Elf Bar Electronic Cigarette Manufacturer News

Time： 2023-05-27

Imiracle, maker of disposable e-cigarette brands Elf Bar, Lost Mary and EB Design products, is calling on the U.S. Food and Drug Administration to reverse the a...

Imiracle, maker of disposable e-cigarette brands Elf Bar, Lost Mary and EB Design 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 impose a scrutiny on the U.S. e-cigarette market. Coherent, clear and depoliticized regulation.

IMiracle Shenzhen Technology Co. Ltd. issued a statement regarding the placement of its products on FDA's Import Alert #98-06. The company said it was disappointed by the FDA's decision to suddenly and arbitrarily place the company's product on the FDA Import Red List.

The company said it was not notified of the decision and had no opportunity to address any concerns with the FDA before taking action.

“The FDA’s job is to provide consistent and coherent regulatory clarity to the U.S. market. This red list announcement fails in that responsibility and provides yet another example of FDA politicized decision-making,” said a spokesperson for Imiracle. “The FDA is singleting out IMiracle’s products despite the company working in good faith through FDA’s PMTA process. At the same time, the FDA is failing to address the deluge of products that manufacturers ignore and never attempt to comply with FDA regulations.”

“This decision also ignores the latest science on e-cigarette use and continues to prevent U.S. adults from using an entire class of nicotine products that the FDA knows are much safer than cigarettes. Additionally, no IMiracle brand was listed as a vape in the National Youth Tobacco Survey.” Determined as the top brand for youth use."

"Given the agency's history of regulating vaping products, the FDA's erratic actions are not surprising. It is appropriate that the industry and its more than 10 million adult consumers demand that the federal government develop a clear and thoughtful regulatory regime, 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 dialogue needed to create an appropriate and fair regulatory regime around the e-cigarette market that is appropriate for all stakeholders."

The FDA issued Import Alert 98-06 last week, saying regulators will detain novel tobacco products, such as e-cigarettes, without marketing authorization at the border.

Affected companies would include all importers, manufacturers and shippers of vaping product brands such as Elf Bar, EB Design, Eonsmoke, Esco Bars and Stik, which are on the agency's red list.

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