Imagining How an Executive Order from President Trump Could Make America Healthy Again for Celiacs
- Jon Bari
- 2 days ago
- 8 min read
Updated: 5 hours ago
"Now faith is the substance of things hoped for,
the evidence of things not seen." Hebrews 11:1
If President Trump were to sign an Executive Order for the Secretary of HHS Robert F. Kennedy, Jr. to issue rulemaking to declare Gluten as a Major Food Allergen and require the labeling of all Gluten grains, it might look something like this draft below.
Presidential Actions: Executive Order Suggested Draft (Yellow highlights represent the critical parts of this draft EO)
Protecting Millions of Americans with Celiac Disease & Gluten-Related Food Allergies to Make America Healthy Again by Requiring the Labeling of Gluten Grains as Major Food Allergens
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:
Section 1. Purpose. Millions of Americans with Celiac Disease and their loved ones struggle daily with eating. Celiac Disease affects greater than 1% of the US population, and the incidence has been increasing over the last several decades.
Celiac Disease is a potentially life-threatening and life-debilitating food allergy,[1] auto-immune disease, and digestive disease. Celiac is triggered by eating gluten, a protein found in wheat, barley, rye and most oats. The only known treatment for Celiac Disease is a strict gluten-free diet for life.
Since the Food Allergen Labeling and Consumer Protection Act (FALCPA) became law on January 1, 2006, only wheat has been required to be labeled in the United States, but barley, rye, and oats have not. In contrast, 87 other countries around the world require the declaration of all gluten containing grains as a major/priority food allergen on all packaged food items.
According to the FDA, Celiacs face "face potentially life-threatening illnesses if they eat gluten, typically found in breads, cakes, cereals, pastas, and many other foods… There is no cure for celiac disease and the only way to manage the disease is to avoid eating gluten." There is no rescue medication (i.e., adrenaline or antihistamine) in the event of accidental gluten ingestion, and unlike other food allergies, one cannot outgrow Celiac.
44% of people with Celiac Disease who follow a strict gluten-free diet still accidentally ingest gluten once a month. There are more than 200 debilitating symptoms that gluten ingestion causes for people with Celiac Disease including anemia, cancer, immunological scarring, intestinal damage, and malnutrition.
On February 13, 2025, I signed an Executive Order establishing the Make America Healthy Again (MAHA) Commission, and its initial mission will focus on the childhood chronic disease crisis. For example, 30 million U.S. children (40.7%) have at least one health condition, such as allergies, asthma, or an autoimmune disease. In the U.S., out of 3.3+ million Americans with Celiac Disease, there are approximately 729,000 U.S. children with Celiac Disease.
60% of Americans have at least one chronic disease, and 40% of Americans have two or more chronic diseases. The estimated prevalence of Celiac Disease in patients with Type 1 Diabetes is approximately 6%. Upwards of 15% of Celiac patients will develop other autoimmune diseases.
The United States has the highest age-standardized cancer incidence rate among 204 countries, nearly double that of the next highest rate, with an 88% increase from 1990-2021. Research published in December 2024 showed that there is a high risk of digestive cancers in patients With Celiac Disease.
78.8 years is the average life expectancy in the United States, which is below that of other comparable countries where the life expectancy averages 82.6 years. This equates to 1.25 billion fewer life years for the United States population. A study published in the Journal of the American Medical Association in 2020 found a small but significant increased risk of mortality in people with Celiac Disease. 77% of young adults do not qualify for military service in the United States. According to the U.S. Department of Defense, DoD Instruction 6130.03, Celiac Disease is a disqualifying condition from service in the military (Medical Standards for Appointment, Enlistment, or Induction into the Military Services, Section 5.12.c.(3), May 6, 2018.
According to THE MAHA REPORT, MAKING OUR CHILDREN HEALTHY AGAIN (Assessment), “allergies are widespread, and autoimmune disorders are rising.” THE MAHA REPORT continued:
Today, over 1 in 4 American children suffers from allergies, including seasonal allergies, eczema, and food allergies.
Eczema (atopic dermatitis) and skin allergies increased from 7.4% of children under 18 from 1997-1999 to 12.7% from 2016-2018.
Between 1997 and 2018, childhood food‑allergy prevalence rose 88%.
Celiac disease rates have increased 5-fold in American children since the 1980s."
With 40% of the American population having the genetic biomarker necessary to develop Celiac Disease, millions more remain at risk of developing this chronic disability that impacts major life activities on a daily basis including eating, learning, working, sleeping, socializing, travelling, etc.
While the availability of gluten free food options has increased over the past decade, too many American Celiacs and their loved ones must still contend with the daily challenge of managing their diet, including with the voluntary labeling of gluten grains, the constant risk of cross-contamination with gluten, especially when eating outside of their home, the dangers of long-term adverse health complications, the high price of gluten free food and the frustration of being diagnosed with a disease that has yet to be cured. Food insecurity happens daily for Celiacs regardless of a person’s age or social status.
In 1985, the FDA Final Rule stated: "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." FDA Final Rule, Supplementary Information, March 6, 1985.)
The 1999 Codex Criteria from the UN's Food & Agriculture Organization (FAO) and World Health Organization (WHO) stated, "The revised list of those foods and ingredients known to cause food allergies and intolerance and whose presence should always be declared was identified as the following: Cereals containing gluten (i.e., wheat, rye, barley, oats, spelt or their hybridized strains) and their products."
There is significant scientific agreement that the best way to protect Celiacs is to require the labeling of gluten grains. Requiring the labeling of gluten on all packaged foods in the U.S. is in alignment with the conclusions of the 2021 Food and Agriculture Organization of the United Nations ("FAO")/World Health Organization ("WHO") Expert Consultation, which was chaired by the FDA’s Dr. Lauren Jackson ("2021 FAO/WHO Expert Consultation"). The 2021 FAO/WHO Expert Consultation found, “[b]ased 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)."[2] The 2021 FAO/WHO Expert Consultation "determined that only foods or ingredients that cause immune-mediated hypersensitivities such as IgE-mediated food allergies and coeliac ["Coeliac" is the Greek spelling of Celiac] disease should be included on the list of foods and ingredients included in section 4.2.1.4 of the GSLPF [General Standard for the Labelling of Prepacked Foods]," and that the GSLPF list includes gluten.
Oats are naturally gluten free. However, oats cultivated in North America and Europe are commonly contaminated by gluten containing grains, including wheat, barley, rye and triticale. Cross contamination of commercial oats with gluten is inevitable. The reason for this is the manner in which oats are grown, harvested, transported, milled, stored and merchandized.
Section 2. Policy. HHS Actions. To Make America Healthy Again, I am directing the Secretary of Health and Human Services to prioritize a public health problem long overdue for robust action: reducing 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. It's time for FDA to address this critical consumer protection food safety issue with the urgency it requires and issue rulemaking requiring the labeling of gluten as a "Major Food Allergen" based on this Executive Order and the Secretary of HHS's existing statutory authority under FALCPA.[3] FALCPA "does not preclude FDA from expanding via regulation the list of major allergens requiring identification under the FALCPA’s labeling scheme."[4] 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 [yet] major food allergens." (H.R. Rep. No. 108-608, at 18. (2004).)
Additionally, the Secretary of Health and Human Services will add gluten-containing grains 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.
Additionally, the Secretary of Health and Human Services will issue a report and prioritize funding Celiac Disease research to: 1) find alternative treatment options, other than a strict gluten-free diet for life, and ideally a cure, and 2) identify the causes for the Celiac Disease epidemic to prevent the disease from activating in more Americans.
Section 3. Definitions. For purposes of this order:
A. The term "Gluten-containing grains" means any one of the following grains (or any crossbred hybrid thereof):
a. Wheat, including any species belonging to the genus Triticum.
b. Rye, including any species belonging to the genus Secale.
c. Barley, including any species belonging to the genus Hordeum.
d. Oats, including any species belonging to the genus Avena sativa.
B. The term “Gluten” means the proteins that:
a. naturally occur in a Gluten-containing grains;
b. Oats are generally contaminated, and often at significant levels, with wheat, barley and rye due to often being grown, harvested, transported, stored, and processed together.
c. cause adverse health effects in persons with Non-IgE-Mediated food allergies including Celiac Disease, IgE-Mediated food allergies, food hypersensitivities and/or food intolerances related thereto.
Section 4. General Provisions.
(a) Nothing in this order shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(d) The Department of Health and Human Services shall provide funding for this order’s publication in the Federal Register.
DONALD J. TRUMP
THE WHITE HOUSE
[DATE], 2025.
Notes
[1] - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4241964/pdf/nihms247178.pdf (pages 5, 11-12); and https://www.fda.gov/media/157637/download (page 10)
[2] -"Due to the lack of data on prevalence, severity and/or potency, or due to regional consumption of some foods, the Committee recommended that some of the allergens,... oats, ... should not be listed as global priority allergens but [Oats] may be considered for inclusion on priority allergen lists in individual countries." See http://www.fao.org/3/cb4653en/cb4653en.pdf
[3] 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
[4] 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
