Today, NJOY announced that the U.S. Food and Drug Administration (FDA) has issued marketing orders for several of its menthol e-vapor products. These include the NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY Extra Menthol 6%. These authorizations follow a thorough FDA review of NJOY’s Premarket Tobacco Product Applications (PMTA), originally submitted in March 2020.
NJOY ACE stands as the sole pod-based e-vapor product authorized by the FDA, marking NJOY as the first to receive FDA approval for menthol e-vapor products to date. Billy Gifford, CEO of Altria, stated, “Altria is Moving Beyond Smoking™ by actively transitioning millions of adult smokers to potentially less harmful alternatives. We are pleased with the FDA’s determination that NJOY’s menthol e-vapor products contribute to public health protection.”
In the first quarter of 2024, NJOY expanded its distribution network to over 80,000 stores, with plans to reach approximately 100,000 stores by year-end. The company also launched its inaugural retail trade program aimed at enhancing retail visibility and product placement.
Shannon Leistra, President and CEO of NJOY, remarked, “With the addition of NJOY menthol e-vapor products, we are uniquely positioned with an FDA-authorized portfolio to support adult smokers in transitioning to smoke-free alternatives. These marketing orders underscore the quality of NJOY products and the robust evidence supporting their authorization.”
Paige Magness, Senior Vice President of Regulatory Affairs at Altria Client Services LLC, emphasized, “FDA authorization of NJOY menthol e-vapor products provides adult smokers and vapers with regulated alternatives, countering illicit flavored disposable e-vapor products on the market. This represents a positive step forward for public health.”
Tobacco harm reduction necessitates a diverse marketplace offering appealing smoke-free tobacco products that satisfy adult smokers. Published data demonstrate that flavors play a crucial role in encouraging adult smokers to explore and adopt smoke-free alternatives. Creating such a marketplace aligns with federal laws requiring comprehensive assessment of tobacco product risks and benefits for both users and non-users.
NJOY operates as a wholly owned subsidiary of Altria, distributing products through Altria Group Distribution Company (AGDC). AGDC boasts extensive U.S. retail coverage and decades of experience in responsible tobacco product retailing.
Following the FDA’s issuance of Marketing Granted Orders (MGOs), Altria is obligated to make additional cash payments totaling $250 million under the Merger Agreement through which Altria acquired NJOY. In May 2024, NJOY submitted a supplemental PMTA for the NJOY ACE 2.0 device, incorporating access restriction technology via Bluetooth® connectivity to prevent underage use. Additionally, NJOY resubmitted PMTAs for Blueberry and Watermelon pod products compatible exclusively with the NJOY ACE 2.0 device.
Under the Merger Agreement terms, Altria may pay up to an additional $250 million in contingent cash payments upon FDA issuance of MGOs for the Blueberry and Watermelon pod products.
Altria is a leader in the U.S. tobacco market for consumers aged 21 and older, with a mission to guide adult smokers towards a smoke-free future. The company’s portfolio includes combustible and smoke-free products, including Philip Morris USA Inc. and U.S. Smokeless Tobacco Company LLC, alongside NJOY as the sole e-vapor manufacturer with FDA market authorizations for a pod-based e-vapor product.
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