Rhonda Kane, MS, RD, Consumer Safety Officer at the Food and Drug Administration (FDA), provided us with the following status report on FDA’s gluten-free food labeling rulemaking:
“FDA published a proposed rule to define the food labeling term “gluten-free” on January 23, 2007, which had a 90-day public comment period that closed on April 23, 2007. As discussed on page 2803 of the proposed rule (posted under the subheading “Gluten-Free” at http://www.cfsan.fda.gov/~dms/lab-cat.html#gluten), FDA committed to conducting a safety assessment on gluten exposure in individuals with celiac disease. FDA conducted this safety assessment in accordance with the data quality criteria discussed in the agency’s report entitled Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food and to comply with the Data Quality Act. Doing so was a lengthy process, which required that FDA’s draft safety assessment be reviewed by an independent panel of scientific experts.
FDA has revised its safety assessment report, as appropriate, to address the expert comments, and efforts are now underway to publish a Federal Register (FR) notice to reopen the comment period on the proposed rule in order to share the safety assessment and solicit public comments on it and its potential use in defining the term “gluten-free” in the final rule. FDA will consider the comments received in response to this notice and on the proposed rule as well as the findings of the safety assessment and the other factors mentioned in the proposal (i.e., ease of compliance and enforcement, stakeholder concerns, economics, trade issues, and legal authorities) to develop a final rule. When the FR notice on the safety assessment is published, a link to it likely will be included at the cited website; therefore, interested entities may wish to check that website periodically for updates.”
Thank you so much Rhonda for this update and for all of your and FDA’s hard work on behalf of the gluten-free community. The care that is being brought to develop this rule is extraordinary and very much appreciated!