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B-X Vapor was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization as mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products, identified as newly deemed tobacco products subject to FDA jurisdiction since August 2016, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements, specifically lacking the necessary marketing authorization order under section 910 of the Act. The violation was identified through FDA review of the company's website, which listed e-liquid products offered for sale or distribution in the United States.