IMiracle Calls on FDA to Reverse Its Action Adding IMiracle to Import Red List

WASHINGTON, May 23, 2023 /PRNewswire/ -- IMiracle Shenzhen Technology Co. Ltd. today issued the following statement regarding placement of its products on the FDA's Import Alert # 98-06:

"IMiracle is disappointed by the U.S. Food and Drug Administration's (FDA) decision to abruptly and arbitrarily add the company's products to the FDA 'import red list.' IMiracle was given no notice regarding this 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.

"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.

"It is the responsibility of every company to stand behind its customers. IMiracle has worked hard to build trusted brands and a loyal customer base anchored by high standards of safety and quality that cannot be replicated or reproduced with illicit copycats or other illegitimate products. While placing bona fide IMiracle products on the import red list, the FDA has simultaneously chosen to take no action to mitigate the flood of counterfeit products into the U.S. marketplace that is the direct result of the agency's inaction.

"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."

This statement is attributable to an IMiracle spokesperson.

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SOURCE IMiracle Shenzhen Technology Co. Ltd.