Functional Food Labeling Gets An FDA Hearing

Consumer groups, trade groups and individuals weighed in on the labeling of functional foods at an FDA hearing yesterday.

The FDA will continue to take written comments until Jan. 5, said Barbara Schneeman, director of the FDA's Office of Nutrition. At that point, the agency will review and decide what action, if any, is necessary.

Functional foods are those that promise a health benefit. Energy drinks, chocolate bars and carbonated teas are among them. Earlier, the agency issued a rare warning letter to Mars, maker of CocoaVia chocolate bars that it says have "real heart benefits." The FDA called the claim "false and misleading" because the bars also include "high levels of saturated fat."

At the hearing, the FDA heard at length from two groups representing opposing views: The Institute of Food Technologists--a nonprofit scientific organization for those working in the food industry, academia and government--and the Center for Science in the Public Interest, which has long advocated for nutrition and health, food safety, alcohol policy, and sound science.

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Bruce Silverglad, CSPI legal affairs director, bluntly said the so-called functional foods "would more aptly [be] named dysfunctional foods. Many 'energy' drinks, for example, primarily consist of water, sugar and caffeine. But the food industry is pressuring the Bush Administration to extend already weak standards for dietary supplement ingredients and label claims to these newfangled products. That approach would make functional foods, a potentially useful idea, about as dependable as 19th-century snake oil."

CSPI noted that although the U.S. Government Accountability Office recommended in 2000 that the FDA require manufacturers to place warning labels on some products, the agency has implemented none of the GAO's recommendations.

The GAO has estimated that functional-food sales will reach $49 billion by 2010, up from $16.2 billion in 1999.

"When the FDA has warned companies, such as the makers of Mars candy and Arizona Iced Tea, that they were violating the law, the firms largely ignored the agency and have continued to market their products," said CSPI senior staff attorney Ilene Ringel Heller, who also testified. "To ensure safety and effectiveness, companies should be required to notify the FDA before adding novel ingredients to foods for purported health benefits," said Heller.

But Pat Verduin, senior vice president and chief science officer at the Grocery Manufacturers Association/Food Products Association, said current laws already mandate that ingredients used to make any food, "including those that bear health, or structure-function claims, must be approved food additives, or Generally Recognized as Safe (GRAS). This would include any novel or unique ingredients being incorporated into foods for functional benefits.

"It is important to also note that under current law, any claim used in marketing and labeling must be truthful, not misleading and substantiated. If a claim is false, misleading or unsubstantiated, current FDA and FTC policy calls for appropriate sanctions to be enforced."

Among the FDA's options, Schneeman said, are to take no action, to reconfigure the framework within it operates regarding functional foods or to provide guidance to marketers of functional foods.

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