AGENCY: Food and Drug Administration, HHS
ACTION: Final rule
SUMMARY: 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 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 ingredients and bear the "gluten-free" claim to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are "gluten-free" in compliance with the 2013 gluten-free food labeling final rule. Finally, this final rule states that we will 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.
Effective date: This rule is effective 13 October 2020.
Compliance date: The compliance date of this final rule is 13 August 2021.
This final rule and previous actions notified under the symbol G/TBT/N/USA/1050 are identified by Docket Number FDA-2014-N-1021. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=FDA-2014-N-1021 and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.