FDA Proposed Rule Addresses Fermented and Hydrolyzed Foods with Gluten-Free Claims

The U.S. Food and Drug Administration (FDA) plans to set
requirements for fermented and hydrolyzed foods or those containing
fermented or hydrolyzed ingredients and carry the “gluten-free” claim.

The proposed rule would apply to foods such as sauerkraut, yogurt,
pickles, cheese, green olives, vinegar, and FDA-regulated beers.
Intended to address the uncertainty of interpreting test methods in
terms of intact gluten, the finalized rule would mandate manufacturers
to maintain records demonstrating: (i) “the food meets the requirements
of the gluten-free labeling final rule prior to fermentation or hydrolysis;
(ii) “the manufacturer has adequately evaluated its process for any
potential gluten cross-contact”; and (iii) “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.” The agency also intends to evaluate the
compliance of distilled foods by using scientifically valid methods to
determine the absence of protein or protein fragments. Comments will
be accepted until February 16, 2016. See Federal Register, November 18,
2015.

Issue 585