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USFDA imposes maximum fine on 22 retailers for selling illegal e-cigarettes

The USFDA has issued civil money penalties to 22 retailers selling illegal e-cigarettes and sought up to a maximum of $19,192 fine for a single violation from each retailer.

HQ Team

September 29, 2023: The USFDA has issued civil money penalties to 22 retailers selling illegal e-cigarettes and sought up to a maximum of $19,192 fine for a single violation from each retailer.

The retailers were selling Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand. The FDA had previously issued warning letters to these retailers, according to a statement.

 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, PhD, M.P.H., director of the FDA’s Center for Tobacco Products.

‘Duly warned’ 

“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.”

This is the first time the agency is seeking civil money penalties 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 who do not take action within 30 days of receiving the complaint risk a default order imposing the full penalty amount.

The FDA also announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products.

Retailer inspection

“These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August,” according to the statement.

Retailers have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. 

Failure to 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, JD., 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.”

23 legal e-cigarette products

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. 

The regulator had also 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.

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 US.

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