| name | labeling-compliance-review |
| title | FDA Labeling Compliance Review |
| description | Conducts FDA labeling compliance reviews for drugs, foods, dietary supplements, and medical devices. Analyzes principal display panels and information panels against FDCA, 21 CFR, and FDA guidance to identify misbranding risks, claims violations, and mandatory disclosure gaps. Use when reviewing product labels, auditing FDA compliance, assessing labeling risk, or preparing for FDA submission. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/labeling-compliance-review |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | regulatory |
| language | en |
FDA Labeling Compliance Review
Structured compliance assessment of FDA-regulated product labeling. Identifies misbranding risks and regulatory gaps with cited corrective recommendations.
Prerequisites
Gather before starting:
- Label files — images or PDFs of all panels (PDP, information, back/side)
- Product classification — drug (OTC/Rx), food, dietary supplement, device, or cosmetic
- Intended use statement — as marketed and as labeled
- Claims substantiation (if applicable) — scientific support for health, structure/function, or nutrient content claims
- Prior FDA correspondence (if any) — warning letters, 510(k) clearance, labeling supplements
Quick Start
- Classify the product and identify controlling CFR parts
- Review PDP for identity, net quantity, and prohibited claims
- Review information panel against product-specific checklist
- Evaluate each claim for type, permissibility, and required disclaimers
- Check mandatory warnings and statements
- Produce findings table with severity, citation, and corrective action
Core Workflow
Step 1: Product Identification
| Field | Detail |
|---|
| Product name (as labeled) | Include trademarked elements |
| Product classification | Drug / Food / Dietary Supplement / Device / Cosmetic |
| Intended use | Conditions, target population, route/method |
| Applicable framework | Controlling CFR parts (e.g., 21 CFR 101 for food, 21 CFR 201 for drugs) |
Step 2: Principal Display Panel (PDP)
Evaluate each element against product-specific requirements:
| Element | Requirement | Citation |
|---|
| Statement of identity | Common/usual name or standard of identity | 21 CFR 101.3 (food) / 201.10 (drug) |
| Net quantity of contents | Lower 30% of PDP, minimum type size per area | 21 CFR 101.105 / 201.51 |
| Established drug name | Prominent, ≥½ size of proprietary name | 21 CFR 201.10(g) |
| Prohibited terms/imagery | No unapproved therapeutic claims, no misleading vignettes |
