FDA Compliance 2 min read · February 10, 2026

U.S. Supplement Label Compliance: The Complete Checklist for International Brands

Why Labels Make or Break Your U.S. Launch

For international supplement brands, labeling is often the single biggest hurdle to U.S. market entry. A label that's perfectly compliant in Europe, Australia, or Asia may violate multiple FDA requirements — and the consequences range from import detention to product seizure.

This comprehensive checklist covers every element your dietary supplement label needs for FDA compliance.

Required Label Elements

Principal Display Panel (Front of Package)

Statement of Identity: The common name of the product (e.g., "Dietary Supplement" or "Vitamin C Supplement")
Net Quantity: Amount of product in the container, in both metric and U.S. customary units
The term "Dietary Supplement": Must appear prominently

Supplement Facts Panel

Serving size and servings per container
Each dietary ingredient listed with amount per serving
% Daily Value based on current Reference Daily Intakes
Proprietary blends must list total weight and ingredients in descending order
"Other ingredients" listed below the panel

Information Panel

Name and place of business of manufacturer, packer, or distributor
Complete list of non-dietary ingredients (excipients, fillers, flavors)
Allergen declarations per FALCPA and FASTER Act
Adequate directions for use (suggested use statement)

Common Mistakes International Brands Make

Using "Nutrition Facts" instead of "Supplement Facts"
Missing or incorrect Daily Value percentages
Ingredient names that don't match FDA conventions
Claims that cross the line from structure/function to drug claims
Missing U.S. address on the label
Metric-only measurements without U.S. customary equivalents

Structure/Function Claims

If your label includes claims like "Supports immune health" or "Promotes joint flexibility," you must:

Have substantiation that the claims are truthful and not misleading
Include the FDA 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."
Notify the FDA within 30 days of first marketing with the claim

Get Expert Help

Label compliance is complex and mistakes are expensive. NPI's FDA Label Review service provides expert analysis of your supplement labels, identifying compliance gaps before they become costly problems. Your first label review is free for Blueprint members.

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