LabelGuard
Allergen Guide

πŸ‡ΊπŸ‡Έ Gluten Allergen in US

Gluten (Cereals containing gluten) is NOT a regulated major allergen in US, but must still appear in the ingredients list if present. US law regulates wheat as the major allergen β€” barley and rye are not FALCPA allergens β€” and "gluten-free" is separately defined as under 20 ppm by 21 CFR 101.91.

What the Rule Is

Gluten is not on the regulated allergen list in United States, but it must still be declared as an ingredient when present, and export markets may treat it differently. FALCPA (2004) and the FASTER Act (2021) define 9 major allergens β€” milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (mandatory since 1 January 2023). Each must be declared either in parentheses in the ingredient list or in a "Contains" statement, and tree nut species must be named individually.

What You Must Include
  • Clear declaration of "Gluten" or specific derivative names
  • Proper emphasis in the ingredients list
  • Declaration of processing aids containing the allergen
Common Violations
  • Using scientific names without the common name "Gluten"
  • Missing hidden sources in compound ingredients
  • Insufficient emphasis in ingredients list
Examples: Compliant vs Non-Compliant

Compliant Examples

Ingredients: Flour, **Gluten**, Sugar

Non-Compliant Examples

Ingredients: Flour, Gluten, Sugar (no emphasis)
How LabelGuard Checks This

LabelGuard scans your label for gluten and all its derivatives including: Wheat flour, Barley malt, Rye, Oats (unless certified GF), Spelt.

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Frequently Asked Questions

What ingredients contain hidden gluten?

Common hidden sources include: Wheat flour, Barley malt, Rye, Oats (unless certified GF), Spelt, Modified starch.

Is gluten one of the major allergens in US?

No β€” gluten is not on the regulated allergen list in US, but it must still appear in the ingredients list if present. US law regulates wheat as the major allergen β€” barley and rye are not FALCPA allergens β€” and "gluten-free" is separately defined as under 20 ppm by 21 CFR 101.91.

How are allergens required to be declared in US?

FALCPA (2004) and the FASTER Act (2021) define 9 major allergens β€” milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (mandatory since 1 January 2023). Each must be declared either in parentheses in the ingredient list or in a "Contains" statement, and tree nut species must be named individually.

Regulation Sources

Last updated: 2026-07-20

Disclaimer: This information is for guidance only and does not constitute legal advice. Always consult official regulations and seek professional legal advice for specific compliance questions.

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