C-store operators face maximum penalties of $19,192 per location
WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) has taken punitive action against 22 retailers accused of selling Elf Bar/EB Design e-cigarettes, issuing penalties of $19,192 per store.
These retailers, spanning 12 states, had previously received warning letters from the FDA notifying them of the unauthorized sale of tobacco products, which lead to the issuance of civil money penalty (CMP) complaints after a second visit by FDA agents.
Announcing the penalties in September 2023, Dr. Brian King, director of the FDA’s Center for Tobacco Products, emphasized the agency’s commitment to enforcing the law and holding violators accountable, noting how these actions mark the first time the FDA has leveled maximum penalties.
At this point, retailers have several options, according to the FDA, including paying the penalty, entering into a settlement agreement, requesting an extension to respond, or filing an answer and requesting a hearing.
Currently, the maximum penalty amount for violating a requirement of the Food Drug & Cosmetic (FD&C) Act relating to tobacco products is $19,192 for a single violation. FDA intends to seek the maximum allowed by law in CMP cases relating to unauthorized tobacco products. However, the FD&C Act also allows for an enhanced penalty amount for certain intentional violations relating to tobacco products, the agency said.
“The Food, Drug and Cosmetic Act also allows for an enhanced penalty amount …”
The FDA also recently issued 168 warning letters to brick-and-mortar retailers for the illegal sale of Elf Bar/EB Design products. These warning letters are the outcome of a nationwide retailer inspection initiative conducted throughout August 2023. Recipients of warning letters must respond within 15 working days, outlining the steps they have taken to rectify the violations and comply with the law. Failure to do so could lead to additional FDA actions like injunctions, seizures, or additional civil money penalties.
In June, the FDA issued 189 similar warning letters to retailers. For the first time, the number of retailers in the convenience channel outnumbered vape and tobacco shops. A month earlier, the FDA enlisted the U.S. Customs and Border Protection agency to “red list” certain vaping products, keeping noncompliant devices from entering the country.
Ann Simoneau, director of the Office of Compliance and Enforcement in the FDA’s Center for Tobacco Products, stressed the agency’s commitment to monitoring the entire supply chain, including retailers, for federal law compliance. This includes follow-up inspections and surveillance of those who have received warning letters.
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