The U.S. Food and Drug Administration (FDA) has officially authorized Juul Labs to market its e-cigarette device and refill capsules in both "Virginia Tobacco" and menthol flavors in the United States. This decision, which ends years of regulatory uncertainty for the company, allows Juul to continue selling five specific products that have been on the market but in regulatory limbo.
The authorized products include the Juul device and its tobacco and menthol flavor pods, each available in 3% and 5% nicotine concentrations. The FDA stated its decision was based on a "rigorous evaluation" of data submitted by Juul, including over 110 scientific studies. The agency determined that granting these marketing orders was "appropriate for the protection of public health," the standard required by the 2009 smoking prevention law. The data reportedly demonstrated high rates of adult smokers completely switching from combustible cigarettes to these specific Juul products, and that this benefit was "sufficient to outweigh the risks," including potential appeal to non-tobacco users.
However, an FDA spokesperson emphasized that this authorization "does not mean these tobacco products are safe, nor are they 'FDA approved.'" The agency will continue to closely monitor Juul's compliance with youth marketing restrictions. This move formally rescinds the FDA's 2022 marketing denial order against Juul, which had been administratively suspended shortly after it was issued. Juul has previously faced criticism and settled lawsuits over accusations of marketing to underage smokers.
