The Food and Drug Administration (FDA) recently issued warning letters to 80 brick and mortar retailers in 15 different states for the alleged sale of unauthorized e-cigarette products. The brands that were highlighted by the agency were Elf Bar and Lost Mary.
Additionally, the FDA announced the filing of complaints for civil money penalties (CMPs) against eight other retailers who “failed to take action after being previously warned about selling unauthorized e-cigarettes,” the agency wrote in a statement.
These warning letters and CMPs are a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that the agency refers to as “popular among youth” or “having youth appeal.”
The FDA cited the 2023 National Youth Tobacco Survey, which stated that more than 50% of youth who use e-cigarettes reported using the brand Elf Bar.
The brand Lost Mary — which is manufactured by the same firm as Elf Bar — was similarly treated as a youth-appealing offering by the FDA.
The Compliance Process
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 the current violations and prevent future ones.
However, failure to 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 their sale of unauthorized tobacco products. Follow-up inspections from the FDA revealed that the retailers had failed to correct the violations, and the agency is now seeking $20,678 from each retailer.
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, the FDA has issued more than 690 warning letters and more than 140 CMP actions to retailers.
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 U.S.
Further information on tobacco products that may be legally marketed in the U.S. is available in the FDA’s Searchable Tobacco Products Database.
