NutraSolutions.com: Structure/Function Statements -- November 2010
Structure/function statements describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans. They may also characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function. Additionally, structure/function statements may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. The Food and Drug Administration (FDA) is the primary federal regulatory agency that has the responsibility of regulating such statements that appear on the labels or labeling of food products.
Conventional Foods vs. Dietary Supplements Historically, structure/function statements have appeared on the labels of conventional foods, dietary supplements, and drugs. The passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory procedures for such statements for dietary supplement labels. While structure/function statements for conventional foods generally focus on nutritive effects, statements for dietary supplements may focus on nutritive as well as non-nutritive effects. For the most part, the FDA regulates structure/function statements in a similar manner for conventional foods as it does for dietary supplements. One big difference is that the FDA does not require conventional food manufacturers to provide notice of structure-function statements and does not require a disclaimer on the labeling of conventional food products like that which is required for dietary supplements.