On Monday, Njoy, an Altria company, submitted its supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration to commercialize and market the Njoy Ace 2.0 device.
The new device features age-gated technology to prevent underage use via Bluetooth connectivity to authenticate the user before unlocking the device. The Richmond, Virginia-based tobacco company also said it 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 and CEO of Njoy.
Njoy Ace is the only pod-based e-vapor product with marketing authorization from the FDA.
In first-quarter 2024, Njoy broadened distribution to more than 80,000 stores and expects to expand to approximately 100,000 stores by year-end, the company said. Njoy also continued the rollout of the brand’s first retail trade program.
"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 of 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. To date, the FDA has not authorized the marketing of any non-tobacco flavored e-vapor products.
Last year Altria acquired the e-vapor company Njoy, whose products are now distributed by Altria Group Distribution Co.
Njoy isn’t the only company introducing new technology to guard against counterfeit products and underage use.Washington, D.C.-based Juul’s PMTA for its next-generation e-cigarette introduces technologies to restrict underage access as well.
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