US FDA Food Labeling Regulations (21 CFR Part 101) 101.70-83: Authorised health claims and their conditions: calcium and vitamin D and osteoporosis (101.72), dietary lipids and cancer (101.73), sodium and hypertension (101.74), saturated fat and cholesterol and coronary heart disease (101.75), fiber-containing grains, fruits and vegetables and cancer (101.76), fruits, vegetables and grains with fiber and coronary heart disease (101.77), fruits and vegetables and cancer (101.78), folate and neural tube defects (101.79), sugar alcohols and dental caries (101.80), soluble fiber from certain foods and coronary heart disease (101.81), soy protein and coronary heart disease (101.82), plant sterol and stanol esters and coronary heart disease (101.83), and the petition procedure (101.70)

What does 101.70-83 require?

Each authorised health claim regulation specifies the substance, the disease, the qualifying food criteria (for example a 'good source' of calcium for the osteoporosis claim, 'low fat' for the lipids and cancer claim, 'low sodium' for the hypertension claim, 'low saturated fat', 'low cholesterol' and 'low fat' for the coronary heart disease claims, a minimum of 0.75 g beta-glucan soluble fiber from whole oats, barley or psyllium per RACC for 101.81, 6.25 g or more of soy protein per RACC for 101.82, and 0.65 g or more of plant sterol esters (1.7 g of stanol esters) per RACC for 101.83 with the daily intake statement), the required and optional elements of the claim, and the model claim language. The claim must identify the substance and the disease, say that the relationship is subject to other factors ('may reduce the risk'), and give the daily intake where the regulation requires it. Petitions for new authorised claims follow 101.70.