Pharmanex wins round two

Overturning a 1998 FDA ruling, a Salt Lake City, UT, judge has ruled that Pharmanex's Cholestin is a dietary supplement, not a drug, and is therefore not subject to FDA approval and regulation. Cholestin is a cholesterol-reducing compound made from red rice yeast, a traditional Chinese medical remedy that is also one of the active ingredients in Merck's (Whitehouse Station, NJ) cholesterol-lowering drug, Mevacor. Last year, FDA deemed Cholestin a drug, demanded its removal from market, and banned import of its active ingredient from China. FDA's action and current ruling is the first legal challenge to the 1994 Dietary Supplement Health and Education Act, which loosely distinguishes drugs and dietary supplements (Nat. Biotechnol. 16, 728), and allows unprecedented claims to be made about the ability of a food or dietary supplement to affect the body's "structure and/or function." FDA, which is reviewing the decision, declined comment.

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Brower, V. Pharmanex wins round two. Nat Biotechnol 17, 316 (1999).

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