsibly selling on! PLUS can offer an attractive alternative in the market.
In order to obtain market authorization for PMTA, manufacturers must demonstrate that the marketing of new tobacco products is for the protection of public health. This requires the FDA to consider the risks and benefits for the overall population, including tobacco product users and non-users, as well as adolescents. on! PLUS is a product of Helix, and following authorization, it is expected that these products will be distributed by Altria Group Distribution Company (AGDC).
Currently, Helix is selling on! nicotine pouches in the United States. In the first quarter of 2024, on! saw a 32% year-on-year increase in shipments and reached a retail market share of 7.1% in the entire oral tobacco category in the United States.
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