The U.S. Food and Drug Administration (FDA) announced on February 26 that it has filed civil monetary penalty complaints (CMPs) against 20 retail entities for selling unauthorized ELFBAR e-cigarette products. The FDA had previously issued warning letters to each retailer regarding their sale of unauthorized e-cigarette products. However, subsequent inspections found that these retailers failed to correct their violations, and the agency is now seeking the maximum penalty amount of $20,678 for each retailer for each individual violation.
Including the complaints announced today, the FDA has filed CMP complaints against over 100 retailers, accusing them of illegally selling ELFBA re-cigarette products. Data shows that these products are appealing to teenagers. According to the 2023 National Youth Tobacco Survey, ELFBA is the most commonly used brand among adolescent e-cigarette users in the United States; over half of middle and high school students who reported using e-cigarettes in the past 30 days stated that they used ELFBAR products during that period.
Dr. Brian King, Director of the FDA's Center for Tobacco Products, stated, "These retailers have failed to address the violations regarding the sale of unauthorized e-cigarette products as previously warned by the FDA. Their continued illegal actions are unacceptable, and as today's actions demonstrate, we are committed to holding them accountable."
Currently, $20,678 is the maximum civil penalty amount that the FDA can seek from individual retailers for a single violation, consistent with similar CMPs filed in September, November, and December 2023 for retailers selling unauthorized ELFBAR products. Retailers may choose to pay the fine, enter into a settlement agreement based on mitigating factors, request an extension for a response, or submit a response and request a hearing. Retailers who fail to take action within 30 days of receiving a complaint are at risk of default judgment for the full penalty amount.
Ele Ibarra-Pratt, acting director of the Enforcement and Compliance Office at the FDA Center for Tobacco Products, stated, "We closely monitor the entire supply chain, including retailers, to ensure compliance with the law. This includes tracking inspections and monitoring of retailers who have received warning letters, and taking enforcement actions as necessary, including filing civil monetary penalty complaints and seeking seizure and injunction."
The CMP action is the latest initiative by the FDA to continuously crack down on unauthorized e-cigarette products throughout the supply chain, especially those popular among teenagers. As of February 15th, the FDA has issued warning letters to over 440 retailers, including brick-and-mortar stores and online retailers, and has filed 100 CMP lawsuits accusing them of selling unauthorized tobacco products.
In addition to actions against retailers, the FDA has issued over 660 warning letters to manufacturers, importers, and distributors, accusing them of illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes. The agency has also filed Civil Money Penalty (CMP) lawsuits against 50 e-cigarette companies, alleging they manufactured unauthorized products, and is coordinating with the Department of Justice to seek injunctions against seven companies manufacturing unauthorized e-cigarette products.
The FDA will continue to take regulatory and enforcement actions against companies manufacturing, distributing, importing, or selling unauthorized e-cigarette products, including pursuing CMP lawsuits against retailers engaged in illegal practices.
2FIRSTS also contacted the relevant person in charge of IMiracle (Heaven Gifts), the parent company of the ELFBAR brand, in relation to this incident. Their full response is as follows:
Since February 2023, IMiracle (Heaven Gifts) has ceased sales of ELFBAR products in the United States. Market feedback indicates that the current ELFBAR products available in the U.S. are not produced by IMiracle (Heaven Gifts), but rather are sourced from VPR or counterfeit workshops in Southeast Asia. We urge consumers to be vigilant and call on U.S. regulatory authorities to crack down on counterfeit goods at the import level. Additionally, we support efforts by U.S. regulatory agencies to strengthen oversight of counterfeit goods in order to effectively protect consumers from the harm of counterfeit products.
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