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.
Notice
1. This article is provided exclusively for professional research purposes related to industry, technology and policy. Any reference to brands or products is made solely for the purpose of objective description and does not constitute an endorsement, recommendation, or promotion of any brand or product.
2. The use of nicotine products, including but not limited to cigarettes, e-cigarettes, and heated tobacco products, is associated with significant health risks. Users are required to comply with all relevant laws and regulations in their respective jurisdictions.
3. This article is strictly restricted from being accessed or viewed by individuals under the legal age.
Copyright
This article is either an original work by 2Firsts or a reproduction from third-party sources with the original source clearly indicated. The copyright and usage rights of this article belong to 2Firsts or the original source. Unauthorized reproduction, distribution, or any other unauthorized use of this article by any entity or individual is strictly prohibited. Violators will be held legally responsible. For copyright-related matters, please contact: info@2firsts.com
AI Assistance Disclaimer
This article may have utilized AI to enhance translation and editing efficiency. However, due to technical limitations, errors may occur. Readers are advised to refer to the sources provided for more accurate information.
This article should not be used as a basis for any investment decisions or advice, and 2Firsts assumes no direct or indirect liability for any errors in the content.
