Wednesday, December 18, 2024

Altria Advances with NJOY ACE 2.0 PMTA Submission to FDA

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Innovative Steps Toward Safer Vaping

Altria, through its subsidiary NJOY, announced a significant stride in responsible vaping technology with the submission of a Pre-Market Tobacco Product Application (PMTA) for the NJOY ACE 2.0 to the US Food and Drug Administration (FDA). This new device is designed with cutting-edge access restriction technology, utilizing Bluetooth connections to enable user authentication before unlocking, ensuring the device remains inaccessible to minors.

Focusing on Flavored E-Cigarettes

The PMTA resubmission by NJOY specifically targets the blueberry and watermelon flavored products, intended for use with the NJOY ACE 2.0. This move builds upon NJOY’s reputation as the provider of the only pod-based e-cigarette product with FDA marketing authorization, which currently includes the NJOY ACE Classic Tobacco and Bold Tobacco pods.

“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,” stated Shannon Leistra, President and CEO of NJOY.

Regulatory Hurdles and Aspirations

Previously, NJOY faced a Marketing Denial Order (MDO) from the FDA for its blueberry and watermelon pods, citing concerns over underage access. With the latest submission, NJOY aims to demonstrate that their new technology can effectively prevent underage use, addressing the FDA’s concerns comprehensively.

Paige Magness, Senior Vice President of Regulatory Affairs at Altria, commented, “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.”

What’s Next for NJOY and Vaping Regulation?

As the vaping industry continues to evolve, the FDA’s decisions on applications like those of NJOY will be crucial in shaping the market for flavored e-cigarettes, balancing the need for adult access to alternatives while preventing underage use. This pivotal moment could set precedents for future product approvals and regulatory measures.

Stay Informed and Engaged

As Altria and NJOY navigate the regulatory landscape, the outcomes will likely influence both market dynamics and public health policies. We invite you to follow this development closely, share your thoughts on vaping innovations, and discuss how technology can help ensure safer vaping experiences. Your engagement is key to understanding and influencing the future of vaping.

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