Tag: EBdesign

  • FDA Issues Civil Money Penalties to 22 Retailers

    FDA Issues Civil Money Penalties to 22 Retailers

    Credit: VetKit

    The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.

    The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the 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, director of the FDA’s Center for Tobacco Products (CTP). “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 complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.

    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 that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.

    Courtesy: US FDA

    In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.

    Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly 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, director of the Office of Compliance and Enforcement in the 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.” 

  • Elf Bar Maker Wants U.S. FDA to Reverse Red List Addition

    Elf Bar Maker Wants U.S. FDA to Reverse Red List Addition

    Imiracle, the manufacturer of Elf Bar, Lost Mary and EB Design vaping products, is calling on the U.S. Food and Drug Administration to reverse the agency’s recent addition of Imiracle products to its import red list and “for coherent, clear and depoliticized regulation of the U.S. vaping market.

    IMiracle Shenzhen Technology Co. Ltd. issued a statement regarding the placement of its products on the FDA’s Import Alert # 98-06. The company said it is disappointed by the FDA’s decision to “abruptly and arbitrarily” add the company’s products to the FDA import red list.

    The company stated that it was given no notice regarding the decision and was provided no opportunity to address any FDA concerns before action was taken.

    “It is the job of the FDA to provide consistent and coherent regulatory clarity to the U.S. marketplace. This red list announcement fails to meet this responsibility and provides yet another example of FDA’s politicized decision-making,” a spokesperson for Imiracle stated. “The FDA is singling out IMiracle’s products, despite the fact that the company was working in good faith through the FDA’s PMTA process. At the same time, the FDA is failing to address the flood of products from manufacturers that have ignored and never attempted to comply with FDA regulations.

    “This decision also ignores the latest science on e-cigarette use and continues to prevent U.S. adults from accessing an entire category of nicotine products that FDA knows are significantly safer than cigarettes. Further, no IMiracle brands have ever been identified in the National Youth Tobacco Survey as top brands used by youth.

    “The FDA’s capricious action is not surprising given the agency’s history of regulating vaping products out of existence. It is appropriate for the industry and its more than 10 million adult consumers to demand a clear and thoughtful regulatory regime from the federal government, and they have done so. The FDA has failed to respond.

    “IMiracle calls on the FDA to reverse its decision to place IMiracle products on the import red list. We welcome the engagement and the conversation needed to create a proper and fair regulatory regime around the e-cigarette marketplace that works for all stakeholders.”

    The FDA last week issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.

    The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as Elf Bar, EB Design, Eonsmoke, Esco Bars and Stik that are on the agency’s “Red List.”