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Lovastatin prior marketing as food or dietary supplement not demonstrated -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

LOVASTATIN PRIOR MARKETING AS FOOD OR DIETARY SUPPLEMENT has not been demonstrated, FDA Deputy Commissioner for Policy William Schultz tells Cholestin marketer Pharmanex in a May 20 letter. Describing the agency's basis for concluding Cholestin is an unapproved new drug, not a supplement, Schultz says Pharmanex has been unable to show the product's key lovastatin component "was marketed as a food or a dietary supplement before clinical investigations of [the ingredient] were made public, and before [it] was approved as a prescription drug."
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