FDA May Ban Benecol As Dietary Supplement

Johnson & Johnson's bid to market a lipid-lowering margarine based onRaisio of Finland's stanol ester ingredient in the USA has suffered a regulatory setback. J&J subsidiary McNeil Consumer Products was hoping to launch cholesterol-lowering spread products in an initial test market (Portland, Oregon) this month, with a full, nationwide introduction scheduled for the New Year.

McNeil planned to launch two Benecol-based margarine products at the beginning of the year, followed by a series of salad dressings shortly thereafter. A third product range is also scheduled for launch towards the end of 1999.

However, the US Food and Drug Administration sent a letter to McNeil noting that "it appears that the plant stanol esters (in Benecol) are an unapproved food additive that may not be used in conventional foods....therefore, considered as a food, the Benecol spread is adulterated under US law and cannot legally be marketed in the USA." The letter was sent to McNeil by Joseph Levitt, director of the FDA's Center for Food Safety and Applied Nutrition.