Cholestin’s Regulatory History
For the past two years, the eyes of the entire dietary supplement industry have been focused on Cholestin’s landmark case with the FDA. The battle, one of David and Goliath proportions, pitted Pharmanex, maker of Cholestin, against the FDA. Industry observers and manufacturers alike followed Cholestin’s fate closely as it represented an example of what might happen to any dietary supplement making health claims with the support of quality science.
The FDA’s Position
The FDA maintained, and continues to maintain, that Cholestin is a drug on the basis that one of its beneficial, natural components, mevinolin, is chemically identical to lovastatin, active ingredient in Merck’s cholesterol-lowering prescription drug Mevacor®. The FDA claimed that under the terms of the Federal Food, Drug and Cosmetic Act and the Dietary Supplement Health and Education Act, Cholestin is not a dietary supplement because lovastatin was not marketed as a dietary supplement or food before FDA approved Mevacor as a drug. The FDA asserts that the law is intended to maintain incentives to establish the clinical safety and efficacy of drug products.
Pharmanex’s Position
Pharmanex contends that the naturally-occurring mixture of statins and other compounds in Cholestin is not comparable to Mevacor’s lovastatin, a synthetically isolated, purified and crystallized drug product.
The Cholestin Timeline
The following timeline tracks the dispute and the legal and regulatory rulings that resulted.
• April 1997: FDA informed Pharmanex that it considered Cholestin to be an unapproved drug.
• April 1997: Under pressure of litigation, Pharmanex filed a Notice of Voluntary Dismissal in order to pursue a dialogue with the FDA and, with the Court’s approval, the case was held in abeyance pending the FDA’s final decision.
• June 1997: The FDA filed a detention order preventing Pharmanex from importing red yeast rice, the raw material necessary to manufacture Cholestin.
• May 1998: The FDA issued its "Final Decision," ruling Cholestin a drug.
• June 1998: Pharmanex filed an Amended Complaint and Motion for Preliminary Injunction, requesting relief from the import ban and a ruling that the FDA decision is contrary to the law.
• June 1998: The Federal District Court of Utah decided that Cholestin is preliminarily declared a dietary supplement and not a drug, allowing Pharmanex to import a limited amount of red yeast rice pending a final ruling in the case.
• August 1998: Pharmanex filed a motion to hold unlawful and set aside the FDA’s decision of May 1998.
• February 1999: Federal District Judge Dale A. Kimball ruled that Cholestin is not a drug and may be legally sold as a dietary supplement.
• February 1999: Following the Federal District Court’s ruling, Pharmanex pulled all of its products, including Cholestin, off retail shelves. Pharmanex now provides products and product information via its Internet site and through a network of representatives and medical professionals on a toll-free telephone number.
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