FDA to Block Benecol

McNeil Consumer Product's plans to sell Benecol may have hit a snag. The FDA has warned the company that selling the product as a dietary supplement instead of as a food subject to government approval violates the law. The agency has threatened to seize the product from store shelves.

Benecol is a margarine that contains sitostanol. Research indicates that the substance appears to help lower blood serum cholesterol. In Finland, where it was created, the product is a huge seller despite its premium price.

McNeil intends to market Benecol as a dietary supplement which would exempt it from FDA regulation by the Dietary Supplement Health and Education Act (DSHEA) of 1994. The FDA insists, however, that the product—a spread sold next to butter and regular margarine, as opposed to a pill—is a food. Not only that, it contains an ingredient never before sold in the United States.

"We don't actually know what [sitostanol] is," said FDA deputy commissioner William Schultz in an Associated Press report. "To assure the safety of the food supply, give FDA that data and let us look at it."

New food ingredients must either obtain FDA approval, or achieve GRAS (Generally Recognized as Safe) status. Sitostanol possesses neither, according to the agency. In addition, foods that advertise a health claim must have FDA approval of that claim.

To end the dispute, McNeil must give the FDA Finnish safety data and information from two studies that demonstrate Benecol's cholesterol lowering effect. The company insists, however, that the product meets Congress' definition of a dietary supplement.