Label claims for foods and supplements: a review of the regulations.

Consumers are confronted with a vast array of food and dietary supplement products claiming to improve health, manage conditions, and reduce disease risks. Most consumers are unaware of the legal requirements, regulatory processes, and scientific evaluation that underlie these label statements. Labeling for foods and dietary supplements is regulated by the US Food and Drug Administration (FDA). Regulations cover 3 main types of health-related statements: health claims, structure/function claims, and nutrient content claims. Health claims must be supported by "significant scientific agreement" among experts that the claimed benefit of a food or food component on a disease or health-related condition is true. When significant scientific agreement is lacking, qualifying statements may be required on the label to describe the strength of the evidence that supports the claim. Structure/function claims describe an effect of a product on body structure or function, and whereas these claims must be truthful and not misleading, they are not subject to premarket scientific review and approval. Nutrient content claims describe the level of a nutrient in a food or supplement and require FDA approval. By understanding the regulatory framework behind label statements and claims, health care professionals can better assist their patients and clients in making informed decisions.