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A “health claim” is defined as any claim made on the label or labeling that expressly or by implication (1) characterizes the relationship of any substance to a (2) disease or health‐related condition.¹ Note the two essential elements of a health claim. A statement lacking either one of these elements does not meet the regulatory definition.

An example of a statement that would be regulated as a health claim is, “Calcium may reduce the risk of osteoporosis.” Calcium is the substance (element 1). Reducing the risk of osteoporosis is the relationship to a disease (element 2). Note that when a packaged product has a claim about a disease or health‐related condition printed on the label, the relationship to the product is usually implied. For example, the statement “May reduce the risk of osteoporosis” on a calcium supplement bottle does not need to directly mention “calcium” for the claim to be a health claim.

Although the definition of “health claim” is simple, in practice it is complicated with the exceptions and muddied with the gray area of implied meanings. Also note how broad this definition is, particularly regarding any implied association. While the universe of health claims is large, only a small number are authorized or accepted under the law. Only those claims supported by scientific evidence and approved or accepted by FDA are allowed. In addition, these claims can be used only under specific conditions.

The ability to make a health claim on a food product is a substantial marketing tool in today’s health‐conscious society. The competition and stakes over health claims are high both in product success and in regulatory repercussion for noncompliance because health claims are regulated stringently. However, ameliorating somewhat this strictness is the fact that there are different types of health‐related claims that are not regulated as health claims. This chapter will cover these health‐related claims in more detail, but the following is a list of the important categories.

Health‐Related Claims That Are Not Regulated as Health Claims

1 Descriptions of general well‐being from consumption of the food.

2 Structure–function claims.

3 Dietary Guidance.

4 Nutrient content claims.