FDA Proposes Compliance Criteria for Gluten-Free Hydrolyzed, Fermented and Distilled Foods

November 19, 2015

By Riëtte van Laack

In 2013, FDA issued a final rule defining criteria for the term gluten-free for purposes of food labeling. The rule was “incomplete” because it did not address how to test fermented, hydrolyzed and distilled foods for compliance with the rule. In 2013, no scientifically valid test for gluten in those types of food was available. FDA stated that it would issue a proposal for compliance testing of those foods at a later date.  That time has come.   

In a proposed rule published earlier this week, FDA proposes to base the compliance for fermented and hydrolyzed foods, not on testing of the final product, but on records concerning the foods before they are fermented or hydrolyzed. Manufacturers must have records assuring that the food, before fermentation or hydrolysis, is gluten-free as that term is defined in the regulation, and assuring that during the manufacturer of the product no contamination with gluten occurs.  Records would need to be retained for two years after the introduction or the delivery for introduction of the food into interstate commerce and must be available to FDA for examination and copying during an inspection upon request.

For distilled foods, FDA proposes to test for the presence of protein and protein fragments. Because distillation is intended to separate volatile components from non-volatile components, the distilled product should not contain protein or protein fragments. Because gluten is a type of protein, the absence of protein and protein fragments would equate to gluten free.

FDA invites comments on the proposed rule and on a number of issues discussed in the preamble, e.g., evidence that fermentation or hydrolytic processes sufficiently break down gluten into peptides that are harmless to persons with celiac disease and how to address foods that are concentrated or dried after fermentation or hydrolysis.

Comments are due by February 16, 2016