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03
2024
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06
OCHA Submits PMTA Application to FDA for Next Generation E-Cigarettes and Fruit Flavored Cigarettes
OCHA Submits PMTA Application to FDA for Next Generation E-Cigarettes and Fruit Flavored Cigarettes
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Recently, Njoy, an OCHA subsidiary, submitted a supplemental Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device. The new device contains access restriction technology designed to prevent underage use. This is accomplished through a Bluetooth connection that authenticates the user before unlocking the device.
Njoy has also resubmitted its PMTA application for its blueberry and watermelon flavored vape products, which are only compatible with Njoy ACE 2.0 devices. The company previously received an FDA injunction against the sale of its blueberry and watermelon flavored e-cigarette cartridges. To date, the FDA has not authorized the sale of any fruit-flavored e-cigarette products.
Given the widespread market for illegally flavored e-cigarettes, the Njoy ACE 2.0 provides the FDA with a reasonable solution that balances the known risks to youth with a legal, regulated option for adults, said Paige Magness, senior vice president of regulatory affairs at O'Chia. Given the FDA's interest in device access restriction technology, we hope that the FDA will prioritize the review and authorization of this application to reduce youth use."
In the first quarter of 2024, Njoy announced that it has expanded the distribution of its legal e-cigarettes to more than 80,000 stores and expects to expand to approximately 100,000 stores by the end of the year, according to the company.
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