The U.S. Food and Drug Administration (FDA) banned sales of about 55,000 flavored e-cigarette products on Thursday because of the health threat they pose to American youth.
“The applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that [e-cigarettes] have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products,” the federal agency wrote in an Aug. 26 statement.
It is the first time the FDA has issued a ban on an electronic nicotine delivery system (ENDS) since they began requiring vape companies to apply for premarket review last year.
The three companies that have their marketing orders denied are JD Nova Group LLC, Great American Vapes, and Vapor Salon. The flavors of the non-tobacco e-cigarette products that are impacted by the ban include Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.
“Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” said acting FDA Commissioner Janet Woodcock.
“Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death,” she continued. “We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
Tobacco companies must submit premarket tobacco product applications (PMTAs) to the FDA, proving that their products provide an overall benefit to public health. If a company fails to make its case, the FDA has the power to order its products off the market.
The FDA said it’s reviewed products for more than 500 companies and more than 6.5 million products, and it has taken other “negative actions” against those applications.
The electronic nicotine product was often marketed as a tool to help adults quit smoking cigarettes, but the product became extremely enticing to youth, with health experts sounding an alarm over a massive uptick in use among children and teens.
“Flavored ENDS products are extremely popular among youth, with over 80 percent of e-cigarette users between ages 12 through 17 using one of these products,” said Mitch Zeller, J.D., head of the FDA’s Center for Tobacco Products. “Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth.”
Millions of Americans are vaping, and some are getting sick. Since June 2019, 2,711 have been hospitalized and 60 have died due to EVALI (e-cigarette-associated lung injury), the devastating lung disease linked to e-cigarettes.
According to research published by JAMA Network Open, about 27 percent of high school students and 10.5 percent of middle schoolers said they have used vape products in 2019. Some users are as young as 11, although it’s illegal to sell vaping products to anyone under 21.
Weihong Lin contributed to this report.