FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes

Agency Took Actions After Retailers Failed to Heed Warning Letters

SILVER SPRING, Md., Sept. 28, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand. The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in these civil money penalty actions.

"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, Ph.D., M.P.H., 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. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for this type of violation. The retailers can 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. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.

In addition to these CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August. Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in 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, J.D., M.B.A, 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."

The collective actions announced today mark yet another step in the agency's continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth. As of Sept. 19, 2023, the FDA has issued more than 400 warning letters to retailers, including brick-and-mortar and online retailers, for selling unauthorized tobacco products. Additionally, the FDA has issued more than 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, and filed civil money penalty complaints against 31 e-cigarette manufacturers.

The FDA will continue to take action against those making, distributing, importing or selling unauthorized e-cigarette products, including seeking civil money penalties against retailers who violate the law. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic Act.

Additional Resources:

• Civil Money Penalties
• Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products
• Premarket Tobacco Product Applications
• Quitting Smoking and Other Tobacco Public Health Resources
• Safety Reporting Portal for Tobacco Products | FDA

Media Contact: Jim McKinney, 240-328-7305
Consumer Inquiries: Email or 888-INFO-FDA (888-463-0332)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration