Читать книгу Food Regulation - Neal D. Fortin - Страница 249

Structure–function claims describe the role of an ingredient in affecting or maintaining the normal structure or function in humans; for example, “antioxidants maintain cell integrity.” While health claims characterize the relationship between a substance and its ability to reduce the risk of a disease or health‐related condition, structure–function claims describe the effect that a substance has on the normal structure or function of the body. The critical distinction here centers on normal versus disease. For example, “calcium builds strong bones” is a structure–function claim about normal bone development. Mention of osteoporosis or other disease (or even implying relationship to disease) would create a health claim.

The line between structure–function claims and drug–health claims can be extremely thin. For example, “supports the immune system” would be viewed as a structure–function claim—on the other hand, “supports your body’s anti‐viral capabilities” would be questioned as a veiled heath claim. Structure–function claims may not explicitly or implicitly link the relationship to a disease or health‐related condition.

Other examples of structure–function claims are, “fiber maintains bowel regularity,” and “antioxidants maintain cell integrity.” These claims focus on maintaining or supporting normal body structures or functions, and do not focus on disease.

Structure–function claims may appear on the labels of foods and dietary supplements without any formal review or premarket approval by FDA.⁹ However, the general Food, Drug, and Cosmetic Act (FD&C Act) requirements still apply, and the claims must be truthful and nonmisleading.

Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements¹⁰ as well as drugs. When used with conventional foods, structure–function claims must be based on the “nutritive” value of the food. However, FDA has not defined “nutritive value” in the context of structure–function claims.¹¹