On July 25, the U.S. Food and Drug Administration (FDA) issued warning letters to 80 brick-and-mortar retailers across 15 states. These retailers were found selling unauthorized Vape products popular among youth, including brands like Elf Bar and Lost Mary. Additionally, the FDA filed complaints for civil money penalties (CMPs) against eight retailers who failed to act after previous warnings.
These actions are part of the FDA’s ongoing efforts to monitor products that appeal to youth through various surveillance systems. The agency’s goal is to curb the sale of unauthorized Vapes that may attract underage users.
Details of the Warning Letters and CMPs
The FDA typically sends warning letters following an investigation or inspection that reveals a violation. Recipients have 15 working days to respond, outlining the steps they will take to correct and prevent future violations. Failure to comply can result in further FDA actions, including CMPs.
For the eight retailers receiving CMPs, the FDA had previously issued warnings for selling unauthorized tobacco products. Follow-up inspections revealed that these retailers did not rectify the violations. Consequently, the FDA is now seeking $20,678 in penalties from each of these retailers.
Ongoing Efforts to Combat Unauthorized Sales
These recent actions are part of the FDA’s broader initiative to address the marketing and sale of unauthorized Vapes. Over the past year, the agency has conducted several inspections to identify retailers violating these regulations.
As a result, the FDA has issued more than 690 warning letters and over 140 civil money penalty actions against retailers selling unauthorized Vapes.
Authorized Vape Products
To date, the FDA has authorized 34 Vape products and devices. Only these products may be lawfully marketed and sold in the United States. For more information on legally marketed tobacco products, visit the FDA’s Searchable Tobacco Products Database.
The FDA’s actions underscore its commitment to protecting public health, particularly that of young people, by ensuring that only authorized Vape products are available in the market.