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

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."