Supplement Label Compliance: FDA Requirements

The Stakes of Label Compliance

FDA warning letters for supplement labeling violations are public record and can destroy brand credibility overnight. In 2023, the FDA issued 47 warning letters to supplement companies — the majority for labeling violations. Understanding the rules is non-negotiable.

Required Label Elements

Principal Display Panel (PDP): - Product name - Net quantity of contents - "Dietary Supplement" designation

Information Panel: - Supplement Facts panel - Ingredient list (for non-nutritive ingredients) - Name and address of manufacturer/distributor - Directions for use

Supplement Facts Panel Requirements

The Supplement Facts panel must include: - Serving size and servings per container - Calories (if applicable) - All dietary ingredients with amounts per serving - % Daily Value (if established) - "†" symbol for ingredients without established DV

Structure/Function Claims

Allowed: "Supports immune health," "Promotes healthy joints," "Helps maintain cardiovascular function"

Not allowed: Disease claims ("treats arthritis," "prevents cancer," "cures diabetes")

Required disclaimer: All structure/function claims must include: 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.

The disclaimer must appear on the label AND in any advertising.

Common Violations

1. Disease claims: "Treats," "cures," "prevents" — automatic violation
2. Missing disclaimer: Required on all products with S/F claims
3. Incorrect serving size: Must reflect realistic consumption
4. Missing ingredient amounts: Every ingredient must have a quantity
5. Proprietary blends: Must list total blend weight; individual amounts optional but recommended
6. Expiration date claims: If stated, must be substantiated by stability data