September 14, 2011
WASHINGTONFDA reported two Duluth, Minnesota companies have agreed to halt distribution of amino-acid products marketed to treat a number of diseases, until requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) are met. West Duluth Distribution Co. (dba CHK Nutrition) and NeuroResearch Clinics Inc., as well as their owners or principals, signed a consent decree of permanent injunction related to allegations the amino acid products featured claims for treating, curing or mitigating disease.
Under terms of the consent decree, the defendants are basically restricted from distributing any of their amino-acid products into interstate commerce until they remove the drug claims from their websites. The companies also must hire an expert to review the claims they make for their products and certify that they are free of all violative claims. Further, FDA can order the defendants to stop distributing their amino-acid products if they fail to comply with FDCA or the terms of the decree.
"By ensuring that CHK Nutrition and NeuroResearch cant distribute these unapproved products, FDA is helping to prevent health risks for consumers that might take these drugs or delay other important treatments, said Dara A. Corrigan, associate commissioner for regulatory affairs at FDA. Until these companies meet FDA requirements, they will no longer be able to process or distribute their products."
During a July 2010 inspection CHK Nutrition and NeuroResearch Clinic, FDA discovered the coordination of CHK Nutrition product sales included claims the products are effective treatments for neurotransmitter diseases. Then in September that same year, FDA found the CHK Nutrition website linked to NeuroResearch Clinics website, which contained multiple statements about amino-acid therapy for the treatment of various diseases, including Parkinsons disease, Alzheimers disease, depression, obsessive-compulsive disorder, attention-deficit hyperactivity disorder and fibromyalgia.
The agency sent a warning to the companies about the unapproved drug claims, but both companies failed to heed the warnings. An early 2011 follow-up review of the same websites revealed the same links between CHK products and claims such products can treat diseases. FDA said it believes the companies will continue to violate the law unless the courts step in.
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