The use of a structure/function claim requires the use of one of the following disclaimers in boldface type in a type size no smaller than one-sixteenth (1/16th) inch inside of an outline box using high-contrast colors between the background and the copy:
- Singular: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease;” or
- Plural: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
You may not modify the wording of these disclaimers.
You must place the disclaimer immediately adjacent to the claim with no intervening material, or elsewhere on the same panel or page that bears the statement. In the latter case, the disclaimer must be placed in a box and linked to the statement by a symbol (e.g., an asterisk) placed at the end of each statement that refers to an identical symbol placed adjacent to the disclaimer. A structure/function claim must have call-outs to the FDA disclaimer wherever there is a claim on the product. Typically, use an asterisk or cross symbol to link the statements together.
I recommend that all brand owners, especially new ones, have all their product claims reviewed by a nutraceutical industry expert, as well as an FDA and FTC attorney.