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FDA: Cholesterol-lowering margarine needs approval


October 29, 1998
Web posted at: 8:24 p.m. EST (0124 GMT)

WASHINGTON (CNN) -- The U.S. Food and Drug Administration has issued a letter to the maker of the new so-called cholesterol-reducing margarine Benecol, advising that the product needs FDA approval before it can be marketed in the United States.

The company, Johnson & Johnson's McNeil Consumer Healthcare, had planned to start marketing the margarine to U.S. consumers next year. It had been trying to market the margarine as a "dietary supplement," which does not require approval.

But the FDA says the margarine is a food with an additive and therefore does require FDA approval. Products that make a health claim also require FDA approval.

A McNeil spokesman told CNN the company has received the FDA letter and is in the process of formulating a response.

The FDA approval process requires rigorous testing that can take years.

Benecol contains a food additive called sitostanol, a plant stanol ester that is thought to inhibit the absorption of LDL, the so-called "bad" cholesterol, into the bloodstream.

In studies, both Benecol and another stanol ester margarine, Unilever's Take Control, were found to lower cholesterol levels by about 10 percent in people with moderately high cholesterol.

The margarine is popular in Finland, where it was created by using byproducts from the country's logging industry.

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