FDA Sends Warning Letters to Companies Marketing E-Cigarettes to Youth

The Food and Drug Administration (FDA) has started sending warning letters to manufacturers and retailers of e-cigarette merchandise that is targeted towards youth. The letters say if the recipients do not stop the manufacturing, distribution, or sale, they risk an injunction, seizure, or fines.

The FDA announced its enforcement priorities for electronic nicotine delivery systems (ENDS) at the beginning of this year. They said they would be prioritizing enforcement for unauthorized ENDS products that are flavored and cartridge-based, products that the manufacturer did not take “adequate measures to prevent underage access,” and products that are targeted to youth or likely to promote youth use. 

“These warning letters notify the retailers and manufacturers that new ENDS products without a marketing authorization order are adulterated and misbranded, and selling or distributing these products to customers in the U.S. is prohibited under the FD&C Act,” an FDA press release says.

The first group of 16 warning letters was sent out on March 9, and the FDA press release says overall they have issued 73 letters to “brick-and-mortar-retailers” in March, with more sent in April. Most recently, 10 letters were sent on April 27 to online retailers. Some items that were specifically mentioned are items like backpacks with pockets designed to conceal an e-cigarette, ENDS products designed to look like smartwatches or fidget spinners, or e-liquids that imitate packaging for food products or feature cartoons.

“The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. He said the letters are meant to send a clear message that these products will not be tolerated and that their focus is still on protecting the youth.

Although the FDA has stopped some activities like compliance checks and inspections because of COVID-19, they say the letters sent relate to inspections done before the stop-work order that applied to state-level inspection contracts.

In December 2019, President Trump signed legislation raising the federal minimum age for sale of tobacco products to 21. “The FDA continues to monitor youth use of all e-cigarette products and will continue to expand its public education efforts and use the agency’s regulatory authority—changing course as necessary—to further ensure all tobacco products, and e-cigarette products in particular, are not marketed to, sold to, or used by youth,” the FDA said.