FDA gluten free labeling rules for food labels and claims

FDA gluten free labeling is voluntary, but foods carrying the claim must meet ingredient restrictions and contain less than 20 ppm of unavoidable gluten. Third-party gluten-free certification is not required and does not replace compliance with 21 CFR 101.91.

For a label review, start with the formula rather than the laboratory report. A low gluten result cannot make a prohibited ingredient acceptable. The ingredient conditions apply separately from the concentration limit.

Which foods can carry a gluten-free claim?

The rule defines gluten-containing grains as wheat, rye, barley and their crossbred hybrids, such as triticale. Wheat includes any Triticum species. Oats are not one of the grains in this definition, but that does not make every oat product eligible. Section 101.91(a) sets out these definitions.

An inherently gluten-free food can qualify for the claim. For other foods, review each ingredient against these restrictions:

• The food cannot contain a gluten-containing grain.
• It cannot contain an ingredient derived from such a grain unless that ingredient has been processed to remove gluten.
• A processed-to-remove-gluten ingredient cannot cause the finished food to contain 20 ppm or more gluten.

Any unavoidable gluten must also remain below 20 ppm. Ordinary wheat flour is an example of an ingredient that has not been processed to remove gluten. Wheat starch is an example of an ingredient that may qualify after such processing, subject to the finished-food limit. These conditions come from section 101.91(a)(3).

Oats labeled gluten-free must contain less than 20 ppm gluten. FDA does not require third-party certification for those oats. A label team should therefore assess the actual oat ingredient and finished food, rather than assume either that oats are prohibited or that they automatically qualify. FDA addresses oats in its gluten-free labeling Q&A.

What does less than 20 ppm gluten mean?

The legal boundary is strict: less than 20 parts per million. Exactly 20 ppm does not meet it. Avoid approval notes or specifications that translate the rule into "20 ppm or less" or "up to 20 ppm." Those phrases include a result the regulation excludes.

A gluten-free claim is not a zero-gluten promise. The rule permits unavoidable gluten below its limit, provided the food also meets the ingredient conditions. That distinction matters when a test result looks acceptable but the formula includes an ingredient that the rule prohibits. A concentration result alone does not establish eligibility.

FDA uses a scientifically valid method when it tests food to assess compliance. The method must reliably detect and quantify 20 ppm gluten in different food matrices, including raw, cooked and baked products. That analytical requirement does not turn exactly 20 ppm into an acceptable label-claim result. Section 101.91(c)(1) describes FDA's testing approach.

Gluten on labels and wheat disclosure

The rule covers "gluten-free," "no gluten," "free of gluten" and "without gluten." Switching between those phrases does not avoid the definition. A food carrying a covered claim is misbranded if it fails the applicable definition or records conditions. Section 101.91(b) sets those consequences.

Gluten-free and wheat-free are not interchangeable. A qualifying processed wheat-derived ingredient can be permitted, but the gluten-free claim does not waive applicable wheat allergen disclosure. An extra condition applies when a gluten-free label names wheat in its ingredient list or the specified "Contains wheat" statement. See section 101.91(b)(3).

An asterisk or other symbol must appear immediately after "wheat." It must point to this exact statement, placed close to the ingredient statement:

The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.

Review the symbol, placement and wording together. The regulation prescribes that sentence, rather than leaving the explanation to the manufacturer's preferred wording.

FDA rules versus certified gluten-free

"Certified gluten free" describes a separate certification choice, not a prerequisite to using a gluten-free claim under FDA's rule. FDA does not endorse, accredit or recommend a particular third-party program. A gluten-free certification logo may appear if its use is truthful and not misleading. FDA explains these limits in its Q&A.

These distinctions follow FDA's small-entity guidance and its certification answers.

FDA lists third-party certification as one possible quality-control option. It does not set every private program's criteria. Assess the chosen program's terms separately, and do not assume all certifiers use the same threshold or testing schedule. The manufacturer remains responsible for compliant food and labeling, with or without a logo. Certification does not transfer that responsibility.

What evidence supports the claim?

FDA's rule does not require manufacturers to test ingredients or finished foods. It also does not excuse them from meeting the definition. Manufacturers need adequate assurance that a food carrying the claim complies. There is no universal batch-testing frequency in this rule. FDA distinguishes testing from the duty to comply.

For a practical approval file, check the formula, supplier assurance and cross-contact controls. Assess testing appropriate to the product, determine whether special records apply, and review the final claim and allergen text. This is a label-review workflow, not a separate FDA-mandated checklist or a complete food-safety assessment.

In that file, record why each grain-derived ingredient is eligible before reviewing finished-food results. This documents how the formula meets the rule's ingredient restrictions, rather than relying on a low test result alone.

Fermented and hydrolyzed foods need special attention

A final low test result does not replace applicable records for fermented or hydrolyzed foods. Where no scientifically valid method is available under section 101.91(c)(1), the rule requires records showing that:

• The food met the gluten-free definition before fermentation or hydrolysis.
• The manufacturer evaluated potential gluten cross-contact.
• Where that evaluation identified a risk, measures prevent gluten introduction.

Foods containing fermented or hydrolyzed ingredients have corresponding ingredient-assurance requirements. Sections 101.91(c)(2) and (3) explain both cases.

Keep these records for at least two years after introduction or delivery for introduction of the food into interstate commerce. That period does not simply run from production. Originals, true copies or electronic records are permitted. They must be available for FDA examination and copying on request during inspection. Section 101.91(c)(4) sets the retention requirements.

Distilled foods have a separate compliance approach. FDA verifies the absence of protein in the distilled component using scientifically valid analytical methods. Section 101.91(c)(5) sets out that approach. Check the product's regulatory jurisdiction before applying it to an alcoholic drink.

Check which agency regulates the product

This guide concerns FDA-regulated foods, including packaged foods and dietary supplements. Do not automatically apply it to USDA meat, poultry and certain egg products, or most TTB-regulated alcoholic drinks. Check the relevant jurisdiction before approving those labels. FDA's scope explanation distinguishes these categories.

RegAffairs AI's answer on FDA gluten-free labeling and certification links to the regulatory sources behind this question.

The operative text used here is 21 CFR 101.91, displayed as current through November 2, 2026.

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