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NJOY Seeks FDA Approval for Access-Restricted Vapor Product

The company also resubmitted applications for its blueberry and watermelon-flavored pods.
Logos for Altria and NJOY

RICHMOND, Va. — NJOY, a subsidiary of Altria Group Inc., submitted 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. 

[Read more: NJOY Takes Legal Action Against Illicit Disposable Vapor Manufacturers]

The 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.

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"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, NJOY president and CEO.

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 more than 80,000 stores and expects to expand to approximately 100,000 stores by the end of the year. NJOY also continued the rollout of the brand's first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space.

NJOY previously received marketing denial orders for its blueberry and watermelon pods. NJOY believes the new applications sufficiently address the FDA's concerns regarding underage use by both incorporating device age and identity-based access restriction and demonstrating that the restrictions are effective at preventing underage access in virtually all cases, the company said.

[Read more: Altria Completes $2.75B NJOY Acquisition]

Currently, the FDA has not authorized the marketing of any nontobacco flavored e-vapor products. A full list of products currently authorized for marketing in the United States may be found via the FDA's new Searchable Tobacco Products Database.

NJOY is a wholly owned subsidiary of Altria, and its products are distributed by Altria Group Distribution Co. Other Altria subsidiaries include Philip Morris USA Inc., John Middleton Co., U.S. Smokeless Tobacco Co. and Helix Innovations.

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