Understanding Labeling Claims

There are five (5) types of claims that can be used in food labeling (1) Nutrient Content Claims, (2) Health Claims, and (3) Structure/Function Claims, (4) General Well Being Claims, and (5) Classical Nutrient-Deficiency Disease Claims.

Nutrient Content Claims

A nutrient content claim directly or by implication describes the nutrient level of the food product or its ingredients. See FDA’s definition of nutrient content in  FDA’s A Food Labelling Guide: Guidance for Industry (Appendix A and B).

Implied Nutrient Content Claims

1. Suggestion that a nutrient is absent or present e.g. “high in oat bran”
2. Claim that a food is made with a particular ingredient that is known to be low in or a good source of a certain nutrient e.g “made with vegetable oil” would suggest low in saturated fats and a statement of “made with oat bran” would suggest high in fiber.
3. Indication that the food has the same amount of nutrient as another food e.g. “Contains same amount of vitamin C as one 8 oz glass of orange juice”

Health Claims

A health claim is any information on a label that directly express or imply a connection between the food and a disease or health-related condition. There are three regulated health claims (1) Nutritional Labeling and Education Act (NLEA) Authorized Health Claim, 2) Authoritative Statement Claim, and 3) Qualified Health Claim.

1. NLEA Authorized Health Claims are claims written in the regulations and are therefore pre-approved. They have been authorized based on the “Significant Scientific Agreement Standard”. This means that the health claim has been studied by a wide body of credible experts who agree with the claim e.g. “Scientific evidence demonstrates that diets low in saturated fat and cholesterol may reduce the risk of CHD. Other evidence demonstrates that the addition of soluble fiber from certain foods to a diet that is low in saturated fat and cholesterol may also help to reduce the risk of cardiovascular heart disease” (21 CFR 101.81).
2. Authoritative Statement Claims are new claims, not in the regulations, that have passed the rigors of evidence-based scientific review based on work done at US government laboratories or the National Academy of Sciences.
3. Qualified Health Claims are claims that do not meet the significant scientific agreement standard as in the above claims. Therefore, they need to include a disclaimer or qualifying statement as a precaution to consumers. e.g. “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.” Qualified health claims allows food companies the freedom of commercial speech. This freedom allows them to share information to consumers about emerging technology in a way that allows the consumer to make a choice given the evidence available. Commercial speech must not be untruthful or misleading in any way. The FDA examines the available evidence to determine how much the evidence for the claim stacks up against the evidence disputing the claim. In circumstances where there is significant evidence against the claim, the FDA will not approve a qualified claim.

Structure/Function Claims

A structure/function claim is a statement that describes the role the nutrient plays in affecting the structure and function of the human body e.g. “calcium builds strong bones”, or the action by which a nutrient or dietary ingredient maintains such structure or function e.g. “fiber helps maintain digestive regularity”. A structure/function claim cannot describe or imply that a nutrient affects a disease or health-related condition.

General Well Being Claims

A general well being claim is a statement describing the general benefits of consuming a nutrient or dietary ingredient. There is no mention of a disease or disease condition e.g. “eating adequate amounts of fruits and vegetables contributes to general good health.”

Classical Nutrient-Deficiency Disease Claim

A classical nutrient-deficiency claim describes the benefit of an essential nutrient in relation to nutrient deficiency disease; while stating how widespread the diseases is in the United States e.g. “vitamin C prevents scurvy”. This claim is hardly used in the United States anymore since fortification of foods have eliminated most of the classical nutrient deficiency diseases.

Reference: Sanchez, M. C. (2015). Food law and regulation for non-lawyers – A US perspective. New York, NY: Springer International.