The Food and Drug Administration has issued complaints for civil money penalties (CMPs) against 22 retailers, including some convenience stores. The retailers illegally sold Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand, the FDA said Thursday.
Among the list were c-stores like a CITGO/Shane’s in Georgia, a Kwik Stop in Florida, a Valero/Lincoln Express Mart in Mississippi and other smoke shops and food stores, the FDA said in a list on its website.
The FDA said it had previously warned the retailers to stop selling unauthorized tobacco products and during followup inspections, the FDA found the retailers had not corrected the violations.
“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 CMPs seek the maximum civil penalty of $19,192 for a single violation from each retailer. The FDA has issued CMPs to retailers for selling unauthorized tobacco products in the past, but this is the first time it is seeking CMPs for the maximum amount allowed against retailers for this type of violation, the agency said.
Retailers can pay the penalty, enter a settlement agreement, request an extension to file or file an answer and request hearing in response to the CMPs. Retailers who do not act within 30 days after receiving the complaint risk a default order imposing the full penalty amount, the FDA said.
The FDA also announced Thursday that it had sent an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These letters were sent in conjunction with a nationwide retailer inspection effort conducted in August.
“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 CTP. “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 for selling unauthorized tobacco products and issued more than 600 warning letters to companies for manufacturing and/or distributing illegal tobacco products. The FDA has filed CMPs against 31 e-cigarette manufacturers.
There are 23 tobacco-flavored e-cigarette products that the FDA has authorized under the premarket tobacco product application (PMTA) process. These are the only e-cigarettes that can be lawfully sold in the U.S., the FDA said.
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