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In Brief: Consummated Productivity

This article was originally published in The Tan Sheet

Executive Summary

Consummated Productivity: Firm receives Dec. 9 FDA warning letter stating that marketing materials for the Edison, N.J.-based company's Bio Normalizer ginseng capsules make unapproved new drug claims implying the product treats "fatal viral infection and advanced cancer" and "prevents spread and metastasis of illness." The product is misbranded, the agency declares, in that it bears inadequate directions and the unsubstantiated suggestion that ginseng capsules are safe and effective for the labeled uses. FDA notes it also has reviewed a testimonial letter and promotional brochures including claims such as "insulin dependent diabetes (type 1) and in children with chronic virus hepatitis B and hepatitis C," "chronic respiratory failure due to pulmonary tuberculosis" and "abstinence-induced oxidative stress in alcoholics is improved by Bio Normalizer"...
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