FDA Proposes New Rule for Gluten-Free Labeling Compliance:

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Fermented, Hydrolyzed and Distilled Food

Rockville, MD-The U.S. Food and Drug Administration (FDA) has released a proposed rule for establishing gluten-free labeling compliance requirements for fermented, hydrolyzed and distilled food.

They are accepting public comment starting today. On August 5, 2013 FDA issued a final rule for the definition of gluten-free for products voluntarily bearing a gluten-free claim as a food that, “does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food).”

However, despite this final rule, there was uncertainty about interpreting results of gluten testing methods for fermented and hydrolyzed food. Because of this uncertainty, the proposed rule seeks to create an alternative process to confirm compliance for products that bear the term gluten-free. Under this proposed rule, compliance will be evaluated based on records made and kept by the manufacturer of the claim-bearing product, which would be made available to FDA for inspection and copying. For distilled products, while gluten is unlikely to be present, because it is a purification process, the proposed rule seeks to verify the adequacy of the distillation process in removing all proteins, including gluten. It is also important to note that distilled products derived from gluten-containing grains can bear gluten-free claims because of the distillation process.

Published in WholeFoods Magazine, January 2016