Structure/Function Claims Readiness: Staying on the Right Side of the DSHEA §6 Line

DSHEA §6 (codified at FDCA §403(r)(6)) allows a dietary supplement label to describe how a nutrient or dietary ingredient affects the structure or function of the human body, or characterise the documented mechanism by which it acts, or describe general well-being. The claim must be truthful and not misleading, the manufacturer must have substantiation, and the label must carry the mandatory disclaimer: "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." The 30-day post-market notification to FDA's Office of Dietary Supplement Programs is mandatory under 21 CFR 101.93.

FDA's 2002 final rule on structure/function claims ("Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body") gives the working test for disease versus non-disease claims. A claim implies disease treatment if it (1) names a specific disease, (2) names a disease's characteristic signs or symptoms, (3) implies the product treats a disease class, (4) uses scientific or lay terminology recognised by the public as disease-related, (5) cites disease-treatment authorities, or (6) implies disease treatment through product name, ingredient name, vignette, or testimonial. Warning letters cluster on signs-and-symptoms language ("reduces joint pain", "clears congestion") and on testimonials that name a disease the product is not approved to treat.

FDA reviews labels. FTC reviews advertising, and FTC's substantiation standard is the one that actually defines what evidence a structure/function claim needs. FTC's 1998 Dietary Supplements Advertising Guide and its 2022 Health Products Compliance Guidance set the standard at "competent and reliable scientific evidence" — typically randomised controlled trials in the proposed population at the proposed dose, with results supporting the specific claim language. A claim supported only by mechanism-of-action data, animal studies, or trials in unrelated populations is exposed to an FTC challenge that ends in a consent decree and disgorgement. Substantiation is held before the claim is made, not assembled after the challenge.

21 CFR 101.93 requires the manufacturer to notify FDA within 30 days of first marketing a structure/function claim, giving the exact claim language, the product name, and the manufacturer's contact information. FDA does not approve the claim — it logs it. But the notification creates a public record FDA's post-market team can audit against the actual label, and a mismatch (label says one thing, notification says another) is itself a finding. The notification also starts FDA's clock for any disease-claim challenge, because the agency is now on notice of the marketed claim.

Days 1–10: claim inventory — every marketed claim across every product, every channel (label, web, retailer detail page, ad). Days 11–25: disease-claim screen — every claim run through the six-factor FDA test, with disposition (keep, modify, remove). Days 26–40: substantiation gap analysis — every kept claim mapped to its competent-and-reliable evidence with FTC-class sufficiency. Days 41–50: 21 CFR 101.93 notification reconciliation. Days 51–60: artwork and digital-content remediation with mandatory-disclaimer audit.