"In some categories, there are entire departments, like the nutrition department at the FDA that have to go, that are not doing their job, they're not protecting our kids!" -- Robert F. Kennedy, Jr.
The FDA Has Failed to Protect 729,000 American Children with Celiac Disease
We agree with Robert F. Kennedy, Jr. that the FDA has failed to protect our kids! In spite of our pleas for help and suggested common sense solutions, the FDA has failed to protect 3.3 million Americans with Celiac Disease, including about 729,000 children like my 11-year-old son Jax.
Celiac is a potentially life-threatening and chronic food allergy and auto-immune disease triggered by eating Gluten, a protein found in Wheat, Barley, Rye & most Oats. Just one crumb of Gluten is like kryptonite to my 11-year-old Superman. In other words, Gluten is poison to Celiacs.
Unlike other food allergies, Jax cannot outgrow Celiac, and there is no rescue medicine (i.e., epinephrine or antihistamine) to take in the event of accidental ingestion of Gluten. The only available treatment is a strict Gluten Free diet for life.
"The greatest crisis that America faces today is the chronic disease epidemic in America's children." -- Robert F. Kennedy, Jr.
The 1999 Codex Criteria found that "ingredients known to cause food allergies and intolerance and whose presence should always be declared" included "cereals containing gluten (i.e. wheat, rye, barley, oats, spelt or their hybridized strains) and their products." That was 26 years ago!
Since 2006, Wheat has been required to be labeled in the US, but Barley, Rye and Oats have not. The FDA has failed to address this safety gap for nearly two decades, even though the FDA has the existing statutory authority to require Gluten labeling under the Food Allergen Labeling and Consumer Protection Act of 2004 ("FALCPA").
Common Sense Solution: Close the Safety Gap By Requiring the Labeling of Gluten
Until there's a treatment for Celiac other than a Gluten Free diet, we believe that requiring the labeling of Barley, Rye and Oats will have the greatest impact on improving safety and the quality of life for Celiacs given life's daily activities that involve food. Eating without fear is our mission!
Imagine if you had a Tree Nut allergy and only Almonds and Pistachios were required to be labeled, but not other Tree Nuts such as Walnuts and Pecans. That would create a massive food safety gap that needed to be closed. Fortunately for those with a Tree Nut allergy, that scenario is not the case. But that similar safety gap does exist with the voluntary labeling scheme of Barley, Rye, and Oats for millions of American Celiacs. We are FED UP!
"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." --Reagan-Udall Report
To help Make America Great Again, Jax submitted a Citizen Petition to the FDA in September 2023 requesting that the FDA require 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 (Docket: FDA-2023-P-3942).
We are grateful to President Trump for nominating Robert F. Kennedy, Jr. to Make America Healthy Again! MAHA!
2006 Marks the Year When Gluten Allergies & Celiac Began Exploding
In a conversation with Dr. Mark Hyman on the Doctor's Farmacy, Robert F. Kennedy, Jr. talked about the explosion in the number of cases of Celiac and Gluten allergies. According to RFK, Jr., the year 2006 marked the first time when farmers started spraying Glyphosate, the active ingredient in Roundup, on crops like Wheat right before harvest.
"And so 2006 marked the date when suddenly these Gluten allergies began exploding, and Celiac Disease and all these kind of Wheat problems that we started seeing in this country. If you measure back and say when did it start, you can look and draw a red line and that's 2006, and it's the year that they began spraying it [Roundup] on Wheat."-- Robert F. Kennedy, Jr.
In 2018, Jax was diagnosed with Celiac when he was 5-year-old. At the time of his diagnosis, Jax had Marsh 3 level damage to his small intestine from Gluten ingestion.
It's instructive to listen to the Joe Rogan Experience with RFK, Jr. discussing the suspected link between Celiac and Glysophate. We also appreciate Full Measure with Sharyl Attkisson for hosting RFK, Jr. in a discussion on how chronic immune diseases like Celiac are plaguing our society. Jax would love the opportunity to share his lived experience on the Joe Rogan Experience and Full Measure about how the FDA has failed to protect children, and how the US is so behind the rest of the world in food allergen labeling.
Secretary Azar Applauds Jax's Advocacy
Like Jax, former HHS Secretary Alex Azar has Celiac Disease, and he is allergic to eating Gluten. It was an honor for Jax to spend time with Secretary Azar who shared with Jax how important it is to advocate and be pleasantly persistent. Secretary Azar told Jax that when he was HHS Secretary, no one from the Celiac community came to meet with him and ask for help.
"Dear Jax, It was an honor meeting you. Thank you for your dedicated efforts advocating for people like us who suffer from Celiac Disease." -- Alex Azar, 24th Secretary of Health and Human Services
Trump Supporters Are More Likely to Avoid Gluten
A 2019 study from researchers at the Department of Agricultural, Food, and Resource Economics, at Michigan State University and the Department of Agricultural Economics, Oklahoma State University found that "supporters of Donald Trump are more likely to identify as avoiding Gluten, relative to non-supporters."
Project 2025's Concept of Mutual Recognition
According to Food Fix, "Project 2025 argues that the U.S. should permanently revise and align their infant formula regulatory standards with other industrialized nations in an effort to boost the infant formula supply in the U.S. This would simultaneously open international markets to domestic producers, in theory making supply chains and markets more resilient to shocks."
"Infants' nutritional needs do not change across borders. If a formula is deemed healthy for European babies, then it is also healthy for American babies." --Project 2025
Just like Project 2025 has advocated for "mutual recognition of other industrialized countries' regulatory standards" to address supply chain lessons from the infant formula crisis, we believe that the US should align its food allergen labeling requirements with what 87 other countries already require for Gluten -- Wheat, Barley, Rye & Oats must be declared on all packaged foods. Period. Full stop.
Given that Gluten is required to be labeled on packaged foods in 87 countries worldwide, many of the American multinational consumer-packaged food manufacturers already label Gluten on their products sold in those 87 other countries. As such, labeling Gluten in the United States would be consistent with many multinationals' existing global operations and best practices.
This map from the Food Allergy Research and Resource Program, Department of Food Science and Technology at the University of Nebraska-Lincoln, clearly shows how behind the US is in food allergen labeling of Gluten.
Celiacs' nutritional needs do not change across borders! If 87 other countries require the labeling of Gluten to protect Celiacs, then the US should also require the labeling of Gluten.
"It's so much easier reading food labels in Europe than it is in the U.S. Even though I don’t speak French, I knew what was safe to eat in France because Gluten is required to be labeled and Europe takes Celiac Disease and Gluten accommodations so much more seriously on packaged foods and prepared meals." --Jax Bari, Age 11
Celiac is Bipartisan
Celiac is bipartisan, it knows no party - Celiac is red, blue and purple, and it impacts 3.3 million Americans, including about 729,000 children like Jax, and their loved ones. For example, Jax has hosted a bi-partisan Congressional Briefing on Celiac research with Congressman John Joyce, M.D. (R, PA-13, Altoona). and Congressman Dwight Evans (D, PA-3, Philadelphia).
Congressman Steve Stivers' (R, OH-15) Gets It: His Daughter Has Celiac
Prior to Rep. Stivers leaving Congress to become the President & CEO of the Ohio Chamber of Commerce in May 2021, Rep. Stivers helped us start the Celiac Congressional Caucus, and shared that his then 11-year-old daughter Sarah, has Celiac.
Bipartisan Celiac Congressional Caucus
Jax has also recruited 9 Members of the US Congress to serve on the Celiac Congressional Caucus including Rep. Madeleine Dean (D, PA-4), Rep. Dwight Evans (D, PA- 3), Rep. Brian Fitzpatrick (R, PA-1), Rep. Chrissy Houlahan (D-PA-6), Rep. John Joyce, M.D. (R, PA-13), Rep. Mary Gay Scanlon (D, PA-5), Rep. Glenn "GT" Thompson (R, PA-15), etc.
Historic Bipartisan Support for Food Allergen Labeling
"Millions of Americans suffering from food allergies could avoid potentially adverse reactions through the simple labeling of foods. This is a commonsense approach to deal with what could be a devastating incident for many individuals." -- Senate Majority Leader Bill Frist, MD
Prior to Senator Bill Frist, M.D. serving as the Senate Majority Leader, he practiced medicine for 12 years as a cardiac surgeon and came face to face with what nutrition was all about in terms of chronic diet-related disease. We are thankful to Senator Frist for his leadership on passing the bipartisan Food Allergen Labeling and Consumer Protection Act of 2004 when he served as Senate Majority Leader. It was great to connect with Senator Frist and share our Celiac journey and why we now need to get Gluten labeled as a Major Food Allergen for 3.3 million Celiacs who are not adequately protected through FALCPA's voluntary labeling scheme for Gluten.
2021 Food and Agriculture Organization of the United Nations/World Health Organization Expert Consultation
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)
2,500+ 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)
Enough is Enough - Stop Poisoning our Kids
"Enough is enough. President Trump and I are going to stop the mass poisoning of American children." -- Robert F. Kennedy, Jr.
My family is grateful to RFK, Jr. for calling out the FDA's Nutrition department for failing to do their job and protect our kids!
Unfortunately, my family knows the FDA's historical failures first hand, even when we have pleaded with the FDA to redress historical failures with actionable solutions by implementing requirements that 87 other already countries do!
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.
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." (emphasis added)
The FDA has failed to date to protect Celiacs, and as recently as January 2025, the FDA has continued to gaslight Gluten as a second-class food allergen.
Jax Called Out FDA Commissioner Califf & Asked for Help
In January 2024, Jax was invited by HHS Secretary Xavier Becerra to attend the first-ever HHS 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.
Watch 10-year-old Jax call out FDA Commissioner Califf at the HHS Food is Medicine Summit on 1/31/24 on requiring the labeling of Gluten, just like Gluten must be declared on all food labels in 87 other countries.
The 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 profits rather than protecting children. Hey FDA, you can actually do both!
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 Findings in the Reagan-Udall Report Sadly Ring True
When we met with FDA Deputy Commissioner Jim Jones, he understood when Jax said that the 25 year historical reckoning that we are seeking epitomized Jim's own finding about the FDA when he served on the Reagan-Udall expert commission (prior to becoming Deputy Commissioner):
"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." --Reagan-Udall Report
We were supported at our 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.
"FDA's sluggish process is failing to protect Celiacs!" -- Brian Ronholm, Director of Food Policy, Consumer Reports
FDA Only Used its Existing Statutory Authority Once in 21 Years to Require New Allergen Labeling for Insect-Based Artificial Food Coloring
According to the Center for Science in the Public Interest in 2022, "Despite the need for periodic, evidence-based updates, FDA actions following the passage of FALCPA [in 2004] have been slow, piecemeal, and largely driven by advocacy from outside stakeholders, including CSPI. For example, the agency's only use of section 403(x) was in 2009, when the agency cited this section as one of several authorities supporting mandatory labeling of carmine/cochineal extract as an allergenic color additive, an action taken in response to a petition that CSPI had submitted 11 years earlier." That single use came with the Listing of Color Additives Exempt from Certification; Food, Drug and Cosmetic Labeling, Cochineal Extract and Carmine Declaration, 74 FR 207, Jan. 5, 2009.
What's Past is Prologue - 6 Year Response Was Late & Inadequate - Citizen Petition to Require Sesame Labeling, 2014
According to the Center for Science in the Public Interest, "FDA deliberated for six years on a 2014 petition from CSPI requesting that sesame be labeled as an allergen. While the agency eventually issued a draft guidance in November 2020 providing voluntary recommendations to manufacturers regarding sesame labeling, it never exercised its authorities under 403(x) or other provisions to require labeling and food safety controls for sesame."
Notwithstanding the FDA's authority under FALCPA's Section 203(b) and 403(w) which enables the Secretary of Health and Human Services to require labels or labeling changes for other food allergens that are not major food allergens like Sesame, Congress still passed the FASTER Act to name Sesame as a Major Food Allergen. This was done in large part since the FDA believed that voluntary labeling of Sesame was sufficient and Congress did not agree with the FDA's myopic reliance on voluntary labeling.
Let's stop the FDA from repeating its past mistakes and Make America Healthy Again!
Resources
One Sheeter - Celiac Journey, Make America Healthy Again, FDA Citizen Petition to Require the Labeling of Gluten
Jax's FDA Citizen Petition - Require the Labeling of Gluten on All Food Products in the US, Just Like Gluten Must Be Declared on all Food Labels in 87 Other Countries, FDA-2023-P-3942
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