By Jennifer Iscol

ACTION ALERT – Have you commented yet? Submit a comment to FDA by 11:59pm EST Wednesday, August 17, 2022

In April 2022, the Food and Drug Administration published draft guidance titled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.”

Our foundation supports FDA’s ongoing work to improve food allergen labeling, but is opposed to the draft as it is written. We are concerned it will create a major obstacle to our community’s goals of improving gluten-free labeling and adding barley and rye to FALCPA (the law that requires top allergens to be clearly labeled).

Under the proposed guidance, FDA will only consider citizen petitions to add major allergens to FALCPA if the foods commonly cause severe IgE-mediated reactions; that is, anaphylaxis due to a food allergy. This approach excludes consideration of citizen petitions related to foods that cause celiac disease because the condition is a non-IgE-mediated immune reaction.

Over 1,400 individuals and organizations have submitted comments to the FDA about the draft guidance. The final day to comment is Wednesday, August 17th, 2022.

COMMENT HERE You can read others’ comments and submit your own (blue “Comment” button). It just takes a couple minutes.

If you have little time, you can simply post a comment supporting our comment and/or the comment of Gluten Free Watchdog or others.

You may use language from this blog post in your comment. Also, Gluten Free Watchdog provides a helpful list of points, some of which you may wish to include. See the section titled “What FDA needs to hear from the celiac disease community:” Adding your own words or story is helpful.

The Celiac Community Foundation of Northern California submitted a comment to FDA, strongly objecting to the draft guidance and asking that it be revised. Some of our main points are summarized below.

Our full comment is here:

1. In its draft guidance, FDA’s approach arbitrarily diminishes the petition rights of an entire class of stakeholders (those related to celiac disease) without explanation. 

2. The proposed guidance fails to explain why a slower disease process deserves less protection in food labeling (celiac disease compared to anaphylactic food allergies).

3. FDA states that a major factor for consideration in adding allergens to FALCPA is the prevalence of the reactions they cause in the U.S. population. Celiac disease is more prevalent than several of the food allergies protected by FALCPA.

4. FDA fails to explain why it does not raise U.S. gluten-free labeling requirements to basic international standards that include mandatory labeling of all gluten-containing grains. 

5. The document’s approach is not consistent with the FASTER Act of 2021, which directed FDA to publish the guidance. The intent and spirit of the FASTER Act is to rationally expand allergen labeling, not arbitrarily restrict it. Furthermore, the Act did not distinguish between different types of immune-mediated food reactions, such as the difference between anaphylactic food allergies and celiac disease.

6. FDA can continue to make progress in its approach to food allergens without impeding progress on gluten-free labeling. We ask that FDA revise the proposed guidance to continue to consider citizen petitions on adding food allergens to FALCPA that cause non-IgE-mediated immune reactions such as in celiac disease.

Special thanks to Tricia Thompson of Gluten Free Watchdog for her leadership on this issue, and to the National Celiac Association, the University of Chicago Celiac Disease Center, and many other organizations and individuals who submitted comments.