WASHINGTON, DC, June 23, 2022 — The Food & Drug Administration (FDA) today issued marketing denial orders for e-cigarettes currently manufactured by Juul Labs, the company whose flavored nicotine pods and targeted marketing caused sharp increases in e-cigarette use and nicotine addiction among youth.
The order applies to Juul’s menthol- and tobacco-flavored e-cigarettes, which the company continued to sell after it withdrew flavors including mango, mint and crème brulee from the market following intense criticism for the role these products played in attracting millions of youth to e-cigarettes.
Nancy Brown, CEO of the American Heart Association, the world’s leading voluntary organization focused on heart and brain health, issued the following statement:
“The FDA’s decisive action against Juul prohibits the sale of products that helped fuel the nationwide e-cigarette epidemic among youth and put millions of kids at risk for a lifetime of tobacco use and nicotine addiction.
“The FDA’s decision sends the strongest possible message that Juul put the health of millions of our nation’s young people at risk with flavored e-cigarettes, high nicotine concentrations and years-long marketing campaigns aimed at kids.
“By including tobacco-flavored e-cigarettes in its denial order, the FDA is prohibiting Juul from marketing products the agency has authorized some other companies to sell, an unmistakable message that Juul cannot be trusted with any product in the marketplace.
“With today’s order, the FDA determined that Juul failed to show its products are appropriate for the protection of public health, a standard set by Congress in the Family Smoking Prevention and Tobacco Control Act.
“We call on Juul to immediately comply with the FDA order so these products no longer threaten public health, and we urge the FDA to take swift and severe enforcement action if the company defies the order.
“We also call on the FDA to issue decisions on all remaining premarket tobacco applications as soon as possible, as we are long past the court-ordered September 9, 2021 deadline for the agency to rule on the applications. Products still sold after that date without an FDA order permitting them to stay on the market are subject to possible FDA enforcement action. The FDA should pursue such action against any product remaining on the market that the agency has not authorized for sale.
“The deadline stems from a 2018 lawsuit filed by seven public health and medical groups and five individual pediatricians challenging an FDA decision to delay a requirement that manufacturers of e-cigarettes and certain other tobacco products demonstrate to the FDA that their products are ‘appropriate for the protection of the public health’. The lawsuit was filed by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual pediatricians.”
About the American Heart Association
The American Heart Association is a relentless force for a world of longer, healthier lives. We are dedicated to ensuring equitable health in all communities. Through collaboration with numerous organizations, and powered by millions of volunteers, we fund innovative research, advocate for the public’s health and share lifesaving resources. The Dallas-based organization has been a leading source of health information for nearly a century. Connect with us on heart.org, Facebook, Twitter or by calling 1-800-AHA-USA1.
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