FDA Issues Injunction Against BioAnue Laboratories

FDA-Issues-Injunction-Against-BioAnue-LaboratoriesA federal court order demands that BioAnue Laboratories of Rochelle, Georgia stops illegally marketing its products as treatments for disease, the U.S. Food and Drug Administration (FDA) announced on its website. The court order, which was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia, says that BioAnue’s products were sold as supplements but were illegally marketed as treatments for conditions such as cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease and diabetes. The FDA did not approve these products for those uses.

In February 2012, the FDA issued a warning letter involving the marketing of the company’s dietary supplements as unapproved new drugs. The firm did not take corrective action following this letter, the FDA said. Additionally, the agency conducted a follow-up inspection in August 2012 and found that BioAnue was manufacturing products in a manner that was not compliant with the FDA’s current good manufacturing practice requirements for dietary supplements.

BioAnue is prohibited from manufacturing or distributing products until independent experts are hired to help bring the practices into compliance with current law. The government has evidence that the company sold unapproved new drugs and failed to follow regulations, said District Judge Marc T. Treadwell. “The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,” said associate commissioner for the FDA’s Office of Regulatory Affairs Melinda Plaisier. “This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.”

BioAnue 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.

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