Cholestin Makers Battle FDA

Agency Wants Product Clasified As Drug

LOS ANGELES, Posted 7:13 p.m. February 5, 1999 -- The makers of the popular cholesterol-reducing product Cholestin is at odds with the Food And Drug Administration.

About 58 million Americans have high cholesterol and CBS 2 News reports many of them might choose to buy Cholestin from a local drug store at about one-tenth the cost of prescription medications.

After reviewing a study sponsored by Cholestin's manufacturers showing the product significantly reduces the amount of bad cholesterol in those who took it, the FDA says the product is a drug and, therefore, should be regulated by the agency.

According to CBS 2 News, Cholestin contains an ingredient found in Chinese rice. This same ingredient is also found in the popular high-cholesterol medication Mevacor.

In the University of California, Los Angeles study, volunteers took two Cholestin capsules twice a day. After 12 weeks, those taking the placebo lowered their cholesterol by only 1 percent. Volunteers taking the real Cholestin dropped their cholesterol by 22 percent. Similar prescription drugs lowered cholesterol by 17 percent.

A spokesperson for Pharmanex Inc., the makers of Cholestin, told CBS he will fight the FDA.

"People have been taking garlic for cholesterol. They've been taking Niacin for cholesterol for decades. This is no different," Bill McGlashen said in a phone interview.

The issue is now in the courts, reports CBS 2 News.

Compiled by Internet Broadcasting Systems Staff