FRIDAY, June 23, 2023 (HealthDay News) -- The U.S. Food and Drug Administration said Thursday it has sent warning letters to 189 retailers, telling them to stop selling unauthorized tobacco products such as Elf Bar and Esco Bars.
Both brands are disposable e-cigarettes sold in flavors known to appeal to kids, including bubblegum and cotton candy. A federal ban on flavored vapes that was issued in early 2020 does not cover disposable vapes.
"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," FDA Commissioner Dr. Robert Califf said in an agency news release. "We are committed to a multi-pronged approach using regulation, compliance and enforcement action and education to protect our nation's youth."
The warning letters were sent following a nationwide inspection blitz conducted over several weeks.
In addition, two studies published in Morbidity & Mortality Weekly Report highlight concerns over the risks of Elf Bar products among young people.
The first study found that Elf Bar was the most popular disposable e-cigarette sold in the United States in December 2022, and that it has fueled a significant rise in e-cigarette sales.
The second study showed thousands of e-cigarette poisoning cases reported to poison centers in the past year, mostly among kids ages 5 and under. Among the cases with brand information reported, Elf Bar was named more than all other brands combined, with nearly all Elf Bar cases occurring among children younger than 5.
"All players in the supply chain -- including retailers -- have a role in keeping illegal e-cigarettes off the shelves," Brian King, director of FDA's Center for Tobacco Products, said in the agency news release. "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."
To help prevent these products from illegally entering the marketplace the FDA issued import alerts for products under both the Elf Bar and Esco Bars brands. An import alert puts these products on the red list, which allows the FDA to detain a product without physically examining it at the time of entry. Last month, the FDA issued orders allowing customs officials to seize shipments of Elf Bar, Esco Bar and two other brands, the Associated Press reported.
In response to the latest action from the FDA, IMiracle Shenzhen Technology Co. Ltd., the maker of Elf Bar, said in a statement that, "In keeping with its previous actions on vaping, this latest move by the FDA willfully ignores the latest science on e-cigarette use and continues to prevent U.S. adults from accessing an entire category of nicotine products that the FDA knows are significantly safer than traditional cigarettes."
Still, the FDA stated that none of the products have received FDA marketing authorization and they come in flavors like cotton candy, which regulators say can appeal to teenagers.
“We’re not going to stand by as bad actors are profiting off the sale of illegal products that are addicting our nation’s youth,” King told the AP. "Today’s action is just part of our longstanding efforts to address those products, particularly flavored disposable products."
More information
For more on the FDA and e-cigarettes, head to the U.S. Food and Drug Administration.
SOURCES: U.S. Food and Drug Administration, news release, June 22, 2023: IMiracle Shenzhen Technology CO. Ltd., statement, June 23, 2023; Associated Press
