The case involving Cholestin, a red yeast product from China, had been closely watched as potentially defining when dietary supplements cross the line into medicine.
But the Food and Drug Administration ruled Wednesday that Cholestin never was a dietary supplement -- because it contains the same ingredient as the powerful prescription anti-cholesterol drug Mevacor.
As such, Cholestin violates federal law forbidding companies to sell products that mimic prescription drugs simply by calling them "natural," said FDA Deputy Commissioner William Schultz.
Manufacturer Pharmanex Inc. vehemently denies Cholestin is a drug, and is challenging the FDA's ruling. A hearing is set for June 15 in U.S. District Court in Salt Lake City.
"We're very confident that our case is absolutely solid," said Pharmanex President Bill McGlashan, arguing that Cholestin merely is a supplement version of red yeast rice, a common Chinese food ingredient.
The FDA won't demand that existing Cholestin supplies be pulled from store shelves, because it's not dangerous. But the FDA will block imports of Pharmanex's ingredient so that, unless a federal judge overturns the decision, supplies will run out, Schultz said.
Consumer advocates welcomed the ruling.
"Certainly this is a signal to the dietary supplement industry that the FDA is trying to draw the line between drugs and supplements," said Bruce Silverglade of Center for Science in the Public Interest. "This is an important test case."
But it comes amid renewed public interest: A Pharmanex-funded study of 83 patients at the University of California, Los Angeles, recently suggested Cholestin with a low-fat diet might help modestly lower cholesterol.
Consumers buy some $5 billion worth of dietary supplements each year, pills, capsules and teas that are not FDA-approved as safe and effective. Congress in 1994 set two major conditions:
FDA-approved drug ingredients cannot also be sold as dietary supplements unless they were sold as a supplement or food prior to the drug's approval.
Supplements may advertise only general aid, such as that Vitamin C is important for a healthy immune system, but may not claim to fight disease.
The Cholestin saga began 14 months ago, when Pharmanex advertised nationally a supplement to lower cholesterol. The company said it was not targeting heart disease patients they need a doctor's care but some 58 million Americans whose cholesterol levels are 200 to 240. That's moderately high, but most doctors don't yet prescribe medication unless patients have other risk factors.
Because lowering cholesterol is key to fighting heart disease, the FDA considered that a drug claim. So Pharmanex now advertises ony that Cholestin promotes healthy cholesterol, which is legal, McGlashan said.
But FDA was more concerned that Cholestin contains the powerful, albeit natural, lovastatin the key ingredient of Merck Inc.'s blockbuster anti-cholesterol drug Mevacor.
Cholestin is red yeast rice that happens to contain lovastatin, Pharmanex argued. It meets federal law because red yeast rice was sold here as a food since 1931, thus predating Mevacor, McGlashan said. Cholestin contains very little lovastatin, and is not the only such food -- oyster mushrooms contain more, he added.
"If I encapsulated oyster mushrooms, would that make them a drug?" he asked.
Schultz responded that FDA took 33 samples of various red yeast rice sold nationwide as flavoring agent for Chinese food. Thirty contained no lovastatin; the others contained much less than Cholestin.
"They have essentially in their manufacturing process created a product that has significant amounts of lovastatin in it," and thus make a drug, he said.
Written by Lauran Neergaard
©1998 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed