By Nanci Hellmich
USA Today, Oct. 30, 2002
The maker of a new cholesterol-lowering margarine said Thursday that it will launch the product next week as planned, despite federal officials’ warning that the margarine is illegal.
The Food and Drug Administration said it could seize the product from stores or take the company to court if the margarine shows up on market shelves.
Still, McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, plans to launch its longawaited Benecol in Portland, Ore., next Wednesday and go national the first week of January.
Company spokesman Ron Schmid says Benecol is a “dietary supplement in food form,” and “it fully complies with the laws regarding the safety of dietary supplements.”
But in a letter to the company dated Wednesday, the FDA said the product is not a dietary supplement but a food that contains an “unapproved food additive.”
The agency occasionally sends out such letters, but usually they are directed at products already on the market.
Benecol, which has been sold in Finland since 1995, contains plant components called stanol esters that are made from wood pulp extracts.
These plant components which are not absorbed by the body, reduce cholesterol levels by inhibiting cholesterol absorption in the intestine, scientists say.
Clinical studies on Benecol showed that when people ate three pats of the margarine a day, their LDL (“bad” cholesterol) levels dropped by 14% to 15% and their total cholesterol fell by 10%.
William Schultz of the FDA said the agency is concerned because “this ingredient has not been marketed in a food in this country, as far as we know.”
He said the agency is not sure whether plant stanol esters should be classified as a food additive or a drug, but either one must have FDA approval
“FDA made the right decision,” said Bruce Silverglade, lawyer with the Center for Science in the Public Interest, a Washington-based consumer group.
But, he said, “if McNeil disregards the FDA warning, the matter could be tied up in court for years. It remains to be seen whether the product would stay on store shelves during that time.”
Schmid said the company will work with the FDA to resolve issues.
But for now, he said, the marketing plan will proceed.