The FDA has granted marketing authorization to Juul Labs for its JUUL device and refill pods in tobacco and menthol flavors. The FDA has not yet made an announcement, but Juul reported the news in a press release.
According to Juul, the authorization covers the original JUUL device and Juul refill pods in Virginia Tobacco and Menthol flavors—both in 3 and 5 percent nicotine strengths.
The FDA green light makes Juul only the second vape manufacturer to receive FDA permission to sell menthol-flavored products. NJOY was granted authorization for four menthol products in June 2024.
Juul Labs has also submitted an application for a second-generation device that allows age verification and device locking, but the FDA has taken no action on that product.
The FDA issued a marketing denial order (MDO) to Juul Labs for all of its PMTAs in June 2022 and ordered retailers to remove the products from store shelves. Juul said the FDA had ignored thousands of pages in its applications that addressed the very issues the agency had used as a basis to issue the denial order. The company sought and received a temporary stay from a federal court the next day.
Two weeks later, the FDA embarrassed itself by reversing course and putting its own denial order on hold, saying some scientific questions deserved additional review. Last year, the agency rescinded its MDO and placed the Juul products back into scientific review.
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