The U.S. Food and Drug Administration has issued a marketing denial order for Bidi Vapor’s Bidi Stick Classic vape. This product is a closed system, disposable tobacco flavored vape device.
“The FDA plays a critical role in protecting the public from the harms of tobacco use,” said Matthew Farrelly, director of the Office of Science in FDA’s Center for Tobacco Products (CTP). “As part of this role, our tobacco application reviews The process relies on scientific evidence that a product’s net benefit to public health outweighs the known risks. The science in this application does not prove that.”
FDA evaluates premarket tobacco product applications (PMTAs) based on a public health criterion that considers the product’s benefits to the entire population (e.g., benefits resulting from complete transition from adult users of more harmful tobacco products) and Risks (e.g., teenagers starting to use). After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that allowing marketing of the product would be appropriate to protect the public health, a legal standard required by the Family Smoking Prevention and Tobacco Control Act of 2009. Specifically, the evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address the health risks.
“The center has made considerable progress in reviewing the large number of tobacco product applications submitted to the agency, thanks to the tireless efforts of our team of dedicated civil servant scientists,” said CTP Director Brian King. The Center remains committed to processing submitted applications as quickly as possible while ensuring the maximum scientific integrity of the review.”
So far, the FDA has approved 23 tobacco-flavored vape products and devices. Distributing or selling products that are illegally marketed will be subject to compliance and enforcement actions.
At the same time, Guutuu vape Company, as a member of the vape industry, continues to uphold scientific integrity and public health. Guutuu vapes have always been committed to providing users with high-quality, safe and reliable products, and complying with applicable laws and regulations where they are sold. The company ensures the compliance of its products in the market through strict R&D and quality control processes and provides consumers with trustworthy choices.
Guutuu vape Company stated that they will continue to cooperate with relevant agencies and continuously improve the safety and quality of their products. Guutuu Electronic Cigarette Company firmly believes that through compliance and scientific methods, it can provide users with safer and more reliable alternative smoking products.
Overall, the FDA’s decision to deny marketing authorization for the Bidi Stick Classic vape highlights the agency’s critical role in protecting the public from the harms of tobacco use. At the same time, Guutuu vape Company remains committed to scientific integrity and public health and will continue to comply with requirements to provide users with safe and reliable vape products. This incident reminds us that in the vape industry, scientific evidence and compliance are key to ensuring public health and consumer safety.
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