FDA Extends Comment Period for Proposed Rule Addressing Fermented and Hydrolyzed Foods with Gluten-Free Claims

The U.S. Food and Drug Administration (FDA) has extended from
February 16 to February 22, 2016, the comment period regarding
requirements for fermented and hydrolyzed foods or those containing
fermented or hydrolyzed ingredients that 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. See Federal Register,
January 22, 2016.

Issue 591