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FDA position on Cholestin violates "letter and spirit" of DSHEA, Pharmanex says.

This article was originally published in The Tan Sheet

Executive Summary

FDA POSITION ON CHOLESTIN VIOLATES "LETTER AND SPIRIT" OF DSHEA, Pharmanex maintains in a statement outlining its "preliminary" reaction to FDA's Sept. 30 letter on the product marketed as a dietary supplement. FDA's position "ignores the facts placed before the agency and appears designed to protect the market for pharmaceuticals approved for the treatment of cholesterol-related conditions -- without regard to Congress's framework for the regulation of dietary supplements" in the Dietary Supplement Health & Education Act, Pharmanex states. The company has not sent FDA a formal response.





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