WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) continued its crackdown on the illegal sale of youth-appealing e-cigarettes by issuing complaints for civil money penalties (CMPs) against 22 retailers on Sept. 28. The FDA previously sent each of these retailers a warning letter based on their sale of the unauthorized tobacco products Elf Bar/EB Design.
During follow-up inspections, the FDA observed that the retailers had not corrected the violations, which resulted in these CMP actions, according to the agency.
"The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable," said Brian King, director of the FDA's Center for Tobacco Products. "These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences."
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. The FDA has issued CMP complaints to retailers for selling unauthorized tobacco products in the past, but this marks the first time the agency is seeking CMPs for the maximum amount against retailers for this type of violation.
The retailers can opt to pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. If they do not take action within 30 days of receiving the complaint, they risk a default order imposing the full penalty amount.
In addition to the CMP complaints, the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products, the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August. Recipients of the warning letters have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. If they fail to promptly correct the violations, they may face additional FDA actions such as injunction, seizure or civil money penalties.
"We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law," said Ann Simoneau, director of the Office of Compliance and Enforcement in the FDA's Center for Tobacco Products. "This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law."
As of Sept. 19, the FDA has issued more than 400 warning letters to retailers, including brick-and-mortar and online retailers, for selling unauthorized tobacco products. The agency also issued 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, and filed CMP complaints against 31 e-cigarette manufacturers.