WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced Thursday that it has authorized the marketing of five JUUL e-cigarette products, including the JUUL device and Virginia Tobacco and Menthol-flavored JUULpods in both 3% and 5% nicotine concentrations. The agency concluded these products meet the standards set under the Family Smoking Prevention and Tobacco Control Act for public health protection.
The FDA’s decision follows an extensive review of more than 110 scientific studies submitted by JUUL Labs as part of its premarket tobacco product applications (PMTAs). The agency determined that the products are “appropriate for the protection of public health,” particularly for adult smokers seeking alternatives to traditional cigarettes. The evidence reportedly showed high rates of adult smokers switching entirely from combustible tobacco to JUUL’s tobacco- or menthol-flavored products.
While these authorizations permit legal marketing to adults aged 21 and older, the FDA emphasized that the products are not “FDA approved,” nor are they considered safe. “There is no safe tobacco product,” the agency stated, adding that non-users—especially youth—should not start using nicotine products.
JUUL Labs responded positively to the announcement, stating it marks a significant milestone in their efforts to provide alternatives to smoking. “This is good news for the millions of Americans who still smoke cigarettes,” the company said in a statement, adding that JUUL is now the only U.S. vapor company with a marketing granted order (MGO) that is not also a cigarette manufacturer.
JUUL highlighted its commitment to a smoke-free future and noted a 98% decline in underage use of its products since 2019. The company also pointed to its age-verification protocols and support for category-wide youth access restrictions.
FDA officials say they will continue to monitor JUUL’s compliance with marketing restrictions designed to limit youth exposure. The agency reserves the right to take further action should the company fail to meet these conditions.
The authorization applies only to the specific products listed and does not include any flavored products beyond Virginia Tobacco and Menthol. The decision brings the total number of FDA-authorized e-cigarette products to 39.
JUUL Labs indicated it is working on next-generation technologies, including updated devices and expanded flavor options intended for adult users, with an emphasis on enhanced user experience and improved access control features to prevent underage use.
The FDA’s full decision materials, including the marketing order letter and environmental assessments, are available on its website.
