FDA Restricts Distribution of Amino-Acid Products
Written by Faith Anderson on September 16, 2011
FDA Inspections Turn up Violations
In July 2010, the FDA conducted an inspection of CHK Nutrition and NeuroResearch Clinics, during which an FDA investigator observed evidence of CHK Nutrition marketing its products with claims that such products are effective treatments for “neurotransmitter diseases.” In September 2010, the FDA reviewed CHK Nutrition’s website and observed a link to NeuroResearch Clinics’ website containing discussions about “amino-acid therapy” for the treatment of Alzheimer’s disease, depression, Parkinson’s disease, attention-deficit hyperactivity disorder, obsessive-compulsive disorder, fibromyalgia, and other unapproved uses.
The Minnesota companies failed to comply with FDA warnings to stop making unapproved drug claims. Upon conducting a follow-up review of the companies’ websites in February 2011, the FDA found an ongoing connection between the sale of CHK Nutrition’s products and claims that they can be used to treat diseases. The FDA believes that, unless restricted by a court, CHK Nutrition and NeuroResearch Clinics would continue to violate the law.
Companies Restricted from Distributing Amino-Acid Products
The consent decree signed by the companies prohibits them from distributing any of their amino-acid products into interstate commerce unless they remove the drug claims from their websites. The Minnesota companies also agreed to hire an expert to review the claims they make for their products and to ensure that they have removed all claims in violation of the Act. Under the decree, the FDA can order the defendants to stop distributing their amino-acid products if they fail to comply with the terms of the decree or the Act. “By ensuring that CHK Nutrition and NeuroResearch can’t distribute these unapproved products, FDA is helping to prevent health risks for consumers that might take these drugs or delay other important treatment,” stated Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Until these companies meet FDA requirements, they will no longer be able to process or distribute their products.”