The Vaping Giant That Almost Died: JUUL's Shocking FDA Reversal

In a significant reversal and a major boost for the embattled vaping company, the U.S. Food and Drug Administration (FDA) on Thursday authorized the marketing of five JUUL Labs Inc. e-cigarette products, including the JUUL device and its Virginia Tobacco and Menthol flavored JUULpods in both 3% and 5% nicotine concentrations.

This decision, following an extensive scientific review, permits these products to be legally marketed to adults 21 and older in the U.S., marking a crucial turning point for a company that has faced billions in lawsuits and a near-bankruptcy experience due to its role in the surge of youth vaping.

The FDA determined that the 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 United States.

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“Regarding these specific products, the applicant submitted robust data, including a two-year longitudinal cohort study, demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavored JUUL products,” the FDA said in a statement on Thursday.

The approval permits these specific e-cigarette products to be legally marketed in the U.S. to adults 21 and older. Juul was clouded with several lawsuits that claimed that Juul and Altria Group Inc. (NYSE:MO) misled consumers, especially young people, about how addictive and risky their products were.

Juul agreed to pay $255 million as part of the settlement, and Altria paid $45.5 million. A federal judge in California approved the release of nearly $202 million in early October, after deducting taxes and other costs. The money is being split among 842,000 approved claims.

Citing Goldman Sachs analysis, the Wall Street Journal reported Juul is now the No. 3 e-cigarette brand in the U.S., after Vuse and Geek Bar. Juul represents about 18% of e-cigarette sales in U.S. stores.

Juul was once worth more than $13 billion, and its compact, stylish e-cigarettes changed how people saw and used vaping devices. But the company later had to cut hundreds of jobs and spend billions settling lawsuits related to its part in the surge of youth vaping.

In 2022, Juul was on the brink of bankruptcy amid a dispute with the FDA over whether its products could remain on the U.S. market. In March 2023, parent company Altria Group divested Juul, recording a loss of at least $12.5 billion. 

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