Readout of Meeting with Office of HHS Secretary Xavier Becerra: Labeling Gluten is Actionable Now
On April 17, 2023, the Bari family traveled to Washington, D.C. and shared their lived experience and Celiac Journey's research on why Gluten needs to be labeled on all packaged foods in the U.S., just like it is 85 countries worldwide. As a follow up to our meetings with the White House Domestic Policy Council staff and senior FDA leadership, we presented to staff from the Immediate Office of U.S. Department of Health and Human Services ("HHS") Secretary Xavier Becerra.
We were honored to have been joined again at the HHS 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 has been treated for Celiac Disease since 2018). Dr. Stallings has also called for Gluten to be required to be labeled on all packaged food products in the U.S. Labeling Gluten as a Major Food Allergen will provide better consumer protection for 3.3 million American Celiacs.
Through the Lens of President Biden's Executive Orders on Advancing Equity and Support for Underserved Communities
As the Baris shared with Secretary Becerra's staff, the evaluation of the public health importance of labeling Gluten as a Major Food Allergen should be conducted now through the lens of President Biden's Executive Order 13985 and Executive Order 14091 on "Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government"(2/16/23).
In addressing how President Biden's Executive Orders are expressly applicable to the decision-making process for labeling Gluten on all packaged foods, Celiac Journey prepared the following Memo to Secretary Becerra's staff entitled, "An 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."
The labeling of Gluten as a Major Food Allergen sits at the intersection of President Biden’s Executive Orders on advancing equity for underserved communities for people with disabilities; the White House Conference and National Strategy on Hunger, Nutrition, and Health; and the Universal Declaration of Human Rights, including the right to feed oneself in dignity (see Section IV.G. in the Memo); and the UN's Convention on the Rights of the Child (see Section IV.H. herein in the Memo).
As per the Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health as part of the White House Conference, "diet-related diseases are some of the leading causes of death and disability in the U.S." According to the President's Executive Order, "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." As per 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 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: Draft Guidance for FDA Staff and Stakeholders, April 19, 2022" Represents a Biased and Unfair Decision-Making Framework
Based on detailed research, analysis and the Celiac community's lived experiences with a chronic disability (as per the Americans with Disabilities Act), we believe that advancing equity must be a central component of the decision-making framework that all FDA functions are routed through, including with "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," Docket: FDA-2021-N-0553, April 19, 2022 ("FDA's Draft Guidance").
However, with respect to the Celiac Disease community, which has been historically underserved and marginalized by the Federal government (i.e., underfunding medical research for Celiac Disease, labeling Gluten only with a voluntary scheme, disqualifying Celiacs from service in the military, excluding Celiac Disease from the CDC’s Index of Diseases & Conditions, etc.), the FDA's Draft Guidance presented an inequitable evaluation framework.
In total, there were 1,903 public comments submitted to the FDA on the FDA's Draft Guidance, and of those, 1,576 comments mentioned Celiac and/or Gluten as a food allergen (82.8% of all comments submitted). There was a common theme among the 1,576 comments: label Gluten to better protect the Celiac community. While the comment period closed on August 16, 2022, the FDA has not provided any updates to the FDA's Draft Guidance or published any responses to the public comments thereto.
When we met with the FDA on December 6, 2022, we asked for an update including whether they were going to revise the FDA's Draft Guidance to include the evaluation of the public health importance of labeling Gluten as a Major Food Allergen. The FDA offered no comment and no timetable, other than to seemingly suggest that because of the volume of comments that they had received during the comment period from April 19, 2022 to August 16, 2022, the FDA could not provide any timeframe for their response. We then pointed out that almost 83% of the comments had a common denominator about labeling Gluten and Celiac Disease. The FDA was still silent.
What's Past is Prologue - Unfortunately
This lack of responsiveness from the FDA is indicative of the agency's past foot-dragging behavior (See Celiac Journey's Public Comments to the FDA, and the section entitled "The FDA Fell Short for a Decade in Protecting the Celiac Community", pages 79-96).
The FDA's slow walking on Celiac Disease is also especially troublesome since according to the 2019 Congressional testimony of Marilyn Geller, CEO of the Celiac Disease Foundation, "Americans are dying because we haven't paid sufficient attention to this disease."
We just do not have the privilege of time to wait any longer! See Section VI in the in the Memo entitled, "FDA's Draft Guidance Illustrates Bias Against Celiac Disease." This is also further discussed in greater detail in the the Section IV in the Memo, "President Biden's Executive Order 13985 On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government & President Biden's Executive Order 14091: Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government." Unfortunately, the FDA's Draft Guidance, which was published in April 2022, is incongruent with HHS Equity Action Plan as also detailed in the Memo).
FDA's Draft Guidance Presents an Inequitable Framework for the Evaluation of the Public Health Importance of Food Allergens Other Than the Major Food Allergens
Jon Bari shared the findings of Celiac Journey, Bari Consulting Group and Gluten Free Finds that the FDA's Draft Guidance presented an inequitable evaluation framework for evaluating the public health importance of food allergens (i.e., Gluten) other than the Major Food Allergens, as well as perpetuated 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 by 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 also 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 HHS to reckon with the fact that labeling Gluten has for many years been 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:
1999 Expert Consultation, 1999 Codex Criteria. 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)
2021 Expert Consultation - 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 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.
We have requested that in addition to the review of our Memo by the Office of HHS Secretary Becerra that the HHS Equity Team review our findings and request as well. As per President Biden's Executive Order 14091, "the Secretary of Health and Human Services... shall, within 30 days of the date of this order [March 16, 2023], ensure that they have in place an Agency Equity Team within their respective agencies to coordinate the implementation of equity initiatives and ensure that their respective agencies are delivering equitable outcomes for the American people."
Evaluating the public health importance of labeling Gluten represents the implementation of a long-overdue equity initiative. Labeling Gluten on all packaged foods represents an equitable outcome for 3.3 million American Celiacs who have been been marginalized in our historically underserved community with a chronic disability.
Dr. Virginia Stallings Joined the Clarion Call to Label Gluten Now
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)
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." 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." (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.
Timeline Leading Up to HHS Meeting
May 6, 2022 - Met with Dr. Sandi Ford, Special Assistant to the President for Health and Science, to inform the White House about the unmet needs of the Celiac community, especially the pediatric community, including with labeling Gluten and funding Celiac research.
June 7, 2022 - Participated in and provided spoken comments in the Breakout Room for Pillar 2 in the Listening Session for the White House Conference on Hunger, Nutrition, and Health.
July 15, 2022 - Submitted written comments via email to the White House Conference on Hunger, Nutrition, and Health.
Summer 2022 - Worked with various organizations, doctors, scientists as well as individuals with Celiac, their parents, caretakers and loved ones, to help generate 1,576 public comments submitted to the FDA on the labeling of Gluten, which represented 82.8% of the 1,903 total comments that the FDA received on Docket number: FDA-2021-N-0553.
August 16, 2022 - Submitted Bari Comments to the FDA's 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, Draft Guidance," April 19, 2022, Docket Number: FDA-2021-N-0553.
September 28, 2022 - The Baris attended the White House Conference on Hunger, Nutrition, and Health and shared our lived experience and policy objective of reducing diet-related disease by labeling Gluten on all food products. Jax Bari’s capsule video was one of the most watched testimonials on "How have you, your family, or your community been affected by diet-related disease?"
October 20, 2022 - Jax Bari met with President Joe Biden and asked for the President's help to protect him and 3.3 million American Celiacs by labeling Gluten as a Major Food Allergen, like it is done in 85 other countries worldwide.
November 10, 2022 - Jax took his case to the White House and met with White House Domestic Policy Council ("DPC") staff to share our lived experience presentation with the DPC on the Celiac community's request for help.
December 6, 2022 - Along with Dr. Stallings, the Bari family 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.
Memo - The Evaluation of the Public Health Importance of Labeling Gluten as a Major Food Allergen Should Be Conducted Now Through the Lens of President Biden's Executive Order 13985 and Executive Order 14091 on "Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government" (2/16/23) - An 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
Presentation - Sharing Our Lived Experience: Jon, Leslie, Jax and Lexi Bari, Celiac Journey & Gluten Free Finds, and Dr. Virginia Stallings, Children’s Hospital of Philadelphia. Prepared For: Secretary Xavier Becerra, Department of Health and Human Services, Immediate Office of Secretary Becerra, Sarah Despres, Steven Lopez, Samantha Satchell and Kimberly Miller-Tolbert.
 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."
 H.R. Rep. No. 108-608, at 18. (2004), https://www.congress.gov/108/crpt/hrpt608/CRPT-108hrpt608.pdf