Table 2.

US approach to classifying health and nutrition claims for foods

Type of claim	Example	FDA authorisation required?	Level of evidence
Nutrient content	Excellent source of vitamin D	No, but must adhere to FDA regulations	If a nutrient content claim is not defined in the regulations, its use is prohibited
Structure-function*	DHA supports your infant’s brain development	No	Manufacturer must have substantiation for the claim but is not required to supply data to FDA†
Qualified health claim	“Little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% whey protein partially hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life.”	No, but FDA reviews before marketing and decides whether to exercise enforcement discretion	Significant scientific agreement standard not met‡
Health claim	“Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect.”	Yes	Significant scientific agreement standard met‡

^*Structure-function claims should derive from the product’s character as a food to avoid regulation as a drug. †It is a statutory requirement that claims in food labelling must be truthful and not misleading (section 403(a), Federal Food, Drug and Cosmetic Act (21 U.S.C. 343(a)). ‡Significant scientific agreement standard: “there is agreement among experts that the totality and quality of the scientific evidence available is sufficient to substantiate the relationship which a health claim refers to.”