Altria Submits PMTA for NJOY ACE 2.0 to FDA

On May 21, the official website of Altria announced that NJOY, a company under Altria, has submitted a Pre-Market Tobacco Product Application (PMTA) to the US Food and Drug Administration (FDA). This new device utilizes access restriction technology to prevent minors from using Bluetooth connections, allowing for user authentication before unlocking the device.

The company has resubmitted a PMTA specifically for blueberry and watermelon flavored products intended for use with the NJOY ACE 2.0 device.

We are excited to build upon our existing FDA authorized products with the NJOY ACE 2.0. This product includes key technological features that prevent minors from accessing flavored NJOY products, while responsibly providing flavored options for adult smokers and e-cigarette enthusiasts," said Shannon Leistra, President and CEO of NJOY.

Currently, the NJOY ACE is the only pod-based e-cigarette product with marketing authorization from the FDA. The NJOY ACE device and NJOY ACE Classic Tobacco (2.4% and 5%) and Bold Tobacco (5%) pods received FDA authorization under the PMTA on April 26, 2022.

However, NJOY had previously received a Marketing Denial Order (MDO) for its blueberry and watermelon pods. NJOY believes that these applications adequately address the FDA's concerns about underage use, by combining device age and identity-based access restrictions, and demonstrating that these restrictions can effectively prevent underage access in almost all cases. Currently, the FDA has not authorized the sale of any non-tobacco flavored e-cigarette products.

Paige Magness, Senior Vice President of Regulatory Affairs at Altria, stated, "Given the widespread presence of illegally flavored e-cigarettes in the market, this product provides a reasonable solution for the FDA to balance the known risks for adolescents while offering a legal and regulated option for adults. We hope that the FDA will prioritize reviewing and authorizing this application.