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FDA, Pharmanex debate status of Cholestin

Is Cholestin a dietary supplement or a drug?

In what many experts consider a pivotal debate within the industry, the Food & Drug Administration has declared Cholestin, marketed as a dietary supplement that helps maintain healthy cholesterol levels, an unapproved drug. As such, it may not be sold in the United States, ruled the agency in a 30-page letter sent to its manufacturer, Pharmanex, on May 20.

The Simi Valley, Calif., firm has countered that its product, composed of red rice yeast, is a food product containing naturally occurring HMG-CoA reductase inhibitors that have been used for centuries in China. A hearing regarding the matter has been scheduled for June 15 in U.S. District Court in Salt Lake City.

The FDA said that it based its final decision on the fact that Cholestin contains lovastatin, an active ingredient in the prescription drug Mevacor, made by Merck to lower cholesterol.

"Under the terms of the federal Food, Drug & Cosmetic Act, as amended by the Dietary Supplement Health & Education Act (DSHEA) of 1994, Cholestin is not a dietary supplement because lovastatin was not 'marketed as a dietary supplement or food' before the FDA approved Mevacor as a drug," explained the agency. "The law is intended to maintain incentives for companies to establish the clinical safety and efficacy of drug products."

But Pharmanex argues that the product contains mevinolin, which, it says, is "different from the synthetically isolated purified, crystallized substance called lovastatin found in Merck's cholesterol-reducing drug." The same substance is also found in black oyster mushrooms, noted William McGlashan, president of Pharmanex.

As part of an extensive investigation to determine Cholestin's regulatory status, undercover FDA agents collected samples of red yeast rice and Cholestin from several stores and analyzed their contents. They determined that Cholestin's manufacturing process produced elevated levels of lovastatin, implying an intent to manufacture a drug.

Pharmanex argued that its manufacturing process is intended to standardize levels of mevinolin. "Pharmanex does not add, enhance, or maximize this natural constituent; it merely employs quality controls to ensure that consumers get the most consistent and highest-quality product."

The product first drew FDA scrutiny last year over its labeling claims, which implied that it lowers cholesterol and even mentioned lovastatin by name. The firm changed its labeling to comply with FDA regulations regarding dietary supplements and removed mention of lovastatin, but the agency continued to consider the product a drug. In November, the agency halted import of the red yeast rice from China but permitted sales of existing supplies in the estimated 35,000 stores that carry it. The product's safety does not appear to be at issue.

Now the matter has become a "content issue, not a claims issue," explained W. Patrick Noonan, Esq., Pharmanex consultant for regulatory affairs.

Merck said it is pleased with the FDA's ruling. "A drug such as Cholestin must be regulated to ensure that it is safe and effective for its intended uses and that medical professionals are fully informed of the benefits and risks associated with the product," said Tracy Stenn, Merck public affairs.

Cholestin, which costs about $25 a month, is targeted at the 28 million Americans with moderately elevated cholesterol counts. In comparison, prescription drugs can cost $72 a month.

Sen. Dianne Feinstein (D, Calif.), Sen. Tom Harkin (D, La.), and the Council for Responsible Nutrition (CRN) separately voiced their concerns with the FDA ruling. "CRN is very concerned about this FDA action, which could have implications for all standardized products," said Annette Dickinson, Ph.D., director of scientific and regulatory affairs at CRN. "We cannot accept the concept that subjecting a dietary supplement ingredient to quality-control procedures for the purpose of standardization transforms a complex mixture from a supplement into a single-entity drug product. We believe FDA is misinterpreting DSHEA in this action."

In other developments, Bionutrics, Phoenix, issued a statement that its dietary supplement, evolvE, which is formulated from rice bran oil to maintain cardiovascular health, was not affected by the decision.



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