FDA cracks down on violators of dietary supplement regulations

 SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations. 

A federal judge granted the FDA a permanent injunction against Truman Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.

Berst marketed the products on his website as alternative herbal medicine for such serious disease conditions as cataracts, viral and bacterial infections, and cancer. Under the Federal Food, Drug and Cosmetic Act, a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. Berst’s products are drugs that have not been approved by FDA for their claimed uses, the FDA noted.

“This company has ignored previous FDA warnings, and has continued to produce and distribute products in violation of federal law,” stated Melinda Plaisier, FDA’s acting associate commissioner for regulatory affairs. “The FDA continues to protect public health by seeking enforcement action against companies that are identified as violating our manufacturing and drug approval requirements.”

The FDA sought the injunction after Berst failed to comply with previous warnings, continuing to market products in violation of federal law. Berst is appealing the injunction with the 9th Circuit Court of Appeals, the FDA reported. 

And FDA secured a cease-and-desist agreement from Venus Pharmaceuticals International of Hauppauge, N.Y. Venus CEO Bharat Kakumanu has agreed to stop production and distribution of dietary supplements into U.S. commerce, and to recall and destroy affected product produced prior to January 2012, due to repeated violations of current good manufacturing practice regulations. In addition, the firm is prohibited from exporting products unless such activity is in compliance with FDA laws and regulations.

“When a company violates public health protections, they put consumers at risk,” Plaisier said. “Our goal at the FDA is to ensure that consumers have access to dietary supplements that meet good manufacturing practices, so that the products do not harm consumers.”

As part of the consent decree, the company must implement a series of corrective actions before it can resume production of dietary supplements. The actions include changing procedures for manufacturing, packaging and labeling dietary supplements so that they meet FDA requirements. In addition, the company must hire an outside auditor to oversee and review progress in implementing the needed changes.