FDA takes action against Georgia dietary supplement manufacturer
August 25, 2014 - A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments
for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug
Administration's manufacturing regulations and other requirements. A federal judge issued the injunction
against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber.
BioAnue's products were sold as supplements but were unapproved new drugs because they were marketed as treatments
for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes,
without approval from the FDA, according to the court order. The order was signed on July 23, 2014 in the
United States District Court for the Middle District of Georgia.
The defendants did not 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. A follow-up FDA inspection in August 2012
revealed that BioAnue was also manufacturing products that were not in compliance with FDA's current good manufacturing practice requirements for
dietary supplements.
The permanent injunction prohibits the manufacture or distribution of products until the defendants hire independent experts to assist in bringing
the firm's manufacturing practices and labeling into compliance with the law.
District Judge Marc T. Treadwell said, in the court order, that the government was able to provide evidence that the defendants sold unapproved new
drugs and failed to follow FDA's current good manufacturing practice regulations for dietary supplements.
"The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases," said Melinda Plaisier, associate
commissioner for the FDA's Office of Regulatory Affairs. "This firm has ignored previous FDA warnings, continued to produce and promote products
with unproven claims and ignored good manufacturing practices."
The defendants' 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security
of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety
and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco
products.
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Source: U.S. Food and Drug Administration
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