Structure / Function Claims: Not Just for Supplements Anymore
Traditionally, when a regulator, a consultant, or an ingredient marketer thought of “claims,” they pigeon-holed them into two broad categories, (1) structure / function claims (SFC) or (2) health claims/qualified health claims (HC/QHC). Dietary supplement ingredients and food ingredients were usually thought to be able to use one but not the other. And for the most part, that has been and continues to be true. If one takes a look at an oat-based cereal, there will be a bona fide FDA qualified health claim, allowing manufacturers to say that soluble fiber from whole oats, oat bran, or oat flour “as part of a low-saturated-fat, low-cholesterol diet, may reduce the risk of heart disease.” On the other hand, a bottle of dietary supplement tablets will carry a bona fide structure/function claim, allowing a glucosamine product to state that it “helps support healthy cartilage and joint function.” So for most observers, the dichotomy is clear, a food carries a QHC and a dietary supplement carries a SFC.
But that dichotomy is changing, and with guidance spelled out in a recent FDA document, structure/function claims will change even faster. Supplements do not seem to be focused on generating the necessary safety and efficacy data to broach health claims, but foods are sporting new and informative SFCs of their own. One popular yogurt now “helps naturally regulate your digestive system.” A claim, interestingly enough, that the yogurt company did not have to pass by the FDA, as required for a supplement SFC, or bear the supplement’s disclaimer that the “…statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Use of a structure/function claim for a food does come with a three stipulations. The most critical is that all of the ingredients in the food, including whatever ingredient(s) is/are providing the functionality, MUST be approved food ingredients. The only two paths for a new ingredient are via a FDA food additive petition (FAP), or through a Generally Recognized As Safe (GRAS) determination. In both cases, the approval for a new food ingredient is based solely upon safety.