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Update: Juul Labs Wins FDA Clearance to Keep E-Cigarettes on US Market
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Update: Juul Labs Wins FDA Clearance to Keep E-Cigarettes on US Market
Jul 17, 2025 11:51 AM

02:23 PM EDT, 07/17/2025 (MT Newswires) -- (Updating with information from the FDA throughout and company comments in the fifth paragraph)

The US Food and Drug Administration said Thursday it has authorized the marketing of five JUUL e-cigarette products through the premarket tobacco product application pathway.

These products include the JUUL device and JUULpods in Virginia tobacco and menthol flavors, each available in 3% and 5% nicotine strengths, the regulator said.

"Following an extensive scientific review, the FDA determined that evidence provided by the company, including new information the company submitted in response to a deficiency letter from the FDA, demonstrates that these specific products meet the legal standard set by the 2009 Family Smoking Prevention and Tobacco Control Act to market new tobacco products in the [US]," the FDA told MT Newswires.

The approval marks a key turnaround for the company, which was nearly pushed into bankruptcy after the FDA ordered a sales ban in 2022 due to unresolved concerns about its toxicology data. Although that ban was quickly put on hold, it triggered a financial crisis and waves of lawsuits, according to a Wall Street Journal report earlier Thursday.

"Today's FDA authorization of JUUL products marks an important step toward making the cigarette obsolete," Juul Labs said in a statement, adding that over two million US adults have fully switched from smoking to JUUL, and underage use of its products has dropped 98% since 2019.

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