For people with celiac disease, understanding food labels is a matter of health and safety
For people with celiac disease, “gluten-free” on a label is the starting point—not the guarantee. Understanding what labeling regulations actually require helps you make informed decisions about which products meet your safety needs.
This guide explains what labels mean, where the regulations fall short, and how to identify products that go beyond the legal minimum.
The FDA “Gluten-Free” Standard
What the Law Requires
Since August 2014, the FDA has regulated the term “gluten-free” on food labels.
The rule:
- Any product labeled “gluten-free,” “free of gluten,” “without gluten,” or “no gluten” must contain less than 20 parts per million (ppm) of gluten
Why 20 ppm?
The FDA chose 20 ppm based on:
- Testing limitations: It’s “reliably detectable” with available testing methods
- Limited research: Studies available at the time suggested most people with celiac disease could tolerate this level
- International alignment: The Codex Alimentarius uses the same threshold
What 20 ppm Means in Practice
| Measurement | Context |
|---|---|
| 20 ppm | 20 mg gluten per 1 kg (2.2 lbs) of food |
| Regular bread | ~75,000-150,000 ppm gluten |
| A crumb (~0.1g) | More gluten than 500g of 20 ppm product |
| Daily intake at 20 ppm | If eating 500g of gluten-free products daily = 10mg gluten |
The Problem with 20 ppm
Here’s what the FDA standard doesn’t tell you:
Research shows some people react to lower levels:
| Study | Finding |
|---|---|
| Catassi et al., 2007 | 10mg/day gluten caused intestinal damage in some patients |
| Akobeng & Thomas, 2008 | No clear safe threshold; sensitivity varies by individual |
| Hollon et al., 2015 | Some patients show immune response to <20 ppm |
The math matters:
- If you eat 500g of products at 19 ppm daily: 9.5 mg gluten
- Research suggests 10mg can cause damage in sensitive individuals
- The “safe” threshold provides less margin than it appears
20 ppm is a minimum standard—not optimal for everyone with celiac disease.
Third-Party Certification: Beyond the FDA Minimum
Several organizations offer certification programs with stricter standards and third-party verification.
Certification Comparison
| Certification | Threshold | Testing | Verification |
|---|---|---|---|
| FDA “Gluten-Free” | <20 ppm | Manufacturer responsibility | None required |
| GFCO | <10 ppm | Required | Annual audits |
| CSA | <5 ppm | Required | Strictest verification |
| NSF Gluten-Free | <20 ppm | Required | Third-party audits |
Why Third-Party Certification Matters
- Independent verification — Not just manufacturer claims
- Regular testing — Ongoing, not just initial
- Facility audits — Protocols reviewed, not just products
- Accountability — Certification can be revoked
Identifying Certified Products
GFCO (Gluten-Free Certification Organization):
- Look for: Crossed grain symbol with “GFCO” text
- Standard: <10 ppm
- Search certified products
CSA (Celiac Support Association):
- Look for: CSA Recognition Seal
- Standard: <5 ppm
- Strictest major certification available
Dedicated Facility:
- Products made in facilities that process no gluten-containing ingredients
- Eliminates cross-contact at manufacturing level
- Not always certified but often safest option
Reading Labels: A Celiac-Safe Approach
What Must Be Disclosed
The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires clear labeling of wheat.
You’ll see wheat listed:
- In the ingredient list (e.g., “wheat flour”)
- In a “Contains” statement (e.g., “Contains: Wheat”)
Critical limitation: FALCPA does NOT require labeling of barley or rye. You must read the full ingredient list.
Ingredients to Watch For
Always avoid:
| Ingredient | Source |
|---|---|
| Wheat (all varieties) | Durum, semolina, spelt, kamut, einkorn, farro, emmer |
| Barley | Including barley malt, malt extract, malt flavoring |
| Rye | All forms |
| Malt | Usually from barley (malt vinegar, malted milk) |
| Brewer’s yeast | Usually from barley |
| Triticale | Wheat-rye hybrid |
Use caution:
| Ingredient | Concern |
|---|---|
| Oats | Only safe if certified GF; conventional oats heavily contaminated |
| Modified food starch | Usually corn in US; verify if concerned |
| Natural flavors | Rarely contain gluten but occasionally do |
| Caramel color | Almost never contains gluten in US |
”May Contain” Statements
Phrases like “may contain wheat” or “processed in a facility that handles wheat” are voluntary—not required by law.
What these statements mean:
- The product doesn’t contain wheat as an ingredient
- There’s potential cross-contact risk
- The manufacturer is being transparent about their facility
How to respond:
- Consider your sensitivity level
- Contact the manufacturer for specifics
- Third-party certification provides more assurance than label claims
What’s NOT Covered by FDA Labeling
The FDA “gluten-free” rule does NOT apply to:
| Product Type | Regulator | Notes |
|---|---|---|
| Alcohol | TTB (Treasury) | Separate rules; labeling inconsistent |
| Meat/poultry | USDA | May voluntarily use “gluten-free” |
| Restaurant food | Local/state | No federal labeling requirements |
| Prescription drugs | FDA (different division) | No gluten labeling requirement |
International Standards
If you travel or purchase imported products, know the differences:
European Union
- “Gluten-free”: <20 ppm
- “Very low gluten”: 21-100 ppm (not used in US)
- Crossed grain symbol widely recognized
Australia & New Zealand
- “Gluten-free”: No detectable gluten (strictest)
- Oats NOT permitted in gluten-free products
- Very rigorous testing requirements
Canada
- “Gluten-free”: <20 ppm
- Mandatory allergen labeling includes wheat, barley, rye, AND oats
Codex Alimentarius (International)
- “Gluten-free”: <20 ppm
- Baseline adopted by many countries
Medications and Supplements
Prescription Medications
The FDA does NOT require gluten disclosure on prescription drugs.
What to do:
- Ask your pharmacist
- Contact manufacturer directly
- Use GlutenFreeDrugs.com database
- Request compounding if needed
Over-the-Counter Medications
Some OTC medications voluntarily disclose gluten content, but it’s not required.
Dietary Supplements
Supplements MAY voluntarily use “gluten-free” labeling. If they do, they must meet the <20 ppm standard.
Advocacy: Making Labels Better
Report Problems
If you believe a product labeled “gluten-free” caused a reaction or is mislabeled:
- Document: Keep packaging, note lot number and expiration date
- Report to FDA: MedWatch reporting system
- Contact manufacturer: Request testing information
- Share with community: Report on Find Me Gluten Free or celiac forums
Support Better Standards
Organizations advocating for improved labeling:
Current advocacy priorities:
- Lower ppm threshold requirements
- Alcohol labeling reform
- Restaurant disclosure requirements
- Prescription drug labeling
Key Takeaways for Celiac-Safe Shopping
The Minimum
- “Gluten-free” on FDA-regulated foods = <20 ppm
- This is a minimum standard, not optimal for all patients
- No verification required—manufacturer self-declares
The Better Option
- GFCO certified = <10 ppm with third-party verification
- CSA certified = <5 ppm with strictest verification
- Dedicated facility = no gluten on premises
The Reality
- Read full ingredient lists—barley and rye aren’t always highlighted
- “Wheat-free” ≠ “gluten-free”
- “May contain” warnings are voluntary—absence doesn’t mean absence of risk
- When uncertain, contact the manufacturer
Your Best Protection
- Prioritize certified products for items you consume frequently
- Know your sensitivity level — some patients tolerate 20 ppm; others don’t
- Verify, don’t assume — formulations and facilities change
- Report problems — your feedback improves safety for everyone
Labeling regulations change. Always verify current requirements with official sources. This guide is for educational purposes and does not replace medical advice.
Sources
- FDA. “Questions and Answers: Gluten-Free Food Labeling Final Rule.” August 2013.
- Catassi C, et al. “A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease.” American Journal of Clinical Nutrition. 2007.
- Akobeng AK, Thomas AG. “Systematic review: tolerable amount of gluten for people with coeliac disease.” Alimentary Pharmacology & Therapeutics. 2008.
- Gluten-Free Certification Organization. “GFCO Certification Standards.” Accessed January 2026.
- FDA. “Food Allergen Labeling and Consumer Protection Act of 2004.” Accessed January 2026.
- Hollon J, et al. “Effect of gliadin on permeability of intestinal biopsy explants from celiac disease patients.” Nutrients. 2015.