WASHINGTON -- The FDA filed a permanent injunction against two Minnesota companies that distributed amino acid products marketed as treatments for Parkinson's disease, Alzheimer's disease, and a number of other neurological disorders.
West Duluth Distribution subsidiaries CHK Nutrition and NeuroResearch Clinics were observed marketing amino acid products for the treatment of "neurotransmitter diseases" in July 2010 during an FDA inspection.
The products were also marketed as being useful in "amino-acid therapy" to treat Parkinson's disease, Alzheimer's disease, depression, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, fibromyalgia, and other conditions, according to a September 2010 review of the two companies' websites, the FDA said in a statement.
The FDA warned the two companies to stop making unapproved drug claims about the supplements, which the groups failed to do. A follow-up review of the companies' websites in February 2011 found persistent unverified medical claims about the offending products.
The injunction, filed on Sept. 13, prohibits the distribution of the amino acid products until the product claims are removed from the companies' websites and their removal is reviewed and cleared by an independent investigator. Should the subsidiaries fail to comply, the FDA can order the companies to stop all distribution of the advertised products.
"Until these companies meet FDA requirements, they will no longer be able to process or distribute their products," Dara Corrigan, the FDA's associate commissioner for regulatory affairs, said in the statement.
By Cole Petrochko, Associate Staff Writer, MedPage Today
Friday, September 23, 2011
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