food labeling gluten-free labeling of fermented or hydrolyzed foods 17 pages in english prethe food and drug administration fda or we is proposing to establish requirements concerning gluten-free labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. these additional requirements for the gluten- free labeling rule are needed to hel ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as gluten-free. there is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. thus we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a gluten-free claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the gluten-free claim and made available to us for inspection and copying. the records would need to provide adequate assurance that the food is gluten-free in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. in addition the proposed rule would require the manufacturer of fermented or hydrolyzed foods bearing the gluten-free claim to document that it has adequately evaluated the potential for gluten cross-contact and if identified that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. likewise manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the gluten-free claim would be required to make and kee records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are gluten-free in compliance with the gluten-free food labeling final rule. finally the proposed rule would state that we would evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food. pre