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 e-cigarette, Suorin Air rechargeable e-cigarette, Suorin empty cigarette box, blu PLUS+ e-cigarette battery, seven types of blu PLUS+ pre-filled e-cigarette oil and 22 types of SMOK brand e-cigarette 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.
