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  Court Reverses FDA Decision to Ban Import of Red Yeast Rice Product CholestinT

June 17, 1998: Boulder, CO. In a stunning victory for the natural products industry and consumers, the Federal District Court of Utah decided that Simi, CA-based Pharmanex, Inc. may continue importing red yeast rice (Monascus purpureus) for manufacture of its popular dietary supplement, Cholestin.T In a preliminary decision, Judge Dale Kimball upheld the original classification of CholestinT as a dietary supplement, rather than a drug as the FDA asserted in September 1997.

This court ruling is in accord with structure/function claims made by Pharmanex that CholestinT promotes healthy cholesterol balance. Over 20 clinical trials have demonstrated that the red yeast contained in CholestinT reduces total cholesterol levels by an average of 25 to 40 points in eight weeks. It decreases harmful levels of low density lipoprotein (LDL) and triglycerides while increasing healthful high density lipoproteins (HDL). Red yeast fermented on rice has been used for more than 2,000 years as a traditional Chinese health food.

Pharmanex President Bill McGlashan is "thrilled" by the court's decision to uphold the Dietary Health and Supplement Act (DSHEA) of 1994, granting consumers continued access to safe and cost-effective natural products. Herb Research Foundation President Rob McCaleb commented, "The FDA, acting on a complaint from a drug company, tried to ban a safe, natural product that can help millions. The court has upheld in thispreliminary ruling, what DSHEA created: the ability to label supplements with truthful claims describing health benefits."

On May 20, 1998 the FDA announced its intent to ban Pharmanex's import of red yeast rice from China, stating that the naturally-occurring compound mevinolin contained in this product was indistinguishable from lovastatin, the purified active compound in Merck's prescription drug Mevacor.T For the past month, natural products industry experts have been voicing concerns about the FDA's interpretation of DSHEA. The Council for Responsible Nutrition and other groups consider the CholestinT case a major industry issue, because the FDA was seekiong to regulate a supplement as a drug because it contained a single chemical similar to one found in a drug. After carefully reviewing the
scientific, legal, and medical information about CholestinT, Judge Kimball found no safety issues or illegal labeling claims that would justify denying the public access to Cholestin.T

-- Krista Morien, HRF
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