For decades, researchers have investigated foods and other elements in people's diets as possible causes of heart disease. Recently, the scientific and medical experts are shifting their emphasis to identifying foods and specific substances in foods that may play a role in preventing heart disease.

What is a Health Claim?
Simply put, a health claim identifies the relationship between a food or nutrient and the risk of a disease or health-related condition. These claims can be printed on food labels that meet certain criteria specified by the U.S. Food and Drug Administration (FDA).

The Health Claim Process
In October 1999, the FDA authorized a health claim for soy protein and heart disease.

We at Protein Technologies International (DPT) took the lead in submitting the health claim petition to the FDA. For almost 1-1/2 years, the FDA carefully reviewed this Health Claim petition for soy. The petition included evidence from more than 50 studies in humans-research spanning more than 20 years.

Many of these studies also were included in a meta-analysis published in The New England Journal of Medicine in August,1995. This research, which combined data from 38 studies, showed that substituting soy protein for animal protein significantly lowered levels of the blood total cholesterol, LDL-cholesterol, and triglycerides. All these are known to increase the risk of heart disease.

Understandably, this meta-analysis caught public attention and contributed to the growing interest in soy protein.

The Soy Protein-Heart Disease Health Claim
The FDA provided two models when they authorized the Health Claim for soy protein and heart disease:

'Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides (list number) grams of soy protein.'

Or:

'25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of (name of food) supplies (list number) grams of soy protein.'

In addition to qualifying as 'low cholesterol' and 'low saturated fat,' soy-based foods bearing this Health Claim must provide at least 6.25 grams of soy protein per serving.

Four servings of a food containing the minimum 6.25 grams of soy protein equals the 25 grams of soy protein required.

Incorporating the recommended amount of soy protein in your daily diet isn't as hard as it may seem.

Getting Your Soy Protein
Traditional soyfoods like tofu and soymilk are widely available, and food manufacturers are constantly developing new soy-based foods more familiar to Western tastes.

Many of these foods-drink or shake mixes, protein bars, and meat or poultry alternatives, among others-are made with isolated soy protein. At 90% protein (based on dry weight), isolated soy protein is the most concentrated form of soy protein available and can be found in DPT's Solae™ brand isolated soy protein.

Other FDA Health Claims

1. Calcium and osteoporosis
2. Sodium and hypertension (high blood pressure)
3. Dietary fat and cancer
4. Dietary saturated fat and cholesterol and risk of coronary heart disease
5. Fiber-containing grain products, fruits, and vegetables and cancer
6. Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease
7. Fruits and vegetables and cancer
8. Folate and neural tube birth defects
9. Dietary sugar alcohol and dental caries (cavities)
10. Dietary soluble fiber, such as that found in whole oats and psyllium seed husk, and coronary heart disease
11. Soy protein and risk of coronary heart disease
12. Plant sterol/stanol esters and risk of coronary heart disease

To view the full claims, go to the FDA, select Dietary Supplements, then 'What are the FDA authorized health claims?'

For more information on the soy protein health claim, please visit the FDA's website