10-Year-Old Takes HHS Leadership & FDA Commissioner to Task at the HHS Food is Medicine Summit: "Do it with Ganas" Mr. Secretary - Please Require Gluten Labeling!

Key Takeaways from the HHS Food is Medicine Summit Remind Us Why the FDA Needs to Require the Labeling of Gluten!

• ICYMI: Jax Bari, age 10, was invited by HHS Secretary Xavier Becerra to attend the first-ever Food is Medicine Summit, and after meeting with Secretary Becerra, Jax bravely spoke truth to power to our nation's health leadership in front of 400 people and asked them to help protect Celiacs by requiring the labeling of Gluten on all food products.

• SMH: FDA Commissioner's response to Jax's question that "there are people on all sides of" requiring the labeling of Gluten as an allergen on packaged foods suggested "whataboutism," and that the FDA is more concerned with protecting corporate profits rather than providing consumer protection.

• POV: The HHS Food is Medicine Summit was ironically a food desert for those with food allergies to the top 9 Major Food Allergens and Gluten. There was no food allergen labeling on any of the food served for lunch or snacks other than the chips, and there was no safe Gluten Free food offered to eat for Celiacs like Jax other than apples and chips. The question for HHS leadership: how do you think that those with food allergies felt about this oversight? The sad answer is that it is just another day in the life for Celiacs. As per President Biden's Executive Orders (13985 and 14091) on advancing equity for underserved communities with a chronic disability such as Celiac Disease, the HHS Food is Medicine was just another example of how Celiacs have been denied opportunities time and again to fully participate in economic, social and civic life. The HHS Food is Medicine Summit reminds us how far we have yet to go as a country for health equity for Celiacs. Period. Full Stop.
  

10-Year-Old Speaks Truth to Power to Nation's Health Leaders

It was an honor for 10-year-old Jax Bari to have been invited by HHS Secretary Becerra to attend the U.S. Department of Health and Human Services (HHS) first-ever Food is Medicine Summit in Washington, D.C. on January 31, 2024. The Food is Medicine Summit was an all-day event with an ambitious agenda for stakeholders at the intersection between food and health.

Jax started the day by meeting with Secretary Becerra and Admiral Rachel Levine, Assistant Secretary for Health and making his case that Gluten should be required to be labeled on all packaged foods in the U.S. (Jax's Citizen Petition, FDA-2023-P-3942), just like Gluten must be declared on all food labels in 87 other countries. Then Jax stood with a microphone and bravely spoke truth to power in front of 400 people. Jax simply asked the seated panel for their thoughts on protecting Celiacs by requiring the labeling of Gluten. As you can see on the video, the "Department of HHS Collaboration and Investments in Food is Medicine" panel included:

• Admiral Rachel Levine, Assistant Secretary for Health (moderator)

• Robert Califf, Commissioner, U.S. Food & Drug Administration

• Tara Schwetz, Deputy Director for Program Coordination, Planning, and Strategic Initiatives, National Institutes of Health

• Andi Lipstein Fristedt, Deputy Director for Policy, Communications and Legislative Affairs at CDC, Centers for Disease Control and Prevention

• Aditi Mallick, Acting Director, CMS Office of Minority Health, Centers for Medicare & Medicaid Services

• Jordan Grossman, Deputy Administrator of the Health Resources and Services Administration, Health Resources and Services Administration

• Roselyn Tso, Director, Indian Health Services

Jax Bari (1:50:05): "I'm Jax Bari, I'm 10 years old, and I'm from Philadelphia, and I have Celiac Disease. I'm wondering, what are your thoughts on making Gluten a major [food] allergen and making it required to be labeled on all packaged foods in the U.S.?"

Admiral Levine (1:50:31): "Thank you very much Jax. Thank you. It was wonderful to meet you before the conference and thank you very much for your advocacy and your courage in terms of speaking out. So Commissioner Califf, regulations. Now this is a surprise question, but something that we would be happy to talk about."

FDA Commissioner Califf (1:50:55): "Well, we know that Gluten issues are increasingly prevalent in our society and affecting a lot of people, so there's a process for changing a label, it's complicated but can be done. And there are people on all sides of an issue like that. I think that the advocacy community, represented by you, is making a case, and we are going to have consider that carefully as we go forward."

Admiral Levine (1:51:23): "Thank you Jax, and I appreciated all of the materials that you gave me. We have regular meetings between us all, and we are going to bring up that topic."

Whataboutism - Who is Actually Against Requiring the Labeling of Gluten?

The FDA Commissioner's comments that "there are people on all sides of" requiring the labeling of Gluten as an allergen on packaged foods suggest that the FDA is more concerned with protecting corporate profits rather than providing consumer protection.

Jax respectfully called out FDA Commissioner Califf who acknowledged that "gluten issues are increasingly prevalent in our society and affecting a lot of people," that "there's a process for changing a label, it's complicated but can be done, but there are people on all sides of an issue like that."

Given that Gluten is required to be labeled on packaged foods in 87 countries worldwide, many of the multinational consumer-packaged food manufacturers already label Gluten on their products sold in those 87 other countries. As such, labeling Gluten is in the United States would be commensurate with their existing global operations and best practices.

On May 15, 2023, the American Bakers Association wrote to Congress that, "We emphasize that the baking industry's priority remains the allergic community's safety." So Commissioner Califf, who are those people who are opposed to labeling Gluten?

Dr. Califf, let's follow the lead of the Food Standards Agency, FDA's counterpart in the United Kingdom.

To gain a better understanding of the support from the global food industry for the mandatory declaration of Gluten on all food labels, it is instructive to review the following best practice guidance from the Food and Drink Federation ("FDF") in the United Kingdom entitled, "Gluten Labelling Guidance: Best Practice for Prepacked Foods which Include or Exclude Cereals Containing Gluten (“Gluten Labeling Guidance”)." 

"The Food and Drink Federation (FDF) is the voice of the UK food and drink industry, the largest manufacturing sector in the country. We communicate our industry's values and concerns to Government, regulators, consumers and the media. We also work in partnership with key players in the food chain to ensure our food is safe and that consumers can have trust in it."

We are hopeful that the FDA comes down on the right side of history now to reduce diet-related disease by requiring the labeling of Gluten on all packaged foods in the US, just like Gluten must be declared on all food labels in 87 other countries. There is overwhelming scientific agreement on this!

Secretary Becerra: It's Much Better to Prevent Than to Remediate

In the spirit of Secretary Becerra sharing his mother Maria Teresa Becerra’s wisdom at the Food is Medicine Summit with "it is much better to prevent than to remediate," we hope that the Secretary will listen to the brave words of 10-year-old Jax speaking truth to power in front of 400 people at the Food is Medicine Summit and asking our nation’s health leaders to help better protect Celiacs by requiring the labeling of Gluten. Celiac robs kids of a carefree childhood. Jax is that kid who loves to go outside to play, but unlike you Secretary Becerra, Jax cannot avoid thinking about his food allergy to Gluten. As a kid, Jax is constantly thinking about how to prevent rather than remediate, every bite, every day!

Jax seemingly received applause and empathy from almost everyone in the room and follow up praise from every panelist and many attendees, everyone except for Commissioner Califf whose on-stage response and post-panel interaction (excluding the smile in the picture when Jax went up to meet him) suggested that the Commissioner was not too happy to have public oversight coming from a 10-year-old boy. There were numerous people in attendance at the Food is Medicine who applauded Jax, came up to Jax afterward and shared that feedback with us.

Jax's Policy Goals = Food is Medicine

The only available treatment for Celiac Disease is strict adherence to a lifelong, Gluten Free diet. There is no pharmacological treatment available. Unlike other food allergies, one cannot outgrow Celiac, there's no rescue medicine (i.e., epinephrine or antihistamine) to take for accidental Gluten ingestion. Recent research from Beyond Celiac shows that 44% of people with Celiac Disease who follow a strict Gluten Free diet still get glutened once a month. Gluten Free food is our only medicine!

Congressional Oversight is Needed on the FDA on Labeling Gluten

Taking the stage after the "Department of HHS Collaboration and Investments in Food is Medicine" panel was already in progress, FDA Commissioner Califf publicly blamed his delay on having to deal with Congressional oversight (which his comments and tone suggested was unpleasant).

If the "F" in FDA really does stand for food, then the FDA should follow the expert recommendations for which there is significant scientific agreement. To that end, 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)

• 2,250+ Comments submitted to the FDA on labeling Gluten including from thought leaders at Children's Hospital of Philadelphia (Dr. Virginia Stallings and Dr. Jonathan Spergel, two of the world's foremost experts on food allergens and labeling), FARE (Food Allergy Research and Education), Pennsylvania Governor Josh Shapiro and Debra Bogen, MD, Acting Secretary of Health of Pennsylvania, Harvard Medical School/Beth Israel Deaconess Medical Center, Consumer Reports, Beyond Celiac, National Celiac Association, Gluten Free Watchdog, University of Chicago Center for Celiac Disease, Elijah-Alavi Foundation, Red Sneakers for Oakley, University of Pennsylvania Law School, etc. (Dockets: FDA-2023-P-3942 & FDA-2021-N-0553)

Time is of the essence. We simply cannot afford a repeat of the FDA's slow walking and ultimate denial of the 2008 FDA Citizen Petition (FDA CP-2008-P-0509) to require the labeling of Gluten. It took the FDA a decade to summarily, arbitrarily and capriciously deny the petition "because the petition did not include adequate information to show that rye and barley are common causes of severe IgE-mediated food allergies" (See Citizen Petition, Pages 84-86).

Just like the 2021 FAO/WHO Expert Consultation (including Dr. Lauren Jackson, Dr. Stefano Luccioli, Dr. Joseph Baumert, and Dr. Stephen Taylor) did not adversely distinguish between IgE-Mediated and Non-IgE-Mediated food allergies in their systematic and thorough assessments which used all three criteria (prevalence, severity and potency) to determine the Risk Assessment of Food Allergens, the FDA must stop discriminating between IgE-Mediated and Non-IgE-Mediated food allergies with Celiac when it comes to equitably evaluating the labeling of Gluten as a Major Food Allergen to protect 3.3 million American Celiacs.

On March 5, 2024, the FDA's Claudine J. Kavanaugh, Director, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, sent a "180 day letter" which stated,

"We are advising you, in accordance with Title 21 Code of Federal Regulations, section 10.30(e)(2), that we have not been able to reach a decision on your petition within the first 180 days of its receipt, nor as of the date of this letter, because of other agency priorities and the limited availability of resources." (emphasis added)

This is why we need action from the White House and Congressional oversight!

HHS Food is Medicine Principles

According to the HHS Press Release for the Food is Medicine Summit, "HHS released five Food is Medicine principles that will guide the Department's work when it comes to educating the public, changing public policies, and integrating nutrition in the services it provides. These principles include:

• Recognizing that nourishment is essential for good health, wellbeing, and resilience.

• Facilitating easy access to healthy food across the health continuum in the community.

• Cultivating understanding of the relationship between nutrition and health.

• Uniting partners with diverse assets to build sustained and integrated solutions.

• Investing in the capacity of under-resourced communities."

Food Desert at the HHS Food is Medicine Summit - No Food Allergen Labeling & No Gluten Free Food Served

After the morning panels recognized that nourishment is essential for good health, wellbeing, and resilience and addressed facilitating easy access to healthy food across the health continuum in the community, the 400 attendees, including Jax, had worked up an appetite when it was announced that lunch was going to be served (2:40:33).

However, there was no food provided for people with food allergies and Celiac Disease at the HHS Food is Medicine Summit! Sadly, ironically, and tellingly, there was no food allergen labeling whatsoever on any of the food served at the Summit other than the chips!

How do you think that it makes those with food allergies like Jax feel when there was no food served for him that he can safely eat? The answer is that it is just another day in the life! Fortunately, we packed Jax a lunch to take to the Food is Medicine Summit, even though when we had registered, we requested special dietary accommodations for the event. This is our lived experiences when food privilege must be checked among those who do not have food allergies like Celiac Disease.

The HHS Food is Medicine Summit reminds us how far we have yet to go as a country for health equity when there was no food allergen labeling on any of the food served other than the chips, and there was no safe Gluten Free food offered to eat for Celiacs like Jax other than apples and chips.

This speaks to Jax's work to shine a light on an underserved community with potentially life-threatening and life-debilitating food allergies, including 3.3 million American Celiacs who can get violently ill after ingesting just a crumb of Gluten, and how hard it is to participate fully in life's daily activities that involve food. How can this be?

As per President Biden's Executive Orders (13985 and 14091), this food desert experience at the HHS Food is Medicine Summit is yet another example of how Celiacs have been denied opportunity to participate fully in economic, social & civic life. See Citizen Petition, pages 77-82). Unfortunately, this is not the first time that this has happened. For example, the White House Conference on Hunger, Nutrition, & Health and the White House Easter Egg Roll each fell short in accommodating the medically required diets of those with food allergies including Celiac Disease.

If the HHS Food is Medicine Summit cannot get lunch right for those with food allergies, how can we expect other government agencies , schools, food service operators, to safely and meaningfully accomodate Celiacs in their day to day lives?

Jax's food is medicine advocacy aligns with the Biden-Harris Administration's National Strategy on Hunger, Health, and Nutrition: "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."

Through the Lens of President Joe Biden's Executive Orders on Advancing Equity and Support for Underserved Communities

As the Baris have shared with Secretary Becerra and senior FDA leadership, 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 requiring the labeling of Gluten on all packaged foods, please see Citizen Petition, Section V. "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" (pages 63-88).

USDA Secretary Tom Vilsack: "Remember that Kid in 4th Grade" - Jax is that Kid Mr. Secretary

We really appreciate Secretary Vilsack sharing his lived experience with starting out his life in an orphanage, being very "plump" when he was adopted and struggling all his life with weight and body image issues. When Secretary Vilsack shared that he had been made fun of as a kid because of his diet-related disease, it resonated with Jax. When Secretary Vilsack acknowledged the emotional toll of his diet-related disease in a personal context, it resonated with us because of the emotional toll that Celiac takes with anxiety over food potentially making you very sick.

Let's Heed the Guidance from Secretary Becerra - "Do it with Ganas!" & "Never Do Mild!"

According to Secretary Becerra's remarks (43:14), "We got to keep this rolling and keep it on time. So, can I simply say this? Where are we going to go from here? How do we move this? How do we not just come together for a summit and then go back and feel like we got too many things in our lives to really push this. I always tell my team here, never do mild when you have a chance to do something in a space that very few will ever get to be. Please let's not do mild... We are fortunate to have partners who want to take this to the next level... But there are kids today who are not eating well!... Frederick Douglass is talking to you. My mom is, in Spanish, talking to you. Please harness this moment. It is great to see how many people have an interest in this. But do it as my mom and dad taught me. Do it with ganas, G-A-N-A-S, Don't look it up. I'm telling you right now what it means. It means more than desire which is what you'll find in the dictionary. It means guts, grit and game all in one. If we do this with GANAS, wow!"

The mission of the U.S. Department of Health and Human Services is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.

If the labeling of gluten was mandatory on all products, our lived experience strongly suggests that the number of gluten-free products available to those who have Celiac would greatly expand. 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 (pages 130-143) 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.

Ahem - Jax is respectfully speaking to you Secretary Becerra and Commissioner Califf! We need a whole-of-government approach here! You already have the existing statutory authority to require the labeling of Gluten on all packaged foods in the U.S., just like Gluten must be declared on all food labels in 87 other countries. See Statement of Legal Grounds in the Citizen Petition (pages 28-31).

"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, Professor of Management and Psychology, the Wharton School, University of Pennsylvania

Once More for Those in The Back...

If you stand for advocating that food is medicine and reducing diet-related disease, but you don't do so when an underserved and marginalized community like Celiacs plead for your help and you have the authority and responsibility to help, you are in fact standing for the calcification of policies that were wrong 20 years ago! What was wrong 20 years ago is even more wrong today in the face of overwhelming scientific agreement determined by systematic and thorough assessments which used all three criteria (prevalence, severity and potency) to determine that Gluten should be required to be labeled to avoid adverse health effects that are potentially life-threatening and life-debilitating. The status quo is unacceptable!

Supporting Materials

• Agenda, HHS Inaugural Food is Medicine Summit: Building a Dynamic Future

• Jax's FDA Citizen Petition to Require the Labeling of Gluten on Food Products in the U.S., 9/13/23, FDA-2023-P-3942 

• Celiac Journey One Sheeter to Require the Labeling of Gluten on Food Products in the U.S., 9/13/23, FDA-2023-P-3942