Structure/function claim

Federal law lets a dietary supplement label describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or characterize the documented mechanism by which it acts, as long as the statement is truthful, not misleading and substantiated (21 CFR 101.93). Supports a sense of calm, part of a nightly routine, and helps maintain healthy skin are examples of the form.

Three conditions attach. The manufacturer must hold substantiation that the claim is truthful. The label must carry the FDA disclaimer. And the company must notify FDA within 30 days of first marketing a product that bears the statement (FDA Labeling Guide ch. VI).

The boundary is any claim that a product affects a named health condition. FDA regards those statements as drug claims, whether made directly, by implication, through a product name, or through citations and testimonials, and a product making them is regulated as a drug (21 CFR 101.93(g)). Structure/function claims do not require FDA preapproval; condition claims do.

CBD sits awkwardly here. FDA's position is that CBD is excluded from the dietary supplement definition altogether (FDA), so the structure/function framework is borrowed rather than granted. Keeping claims within it is still the conservative practice across the hemp industry.