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.

When the new food ingredient has jumped the safety hurdle, and has been approved for use as a safe food ingredient, the next caveat, efficacy, is then in play.  Because the FDA states that the claim “must be truthful and not misleading,” there must be a sufficiently robust and persuasive human clinical study to provide a truthful SFC. The study’s protocol design, statistical power, relevant endpoints, inclusion/exclusion parameters for the subjects, length of testing, etc. are all germane to the clinical study, and all may be modified to generate the final burden of a truthful claim.

The third and final requirement is that the claim must derive from the use of the functional ingredient contained within the food; that is, the ingredient upon which the claim is based must also have some utility in the food, e.g., provide nutritional value, taste, or aroma. This requirement is to prevent using food simply as a delivery system for the functional ingredient. This is important, as back in the mid-1980s, a specific food—Nutrilab’s “Starch-Blocker”—was ruled “not a food” because the kidney bean ingredient to promote the SFC did NOT contribute to the food’s attributes of “taste, aroma and nutritive value.”[1]

The market share-driven impetus will be for innovative companies to use these consumer friendly claims on favored food products. It won’t be long until that bag of corn chips claims “digestive tract transit time improvement” because of a taste-modifying prebiotic fiber, or the ice cream with a new tangier flavor note will be provided by probiotic “gut friendly” bacteria, or a sport beverage sporting a pictogram of a flexing knee joint brought about by a cartilage-healthy nutritive ingredient. However, the entrepreneurial company should not put that initial investment of venture capital entirely into the design, conduct of the human clinical studies, and end up with depleted capital and the sudden realization that the safety was ignored. No matter how persuasive the efficacy data are is to “Big-Food” and “Big-Beverage,” and no matter how tempting the structure/function claim will look on that final food product, “Big-Food/Big-Beverage” will not and cannot plan to commercialize any amazingly effective ingredient until safety has been addressed.

Reference

[1] http://www.nytimes.com/1982/10/10/weekinreview/ideas-and-trends-starch-blocker-suit-backfires.html