The Biden Administration FAILED to Protect Celiacs by Refusing to Require the Labeling of Gluten Grains as Major Food Allergens
- Jon Bari
- 14 hours ago
- 11 min read
Updated: 11 minutes ago
Overview
The Biden Administration FAILED to protect 3.3 million American Celiacs, including 729,000 children. Watch this video for just one example. The Biden Administration FAILED to enact Celiac Journey's common sense solution to require the labeling of Gluten grains on all packaged foods in the United States, just like Gluten must be declared on all food labels in 87 other countries (FDA Citizen Petition, FDA-2023-P-3942). The U.S. is so far behind the rest of the world!
Starting when he was 9-years-old in 2022, Jax Bari personally met with: President Biden; HHS Secretary Xavier Becerra; HHS Assistant Secretary of Health Rachel Levine, MD; FDA Commissioner Robert Califf, MD; FDA Deputy Commissioner of Human Foods Jim Jones; The White House Domestic Policy Council & Office of Public Engagement; etc. From President Biden on down, they each FAILED to protect Celiacs!
HHS Assistant Secretary of Health Levine & FDA Commissioner Califf Failed - Watch the Whataboutisms
On January 31, 2024, Jax Bari, age 10, was personally invited by former HHS Secretary Xavier Becerra to attend the first-ever HHS Food is Medicine Summit. After meeting with Secretary Becerra and HHS Assistant Secretary of Health Rachel Levine, MD, Jax bravely spoke truth to power to our nation's health leadership in front of 400 people at the HHS Great Hall and asked them to help protect Celiacs by requiring the labeling of Gluten on all food products.
FDA Commissioner Califf's response to Jax's question was insulting! To refer to Celiac Disease as "Gluten issues" was dismissive. To say that 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 corporate profits rather than consumer protection. After Jax spoke, there were so many people who came up to Jax at the HHS Food is Medicine Summit and thanked him for calling out the FDA on is failures!
In response to Jax's question, Secretary Levine concluded with, "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." To the best of our knowledge, Jax's common sense solution with his FDA Citizen Petition was never discussed between Secretary Levine and Commissioner Califf in meetings, and even if it was, they FAILED to protect Celiacs by issuing rulemaking to require the labeling of Gluten.
President Biden Failed
In August 2021, President Biden applauded Jax's efforts: "I admire your courage and the incredible work you've done to help the millions of Americans like you who live with Celiac disease."
In October 2022, Jax (age 9) met with President Biden and asked for the President's help to protect him and 3.3 million American Celiacs by requiring the labeling Gluten as a Major Food Allergen, just like Gluten must be declared on all food labels in 87 other countries. To give the President some perspective, Jax told POTUS that insulin is to diabetics as Gluten Free food is to Celiacs. Jax was then invited to the White House to make his case to the Domestic Policy Council. President Biden and the Domestic Policy Council failed to help!
So President Biden admired Jax's "courage and the incredible work" that 9-year-ol Jax has "done to help the millions of Americans" like him "who live with Celiac disease." However, President Biden did nothing to help Jax and to protect Celiacs with mandatory food allergen labeling so Celiacs and their caregivers know what is safe to eat.
The Biden Administration's National Strategy on Hunger, Nutrition, and Health declared that "diet-related diseases are some of the leading causes of death and disability in the U.S." However, the National Strategy did not mention Celiac Disease or food allergen labeling, even though Celiac Journey worked to inform the White House through listening sessions, comment submissions, meetings and other engagement initiatives. For example, Jax's video submission was the top ranked video to the White House Conference on Hunger, Nutrition and Health.
In contrast, the MAHA Report Assessment from the Trump Administration that was released on May 22, 2025 included express references to Celiac Disease, food allergies and autoimmune diseases. The Biden Administration failed to protect Celiacs and issue rulemaking to require the labeling of Gluten!
HHS Assistant Secretary of Health Levine Failed Again
On June 3, 2024, three days after Celiac Awareness Month ended, Secretary Levine posted,
"May was Celiac Awareness Month -- I was lucky to meet Jax, a young advocate for those with Celiac disease, at @HHSGov's Food is Medicine Summit. He is helping to ensure food has clear gluten labels to protect the millions of Americans who suffer from this disease."
So we had an 11-year-old boy helping to ensure food has clear Gluten labels to protect the millions of Americans who suffer from Celiac Disease.
But what did the HHS Assistant Secretary of Health do to ensure food has clear Gluten labels to protect 3.3 million Americans who suffer from Celiac Disease? Nothing!
HHS Secretary Becerra Failed
In January 2024, Jax met with Secretary Becerra and pleaded for help since the HHS Secretary has existing statutory authority to require the labeling of Gluten as a Major Food Allergen under the Food Allergen Labeling and Consumer Protection Act of 2004. [1]
"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." -- FDA's Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, March 5, 2024
At the HHS Food is Medicine Summit, Secretary Becerra shared his mother Maria Teresa Becerra’s wisdom that "it is much better to prevent than to remediate." To that end, we had hoped that the Secretary would have listened to the brave words of 10-year-old Jax speaking truth to power 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 like you shared, but unlike you Secretary Becerra, Jax cannot avoid thinking about his food allergy to Gluten.
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!"
As a kid, Jax is constantly thinking about how to prevent rather than remediate, every bite, every day! That's why Jax appealed to Secretary Becerra for help. Secretary Becerra and his his HHS team did nothing at all!
HHS Assistant Secretary of Health Levine Failed Again
In June 2024, Jax met with Secretary Levine and she appeared to be more interested in asking questions about Jax going to overnight camp and his summer activities rather than acting on Jax's FDA Citizen Petition to require the labeling of Gluten.
Jim Jones Failed
In August 2024, Jax met with FDA Deputy Commissioner of Human Foods Jim Jones. Jones seemed to understand how the lack of mandatory Gluten labeling is public health problem long overdue for robust action, and that it was time to reduce chronic diet-related disease by requiring the labeling of Gluten on all packaged foods in the United States, just like Gluten must be declared on all food labels in 87 other countries.
This appeared to resonate with Jones because of his own finding about the FDA when he was one of six experts who wrote the Reagan-Udall report, Operational Evaluation of the FDA's Human Foods Program, which stated in part:
"This [FDA] culture creates an environment where decision-making is unacceptably slow. From an external perspective, the Human Foods Program can be left appearing sluggish and non-responsive to public health concerns."
Jax was joined at the FDA meeting by Brian Ronholm, Director of Food Policy with Consumer Reports who urged the FDA on behalf of Consumer Reports' 6 million members to require the labeling of Gluten.
However the Biden Administration's FDA failed again!
Jax asked FDA Deputy Commissioner Jones for the FDA to announce intended rulemaking now on requiring the labeling of Barley, Rye and Oats. Initially Deputy Commissioner Jones seemed amenable to bypassing the Request for Information stage and requiring the labeling of Barley, Rye and Oats. DC Jones even said that he wanted to "streamline processes" and not "elongate" them, and this was in the context of Jax's request to issuing Rulemaking.
Then the FDA's staff lead Pat Hansen, Deputy Director, Office of Nutrition and Food Labeling, CFSAN, said she would like to issue a Request for Information, and DC Jones quickly changed his tune. As a former regulator, Ronholm called this out and tried to get a timeline pinned down, but was unsuccessful in doing so. Ronholm also said that all of the information is already known and tried to get some clarification as to what the FDA might want to still learn, but Hansen could not even give one example of more information that they may want.
Ronholm published the following article in Food Safety News after the meeting - "FDA's Sluggish Process is Failing to Protect Celiacs," Brian Ronholm, Director of Food Policy, Consumer Reports, Food Safety News, September 19, 2024.
The Biden Administration's FDA Failed
Under the Biden Administration, the FDA failed to understand that the Celiac community is in crisis - every bite every day!
We have met with senior members of FDA's Nutrition Department several times including most recently with Jim Jones, FDA Deputy Commissioner of Human Foods. The meetings were in response to Jax's FDA Citizen Petition to require the labeling of Gluten on all food packages in the US, just like Gluten must be declared on all food labels in 87 other countries.
Under the Biden Administration, the FDA had no urgency and no willingness to even say when a simple Request for Information might be published by the FDA, which appears to be another example of why we are hopeful that the Trump Administration will help Make America Healthy Again for Celiacs by requiring the labeling of Gluten.
Summary of Biden Administration Failures
Failed to include any mention about Celiac Disease and food allergen labeling in the Biden-Harris Administration's National Strategy on Hunger, Nutrition, and Health that declared "diet-related diseases are some of the leading causes of death and disability in the U.S."
Failed to meaningfully respond to Jax's FDA Citizen Petition (FDA-2023-P-3942) to require the labeling of Gluten.
Failed to issue rulemaking to require the labeling of Gluten. Instead, on March 5, 2024, the FDA's Claudine 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."
Issued deeply flawed food allergen labeling guidance days before President Trump's Inauguration that failed to follow gold-standard science for which there is global significant scientific agreement on requiring the labeling of Gluten.
Failed to follow the FDA's 1985 Final Rule - "The agency finds that labeling packaged foods as 'gluten free' would not be as desirable as actually identifying on the food label the source of the gluten that is used in the food. Under 21 CFR 101.4(a), wheat gluten and other gluten sources must be identified by name when they are used in food."
Gaslit Gluten as a second class food allergen & Celiac as not a potentially life-threatening food Allergy!
Failed to provide any safe food at the HHS Food is Medicine Summit. The Food is Medicine Summit was 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 potato chips. The question for HHS leadership: how do you think that those with food allergies felt about this oversight, especially at the Food is Medicine Summit? The sad answer is that it was just another day in the life for Celiacs. HHS never apologized for this glaring oversight!
Additional Resources on How the Biden Administration Failed
Jax Bari Talked Food Policy with President Biden and Asked for Help: Please Label Gluten, October 25, 2022.
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!, March 30, 2024.
Readout of White House Meeting on Labeling Gluten as a Major Food Allergen to Protect Celiacs, November 24, 2022.
Readout of Meeting with Office of HHS Secretary Xavier Becerra: Labeling Gluten is Actionable Now, May 2, 2023.
FDA Meeting on Health Equality: End the Gluten Guessing Game & Label Gluten as a Major Food Allergen, January 18, 2023.
Takeaways from the White House Conference on Hunger, Nutrition and Health, Let's Get Gluten Labeled!, October 15, 2022.
White House Conference on Hunger, Nutrition & Health: Reduce Diet-Related Disease By Labeling Gluten, September 14, 2022.
FDA Should Follow the 2021 FAO/WHO Expert Consultation & 1,576 Public Comments on Labeling Gluten, September 2, 2022
Notes
[1] See Derr LE. "When food is poison: the history, consequences, and limitations of the Food Allergen Labeling and Consumer Protection Act of 2004." Food Drug Law Journal, 2006;61(1):65-165. PMID: 16838459. When Food is Poison was written by Laura 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.
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." (Source: https://www.congress.gov/108/crpt/srpt226/CRPT-108srpt226.pdf ) "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." https://www.congress.gov/108/crpt/srpt226/CRPT-108srpt226.pdf
