The U.S. Food and Drug Administration (FDA) has taken action against Georgia-based BioAnue Laboratories, the agency announced in a news release issued August 25th.
The supplement manufacturer has been issued an injunction from a federal judge ordering the company to cease manufacturing and distributing products until independent reviewers are hired to ensure that manufacturing practices and labeling comply with current laws.
According to the FDA news release, BioAnue was marketing its supplement products as treatments for medical conditions, including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease and diabetes without approval. The order, which was signed on July 23, 2014 by District Judge Marc T.
Treadwell in the United States District Court for the Middle District of Georgia, said that these products were unapproved new drugs because they were touted as treatments without approval from the FDA.
The government showed that the BioAnue engaged in these actions and therefore failed to comply with the FDA’s current good manufacturing practice regulations for dietary supplements, said Judge Treadwell in the court order.
Products manufactured and distributed by BioAnue
Products manufactured and distributed by BioAnue include: TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage.
BioAnue failed to take appropriate corrective measures after the FDA issued a warning letter on February 9, 2012 regarding the improper marketing of supplements as unapproved new drugs.
To make matters worse, the agency discovered that the firm’s manufacturing practices were not in line with the FDA’s current good manufacturing practice requirements for dietary supplements.
Melinda Plaiser, associate commissioner for the FDA’s Office of Regulatory Affairs, said in the release “The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,”
“This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.” said Plaiser.