FDA & Compliance

Supplement Claims: What You Can and Can't Say on Your Label

What you write on your supplement label and marketing materials is not just a branding decision — it is a legal one. The FDA and FTC regulate supplement claims with specific, enforceable rules, and violations can trigger warning letters, product seizures, and lawsuits. Understanding the claim categories is essential for any supplement brand founder. Here is the framework.

The Four Types of Supplement Claims

1. Structure/Function Claims (Generally Allowed)

Structure/function claims describe the role of a nutrient or dietary ingredient in maintaining the structure or function of the body. These are the bread and butter of supplement marketing. They do not require FDA pre-approval but must be truthful, not misleading, and substantiated by adequate evidence.

Examples of legal structure/function claims:

• "Supports healthy digestion"
• "Promotes joint comfort and mobility"
• "Helps maintain healthy blood pressure levels already within normal range"
• "Supports cognitive function and mental clarity"
• "Promotes restful sleep"
• "Supports the body's natural stress response"

Requirements for structure/function claims:

1. You must notify the FDA within 30 days of first marketing the product with the claim (Form 3571).
2. You must include the disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
3. You must have substantiation — competent and reliable scientific evidence — supporting the claim. You do not need to submit this to the FDA proactively, but you must have it available if challenged.

2. Health Claims (Heavily Regulated)

Health claims describe a relationship between a nutrient and a disease or health condition. These require FDA authorization through either the Significant Scientific Agreement (SSA) standard or the qualified health claim process. Only a handful of health claims are currently authorized for supplements.

Examples of authorized health claims:

• "Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life."
• "Diets low in sodium may reduce the risk of high blood pressure."

Most supplement brands should avoid health claims unless using one of the specifically authorized claims verbatim. The qualification and approval process is expensive and time-consuming.

3. Nutrient Content Claims (Specific Rules)

Nutrient content claims characterize the level of a nutrient in the product. They use defined terms like "high," "good source," "rich in," or "free." Each term has a specific regulatory definition:

• "High" or "Rich in": Contains 20% or more of the DV per serving
• "Good source": Contains 10–19% of the DV per serving
• "More" or "Added": Contains at least 10% more of the DV than a reference food
• "Free": Contains none or a trivial amount (defined per nutrient)

4. Disease Claims (Prohibited)

A supplement may never claim to diagnose, treat, cure, mitigate, or prevent a disease. A product that makes a disease claim is legally classified as an unapproved new drug. The FDA defines "disease" broadly to include any condition other than normal healthy states.

Words and phrases that trigger disease claim concerns:

• Names of diseases: diabetes, cancer, Alzheimer's, arthritis, depression, anxiety, ADHD
• Action words: treats, cures, heals, fights, combats, prevents, reverses, eliminates
• Implying drug equivalence: "natural alternative to [drug name]" or "as effective as [drug name]"
• Before/after claims implying disease resolution: "Before: joint pain. After: pain-free"
• Product names that imply treatment: "Arthri-Cure," "DiabetaFix," "CancerGuard"

The FTC Dimension: Advertising Claims

While the FDA regulates labeling, the Federal Trade Commission (FTC) regulates advertising — which includes your website, social media, emails, paid ads, and influencer content. The FTC requires that all advertising claims for supplements be:

• Truthful and not misleading
• Substantiated by competent and reliable scientific evidence (typically interpreted as at least one well-designed human clinical trial)
• Clear about what is an opinion vs. a factual claim

The FTC has been especially active in pursuing supplement brands for deceptive health claims, with fines reaching into the millions. They also hold brands responsible for third-party claims made by affiliates and influencers promoting your products.

Practical Guidelines for Writing Claims

1. Use "supports" and "promotes" language: "Supports immune health" is almost always safer than "boosts immunity."
2. Add qualifiers when referencing health markers: "Helps maintain healthy cholesterol levels already within normal range" is compliant; "Lowers cholesterol" is not.
3. Avoid naming diseases entirely: If you find yourself writing the name of a disease, rethink the claim.
4. Review customer testimonials: Remove or edit reviews that make disease claims before displaying them on your website or marketing.
5. Brief your influencers: Provide approved talking points and a list of claims they cannot make. You are responsible for what they say about your product.
6. When in doubt, consult a regulatory attorney: The cost of a compliance review ($500–$2,000) is trivial compared to the cost of a warning letter.

CoreXponent Reviews Every Claim

At CoreXponent, compliance review is built into our brand development process. We review every label claim, website copy, and marketing material against FDA and FTC requirements before they go live — ensuring your brand communicates effectively within the legal boundaries.