Soy Protein Health Claim

In October 1999 the Food and Drug Administration (FDA) of the US gave food manufacturers permission to claim on foods high in soy protein that they may help lower heart disease risk. A similar claim was approved a few years before for oat bran. Allowing health claims encourages food manufacturers to make more healthy products. Soon after the soy protein health claim was approved concerns arose about certain components in soy products, particularly isoflavones and anti-nutrition compounds. According to Elizabeth A. Yetley, Ph.D., lead scientist for nutrition at the Food and Drug Administration's Center for Food Safety and Applied Nutrition, every dietary health claim that has ever been published has had controversy. All foods, including soy, consists of many chemicals that can be beneficial for most people, but can be harmful to some people when used inappropriately.

Many controlled clinical studies have shown that foods rich in soy protein can have considerable value to heart health. A review of these scientific studies prompted Food and Drug Administration to allow a health claim on food labels stating that a diet containing 25 grams of soy protein, also low in saturated fat and cholesterol, may reduce the risk of heart disease. Most research involved whole soy foods including soy milk, tofu and soy protein. The recent controversy focuses mainly on specific components of soy, such as the soy isoflavones, but not the whole soybean or intact soy protein. These isoflavones extracts are sold as dietary supplements for use by women to help ease menopausal symptoms. Isoflavones act as weak estrogens and could have drug-like effect in the body. Some suggest that intake of isoflavones might increase the risk of breast cancer. Scientists are far from conclusive. Some studies even show the opposite, that soy may help prevent breast cancer. The Food and Drug Administration claim is only limited to foods containing intact soy protein and not to isoflavones extracts. According to Margo Woods, D.Sc., associate professor of medicine at Tufts University, there are probably hundreds of protective compounds in soy foods and it is just too big a leap to assume that a pill could do the same thing.

The Food and Drug Administration determined that diets 25 g of soy protein (four daily servings of 6.25 g soy protein) can reduce levels of low-density lipoproteins (bad cholesterol) by as much as 10 percent.The quantity of 25 g soy protein seems high but soy protein is actually easy to consume 25 g of soy protein. For example following foods are rich in soy protein:

• Four ounces of firm tofu contains 13 g of soy protein.
• A soy burger contains 10 to 12 g of protein.
• One cup of soymilk contains 10 g of protein.
• One soy protein bar delivers 14 g of protein.
• One half cup of tempeh provides 19.5 g of protein.

Criteria for Soy Protein Health Claim

To qualify for the soy protein health claim, foods must contain at least 6.25 grams of soy protein per serving and comply to other criteria, such as low content of fat, sodium and cholesterol. To qualify for the soy protein health claim, foods must contain per serving:

• 6.25 g soy protein
• less than 3 g fat
• less than 1 g saturated fat
• less than 20 mg cholesterol
• less than 480 mg sodium for individual foods, less than 720 mg sodium for main dish, and less than 960 mg sodium for complete meal.