The U.S. Food and Drug Administration (FDA) has declared that 189 retailers have received warnings for vending unauthorized tobacco goods, namely Elf Bar and Esco Bars products. These brands of disposable e-cigarettes come in flavors such as bubblegum and cotton candy, known to attract young consumers.
FDA Commissioner Robert M. Califf, M.D., stated the FDA's readiness to utilize all its powers to prevent these and other illicit products designed to appeal to the young, from being accessed by them. He further explained the FDA's commitment to employing a diverse approach incorporating regulation, enforcement action, compliance, and education to protect young Americans.
The warnings were a consequence of a nationwide inspection campaign over the past weeks to clamp down on these unauthorized e-cigarette sales. The FDA continually reviews the market and took these steps following the discovery of data revealing the appeal and potential risks of these products to the young. In particular, FDA's persistent monitoring identified Elf Bar and Esco Bars as two of the most popular brands in the U.S., with high appeal to the youth.
Furthermore, two research articles released today in the Centers for Disease Control and Prevention’s Morbidity & Mortality Weekly Report underline the risks associated with Elf Bar products among young consumers. The first study evaluated e-cigarette retail sales, which generally correspond with usage patterns among youth. The study found that Elf Bar was the top-selling disposable e-cigarette in the U.S. in December 2022. This aligns with findings from the International Tobacco Control Survey indicating that Elf Bar was the leading disposable e-cigarette brand among individuals aged 16 to 19 in the U.S. as of August 2022.
A second study identified thousands of e-cigarette exposure incidents reported to U.S. poison centers in the last year, predominantly among children under 5 years old. Among the few cases where the brand was reported between April 2022 and March 2023, Elf Bar was the most frequently mentioned, especially among children under 5 years old.
Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products (CTP), asserted that all those involved in the supply chain, including retailers, share the responsibility of keeping illegal e-cigarettes off the market. He emphasized that this latest inspection campaign should serve as a wake-up call to retailers selling Elf Bar and Esco Bars products nationwide. He warned that non-compliance with the law may invite warning letters or other actions from the FDA.
The actions today are a continuation of the FDA's efforts to address youth-attractive e-cigarettes, including flavored disposable ones. Last month, the FDA issued import alerts for all products of both Elf Bar and Esco Bars, placing them on a red list that subjects them to detention without physical examination.
The sale of Elf Bar and Esco Bars products is currently unauthorized as they lack the necessary marketing authorization from the FDA. Currently, only 23 tobacco-flavored e-cigarette products and devices that have received FDA authorization are lawfully sold in the U.S. Illegal sale or distribution of these unauthorized products can invite compliance and enforcement actions from the FDA, usually starting with a warning letter. Upon receipt, companies have 15 working days to respond with corrective measures and future violation prevention strategies.
As of June 16, the FDA has sent more than 570 warning letters to firms for manufacturing, selling, or distributing illegal tobacco products, including e-cigarettes. Additionally, civil money penalty complaints have been filed against 12 e-cigarette manufacturers. In October 2022, the first complaints for permanent injunctions were lodged against six e-cigarette manufacturers. Warning letters were sent in May 2023 to two firms responsible for unauthorized flavored, disposable e-cigarette products: Shenzhen Innokin Technology Co. Ltd. for Esco Bars and Breeze Smoke, LLC for Breeze products. Also in May 2023, a nationwide inspection campaign was carried out to control the sale of unauthorized e-cigarettes popular among the youth—specifically Puff and Hyde products—resulting in more than 30 retailers and one distributor receiving warning letters. Failure to promptly correct violations may result in further FDA actions such as injunction, seizure, and/or civil money penalties.
In an effort to enhance the monitoring capabilities of the tobacco landscape, the FDA and the National Institutes of Health announced earlier this month that funding has been awarded for a new Center for Rapid Surveillance of Tobacco (CRST). This specialized center will supplement the internal surveillance efforts of CTP by providing additional information about changes in the tobacco product marketplace and tobacco use patterns.