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FDA: Minnesota Companies Agree to Halt Sale of Amino-acid Products with Unapproved Claims
Date:9/14/2011

SILVER SPRING, Md., Sept. 14, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that two 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 are met.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

West Duluth Distribution Co., a corporation doing business as CHK Nutrition, and NeuroResearch Clinics Inc., both of Duluth, Minn., and their owners or principals, signed a consent decree of permanent injunction, which was entered by the U.S. District Court for the District of Minnesota on September 13.

The complaint for permanent injunction alleges that the companies violated the Federal Food, Drug and Cosmetic Act. As alleged in the complaint, CHK Nutrition's amino-acid products are marketed with claims that they may cure, mitigate, or treat diseases. The products are not the subject of approved new drug applications nor do they qualify for exemption from the premarket approval process as investigational new drugs. Therefore, the amino-acid products are unapproved new drugs within the meaning of the Act.

The consent decree prohibits the defendants from distributing any of their amino-acid products into interstate commerce unless and until they remove the drug claims from their websites. The defendants also agreed to hire an expert to review the claims they make for their products and certify that they have omitted all violative claims. Under the decree, FDA can order the defendants to stop distributing their amino-acid products if they fail to comply with the Act or the terms of the decree.  

"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 trea
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SOURCE U.S. Food and Drug Administration
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