Elf Bar E-cigarette Manufacturer Seeks to Have U.S. FDA Remove Border Detention List

Today, on May 26, news reports that the manufacturer of the disposable e-cigarette brands Elf Bar, Lost Mary, and EB Design, Imiracle, is calling on the U.S. Food and Drug Administration (FDA) to remove its products from the agency's recently added import red list and to implement coherent, clear, and non-political regulation of the U.S. e-cigarette market.

IMiracle Shenzhen Technology Co. Ltd. issued a statement regarding its products' position on the FDA's import alert #98-06. The company expressed disappointment over the FDA's sudden and arbitrary decision to include its products on the FDA's import red list.

The company stated that it did not receive any notification regarding this decision and had no opportunity to address any issues with the FDA before action was taken.

"The FDA's job is to provide consistent and coherent regulatory clarity for the U.S. market. This red list announcement fails to fulfill that responsibility and is yet another example of the FDA's politicized decision-making," said a spokesperson for Imiracle. "The FDA is singling out IMiracle's products, despite the company sincerely working through the FDA's PMTA process. Meanwhile, the FDA has failed to address the proliferation of products that manufacturers neglect and have never attempted to comply with FDA regulations."

"This decision also ignores the latest science regarding e-cigarette use and continues to prevent American adults from accessing a whole category of nicotine products that the FDA knows to be far safer than cigarettes. Furthermore, in the National Youth Tobacco Survey, no IMiracle brand was identified as a top brand used by youth."

"Given the agency's history of regulating e-cigarette products, the FDA's erratic actions are not surprising. It is appropriate for the industry and its more than 10 million adult consumers to demand that the federal government establish a clear and thoughtful regulatory framework, which they have done. The FDA has failed to respond."

"IMiracle calls on the FDA to revoke the decision to include IMiracle products on the import red list. We welcome participation and dialogue necessary to establish an appropriate and fair regulatory framework around the e-cigarette market for all stakeholders."

The FDA issued import alert 98-06 last week, stating that the agency will detain new tobacco products, such as e-cigarettes, at the border if they do not have marketing authorization.

Affected companies will include all importers, manufacturers, and transporters of e-cigarette product brands such as Elf Bar, EB Design, Eonsmoke, Esco Bars, and Stik, all of which are on the agency's red list.