Gluten-Free Labeling of Fermented or Hydrolyzed Foods

Respondents to the information collection are manufacturers of foods that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients and bear the claim “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” It imposes recordkeeping that FDA believes will provide a reasonable assurance that food so labeled is gluten-free before fermentation or hydrolysis; that the manufacturer has evaluated the potential for cross-contact with gluten during the manufacturing process; and that measures have been taken to prevent the introduction of gluten into the food during the manufacturing process.

The latest form for Gluten-Free Labeling of Fermented or Hydrolyzed Foods expires 2023-08-31 and can be found here.

ONE TIME Recordkeeping for rule implementation

Federal Enterprise Architecture: Health - Consumer Health and Safety