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FDA warning letter

This article was originally published in The Rose Sheet

Executive Summary

Claims that Tedco soaps and moisturizing products can treat various diseases including AIDS, bronchitis, cancer, herpes, lupus and ulcers makes them new drugs as defined in the FD&C Act, FDA states in a warning letter to the West Monroe, La. company. "There is no substantial evidence that these are generally recognized as safe and effective" and they may not be legally marketed as drugs in the U.S. without approved new drug applications, the agency says. The July 18 letter cites four Tedco products: Miracle II Soap, Neutralizer, Neutralizer Gel and Skin Moisturizer. The products are sold through a catalog and Web site, miracleii.biz. Tedco says it has no direct connection with the Web site and notes the disease claims were testimonials posted by customers who have used the products...
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