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Shijin Vapor, LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as tobacco products under FDA jurisdiction since August 2016, failed to comply with FD&C Act requirements mandating that "new tobacco products" obtain marketing authorization before commercial distribution in the United States. The FDA determined the products were being offered for sale without the legally required premarket approval.