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On Jan. 19, FDA issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for their blu PLUS+ brand e-cigarette products. The companies must not market or distri
On Jan. 19, FDA issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for their blu PLUS+ brand e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these MDOs.
“Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King., Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”
