FDA Permits Health Claims On Soyfoods
On Tuesday, October 26th, 1999, the U.S. Food & Drug Administration (FDA) put into effective a policy allowing food companies to link the heart disease-fighting properties of soybean protein. Soy Claims Now Allowable by the FDA Coronary heart disease (CHD) causes more deaths in the U.S. than any other disease. 2.5 grams of soy protein daily is required to show a significant cholesterol-lowering effect. Soy protein, combined with a diet low in saturated fat and cholesterol, may reduce the risk of CHD. Clinical trials show that consumption of soy protein, compared to those from milk, can lower total and LDL cholesterol. This sweeping change is historic in light of traditional attempts by the FDA to limit the health claims that food makers can make about their products -- in their literature, on their labels, and in their advertising -- even when the scientific community overwhelmingly supports such claims. The announcement marks the first time that the FDA has approved any health claim on soybeans. It is only the 11th health claim to clear FDA approval in the 1990's. (The best known is the claim that soluble fiber in whole oats lowers the risk of heart disease.) Virtually all of Lumen Foods' meat and milk replacement products easily meet the new requirements for the health claim, which is simply that the subject food must contain 6.25 grams of soy protein per serving, one fourth of the 25 grams of soy protein needed to show a significant cholesterol-lowering effect. (Actually the soy proteins sold by Lumen Foods go well beyond these requirements, with hefty levels of cancer-fighting isoflavones as shown in tests conducted on Lumen Foods products by Rutgers University's Center for Advanced Food Studies.)		A variety of food producers, many quite larger than Lumen Foods, are moving to take advantage of the FDA decision, Kellogg Co. reports that it is developing a cereal made from soybeans. (We already have one in our virtual store), and ConAgra, Inc., General Mills, Inc. and Campbell Soup Co. reported to the Wall Street Journal (10/26/99) that they are also exploring putting soybean protein into their products. But no specifics were disclosed. Getting the FDA Started The FDA started investigating the health claim when Protein Technologies (Dupont Co.) filed a petition in May 1998, requesting that the FDA accept its health studies. (These studies concur with findings reached by the University of Toronto in 1993 - a study in which Lumen Foods played a very active role.) What followed was a ruling that was entered in the Federal Register in November 1998, which has now seen its final amendment. Although the FDA did not accept Protein Technologies' proposal that the soybean-plant chemicals, isoflavones, be said to prevent heart disease, reduce certain types of cholesterol, promote health bones in women, and help reduce risk of breast and prostate cancer, the issue is expected to be revisited in the coming months. (The evidence in these areas is quite strong. See Dr. Suzanne Paxton's summary on scientific studies supporting the anti-cancer, anti-heart disease properties of soy protein.) Elsewhere: read the nutrition facts of Lumen Foods' meat and milk replacements, and their isoflavone levels.

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