FDA Issues Largest Fines to 22 Retailers for Selling Elf Bar E-Cigarettes

Disposable vaping e-cigarette products are displayed in a convenience store in El Segundo, Calif., on June 23, 2022. Patrick T. Fallon/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) has fined 22 retailers over the illegal sale of Elf Bar e-cigarettes, a popular youth-appealing brand, after discovering they did not comply with a previous warning letter.

The FDA is seeking the maximum civil money penalty of $19,192 for a single violation from each retailer. This marks the first time the FDA has asked for the maximum amount of fines for this type of violation, the agency stated on Sept. 28.

“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement.

“These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences,” he added.

They may pay the penalty, enter into a settlement agreement, or request an extension of time to file an answer to the complaint. Inaction within 30 days may result in a default order imposing the full penalty amount.

More than 400 retailers, including brick-and-mortar and online retailers, have received a warning letter from the FDA for selling unauthorized tobacco products as of Sept. 19, according to the agency. They will have 15 working days to correct the violation.

Ann Simoneau, director of the Office of Compliance and Enforcement in the FDA’s Center for Tobacco Products, said the agency would continue to monitor closely retailers for compliance with federal law.

“This includes follow-up inspections and surveillance of those who have received a warning letter and taking additional action, as appropriate, to enforce the law,” Ms. Simoneau said in a statement.

Elf Bar products are manufactured in Shenzhen, China, but they have not received marketing approval from the FDA. According to the International Tobacco Control Survey, Elf Bar was the top disposable e-cigarette brand reported among people aged 16 to 19 in the United States as of August 2022.

The FDA said on June 22 that there have been thousands of cases of e-cigarette exposure reported to U.S. poison centers in the past year, with most of these cases involving children under the age of five.

“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 five years old,” it stated.

E-Cigarette Use Among Young Adults

A recent study from the U.S. Centers for Disease Control and Prevention (CDC) has revealed that more than one in 10 American young adults were using vapes, a concern given the negative impact e-cigarette usage can have on young brains.

A woman is seen vaping in Melbourne, Australia, on May 3, 2023. AAP Image/Diego Fedele

The July 21 CDC study (pdf) found that 11 percent of young adults aged 18-24 were current e-cigarette users.

Vaping among this demographic is a concern “because nicotine adversely impacts brain development, which continues into the early to mid-20s.” Young adults were the most likely to use e-cigarettes among all adults.

Young adults were also found to be more likely to be dual users of e-cigarettes and cigarettes when compared to adults aged 45 and above.

“Dual use of tobacco products is a health concern because it may result in greater exposure to toxins and worse respiratory outcomes than using either product alone,” the study stated.

According to the CDC, most vapes contain nicotine. Vapes that do not disclose whether they contain nicotine have been found to have the substance. This is even true for vape liquids that are being marketed as zero percent nicotine.

Naveen Athrappully contributed to this report.