80 Retailers Warned Over Sale of Unauthorized E-Cigarette Products
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued warning letters to 80 brick-and-mortar retailers in 15 different states for selling unauthorized e-cigarette products popular with youth, including Elf Bar and Lost Mary.
The 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.
For the retailers receiving the CMPs, the FDA previously issued warning letters for their sale of 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, which is commensurate with other penalties the agency has sought this year.
These warning letters and CMPs are a result of the FDA's ongoing monitoring of multiple surveillance systems to identify products that are popular among underage smokers or have youth appeal. The 2023 National Youth Tobacco Survey found that more than 50% of youth who use e-cigarettes reported using the brand Elf Bar. Additionally, the brand Lost Mary was identified as another popular youth brand following agency review of retail sales data and emerging internal data.
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 February, March and May. Subsequently, 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.
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 action, including monetary penalties.