Level 3

KEY POINTS:

  • Naturally gluten-free grains and flours NOT labeled gluten-free may be contaminated with wheat, barley, and rye. 1
  • Under the Food and Drug Administration's (FDA) proposed rule, labeled gluten-free grains and flours should contain less than 20 ppm of gluten. 2
  • Manufacturers of labeled gluten-free grains and flours (and gluten-free products in general) take several steps to make sure their products truly are gluten-free. 3 These steps may include:
    • Using a dedicated gluten-free processing facility, dedicated processing room, dedicated processing lines, or dedicated processing equipment.
    • Following current Good Manufacturing Practices including scrupulous cleaning procedures.
    • Implementing a Hazard Analysis Critical Control Points plan.
    • Implementing an Allergen Control Plan.
    • Testing of at risk ingredients, such as grains and flours.
    • Testing of finished food products.
    • Validating in-house testing procedures.
    • Sending finished product to third party testing facilities for independent testing using state-of-the-art testing methods (e.g., R5 ELISA).
  • Routine testing of finished products using state-of-the-art testing methods is the most important step manufacturers should take to ensure labeled gluten-free products truly are gluten-free as defined by the FDA's proposed rule

TAKE HOME MESSAGES:

  • Manufacturers of labeled gluten-free grains and flours may take several steps to make sure their products are truly gluten-free.
  • These steps should include routine testing of finished products using state-of-the-art testing methods.

RESOURCES FOR YOU:

Gluten-Free Dietitian. Assessing the Gluten Content of Foods: Sandwich ELISAs. http://www.glutenfreedietitian.com/newsletter/2011/02/28/assessing-the-gluten-content-of-foods-sandwich-elisas/ . Accessed November 3, 2011.

References:

  1. Thompson T, Lee AR, Grace T. Contamination of naturally gluten-free grains, seeds, and flours in the United States: A pilot study. J Am Diet Assoc. 2010;110:937-940.
  2. U.S. Food and Drug Administration. Federal Register Proposed Rule-72 FR 2759 January 23, 2007. Food Labeling: Gluten Free Labeling of Foods. http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm077926.htm. Accessed October 13, 2011.
  3. Gluten Free Dietitian. Contamination of Naturally Gluten-Free Grains: Part 2. http://www.glutenfreedietitian.com/newsletter/contamination-of-naturally-gluten-free-grains-part-2/ . Accessed November 3, 2011.

Revision Date: 8-29-12 
Author: Tricia Thompson, MS, RD 
Editors: Melinda Dennis, MS, RD, LDN and Daniel Leffler, MD, MS

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