In honor of National Celiac Awareness Day on September 13th and the upcoming first anniversary of the White House Conference on Hunger, Nutrition, and Health on September 28th, Jax Bari, age 10, has filed a Citizen Petition with Secretary Xavier Becerra of the Department of Health and Human Services and FDA Commissioner Robert M. Califf, M.D. to label Gluten as a Major Food Allergen (Docket Number: FDA-2023-P-3942).
Background
Labeling Gluten (Wheat, Barley, Rye and Oats) as a Major Food Allergen on all packaged foods in the U.S., like it is in more than 85 other countries around the world, will better protect 3.3 million American Celiacs. Labeling Gluten is in alignment with the conclusions of international food safety authorities and expert committees comprised of scientists, regulators, physicians, clinicians, and risk managers from academia, government and the food industry, as well as consumers, including:
2021 Food and Agriculture Organization of the United Nations/World Health Organization Expert Consultation on Risk Assessment of Food Allergens, which included the FDA’s Dr. Lauren Jackson, Chair, and the FDA’s Dr. Stefano Luccioli ("2021 FAO/WHO Expert Consultation"). The 2021 FAO/WHO Expert Consultation found, "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)." (emphasis added)
1,576 Comments submitted to the FDA on Labeling Gluten in Summer 2022 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 and former Editor and Chair of the National Academies of Sciences, Engineering, and Medicine, Committee on Food Allergies; Beyond Celiac; National Celiac Association; Gluten Free Watchdog; Celiac Community Foundation of Northern California; University of Chicago Center for Celiac Disease; etc. (Docket: FDA-2021-N-0553:)
This Citizen Petition is a response to President Biden's nationwide call-to-action with the "White House Challenge to End Hunger and Build Healthy Communities." Labeling Gluten will reduce the treatment burden, food insecurity and diet-related disease for millions of Americans with Celiac Disease, a potentially life-threatening food allergy, auto-immune disease and digestive disease from adverse health effects that can arise following Gluten ingestion.
Requested Action: Declare Gluten as a Major Food Allergen
Today, Wheat is required to be labeled in the U.S., but Gluten is not. Gluten is found in Wheat, Barley, Rye and most Oats.
This Citizen Petition is requesting a long-overdue reckoning by the FDA to better protect more than 3.3 million Americans with Celiac Disease by labeling Gluten (Wheat, Barley, Rye and Oats) as a Major Food Allergen on all packaged foods, just like labeling Gluten is required in more than 85 other countries, including in Canada and across Europe.
Under its existing authority in the Food Allergen Labeling and Consumer Protection Act ("FALCPA") in statute at 21 U.S.C. § 343(x), we request that the FDA issue a rule to:
require that all ingredients with Gluten be listed by name in the ingredient lists of all foods; and
add Gluten to the FDA’s list of allergens in Sec. 555.250 of its Compliance Policy Guides Manual, "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens" to address both labeling and cross contact issues related to food manufacturing practices.
Labeling Gluten comports with the "White House Conference Pillar #2, Integrate nutrition and health: Prioritize the role of nutrition and food security in overall health, including disease prevention and management, and ensure that our health care system addresses the nutrition needs of all people."
National Celiac Association
"As a father of a son with Celiac Disease, I recognize the importance of consistent labeling on packaged food items and the positive impact that this will have on our community," said Chris Rich, CEO & Executive Director of the National Celiac Association. "With more than 85 countries considering Gluten a Major Food Allergen, I feel that the timing is right for this same designation to be considered in the U.S. for the protection and well-being of consumers affected by Celiac and Gluten sensitivities."
Honorable Dr. David J. Shulkin, 9th Secretary of the U.S. Department of Veterans Affairs
"It should not be this hard to know what is safe to eat, but for those with Celiac Disease and their caretakers, it’s a daily struggle," said the Honorable Dr. David J. Shulkin, Ninth Secretary of the U.S. Department of Veterans Affairs. "While many healthcare issues can be complex and costly, labeling gluten is not. Gluten is required to be labeled in 85 other countries worldwide. As such, many consumer-packaged food manufacturers already label Gluten on their products sold in those other countries, and doing so in the U.S. would be consistent with their existing operations."
Advancing Equity Must Be a Central Component of FDA Decision-Making to Evaluate this Citizen Petition and Protect Celiacs, An Underserved Community With a Chronic Disability
We are respectfully requesting that the evaluation of this Citizen Petition be conducted now through the lens of President Biden's Executive Order 13985 on "Advancing Racial Equity and Support for Underserved Communities Through the Federal Government" (January 20, 2021) and President Biden's Executive Order 14091 on "Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government." (February 16, 2023):
"Because advancing equity requires a systematic approach to embedding fairness in decision-making processes, executive departments and agencies (agencies) must recognize and work to redress inequities in their policies and programs that serve as barriers to equal opportunity." --- President Biden's Executive Order 13985
According to the HHS Equity Action Plan, "advancing equity must be a central component of the decision-making framework that all agency functions are routed through."
The Celiac community represents an underserved community which shares a particular characteristic including a chronic disability with a potentially life-threatening and life-debilitating food allergy triggered by eating Gluten which causes numerous adverse health consequences. (See the case involving Colonial Williamsburg as decided the Fourth Circuit Court of Appeals, No. 18-1725, Argued: January 29, 2019; Decided: May 31, 2019).
For someone with Celiac Disease, eating, sleeping, thinking, learning and working are major life activities that can be impacted on a daily basis through the ingestion of Gluten, and there are various bodily systems which can be impacted including: gastrointestinal (digestive), nervous (anxiety, ataxia and neuropathy), skeletal, reproductive (infertility) and integumentary.
According to the Biden-Harris Administration's National Strategy on Hunger, Nutrition, and Health was released and the revised language on disabilities read as follows:
"The toll of hunger and diet-related diseases is not distributed equally; these challenges disproportionately impact communities of color, people living in rural areas, people living in territories, people with disabilities, older adults, LGBTQI+ people, military families, and Veterans." (emphasis added)
This Citizen Petition includes a detailed analysis of how Celiacs belong to an underserved community of persons with disabilities who have systematically been denied a
full opportunity to participate in aspects of economic, social, and civic life.
What is Food Allergy? The Similarities and Differences Between Non-IgE-Mediated Mechanisms with Celiac Disease & Typical IgE-Mediated Mechanisms
Redressing Inequities in FDA's Consumer Protection Policies & Programs
This Citizen Petition is requesting a long-overdue reckoning by the FDA to better protect more than 3.3 million Americans ("greater than 1% of the U.S. population") with Celiac Disease and address scientific, governmental, and societal biases including that:
1. 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.
2. 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.
3. 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.
Dr. Virginia Stallings Joined the Clarion Call to Label Gluten Now
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)
Members of the 2021 FAO/WHO Expert Consultation who Recommended that Gluten Should be Listed as a Priority/Major Food Allergen
The 2021 FAO/WHO Expert Consultation (FDA Ref. 45, Annex 1) was comprised of 20 (twenty) “experts” including:
Dr. Joseph Baumert, Professor and Director of the Food Allergy Research and Resource Program (FARRP), Department of Food Science and Technology at the University of Nebraska-Lincoln; (Pictured in top row of photograph, 3rd from left)
Dr. Lauren Jackson, Chief, Process Engineering Branch, Food and Drug Administration. Division of Processing Science & Technology, Institute for Food Safety & Health, who served as Chairperson of the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens (FDA Ref. 45); (Pictured in top row of photograph, 1st person on left)
Dr. Stefano Luccioli, Medical Officer and Allergy Specialist at the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, and Board-certified doctor in allergy/immunology who sees patients at the General Internal Medicine clinic at MedStar Georgetown University Hospital in Washington, D.C.; and Chairperson of Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens Part 3: Review and establish precautionary labelling in foods of the priority allergens (Pictured 2nd row of photograph, 4th person from left).
Dr. Stephen Taylor, Professor and Founding Director (Retired) of the Food Allergy Research and Resource Program (FARRP), Department of Food Science and Technology at the University of Nebraska-Lincoln. Dr. Taylor was also one of six scientists who served on the Ad Hoc Panel on Food Allergens met in Geneva, Switzerland in February 1999 to provide advice to the Joint FAO/WHO Expert Committee on Food Additives about criteria for labelling food allergens. Their treatise was memorialized in the 1999 FAO/WHO Expert Consultation; also referred to as the "1999 Codex criteria" as detailed in the FDA’s Draft Guidance and cited as "FDA Ref. 25." (Pictured in bottom row of photograph, 2nd person from left).
Celiac Disease Overview
Celiac Disease is a potentially life-threatening food allergy, auto-immune disease and digestive disease that impacts at least 3.3 million Americans, greater than 1.0% of the general population.
Researchers are finding that Celiac Disease prevalence is doubling approximately every 15 years, making it a public health epidemic. Gluten ingestion for people with Celiac can cause anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition, etc.
The only available treatment is strict adherence to a lifelong, Gluten Free diet. There is no rescue medication in the event of accidental ingestion and one cannot outgrow Celiac.
44% of people with Celiac Disease who follow a strict Gluten Free diet still get glutened once a month, and "many with Celiac Disease pay over 40% more in annual healthcare costs."
If the labeling of Gluten was mandatory on all products, our research and lived experience strongly suggest that the number of Gluten Free food products available to those who have Celiac Disease would greatly expand just by virtue of those food products that do not contain Gluten being labeled as such. According to The New York Times, "because use of the gluten-free claim is voluntary, many foods that are in fact gluten-free might not be labeled as such." Voluntary labeling makes Celiacs beholden to a premium marketplace of food items in which the price of Gluten Free foods is 2x-6x more on a per ounce basis than their Gluten containing counterparts.
About Jax Bari
Jax was diagnosed with Celiac Disease at age 5. As he learned to read, Jax started with fairy tales and food labels. Along with his family, Celiac community and doctors from the Children's Hospital of Philadelphia ("CHOP"), Jax is working to increase federal and state funding for Celiac research to find a treatment other than a Gluten Free diet. Jax has raised $100,000 for CHOP through the Commonwealth of Pennsylvania. Jax has also talked food policy with President Biden and was invited to make his case to the White House Domestic Policy Council and senior FDA leaders to label Gluten as a Major Food Allergen on all packaged foods in the US, just like it is in 85 countries worldwide. Today, Jax is 10 years old and a rising 5th grader in Philadelphia. This young lobbyist still makes time to be a kid, too. Jax loves pizza, playing soccer and tennis, going skiing, collecting baseball cards, playing fantasy football and listening to Taylor Swift.
Note
While the requested action under this Citizen Petition is for the FDA to regulate Gluten in a manner similar to a Major Food Allergen under the FALCPA (and that this is the preferred implementation thereof), this Citizen Petition is asking that the FDA use any labeling scheme available under its existing statutory and discretionary authority to require that Gluten be declared on all packaged foods in the United States.
Resources (Docket Number: FDA-2023-P-3942)
Press Release - "1st Anniversary of White House Conference on Hunger, Nutrition & Health Marked with FDA Citizen Petition to Label Gluten," 9/28/23
Exhibits to Citizen Petition (Docket Number: FDA-2023-P-3942)
Exhibit 1 - Dr. Virginia A. Stallings, "Comments on '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’, FDA Docket Number: FDA-2021-N-0553,' FDA Comment ID: FDA-2021-N-0553-1169, FDA Tracking Number: l6g-mawc-nbs8, August 5, 2022.
Exhibit 2 - 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.
Exhibit 3 - Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives. Evaluation of certain food additives and contaminants: fifty-third report of the Joint FAO/WHO Expert Committee on Food Additives. 2000. WHO Technical Report Series 896. World Health Organization, Geneva (“1999 FAO/WHO Expert Consultation”; also referred to as the “1999 Codex Criteria” as detailed in the FDA’s Draft Guidance and cited as “FDA Ref. 25”). (Annex 4, pages 124-128)
Exhibit 4 - Celiac Journey’s One Sheeter for the White House Conference on Hunger, Nutrition and Health, Policy Objective: Reduce Diet-Related Disease by Labeling Gluten, Washington, D.C., September 28, 2022.
Exhibit 5 - Derr, Laura E. "When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004." Food and Drug Law Journal, vol. 61, no. 1, 2006, pp. 65-165. Note: When Food is Poison was written by Ms. Derr 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.
Exhibit 6 - Bari Consulting Group, Celiac Journey and Gluten Free Finds, "Sharing Our Lived Experience with Celiac Disease - Comments on '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,' August 16, 2022." FDA Comment ID: FDA-2021-N-0553-1584, FDA Tracking Number l6w-qe9m-4tjy, August 16, 2022. Cover Letter from Bari Consulting Group, Celiac Journey and Gluten Free Finds to Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration and Frank Yiannas, Deputy Commissioner for Food Policy and Response, U.S. Food and Drug Administration.
Exhibit 7 - 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 2022.
Call to Action: Submit Comments to FDA to Support Citizen Petition to Label Gluten as Major Food Allergen
Major Comments Submitted to the FDA (partial list)
Matt Bzdel, Chief Executive Eater, @glutenfreestreetgang, January 16, 2024, Comment ID: FDA-2023-P-3942-0107; Tracking Number: lrf-bt4u-iiz3
Alice Bast, Beyond Celiac, April 2, 2024, Comment ID: FDA-2023-P-3942-0718; Tracking Number: lui-jltf-zdun
Debra L. Bogen, MD, FAAP, Acting Secretary of Health, Pennsylvania Department of Health, on behalf of Pennsylvania Governor Josh Shapiro's Administration, April 2, 2024, Comment ID: FDA-2023-P-3942-0734, Tracking Number: lul-j5or-r992
Eric Feldman, J.D., Ph.D., Heimbold Chair in International Law, Professor of Law; Professor of Medical Ethics & Health Policy; and Deputy Dean for International Programs, University of Pennsylvania Carey Law School, December 17, 2023, Comment ID: FDA-2023-P-3942-0083; Tracking Number: lq9-y1ag-k9mv
Ciaran P. Kelly, MD, Professor of Medicine, Harvard Medical School, J. Thomas LaMont Professor of Gastroenterology, Associate Director, Gastroenterology Training Fellowship and Director, Celiac Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, October 4, 2023, Comment ID: FDA-2023-P-3942-0011; Tracking Number: lne-nfk7-siki
Francisco Leon, MD, PhD, Immunologist, Entrepreneur, Chief Scientific Officer Provention Bio, a Sanofi Company, November 20, 2023, Comment ID: FDA-2023-P-3942-0069; Tracking Number: lp4-skl1-rx3w
Sung Poblete, PhD, RN, CEO, FARE (Food Allergy Research and Education), February 27, 2024, Comment ID: FDA-2023-P-3942-0615; Tracking Number: lt5-7a12-hqf5
Blair Raber, Founder of the Celiac Disease Program at Children’s National Hospital, Comment ID: FDA-2023-P-3942-0082; Tracking Number: lq0-a1jb-ejfzDecember 11, 2023
Red Sneakers for Oakley, January 23, 2024, Comment ID: FDA-2023-P-3942-0126; Tracking Number: lrq-v2vu-ip7k
Christopher Rich, CEO / Executive Director, National Celiac Association, November 2, 2023, Comment ID: FDA-2023-P-3942-0050; Tracking Number: loh-o29z-1i6d
Brian Ronholm, Director, Food Policy Consumer Reports and Michael Hansen, PhD, Senior Scientist, Consumer Reports, January 5, 2024, Comment ID: FDA-2023-P-3942-0098; Tracking Number: lr0-v6ex-ha38
Thomas Silvera, MSHS-PH, Co-Founder/Vice President, Elijah-Alavi Foundation, January 16, 2024, Comment ID: FDA-2023-P-3942-0108; Tracking Number: lrg-i4h9-c5dp
Arunjot Singh, MD, Assistant Professor of Clinical Pediatrics, Co-Director, Children's Hospital of Philadelphia's Center for Celiac Disease, Division of Gastroenterology, Hepatology & Nutrition, Perelman School of Medicine, University of Pennsylvania, October 29, 2023, Comment ID: FDA-2023-P-3942-0028; Tracking Number: loc-acte-6f7c
Jonathan Spergel, MD, PhD, Professor of Pediatrics, Chief, Allergy Section, Stuart E. Starr Chair of Pediatrics, Director of Center for Pediatric Eosinophilic Disease, Director, FARE Center of Excellence at The Children's Hospital of Philadelphia, November 14, 2023, Comment ID: FDA-2023-P-3942-0064; Tracking Number: loy-s86u-qo7p
Virginia Stallings, MD, Board Certified Nutrition Pediatrician, Jean A. Cortner Endowed Chair in the Division of Gastroenterology, Hepatology and Nutrition at Children's Hospital of Philadelphia ("CHOP") and Director of CHOP's Nutrition Center; Emeritus Professor CE of Pediatrics (Gastroenterology, Hepatology and Nutrition), Perelman School of Medicine, University of Pennsylvania; and Report Editor and Chair of the National Academies of Sciences, Engineering, and Medicine, Committee on Food Allergies: "Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management and Public Policy." November 29, 2023, Comment ID: FDA-2023-P-3942-0078; Tracking Number: lpl-adrl-zbxc
Seth Togal, Jennifer Togal and Adina Togal, the family who inspired The ADINA Act to require the labeling of Gluten in medicine, January 24, 2024, Comment ID: FDA-2023-P-3942-0128; Tracking Number: lrs-dz94-bo0i