Notice2026-01121
Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 22, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) received a citizen petition from Celiac Journey requesting that we act to protect consumers with celiac disease by requiring that all ingredients with gluten be listed by name in the ingredient list and by requiring cross- contact controls with gluten-containing grains. We are issuing this document to request comment on the issues raised in the petition and on specific questions related to these issues.
Full Text
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<title>Federal Register, Volume 91 Issue 14 (Thursday, January 22, 2026)</title>
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[Federal Register Volume 91, Number 14 (Thursday, January 22, 2026)]
[Notices]
[Pages 2781-2786]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01121]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-3942]
Labeling and Preventing Cross-Contact of Gluten for Packaged
Foods; Request for Information
AGENCY: Food and Drug Administration, Department of Health and Human
Services.
ACTION: Petition for rulemaking; request for information.
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SUMMARY: The Food and Drug Administration (FDA or we) received a
citizen petition from Celiac Journey requesting that we act to protect
consumers with celiac disease by requiring that all ingredients with
gluten be listed by name in the ingredient list and by requiring cross-
contact controls with gluten-containing grains. We are issuing this
document to request comment on the issues raised in the petition and on
specific questions related to these issues.
DATES: Submit either electronic or written comments and scientific data
and information by March 23, 2026.
ADDRESSES: You may submit comments and information as follows. Please
note that late, untimely filed comments will not be considered. The
<a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of March 23, 2026.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-P-3942 for ``Labeling and Preventing Cross-Contact of Gluten
for Packaged Foods; Request for Information.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Carol D'Lima, Office of Nutrition and
Food Labeling (HFS-800), Nutrition Center of Excellence, Human Foods
Program, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2371; Meridith L. Kelsch, Office of Policy,
Regulations, and Information, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
A. Citizen Petition
In September 2023, Celiac Journey submitted a citizen petition
(Docket No. FDA-2023-P-3942) requesting that FDA act to protect
consumers with celiac disease (CD) by better enabling them to identify,
through labeling, whether a food includes gluten-containing grains
(GCGs), and to address cross-contact with GCGs. For purposes of this
document, GCGs refers to the cultivated crops that have naturally
occurring gluten protein. These include wheat (Triticum), rye (Secale),
barley (Hordeum), and crossbreeds like triticale (crossbreed of rye and
wheat). Celiac Journey's petition, in part, asks that FDA: (1) issue a
rule to require that all ingredients with gluten be listed by name in
the ingredient lists of all foods, and (2) add gluten to the list of
allergens
[[Page 2782]]
in Sec. 555.250 of FDA's Compliance Policy Guide (CPG) entitled
``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. The petition also makes
additional requests, such as asking that oats be included as GCGs
because they often contain gluten due to cross-contact. Under FDA's
citizen petition regulations, when reviewing a petition, we may publish
a notice in the Federal Register requesting information and views (21
CFR 10.30(h)(3)).
We note that, in May 2023, FDA issued a draft CPG entitled ``Sec
555.250: Major Food Allergen Labeling and Cross-contact'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555250-draft-major-food-allergen-labeling-and-cross-contact">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555250-draft-major-food-allergen-labeling-and-cross-contact</a>). This
draft CPG, if finalized, would replace the existing CPG Sec 555.250,
entitled ``Statement of Policy for Labeling and Preventing Cross-
contact of Common Food Allergens'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555250-statement-policy-labeling-and-preventing-cross-contact-common-food-allergens">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555250-statement-policy-labeling-and-preventing-cross-contact-common-food-allergens</a>) and
serve as a guidance for FDA staff on FDA's enforcement policy regarding
major food allergen labeling and cross-contact. Celiac Journey's
petition extends its requested revision of Sec. 555.250 to the
potential updated version. Although the petition was not submitted
specifically in response to the draft CPG, we are also considering this
petition as we finalize the CPG.
We are issuing this request for information (RFI) to request
comments about the issues presented in Celiac Journey's petition and on
specific questions related to these issues. In addition, consistent
with the Make Our Children Healthy Again Strategy \1\ issued by the
Make America Healthy Again (MAHA) Commission, publishing this RFI is
the first step in making recommendations about providing more
transparency in disclosures of ingredients that impact certain health
conditions, such as gluten for those with CD, and other established
food allergens.
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\1\ Strategy Report: Make Our Children Healthy Again, available
at: <a href="https://www.whitehouse.gov/wp-content/uploads/2025/09/The-MAHA-Strategy-WH.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/09/The-MAHA-Strategy-WH.pdf</a>.
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B. Health Conditions Associated With Consumption of GCGs
Consumption of GCGs has been associated with a number of different
immune-mediated food allergies, including Immunoglobulin E (IgE)-
mediated anaphylaxis and CD, and can cause allergic reactions and other
adverse health consequences in consumers who have these conditions.
Among the GCGs, self-reported IgE-mediated allergy to wheat with
``confirmed'' signs or symptoms and doctor diagnosis has a prevalence
of up to 0.3% of children and 0.5% of the adult population (Ref. 1,
Ref. 2, and Ref. 3 Table 3). If sufficient amounts of glutens or other
proteins are consumed, individuals with an IgE-mediated allergy to GCGs
can experience acute allergic reactions of variable severity from
limited symptoms of itching, hives, or abdominal cramps to vomiting,
diarrhea, wheezing, and the possibility for life-threatening
anaphylaxis.
According to the National Institutes of Diabetes and Digestive and
Kidney Diseases (NIDDK), an estimated 2 million people (about 0.7%) in
the United States have CD (Ref. 4), a chronic inflammatory disorder of
the small intestine triggered by the ingestion of certain storage
proteins referred to as gluten, occurring in wheat, rye, barley, and
crossbreeds of these grains (e.g., triticale). In people with CD, foods
that contain gluten trigger the production of antibodies that attack
and damage the lining of the small intestine. This can lead to a wide
variety of acute health consequences affecting the digestive tract
(e.g., abdominal bloating, cramping and pain, chronic diarrhea) or more
atypical symptoms such as fatigue, irritability, bone or joint pain, or
blistering skin rash. For people with CD, chronic exposure to GCGs can
also lead to nutrient deficiencies, autoimmune disease, and intestinal
cancers.
Other health conditions triggered by consumption of GCGs include
eosinophilic esophagitis, food protein-induced enterocolitis syndrome,
and non-celiac gluten sensitivity (NCGS, also called gluten
intolerance, and not considered an immune-mediated food allergy).
Individuals with IgE-mediated and/or non-IgE-mediated reactions due to
GCGs generally are advised to follow a gluten-free diet. They are also
typically advised to check labels for information on GCGs to which they
are allergic so that potential allergen hazards can be avoided.
C. Legal Framework Related to GCGs
Several existing statutory and regulatory provisions are relevant
to GCGs. The following is a brief overview of some such provisions that
are relevant to Celiac Journey's petition and questions presented in
this RFI. In general, labeling on packaged foods must include the
common or usual name of each ingredient (if there is more than one)
(see section 403(i) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 343(i))). For example, the label of a food made with
rye flour must declare this ingredient by its common or usual name,
``rye flour,'' rather than simply ``flour'' (``flour,'' declared
unqualified, refers to flour from ``wheat'' (21 CFR 137.105,
101.4(b)(15))).
Additionally, specific labeling provisions apply to the declaration
of some food ingredients. For example, spices, natural flavor, and
artificial flavor may be declared using a collective term (e.g.,
``spice,'' ``natural flavor,'' or ``artificial flavor,'' respectively)
(21 CFR 101.22(h)(1)). Likewise, some color additives may be declared
as ``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added''
(21 CFR 101.22(k)(2)). Also, incidental additives are generally exempt
from the ingredient declaration requirements (see 21 CFR
101.100(a)(3)). Further, some ingredients may be derived from GCGs, but
the presence of the GCG may not be apparent to consumers based on the
common or usual name (e.g., ``malt extract'' and ``malt syrup'' derived
from barley) (see CPG Sec 515.200 ``Malt Extract; Malt Syrup; Malted
Cereal Syrup; Liquid Malt; Dried Malt,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-515200-malt-extract-malt-syrup-malted-cereal-syrup-liquid-malt-dried-malt">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-515200-malt-extract-malt-syrup-malted-cereal-syrup-liquid-malt-dried-malt</a>).
The label of a food that contains an ingredient that is or contains
a ``major food allergen'' must declare the presence of the allergen in
a manner described by the law (section 403(w) of the FD&C Act (21
U.S.C. 343(w))). The ``major food allergens'' are milk, egg, fish,
Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame,
as well as food ingredients that contain protein derived from such
foods (with certain exceptions) (section 201(qq) of the FD&C Act (21
U.S.C. 321(qq))). Major food allergens used as ingredients in packaged
foods and regulated under the FD&C Act must be declared by the name of
the food source from which the major food allergen is derived either in
the ingredient list or the ``Contains'' statement (section 403(w) of
the FD&C Act). Unlike other ingredients, major food allergens do not
fall under the labeling exceptions for certain food components, such as
flavoring, coloring, or incidental additives (section 403(w)(4) of the
FD&C Act). Congress established the list of ``major food allergens,''
and FDA does not have the authority to alter the list. However, we
[[Page 2783]]
may issue regulations regarding the disclosure of a food allergen
(other than a major food allergen) in a spice, flavoring, coloring, or
incidental additive (section 403(x) of the FD&C Act (21 U.S.C. 343(x)))
and may issue other regulations for non-major food allergens (see 21
U.S.C. 343 note).
Among the GCGs, wheat is a major food allergen and, thus, any
ingredient derived from wheat must also be declared as ``wheat'' either
in the ``Contains'' statement or in the ingredient list or both
(section 403(w) of the FD&C Act). For example, if wheat is a formulated
component of a flavoring, coloring, or incidental additive, ``wheat''
must be declared either in the ingredient statement or the ``Contains''
statement (section 403(w)(4) of the FD&C Act).
FDA regulations allow for the voluntary labeling of foods as
``gluten-free'' and establish criteria that must be met to use such
labeling (see 21 CFR 101.91(a)). For purposes of such labeling, a
``gluten-containing grain'' means wheat, rye, barley, or their
crossbred hybrids (21 CFR 101.91(a)(1)). A ``gluten-free'' claim may
only be made if the food does not contain an ingredient that is: (1) a
GCG; (2) derived from a GCG that has not been processed to remove
gluten; or (3) derived from a GCG that has been processed to remove
gluten, if the use of that ingredient results in the presence of 20
parts per million (ppm) or more gluten in the food (i.e., 20 milligrams
(mg) or more gluten per kilogram (kg) of food). In the case of
fermented or hydrolyzed foods or ingredients, any GCGs must be
processed to remove gluten prior to the fermentation or hydrolysis. A
``gluten-free'' claim is also permissible when the food inherently does
not contain gluten. In addition to these criteria, a gluten-free claim
may only be made if any unavoidable presence of gluten in the food
bearing the claim is below 20 ppm (21 CFR 101.91(a)(3)).\2\ Also, oats,
which contain proteins called avenins, are not considered GCGs under
this gluten-free rule. Thus, a food bearing a ``gluten-free'' claim can
include oats as long as the oats meet the standards for the unavoidable
presence of gluten in the definition of ``gluten-free.''
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\2\ The regulation also addresses the use of the ``gluten-free''
claim for fermented and hydrolyzed food, or foods that contain
fermented or hydrolyzed ingredients (21 CFR 101.91(b) and (c)).
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FDA regulations also address food allergen cross-contact. Under 21
CFR part 117, a ``food allergen'' means a ``major food allergen'' as
defined in section 201(qq) of the FD&C Act, and ``allergen cross-
contact'' means the unintentional incorporation of a food allergen into
food (21 CFR 117.3). Our regulations also include current good
manufacturing practice (CGMP) requirements and preventive controls
requirements to significantly minimize or prevent allergen cross-
contact (see 21 CFR part 117). In addition, juice and seafood
processors should also consider allergen cross-contact under sanitation
standard operating procedures or in their Hazard Analysis and Critical
Control Point (HACCP) plan under 21 CFR parts 120 and 123,
respectively.
D. FDA's Allergen Evaluation Framework
In January 2025, FDA issued a final guidance titled ``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'' (Allergen Evaluation
Guidance) (Ref. 3). The Allergen Evaluation Guidance identifies the
scientific factors and other information relevant to evaluating the
public health importance of food allergens other than one of the major
food allergens listed in the FD&C Act (hereafter referred to as non-
listed food allergens) and discusses how FDA generally intends to
evaluate the total body of evidence.
The Allergen Evaluation Guidance describes four scientific factors
that FDA intends to consider when evaluating the public health
importance of non-listed food allergens: (1) evidence of IgE-mediated
food allergy; (2) the prevalence of an IgE-mediated food allergy in the
U.S. population; (3) the severity of IgE-mediated food allergic
reactions; and (4) allergenic potency (the amount of food allergenic
protein required to elicit an IgE-mediated food allergic reaction in a
sensitized individual). While the Allergen Evaluation Guidance focuses
on IgE-mediated food allergies, FDA has acknowledged that because some
foods can cause both IgE-mediated and non-IgE-mediated reactions,
evidence of non-IgE-mediated reactions and allergies associated with
the food can be useful information in an evaluation of the public
health importance of such a food allergen. The Allergen Evaluation
Guidance affirms that food allergens causing non-IgE-mediated allergies
may also raise public health concerns, and FDA intends to evaluate the
public health importance of these allergens on a case-by-case basis.
Beyond the four scientific factors, the Allergen Evaluation Guidance
also states that to evaluate whether a non-listed food allergen is of
public health importance, FDA may seek or request data and other
information relevant to the labeling and production of food containing
the food allergen.
Examples of such data and other information are:
<bullet> Data and other information relevant to the prevalence in
the United States of food allergic reactions that could be attributed
to exposure to the food allergen that is not disclosed on the label of
food products;
<bullet> Prevalence and amounts of the undisclosed food allergen,
such as situations in which source information about a non-listed food
allergen used as an ingredient is not required to be included in the
food label; examples of this include spice, color, flavoring, or when
the common or usual name of the food ingredient does not include the
source (e.g., malt extract does not disclose ``barley'' as the source);
<bullet> Characteristics of food products and food production
practices;
<bullet> Data from patient-centered studies or other patient-
centered information (e.g., food allergy quality-of-life
questionnaires) regarding patients' experiences, perspectives, needs,
and priorities regarding avoidance of foods that are or contain food
allergens; and
<bullet> Data on clinically cross-reactive food allergies to the
food and, if relevant, whether potential cross-reactivity to the food
allergen would not be well-recognized in the U.S. allergic population.
II. Request for Comment
We invite comments concerning adverse reactions due to
``ingredients of interest'' (i.e., non-wheat GCGs and oats) in the
United States. We also invite comments on labeling issues or concerns
with identifying ingredients of interest on packaged food products in
the United States. We specifically invite comment in response to the
questions below. Any party submitting comments need not address all the
questions listed in this request. Please provide applicable data and
references, if available.
A. Data and information on IgE-mediated and non-IgE-mediated food
allergies and adverse reactions to non-wheat GCGs (including
prevalence, severity, and potency).
Celiac Journey's petition cites information in reports by the Food
and Agriculture Organization of the United Nations (FAO)/World Health
Organization (WHO) expert consultation to support the assertion that
ingredients of interest (i.e., rye, barley, and oats) are GCGs that
require additional labeling standards in the United States. FDA has
reviewed the information in recent
[[Page 2784]]
FAO/WHO global reports relevant to this petition (see Ref. 5 and Ref.
6). We note that our review of this information indicates that there is
limited U.S. data on adverse reactions to ingredients of interest. An
FDA summary of the limited data in the FAO/WHO reports for IgE-mediated
food allergies to non-wheat GCGs is available in Ref. 7.
As background, in 2019, the Codex Alimentarius Commission (CAC)
tasked the FAO/WHO to form an Expert Consultation on Risk Assessment of
Food Allergens (hereafter referred to as expert consultation) to
develop criteria to determine which foods are priority allergens at a
global level, and to validate and update the list of allergenic foods
and ingredients in section 4.2.1.4 of the General Standard for the
Labelling of Pre-Packaged Foods (GSLPF) based on risk assessment. As
highlighted in ``Part 1: Review and validation of Codex Alimentarius
priority allergen list through risk assessment'' (Ref. 5) of the
resulting report, the expert consultation identified prevalence,
severity, and potency of IgE-mediated allergy and CD as the main
criteria. Based on these criteria, the expert consultation recommended
modifying the definition for cereals listed as priority allergens to
include ``Cereals containing gluten (e.g., wheat and other Triticum
species, rye and other Secale species, barley and other Hordeum species
and their hybridized strains).'' The expert consultation's report found
wheat to have sufficient prevalence, severity, and potency of IgE-
mediated food allergies and noted that it is associated with CD
toxicity. In contrast, the report stated that there is very limited
data on the prevalence, severity, and potency of IgE-mediated food
allergies for barley and rye (and crossbreeds of these cereal grains),
but included them on the GSLPF priority list because they are foods
that have potential to cause CD toxicity. The expert consultation's
report also considered that these cereals are IgE-cross-reactive with
wheat, thereby posing a risk to wheat-allergic consumers.
Consistent with the expert consultation's report, IgE-mediated
reactions causing anaphylaxis are well-described for wheat, which is a
major food allergen. However, apart from limited data showing that
these cereals may have clinical cross-reactivity with wheat allergy,
there is very little data on how frequently non-wheat GCGs cause IgE-
mediated allergies and associated life-threatening reactions. Also,
there are limited potency data for non-wheat GCGs, including what are
dose exposures from undisclosed ingredients in food products that cause
adverse allergic reactions. In the absence of such data, community
report data (such as abstracts, research queries, patient surveys or
registries of adverse reactions or food challenge data, etc.) could
provide evidence of IgE-mediated allergies to non-wheat GCGs.
In addition to IgE-mediated allergies, consumption of gluten can
cause CD toxicity. There are well-established data on the prevalence
and potential severe health consequences of CD in the U.S. population
(Ref. 8). As described in the Allergen Evaluation Guidance, FDA will
consider evidence of non-IgE-mediated reactions as supplemental
information in the evaluation of the public health importance of a food
allergen.
Because there is well-documented information on the prevalence and
severity of GCGs causing CD and on IgE-mediated allergies specifically
to wheat, for this RFI, we are particularly interested in data that can
quantify and characterize IgE- and non-IgE-mediated reactions to non-
wheat GCGs in U.S. food products. FDA is particularly interested in
data and information regarding prevalence, severity, and/or potency
relating to:
1. Non-wheat GCGs causing IgE-mediated allergies or reactions,
including anaphylaxis, in the United States. This could include
published or unpublished clinical study data, community reports, or
other data, such as food challenge data. Please provide units of
measure, where available (e.g., for prevalence information, 1 in 10,000
adults; for severity information, percent of reactions characterized as
anaphylaxis, number of emergency visits, etc.).
2. Clinically cross-reactive food allergies between wheat and any
of the non-wheat GCGs. This could include study data, community
reports, or other relevant information.
3. Non-wheat GCGs causing non-IgE-mediated reactions in individuals
with CD or other food allergic conditions (e.g., eosinophilic
gastrointestinal disorders).
B. Data and information on gluten in oats (including frequency and
amounts of gluten in oats), and the prevalence, severity, and potency
of IgE-mediated and non-IgE-mediated allergy and adverse reactions to
oats.
Celiac Journey's petition requests that we include oats as a GCG
because they often contain gluten due to cross-contact. Although FDA
does not consider oats to be a GCG (21 CFR 101.91(a)(1)), we recognize
that a major concern underlying the use of oats is cross-contact with
wheat and cereals like barley or rye, resulting in concentrations of
gluten that are potentially significant in the context of exacerbation
of CD or IgE-mediated reactions (Ref. 9). Recent work conducted by the
FAO/WHO expert consultation provides information related to the extent
of gluten presence in oats due to cross-contact (Ref. 5). The expert
consultation did not consider oats to be a cereal priority allergen
because this food poses a low public health risk of causing IgE-
mediated allergy or CD toxicity. Nevertheless, the consultation
recognized that oats can have potentially significant levels of GCGs
due to cross-contact.
Because oats may have gluten, due to cross-contact, and because the
citizen petition asks FDA to consider oats as a GCG, FDA requests the
following information:
4. To what extent do oat food products contain GCGs as a result of
cross-contact? What amounts of GCGs are usually present? What other
grains or ingredients contain GCGs due to cross-contact (and how do
amounts compare to amounts in oats)?
5. What is the prevalence, severity, and potency of IgE- or non-
IgE-mediated adverse reactions due to consumption of the following oat-
containing ingredients?
a. Pure or gluten-free oats alone?
b. Oats having cross-contact with GCGs, and, in particular, non-
wheat GCGs?
Please provide relevant studies or data and provide the unit of
measure (e.g., 1 in 10,000 adults).
6. To what extent are oat products labeled in a way to indicate/not
indicate the presence of GCGs (e.g., ``may contain gluten'')? If
specific products or product categories are identified, please provide
labels or photos and provide information about the type of food (e.g.,
packaged food product or food from a retail food establishment or
elsewhere).
7. What potential challenges might there be if there were
requirements to eliminate, minimize, or label the presence of non-wheat
GCGs in food products containing oats?
C. Data and information on undisclosed ingredients of interest
(including their prevalence and usage amounts in food products and
adverse events resulting from consumption of these food products).
As explained in the background section, in general, an ingredient
must be declared by the common or usual name on the label or labeling
of packaged foods (see section 403(i) of the FD&C Act). Wheat is also a
major food allergen and, thus, when used as an ingredient, wheat must
be declared as ``wheat'' either in the ``Contains''
[[Page 2785]]
statement or in the ingredient list (section 403(w) of the FD&C Act).
However, the ingredients of interest are not major food allergens, so,
under certain circumstances, it may be permissible for a packaged food
that contains an ingredient of interest not to explicitly name the food
source (e.g., rye, barley, oats) on the label or labeling. For example,
if the ingredient of interest falls under the regulatory provisions
described above for incidental additives, spices, flavoring, or
coloring, the presence of rye, barley, or oats might not be declared on
the label. Also, there are instances when the common or usual name of
an ingredient does not reflect that it is derived from an ingredient of
interest. For example, malt extract, which is derived from barley, may
be labeled as ``barley malt,'' but it can also be referred to as ``malt
extract'' or ``malt syrup,'' which do not disclose the barley source of
the ingredient to consumers.
We are aware that there are ingredients derived from ingredients of
interest that do not disclose the source. Specifically, we are aware of
``malt,'' ``malt extract,'' and ``malt syrup,'' but note that many of
the food products on the market with these ``malt''-type ingredients
declare the barley source in the ingredients list. Also, although there
are labeling exceptions described above with regard to spices,
flavoring, coloring, or incidental additives, it is unclear whether any
non-wheat GCG or oat ingredients are ever used as such. Celiac
Journey's petition is asking us to require that all ingredients with
gluten be listed by name in the ingredient lists of all foods, however,
our review indicates that most ingredients appear to already declare
the gluten source as described above. Therefore, we pose the following
questions:
8. What are instances where ingredients of interest (rye, barley,
or oats) would be undisclosed on a food package and potentially cause
adverse reactions?
9. What is the prevalence and severity of IgE- and non-IgE-mediated
adverse reactions to undisclosed ingredients of interest in food
products. Please provide relevant studies or data and provide the unit
of measure (e.g., 1 in 10,000 adults) to the extent it is available.
a. If possible, please provide information on the symptoms and
severity of reactions. Additionally, please specify the suspected food
or ingredient and whether the reaction was from consumption of rye,
barley, a crossbreed, or oats. If available, please provide pictures of
product labels.
b. Please specify if reactions were from a packaged food product or
food from a retail establishment or elsewhere.
10. We would like information about undisclosed ingredients of
interest in packaged foods or in restaurant foods. Please specify the
types of ingredients, frequency, and amounts of undisclosed ingredients
of interest in foods. We are particularly interested in data, but
specific examples and pictures of packages or labels may be helpful to
illustrate the issue. For amounts, please provide a unit measure (e.g.,
``5 grams of gluten per kilogram (ppm) of packaged food product'' or
``50 milligrams of total gluten protein per serving''). Please specify
whether the ingredients of interest are undisclosed for any of the
following reasons:
a. Because the common or usual name of an ingredient does not list
the GCG source in a way that it is apparent that GCG is present (e.g.,
malt extract). Specify the types of ingredients, prevalence, and usage
amounts in foods.
b. Because they are used as processing aids or incidental
additives.
c. Because they are part of a spice mix, flavoring, or coloring.
d. Because they are present due to cross-contact.
11. What potential challenges might there be if there were
requirements to label the presence of non-wheat GCGs and oats in foods
that do not currently require their disclosure in the ingredient
statement for one of the reasons described above?
D. Data and information related to ingredients of interest,
including potential consumer perspectives and experiences.
12. Please provide data from patient-centered studies or
information (e.g., food allergy quality-of-life questionnaires)
regarding patients' experiences, perspectives, needs, and priorities
regarding avoidance of foods that are or contain ingredients of
interest.
13. We are interested in information and studies on consumer
purchasing and consumption choices related to GCGs, including cost
considerations, labeling information (e.g., gluten-free, undisclosed
ingredients), and consumption of oats. Specifically, we are interested
in the following information:
a. How heavily do consumers rely on purchasing foods voluntarily
labeled as ``gluten-free'' versus purchasing foods that do not declare
a GCG in the ingredient statement?
b. For foods that are not voluntarily labeled as ``gluten-free''
and do not declare a GCG in their ingredient statement, do consumers
avoid foods that contain certain ingredients because they may contain
undisclosed gluten (for example, foods labeled as containing
``flavors,'' ``colors,'' or ``spices'')? Please provide specific
examples and labels, if available.
c. Do consumers generally avoid oats or other ingredients that may
contain gluten due to cross-contact even when no GCGs or gluten terms
are listed? If so, please provide specific examples and labels, if
available.
III. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.
* 1. Gupta, R.S., Warren, C.M., Smith, B.M., Jiang, J., Blumenstock,
J.A., Davis, M.M., Schleimer, R.P., Nadeau, K.C., 2019. ``Prevalence
and Severity of Food Allergies Among US Adults,'' JAMA network open
2, e185630-e185630. Doi: 10.1001/jamanetworkopen.2018.5630.
Available at: <a href="https://doi.org/10.1001/jamanetworkopen.2018.5630">https://doi.org/10.1001/jamanetworkopen.2018.5630</a>.
2. Gupta R.S., Warren C.M., Smith B.M., Blumenstock J.A., Jiang J.,
Davis M.M., Nadeau K.C., ``The Public Health Impact of Parent-
Reported Childhood Food Allergies in the United States,''
Pediatrics, 142(6):e20181235, 2018. Doi: 10.1542/peds.2018-1235.
Available at: <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC6317772/">https://pmc.ncbi.nlm.nih.gov/articles/PMC6317772/</a>.
* 3. FDA. ``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.'' January 2025. Available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-fda-staff-and-interested-parties-evaluating-public-health-importance-food-allergens-other">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-fda-staff-and-interested-parties-evaluating-public-health-importance-food-allergens-other</a>.
4. Choung R.S., Unalp-Arida A., Ruhl C.E., Brantner T.L., Everhart
J.E., Murray J.A., ``Less hidden celiac disease but increased gluten
avoidance without a diagnosis in the USA: Findings from the National
Health and Nutrition Examination Surveys from 2009 to 2014,'' Mayo
Clinic Proceedings, pii:S0025-6196(16)30634-6, 2016. Doi:10.1016/
j.mayocp.2016.10.012. Available at: <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC5459670/">https://pmc.ncbi.nlm.nih.gov/articles/PMC5459670/</a>.
[[Page 2786]]
* 5. FAO and WHO. 2022. ``Risk Assessment of Food Allergens. Part
1--Review and validation of Codex Alimentarius priority allergen
list through risk assessment. Meeting Report.'' Food Safety and
Quality Series No. 14. Rome. Available at: <a href="https://doi.org/10.4060/cb9070en">https://doi.org/10.4060/cb9070en</a>.
* 6. FAO and WHO. 2023. ``Risk Assessment of Food Allergens--Part 5:
Review and establish threshold levels for specific tree nuts (Brazil
nut, macadamia nut or Queensland nut, pine nut), soy, celery, lupin,
mustard, buckwheat and oats. Meeting report.'' Food Safety and
Quality Series, No. 23. Rome. Available at: <a href="https://doi.org/10.4060/cc8387en">https://doi.org/10.4060/cc8387en</a>.
* 7. Memorandum from Ben Remington, Senior Scientist, HFP, Summary
and review of information from FAO/WHO reports and other sources
relevant to the citizen petition from Celiac Journey (Docket No.
FDA-2023-P-3942), Aug. 13, 2025.
* 8. Memorandum from Stefano Luccioli, Senior Medical Officer and
Allergen Coordinator, HFP, OFCSDSI, DCC, Data and information
reported by the ad hoc Joint FAO/WHO Expert Consultation on Risk
Assessment of Food Allergens on gluten-containing grains (GCGs) and
oats as priority allergenic foods causing celiac disease or other
non-IgE-mediated food allergy, Aug. 24, 2025.
9. Do, A.B., Khuda, SE, Sharma, G.M., 2018. ``Undeclared Food
Allergens and Gluten in Commercial Food Products Analyzed by
ELISA,'' Journal of AOAC International 101, 1-13. Available at:
<a href="https://doi.org/10.5740/jaoacint.17-0384">https://doi.org/10.5740/jaoacint.17-0384</a>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-01121 Filed 1-21-26; 8:45 am]
BILLING CODE 4164-01-P
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