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Guide

Gluten-free labeling of foods (FDA)

A US gluten-free claim is a voluntary claim with a mandatory meaning: the food must meet FDA’s 21 CFR 101.91 rule, generally under 20 ppm gluten, without wheat, rye, barley or their hybrids as ingredients. It is not a synonym for “Contains: wheat” being absent.

Reviewed against official guidance.SourcesNot legal advice.

The short answer

A US gluten-free claim is a voluntary claim with a mandatory meaning: the food must meet FDA’s 21 CFR 101.91 rule, generally under 20 ppm gluten, without wheat, rye, barley or their hybrids as ingredients. It is not a synonym for “Contains: wheat” being absent.

Where this shows up in a real kitchen

Oat cookies labeled gluten-free get people sick when the oats are wheat-contaminated. FALCPA would not have required “wheat” if wheat was never an ingredient — the gluten-free claim still fails. UK gluten-free rules exist too; do not mix the logos and assume the tests are identical in paperwork.

The US rule

FDA’s gluten-free labeling rule defines the claim, including how oats and fermented foods are handled. You may not use the claim if the food has wheat as an ingredient. Testing and supplier control are how you know you are under 20 ppm. The gluten-free page on FDA.gov is the primary source.

How to apply it

If you do not need the claim, do not make it. If you do, lock suppliers of oats, spices and starches, test, and keep wheat, rye and barley out of the formula. Still declare milk or egg if they are present — gluten-free is not allergen-free.

  1. Decide whether you need the claim at all.
  2. Remove wheat, rye, barley and hybrids from the formula.
  3. Control oats and shared equipment, then verify gluten levels.
  4. Keep FALCPA names for milk, egg, soy, nuts — the claim does not replace them.

Worked example

A certified gluten-free brownie using cocoa, sugar, butter (milk), eggs, almond flour: Contains: milk, egg, almond. No wheat. A “gluten-free” brownie that uses regular soy sauce with wheat is misbranded even if the front is full of wheat-ear logos.

Checks that belong on this pack

CheckWhy it matters
Wheat is not an ingredientSpelt counts as wheat.
Oats are gluten-free grade if usedCommodity oats are a common failure.
Soy sauce is wheat-free if the claim is usedTamari still needs a spec.
Contains line still lists milk and nuts that are presentGluten-free customers can still have milk allergy.

Printing GLUTEN-FREE because you used almond flour once

A flour swap without a 101.91 process is a claim, not a feeling.

What LabelClear can and cannot print

Declare wheat when wheat is in the recipe. Add a gluten-free claim only when you mean the FDA definition — the generator will not certify 20 ppm.

Questions

Is gluten-free the same as wheat-free?
Wheat-free is about wheat. Gluten-free also covers rye and barley and a ppm limit.
Do I have to certify?
FDA does not require a third-party mark. The claim still has to be true.
Can I use a UK “gluten free” logo as-is?
You still have to meet the US rule on a US pack. Marks have their own licence terms.

Official sources

Everything on this page traces back to these. Where they and we disagree, they are right — tell us and we'll fix it.