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Food Safety Command Center 15 items

Gluten-Free Labeling Verification Checklist

Verify eligibility to make a gluten-free claim under FDA's rule, covering the 20 ppm threshold, ingredient sourcing, cross-contact controls, testing, and label compliance.

21 CFR 101.91FDA Gluten-Free Rule

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Gluten-Free Claim Eligibility

  • Does the finished product contain less than 20 ppm of gluten? *
  • Is the product free of any gluten-containing grain (wheat, rye, barley, or their crossbred hybrids)? *
  • If a gluten-containing grain was processed to remove gluten, is the result verified below 20 ppm? *

Ingredient Sourcing

  • Are ingredient specifications reviewed to confirm gluten-free status of all inputs? *
  • Are oats verified as gluten-free (purity-protocol or tested) where used? *
  • Are supplier certificates of analysis or gluten-free certifications on file? *

Cross-Contact Controls

  • Are cross-contact controls in place to prevent gluten introduction during manufacturing? *
  • Are shared lines cleaned and validated before gluten-free production runs? *
  • Is airborne flour contamination controlled where gluten-containing products are also produced? *

Analytical Testing

  • Is finished product tested for gluten using a validated method (e.g., R5 ELISA)? *
  • Are testing frequency and sampling plans documented? *
  • Recorded gluten test result (ppm)

Label Compliance

  • Is the gluten-free claim used only on products that meet the rule's requirements? *
  • Are equivalent claims (no gluten, free of gluten, without gluten) held to the same standard? *
  • Are records supporting the gluten-free claim retained and available? *

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