WASHINGTON--A federal judge last month issued an injunction against a dietary supplement manufacturer that marketed products as treating such medical conditions as cancer, HIV/AIDS and heart disease, FDA announced Monday.
BioAnue Laboratories of Rochelle, Georgia is enjoined from selling products until the company complies with FDA cGMPs (current Good Manufacturing Practices) for dietary supplements and other requirements. The permanent injunction against BioAnue Laboratories and its operators Gloria and Kelly Raber prohibits the manufacture or distribution of products until the defendants retain independent experts to help bring the firm’s manufacturing practices and labeling into compliance with federal law.
Marc T. Treadwell, U.S. District Judge in the Middle District of Georgia, said the government furnished evidence the defendants sold unapproved new drugs and neglected to follow cGMPs for dietary supplements, FDA stated in a press release.
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.
On its website, the company disclosed the issuance of the injunction and noted it cannot sell supplements until FDA approves its product labeling and literature.
"We are currently working with a specialty lawyer in order to comply with this injunction," BioAnue Laboratories CEO Gloria Raber stated in the note to customers. “We are working diligently to get out approval from the FDA."
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, according to the agency.