Functional foods promise a lot. There's breakfast cereal with probiotics for gut health, energy drinks that'll help you stay up all night, and orange juice that will lower your cholesterol. But critics warn that this burgeoning field is in danger of becoming dysfunctional without regulation about what claims can be made and under what circumstances.
The U.S. Food and Drug Administration will hold a public hearing Dec. 5 in Washington, D.C., to determine what role, if any, the agency should play in defining and regulating functional foods.
According to the docket published in the Federal Register, the Federal Food, Drug and Cosmetic Act defines dietary supplement but not conventional food or functional food. "We regulate conventional foods being marketed as 'functional foods' under the same regulatory framework as other conventional foods," FDA officials stated in the docket, also noting that the agency has established regulations on food fortification, health claims and dietary supplements.
Mounting pressure from watchdog groups such as the Center for Science in the Public Interest and even the government's own accounting office has convinced the FDA that it must address the issue of functional foods. "Although we are confident that the existing provisions of the act are adequate to ensure that conventional foods being marketed as 'functional foods' are safe and lawful, we believe that it would be in the best interest of public health to begin a dialogue with industry, consumers and other stakeholders regarding the regulation of these products," the FDA docket said. "For the purpose of this hearing, we are not considering dietary supplements to be encompassed by the term 'functional foods.'"
In July 2000, the General Accounting Office (now the Government Accountability Office) recommended that functional foods carry disclaimers on labels, similar to those on dietary supplements. It also wanted manufacturers of functional foods to notify the FDA about the safety of the ingredients in their products as well as any structure/function claims they make. Currently, any structure/function claims unrelated to the food's taste, aroma or nutritive value make the product a drug, according to the FDA.
In a 2005 report, the Institute of Food Technologists, an international nonprofit scientific group based in Chicago, said this requirement is too restrictive and that label claims should be allowed based on either nutritive value or "the provision of a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for plausibility."
The IFT also recommended, however, that any label claims regarding the effects of functional foods first be evaluated by a panel of independent experts. The group also said the government should provide incentives, such as market exclusivity, for companies to research functional foods. IFT even suggested a definition of functional foods: those "that provide a health benefit beyond basic nutrition [for the intended population]."
And CSPI, in its November Nutrition Action Health Letter, lambastes mangosteen, noni and pomegranate juices for making fantastic health claims, like those on POM Wonderful suggesting that consumers who drink it can "Cheat Death," or fight "heart disease, premature aging, Alzheimer's, even cancer." CSPI's article says these superfruits don't have enough science behind them to back such claims. The so-called food police petitioned the government in 2002 to address several issues, such as the use of novel ingredients in food.
Anyone wishing to make an oral presentation at the FDA public hearing must submit a notice of participation by Nov. 14. All other interested parties must submit a notice of participation by Nov. 28. Those wishing to submit written or electronic comments may do so until Jan. 5, 2007. The full text of the announcement of the public hearing and all its supporting documentation is available at www.cfsan.fda.gov/~lrd/fr061025.html.