In the fierce competition for consumer dollars between companies in the food, beverage and supplement areas, trying to distinguish a product line from a slew of competing products often leads to aggressive labeling and marketing campaigns. Claim formulation is an integral part of labeling and advertising strategies. Claims for food, beverage and supplement products come in essentially three forms—health claims, nutrient-content claims and structure-function claims; however, nutrient-content claims have been generating unique attention. While the Food and Drug Administration (FDA) has always regulated such claims, competitors and consumers have been taking companies to task for alleged improper claims. Companies making nutrient-content claims must ensure that claims used in labeling and advertising are compliant, in order to avoid unwanted attention from regulators, competitors and consumer litigants.
The FDA is the federal regulatory agency charged with regulating the labeling of food, beverage and supplement products. The FDA has issued regulations which implement various provisions of the Federal Food, Drug and Cosmetic Act (FFDCA) regarding labeling; those regulations are set forth in the Code of Federal Regulations (CFR) at 21 CFR Part 101. More specifically, 21 CFR 101.13 sets forth the general requirements and parameters for nutrient-content claims.