Judge Marc T. Treadwell, of the United States District Court for the Middle District of Georgia has issued a permanent injunction against dietary supplement manufacturing company BioAnue Laboratories of Rochelle, GA and its owner/operators, Gloria and Kelly Raber, ordering them to stop illegally marketing its products as treatments for disease, and to terminate the sale of its products until the company complies with FDA manufacturing regulations and other requirements. The action signed July 23, 2014, came more than 2-years after the defendants “failed to take appropriate corrective action in response to a FDA warning letter issued on Feb. 9, 2012, involving the marketing of the firm’s dietary supplements as unapproved new drugs,” he stated.
A follow-up inspection conducted in August 2012 uncovered that BioAnue was also manufacturing products that were not in compliance with FDA’s current good manufacturing practice requirements for dietary supplements.”
“The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,” added FDA’s Office of Regulatory Affairs associate commissioner Melinda Plaisier. “This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.”
BioAnue Laboratories’s products include: TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage. Although marketed as “supplements,” representatives from the Food and Drug Administration contend they are actually “ unapproved new drugs because they were marketed as treatments for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes.”