FDA Acts to Protect Kids by Denying Marketing Applications for Juul E-Cigarettes, Acting to Remove Product that Drove Youth E-Cigarette Epidemic

WASHINGTON, D.C. – The FDA’s decision today denying marketing applications for all Juul products currently marketed in the United States, including Juul’s menthol-flavored products, represents the most significant action the FDA has taken to reverse the youth e-cigarette epidemic. Juul, more than any other product or company, has been responsible for creating and fueling the youth e-cigarette epidemic. The impact of this decision will be substantial because Juul products continue to be widely used by youth.

This decision is based on FDA’s conclusion 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.” The FDA also raised concerns about “potentially harmful chemicals leaching from the company’s proprietary e-liquid pods.”

Today’s decision does not directly address a major concern – Juul’s role in driving the youth e-cigarette epidemic and the continued role of flavored e-cigarettes, including menthol-flavored products sold by Juul and other manufacturers, in sustaining youth e-cigarette use. These remain critical issues requiring FDA to deny marketing applications for all flavored e-cigarettes, including all menthol-flavored products and the flavored disposable products like Puff Bar that have become so popular with kids.

There is no doubt about Juul’s role in driving the youth e-cigarette epidemic. It introduced a sleek, cool, easy-to-hide product that was sold in appealing flavors including menthol, delivered massive doses of nicotine that can quickly addict kids, and was launched with youth-oriented marketing. Largely because of Juul, e-cigarette use among high school students more than doubled from 2017 to 2019 (from 11.7% to 27.5%) and over 5.3 million U.S. kids used e-cigarettes in 2019 – an increase of over 3 million in just two years. A growing number of these kids used e-cigarettes frequently or daily, a sure sign of addiction caused by high-nicotine products like Juul. While rates have since declined because of factors including government restrictions on flavored products and the impact of the Covid-19 pandemic, youth e-cigarette use remains a serious public health problem, with over 2 million kids using e-cigarettes in 2021, according to the 2021 National Youth Tobacco Survey. Juul remains one of the most popular brands among kids.

To truly end the youth e-cigarette epidemic, the FDA must clear the market of all flavored e-cigarettes, including menthol-flavored products. Menthol is a flavor that has been used by the tobacco industry to introduce kids to their products for decades. According to the 2021 National Youth Tobacco Survey, nearly 30% of youth who use flavored e-cigarettes reported using menthol-flavored products, including 46% of youth who used flavored cartridge-based products. There is no public health justification for allowing menthol-flavored e-cigarettes to remain on the market.

Juul’s history shows that its products are highly appealing to kids and it cannot be trusted to act responsibly. In denying these applications, the FDA has acted to protect our nation’s kids, not the company that is most responsible for the youth e-cigarette epidemic.