The U.S. Food and Drug Administration (FDA) has authorized the use of a health claim about the association between soy protein and reduced risk of coronary heart disease (CHD).

1. What is the soy/heart disease preventive health claim?
A health claim sets forth a "relationship" between a food substance and a disease. By law, the relationship can only be one of "risk reduction" that the food "may prevent." In this setting, the food substance is soy protein and the disease is heart disease or elevated cholesterol. Additionally, FDA generally requires that all claims have important public health provisos that limit the applicability of the claim. FDA generally promulgates, as part of the rule, a MODEL health claim. This MODEL need not be used in its exact terms. However, any claim appearing on a food package must be a complete health claim, wherever it appears. Completeness is judged by inclusion of such words as "soy protein," "heart disease" or "the consequences of elevated cholesterol," "reduce the risk of," and the specific provisos that FDA has identified.

The final regulations set forth the following two MODEL health claims for foods containing soy protein which has all the required elements:

"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 _____ grams of soy protein."

"Diets low in saturated fat and cholesterol that include 25 grams of soy protein may reduce the risk of heart disease. One serving of [name of food] provides ______ grams of soy protein."

Other wording is permissible but each presentation of the claim must have the provisos relating to a diet low in saturated fat and cholesterol. FDA has also stated that identification, in the claim, of the total amount of soy protein needed, as contrasted to the amount in the product, is also an essential proviso so that consumers understand that how many of such labeled products they must eat per day.

2. What elements must a health claim contain?
A health claim describing the reduction in heart disease risk associated with diets low in saturated fat and cholesterol and including soy protein may be made on the label or labeling of a food containing soy protein, if the claim satisfies all of the following criteria:
  • The claim states that diets that are low in saturated fat and cholesterol and that include soy protein "may" or "might" reduce the risk of heart disease.
  • The claim uses the term "heart disease" or "coronary heart disease" or "consequence of high cholesterol levels" to specify the disease.
  • The claim uses the term "soy protein" to specify the substance in the food that is beneficial.
  • The claim contains reference to the fact that the diet must be low in "saturated fat" and "cholesterol" to achieve the benefits.
  • The claim does not imply that consumption of diets low in saturated fat and cholesterol and high in soy protein is the only recognized means of reducing the risk of coronary heart disease.
  • The claim specifies that it is necessary to consume at least 25 grams of soy protein daily to achieve a reduction in the risk of heart disease and specifies the amount of soy protein in a serving of the particular product on whose label the claim appears.
  • There is no quantification of the risk, such as a statement that 25 grams produces a risk reduction of X percent, because such a specific claim with a defined benefit would be viewed by FDA as a drug claim.

3. What products can carry the claim?
In order to carry a labeling claim about the benefits of soy protein, a food must satisfy the following criteria:
  • The food must be low in saturated fat and low in cholesterol, as those phrases are defined in FDA's regulations in terms of amounts per "reference amount customarily consumed" (RACC). This may differ from the product's labeled serving size. To be low in saturated fat means 1 g or less of saturated fat per RACC and no more than 15 percent of calories from saturated fat. Low in cholesterol generally means 20 mg or less of cholesterol per RACC.
  • The food product must have at least 6.25 g of soy protein per reference amount customarily consumed.
  • Although not a concern for soy protein products, a rule known as "the jelly bean rule" states that a product must contain at least 10 percent of a nutrient. For the soy health claim, the amount of soy protein required to be present (6.25 g) is automatically more than 10 percent of the RDI (50 g).

4. Are there foods for which a health claim about the benefits of soy protein are prohibited?
In addition to the limits on saturated fat and cholesterol stated above specifically for the soy health claim, no food may bear any health claim if it contains more than 13.0 g of fat, 4.0 g of saturated fat, 60 mg of cholesterol, or 480 mg of sodium per RACC.

5. How should the health claim appear on the food label?
All information required to be included in the claim must appear in one place, without other intervening material. Note that the entire claim should appear in the same type size and font, as it would likely be construed as misleading by the FDA to make some parts of the claim smaller than others. There is no minimum or maximum font size or type specified.

Where packaging is too small to include the entire claim on the actual product label, the claim may appear in its entirety on an accompanying pamphlet or hang tag. It is not permissible to divide the claim and use asterisks or other methods to tie the claim together. The whole claim must appear in each and every location selected. Thus, a small package cannot contain a symbol of soybean in a heart with a reference to the full claim which may appear on a hang tag.

6. What is the relationship between a health claim and the Nutrition Facts panel?
A product that makes a health claim must also contain a Nutrition Facts panel that follows FDA's specifications.

7. What is the difference between a "health claim" about soy protein and a "nutrient content" claim for soy protein? May a food label have both a health claim and a nutrient content claim?
While a health claim about soy protein refers to a claim described above discussing the positive relationship between consumption of soy protein and reduction of cardiovascular risk, a "nutrient content" claim is a claim about the level of soy protein in the food (such as a label statement that indicates that a particular product is "high in soy protein" or an "excellent source of soy protein".)

Nutrient content claims are regulated by FDA separately and may appear anywhere on the label. If the declaration of soy protein content implies that level is high, then the soy protein nutrient content claim may be made only if the food product contains at least 10 g of protein per RACC. There are limitations with regard to type size (no greater than two times the statement of identity) as well as specifics with regard to use of such modifying terms as "free, "low," and "high."

A product bearing a health claim for soy protein may also bear a nutrient content claim if the product meets the requirements for both claims.

8. May a food label contain a health claim for soy protein and also contain a structure/function claim?
If a food is also eligible for a specific health claim, that food label may bear both the health claim and any truthful structure/function claim.

A structure/function claim is a claim that discusses what a food substance does metabolically so long as the relationship between that metabolic function and a potential disease is not known or is not clear. Structure/function claims, such as, "fiber makes one regular" or "calcium is used to build bones," are permitted on any food substance at any time and are not governed by any regulations other than the fact that the claim must be true.

However, a claim to lowering blood sugar would be construed as a claim relating the food substance to a disease (diabetes) and would be viewed as a health claim. The effect described in the structure/function claim is derived from the food's nutritional content, and the structure/ function claim does not describe prevention or treatment of a disease or its symptoms.

9. If a food has a label claim about the health benefits of soy protein, can it also have other FDA-authorized health claims?
Yes, food labels are permitted, where appropriate, to bear multiple health claims or multiple nutrient content claims.

10. If I put a health claim about soy protein on the label of a food, what can I say in advertising and other promotional or educational materials?
Advertising is regulated by the Federal Trade Commission (FTC). The FTC has promulgated guidance that, until a health claim is authorized by FDA, its use in advertising will be deemed false and misleading. With the use of the health claim, in turn, advertising for foods containing soy protein may contain statements that are true and not misleading about soy's benefits, without the need for specific provisos and disclaimers as required by FDA. Moreover, advertising materials need not use the same structure or language required for a health claim on food labeling. Finally, such requirements as presentation of the claim in a single location are also not applicable, provided, as always, that the resulting presentation is not false or misleading to the consumer.

11. What about the use of a health claim on USDA-regulated products?
If a product contains more than 2 percent cooked meat or poultry or 3 percent raw meat or poultry, it is regulated by USDA, which takes the position that an FDA-authorized health claim is not permitted on a USDA-regulated product unless USDA has specifically authorized the claim as well.