On September 14, 2023, the FDA issued warning letters to 15 online retailers and 3 manufacturers and/or distributors, accusing them of selling or distributing unauthorized electronic cigarette products. In addition, in one case, a retailer illegally sold products to underage buyers. The warning letter lists a series of popular and attractive e-cigarette products for young people, including disposable products sold under brands such as Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech.


Through rapid monitoring and data-driven survey methods, key e-cigarette products that attract young people have been identified. Retail sales data, internal data from surveys targeting young people, and other data sources helped the FDA determine the increasing popularity of these products that appeal to young people, and then prioritize investigating the entire supply chain from manufacturers to distributors to retailers.


Given the rapid development of the e-cigarette industry, we must have flexible monitoring tools to best keep up with the pace of protecting public health, "said Brian King, Ph.D. and Master of Public Health at the FDA Tobacco Products Center. They are an important component of our comprehensive monitoring toolbox, enabling us to proactively identify and quickly avoid emerging threats, especially those that affect young people in our country


The company that received the warning letter today is selling or distributing electronic cigarette products in the United States without FDA authorization, which violates the Federal Food, Drug, and Cosmetic Act. The recipient of the warning letter has 15 working days to respond and explain the measures they will take to correct the violation and prevent future occurrences of the violation.

Today's warning letter is the latest in a series of efforts taken by the FDA throughout the entire supply chain to address the issue of tobacco products that attract young people. Most recipients of warning letters will take corrective measures. Failure to promptly correct violations may result in the FDA taking additional actions, such as injunctions, seizures, or civil fines. Last year, the FDA issued the first batch of bans and civil fines against e-cigarette manufacturers, and issued the first warning letter to distributors of illegal e-cigarettes. Since January 2023, the agency has imposed civil fines on 29 manufacturers who illegally sell electronic cigarettes.

To help provide information for these compliance and law enforcement efforts, the agency continues to expand its monitoring capabilities to quickly identify emerging products and take action to protect public health. In June, the FDA and the National Institutes of Health (NIH) provided funding for the new Tobacco Rapid Monitoring Center (CRST). By rapidly monitoring and reporting information, CRST will enhance the FDA and research community's ability to understand, document, and quantify the rapid changes in the tobacco product market and tobacco usage patterns. CRST will increase the FDA's time sensitive data source equipment, which provides potentially actionable information faster than traditional data collection methods.