FDA to Begin Substantive Review of on!® Nicotine Pouches

Altria Client Services today announced that the Food and Drug Administration (FDA) has accepted and filed for substantive review premarket tobacco product applications for 35 on!^® products manufactured by Helix Innovations LLC, an Altria joint venture responsible for the global on!^® nicotine pouch product portfolio.

To support these applications, Altria submitted over 66,000 pages of documentation, including six primary studies.

“We believe the scientific evidence in these applications demonstrates that the marketing of on!^® is appropriate for the protection of public health,” said Paige Magness, Senior Vice President, Regulatory Affairs for Altria Client Services. “on!^® nicotine pouches are a key part of our vision to responsibly lead the transition of adult smokers to a non-combustible future.”

FDA will now undertake a substantive scientific review of the applications.

on!^® nicotine pouches are tobacco leaf-free and are available in seven flavors and five nicotine levels. In the fast-growing nicotine pouch category, on! ^® currently offers the broadest portfolio of choices for adult tobacco consumers seeking alternatives to traditional tobacco products.

on! ^® was distributed in over 28,000 stores at the end of the first quarter, including the top five convenience store chains by volume. According to IRI, total oral tobacco derived nicotine category sales in 2019 grew approximately 275% compared to 2018.

Altria’s Profile

Altria’s wholly owned subsidiaries include Philip Morris USA Inc. (PM USA), U.S. Smokeless Tobacco Company LLC (USSTC), John Middleton Co. (Middleton), Sherman Group Holdings, LLC and its subsidiaries (Nat Sherman), Ste. Michelle Wine Estates Ltd. (Ste. Michelle) and Philip Morris Capital Corporation (PMCC). Altria owns an 80% interest in Helix Innovations LLC (Helix). Altria holds equity investments in Anheuser-Busch InBev SA/NV (ABI), JUUL Labs, Inc. (JUUL) and Cronos Group Inc. (Cronos).

The brand portfolios of Altria’s tobacco operating companies include Marlboro^®, Black & Mild^®, Copenhagen^®, Skoal^® and on!^®. Ste. Michelle produces and markets premium wines sold under various labels, including Chateau Ste. Michelle^®, 14 Hands^® and Stag’s Leap Wine Cellars^™, and it imports and markets Antinori^®, Champagne Nicolas Feuillatte^™ and Villa Maria Estate^™ products in the United States. Trademarks and service marks related to Altria referenced in this release are the property of Altria or its subsidiaries or are used with permission.

More information about Altria is available at altria.com and on the Altria Investor app, or follow Altria on Twitter, Facebook and LinkedIn.

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