According to US media csnews reported on January 23, the US Food and Drug Administration (FDA) recently issued a market denial order (MDO) targeting companies such as Bidi Vapor, Shenzhen Youmi Information Technology Co., Ltd., Fontem US and Shenzhen IVPS Technology Co., Ltd. A variety of products, including Bidi Stick classic vape, Suorin Air rechargeable vape, Suorin empty cigarette box, blu PLUS+ vape battery, seven types of blu PLUS+ pre-filled vape oil and 22 types of SMOK brand vape products.
The FDA emphasizes public health standards that consider risks and benefits for entire population groups when evaluating premarket tobacco product applications (PMTAs). After reviewing PMTAs for companies such as Bidi Vapor, the FDA determined that these applications lacked sufficient evidence to show that allowing these products to be marketed would be beneficial to protecting public health and violated the legal standards of the Family Smoking Prevention and Tobacco Control Act of 2009. “Adequate scientific review is a key pillar of FDA regulation,” said Brian King, director of the FDA’s Center for Tobacco Products. “It is the applicant’s responsibility to ensure that the PMTA contains sufficient scientific evidence to meet statutory public health standards, and in these In this case, such evidence was missing.”
Bidi Vapors expressed disappointment with the FDA’s decision, but stressed that it only affects one product. Bidi CEO Niraj Patel said: “Bidi Vapor is reviewing this opinion based on its nature. In the meantime, the decision only affects our ‘classic’ or tobacco flavored products. Our remaining 10 flavors are still undergoing scientific review and are available Sales. We are currently investigating legal remedies and expect updates in the coming days. We are now asking our wholesalers and retail partners to direct their questions to our sales representatives.”
As a result of the MDO, Bidi or other companies may not sell or distribute products on the above product list on the U.S. market without FDA risk enforcement action. The FDA may require distributors or retailers to comply as part of its increased enforcement of illegal tobacco products in recent years.
Veehoo vapes say they can take the following measures to deal with the current situation:
Scientific research and data support: It can increase scientific research on products and collect and provide more data to support the safety and public health benefits of its products. This can include conducting independent research, testing and clinical trials to assess the impact and potential risks of the product.
Cooperation with the FDA: vape companies such as Veehoo can actively cooperate with relevant authorities and share their scientific research and data in order to negotiate with the FDA and meet its review requirements. Collaboration with relevant authorities will help build trust and transparency while also helping to ensure that products comply with regulatory standards.
Product innovation and improvement: Veehoo vapes can continuously carry out product innovation and improvement to improve product quality and safety. This can include improving the design of vape devices, developing safer battery technology, and exploring healthier e-liquid ingredient formulations. Through continuous improvement, veehoo vapes can provide products that are safer and more in line with public health needs.
Education and awareness-raising: Veehoo vapes can increase public education and awareness-raising efforts. This can include providing information on the science, usage and potential risks of vapes to help consumers make informed choices.
Cooperation with industry organizations: Veehoo vapes can actively cooperate with relevant industry organizations to jointly formulate and comply with industry standards and best practices. This will help improve the reputation and sustainability of the entire vape industry and jointly address regulatory challenges.
In short, facing the challenge of FDA market rejection orders, vape companies such as Veehoo can respond by increasing scientific research, cooperating with the FDA, improving product innovation, raising educational awareness, and cooperating with industry organizations. These measures will help ensure product safety and compliance with public health standards, while also helping to maintain the sustainable development of the vape industry.
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