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March 25, 1999
Web posted at: 4:30 p.m. EST (2130 GMT)

In this story: No set FDA policy for functional foods FDA approval not required for dietary supplements RELATED STORIES, SITES

(CNN) -- A consumer group Thursday called on the Food and Drug Administration (FDA) to tighten controls over foods that make unproven claims about the health benefits of added herbal medicines, amino acids, plant extracts and other unconventional ingredients.

The Center for Science in the Public Interest (CSPI) urged the agency to make sure all such ingredients are safe and label claims are valid.

These "functional foods" have drug-like ingredients added to increase the foods' health benefits. CSPI recognized that some functional foods do work. For example, calcium-fortified orange juice gives people who don't like to drink milk the equivalent amount of calcium found in a glass of milk.

No set FDA policy for functional foods

But CSPI contended, too many companies tout unproven ingredients and make misleading health claims. The group said the result is a confused consumer public that may come to doubt legitimate healing foods.

"While functional foods hold much promise, without effective regulation, they may merely become the snake oil of the next century," CSPI director Michael Jacobson wrote to FDA commissioner, Jane Henney.

Functional foods have grown into a booming industry. It is estimated companies will make $15 billion off them this year.

Even so, the FDA's food chief, Joseph Levitt, acknowledged the agency does not have a set policy on what foods qualify for this category.

Developing a policy is a top priority that the FDA hopes to complete this year, Levitt said. He also said this is "an area of enormous public interest" that will require setting boundaries.

Some food companies named in the CSPI's report were angry at the charges.

Kellogg's carrot cake was singled out for its claim that its ingredient psyllium is "a natural soluble fiber that actively works to promote heart health."

CSPI said the cake "contains too much fat to qualify for an FDA-approved heart-disease-prevention claim so the company merely claims it can 'promote heart health.'"

But Gene Grabowski of the Grocery Manufacturers of America, which represents brand-name manufacturers of functional foods, said the fact that Kellogg's carrot cake contains fat "does not negate the beneficial properties" of the psyllium fiber added to it.

"These are foods that have met scientific tests of safety and nutrition, and we think it's irresponsible to say they're bad," Grabowski said.

FDA approval not required for dietary supplements

The issue is complicated by a 1994 law passed by Congress saying dietary supplements can carry claims that a product may affect the structure or functioning of the body -- but not claims that they can treat, diagnose, cure or prevent a disease.

This raises the question of how to regulate food with dietary supplements added to them. While the FDA must declare new foods safe before they are marketed, Congress said dietary supplements may sell without FDA approval to assure they are safe or effective.

In December, the FDA did stop the sale of a functional food. The agency said McNeil Pharmaceuticals had to prove that its Benecol cholesterol-lowering margarine is safe before hits shelves.

McNeil said Benecol was not a new food, but rather a dietary supplement and therefore did not require FDA approval.

The FDA cited a law saying dietary supplements may not masquerade as foods. Benecol, made from an ingredient in trees, looks and tastes like regular margarine and would be sold in stores next to butter.

The manufacturer is now awaiting FDA approval.

The Associated Press and Reuters contributed to this report.