FDA Proposes Requirements for Using “Gluten-Free” Claims

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The U.S. Food and Drug Administration (FDA) announced a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, Gluten-Free Labeling of Fermented or Hydrolyzed Foods, pertains to FDA regulated beers as well as other foods. Due to the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records produced and kept by the manufacturer.

The proposed rule seeks to require manufacturers to keep records demonstrating that:

  • the food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, and
  • the manufacturer has adequately evaluated its process for any potential gluten cross-contact, and
  • where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

The comment period on this proposed rule is now open and the Brewers Association urges all affected brewers to read the rule and provide comments to FDA if they are so inclined. The comment period closes on February 16, 2016.