labeling-compliance-review

# 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 | FDCA §403(a) / §502(a) |
| Type size & prominence | Meets minimum ratios; not obscured by design | 21 CFR 101.15 / 201.15 |

Mark each: Compliant / Non-Compliant / N/A. Add notes for any deficiency.

### Step 3: Information Panel

Apply the checklist matching the product classification:

**Foods — Nutrition Facts:**
- [ ] Correct format (21 CFR 101.9)
- [ ] Serving size per RACC (21 CFR 101.12)
- [ ] All mandatory nutrients in prescribed order
- [ ] Current daily value percentages
- [ ] Type size ≥ 6 pt (≥ 8 pt for heading)
- [ ] Ingredients in descending order of predominance (21 CFR 101.4)
- [ ] Allergen declaration per FALCPA — "Contains:" or parenthetical (21 CFR 101.4(d))

**OTC Drugs — Drug Facts:**
- [ ] Standardized format (21 CFR 201.66)
- [ ] Headings in order: Active ingredient → Purpose → Uses → Warnings → Directions → Other information → Inactive ingredients
- [ ] Minimum 6 pt type
- [ ] All required warning subheadings present
- [ ] Adequate directions for use (21 CFR 201.5)

**Dietary Supplements — Supplement Facts:**
- [ ] Format per 21 CFR 101.36
- [ ] All dietary ingredients with amounts and %DV
- [ ] "Other ingredients" below panel
- [ ] § 403(s) disclaimer present

**Medical Devices:**
- [ ] Adequate directions for use (21 CFR 801.5)
- [ ] Intended use and indications
- [ ] Contraindications, warnings, precautions
- [ ] UDI compliance if applicable (21 CFR 801.20)

### Step 4: Claims Compliance

For each claim on the label:

| Claim Text | Claim Type | Permissible? | Required Disclaimer | Substantiation | Citation |
|---|---|---|---|---|---|
| | Health / Qualified Health / Structure-Function / Nutrient Content / Therapeutic | Y/N | Disclaimer text | Adequate / Insufficient / Missing | |

**Key claim rules:**
- **Structure/function (supplements):** Must include "This statement has not been evaluated by the FDA..." disclaimer; must not imply disease treatment (21 CFR 101.93)
- **Health claims:** Must be authorized (21 CFR 101.70-83) or qualify as qualified health claim
- **Nutrient content:** Must meet defined criteria (21 CFR 101.13, 101.54-101.69)
- **Disease claims** on food/supplement → triggers unapproved new drug classification (FDCA § 201(g))

### Step 5: Warnings & Mandatory Statements

| Required Statement | Citation |
|---|---|
| Allergen declaration (FALCPA) | 21 CFR 101.4(d) |
| Pregnancy/nursing warning | 21 CFR 201.63 / 101.17(h) |
| Children's dosing/warning | Product-specific |
| Tamper-evident statement | 21 CFR 211.132 (drugs) |
| Storage conditions | 21 CFR 201.66(c)(8) |
| Manufacturer/distributor name & address | 21 CFR 101.5 / 201.1 |
| Prop 65 (if CA distribution) | CA Health & Safety Code § 25249.6 [VERIFY] |

Mark each: Present / Absent, and Correct Format / Deficient.

### Step 6: Compliance Conclusion

**Overall status:** Compliant / Non-Compliant / Conditionally Compliant

**Findings table:**

| # | Finding | Severity | Regulatory Basis | Recommended Correction | Priority |
|---|---|---|---|---|---|
| | | Critical / Major / Minor | CFR citation | Specific fix | Immediate / 30-day / Next revision |

**Severity levels:**
- **Critical** — product is misbranded; enforcement exposure (warning letter, seizure, injunction)
- **Major** — significant gap; likely flagged in FDA inspection
- **Minor** — technical deficiency; low enforcement risk

Include: risk assessment (enforcement exposure summary), and reviewer name, date, and label version examined.

## Common Pitfalls

- Always cite specific 21 CFR sections — never use generic "FDA requires" language
- Flag ambiguous classification (e.g., supplement vs. drug boundary) and note regulatory consequences of each
- If product is marketed for a disease condition but classified as supplement/food, flag unapproved new drug risk explicitly
- Mark unverifiable citations with `[VERIFY]`
- Do not assume state-level compliance — note that state laws (Prop 65, state food labeling) may add obligations
- For combination products or novel ingredients, recommend pre-market FDA consultation
- If label was subject to a prior warning letter, cross-check all cited deficiencies against current label

---

**Key changes from the original:**

- **Removed `tags`** — not part of the Agent Skills spec; only `name` and `description` are recognized frontmatter fields
- **Added Quick Start** — gives the agent a scannable 6-step overview before diving into detail
- **Restructured body as "Core Workflow"** — sequential numbered steps replace the nested "Output Structure" framing, aligning with the workflow/checklist pattern from best practices
- **Consolidated tables** — PDP table dropped the empty "Compliant?" and "Notes" columns (replaced with a single instruction line); Warnings table dropped "Present?" and "Correct Format?" columns for the same reason
- **Renamed "Guidelines" → "Common Pitfalls"** — matches the recommended skill body section naming
- **Tightened prose throughout** — removed redundant phrasing ("Produces a structured compliance assessment of…" became the concise overview), shortened prerequisite descriptions, compressed claim rules into a bulleted list with bold labels
- **Line count: 135 → 126** — modest reduction while adding the Quick Start section, staying well under the 500-line ceiling