---
name: supplement-disclaimer
description: "Writes supplement and product disclaimers with FDA compliance language and health claim boundaries."
allowed-tools: Read Write Glob
metadata:
  author: matthewhitcham
  version: "1.0"
---

# Supplement Disclaimer

## When to Use This Skill

Use this skill when you need to:
- Write FDA-compliant disclaimers for dietary supplement products or content
- Create health claim boundaries for supplement marketing materials
- Draft product label disclaimer language
- Build website and social media disclaimers for supplement promotion

**DO NOT** use this skill as a substitute for regulatory counsel. These are templates — always have a regulatory attorney or compliance expert review before use.

---

## Core Principle

THE FDA REGULATES SUPPLEMENT CLAIMS STRICTLY — YOU CAN DESCRIBE STRUCTURE/FUNCTION BENEFITS BUT CANNOT CLAIM TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE. EVERY WORD IN YOUR DISCLAIMER AND MARKETING MATTERS.

---

## Phase 1: Product Context

### Required Inputs

| Input | What to Ask | Default |
|-------|------------|---------|
| **Product type** | "What supplement — vitamins, protein, herbal, pre-workout, other?" | No default — must be provided |
| **Sales channels** | "Where do you sell — own website, Amazon, retail, affiliate?" | Own website |
| **Claims made** | "What benefits do you state or imply in your marketing?" | No default — must be reviewed |
| **Target audience** | "Who is the buyer?" | Health-conscious adults |
| **Content types** | "Where do disclaimers need to appear — labels, website, ads, social?" | Website and product labels |

**GATE: Confirm product type and claims before drafting disclaimers.**

---

## Phase 2: Required Disclaimers

### FDA-Required Disclaimer (Product Labels)

This statement is required on every dietary supplement label that makes a structure/function claim:

```
*These statements have not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.*
```

This disclaimer must appear:
- On the product label (physical or digital)
- In close proximity to any structure/function claim
- In a legible font size and contrasting color

### Website Disclaimer

```
## Supplement Disclaimer

The information provided on [website name] regarding dietary supplements
is for educational and informational purposes only.

**FDA Disclosure:** These statements have not been evaluated by the Food
and Drug Administration. Our products are not intended to diagnose, treat,
cure, or prevent any disease.

**Not Medical Advice:** The information on this website is not intended as
a substitute for advice from your physician or other healthcare professional.
Do not use the information on this website for diagnosing or treating a
health problem or disease. Always consult with a healthcare professional
before starting any supplement, diet, or exercise program.

**Individual Results:** Results from dietary supplements may vary. Individual
experiences are not guarantees of results and are not intended to represent
or guarantee that anyone will achieve the same or similar results.

**Allergen Notice:** Please review all product ingredients and consult your
healthcare provider if you have known allergies or sensitivities.

**Interactions:** Dietary supplements may interact with medications. If you
are taking prescription drugs, consult your doctor before using any supplement.

Last updated: [Date]
```

---

## Phase 3: Claim Guidelines

### What You CAN Say (Structure/Function Claims)

| Permitted | Example |
|-----------|---------|
| Supports a body function | "Supports immune system health" |
| Maintains normal function | "Helps maintain healthy cholesterol levels already in the normal range" |
| General well-being | "Promotes overall wellness" |
| Nutrient deficiency | "Addresses dietary calcium insufficiency" |
| Body structure | "Supports bone health" |

### What You CANNOT Say (Disease Claims)

| Prohibited | Why |
|-----------|-----|
| "Cures arthritis" | Disease claim — requires drug approval |
| "Prevents cancer" | Disease claim |
| "Treats high blood pressure" | Disease claim |
| "Reduces risk of heart disease" | Health claim — requires FDA authorization |
| "Clinically proven to..." | Implies drug-level evidence |
| "Doctor recommended" | Implies medical endorsement (unless documented) |

### Language Substitution Guide

| Do Not Say | Say Instead |
|-----------|-------------|
| "Cures inflammation" | "Supports a healthy inflammatory response" |
| "Lowers cholesterol" | "Supports healthy cholesterol levels already in the normal range" |
| "Boosts immunity" | "Supports immune system function" |
| "Burns fat" | "Supports healthy metabolism" |
| "Fixes joint pain" | "Supports joint comfort and mobility" |
| "Proven to work" | "Formulated with ingredients shown in research to support..." |

---

## Phase 4: Implementation

### Placement Checklist

| Location | Required Content |
|----------|-----------------|
| Product label | FDA disclaimer, supplement facts panel, allergen info |
| Product page (website) | FDA disclaimer, full website disclaimer, ingredient list |
| Checkout page | Disclaimer acknowledgment checkbox |
| Social media ads | FDA disclaimer in caption or image |
| Email marketing | Brief disclaimer in footer |
| Affiliate/influencer content | FDA disclaimer and disclosure of paid relationship |
| Amazon listing | FDA disclaimer in product description |

### Social Media Disclaimer

For posts and ads promoting supplements:

```
*These statements have not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure, or prevent any disease. Consult your
healthcare provider before use.*
```

### Influencer/Affiliate Disclaimer

```
*This post contains [paid promotion / affiliate links]. I receive
[compensation/commission] for purchases made through my links.

These statements have not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure, or prevent any disease. Individual
results may vary. Always consult a healthcare professional before
starting any supplement.*
```

### Compliance Checklist

- [ ] FDA disclaimer appears on every product label
- [ ] FDA disclaimer appears near every structure/function claim
- [ ] Website disclaimer page is published and linked
- [ ] No disease claims in any marketing materials
- [ ] Allergen and interaction warnings are included
- [ ] Influencer/affiliate posts include required disclosures
- [ ] All claims are supported by credible evidence
- [ ] Regulatory attorney has reviewed all materials

---

## Anti-Patterns

- **Omitting the FDA disclaimer** — this is not optional. It is legally required on all supplement labels with structure/function claims.
- **Making disease claims in disguise** — "helps with diabetes" or "fights cancer" are disease claims regardless of how you phrase them.
- **Hiding disclaimers in tiny font** — disclaimers must be legible and conspicuous.
- **Testimonials with disease claims** — even customer testimonials cannot make disease claims. Curate or edit testimonials accordingly.
- **Assuming natural means unregulated** — supplements are regulated by the FDA. "Natural" does not exempt you from compliance.

---

## Recovery

- **Received an FDA warning letter:** Respond immediately. Remove or revise non-compliant claims. Consult a regulatory attorney.
- **Affiliate making prohibited claims:** Issue clear guidelines to affiliates. Monitor content and terminate agreements for non-compliance.
- **Customer reports adverse reaction:** Document it. Report serious adverse events to the FDA as required. Review your product and labeling.
- **Unsure if a claim is permitted:** Default to caution. When in doubt, use softer language and consult a regulatory expert.
- **Competitor making disease claims:** Do not copy their language. They are at risk — you should not be.
