After receiving comments from industry and consumer groups, FDA will decide whether there should be a regulatory definition of functional foods, and if so, what it should be. A public hearing in December solicited input from all parties.

Regulators said they will use that input to decide if there should be new labeling requirements. The Food Products Association’s (FPA) position is that no separate category or definition of functional foods is necessary.

 “Current statutory and regulatory provisions require that ingredients used in the formulation of any food, including those that bear health, or structure-function claims, must be approved food additives, or generally recognized as safe (GRAS), for the intended use,” said Pat Verduin, FPA senior vice president and chief science officer. “This would include any novel or unique ingredients being incorporated into foods for functional benefits.”

The Institute of Food Technologists (IFT), which advanced the concept of functional foods as a category in a 2005 report, advocated new regulatory guidelines to allow food marketers to describe products as functional foods, as long as product labels reflected current scientific evidence.

“Under existing regulatory policies, some food label claims cannot be factual and still accurately represent the science,” said IFT expert panel member Barbara Petersen. “This limits the scope and accuracy of consumer information and hinders the development and marketing of functional foods.”

Consumer groups testifying at the hearing were highly skeptical of the entire concept. The Center for Science in the Public Interest said while creating a functional foods category might prove useful to consumers in theory, it does not trust the industry or government regulators to make it beneficial in practice.

“The food industry is pressuring the Bush Administration to extend already weak standards for dietary supplement ingredients and label claims to these newfangled products,” said Bruce Silverglad, CSPI legal affairs director. “That approach would make functional foods, a potentially useful idea, about as dependable as 19th-century snake oil.”