The U.S. Food and Drug Administration announced on July 25 that it had issued warning letters to 80 brick-and-mortar retailers in 15 states for selling unauthorized e-cigarette products, including Elf Bar and Lost Mary.
The regulatory agency also filed complaints for civil money penalties (CMPs) against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.
“These warning letters and CMPs are a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. The 2023 National Youth Tobacco Survey, according to an FDA release, found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.
Additionally, the brand Lost Mary—manufactured by the same firm as Elf Bar—was identified as popular or youth-appealing following an agency review of retail sales data and emerging internal data from a youth-use survey.
The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. Warning letter recipients have 15 working days to respond with the steps they will take to correct current violations and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including CMPs.
For the retailers receiving the eight CMPs, the FDA previously issued warning letters for to them for selling unauthorized tobacco products. Follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking $20,678 from each retailer.
These actions are the latest in the FDA’s ongoing efforts to address the marketing and sale of unauthorized e-cigarettes that appeal to youth. Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes, including in May, March, and February. As a result of these actions, the FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.
To date, the FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. Further information on tobacco products that may be legally marketed in the United States is available in the FDA’s Searchable Tobacco Products Database.