US FDA Food Labeling Regulations (21 CFR Part 101) 101.14: Health claims: only authorised claims, the general requirements (disqualifying nutrient levels, the 10 percent minimum nutrient contribution, complete and truthful wording, no claim on infant foods), and qualified health claims under enforcement discretion (101.14)

What does 101.14 require?

A health claim (an express or implied characterisation of the relationship between a substance and a disease or health-related condition) may be made only if it is authorised by an FDA regulation in Subpart E, by an authoritative statement notification under the FDA Modernization Act, or is a qualified health claim exercised under FDA enforcement discretion with the required qualifying language. The food must pass the general tests of 101.14(e): no disqualifying level of fat (13 g), saturated fat (4 g), cholesterol (60 mg) or sodium (480 mg) per RACC, per labeled serving or, where it applies, per 50 g; it must contain at least 10 percent of the Daily Value of vitamin A, vitamin C, iron, calcium, protein or fiber before fortification (the 'jelly bean rule'); the claim must be complete, truthful and not misleading, must state the significance of the substance in the context of the total daily diet, and may not be made on foods for infants and toddlers under two. All information required by the specific claim regulation must appear in one place without intervening material, or be referenced to another panel.