FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco Bars E-Cigarettes
For Immediate Release: June 22, 2023
Today, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are disposable e-cigarettes that come in flavors known to appeal to youth, including bubblegum and cotton candy.
“The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” said FDA Commissioner Robert M. Califf, M.D. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.”
The warning letters were the result of a nationwide retailer inspection blitz over the past several weeks cracking down on the sale of these unauthorized e-cigarettes. The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.
In addition, two studies published today in the Centers for Disease Control and Prevention’s Morbidity & Mortality Weekly Report reinforce concerns about the risks of Elf Bar products among young people. The first study assessed retail sales of e-cigarettes, which typically align closely with patterns of youth use. This study found Elf Bar was the most popular disposable e-cigarette sold in the U.S. in December 2022. That study aligns with recent findings from the International Tobacco Control Survey, which found that as of August 2022, Elf Bar is the top disposable e-cigarette brand reported among persons ages 16 to 19 in the U.S.
A second study showed thousands of e-cigarette exposure cases reported to U.S. poison centers in the past year, most of which were among kids younger than 5 years old. Among the limited number of cases with brand information reported from April 2022 to March 2023, Elf Bar was cited more than all other brands combined, with nearly all Elf Bar cases occurring among children younger than 5 years old.
“All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products (CTP). “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”
Today’s actions are the latest in the FDA’s efforts to address e-cigarettes that have a high youth appeal, including flavored disposable products. To help prevent these products from illegally entering the marketplace, last month, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on the red list, which makes them subject to Detention Without Physical Examination and allows the FDA to detain a product without physically examining it at the time of entry.
Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations.
As of June 16, the FDA has issued more than 570 warning letters to firms for manufacturing, selling and/or distributing illegal tobacco products, including e-cigarettes, and filed civil money penalty complaints against 12 e-cigarette manufacturers. In October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. In May 2023, the FDA issued warning letters to the firms responsible for two brands of unauthorized flavored, disposable e-cigarette products: Shenzhen Innokin Technology Co. Ltd. for Esco Bars products and Breeze Smoke, LLC for Breeze products. Also, in May of 2023, the FDA conducted a nationwide blitz to crack down on the sale of unauthorized e-cigarettes popular with youth—specifically Puff and Hyde products—which resulted in warning letters to more than 30 retailers and one distributor. After receiving a warning letter, a majority of companies correct the stated violations. However, failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure and/or civil money penalties.
To further expand surveillance capabilities of the dynamic tobacco landscape, the FDA and the National Institutes of Health announced earlier this month that funding was awarded for a new Center for Rapid Surveillance of Tobacco (CRST). This specialized center will complement CTP’s internal surveillance efforts by providing additional rapid information about changes in the tobacco product marketplace and tobacco use patterns.
Related Information
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Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: FDA.gov
