A cholesterol reducing margarine, created in Finland and derived from wood pulp extracts, is poised to make it to store shelves in the United States in 1999. The margarine, Benecol, has been a huge success both commercially and clinically overseas, proving effective in lowering cholesterol by as much as 14 percent.
However, CBS News Correspondent Elizabeth Kaledin reports that the Food and Drug Administration has warned the manufacturer that the sale of the product is illegal, and may even seize the product from grocery shelves.
The issue concerning the FDA is not what Benecol 'does', but just what exactly Benecol 'is'.
"The company is marketing it as what's called a dietary supplement, and what we're saying is they need to market it as a food" says FDA Deputy Commissioner for Policy Bill Schultz.
It is a crucial distinction. Additives to foods are subjected to a lengthy and expensive FDA approval process as are the health claims they make, but dietary supplements such as vitamins, minerals and herbs remain largely unregulated.
In a statement issued today, McNeil Consumer Products, the makers of Benecol, insist their product is not a food and stress they have voluntarily submitted the most comprehensive safety package the FDA has ever received for a dietary supplement.
MacNeil had hoped to introduce Benecol in a test market later this week and nationwide in January. MacNeil's competitors have dozens of so-called functional foods such as the margarine in the pipeline, so consumer advocates say Benecol is an important test case for the FDA.
"This is the very first large company to try to sell a food product as a dietary supplement" says Bruce Silverdale with the Center for Science in the Public Interest. "Hopefully the FDA will require the company to prove that the ingredients are safe and the claims are valid".
The FDA and MacNeil have agreed to meet this week to discuss Benecol's future. Any decision will set a precedent in the growing struggle to regulate what some are dubbing the foods of the twenty-first century.
Reported By Elizabeth Kaledin