Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period

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The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule on the "gluten-free" labeling of foods, published in the Federal Register of January 23, 2007 (72 FR 2795). In that document, FDA proposed to define the term "gluten- free," for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as "prohibited grains"); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited 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; or 20 ppm or more gluten. FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten exposure and seek comments on the safety assessment and its potential use in defining the term "gluten-free" in the final rule. A report by FDA discussing a health hazard assessment we conducted, which included a safety as