It is being reopened to announce the availability of and solicit comments on the report entitled “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” (“Gluten Report”), which discusses the FDA’s gluten safety assessment.
FDA is also seeking comments on whether or not the safety assessment should affect FDA's proposed definition of “gluten-free” in the final rule, and on a number of related issues. FDA tentatively concluded in the 2007 proposal that foods containing less then 20 ppm of gluten, could be labeled as gluten-free.
FDA is seeking comments on its tentative conclusions that the safety assessment-based approach may lead to a conservative, highly uncertain estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure; and that the final rule should adopt the proposed rule’s approach to defining the term “gluten-free,” because that approach takes into account the availability of reliable analytical methods and also considers other practical factors related to the needs of individuals with celiac disease and their food consumption.
Written or electronic comments must be submitted by Oct. 3. Submit electronic comments to http://www.regulations.gov/. Submit written submissions via fax to (301) 827-6870 or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Click here to view the notice.