FDA Warns Firms Illegally Selling E-Cigarettes Resembling Products With Smart Technology, Including Phones and Gaming Devices
Products have features that may appeal to youth
October 30, 2024
On October 30, 2024, FDA announced that the agency issued warning letters to nine online retailers and one manufacturer for selling and/or distributing unauthorized disposable e-cigarettes with designs and functionalities that resemble smart technology, including phones and gaming devices. The products cited in the warning letters are advertised as having a variety of designs and functions that may appeal to youth, such as the ability to play games, connect to a smartphone, receive text or call notifications, play music, or personalize products with custom wallpaper.
“These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “They’re illegal to sell and a flagrant attempt to target kids.”
Further, the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because the designs help conceal the nature of the products as tobacco products from parents, teachers, or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market include:
The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug, and Cosmetic Act. In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty.
“FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”
This latest round of warning letters marks another step in FDA’s continued efforts to remove unauthorized e-cigarette products from the market, particularly those that appeal to youth. To date, FDA has issued more than 700 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 690 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against more than 75 manufacturers and more than 150 retailers for distribution and/or sale of unauthorized tobacco products.
As of October 30, 2024, FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can consult to determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement.