The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Truman Berst who sells, as Alternative Health & Herbs Remedies, herbs and dietary supplements with disease-treatment claims. A federal court in Oregon determined in September 2012 that Berst had violated federal law by claiming that the company’s herbal tinctures, capsules, topical products, eyewashes, and compresses could address serious diseases, such as cataracts, viral and bacterial infections, and cancer. According to an FDA spokesperson, “This company has ignored previous FDA warnings and has continued to produce and distribute products in violation of federal law. The FDA continues to protect public health by seeking enforcement action against companies that are identified as violating our manufacturing and drug approval requirements.”
FDA had apparently warned the company as early as 2004 that its products were being distributed as unapproved and misbranded drugs. According to an agency press release, Berst has taken an appeal from the injunction to the Ninth Circuit Court of Appeals.
In a related development, Venus Pharmaceuticals International, Inc. and its CEO Bharat Kakumanu have agreed to cease producing and distributing dietary supplements in the United States, and to recall and destroy products made before January 2012, according to the terms of a consent decree approved by a federal court in New York. FDA accused the company of repeatedly violating current good manufacturing practice regulations thus rendering its products adulterated under the FFDCA. The company will also be required to implement corrective actions before it can resume dietary supplement production and must hire an outside auditor to oversee and review its progress in implementing the required changes. See FDA Press Releases, October 25, 2012.