labeling-compliance-review

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:

1. Label files — images or PDFs of all panels (PDP, information, back/side)
2. Product classification — drug (OTC/Rx), food, dietary supplement, device, or cosmetic
3. Intended use statement — as marketed and as labeled
4. Claims substantiation (if applicable) — scientific support for health, structure/function, or nutrient content claims
5. Prior FDA correspondence (if any) — warning letters, 510(k) clearance, labeling supplements

Quick Start

1. Classify the product and identify controlling CFR parts
2. Review PDP for identity, net quantity, and prohibited claims
3. Review information panel against product-specific checklist
4. Evaluate each claim for type, permissibility, and required disclaimers
5. Check mandatory warnings and statements
6. 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