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DSHEA not intended to "undermine" drug regulatory regime, Merck tells FDA.

This article was originally published in The Tan Sheet

Executive Summary

DSHEA NOT INTENDED TO "UNDERMINE" DRUG REGULATORY REGIME, Merck asserts in comments to FDA on the regulatory status of Cholestin. In opposition to claims by Pharmanex that Cholestin is marketed squarely within the Dietary Supplement Health & Education Act as a dietary supplement, Merck declares the law "was not designed to undermine the drug regulatory regime (with its incentives and protections to develop new drugs, including orphan drugs), by giving rise to an unregulated generic drug market for `dietary ingredients.'"
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