They say that an elephant never forgets. In that spirit, let's refresh the FDA's institutional memory in order for them to issue new rulemaking to better protect 3.3 million Americans with Celiac Disease from consuming potentially life-threatening food allergens in Gluten.
"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
Let's step back in time to March 1985. President Ronald Reagan was in office, and USA for Africa released its all-star anti-hunger anthem, "We are the World." In that same month, the FDA issued a Final Rule affirming that "wheat gluten, corn gluten [1] and zein are generally recognized as safe (GRAS) as direct human food ingredients" (Docket No: 82N-0259). Accompanying the FDA's Final Rule on Wheat Gluten, the FDA issued "Supplementary Information" that found that labeling Gluten ingredients is more "desirable" than Gluten Free labeling, and moreover that all Gluten ingredients must be declared on all food labels!
That was 40 years ago, but to this date, the FDA has never enforced this, and the labeling of Barley, Rye and Oats remains voluntary in the US. As recently at April 2023, the Center for Science in the Public Interest stated that Gluten containing grains "are currently not clearly labeled on most foods and beverages." This has endangered Celiacs with every bite, every day for the past 40 years!
Based on the FDA's historical Rulemaking and Supplementary Information related thereto (along with the FDA's existing statutory authority to require new food allergen labeling under the Food Allergen Labeling and Consumer Protection Act (FALCPA)), the FDA should immediately grant Jax Bari's FDA Citizen Petition. This will Make America Healthy Again by expressly requiring the labeling of Barley, Rye and Oats (in addition to Wheat which is already required to be labeled) on all packaged foods in the US, just like Gluten must be declared on all food labels in 87 other countries. Barley, Rye and Oats must now be declared on all food labels, and ideally classified by the FDA as Major Food Allergens. Period. Full Stop.
Historical Background on FDA's Thinking on Food Allergen Labeling for Persons with Celiac Disease - Gluten Sources Must be Identified by Name
In the late 1970s, the FDA began to recognize allergen-related hazards and considered regulations for declaring ingredients and allergens on food labels. For example, in 1985, the FDA mandated that the specific source of Gluten be identified on food labels when it recognized Wheat Gluten, Corn Gluten and Zein as generally recognized as safe (GRAS, see Federal Register, 21 CFR Part 184, Docket No.: 82N-0259). The FDA believed that identifying the Gluten source (i.e., wheat or corn) was sufficient to protect "gluten-sensitive individuals," and thus rejected citizen requests for mandatory "Gluten Free" labeling.
According to When Food is Poison, "Although a 'gluten-free' standard was likely scientifically infeasible at the time [in 1985], FDA's statement nevertheless reflects a failure to appreciate the fact that 'wheat gluten' is but the tip of the iceberg in terms of ingredients that individuals sensitive to gluten must avoid, and that identification of 'wheat gluten' on the label would be only a partial remedy for people with celiac disease in contrast to 'gluten-free' labeling."
To further unpack this in 2025, one must review the Federal Register (Vol. 50. No. 44) from 1985 on the FDA's Final Rule because the FDA's findings from 40 years ago clearly support Jax's FDA Citizen Petition to require the labeling of Barley, Rye and Oats (Docket No.: FDA-2023-P-3942). According to the Supplementary Information contained in the Federal Register, the FDA memorialized:
"One comment, from a person suffering from celiac disease, stated that labeling foods as 'gluten free' would be a helpful label for packaged food products. FDA discussed in its proposal (48 FR 31888) that persons with celiac disease are unable to ingest gluten from wheat and from some other sources without intestinal upset. However, FDA also noted that these same individuals are able to consume without ill-effects gluten derived from corn, rice, potato, and other foods. Because glutens do not always initiate intestinal upset in persons with celiac disease, the agency [FDA] 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 believes, therefore, that the labeling already required is adequate to alert the public and protect gluten sensitive individuals." (emphasis added)
In the spirit of time travel with the 1985 blockbuster movie Back to the Future, the FDA Final Rule and Supplementary Information foreshadowed an upside-down world today. In 1985, the FDA stated that voluntary Gluten Free labeling "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), the FDA found that "wheat gluten and other gluten sources must be identified by name when they are used in food." Today, only Wheat is required to be labeled, but Barley, Rye and Oats are not. That's incongruent with the FDA's finding that "Under 21 CFR 101.4(a), wheat gluten and other gluten sources must be identified by name when they are used in food."
Food Labeling Requirements: FALCPA & 21 CFR 101.4
The Food Allergen Labeling and Consumer Protection Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require food labels to declare the presence of Major Food Allergens. The allergen labeling requirements introduced by FALCPA were added as a separate section (403(w)) to the FD&C Act, working in conjunction with existing Food Labeling regulations such as 21 CFR 101.4(a).
In January 2025, the FDA published its Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry ("FDA's Q&A"). In that document, the FDA discussed how FALCPA works in conjunction with existing Food Labeling regulations including 21 CFR 101.4. For example, in the FDA's Q&A, the FDA detailed its current thinking as of January 2025:
Question: "Are only the tree nuts listed in Table 1 required to be declared as major food allergens? Should manufacturers declare tree nuts that are used as ingredients but not listed in the table as allergens in the 'Contains' statement?"
Answer: "Only the tree nuts listed in Table 1 are considered major food allergens, and, therefore, must meet the food allergen labeling requirements of section 403(w) of the FD&C Act. Because other tree nuts that are not listed in Table 1 do not have a robust body of evidence to support inclusion as a major food allergen, they should not be included in the 'Contains' statement even if they are used as ingredients because the 'Contains' statement is reserved for major food allergens. Tree nuts used as ingredients, but not listed in Table 1, would still be required to be listed by common or usual name in the ingredient list (21 CFR 101.4)." (emphasis added)
By the FDA's same logic, when Barley, Rye and Oats are used as ingredients in food products, but not (yet) required to be declared as Major Food Allergens, Barley, Rye and Oats would still be required to be listed by common or usual name in the ingredient list (21 CFR 101.4). Why is this not the case?
In January 2025, the FDA also 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 Interested Parties" ("Final Guidance"). The FDA found that,
"We use variations of the term 'declare' when that term is used in the FD&C Act, our regulations, or an FDA guidance document to describe information that is present on a food label. For example, the label requirements in 21 CFR 101.4 for the designation of ingredients and our 'Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004' (Edition 4)' (Ref. 15) both use variations of the term 'declare' when describing information presented on a food label. Likewise, we use variations of the term 'undeclared' when describing a label that does not comply with label requirements in the FD&C Act or our food labeling regulations." (emphasis added)
That said, the FDA's Final Guidance provides an unfair and biased framework that misleadingly others the consumer protection needs of Celiacs. The Final Guidance focuses on IgE-Mediated food allergies when the Guidance should not discriminate between IgE-Mediated and Non-IgE-Mediated food allergies. The FDA must be stopped from continuing to gaslight Gluten as a second-class allergen and Celiac as a non-potentially life-threatening food allergy.
These are examples of how the FDA has continued to dangerously perpetuate flawed scientific, governmental, and societal biases against Celiacs 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 in the U.S.
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 the Non-IgE-Mediated food allergy with Celiac 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, other auto-immune diseases, etc.
It's time to Make America Healthy Again and material changes at the FDA cannot come soon enough!
September 10, 2008: Citizen Petition to Label Barley and Rye in 2008
The FDA would be well advised to not let history repeat itself. According to the FDA's Final Guidance issued in January 2025,
"In 2008 [September 10], we [FDA] received a citizen petition [submitted by Hallie Jane Davis] asking us to [amend] ... FALCPA to include barley and rye in the list of common allergens requiring disclosure on packaging (Ref. 18)… In 2018 [February 6], 'We [FDA] denied the request regarding barley and rye because the petition did not include adequate information to show that rye and barley are common causes of severe IgE-mediated food allergies (Ref. 22)." (emphasis added)
It is important to note that there was a 10-year delay from 2008 to 2018 (encompassing three different Presidential administrations for President George W. Bush, 2001-2009; President Barack Obama, 2009-2017; and President Donald J. Trump, 2017-2021) for the FDA to summarily deny the 2008 Citizen Petition based on a pretext "because the petition did not include adequate information to show that rye and barley are common causes of severe IgE-mediated food allergies."
When the FDA denied the 2008 Citizen Petition, the FDA never once mentioned its 1985 Final Rule which stated:
"[T]he 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 believes, therefore, that the labeling already required is adequate to alert the public and protect gluten sensitive individuals."
Instead on February 6, 2018 (in response to the 2008 Citizen Petition filed almost a decade earlier), Deputy Commissioner Douglas Stearn, Center for Food Safety and Applied Nutrition, Food and Drug Administration, wrote to Ms. Davis,
"Your petition does not include adequate information to show that rye and barley are common causes of severe immunoglobulin E (lgE)-mediated allergies, such as wheat and other major food allergens under FALCPA. Rather, your petition focuses on the needs of people with celiac disease, which we have taken steps to address. Your citizen petition provides as a statement of grounds: 'It has been shown that celiacs are not just sensitive to wheat, but are also sensitive to the gluten of rye and barley' (Petition at page 1). We agree with this statement and note that information voluntarily provided on food labels concerning the absence of gluten-containing grains may provide additional label information that is helpful to consumers seeking to avoid barley and rye." (emphasis added)
Just like the 2021 FAO/WHO Expert Consultation (which included Dr. Lauren Jackson (FDA), Dr. Stefano Luccioli (FDA), 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.
In her 2008 Citizen Petition, the docket is clear - Ms. Davis did provide a lot of medical and scientific research showing the severe adverse health effects that can occur when Celiacs ingest even a very small quantity ("10mg") of Gluten including intestinal damage, cancer, failure to thrive, osteoporosis, etc. Ms. Davis also discussed and presented research on the comorbidities of Celiac with other auto-immune diseases and her lived experience with food insecurity.
Nonetheless, Mr. Stearn was dismissive in his response when he wrote, "Your petition does not include adequate information to show that rye and barley are common causes of severe immunoglobulin E (lgE)-mediated allergies, such as wheat and other major food allergens under FALCPA. Rather, your petition focuses on the needs of people with celiac disease, which we have taken steps to address."
In other words, while Ms. Davis did not include information that Rye and Barley are common causes of severe immunoglobulin E (lgE)-mediated allergies, she did provide information to the FDA on the adverse effects that occur in Celiacs with the ingestion of Gluten and why it is common sense to require the labeling of Gluten as a Major Food Allergen, just like the 1999 Codex Criteria had recommended.
Conclusion - MAHA
Back in 2004, the FDA published a White Paper entitled "Defining the Customer in a Regulatory Agency." The FDA would be well served to embrace this concept once again.
"In carrying out its public health mission, FDA clearly understands that the American public is the primary customer of the agency’s work and the products we regulate."
Based on the FDA's historical Rulemaking and associated Supplementary Information, along with its existing statutory authority under the Food Allergen Labeling and Consumer Protection Act, the FDA should approve Jax Bari’s Citizen Petition without delay. This action would Make America Healthy Again by mandating the labeling of Barley, Rye, and Oats -- alongside the already required Wheat labeling -- on all packaged foods in the U.S. This move aligns with practices in 87 other countries where Gluten must be declared on all food labels. The FDA should require the labeling of Barley, Rye, and Oats as Major Food Allergens to protect Celiac consumers and their loved ones more effectively.
Note
[1] According to University of Illinois food engineer Kent Rausch, "This is a textbook fact. Wheat contains gluten. Corn does not. There has never been any reason why corn gluten meal and another wet milling coproduct, corn gluten feed, should contain the word gluten. Gluten is found in wheat, barley, and rye -- not in corn or corn coproducts."
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
Federal Register, 21 CFR Part 184, Docket No.: 82N-0259, Action: Final Rule, "Wheat Gluten, Corn Gluten, and Zein; Affirmation of GRAS Status," Food and Drug Administration, Volume 50, No. 44, Page 8997, Rules and Regulations, March 6, 1985.
Code of Federal Regulations, Subchapter B - Food for Human Consumption, Part 101 - Food Labeling, Section 101.4 Food; designation of ingredients, 21 CFR 101.4.
"When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004." Laura E. Derr, Food and Drug Law Journal, vol. 61, no. 1, 2006, pp. 65–165, Footnote 196, Page 98.
"Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry," Food and Drug Administration, January 2025.
"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 Interested Parties," Food and Drug Administration, January 2025.