Altria Group, Inc. (Altria) announced the submission of Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) for its innovative on!PLUS oral nicotine pouch products. The PMTAs were submitted by Altria's wholly owned subsidiary Helix Innovations LLC (Helix). on!PLUS is a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary "soft-feel" material to provide a more comfortable product experience.

The on!PLUS pouch is designed for adults who dip and adult dual users (i.e., adults who smoke and dip). on!PLUS pouches are seamless and larger than the leading U.S. TDN brands. Similar to the currently marketed on!®?

products, on!PLUS packaging features a department to responsibly dispose of used product. Helix submitted PMTAs for three distinct on!PLUS various varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.

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 users and non-users of tobacco products, and youth. on!PLUS are products of Helix and upon authorization, The company expects the products to be distributed by Altria Group Distribution Company (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 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.

Altria's Profile: The company have a leading portfolio of tobacco products for U.S. tobacco consumers age 21+. The company's Vision is to responsibly lead the transition of adult smokers to a smoke-free future (Vision). The company are Moving Beyond smoking??, leading the way in moving adult smokers away from cigarettes by taking action to transition millions to potentially less harmful choices - believing it is a substantial opportunity for adult tobacco consumers, businesses and society.

wholly owned subsidiaries include leading manufacturers of both combustible and smoke-free products. Incombibles, company own Philip Morris USA Inc. (PM USA), the most profitable U.S. cigarette manufacturer, and John Middleton Co. (Middleton), a leading U.S. cigar manufacturer.

smoke-free portfolio includes ownership of U.S. Smokeless Tobacco Company LLC (USSTC), the leading global moist smokeless tobacco (MST) manufacturer, and Helix Innovations LLC (Helix), a leading manufacturer of oral nicotine pouches, and NJOY, LLC (NJOY), currently the only e-vapor manufacturer to receive market authorizations from the U.S. food and Drug Administration (FDA).