Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter
FDA CGMP, dietary supplement marketing, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, manufacturing practices, permanent injunction, Structure-Function Claims, Warning Letters
On August 8, 2014, the U.S. Food and Drug Administration ("FDA") obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In addition to purported manufacturing deficiencies, the Company, BioAnue, sold dietary supplements that were marketed as treatments for common diseases, causing the FDA to deem these products to be unapproved new drugs. The FDA’s announcement can be found here. BioAnue received a warning letter from the…