Benecol, a cholesterol-reducing margarine, looks like the first big test case. Developed in Finland, Benecol has been a commercial and clinical success overseas. McNeil Consumer Products, makers of Benecol, hoped to introduce the product throughout the U.S. in January but ran into a stern warning from FDA, delaying the product's rollout. "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," said FDA deputy commissioner for policy Bill Schultz, commenting on the issue. McNeil insists Benecol is not a food and voluntarily submitted a comprehensive set of safety information to FDA. The two sides agreed to meet to discuss the marketing of Benecol. The result of these discussions is likely to have significant repercussions for the dozens of functional foods in the pipeline. Food industry groups hope to work with FDA on this issue.
Labeling foods of the future
"Functional" foods are poised to become the hottest trend in food marketing, but labeling remains an unresolved issue. The Food and Drug Administration says it is working on regulations for these loosely defined products that claim to offer a health benefit beyond basic nutrition, but offers no timetable.