IGMPI India

Dietary supplement manufacturer, BioAnue Laboratories of Rochelle, Georgia, is under a federal court order to cease the illegal marketing of its products as treatments for medical conditions like cancer, HIV/AIDS and heart disease. The company is enjoined from selling products until it complies with FDA cGMPs (current Good Manufacturing Practices) for dietary supplements and other requirements.

BioAnues products were sold as supplements but were, in fact, unapproved new drugs since they were marketed as treatments for conditions such as cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease (COPD), and diabetes, without having received approval from the FDA. Federal law prohibits dietary supplement firms from making so-called disease claims—that products diagnose, cure, mitigate, treat, or prevent disease. Such medical claims require prior approval from FDA, and the agency treats unauthorized claims as the marketing of an unapproved new drug.

FDA issued a warning letter to BioAnue Laboratories on Feb. 9, 2012, but the company failed to take corrective action in response to it, and a subsequent inspection revealed the firm was manufacturing products that were out of compliance with cGMPs. The firm ignored previous FDA warnings, continued to produce and promote products with unproven claims, and ignored good manufacturing practices.