The U.S. Food and Drug Administration (FDA) has authorized the marketing of four menthol-flavored e-cigarette products from NJOY LLC, an affiliate of Altria Group Inc (NYSE:MO).
This decision, made through the premarket tobacco product application (PMTA) pathway, marks the first time non-tobacco flavored e-cigarette products have received FDA authorization.
The authorized products include NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%.
These products are designed to provide a benefit to adult smokers by offering a less harmful alternative to traditional cigarettes. However, the FDA emphasizes that all tobacco products, including e-cigarettes, are harmful and potentially addictive.
The FDA evaluates PMTAs based on a public health standard, considering the risks and benefits of the product to the population as a whole.
Related Read: Some Breather For E-Cigarette Maker Juul As FDA Reconsiders Marketing Denials Issued Two Years Ago
The agency determined that these menthol-flavored products could aid adult smokers in completely switching from traditional cigarettes, which outweighed the risks associated with youth appeal.
Stringent marketing restrictions have been placed on these products to prevent youth access and exposure.
The FDA will monitor the marketing of these products and enforce compliance with statutory and regulatory requirements. The agency may suspend or withdraw authorization if continued marketing is deemed inappropriate for public health protection, particularly if there is increased youth use or decreased switching among current smokers.
The FDA has received nearly 27 million applications for regulated products and has made determinations on more than 26 million. To date, 27 tobacco- and menthol-flavored e-cigarette products and devices have been authorized.
Price Action: MO shares are trading higher by 0.79% at $45.79 at last check Friday.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Image created using artificial intelligence via Midjourney.
