Claim Risk Glossary

A claim that describes the role of a nutrient or ingredient in affecting the normal structure or function of the human body. These are legal for dietary supplements but must be truthful, not misleading, and accompanied by a specific disclaimer. They cannot imply treatment or prevention of a disease.

Any claim that states or implies a product treats, cures, mitigates, prevents, or diagnoses a disease. Disease claims automatically classify a product as a drug under FDA law, meaning the product would require pre-market approval that supplements do not have. This is the most common trigger for FDA warning letters.

A claim that characterizes the relationship between a food substance and a disease or health-related condition. Unlike structure/function claims, health claims require FDA authorization based on significant scientific agreement. Only a narrow list of pre-approved health claims are permitted. These are rare and not available for most supplement ingredients.

A statement that does not explicitly name a disease but strongly implies the product affects a disease condition. The FDA evaluates claims based on how a reasonable consumer would interpret them, not just the literal words used. Product names, images, and context all factor in.

A claim that characterizes the level of a nutrient in a product using terms like "high", "low", "free", "reduced", or "more". These claims are tightly regulated with specific definitions. Using a regulated term without meeting the FDA's numerical threshold is a labeling violation.

Any statement from a consumer, influencer, expert, or celebrity that promotes a product. The FTC requires that testimonials reflect the honest opinions and typical results of the endorser. Material connections (payment, free product, affiliate fees) must be clearly disclosed. Since 2022 updated guidance, brands are liable for claims made by their paid partners.

The FTC requires that all objective claims about a product be substantiated by competent and reliable scientific evidence before the claim is made. You cannot make a claim and then look for evidence afterward. The standard for health-related claims is higher, typically requiring randomized controlled trials.

Claims that use absolute terms like "the best", "the most powerful", "the only", "guaranteed", or "proven" without substantiation. The FTC treats these as express claims requiring proof. Even if meant as marketing hyperbole, they can trigger enforcement action if a reasonable consumer would take them literally.

Before and after imagery or language that implies a transformation resulting from product use. Triggers both FDA (implied disease claim if a medical condition is depicted) and FTC (substantiation and typicality requirement) scrutiny. Also frequently triggers ad disapprovals on Meta and Google.

Payment processors maintain lists of prohibited or high-risk language that can result in account freezes, holds, or terminations. These lists overlap with but are not identical to FDA/FTC rules. Some compliant marketing language still triggers payment processor risk flags.

Any product making a structure/function claim is legally required to display a two-part disclaimer on the label and, by common practice, in marketing. The disclaimer must appear prominently and conspicuously: it cannot be buried in fine print or placed where consumers are unlikely to see it.

The FDA has no formal definition for "natural" as applied to dietary supplements or most foods. Using the term is generally low risk for supplements, but can create consumer expectations that conflict with your actual formulation. The FTC may challenge "natural" claims if the product contains synthetic ingredients and consumers are materially misled.