The comment below was submitted by the Celiac Community Foundation of Northern California to the FDA on its draft guidance: “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act”

August 16, 2022

Comments submitted by Jennifer Iscol
President, Celiac Community Foundation of Northern California
In response to Docket Number FDA-2021-N-0553-0005
Email: jiscol@celiaccommunity.org
Web: www.celiaccommunity.org

Dear FDA,

This comment concerns FDA Docket Number FDA-2021-N-0553-0005, FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for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 Stakeholders.

As an all-volunteer nonprofit, the Celiac Community Foundation of Northern California provides evidence-based support, education and advocacy for those with celiac disease and other gluten-related disorders, facilitates research, and administers Camp Celiac in Livermore, California.

We appreciate and support FDA’s longstanding and ongoing work on food labeling for individuals with medical dietary restrictions such as IgE-mediated food allergies, celiac disease and other gluten-related disorders.

We support the comments to the docket that were submitted to FDA by Gluten Free Watchdog, the University of Chicago Celiac Disease Center, and the National Celiac Association. In addition to those comments, we have the following questions and comments.

What is the rationale for FDA to narrow consideration of FALCPA-related citizen petitions only to those on foods that commonly cause IgE-mediated reactions? 

In the proposed guidance, FDA defines celiac disease as a type of immune-mediated food allergy.

However, FDA chooses to focus the document only on IgE-mediated food allergies, “which are capable of triggering anaphylaxis and are considered the most severe and immediately life-threatening food allergies.” 

FDA fails to state why citizen petitions on adding allergens that cause non-IgE-mediated immune reactions to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) should be excluded from consideration. This approach arbitrarily diminishes the petition rights of an entire class of stakeholders without explanation. 

According to the FDA’s website page on Food Allergies, “Protecting the public health of consumers with food allergies and conditions like celiac disease is a high priority for the FDA.” (https://www.fda.gov/food/food-labeling-nutrition/food-allergies). FDA published the gluten-free labeling rule as a requirement of FALCPA. Continuing to consider citizen petitions related to celiac disease is consistent with the intent of FALCPA. 

The proposed guidance suggests using prevalence of an IgE-mediated food allergy in the U.S. population as one of four scientific factors to consider when evaluating the public health importance of a food allergen. Celiac disease impacts about one percent of the population, which is comparable or higher prevalence than several of the IgE-mediated food allergies already protected under FALCPA, including allergies to eggs (.8%), soy (.6%) and sesame (.2%). (https://www.gastrojournal.org/article/S0016-5085(20)35165-9/fulltext and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324316/)

Why is FDA proposing a framework that may cause individuals with an immune-mediated food reaction that has a slower disease process than anaphylaxis to be excluded from the regulatory protection that FALCPA’s mandatory food labeling provides?

Untreated celiac disease can be life threatening. FDA itself states that the gluten-free labeling rule is “important for people with celiac disease, who face potentially life-threatening illnesses if they eat gluten…” (https://www.fda.gov/consumers/consumer-updates/gluten-free-means-what-it-says)

As FDA states in the proposed guidance, anaphylactic food reactions can occur within minutes to hours of ingestion and can be life-threatening. Gluten can trigger symptoms in people with celiac disease in minutes, hours or days, but irreversible or life-threatening damage can take years or decades to accrue. The proposed guidance fails to explain why a slower disease process deserves less protection.

The FDA’s gluten-free labeling rule was an important advance for people with celiac disease and other gluten-related disorders when it was finalized in 2013. However, voluntary gluten-free labeling is as unsafe and insufficient for people with celiac disease as voluntary labeling of the nine major allergens would be for people with IgE-mediated reactions. 

What is FDA’s justification for continuing to fail to align gluten-free labeling with international standards?

Gluten-free labeling in the United States is substantially inadequate by international standards. Canada, Australia, New Zealand, the United Kingdom and European Union member countries all require mandatory labeling of gluten-containing grains. In addition, the 2021 FAO/WHO Expert Consultation on Risk Assessment of Food Allergens (cited in FDA’s proposed guidance at Ref. 45) states that all cereals containing gluten should be considered “priority allergens” mandating disclosure (https://www.fao.org/3/cb4653en/cb4653en.pdf). Until gluten-free labeling in the United States is improved and aligned with international standards, FDA should leave the door open to its improvement, including by citizen petition.

How is the proposed guidance consistent with the intent and spirit of the FASTER Act?

FDA’s proposed guidance appears to stem from a requirement of the FASTER Act of 2021, which directed the U.S. Department of Health and Human Services to develop a regulatory process and scientific criteria for defining major food allergens within 18 months of the passage of the Act.

The stated goal of the Act is to “improve the health and safety of Americans living with food allergies and related disorders…” and to “expand, enhance, or improve” federal activities related to food allergies.” (https://www.congress.gov/bill/117th-congress/senate-bill/578/text)

The Act does not distinguish between IgE-mediated and non-IgE-mediated reactions. The food allergy community has long supported legislative and regulatory advocacy for celiac disease and other gluten-related disorders. The intent and spirit of the FASTER Act is to rationally expand, not shut down, FDA’s labeling of foods that cause immune reactions, regardless of the type of immune process.

How does the exclusion of petitions on foods that cause non-IgE-mediated reactions further the stated goal of the guidance?

The world of allergens is large and complex — FDA describes 160 known food allergens and developed the proposed guidance to help evaluate emerging evidence on them. In contrast, foods that trigger celiac disease are well known and few. 

There are only three types of grain that contain gluten: wheat, barley and rye. Wheat is already regulated under FALCPA as a major allergen. That leaves just barley and rye for consideration. It’s not clear how preemptively excluding from consideration non-IgE-mediated reactions to two foods (barley and rye) aids FDA’s assessment of IgE-mediated reactions to the other 158 food allergens.

IgE-mediated reactions to barley and rye are relatively uncommon. These grains will not make the cut for FALCPA’s mandatory labeling if the criteria centers on IgE-mediated reactions. However, they must be considered for addition to FALCPA for the health, safety and quality of life of people with celiac disease and other gluten-related disorders.

Why is FDA proposing to shut down progress on gluten-free labeling?

FDA rightfully considers food allergen labeling a work in progress. FALCPA originally only included the top eight allergens for mandatory labeling, and the FASTER Act added one additional allergen (sesame) to FALCPA. Now, in the proposed guidance, FDA is suggesting a framework for future consideration of additional foods to add to FALCPA from among 160 known allergens. 

Similarly, gluten-free labeling should be considered a work in progress. Eighteen years after its passage, the full potential of FALCPA is unrealized for the millions of Americans with gluten-related disorders. FALCPA was passed in 2004 and directed FDA to issue a gluten-free labeling rule by 2008. FDA issued the final rule in 2013, five years late, and issued a final rule on the gluten-free labeling of fermented or hydrolyzed foods in 2020, an additional seven years later. FDA’s work on gluten-free labeling is slow and far from done. Shutting down a primary path to its improvement is inefficient, counterproductive and ill-considered.

If stakeholders with celiac disease continue to find voluntary gluten-free labeling inadequate to protect their health and quality of life, how should they communicate that to FDA?

If FDA proceeds with its proposed guidance as written and thereby excludes from consideration a category of citizen petitions on FALCPA, it’s not clear how impacted stakeholders should communicate with FDA.

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.

Finally, we respectfully request that FDA reopen the comment period for the proposed guidance after the August 17, 2022, deadline for comments has passed. The potential impact of the proposed guidance on the future of gluten-free labeling is difficult to grasp, even for experienced stakeholders. After two decades of advocacy, stakeholders with celiac disease and other gluten-related disorders deserve more than 120 days to comment on a proposed change of this magnitude. 

Thank you for your consideration.

Jennifer Iscol
President, Celiac Community Foundation of Northern California