INTERNATIONAL TRADE LAW
Importing Gluten-Free Food: FDA Rules
To label imported food “gluten-free,” it must contain less than 20 parts per million (ppm) of gluten and meet the FDA’s definition of the term — and that standard applies to imported food exactly as it applies to food made in the United States. The “gluten-free” claim is voluntary, but once you make it, the FDA’s rule is mandatory, and getting it wrong is a labeling violation that can hold your shipment at the border.
The FDA Gluten-Free Standard
The FDA published its final rule defining “gluten-free” on August 5, 2013, with compliance required by August 5, 2014. It is codified at 21 CFR 101.91. The rule sets a single national standard so that consumers with celiac disease can rely on the claim regardless of where the food was produced.
Under the rule, a food may be labeled “gluten-free” only if it meets all of these conditions:
- It does not contain an ingredient that is a gluten-containing grain — wheat, rye, barley, or their crossbred hybrids (including varieties such as spelt, durum, and triticale).
- It does not contain an ingredient derived from those grains that has not been processed to remove gluten.
- If it contains an ingredient derived from those grains that was processed to remove gluten, the food still contains less than 20 ppm gluten.
- Any unavoidable presence of gluten in the food is below 20 ppm.
The same standard governs the related claims “no gluten,” “free of gluten,” and “without gluten.”
Why 20 ppm
Twenty parts per million is the lowest level that can be reliably and consistently detected using scientifically validated analytical methods. The FDA does not require testing, but if it tests a product bearing the claim, it uses methods validated to detect gluten at 20 ppm in both raw and cooked or baked foods. For an importer, that means the claim has to be defensible by analysis — a marketing statement is not enough.
What This Means for Importers
Imported food is held to the identical standard, and the importer is responsible for the accuracy of the claim on the U.S. label. Practically, that breaks down into three obligations.
| Obligation | What it looks like in practice |
|---|---|
| Accurate labeling | The U.S. label’s “gluten-free” claim must be truthful and meet 21 CFR 101.91 |
| Supporting records | Test results, certificates of analysis, or supplier documentation showing the food is below 20 ppm |
| Contamination control | Confirmation that sourcing, processing, and shipping do not introduce gluten cross-contact |
Because a “gluten-free” claim is a label statement, an unsupported or inaccurate claim is misbranding — one of the most common reasons FDA-regulated food is detained at entry.
Labeling, Not Just Testing
A gluten-free claim does not exempt imported food from the rest of U.S. food labeling law. The label still needs the statement of identity, net quantity, ingredient list, allergen declaration, and Nutrition Facts. A product can be genuinely below 20 ppm and still be refused for an unrelated labeling defect, so the gluten-free claim should be reviewed as part of the full label, not in isolation. These requirements sit alongside the broader FDA food import rules.
How a Gluten-Free Shipment Gets Held
If the FDA questions a gluten-free claim — or any other label element — it issues a Notice of Detention and gives the importer a window to respond with evidence. That is the moment private lab results and supplier records earn their keep. If the importer cannot overcome the appearance of a violation, the shipment is refused and must be exported or destroyed. See our guides to the FDA detention process and the Notice of Refusal for how that sequence runs.
Frequently Asked Questions
What is the FDA’s threshold for “gluten-free”?
Less than 20 ppm of gluten. That is the lowest level reliably detectable by validated test methods, and it applies whether the food is domestic or imported.
Is the gluten-free label required?
No — using the claim is voluntary. But if a food bears “gluten-free,” “no gluten,” “free of gluten,” or “without gluten,” it must meet the FDA’s definition under 21 CFR 101.91.
Do imported gluten-free foods follow the same rule as domestic ones?
Yes. The standard is identical, and the U.S. importer is responsible for the accuracy of the claim on the product’s U.S. label.
Does the FDA require gluten testing before import?
The rule does not mandate testing, but the importer must be able to support the claim. If the FDA tests the product and finds 20 ppm or more, the food is misbranded — so documentation and, where appropriate, testing are how importers protect the claim.
A gluten-free claim is a legal statement, not a marketing flourish, and the importer owns it at the border. Reidel Law Firm helps importers review labels and build records that support FDA claims, on flat-fee terms. Get an import compliance memo.
