The Food and Drug Administration announced plans yesterday to allow foods containing soy protein to carry labels that state it can help cut the risk for heart disease.
The health claim authorization, which goes into effect Tuesday, makes soy protein the 11th food for which companies have received FDA authorization to tout health benefits.
According to the FDA, low-fat, low-cholesterol foods that contain 6.25 grams per serving of soy protein can carry labels stating it can help reduce the risk of heart disease. Scientific studies show that it takes about 25 grams of soy protein--or roughly four servings daily of these foods--to produce a significant reduction in blood cholesterol levels.
How much cholesterol can be lowered is not stated in the health claim. But Susan Pilch, team leader for nutrition dietary supplements and health claims at the FDA, said that those who consume 25 grams of soy protein a day "may be looking at a 5 to 10 percent reduction" in total cholesterol and low density lipoprotein (LDL), the so-called "bad" cholesterol.
Among the foods eligible to carry the new health claims are soy-based beverages, such as Ensure and Sustacal; tofu; tempeh; soy-based meat alternatives such as burgers and "hot dogs" and some baked goods.
The request for the health claim was filed by Protein Technologies International Inc. on May 4, 1998. The FDA published the health claim as a proposal rule on Nov. 11, 1998. About 130 public comments were filed to the agency from a variety of consumer groups, trade associations, companies, physicians and researchers. Nearly all supported the health claim, Pilch said.
But some consumer groups worry that the health claim will be misused by food companies and misinterpreted by the public. Some studies suggest that the best cholesterol-lowering benefits are achieved when soy foods also contain isoflavones, weak, estrogen-like substances made by plants. The way soy is processed can greatly reduce the amount of isoflavones present. Food labels are not required to include the amount of isoflavones.
"Some health claims can steer people in the direction of healthy diets," said Bonnie Liebman, director of nutrition for the Center for Science in the Public Interest, a Washington-based consumer group. "But I am concerned that some companies may be able to exaggerate the benefits of their foods."
Until research answers the isoflavone question, the best bet for consumers, Liebman said, "is to play it safe by eating soy protein in its most natural form. Tofu is one way. Some powders and drinks and some foods like soy-based breakfast links would be others."