The U.S. Food and Drug Administration has issued a marketing denial order to Shenzhen Youmei Information Technology Co., Ltd. for two Suorin e-cigarette products. In addition, the Authority also issued a rejection order against Fontem US, LLC’s Blu PLUS+ brand e-cigarette products.
"A thorough scientific review of tobacco product applications is a key pillar of FDA's comprehensive regulatory approach, and applicants are responsible for ensuring they include sufficient scientific evidence in their applications," said Brian King, director of the FDA's Center for Tobacco Products (CTP). , to meet the necessary public health standards required by law. In these cases, it is precisely such evidence that is lacking."
These companies are not allowed to sell or distribute these products in the United States or risk FDA enforcement action. The companies may submit new applications for these rejected products, according to a press release from the agency.
