FDA Takes Action Against Unauthorized E-Cigarettes Promoted at Industry Trade Show

September 13, 2024

On September 13, FDA issued six warning letters to manufacturers and retailers for the sale or distribution of unauthorized e-cigarette products promoted at an industry trade show.

Subsequent to observations made by Center for Tobacco Products (CTP) staff attending the trade show, FDA conducted investigations and has issued warning letters to six retailers and manufacturers for selling or distributing unauthorized e-cigarette products. Regulated entities must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act. Under these requirements, the sale and distribution of unauthorized tobacco products is illegal, including at industry events such as trade shows or expos.

“Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows,” said John Verbeten, Director of CTP’s Office of Compliance and Enforcement. “We remain committed to identifying and taking action against those breaking the law, including at these events.”

FDA also announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz. Results from the recently released 2024 National Youth Tobacco Survey found that Breeze and Mr. Fog were among the top five most commonly used brands among youth who use e-cigarettes. Additionally, Raz was identified as a popular brand through routine surveillance, with youth-appealing flavors such as sour mango pineapple and razzle dazzle.

The companies receiving these warning letters sold or distributed e-cigarette products that have not been granted marketing authorization from FDA, in violation of the law. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violations cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

These actions are part of the agency’s ongoing efforts to crack down on unauthorized e-cigarettes across the supply chain, including retailers. Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes—including in August, July, June, May, March, and February. As a result of these actions, FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes. During 2023-2024, e-cigarette use among U.S. youth dropped by nearly 25%—a decrease from 2.13 million youth to 1.63 million youth. To date, FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products and devices that currently may be lawfully marketed and sold in the United States. Further information on tobacco products that may be legally marketed in the United States is available in FDA’s Searchable Tobacco Products Database.