Why FDA Label Compliance Matters

Food labels are one of the first things the FDA and U.S. Customs & Border Protection examine when your shipment arrives in the United States. A non-compliant label can result in detention, refusal of admission, or a recall — even if the product itself is perfectly safe.

U.S. food labeling requirements are governed primarily by the Fair Packaging and Labeling Act (FPLA) and 21 CFR Parts 101–199. These are more detailed and strict than most international standards.

Mandatory Label Elements

Required on Every Food Label for U.S. Market

  • ✅ Statement of identity (product name)
  • ✅ Net quantity of contents (in both metric and U.S. customary units)
  • ✅ Ingredient list (in descending order by weight)
  • ✅ Nutrition Facts panel
  • ✅ Allergen declaration
  • ✅ Name and address of manufacturer, packer, or distributor
  • ✅ Country of origin (for most products)

1. Statement of Identity

The product name must appear prominently on the Principal Display Panel (PDP) — the front of the package. It should be the common or usual name of the food. Generic descriptors are required when no standard identity exists.

2. Net Quantity of Contents

This must be declared on the lower 30% of the PDP. For products sold in the U.S., you must declare net quantity in both metric (grams/milliliters) and U.S. customary units (ounces/fluid ounces). The minimum type size is determined by the PDP area and is strictly regulated.

3. Ingredient List

All ingredients must be listed by their common or usual name in descending order of predominance by weight. Sub-ingredients of compound ingredients must also be declared. Color additives must be listed by their specific FDA-approved name (not generic "artificial color").

⚠️ Note: The EU uses INCI names for some ingredients, but the U.S. uses different naming conventions. Ensure your ingredient names comply with FDA's permitted names, not EFSA or Codex standards.

4. Nutrition Facts Panel

The Nutrition Facts panel must follow the updated 2020 FDA format, which includes:

Serving sizes must reflect actual amounts people typically consume, not manufacturer-preferred serving sizes. FDA has prescribed Reference Amounts Customarily Consumed (RACCs) for each food category.

5. Allergen Declaration — FALCPA & FASTER Act

The U.S. currently recognizes 9 major food allergens that must be declared:

Allergens must be declared either in the ingredient list (using common names in parentheses) or in a separate "Contains" statement immediately after the ingredient list. Both methods are acceptable but must be consistent.

6. Name and Place of Business

The label must include the name and address of the manufacturer, packer, or distributor. If the product is not manufactured by the company named, a qualifying phrase such as "Manufactured for" or "Distributed by" must precede the name.

Common Label Mistakes That Cause Customs Issues

✅ Regovant offers label review services as part of our food consulting package. We review your label against all current FDA requirements before your first shipment.
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