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.

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