80 Retailers Warned Over Sale of Unauthorized E-Cigarette Products
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.