The short answer
“Gluten-free”, “organic” and “non-GMO” are three very different claims, controlled by different U.S. agencies:
| Claim | Who controls it | The key rule |
|---|---|---|
| Gluten-free | FDA | Voluntary claim; the food must meet FDA’s definition, including less than 20 parts per million (ppm) gluten (21 CFR 101.91). |
| Organic | USDA National Organic Program | Only certified products can be sold or labeled as organic in the U.S. Organic imports need an NOP Import Certificate. |
| Non-GMO | FDA (truthful labeling) and USDA (bioengineered disclosure) | Voluntary; must be truthful and not misleading. Separately, some foods must carry a USDA “bioengineered” disclosure. |
Getting any of them wrong can make the food misbranded — and for organic, the shipment can be stopped at the border.
Gluten-free (FDA)
FDA’s gluten-free rule, published in August 2013, sets one standard for any food labeled “gluten-free”, “no gluten”, “free of gluten” or “without gluten”:
- Gluten comes from wheat, rye, barley and their crossbreeds.
- The food must not contain an ingredient that is one of those grains, or derived from them and not processed to remove gluten — and any unavoidable gluten must be below 20 ppm.
- Oats can be labeled gluten-free if the finished food is below 20 ppm.
- The claim is voluntary — you don’t need it, but if you use it, you must meet the standard.
Fermented or hydrolyzed foods (for example soy sauce, yogurt, beer-style drinks, vinegar or hydrolyzed proteins) have extra rules since August 13, 2021: the manufacturer must keep records showing the food was gluten-free before fermentation or hydrolysis, and that the risk of gluten cross-contact was evaluated and controlled. Records must be kept for at least 2 years.
Organic (USDA)
“Organic” is controlled by the USDA, not FDA. Under the Strengthening Organic Enforcement rule (fully in force since March 19, 2024):
- Every organic shipment needs an NOP Import Certificate, issued electronically by the exporter’s certifier in USDA’s Organic Integrity Database before export.
- The importer must be certified under the USDA organic regulations. Customs brokers who only clear the goods generally are not.
- Products handled by an uncertified business cannot be sold, labeled or represented as organic in the U.S.
- Since October 1, 2025, organic shipments that arrive without a valid certificate cannot be fixed at the port — they must be re-exported, destroyed or (in limited cases) donated.
Equivalence arrangements: the U.S. has organic equivalence arrangements with Canada, Japan, Korea, Switzerland, Taiwan, the United Kingdom and the European Union, and recognition agreements with Israel and New Zealand. Products from these partners can be certified to their own standard (with conditions). Exporters elsewhere — for example in India, Mexico or Peru — need certification to the USDA organic standard by a USDA-accredited certifier.
Non-GMO and the “bioengineered” disclosure
“Non-GMO” is voluntary. FDA’s guidance on voluntary labeling says such claims must be truthful and not misleading. Avoid wording that suggests the product is safer or better because it is non-GMO, and be careful with “GMO-free” on foods where no GMO version exists (such as salt or water). Private verification seals are private programs, not government approval.
The USDA “bioengineered” disclosure is mandatory for some foods. Under the National Bioengineered Food Disclosure Standard (7 CFR part 66), mandatory compliance began January 1, 2022. Foods that are or contain detectable bioengineered material — common examples are ingredients from some corn, soybeans, canola and sugar beets — may need a disclosure (text, the USDA symbol, a QR code or other permitted options). Very small food manufacturers are exempt.
Example: corn snacks from Mexico
A tortilla chip maker labels its U.S. pack “Gluten-Free · Organic · Non-GMO”. To keep all three, it needs: lot testing below 20 ppm gluten and a plant with no wheat cross-contact; USDA organic certification, a certified U.S. importer and an NOP Import Certificate for every shipment; and evidence that its corn is not bioengineered. If any one fails, that claim must come off the label.
Checklist before you print
- 1Gluten-freeBelow 20 ppm, no gluten grains unless processed to remove gluten, records for fermented or hydrolyzed foods.
- 2OrganicUSDA certification (or an equivalence arrangement), a certified importer, and an NOP Import Certificate per shipment.
- 3Non-GMOSupplier evidence, truthful wording, and a check whether a bioengineered disclosure is needed.
- 4The rest of the labelClaims do not replace the basics — Nutrition Facts, ingredients, allergens and net quantity.
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Frequently asked questions
What is the gluten limit for “gluten-free” in the US?
Less than 20 parts per million (ppm) of gluten, under FDA’s rule at 21 CFR 101.91.
Can I sell EU-certified organic food as organic in the US?
The U.S. has an organic equivalence arrangement with the EU, so EU-certified products can be sold as organic subject to the arrangement’s terms — but every shipment still needs an NOP Import Certificate and a certified importer.
Is a “non-GMO” claim regulated?
It is voluntary, but it must be truthful and not misleading under FDA labeling law. Separately, USDA requires a bioengineered disclosure on certain foods.
Who regulates the word “organic” on food labels?
The U.S. Department of Agriculture’s National Organic Program, not FDA.
Sources
- Federal Register — Gluten-free labeling of fermented or hydrolyzed foods (August 13, 2020; summarizes the 2013 rule, 78 FR 47154)
- USDA AMS — Strengthening Organic Enforcement: imports (updated June 2026)
- Federal Register — Strengthening Organic Enforcement final rule (January 19, 2023)
- Federal Register — National Bioengineered Food Disclosure Standard final rule (December 21, 2018)
Dates and requirements checked on November 11, 2026. This article is general information, not legal advice.