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 Last year, the agency rescinded its MDO and placed the Juul products back into scientific review.
The Freemax REXA PRO and REXA SMART are highly advanced pod vapes, offering seemingly endless features, beautiful touchscreens, and new DUOMAX pods.
The OXVA XLIM Pro 2 DNA is powered by a custom-made Evolv DNA chipset, offering a Replay function and dry hit protection. Read our review to find out more.
The SKE Bar is a 2 mL replaceable pod vape with a 500 mAh battery, a 1.2-ohm mesh coil, and 35 flavors to choose from in 2% nicotine.
Because of declining cigarette sales, state governments in the U.S. and countries around the world are looking to vapor products as a new source of tax revenue.
The legal age to buy e-cigarettes and other vaping products varies around the world. The United States recently changed the legal minimum sales age to 21.
A list of vaping product flavor bans and online sales bans in the United States, and sales and possession bans in other countries.