FDA Issues Civil Fines to Retailers for Illegal E-Cigarette Sales

Recently, according to the official website of the U.S. Food and Drug Administration (FDA), the FDA has decided to impose civil monetary penalties (CMPs) on 22 American retailers for illegally selling the popular e-cigarette brand ELFBAR/EB Design to minors. The FDA will also issue warning letters to 168 physical stores that have been illegally selling these products.

The FDA had previously issued warning letters to these retailers, urging them to cease the sale of unauthorized tobacco products. However, upon further examination, the FDA discovered that these retailers had not rectified the aforementioned violations. Consequently, the agency has resorted to this mandatory civil penalty measure.

Dr. Brian King, director of the FDA's Center for Tobacco Products (CTP), stated:

The FDA has made it clear that we intend to fully utilize our authority to hold those who violate the law accountable. These retailers have been explicitly warned about the consequences they will face if they fail to rectify their non-compliant actions. By choosing to ignore these warnings, they are now going to face the consequences.

These complaints seek a maximum civil penalty of $19,192 for each retailer's individual violation. While the FDA has previously issued civil penalty complaints against retailers for selling unauthorized tobacco products, this marks the agency's first time seeking the maximum penalty for such violations through CMP. Retailers have the option to pay the fines, enter into consent decrees, request an extension to respond to the complaints, or submit a response and request a hearing. Companies that fail to take action within 30 days of receiving the complaint will be subject to default and will be fined the full amount.

In addition to complaints about civil fines, the FDA has also announced that it has issued warning letters to 168 brick-and-mortar stores illegally selling ELFBAR/EB Design products. These warning letters are a result of nationwide retail inspections conducted in August. Retailers who receive these warning letters have 15 working days to respond with the steps they have taken to correct any violations and ensure compliance with the law. Failure to promptly correct violations may result in further action by the FDA, such as issuing injunctions, seizing products, or imposing civil fines.

Ann Simoneau, Director of Compliance and Enforcement at CTP, stated, "We will continue to closely monitor all participants in the supply chain, including retailers, to ensure their compliance with federal laws. This includes conducting follow-up inspections and monitoring on retailers who have received warning letters, and taking further action as appropriate to enforce the law."

As of September 19, 2023, the FDA has issued warning letters to over 400 retailers, including both physical stores and online retailers, for selling unauthorized tobacco products. In addition, the FDA has sent warning letters to over 600 companies for manufacturing or distributing illicit tobacco products, including e-cigarettes, and has filed civil monetary penalty complaints against 31 e-cigarette manufacturers.