FDA Update: Agency Denies Marketing Authorization For JUUL Products

On June 23, the U.S. Food and Drug Administration (FDA) issued marketing denial orders to e-cigarette producer JUUL Labs Inc., ordering the company to remove all JUUL products from the market.

After reviewing JUUL’s premarket tobacco product applications, the FDA ruled that the applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, MD, MACC.

Previous research has shown that there is a link between e-cigarettes and heart attack and coronary artery disease. E-cigarette use and nicotine addiction has also been shown to lead to increased risk of tobacco use, which is the leading cause of preventable disease and death in the U.S.

This decision marks a major step in regulating e-cigarettes in the U.S., and the ACC will continue to advocate for regulations and legislation meant to prevent the use of e-cigarette and tobacco products.

Learn more about the FDA’s order here.

Clinical Topics: Prevention, Atherosclerotic Disease (CAD/PAD), Smoking

Keywords: Myocardial Infarction, Tobacco Use, Marketing, Tobacco Products, Coronary Artery Disease, United States Food and Drug Administration, Public Health, Tobacco Use Disorder, Vaping, Electronic Nicotine Delivery Systems, ACC Advocacy

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