Celiac.com 04/26/2012 - A recent statement by the FDA announces that the agency is gathering data to respond to calls for an "alternative approach" to determining a specific gluten threshold level other than the proposed level of under 20 parts per million gluten as one of the criteria to define the term “gluten-free.”
The statement directly acknowledges that people with celiac disease must avoid gluten for life in order to prevent harmful health effects.
It finished a safety assessment of gluten exposure in individuals with celiac disease, and that it had gotten that assessment peer-reviewed.
This was done to gather more data regarding possible alternative approaches to establishing a specific gluten threshold level as one of the criteria to define “gluten-free.”
These would be alternative approaches that differ from the "analytical methods-based approach" used by the FDA in its proposed rule for "gluten-free" products. That proposal established product ingredients under 20 parts per million gluten as one of the criteria for defining the term “gluten-free.”
The FDA statement also noted that CFSAN had published a Federal Register notice in August 2011, reopening the comment period on the Agency’s proposed rule on “gluten-free” food labeling.
The notice announces the publication of the FDA's safety assessment on gluten exposure in people with celiac disease, and asks for public comment on the safety assessment, and on any other issues that might affect the definition of the term “gluten-free” in the Agency's final rule.
Lastly, the statement announces that the FDA will review and consider those public comments before issuing its final rule defining “gluten-free” for labeling food products, including dietary supplements. The FDA intends to complete the entire process and issue the rule by the end of fiscal year 2012.