On December 6, 2022, the Bari family traveled to College Park, Maryland and met with senior FDA leadership to share their lived experiences and research on the unmet needs of 3.3 American Celiacs with the voluntary labeling scheme of Gluten. This was the latest presentation on Celiac Journey's "Label Gluten Now as a Major Food Allergen" campaign.
Dr. Virginia Stallings Joined the Clarion Call to Label Gluten Now
The Bari family was honored to have been joined at the FDA meeting by Dr. Virginia Stallings, a board-certified nutrition pediatrician, Professor of Pediatrics and Director of the Nutrition Center at the Children's Hospital of Philadelphia (where Jax is treated for Celiac) who along with the Baris has called for Gluten to be labeled as a Major Food Allergen. Dr. Stallings is very well known and respected by the FDA's senior leadership in the fields of nutrition, food allergies and labeling. Previously, Dr. Stallings served as the Editor and Chair of the National Academies of Sciences, Engineering, and Medicine, Committee on Food Allergies which published the 574 page seminal work that was funded by the FDA: "Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management and Public Policy."
With respect to labeling Gluten as a Major Food Allergen, Dr. Stallings opined,
"While a Non-IgE-Mediated food allergy does not trigger anaphylaxis and is not immediately life-threatening, people with Celiac Disease face potentially life-threatening and severe adverse health effects that can arise through gluten ingestion including by way of example and not limited to: anemia, cancer, heart disease, immunological scarring, intestinal damage and malnutrition… A gluten free diet is not all that is needed to treat Celiac Disease; rather a gluten free diet is all that has ever been historically available to treat Celiac Disease. Additionally, with respect to labeling food products in the United States, the voluntary gluten free labeling scheme does not sufficiently protect consumers who are on medically required and very restrictive gluten free diets. My strong recommendation is that gluten be labeled on all packaged foods in the United States, in accordance with the 2021 FAO/WHO Expert Consultation, just like it is in more than 85 countries around the world." (emphasis added)
In attendance at the meeting were the following senior leaders from the FDA:
Dr. Susan Mayne, FDA's Director, Center for Food Safety and Applied Nutrition (CFSAN)
Dr. Claudine Kavanaugh, FDA's Director, Office of Nutrition and Food Labeling (ONFL)
Dr. Pat Hansen, FDA's Deputy Director, Office of Nutrition and Food Labeling
Dr. Stefano Luccioli, FDA's Acting CFSAN Chief Medical Officer and Allergen Coordinator
Emily Rose Carey, FDA's Policy Analyst, Office of Executive Programs
At the meeting, Leslie shared insight from Celiac Journey's discussion with FDA Commissioner Robert Califf at the White House Conference on Hunger, Nutrition and Health on September 28, 2022. Unfortunately, Commissioner Califf was unable to attend and personally hear the appeal from Dr. Stallings and Jax. That said, Leslie also discussed Celiac Journey's policy objective from the White House Conference of reducing diet-related disease by labeling Gluten as a Major Food Allergen on all packaged foods in the U.S., like it is done 85 countries around the world. The Baris shared a summary of Celiac Journey's comments in response to the FDA's “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 – Draft Guidance”, April 19, 2022, Docket number: FDA-2021-N-0553 (“FDA’s Draft Guidance”). For reference, please see Celiac Journey's complete comments to the FDA's Draft Guidance.
Presentation by Celiac Journey to FDA's Senior Leadership: Sharing Our Lived Experience, Policy Objective: Reduce Diet-Related Disease by Labeling Gluten as a Major Food Allergen
Jon shared the findings of Celiac Journey, Bari Consulting Group and Gluten Free Finds that the FDA’s Draft Guidance presents an inequitable evaluation framework, as well as perpetuates flawed and ingrained scientific, governmental and societal biases including:
A Gluten Free diet is all that is needed to treat Celiac Disease, as opposed to all that has ever been historically available to treat Celiac Disease.
With respect to labeling food products in the United States, the voluntary Gluten Free labeling scheme sufficiently protects consumers who are on medically required and very restrictive Gluten Free diets, as opposed to all that has ever been historically utilized labeling-wise.
Othering the consumer protection needs for Celiacs in the United States with not evaluating the public health importance of Gluten as a food allergen because this Non-IgE-Mediated food allergy is not capable of triggering anaphylaxis and being immediately life-threatening, while seemingly ignoring that Celiacs face potentially life-threatening and severe adverse health effects that can arise through Gluten ingestion, including by way of example and not limitation: anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition, etc.
The Baris shared their frustration that the FDA has othered the consumer protection needs of the Celiac community by lumping Celiac and lactose intolerance together, most recently in the FDA's Draft Guidance, "Immune-mediated mechanisms that are not IgE-mediated (such as mechanisms associated with celiac disease and contact dermatitis), and mechanisms that are not immune-mediated (such as lactose intolerance) typically are not associated with anaphylaxis or other immediately life-threatening conditions." According to the Cleveland Clinic, lactose intolerance is a non-immune-mediated food sensitivity that "is inconvenient but not life-threatening."
Jax and Jon implored the FDA that labeling Gluten now is in alignment with the conclusions of international food safety authorities and expert committees comprised of scientists, regulators, physicians, clinicians, individuals and risk managers from academia, government and the food industry including:
Food and Agriculture Organization of the United Nations/World Health Organization. "Summary report of the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Part 1: Review and validation of Codex priority allergen list through risk assessment" 2021 ("2021 FAO/WHO Expert Consultation"). The 2021 FAO/WHO Expert Consultation was chaired by the FDA's Dr. Lauren Jackson, and in 2022, the complete report was published, "FAO and WHO 2022 Risk Assessment of Food Allergens. Part 1 - Review and validation of Codex Alimentarius priority allergen list through risk assessment. Meeting Report. Food Safety and Quality Series No. 14, Rome."
1,576 Comments Submitted to the FDA on the Public Health Importance of Labeling Gluten as Major Food Allergen in Summer 2022. On April 19, 2022, the FDA published “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 – Draft Guidance,” April 19, 2022, Docket number: FDA-2021-N-0553 (“FDA’s Draft Guidance”). It is instructive to read some of the comments submitted including from: Dr. Virginia Stallings, a board-certified nutrition pediatrician, Professor of Pediatrics and Director of the Nutrition Center at the Children’s Hospital of Philadelphia; Beyond Celiac; Celiac Journey; Celiac Disease Program at Children’s National Hospital; Davis Family (Shannon, Brian and Joshua); National Celiac Association; Gluten Free Watchdog; University of Chicago Center for Celiac Disease, etc.. In total, we helped to generate a total of 1,903 comments submitted to the FDA on Docket FDA-2021-N-0553, and of those, 1,576 comments (82.8%) mentioned Celiac and/or Gluten as a food allergen.
The Baris thanked Dr. Luccioli for his service on the 2021 FAO/WHO Expert Consultation which was the authoritative body chaired by the FDA’s Dr. Lauren Jackson, Chief, Process Engineering Branch, Division of Processing Science & Technology, Institute for Food Safety & Health, that determined:
“Based on systematic and thorough assessments which used all three criteria (prevalence, severity and potency), the Committee recommended that the following should be listed as priority allergens: Cereals containing gluten (i.e., wheat and other Triticum species, rye and other Secale species, barley and other Hordeum species and their hybridized strains), crustacea, eggs, fish, milk, peanuts, sesame, specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut).”[6] (emphasis added)
President Biden's Executive Order 13985, "Advancing Racial Equity and Support for Underserved Communities Through the Federal Government"
Informed by their lived experience and stories shared with them over the years by thousands of members of the Celiac community, Jon stated that he believes that in accordance with President Joe Biden’s Executive Order 13985, advancing equity requires a systematic approach to embedding fairness in the decision-making processes that all FDA functions are routed through. Using that lens and framework, the Baris shared that the FDA’s Draft Guidance released on April 19, 2022 suggests systemic food privilege that contributes to food insecurity, and the Biden-Harris Administration can work to redress historical inequities in various agencies’ policies and processes towards the Celiac community, including with HHS/FDA declaring that Gluten is a Major Food Allergen and that Gluten must be labeled on all packaged foods.
Section 2(a) of Executive Order 13985 provides that,
“The term ‘equity’ means the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.” Further, section 2(b) provides that, “the term ‘underserved communities’ refers to populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, as exemplified by the list in the preceding definition of equity.” (emphasis added)
The Celiac community represents an underserved community which shares a particular characteristic including a chronic disability under the ADA [1] and a potentially life-threatening and life-debilitating food allergy to eating Gluten with numerous adverse health consequences associated with the ingestion of Gluten.
The Celiac community has been systemically denied a full opportunity to participate in important aspects of daily economic, social and civil life. For someone with Celiac Disease, eating, sleeping, thinking, learning and working are major life activities that can be impacted on a daily basis, and there are various bodily systems which can be impacted through the ingestion of Gluten including: gastrointestinal (digestive), nervous (anxiety, ataxia and neuropathy), skeletal, reproductive (infertility) and integumentary.
Celiacs Have Been Historically Underserved by the Federal Government
Therefore, with respect to the Celiac Disease community, which has been historically underserved and marginalized by our Federal government, including by way of example and not limitation:
Underfunding NIH biomedical research for Celiac Disease over many years (on average, the Federal government spent about $3.4 million annually on Celiac research from 2011-2020, which is about $1.00 per American with Celiac per year, and that is way too low). Funding for Celiac research has been disproportionately low as compared to NIH funding research for food allergies, digestive diseases, auto-immune diseases and/or foodborne illness, especially when evaluating the various amounts spent with regard to disease prevalence, treatment burden and other available treatment options . According to a Congressionally mandated report "Enhancing NIH Research on Autoimmune Disease" published in May 2022 from the National Academy of Sciences, Engineering and Medicine, "There is a lack of long-term (20 years or more) population-based epidemiology studies on autoimmune disease, the committee found. Such studies would allow for, among other things, assessing trends, risk factors, and costs of disease; identifying differences among population subgroups; and determining the prevalence of under-researched autoimmune diseases, such as celiac disease.”
Labeling Gluten only with a voluntary scheme since 2014 - Under the Food Allergen Labeling and Consumer Protection Act ("FALCPA"), mandatory labeling of the top 8 Major Food Allergens started on January 1, 2006. In contrast, the FDA delayed action on the FDA's final rule for Gluten Free labeling until August 5, 2014, in spite of a FALCPA deadline of August 4, 2008, and that on January 23, 2007, the FDA published its proposed rule on the voluntary labeling of Gluten Free products that for all intents was the final rule ultimately enacted on August 5, 2014. Moreover, this unnecessary delay by the FDA happened notwithstanding the House of Representatives Report (H.R. Rep. No. 108-608, at 18. (2004)) on FALCPA stating, "Given the devastating nature of celiac disease, the Committee urges the Secretary to move expeditiously in implementing the requirements of this section."
Disqualifying Celiacs from service in the military [2]
Excluding Celiac Disease from the CDC’s Index of Diseases & Conditions
Excluding Celiacs from Medicare coverage for medical nutrition therapy (MNT) which is currently limited to patients with diabetes and kidney failure, leaving millions of older Americans with leading diet-related diseases, without access to nutrition counseling.
Excluding Celiac Disease (through June 2022) from the NIH’s "Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC)" that provides research and funding data on how NIH allocates its financial resources. Celiac was finally added to the RCDC list in July 2022 following the House Appropriations Committee distributing its FY2023 Budget Report which included the following language about Celiac Disease: “The Committee thanks NIH for establishing a Research Condition, Disease Categorization (RCDC) for celiac disease.”
Excluding representation from Celiac Disease advocacy organization(s) on the National Institute of Allergy and Infectious Diseases ("NIAID") Autoimmune Diseases Coordinating Committee ("ADCC") from 1998-2020.[3] As of May 29, 2020, there were 17 members from patient advocacy organizations represented on the ADCC. "NIAID chairs the NIH Autoimmune Diseases Coordinating Committee (ADCC), which was established in 1998 at the request of Congress. The purpose of the ADCC is to facilitate coordination of research across the National Institutes of Health (NIH), federal agencies, professional societies, and patient and advocacy organizations with an interest in autoimmune diseases. It was not until after the “Celiac Disease-Focused Autoimmune Disease Coordinating Committee Meeting” on May 29, 2020 that the Celiac Disease Foundation and Beyond Celiac were invited to join as members of the ADCC.
Funding various agencies, facilities, schools, programs, etc. that exclude Celiacs from full and equal participation in life’s daily activities that involve food, etc.
HHS Secretary Xavier Becerra Has Existing Statutory Authority to Label Gluten Now
According to the Food & Drug Law Journal's seminal article in 2006 that was published entitled, "When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004" ("When Food Is Poison"), FALCPA "does not preclude FDA from expanding via regulation the list of major allergens requiring identification under the FALCPA's labeling scheme."[4] Section 203(b) states that the labeling requirements established under new section 403(w) "do not prevent the Secretary from requiring labels or labeling changes for other food allergens that are not major food allergens."[5] (emphasis added)
"When Food is Poison" was written by Laura Derr Sim, Esq. when she was a student at Harvard Law School, under the supervision of Lecturer on Law Peter Barton Hutt, Partner at Covington & Burling in Washington, D.C., for Harvard Law School's Winter 2005 Food and Drug Law course. Mr. Hutt was also former Chief Counsel to the FDA from 1971-1975. When Food is Poison won First Place in the 2005 H. Thomas Austern Memorial Writing Competition (long papers) sponsored by the Food and Drug Law Institute.
“Precedent is a poor reason for decisions. It calcifies the status quo without a compelling rationale. It doesn’t matter how long a tradition has stood. If the old way is wrong, it should be challenged and changed. Progress lies in improving the future, not defending the past.” -- Adam Grant, The Wharton School, University of Pennsylvania
Leadup to the FDA Meeting
The FDA meeting was a follow up to 9 year old Jax meeting President Joe Biden on October 20, 2022 and asking for the President's help to protect him by labeling Gluten as a Major Food Allergen (like it is done in 85 other countries worldwide), the Bari family's meeting with the White House Domestic Policy Council staff on November 10, 2022 and the Bari family's attendance at the White House Conference on Hunger, Nutrition and Health on September 28, 2022.
Gluten Should Be Labeled as a Major Food Allergen in the U.S., Just Like It Is in 85 Other Countries, July 8, 2021
Presentation
Presentation by Celiac Journey to FDA Senior Leadership: Sharing Our Lived Experience, Policy Objective: Reduce Diet-Related Disease by Labeling Gluten as a Major Food Allergen, December 6, 2022
Notes
[1] In May 2019, in a case involving the disability rights of a child who has a severe allergy to Gluten, the U.S. Fourth Circuit Court of Appeals cited that "[t]he ADA [Americans with Disabilities Act] defines a 'disability' in pertinent part as 'a physical or mental impairment that substantially limits one or more major life activities' and that "[e]ating is a major life activity." J.D., by his father and next friend, Brian Doherty, Plaintiff-Appellant v. Colonial Williamsburg Foundation, Defendant-Appellee, National Disability Rights Network; Disability Law Center for Virginia; Scott Hayes; Virginia Food Allergy Advocates, Amici Supporting Appellant. Vacated and Remanded-Appeal from the United States District Court for the Eastern District of Virginia, at Newport News. Rebecca Beach Smith, District Judge. (4:17-cv-00101-RBS-RJK); United States Court of Appeals for the Fourth Circuit, No. 18-1725, Argued: January 29, 2019; Decided: May 31, 2019. See also "Colonial Williamsburg - Lessons Learned About the Civil Rights of the Celiac Community"
[2] U.S. Department of Defense, DoD Instruction 6130.03, Medical Standards for Appointment, Enlistment, or Induction into the Military Services, Section 5.12.c.(3), May 6, 2018.
[3] As of July 1, 2020, of the 52 members of the ADCC, there were 17 members representing specific diseases. A full one third of the ADCC members came from patient advocacy organizations outside of the NIH. There were no representatives of any organization or physician/scientist representing the Celiac Disease community. However, there were multiple non-NIH employees on the ADCC including representatives for the following: Crohn’s/Colitis (3 people); Type 1 Diabetes (2 people), Juvenile Diabetes (1 person); Sjogren’s Syndrome (2 people), Lupus (1 person), Arthritis (1 person); Multiple Sclerosis (1 person), Psoriasis (1 person), Neuromyelitis Optica (NMOSD)/Devic disease (1 person).
[4] When Food is Poison, Page 141, including footnotes 423-424: "See FALCPA 203(b), 21 U.S.C.A. 343(note); FALCPA 203(a), 21 U.S.C.A. 343(x). The Senate Committee Report states that it intends for any regulations issued by FDA requiring the identification of additional allergens to prescribe disclosure in 'a manner consistent with' the FALCPA. S. Rep. No. 108-226, at 10." "The legislation also adds a second misbranding provision to account for other food allergens. In particular, section 403(x) provides that FDA has the authority to require by regulation appropriate labeling of any spice, flavoring, coloring, or incidental additive ingredient that is, or includes as a constituent, a food allergen that is not a major food allergen. The committee does not intend the listing of all spices or flavorings in a product but intends that the Secretary will require the food allergen to be identified on the label in a manner consistent with this legislation."
[5] H.R. Rep. No. 108-608, at 18. (2004), https://www.congress.gov/108/crpt/hrpt608/CRPT-108hrpt608.pdf
Gratitude
I want to extend special thanks to my daughter, Lexi Bari (Jax's sister), who has helped me research Celiac Disease and write about our public policy efforts to get Gluten labeled as a Major Food Allergen. Advocating for the needs of the Celiac community is a labor of love for our family!