Review every food claim in its full context

Why this review needs product evidence

A few words can trigger defined conditions, disclosures, nutrient levels, or authorization questions. Qualifiers must be read with the main statement, and evidence should support the exact wording used for the relevant product and serving. A claim can also affect product classification or make an otherwise accurate label misleading in context.

Recommended review sequence

1. Capture every express and implied claim from the package and connected marketing materials.
2. Classify the claim type without assuming that marketing terminology controls the legal category.
3. Check defined terms, qualifying levels, required disclosures, disqualifying nutrients, and any authorization pathway.
4. Match substantiation to the exact product, serving, population, conditions of use, and wording.
5. Review images, testimonials, asterisks, nearby text, and prominence so qualifiers do not contradict the main message.
6. Freeze the approved claim inventory and rerun review after any wording or formulation change.

Evidence to keep with the released label

Keep the claim text, location, screenshot or artwork version, classification rationale, nutrient calculation, scientific or factual support, required disclosure, and approval owner in one register. Evidence for a broad ingredient benefit is not automatically evidence for a finished-product claim.

What the pre-check cannot prove

Common failures include using “healthy,” “low,” “free,” or similar terms without checking defined conditions; truncating a qualified claim in marketplace titles; and treating a competitor label as precedent. The automated pre-check flags patterns and missing support, but does not authorize or approve claims.

Automatic extraction is accepted only when required text is present in two OCR passes, image quality and layout evidence meet the configured threshold, and the submitted product facts agree with the recognized text. Otherwise the upload is rejected for clearer, complete panels. This does not establish population-wide OCR accuracy or regulatory compliance.

Official starting points

• FDA label claims overview
• 21 CFR Part 101 Subpart D

Continue the food label review