Going Gluten-Free: FDA’s Rule on “Gluten-Free” Labeling: Summary and Guidance


Questions include how to prevent cross-contamination and how to comply with FDA’s gluten-free rules.

This rule states that the "gluten-free" label can apply only to foods and supplements that do not contain an ingredient that is: 1) a gluten-containing grain, 2) derived from a gluten-containing grain that has not been processed to remove gluten, or 3) derived from a gluten-containing grain that has been processed to remove gluten if the use of that ingredient results in the presence of 20 ppm or more gluten in the finished food or supplement.

In an online Q&A guidance document, FDA suggests the following quality-control measures as options for food and supplement manufacturers seeking compliance with the labeling rule:

  • Conduct in-house gluten testing of raw ingredients or finished foods 

  • Partner with a third-party laboratory to conduct in-house gluten testing       

  • Request certificates of gluten analysis from ingredients suppliers

  • Participate in a third-party gluten-free certification program

The online Q&A document also calls out the specific methods FDA uses to determine compliance with the rule: the sandwich ELISA R5-Mendez Method and Morinaga Wheat Protein ELISA Kit (Gliadin).

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