FDA NEWS RELEASE
Federal judge grants permanent injunction against Oregon herb and supplement manufacturer
A federal judge has granted the U.S. Food and Drug Administration a permanent injunction against Truman J. 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 markets the products on his website, www.healthherbs.com, as alternative herbal medicine for serious disease conditions, such 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 which have not been approved by FDA for their claimed uses.
"This company has ignored previous FDA warnings and has continued to produce and distribute products in violation of federal law," said 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 products include herbal tinctures, capsules, topical products, eyewashes, and compresses, and have names such as Eyebright Leaf, Fennel Seed, Nerves, Truman's Hoxy Tumors BeGone, Bilberry Complex, Can Free, Skin Tumors, Antibiotic, Truman's Symplex Powder, and Black Salve.
U.S. District Judge Michael Hogan of the District of Oregon, Eugene Division, ruled on September 20, 2012, that Berst violated federal law by distributing unapproved and misbranded drugs. The court ordered, Berst to stop distributing his products until all treatment claims are removed from his website, an expert reviews the products claims, and the FDA authorizes resumption of operations. Under the order, the FDA may take action against Berst for failing to comply, including requiring him to stop product distribution and to recall products on the market.
The FDA sought an 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.
For more information:
Warning Letter, Jan. 16, 2007
Warning Letter, March 17, 2005
Eye rinse recall, Dec. 2, 2004
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is 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.
For Immediate Release: Oct. 25, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, [email protected]
Consumer Inquiries: 888-INFO-FDA