The Food and Drug Administration (FDA) has issued marketing granted orders (MGOs) for Juul e-cigarettes.
“Today, the U.S. Food and Drug Administration authorized the marketing of five Juul e-cigarette products through the premarket tobacco product application (PMTA) pathway—the Juul device, Virginia Tobacco flavor Juulpods (3% and 5% nicotine concentration) and Menthol flavor Juulpods (3% and 5% nicotine concentration),” a U.S. Department of Health and Human Services (HHS) spokesperson said in a statement to CSP Daily News on Thursday.
“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 United States,” the HHS spokesperson added.
The products include the on-market Juul System, which is a closed, cartridge-based nicotine vapor product that utilizes proprietary heating technology to aerosolize and deliver nicotine without combustion.
As part of Juul’s 2020 applications, the company said it submitted more than 110 scientific studies to FDA covering nonclinical, clinical, and behavioral science.
“While today’s actions permit these specific e-cigarette products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved’,” according to a HHS spokesperson. “FDA will closely monitor compliance with robust restrictions to limit youth exposure to marketing and will act appropriately if company fails to comply with requirements.”
Juul CEO K.C. Crosthwaite told CSP in an email Thursday that “today's FDA authorization of Juul products marks an important step toward making the cigarette obsolete. More than two million adult Americans have switched completely away from deadly cigarettes using Juul products. Meanwhile, underage use of our products is down 98% since 2019, to one-half of one percent of youth.”
Crosthwaite added that the electronic-cigarette maker strongly supports the FDA’s role in regulating tobacco and nicotine products.
“Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products that are high-quality, innovative, backed by rigorous research, made in FDA-inspected manufacturing facilities, and marketed and sold responsibly,” Crosthwaite said.
In 2024, the FDA rescinded MDOs for Juul Labs Inc. regarding all of the company’s products marketed in the United States.
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