FDA Releases Proposed Rule to Establish ‘Gluten-Free’ Labeling Compliance Requirements for Fermented, Hydrolyzed and Distilled Foods

November 17, 2015

The U.S. Food and Drug Administration today released 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, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers.

In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten. Due to this uncertainty, 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 that are made and kept by the manufacturer.

The proposed rule, when finalized, would require these manufacturers to make and keep records demonstrating assurance 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.

Distilled foods such as distilled vinegars are also included in the proposed rule. Distillation is a purification process that separates volatile components from non-volatile components such as proteins. Thus, when properly done, gluten should not be present in distilled foods. The proposed rule states that FDA would evaluate compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

The FDA is accepting public comments beginning Wednesday, November 18. To electronically submit comments to the docket, visit www.regulations.gov and type docket number “FDA-2014-N-1021” in the search box.