Final FDA guidance published on evaluating the public health importance of food allergens other than the major food allergens: What are the implications for gluten?
This month (January 2025) the FDA published the final guidance, “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Interested Parties.” It is available at https://www.fda.gov/media/157637/download?attachment.
Gluten Free Watchdog submitted comments on the draft. This week, GFWD had a very informative and helpful call with FDA staff. We discussed the changes that were made to the final guidance document. 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. 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.
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. The opening isn’t wide. But maybe wide enough if we are willing to do the work to push through…
Comments (8)
I’m willing to do anything to get the FDA to listen to the fact that Celiac disease can kill a person due to the severe malnutrition it causes and the attack on the body that ensues due to gluten exposure (and perhaps other proteins that no one has looked into yet). My life was changed forever by misdiagnosis after misdiagnosis for 40 years. I am hopeful that finally, maybe someone who can change food labeling laws might listen. Thank you for persevering.
I would like to enjoy a less fearful life when eating out.I make my own food to cut down on accidental gluten poisoning.Of course,I miss out on socialization this way.The FDA allows far too much gluten at 20 PPM.Untreated Celiac Disease disabled me at 41yo.Although I have a BSN,I did not hear about gluten intolerance until I reached 58yo.I am alive only because of this
Would it do any good to start a petition to get gluten named as an allergen?
There is a petition before FDA (filed in September 2023) to add gluten as a major allergen. Based on our conversation with the FDA, they are interested in additional data. We have to decide how best to proceed.
I tried clicking on the article and it just remained blank, can you rectify this problem please. Thank you Dan S.
Hmm. It appears to be working. Maybe try again. If you can’t open the file, you can access it from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-fda-staff-and-interested-parties-evaluating-public-health-importance-food-allergens-other
Hi Tricia Thank you for all you do with this serious health problem, Please do start a Petition for Gluten as an allergen
My only Concern is if the Restaurant Lobbyists get involved with the FDA then Gluten will not be classified as an Allergen
This will become Politics as Usual?
There is an existing 2023 petition (not from us) asking FDA to label gluten as a major food allergen. We (GFWD) are in the process of determining the best way forward to provide the FDA with additional data. We may file our own petition adhering to the blueprint in the guidance document. BUT we have an existing 2017 petition asking for increased enforcement of the gluten-free labeling rule so that may not be the expeditious route.