What the screen does
ClaimShield applies a finite set of text rules to the copy and product type you submit. The rules look for possible disease-claim language, drug implications, selected substantiation phrases, and possible dietary-supplement label/labeling disclaimer review points. Matches are screening signals for human review.
Each current rule category links directly to the official FDA, FTC, or eCFR material used for orientation, with a source-review date. The 0–100 value is a heuristic prioritization score, not a probability of illegality, deception, enforcement, or consumer harm.
What it does not establish
- It does not decide whether copy is lawful or compliant.
- It does not evaluate study quality, formulation, dose, audience, disclosures, images, page context, or every express and implied message.
- It does not cover every federal, state, local, or international requirement.
- It cannot infer whether submitted copy is a label, labeling, an advertisement, or another communication. That distinction can change which requirements apply.
- FDA says wording and the complete labeling context determine whether a statement is a disease claim; a keyword match is not an agency determination.
- The DSHEA disclaimer review signal is limited to possible dietary-supplement structure/function statements. FTC guidance says that disclaimer is not generally required in other advertising and cannot cure an otherwise deceptive claim.
- A short citation in a result is an orientation aid, not an agency finding or legal opinion.
Lower-risk drafts are editing suggestions, not compliant copy or permission to publish. Qualified counsel and relevant subject-matter experts should review the complete claim, evidence, and context.
Primary references for human review
- eCFR — 21 CFR 101.93
- FDA — Structure/function claims compliance guide
- FTC — Health Products Compliance Guidance
These links are authoritative starting points, but FDA and FTC guidance does not itself decide a particular case and applicable law can change. Review the current source text and obtain advice for the specific product, evidence, medium, audience, and jurisdiction.