Bottom line: What the FDA appears to want is data on celiac disease and gluten, including at the community level (in others words, data that isn’t necessarily in the scientific literature per se). This is good news. It appears that a door has opened to us.

Data on celiac disease and gluten can supplement data on IgE allergies to barley and rye when the FDA is evaluating the public health importance due to a citizen petition.

One important update—while the guidance focuses on IgE-mediated food allergies, non-IgE-mediated reactions can be used as supplemental data by the FDA to evaluate the public health importance of a food allergen.

GFWD had a very informative and helpful call with FDA staff. We discussed the changes that were made to the guidance document.