May 23, 2023, After IMiracle‘s Products Elf Bar was Added to FDA Import Red List a few days before, IMiracle Shenzhen Technology Co. Ltd., the parent company of Elfbar, expressed disappointment at the U.S. Food and Drug Administration’s (FDA) decision to add the company’s products to the FDA ‘import red list.
IMiracle Products Added to FDA Import Red List
IMiracle Shenzhen Technology Co. Ltd. expressed disappointment at the U.S. Food and Drug Administration’s (FDA) decision to add the company’s products to the FDA ‘import red list.’ The company was given no notice or opportunity to address any concerns before action was taken.
FDA Decision Criticized
IMiracle criticized the FDA for failing to provide consistent and coherent regulatory clarity to the U.S. marketplace. The company accused the FDA of singling out its products despite working in good faith through the FDA’s PMTA process. IMiracle also pointed out that the FDA is failing to address the flood of products from manufacturers that have ignored and never attempted to comply with FDA regulations.
Decision Ignores Latest Science
IMiracle stated that the decision 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.
IMiracle Calls for Reversal of Decision
IMiracle called on the FDA to reverse its decision and engage in conversation to create a proper and fair regulatory regime around the e-cigarette marketplace that works for all stakeholders. The company emphasized its responsibility to stand behind its customers and its commitment to building trusted brands anchored by high standards of safety and quality.
About IMiracle and Elfbar
IMiracle Shenzhen Technology Co. Ltd. is a leading manufacturer of vaping products, including its popular Elfbar brand. The company is committed to providing high-quality and safe products to its customers.