FDA Halts Benecol Margarine Test- Marketing:
FDA has stymied Johnson & Johnson’s (JNJ) plans to test-market its new cholesterol-lowering margarine, Benecol. FDA asserts that Benecol is a food, not a dietary supplement, and thus must get FDA approval. JNJ argues that Benecol is exactly the type of product DSHEA was intended to cover. As a dietary supplement, Benecol could be sold immediately. Discussions to resolve the issue between FDA and JNJ’s McNeil Consumer Healthcare division were expected to begin the first week in November. JNJ is the U.S. partner of Raisio, the Finnish food company that developed Benecol. Meanwhile, Unilever’s (UN) Lipton subsidiary has developed its own cholesterol-lowering margarine product and says it will market it as part of its new Take Control product line.