Federal Judge Bars Oregon Company from Sales of Herbs, Supplements
October 26, 2012
EUGENE, Ore. Alternative Health & Herbs Remedies, a self-described Christian group of natural health professionals run by Truman J. Berst, has been permanently enjoined from selling products represented as herbs and supplements with claims for treating diseases, the federal agency regulating the dietary supplement industry announced Thursday.
Michael R. Hogan, a federal judge in Eugene, Ore., last month granted the permanent injunction and ruled Berst violated U.S. law by distributing unapproved and misbranded drugs, according to FDA. Berst is appealing the ruling to the U.S. Court of Appeals for the 9th Circuit, the agency noted.
This company has ignored previous FDA warnings and has continued to produce and distribute products in violation of federal law," said Melinda Plaisier, FDAs acting associate commissioner for regulatory affairs, in a statement. The FDA continues to protect public health by seeking enforcement action against companies that are identified as violating our manufacturing and drug approval requirements."
On its website, Alternative Health & Herbs Remedies is characterized as "a non-profit Christian group of natural health professionals committed to helping ALL people to better health through God, healing, education and manufacturing the highest quality tried-and-proven herbal and natural health products."
Berst's products are promoted as alternative medicine for such disease conditions as cataracts, infections and cancer, but FDA said they are unapproved drugs since they are intended to diagnose, cure, mitigate, treat or prevent a disease. The injunction impacts a number of products, including herbal tinctures, capsules, topical products, eyewashes, and compresses with such names as Eyebright Leaf, Fennel Seed, Nerves, Trumans Hoxy Tumors BeGone and Bilberry Complex.
In a ruling Sept. 20, the court ordered Berst to cease distributing his products until all treatment claims are removed from his website, an expert reviews product claims and FDA authorizes the company to resume operations.
Berst has been on FDA's radar for several years. In December 2004, the agency announced that his company agreed to do a nationwide recall of eye rinse products after an FDA inspection of his facilities concluded manufacturing conditions and controls were insufficient to produce a sterile product.
A few months later, Berst received a letter cautioning him that his manufacturing facility was significantly deviating from current good manufacturing practice regulations. FDA sent yet another warning letter in January 2007, contending Berst's products were being marketed to treat diseases and therefore classified as unapproved drugs.
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