FDA Letter OKs Benecol

The FDA has completed its safety review of plant stanol esters, the active ingredient in McNeil Consumer Healthcare's Benecol, a margarine that may have a beneficial effect on blood serum cholesterol levels. This action follows the Fort Washington, PA-based company's filing of supportive scientific information on both the product and its active ingredient and clears the way for marketing the margarine in the U.S.

Alan Rulis of the FDA center for food safety and applied nutrition said his agency is not endorsing the product or its claims. Instead, he said the FDA merely reviewed the testing done by McNeil and then sent a letter stating that the agency had no more questions about the safety of the product. The letter also said that the FDA "is not aware of any scientific evidence that plant stanol esters would be harmful."

Rulis cautioned, however, that the FDA "believes it would be both prudent and responsible for McNeil to continue to monitor, through scientific studies... consumers' dietary exposure to plant stanol esters...."

The agency letter also said that the company would not violate FDA labeling rules if its claims the margarine contains an ingredient that "helps promote healthy cholesterol levels."

The margarine containing the plant stanol ester was developed in Finland and has been sold there since 1995. McNeil bought the international marketing rights from the Finnish developer, The Raisio Group.

McNeil announced that the margarine will be sold in the United States under the brand name Benecol and should be stocked in grocery dairy cases by May 26. Two types of spreads will be offered: A regular with 45 calories and a light with 30 calories. A package containing 21 8-gm servings will retail for about $4.99.

This action takes place in the wake of the completion of a similar FDA review for T.J. Lipton's (Englewood, NJ) Take Control spread. Click here to see related article. (Click here to see related article). According to Lipton, that product is in heavy demand in New York and Chicago only two weeks after first arriving on store shelves.

"Shoppers are excited about the product," said John Fondakowski, store manager at the Arlington Heights, IL, Cub Foods store where the product sales are unusually brisk. "Take Control is selling about four times faster than a margarine or spread typically would."

The product is currently arriving in supermarkets nationwide.