The Food and Drug Administration (FDA) has reopened the comment period for its proposed “gluten-free” food labeling rule. Originally published in January 2007, the proposed rule would have defined the term “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 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 seeks comments on a report titled “Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten,” and whether the assessment should affect the proposed definition of “gluten-free” in the final rule. According to the agency, the less than 20 ppm tolerance level was based, in part, on available methods of detection. An agency spokesperson said, “Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance.” Comments are requested by October 3, 2011. See FDA News Release, August 2, 2011; Federal Register, August 3, 2011.