Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods

The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning "gluten-free" labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help 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." Currently, FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a "gluten-free" claim 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 need to provide adequate assurance that the food or ingredients used in the food are "gluten-free" before fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the "gluten-free" claim to make and keep these records. In addition, because currently there is no scientifically valid analytical method effective in detecting and quantifying the gluten protein content in fermented or hydrolyzed foods the final rule requires the manufacturer of these kinds of 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, the final rule requires manufacturers of foods that contain fermented or hydrolyzed ingred