Since the roll-out of nutrition labeling rules by the Food and Drug Administration (FDA or the agency) in 1993, it has been understood that statements about the level of a nutrient (“nutrient content claim”) or the health benefits associated with the level of a nutrient or food (“health claim”) require regulatory approval. Claims such as “light,” “low-fat,” and “good source” are useful to consumers but—from a communications standpoint—offer a tired message.
In the name of innovation, there often are calls to “think outside the box.” In the regulatory arena, such creativity all too often is constrained by the regulatory parameters within which food marketers must operate. Food labeling regulations define the box. While the contours of the box are sometimes fuzzy, when a claim puts the marketer decidedly outside the box, the negative consequences of adverse regulatory action can be substantial.