NJOY Submits Premarket Tobacco Product Applications to the FDA for NJOY ACE 2.0 Featuring Bluetooth®-enabled Access Restriction Technology

20.05.24 22:15 Uhr

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Today, NJOY, an Altria company, announces the submission of a supplemental Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) to commercialize and market the NJOY ACE 2.0 device. This new device incorporates access restriction technology designed to prevent underage use via Bluetooth® connectivity to authenticate the user before unlocking the device. The company also re-submitted PMTAs for Blueberry and Watermelon pod products that work exclusively with the NJOY ACE 2.0 device.

"Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products. NJOY ACE 2.0 includes critical technology features to prevent underage access to flavored NJOY products, while also responsibly providing flavored options for adult smokers and vapers,” said Shannon Leistra, President & Chief Executive Officer of NJOY.

NJOY ACE currently remains the only pod-based e-vapor product with marketing authorization from the FDA. In the first quarter of 2024, NJOY broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end. NJOY also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space.

"Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, Senior Vice President, Regulatory Affairs of Altria Client Services LLC. "We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”

NJOY previously received Marketing Denial Orders (MDO) for its Blueberry and Watermelon pods. NJOY believes these applications sufficiently address the FDA’s concerns regarding underage use by both incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco flavored e-vapor products.

Notes:

To secure market authorization under a PMTA, manufacturers must demonstrate that marketing of a new tobacco product is appropriate for the protection of public health (APPH), which requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

On April 26, 2022, the FDA authorized the NJOY ACE device and NJOY ACE Classic Tobacco (2.4% and 5%) and Rich Tobacco (5%) pods as APPH.

The FDA issued MDOs for the NJOY ACE Blueberry (2.4% and 5%) and Watermelon (2.4% and 5%) pods noting:
"...Rather, for flavored Electronic Nicotine Delivery System (ENDS), only the most stringent mitigation measures – specifically device access restrictions – have such mitigation potential.”

NJOY is a wholly owned subsidiary of Altria. NJOY's products are distributed by Altria Group Distribution Company (AGDC). Our sales force has significant U.S. retail coverage and decades of experience supporting the responsible retailing of tobacco products.

Altria’s Profile

We have a leading portfolio of tobacco products for U.S. tobacco consumers age 21+. Our Vision is to responsibly lead the transition of adult smokers to a smoke-free future (Vision). We 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, our businesses and society.

Our wholly owned subsidiaries include leading manufacturers of both combustible and smoke-free products. In combustibles, we 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. Our smoke-free portfolio includes ownership of U.S. Smokeless Tobacco Company LLC (USSTC), the leading global moist smokeless tobacco (MST) manufacturer, 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) for a pod-based e-vapor product.

Additionally, we have a majority-owned joint venture, Horizon Innovations LLC (Horizon), for the U.S. marketing and commercialization of heated tobacco stick products.

Our equity investments include Anheuser-Busch InBev SA/NV (ABI), the world’s largest brewer, and Cronos Group Inc. (Cronos), a leading Canadian cannabinoid company.

The brand portfolios of our operating companies include Marlboro®, Black & Mild®, Copenhagen®, Skoal®, on!® and NJOY®. Trademarks related to Altria referenced in this release are the property of Altria or our subsidiaries or are used with permission.

Forward-Looking and Cautionary Statements

This release contains certain forward-looking statements that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements relate to regulatory filings that are inherently subject to risks and uncertainties, and we cannot predict any regulatory outcomes. Other risk factors are detailed from time to time in our publicly filed reports, including our Annual Report on Form 10-K for the year ended December 31, 2023 and our Quarterly Reports on Form 10-Q. These forward-looking statements speak only as of the date of this press release. We assume no obligation to provide any revisions to, or update, any projections and forward-looking statements contained in this release.

Learn more about Altria at www.altria.com and follow us on X (formerly known as Twitter), Facebook and LinkedIn.

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