US FDA Food Labeling Regulations (21 CFR Part 101) 101.93: Dietary supplement structure and function statements: the 30-day FDA notification, the disclaimer 'This statement has not been evaluated by the Food and Drug Administration...' in boldface with the required placement, and the distinction from disease claims (101.93)

What does 101.93 require?

A dietary supplement that bears a statement of nutritional support (a structure or function claim, a general well-being claim, or a nutrient deficiency claim) under section 403(r)(6) of the Act must carry the disclaimer that the statement has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure or prevent any disease, in boldface type, enclosed in a box or on the same panel as the statement, linked by a symbol where the disclaimer is elsewhere on the label, and must notify FDA within 30 days of first marketing with the text of the statement. A statement that claims to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases, expressly or implicitly (including through product names, citations, pictures or symbols), is a disease claim not permitted under this section.