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     185  0 Kommentare NJOY Submits Premarket Tobacco Product Applications to the FDA for NJOY ACE 2.0 Featuring Bluetooth-enabled Access Restriction Technology

    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.

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    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.

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

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