FDA Sets "Gluten-Free" Labeling Standards


The FDA’s new final rules on gluten-free labeling went into effect on September 4, 2013. Manufacturers have until August 5, 2014 to comply with the FDA’s new rules. Many manufacturers currently label their food with a "gluten-free" labeling claim. However, there is no current regulatory definition for the "gluten-free" claim in the United States. According to the FDA, "Establishing a definition of the term ‘gluten-free,’ and uniform conditions for its use in food labeling, will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled."

The FDA rule defines and sets conditions on the voluntary use of the term "gluten-free" on foods, as follows:

  • Foods that inherently do not contain gluten (e.g., raw carrots or grapefruit juice) may use the "gluten-free" claim;
  • Foods with any whole, gluten-containing grains (e.g., spelt wheat) as ingredients may not use the claim;
  • Foods with gluten-containing grains that are refined but still contain gluten (e.g., wheat flour) may not use the claim;
  • Foods with gluten-containing grains that have been refined in such a way to remove the gluten may use the claim, so long as the food contains less than 20 ppm gluten and has less than 20 mg gluten per kg (e.g. wheat starch); and,
  • Foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten containing grains.

Foods labeled as "without gluten," "free of gluten" or "no gluten" also fall within the scope of the rule. Read more about the rule here.

Labeling Action Items
Anyone affixing a "gluten-free" or similar label on food products should ensure that the product complies with the FDA’s new rules. The final rule does not specifically require manufacturers to test for the presence of gluten in their starting ingredients or finished foods labeled gluten-free. However, manufacturers are responsible for ensuring that foods bearing a gluten-free claim meet the requirements of the final rule. The FDA has stated that it "may use the full range of its routine post-market monitoring activities to enforce the final rule on gluten-free food labeling." This would include manufacturing facility inspection, food label reviews and follow up on industry/consumer complaints.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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