FDA has authorized the JUUL device and its tobacco and menthol pods

In June 2022, the FDA issued a marketing denial order (MDO) to Juul Labs for all of its Premarket Tobacco Product Applications (PMTAs) and ordered retailers to remove the products from store shelves. Juul claimed that the FDA had disregarded the substantial documentation in its applications that addressed the very issues the agency used as the basis for the denial order. The company received a temporary stay from a federal court the next day.

Juul Labs submitted an application for a second-generation device that allows for age verification and device locking. However, the FDA has not taken action on that product.

Two weeks later, the FDA embarrassed itself by reversing its decision and putting its denial order on hold. The agency said that some scientific questions deserved additional review. Last year, the agency rescinded its MDO and returned the Juul products to scientific review.

With the FDA's approval, Juul becomes only the second vape manufacturer to receive permission to sell menthol-flavored products. In June 2024, NJOY was granted authorization for four menthol products.

FDA has authorized the JUUL device and its tobacco and menthol pods

The FDA granted marketing authorization to Juul Labs for its JUUL device and tobacco- and menthol-flavored refill pods. Although the FDA has not yet announced this decision, Juul reported the news in a press release.The FDA's decision also considers the potential risks of youth initiation and continued use of e-cigarettes.

According to Juul, the authorization covers the original Juul device and Juul refill pods in Virginia tobacco and menthol flavors, with 3 and 5 percent nicotine strengths.

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