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.
We welcome news tips, article submissions, interview requests, or comments on this piece.
Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn
Notice
1. This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.
2. The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.
3. This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.
4. Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.
Copyright
This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.
For copyright-related inquiries, please contact: info@2firsts.com
AI Assistance Disclaimer
This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.
We welcome any corrections or feedback. Please contact us at: info@2firsts.com
