On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients.

The proposed rule builds on the FDA’s 2013 final rule defining the term “gluten-free” for voluntary use in labeling of foods. Under the 2013 final rule, manufacturers could label their products as “gluten-free” if it does not: (a) contain an ingredient that is a gluten-containing grain; (b) an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten; or (c) an ingredient that is derived from a gluten-containing grain, and that has been processed to remove gluten, if the use of that ingredient.

At its core, the proposed rule would amend the FDA’s existing gluten-free rule to provide alternative means for FDA to verify compliance for fermented, hydrolyzed, or distilled foods (including beverages, such as beer) based on records maintained by the manufacturer of the food.  Specifically, manufacturers would be required to make and keep records demonstrating assurance that:

  1. The food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis;
  2. The manufacturer has adequately evaluated its process for any potential gluten cross-contact; and
  3. 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 FDA, however, is soliciting comments and data to determine if, and to what extent, manufacturers of fermented or hydrolyzed foods can adequately quantify the gluten content contained in the final product.  Among other things, the FDA is requesting:

  • Comments, including scientific data, on any studies that have been conducted to demonstrate whether any fermentation or hydrolytic processes sufficiently break down gluten into peptides that are harmless to persons with celiac disease;
  • Research into methods that can be used to quantify the gluten protein content in fermented or hydrolyzed foods in terms of intact gluten, including the use of ELISA-based methods and Mass Spec testing;
  • Comments and data on the feasibility and circumstances under which a food can be processed to remove gluten and the methods by which the absence of gluten can be determined;
  • Comments and information relating to the removal of gluten in beers, including: (1) efficacy of competitive ELISA-based methods; (2) the effect of enzymes used to break down the gluten; and (3) scientific research regarding whether beer derived from gluten-containing grains that may still contain protein fragments from gluten.

The comment period is open for 90 days, and comments can be submitted through February 16, 2016.

In addition, the FDA is also soliciting comment on the related information collection issues under the Paperwork Reduction Act.  These comments must be submitted by December 18, 2015.