FDA Denies Promoting of Suorin and blu PLUS+ E-Cigarette Items
On Jan. 19, the FDA gave promoting refusal orders (MDOs) to Shenzhen Youme Data Innovation Co. Ltd. for two Suorin brand e-cigarette items and to Fontem US, LLC for their blu PLUS+ brand e-cigarette items. The organizations should not advertise or appropriate these items in the US or they risk FDA authorization activity. The organizations might submit new applications for the items that are dependent upon these MDOs.
"Careful logical survey of tobacco items applications is a vital mainstay of FDA's complete administrative methodology," said Brian Ruler., Ph.D., M.P.H., Head of FDA's Middle for Tobacco Items. " It is the applicant's responsibility to ensure that the application contains sufficient scientific evidence to satisfy the legal public health standard. Such evidence was lack...
