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.
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.
LabelGuard scans your label for gluten and all its derivatives including: Wheat flour, Barley malt, Rye, Oats (unless certified GF), Spelt.
Start Your Compliance CheckCommon hidden sources include: Wheat flour, Barley malt, Rye, Oats (unless certified GF), Spelt, Modified starch.
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.
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.
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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