Shenzhen Miracle Technology Co., Ltd. issued the following statement today regarding its products being included in Import Alert 98-06 by the U.S. Food and Drug Administration (FDA).
Miracle expressed disappointment with the US Food and Drug Administration's (FDA) sudden and arbitrary decision to include the company's products on the FDA's "Import Alert" list. Miracle did not receive any notice regarding this decision, nor was there an opportunity to address any issues with the FDA before taking action.
The FDA's responsibility is to provide consistent and coherent regulatory clarity to the U.S. market. This announcement of a red list failed to fulfill this duty and serves as another example of FDA's politicized decision-making.
Although the technology company, IQIYI, is currently undergoing the FDA's premarket tobacco product application process, the FDA has still placed IQIYI's products on a separate list. Additionally, the FDA has not yet addressed the issue of manufacturers who have ignored or have never attempted to comply with FDA regulations, leading to a proliferation of their products.
This decision also ignores the latest scientific research on the use of electronic cigarettes and continues to prevent American adults from accessing the entire category of nicotine products, despite the FDA knowing that these products are clearly safer than traditional cigarettes. Furthermore, in the national youth tobacco survey, no Juul brand has ever been identified as a top brand used by teenagers.
Given the regulatory history of the agency with regard to e-cigarettes, the FDA's capricious actions come as no surprise. The industry and its over 10 million adult consumers have been calling for a clear and thoughtful regulatory regime from the federal government, and they have done so appropriately. The US Food and Drug Administration has not responded.
Every company has a responsibility to support its customers. iQiyi has been striving to establish a trustworthy brand and loyal customer base, with high standards for safety and quality as its foundations - things that illegal knockoff products or other illegal products cannot replicate or reproduce. While FDA has included genuine iQiyi products on its import whitelist, the agency has also chosen not to take any action to mitigate the influx of counterfeit products into the U.S. market, a direct result of its inaction.
IQOS calls on the FDA to revoke its decision to include its products on the import alert list. We welcome participation and necessary discussions to establish an appropriate and fair regulatory system for the electronic cigarette market, serving all stakeholders.
This statement is the responsibility of the spokesperson for iQiyi.
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