[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Rules and Regulations]
[Pages 47154-47179]
[FR Doc No: 2013-18813]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2005-N-0404]
RIN 0910-AG84

Food Labeling; Gluten-Free Labeling of Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a
final rule to define the term ``gluten-free'' for voluntary use in the
labeling of foods. The final rule defines the term ``gluten-free'' to
mean that the food bearing the claim does not contain an ingredient
that is a gluten-containing grain (e.g., spelt wheat); an ingredient
that is derived from a gluten-containing grain and that has not been
processed to remove gluten (e.g., wheat flour); or an ingredient that
is derived from a gluten-containing grain and that has been processed
to remove gluten (e.g., wheat starch), 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); or inherently does not contain gluten; and that any unavoidable
presence of gluten in the food is below 20 ppm gluten (i.e., below 20
mg gluten per kg of food). A food that bears the claim ``no gluten,''
``free of gluten,'' or ``without gluten'' in its labeling and fails to
meet the requirements for a ``gluten-free'' claim will be deemed to be
misbranded. In addition, a food whose labeling includes the term
``wheat'' in the ingredient list or in a separate ``Contains wheat''
statement as required by a section of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and also bears the claim ``gluten-free''
will be deemed to be misbranded unless its labeling also bears
additional language clarifying that the wheat has been processed to
allow the food to meet FDA requirements for a ``gluten-free'' claim.
Establishing a definition of the term ``gluten-free'' and uniform
conditions for its use in food labeling will help ensure that
individuals with celiac disease are not misled and are provided with
truthful and accurate information with respect to foods so labeled. We
are issuing the final rule under the Food Allergen Labeling and
Consumer Protection Act of 2004 (FALCPA).

DATES: Effective date: The final rule becomes effective on September 4,
2013. Compliance date: The compliance date of this final rule is August
5, 2014. See section II.B.4 (comment 35 and response 35) for an
additional explanation of the compliance date and implementation of
this final rule.

FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-2371, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Rule

    Need for the rule: Celiac disease is a hereditary, 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. Celiac disease has no
cure, but individuals who have this disease are advised to avoid all
sources of gluten in their diet to protect against adverse health
effects associated with the disease. Many manufacturers currently label
their food with a

``gluten-free'' labeling claim. However, there is no current regulatory
definition for the ''gluten-free'' claim in the United States.
Establishing in this final rule a regulatory definition of the food
labeling term ``gluten-free'' and uniform conditions for its use in the
labeling of foods is necessary to ensure that individuals with celiac
disease are not misled and are provided with truthful and accurate
information with respect to foods so labeled; this final rule is also
necessary to respond to a directive of FALCPA (title II of Pub. L. 108-
282).
    Legal authority: Consistent with section 206 of FALCPA and sections
403(a)(1), 201(n), and 701(a) of the FD&C Act (21 U.S.C. 343(a)(1),
321(n), and 371(a), respectively), we are issuing requirements for the
use of the term ``gluten free'' for voluntary use in the labeling of
foods.

Major Provisions of the Rule

    The final rule defines and sets conditions on the use of the term
``gluten-free'' in foods, including:
     Foods that inherently do not contain gluten (e.g., raw
carrots or grapefruit juice) may use the ``gluten-free'' claim.
     Foods with any whole, gluten-containing grains (e.g.,
spelt wheat) as ingredients may not use the claim;
     Foods with ingredients that are gluten-containing grains
that are refined but still contain gluten (e.g., wheat flour) may not
use the claim;
     Foods with ingredients that are gluten-containing grains
that have been refined in such a way to remove the gluten may use the
claim, so long as the food contains less than 20 ppm gluten/has less
than 20 mg gluten per kg (e.g. wheat starch);
     Foods may not use the claim if they contain 20 ppm or more
gluten as a result of cross-contact with gluten containing grains.
    For reasons discussed in more detail in this document, under
limited circumstances we intend to exercise enforcement discretion with
respect to the requirements for ``gluten-free'' labeling for FDA-
regulated beers that currently make a ``gluten-free'' claim and that
are: (1) Made from a non-gluten-containing grain or (2) made from a
gluten-containing grain, where the beer has been subject to processing
that the manufacturer has determined will remove gluten below a 20 ppm
threshold. We plan to issue a proposed rule to address our compliance
approach to fermented or hydrolyzed products.
    In addition, the final rule provides that:
     A food that bears the claim ``no gluten,'' ``free of
gluten,'' or ``without gluten'' in its labeling and fails to meet the
requirements for a ``gluten-free'' claim will be deemed to be
misbranded.
     A food whose labeling includes the term ``wheat'' in the
ingredient list or in a separate ``Contains wheat'' statement as
required by FALCPA and also bears the claim ``gluten-free'' will be
deemed to be misbranded unless its labeling also bears additional
language clarifying that the wheat has been processed to allow the food
to meet FDA requirements for a ``gluten-free'' claim.
    By defining ``gluten-free'' and the conditions under which a
``gluten-free'' claim can be used, the final rule makes it easier for
individuals with celiac disease to make informed purchasing decisions.
This will enable them to adhere to a diet they can tolerate without
causing adverse health effects and to select from a variety of
available gluten-free foods.

Costs and Benefits

    Full compliance with the final rule would have annualized costs of
about $7 million per year and annual health benefits of about $110
million per year:

                    Annual Benefit and Cost Overview
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------------------------------------------------------------------------
Benefits.....................  Health Gains for       $110,000,000.
                                Individuals With
                                Celiac Disease.
                               Search Cost Reduction  Unknown.
Costs........................  Relabeling of Foods..  $1,000,000.
                               Testing of Foods.....  $5,800,000.
Net Benefits.................  .....................  >$103,000,000.
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Table of Contents

I. Background
    A. What is celiac disease?
    B. How prevalent is celiac disease in the United States?
    C. What did the Food Allergen Labeling and Consumer Protection
Act of 2004 do with respect to celiac disease? What other activities
did we conduct for this rulemaking?
    D. What did we propose to do?
II. What issues did the comments raise? What are FDA's responses to
the comments? What does the final rule say?
    A. What general comments did we receive? What regulatory
approach should we take?
    B. What comments did we receive on the proposed rule?
III. What is the legal authority for this rule?
IV. Analysis of Impacts--Final Regulatory Impact Analysis
V. How does the Paperwork Reduction Act of 1995 apply to this final
rule?
VI. What is the environmental impact of this rule?
VII. What are the federalism impacts of this rule?
VIII. References

I. Background

A. What is celiac disease?

    Celiac disease (also known as celiac sprue and gluten-sensitive
enteropathy) is a chronic inflammatory disorder of the small intestine
in genetically susceptible individuals. It is triggered by ingesting
certain storage proteins, commonly referred to as ``gluten,'' that
naturally occur in some cereal grains (Refs. 1 through 3). In such
individuals, the consumption of gluten stimulates the production of
antibodies and inflammatory cells, resulting in an abnormal immune
response, which damages the tiny, fingerlike protrusions called
``villi,'' that line the small intestine and function to absorb
nutrients from food (Ref. 4). Over time, continued dietary exposure to
gluten can destroy the intestinal villi of individuals with celiac
disease, leading to a lack of absorption of nutrients and a wide
variety of other serious health problems (Ref. 4).
    The symptoms and clinical manifestations of celiac disease are
highly variable among affected individuals and differ in severity. The
reasons for this variability are unknown, but may depend upon the
individual's age and immunological status, the amount, duration or
timing of the exposure to gluten, and the specific area and extent of
the gastrointestinal tract involved in the disease (Ref. 5). Symptoms
of celiac disease may be: (1) ``Classical,'' affecting the digestive
tract (e.g., abdominal bloating; cramping and pain; chronic diarrhea;
vomiting; constipation) and resulting in gastrointestinal
malabsorption; or (2) ``atypical,'' affecting mainly other parts of the
body (e.g., fatigue; irritability; behavior changes; bone or joint
pain; tingling numbness in the legs; ulcers in

the mouth; tooth discoloration or loss of enamel; itchy skin rash with
blisters called dermatitis herpetiformis) (Refs. 1, 4, 6, and 7).
    A large portion of the subpopulation that has celiac disease may
not experience any symptoms at all, and these individuals are
classified as having either the ``silent'' or ``latent'' form of celiac
disease (Refs. 1 and 8). Persons who have the silent form of celiac
disease have most of the diagnostic features commonly seen in
individuals with classical or atypical celiac disease, such as specific
serum antibodies and evidence of damaged intestinal villi. Those who
have the latent form of celiac disease have specific serum antibodies,
but no evidence of damaged intestinal villi (Ref. 1).
    In addition to the aforementioned clinical symptoms and ailments,
celiac disease is associated with a number of significant health
problems and disorders, including iron-deficiency anemia, vitamin
deficiencies, protein-calorie malnutrition, weight loss, short stature,
growth retardation in children, delayed puberty, infertility,
miscarriage, and osteoporosis (Refs. 1, 6, 9, and 10). Individuals with
unmanaged celiac disease are at an increased risk of developing other
serious medical conditions, such as Type I diabetes mellitus,
intestinal cancers, and both intestinal and extraintestinal non-
Hodgkin's lymphomas (Refs. 7, 11, 12, and 13).
    Celiac disease has no cure, but individuals who have this disease
are advised to avoid all sources of gluten in their diet (Refs. 1 and
6). Over time, strictly avoiding consumption of gluten can resolve the
symptoms, mitigate and possibly reverse the damage, and reduce the
associated health risks of celiac disease (Ref. 14). For some
individuals with celiac disease, failure to avoid consumption of gluten
can lead to severe and sometimes life-threatening complications that
can affect multiple organs of the body (Refs. 5, 6, and 15).

B. How prevalent is celiac disease in the United States?

    Precise prevalence data for celiac disease are not available. In
the January 23, 2007, proposed rule (72 FR 2795 at 2797), we cited
estimates regarding the overall prevalence of celiac disease in the
United States ranging from about 0.4 percent to about 1 percent of the
general population, or approximately 1.5 to 3 million Americans (Refs.
1 and 16). According to the National Health and Nutrition Examination
Survey (NHANES) 2009-2010 survey data on medical conditions, 0.14
percent of the civilian, non-institutionalized population of the United
States reported having been told by a medical professional that they
have celiac disease (Ref. 17). Researchers examining serological data
from a subset of the NHANES 2009-2010 study population for evidence of
celiac disease estimated the prevalence of celiac disease at 0.71
percent (Ref. 18).
    The discrepancy between estimated prevalence and diagnosed cases
has been linked primarily to the fact that celiac disease can be silent
or latent, as described in section I.A. Silent and latent forms of
celiac disease may go undetected in an individual for years before the
person develops symptoms causing him or her to seek medical attention.
In addition, celiac disease is often mistaken for other
gastrointestinal malabsorption disorders that have similar diarrheal
symptoms (e.g., irritable bowel syndrome), which further delays its
diagnosis (Ref. 19). Only recently has the medical community become
more aware of the need to screen for celiac disease when patients
experience health problems that may be associated with the disease or
when patients have family members, especially first- and second-degree
relatives, who have celiac disease (Ref. 1).

C. What did the Food Allergen Labeling and Consumer Protection Act of
2004 do with respect to celiac disease? What other activities did we
conduct for this rulemaking?

    FALCPA, Title II of Public Law 108-282, was enacted on August 2,
2004. Section 206 of FALCPA directs the Secretary of Health and Human
Services (HHS) (the Secretary), in consultation with appropriate
experts and stakeholders, to issue a rule to define, and permit use of,
the term ``gluten-free'' on the labeling of foods. This rulemaking
implements section 206 of FALCPA.
    FALCPA does not require that we establish a threshold level for
gluten. Nonetheless, an important scientific issue associated with the
issuance of this rule is the potential existence of a threshold level
below which it is unlikely that an individual with celiac disease will
have an adverse health effect.
    To address this issue, among others, we established an internal,
interdisciplinary group (the Threshold Working Group) to review the
scientific literature on the issue of a threshold level for gluten. The
Threshold Working Group's report, ``Approaches to Establish Thresholds
for Major Food Allergens and for Gluten in Food'' (issued in draft and
later revised, referred to herein as the ``Thresholds Report'' except
where noted) (Ref. 20), summarized the current state of scientific
knowledge with respect to a dose-response relationship for gluten, and
presented the following four potential approaches that we might
consider in establishing such a threshold level, if we chose to do so
(Ref. 20, pp. 2 and 38-41; Ref. 21 at pp. 2 and 42-45):
     Analytical methods-based--thresholds are determined by the
sensitivity of the analytical method(s) used to verify compliance.
     Safety assessment-based--``safe'' level is calculated
using the No Observed Adverse Effect Level (NOAEL) from available human
challenge studies, applying an appropriate ``uncertainty factor''
multiplier to account for knowledge gaps.
     Risk assessment-based--examines known or potential adverse
health effects resulting from human exposure to a hazard; quantifies
the levels of risk associated with specific exposures and the degree of
uncertainty inherent in the risk estimate.
     Statutorily derived--uses an exemption articulated in an
applicable law and extrapolates from that to other potentially similar
situations.
    As the Thresholds Report explained, the term ``threshold'' has
multiple meanings, including toxicological and statutory (or
regulatory) (see Ref. 20 at p. 10). The Threshold Working Group noted
that ``[u]nderstanding thresholds for gluten will help FDA develop a
definition of `gluten-free' and identify appropriate uses of the
term.'' The Threshold Working Group recognized that setting such a
regulatory threshold likely would require consideration of additional
factors not addressed in the Thresholds Report, such as ease of
compliance and enforcement, concerns of stakeholders (i.e., industry,
consumers, and other interested parties), economics (e.g., cost/benefit
analysis), trade issues, and legal authorities (Ref. 20 at p. 41).
    The Thresholds Report concluded that it was not possible for us to
use the quantitative risk assessment-based approach due to the lack of
sufficient data from human clinical trials and the lack of sufficient
data on exposure, and that the statutorily derived approach is not
viable in the absence of applicable statutory provisions (Ref. 20 at
pp. 4, 60, and 61). Thus, the two approaches identified in that report
as viable for establishing a threshold for gluten were the analytical
methods-based approach and the safety assessment-based approach.

    In the Federal Register of June 17, 2005 (70 FR 35258), we
published a notice announcing the availability of the draft version of
the Thresholds Report. We invited interested persons to submit comments
and any scientific data or other information to the docket during a 60-
day comment period that ended on August 16, 2005. The Threshold Working
Group considered the comments, data, and information submitted, and
made appropriate revisions to the draft Thresholds Report. On May 25,
2006, we posted our response (Ref. 22) to the comments, data, and other
information that we received. We also posted the revised Thresholds
Report (Ref. 21). Both documents are dated March 2006.
    Additionally, in the Federal Register of May 23, 2005 (70 FR
29528), we announced that our Food Advisory Committee (FAC) would hold
a public meeting on July 13 through 15, 2005, to evaluate the draft
version of the Thresholds Report. One purpose of the meeting was for
the FAC to determine whether the four approaches considered in the
Thresholds Report for establishing a threshold level for gluten were
scientifically sound. We invited experts to address a number of
specific issues related to sensitivities to gluten. In addition, we
invited interested persons to submit comments and any scientific data
or other information relevant to the issues pending before the FAC.
    During the public meeting, the FAC heard presentations from invited
experts on the diagnosis and treatment of celiac disease, the quality
of life issues faced by those who have celiac disease and their
families, the relationship between gluten proteins in various grains
and celiac disease, analytical methods for detecting and measuring the
levels of gluten in food, the value and use of prospective and
retrospective gluten tolerance studies, and a summary of existing
national and international definitions of ``gluten-free'' for food
labeling. Further, members of the general public, including those
representing trade associations, industry, consumers, and other
stakeholders, gave brief presentations before the FAC to share their
perspectives on some of the same topics addressed by the invited
experts. The speaker presentations, public comments, FAC discussions,
and the FAC responses to a set of specific questions and the charge to
the FAC posed by FDA's Center for Food Safety and Applied Nutrition
(CFSAN) are recorded in the transcript of the meeting, which is
available through the FDA Docket No. 2005N-0231 and is posted at
CFSAN's Web site (http://www.fda.gov/ohrms/dockets/ac/cfsan05.html).
Copies of the transcript materials that specifically address the topics
of celiac disease and a gluten threshold level are also available
through the docket for this rulemaking. A summary of the FAC responses
to the questions is provided in the Summary Minutes (Ref. 23).
    The FAC concluded that the Thresholds Report ``includes a
comprehensive evaluation of the currently available data and
descriptions of all relevant approaches that could be used to establish
[a] threshold . . . for gluten in food'' (Ref. 23, p. 1). The FAC also
identified the risk-assessment approach as the strongest of the four
approaches proposed in the Thresholds Report, assuming the availability
of sufficient data (Ref. 23, p. 1).
    In the Federal Register of July 19, 2005 (70 FR 41356), we
announced that we would hold a public meeting on August 19, 2005, to
discuss the topic of gluten-free food labeling. We gave interested
persons until September 19, 2005, to comment on a list of specific
questions concerning food manufacturing, analytical methods, and
consumer purchasing practices and views about gluten-free foods (70 FR
41356 at 41357). In addition, we invited experts to address these
issues at the meeting, and invited members of the general public,
including individuals with celiac disease and their caregivers, to
share their views about foods produced and labeled as ``gluten-free.''
We received more than 2,400 comments about the public meeting or the
list of questions cited in the notice announcing the meeting. The vast
majority of these comments were from individuals with celiac disease,
their caregivers, and celiac disease associations; we also received
comments from the food industry. Most consumers said that they
appreciate and use ``gluten-free'' labeling claims to identify packaged
foods they can eat when trying to avoid gluten. Many consumers stated
that a ``gluten-free'' labeling claim makes it easier to shop for
groceries, saving the consumers both time and the frustration
experienced when reading often lengthy and complicated ingredients
lists that the consumers did not understand. Many consumers also stated
that they primarily purchase packaged foods bearing a ``gluten-free''
labeling claim and that a standardized definition of the term ``gluten-
free'' for foods marketed in the United States would give them more
assurance that foods bearing this claim are appropriate for individuals
trying to avoid gluten. The comments reflected a consensus of opinion
among individuals with celiac disease, and the organizations which
represent them, that wheat, rye, and barley should be excluded from any
products labeled as ``gluten-free.'' However, comments from these
individuals and organizations varied with respect to whether we should
exclude oats from any products labeled as ``gluten-free.''
    Industry comments submitted in response to the 2005 public meeting
or to the list of questions cited in the notice announcing the meeting
indicated that currently there is no universal understanding among
manufacturers of what the term ``gluten-free'' means and there is no
uniform industry standard for producing foods bearing this labeling
claim. Several industry comments expressed the opinion that a
standardized definition for ``gluten-free'' could help promote fair
competition among packaged foods marketed as gluten-free in the United
States, because all manufacturers would have to adhere to the same
requirements if they label their products ``gluten-free.''

D. What did we propose to do?

    In the Federal Register of January 23, 2007 (72 FR 2795), we
published a proposed rule to define the term ``gluten-free'' and allow
its voluntary use in the labeling of foods. In brief, the proposed rule
would:
     Define the term ``gluten-free'' for voluntary use in the
labeling of foods, to mean that the food does not contain any of the
following: An ingredient that is any species of the grains wheat, rye,
barley, or a crossbred hybrid of these grains (collectively referred to
in the proposed rule as ``prohibited grains''); an ingredient that is
derived from a prohibited grain and that has not been processed to
remove gluten (e.g., wheat flour); an ingredient that is derived from a
prohibited grain and that has been processed to remove gluten (e.g.,
wheat starch), if the use of that ingredient results in the presence of
20 ppm or more gluten in the food; or 20 ppm or more gluten.
     Deem a food to be misbranded that bears the claim
``gluten-free'' or similar claim in its labeling and fails to meet the
conditions specified in the proposed definition of ``gluten-free.''
     Deem a food to be misbranded if it bears a ``gluten-free''
claim in its labeling if the food is inherently free of gluten and if
the claim does not refer to all foods of that same type (e.g., ``milk,
a gluten-free food'' or ``all milk is gluten-free'').

     Deem a food made from oats that bears a ``gluten-free''
claim in its labeling to be misbranded if the claim suggests that all
such foods are ``gluten-free'' or if 20 ppm or more gluten is present
in the food.
    The proposed rule would create a new Sec.  101.91 entitled
``Gluten-free labeling of food.'' In the preamble to the proposed rule
(72 FR 2795 at 2803), we stated that, after publication of the proposed
rule, we would conduct a safety assessment for gluten exposure
consistent with the safety assessment-based approach described in the
Thresholds Report. We requested comments providing data relevant to the
safety assessment. We stated that we would publish a notice in the
Federal Register seeking comment on the draft safety assessment and its
potential use in the final rule and that we would consider public and
peer-review comments in revising the safety assessment, as appropriate.
Under the safety assessment-based approach, the labeling threshold
would be determined at least in part on the basis of a ``safe'' level
or ``tolerable daily intake'' (TDI) of a substance as calculated using
the NOAELs and the Lowest Observed Adverse Effect Levels from available
dose-response data in animals or humans and applying one or more
appropriate ``uncertainty factors'' to account for gaps, limitations,
and uncertainty in the data and for inter-individual difference (i.e.,
variability among individuals within the target population).
    We subsequently completed a health hazard assessment of the adverse
health effects of gluten exposure in individuals with celiac disease
that included a safety assessment for gluten, and we submitted a report
on this health hazard assessment, the ``Gluten Report,'' to scientific
experts for peer review. In the preamble to this final rule, we
generally use the term ``safety assessment'' to mean the entire
analysis reported in the ``Gluten Report'', because this language is
consistent with the Thresholds Report's use of the term ``safety
assessment-based approach.'' We revised the ``Gluten Report'' after
considering the experts' comments and made a report concerning the peer
review available at our Web site at http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/UCM264152.pdf.
    In the Federal Register of August 3, 2011 (76 FR 46671), we
published a notice (2011 notice) that reopened the comment period for
the proposed rule, in part, to announce the availability of the
``Gluten Report'' and to invite comments on the report. We also asked
whether and if so, how, the safety assessment should affect FDA's
proposed definition of ``gluten-free'' in the final rule. Finally, we
sought comment on our tentative conclusion that the safety assessment-
based approach may lead to a conservative, highly uncertain estimation
of risk to individuals with celiac disease associated with very low
levels of gluten exposure, and that the final rule should adopt the
proposed rule's approach to defining the term ``gluten-free.'' We also
sought comment on a few other matters unrelated to the questions about
the safety assessment and its potential use in the final rule.
    We received a number of comments concerning our safety assessment.
To the extent those comments address the potential use of the safety
assessment in the final rule, we describe and respond to them in part
II. We discuss and respond to comments that focused on the safety
assessment's methodology in ``FDA's Responses to Comments on the Report
Titled `Health Hazard Assessment for Gluten Exposure in Individuals
With Celiac Disease: Determination of Tolerable Daily Intake Levels and
Levels of Concern for Gluten,' '' (Ref. 24) which is available at
http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM362401.pdf. We received nearly 2,000
submissions in response to both the proposed rule and to the 2011
notice announcing the reopening of the comment period. Most submissions
came from individuals, and we also received comments from industry and
trade associations, consumer and advocacy groups, academic
organizations, and foreign government agencies. For example, many
comments from consumers stated that they currently must search the list
of ingredients on each product and that it is difficult to do so
because the presence of gluten is not always evident to a layperson
from the information on the label. Some comments noted that consumers
often contact the manufacturer to confirm if the food contains gluten
and that this task requires significant time and effort. The comments
stated that foods labeled ``gluten-free'' according to a standard
definition would provide an easier and faster way to identify such
foods. Despite the apparent broad consensus among comments about the
need for a standard definition of ``gluten-free,'' the comments raised
many distinct issues about how such a definition should be developed
and implemented.
    We discuss the issues raised in the comments on the proposed rule
as well as the 2011 notice, and also describe the final rule, in
section II. For ease of reading, we preface each comment discussion
with a numbered ``Comment,'' and each response by a corresponding
numbered ``Response.'' We have numbered each comment to help
distinguish among different topics. The number assigned is for
organizational purposes only and does not signify the comment's value,
importance, or the order in which it was received.

II. What issues did the comments raise? What are FDA's responses to the
comments? What does the final rule say?

A. What general comments did we receive? What regulatory approach
should we take?

    As explained in sections I.C and I.D, the Thresholds Report
summarized the current state of scientific knowledge with respect to a
dose-response relationship for gluten, and presented four potential
approaches that we might consider in establishing such a threshold
level. We decided to issue a proposed rule that used one of those
approaches, an analytical methods-based approach, under which the
thresholds are determined by the sensitivity of the analytical
method(s) used to verify compliance. However, we also conducted a
safety assessment in which we reviewed available human challenge
studies, exposure data, and other information, applying certain
specified assumptions and appropriate ``uncertainty factor''
multipliers to account for knowledge gaps, to arrive at an estimation
of risk to individuals with celiac disease associated with very low
levels of gluten exposure. In the safety assessment we estimated level
of concern (LOC) values for individuals with celiac disease, depending
upon the corresponding age group and whether the adverse health effects
are clinical or morphological and/or physiological in nature, at the
90th percentile level of intake of ``all celiac disease grain foods.''
As described in the ``Gluten Report,'' the estimated gluten LOC values
for individuals with celiac disease range from 0.01 to 0.06 ppm.
However, as we noted in the 2011 notice, this estimation of risk to
individuals with celiac disease associated with very low levels of
gluten exposure may be conservative and highly uncertain.
    Many comments supported our tentative conclusion to use the
analytical method-based approach, rather than the safety assessment-
based approach, and supported our proposed

criteria for defining the term ``gluten-free,'' including the proposed
requirement that food bearing a ``gluten-free'' claim not contain 20
ppm or more gluten. Some comments argued that the safety assessment-
based approach should be followed. The comments on our approach raised
four primary points concerning which approach to use in the final rule,
addressed in more detail in the following bulleted list. These were:
     The potential impact of the choice of approach on the
availability of foods that could be labeled ``gluten-free'';
     The potential impact on the health of individuals with
celiac disease of the choice of approach for establishing a regulatory
definition of ``gluten-free'';
     The availability of analytical methods to evaluate
compliance and to enforce a regulatory definition of ``gluten-free'' at
different levels; and
     The relationship between FDA's definition of ``gluten-
free'' and that of international bodies.
1. How would the choice of approach affect the availability of gluten-
free foods?
    (Comment 1) Several comments stated that using an extremely low
level of gluten, such as those estimated in the safety assessment, to
define ``gluten-free'' could cause some manufacturers to stop
identifying food as gluten-free. The comments explained that, under the
safety assessment-based approach, a manufacturer might stop identifying
a food as gluten-free because the food could not meet a very low gluten
threshold (e.g., 0.01 ppm gluten) for reasons such as an ingredient's
cross-contact with gluten-containing grain during agricultural
production or supply stages or difficulty separating gluten-containing
and gluten-free products in mixed-use processing facilities.
    Many comments from individuals with celiac disease stated that they
rely on products labeled ``gluten-free'' to reduce the time spent
reading ingredient lists on products to determine if the foods are safe
for them to eat. These comments expressed concern that if we establish
a gluten content that is lower than < 20 ppm gluten for purposes of
defining the term ``gluten-free,'' manufacturers might find it
difficult to manufacture foods that consistently met the lower gluten
content. The comments stated that this may result in fewer foods
labeled ``gluten-free.'' The comments suggested that a decrease in the
number and variety of foods labeled ``gluten-free'' would mean that
individuals with celiac disease would have to invest more time and
effort to identify appropriate foods, and could reduce compliance with
a gluten-free diet, with potential adverse health consequences for
them.
    One comment stated that, even if an analytical method were
available to test for the presence of gluten at levels below 1 ppm,
``it would become increasingly costly for food companies, despite
thorough adherence to good manufacturing practices, either to clean
equipment adequately or to invest in dedicated equipment in order to
meet the increasingly lower gluten threshold. This in turn would lead
to more expensive food products developed for celiac consumers, or to
companies stopping the production of `gluten free' food products, thus
reducing the food choices available for gluten sensitive consumers.''
Other comments echoed that the result of adopting the safety
assessment-based approach would be more costly food or fewer food
options for individuals who have celiac disease.
    (Response 1) We agree with the comments that the food industry may
be unable to consistently meet a standard limiting the presence of
gluten in foods labeled ``gluten-free'' to < 1 ppm, and that such a low
level cannot, as of the date of this final rule, be verified through
scientifically valid analytical methods. We also agree that such an
approach would result in the removal from the market of many products
that currently meet the criterion of < 20 ppm gluten in the definition
of ``gluten-free'' and bear the claim, or discourage the introduction
of new foods labeled as ``gluten-free,'' because manufacturers could
not meet a gluten limit much lower than < 20 ppm. Limiting the
availability of the number and variety of foods labeled ``gluten-free''
would be detrimental to individuals with celiac disease who are already
challenged by the complexities of adhering long term to a gluten-free
diet.
    As for the comment's claim that an analytical method to detect very
low gluten levels would be cost prohibitive, in the absence of such
methods, we decline to speculate about their cost and whether
manufacturers would be willing to incur such costs.
    (Comment 2) Several comments indicated that consumers are uncertain
about how much gluten 20 ppm represents and its relevance to the total
amount of gluten that most individuals with celiac disease can
tolerate.
    (Response 2) Twenty ppm gluten is a concentration level rather than
an absolute quantity of gluten in a food. Twenty ppm is the same as
0.002 percent. For example, at a concentration level of 20 ppm gluten,
a 28.35 gram (g) or 1-ounce portion of food would contain 0.567 mg
gluten (20 mg/kg x 28.35 g x 1 kg/1000 g = 0.567 mg). Because 20 ppm
refers to a concentration and not an absolute quantity of gluten, if
the ingredients of a food are all below 20 ppm, the end product cannot
have a concentration that exceeds 20 ppm. The amount of gluten to which
a person with celiac disease would be exposed in consuming food labeled
``gluten-free'' would depend upon the total quantity/weight of food
consumed and the actual concentration of gluten in the product. On our
own initiative, we have revised the final rule to describe the
equivalent concentration of 20 mg gluten per kg of food to further
harmonize our rule with international standards, such as those used in
Codex Standard 118-1979 and European Commission Regulation No 41/2009.
2. How might the choice of approach affect the health of individuals
with celiac disease?
    (Comment 3) Several comments supported the proposed < 20 ppm gluten
level as a criterion for labeling food as ``gluten-free.'' The comments
asserted that individuals with celiac disease have for many years been
consuming food products with levels of 20 ppm or more without adverse
effect, and that products whose gluten levels are < 20 ppm should be
safe for most individuals with celiac disease. The comments did not
provide data to support these assertions.
    Other comments expressed the belief that adopting a gluten level
well below 20 ppm would reduce the risk of adverse health outcomes that
individuals with celiac disease might experience at the proposed level
of < 20 ppm gluten.
    (Response 3) The final rule adopts a gluten content of < 20 ppm for
parts of the definition of the ``gluten-free'' labeling claim, using
the analytical methods-based approach. The scientific research
conducted thus far and the information presented in our Gluten Report
support a conclusion that most individuals with celiac disease can
tolerate food that contains variable trace amounts and concentrations
of gluten (see 76 FR 46671 at 46674 through 46675).
    As we stated in the 2011 notice: ``To the extent it is possible to
do so and protect public health, we believe that we should set a gluten
threshold level for `gluten free' labeling that best assists most
individuals with celiac disease in adhering life-long to a `gluten-
free' diet without causing adverse health consequences. If the
prevalence of persons with celiac disease not

following a `gluten-free' diet increases because there are fewer foods
labeled `gluten-free' to choose from (because the criteria for making
`gluten-free' labeling claims are too stringent for most food
manufacturers to meet) or such foods become more expensive (because any
changes made by manufacturers to enable them to meet more stringent
criteria to make foods labeled `gluten-free' may increase their
production costs), then these individuals could be at a higher risk of
developing serious health complications and other diseases associated
with celiac disease. In other words, moving to a definition of `gluten-
free' that adopts a criterion that is much lower than < 20 ppm gluten
could have an adverse impact on the health of Americans with celiac
disease.'' (See 76 FR 46671 at 46675).
    Thus, while we disagree with the comments to the extent that they
suggest that there is clear evidence that individuals with celiac
disease have been consuming food with gluten content at or above 20 ppm
without adverse effect, we believe that the available data and
information support a determination that retaining the < 20 ppm part of
the criteria for defining ``gluten-free'' is protective of public
health.
    For similar reasons, we also disagree with the comments suggesting
that adopting a gluten level well below 20 ppm would reduce the risks
of adverse health outcomes for individuals with celiac disease.
Although the safety assessment estimated that highly sensitive
individuals with celiac disease may not be fully protected if they
consume foods containing a trace level of gluten above 0.01 ppm but
below 20 ppm (see 76 FR 46671 at 46675), statements by some celiac
disease researchers, based on their experience and epidemiological
evidence, suggest that variable trace amounts and concentrations of
gluten in foods can be tolerated by most individuals with celiac
disease without causing adverse health effects (id. at 46674-46675).
Thus, revising the proposed threshold gluten content for defining
``gluten-free'' to lower than 20 ppm (as per the safety assessment
results) would not offer additional protection or clinical benefits to
individuals with celiac disease. Moreover, other comments about the
methodology used and studies chosen in the safety assessment suggest
that the conclusions based on this information have led to highly
conservative tolerance estimates for gluten. As such, although clearly
defined gluten thresholds cannot be determined at this time of this
final rule, there is no evidence that consumption of food products
containing less than 20 ppm gluten would pose a risk of adverse health
effects for the large majority of individuals with celiac disease.
Future research and improved data on defining gluten thresholds may
lead us to revisit our conclusion.
    The varying needs of individuals with celiac disease may be best
addressed by focused education and outreach. We acknowledge the offers
of assistance we received in comments from several health care
professionals, celiac disease organizations, and others to provide
educational materials and conduct seminars that may help individuals to
fully understand how the labeling can be used in their adherence to a
gluten-free diet.
    Although many comments focused on the < 20 ppm part of the
criteria, under the final rule there are other criteria for when a food
can and cannot be labeled ``gluten-free.'' These other criteria also
are intended to reduce exposure to gluten in products labeled ``gluten-
free.'' In essence, the definition of ``gluten-free'' is structured in
such a way that manufacturers who wish to use a ``gluten-free'' claim
cannot use as ingredients in their foods gluten-containing grains, or
ingredients derived from those grains that have not been processed to
remove gluten, regardless of the ultimate presence of gluten in the
food.
    Finally, we note that some comments indicated that some
manufacturers of foods that may contain gluten--either because they
contain ingredients that have been processed to remove gluten but
retain some amount of gluten, or due to cross-contact--are able to
produce foods that contain well below 20 ppm gluten, through the
selection of ingredients, the use of facilities dedicated to only
producing gluten-free foods, and the use of additional specific
manufacturing controls that can prevent gluten cross-contact
situations. We encourage the development and implementation of
manufacturing practices that will ensure foods bearing the claim
``gluten-free'' meet the requirements in this final rule.
    (Comment 4) One comment asserted that the results of the safety
assessment demonstrate that there is no specific level of gluten that
typically produces an adverse response in those sensitive to gluten and
supported FDA's proposed approach as protective of most people with
celiac disease based on currently available data and methodologies. The
comment suggested that, if the proposed approach is used, manufacturers
of products bearing a ``gluten-free'' claim also should be required to
disclose the products' actual gluten content level (in mg per serving)
on the label. The comment explained that disclosing the products'
actual gluten content level will help individuals determine if a
product is appropriate for their individual health needs and better
control their gluten consumption. The comment also stated that, if the
final rule adopts a < 20 ppm gluten limit, we should amend it quickly
as new data become available concerning gluten tolerance or analytical
methods.
    (Response 4) We agree that the research described in the safety
assessment and other data suggest that there is considerable human
variability in response (in both kind and degree) to dietary gluten,
and we took this inter-individual variability into account in the
safety assessment by using a multiplier of 10 as one of the 2
uncertainty factors used to reduce the estimated TDI gluten levels.
However, because of this variability and other uncertainties, as we
noted in the 2011 notice, the safety assessment-based approach would
lead to a conservative, highly uncertain estimate of risk to
individuals with celiac disease associated with very low levels of
gluten exposure. We also agree with the comment that we will need to
continue to evaluate newer scientific knowledge and clinical findings,
particularly on the long-term needs of those with celiac disease, and
scientifically valid analytical methods for quantifying lower gluten
content, as they become available. If those findings change our
consideration of the various factors that we have applied in this
rulemaking, we may, as suggested by the comment, consider reviewing the
standard for ``gluten-free'' labeling. In the meantime, we encourage
manufacturers of gluten-free foods to produce such foods with as little
gluten as possible and to continue research in processing methods to
reduce levels further.
    We disagree with the comment's suggestion that we require
manufacturers of gluten-free products to disclose their products'
actual gluten content level on the labels. First, requiring a gluten-
free product's label to disclose the product's actual gluten content
level would be impractical because there might be variability in gluten
content of a particular food due to natural variation in ingredients,
minor modifications in the food's formulation, or changes in other
manufacturing practices. Manufacturers also might change ingredient
suppliers to reduce their manufacturing costs or buy ingredients from
different suppliers if a particular ingredient were in short supply; in
these situations, the gluten content of an ingredient also might

change. Thus, if we were to require manufacturers to disclose a
product's actual gluten content, we would, in effect, be requiring
manufacturers to test each batch of a food product that is already
eligible to bear a ``gluten-free'' claim (e.g., did not contain 20 ppm
or more gluten) and to reprint labels any time there was a slight
variation in the gluten content of that food. This requirement would
discourage manufacturers from marketing foods with a ``gluten-free''
label, and this, in turn, would limit the availability and variety of
gluten-free foods for individuals with celiac disease.
    Second, 20 ppm is currently the lowest level at which analytical
methods have been scientifically validated to reliably and consistently
detect gluten across a range of food matrices. Therefore, we are not in
a position to identify a specific analytical method that a firm could
use to identify the actual level of gluten in a food below 20 ppm.
    We are aware that some independent third-party organizations
currently certify products with respect to their gluten content, and
that manufacturers of gluten-free products that obtain such
certification may currently include information regarding the certified
status of their products on their labels. We will evaluate such
labeling to ensure such information is truthful and not misleading and
meets other applicable FDA requirements.
3. What analytical methods are available to evaluate compliance and to
enforce a regulatory definition of ``gluten-free'' at very low levels?
    (Comment 5) Some comments stated that there is no analytical method
to measure gluten at the levels identified in the safety assessment
(0.01 to 0.6 ppm).
    (Response 5) We agree with the comments that it is currently not
possible to reliably and consistently test for gluten at the very low
levels identified in the safety assessment. There are methods with
limits of detection that are lower than the level at which they have
been validated. Thus far, the reliability of those methods at these
lower limits has not been demonstrated. Twenty ppm remains the level of
gluten that can reliably and consistently be detected in a variety of
food matrices.
    (Comment 6) Numerous comments concurred with the proposed level of
< 20 ppm as among the criteria for a ``gluten-free'' definition based
on the analytical methods-based approach, but stated that we should
reduce the gluten content used as part of the criteria to define the
term ``gluten-free'' when validated analytical methods become available
to reliably detect gluten in foods at lower levels. In contrast, other
comments said that more sensitive analytical methods should not be the
determining factor in lowering the gluten threshold level unless there
is scientific evidence (e.g., evidence-based, peer-reviewed published
studies) demonstrating that 20 ppm gluten in foods labeled ``gluten-
free'' is ``toxic'' to those with celiac disease.
    (Response 6) We agree, in part, with the comments. If future data
indicate that the gluten content of < 20 ppm is not sufficiently
protective of the health of individuals with celiac disease and
analytical methods become available that can reliably detect gluten in
a range of food matrices at levels below 20 ppm, we will reevaluate the
< 20 ppm gluten level that we have included as part of the criteria for
the definition of ``gluten-free.'' We agree that any changes to this
gluten level should be supported by all available data, including data
on analytical methods as well as epidemiological and clinical data on
the impact of any change on the health of individuals with celiac
disease.
    In sum, defining the term ``gluten-free'' for use in the voluntary
labeling of food involves the consideration of multiple factors,
including currently available analytical methods and the needs of
individuals with celiac disease, as well as factors such as ease of
compliance and enforcement, stakeholder concerns, economics, trade
issues, and legal authorities. An important consideration is that, as
the comments suggest, lowering the gluten level below 20 ppm will make
it far more difficult for manufacturers to make food products that
could be labeled as ``gluten-free,'' thereby reducing food choices for
individuals with celiac disease. While the safety assessment results
suggest that there may be some individuals with celiac disease who are
highly sensitive to gluten exposure even at very low levels, the safety
assessment, by its nature, may lead to a conservative, highly uncertain
estimation of risk for these individuals. Given the various factors we
have to consider and the data available to us, we decline to revise the
rule to adopt a safety assessment-based approach at this time. However,
if new data and information become available in the future that affect
the factors we considered in defining ``gluten-free,'' we may consider
whether further refinement of the ``gluten-free'' definition would be
appropriate.
4. Is the rule consistent with international standards?
    (Comment 7) A few comments asked how our proposed definition of
``gluten-free'' differed from those used in other countries. Many
comments focused on the < 20 ppm gluten content as the only element of
our proposed rule that would apply to international products. Other
comments questioned how differences would affect the United States in
international trade negotiations, considering the World Trade
Organization Agreements on Technical Barriers to Trade (TBT Agreement)
and Application of Sanitary and Phytosanitary Measures (SPS Agreement).
    Several comments supported the proposed definition of ``gluten-
free'' as an opportunity to harmonize international standards for this
term. Some comments cautioned against using a lower gluten content
value, stating that a lower level would not allow harmonization with
international trading partners such as Canada and the European Union,
which use a standard of no greater than 20 ppm gluten.
    Many comments commented on a definition of ``low gluten'' as
allowed in Australia and New Zealand. Most comments stated that ``low-
gluten'' labeling is meaningless for individuals who wish to avoid
gluten, but other comments supported ``low-gluten'' claims to allow for
differences in individual gluten tolerance or personal preference.
    (Response 7) The 2011 notice indicated that the < 20 ppm part of
the criteria consistent with approaches taken by the Codex Alimentarius
Commission's revised ``Codex Standard for Foods for Special Dietary Use
for Persons Intolerant to Gluten (Codex Standard 118-1979)'' and also
with the European Commission's Commission Regulation (EC) No 41/2009,
concerning ``the composition and labeling of foodstuffs suitable for
people intolerant to gluten'' (76 FR 46671 at 46674). The Codex
Standard established a threshold of 20 mg gluten per kg of product
(which is equivalent to 20 ppm gluten) for foods labeled ``gluten-
free,'' and the European Commission regulation requires that foods
labeled as ``gluten free'' not contain more than 20 ppm gluten (Refs.
25 and 26).
    The final rule's definition of ``gluten-free'' is similar, but not
identical, to requirements or positions by the Codex Alimentarius
Commission, the European Commission, and Canada. For example, although
our final rule, Codex Standard 118-1979, and European Commission
Regulation No 41/2009

(Ref. 26) identify wheat, rye, and barley as gluten-containing grains,
and allow foods containing ingredients made from wheat, rye, barley, or
their crossbred varieties to be labeled ``gluten-free'' if the
ingredients have been processed so that the gluten content in the food
is reduced, the requirements differ in the amount of reduction
required. Codex Standard 118-1979 and European Commission Regulation No
41/2009) require gluten in these ingredients not exceed 20 mg/kg,
whereas our final rule requires the use of ingredients processed to
remove gluten does not result in the presence of 20 ppm or more gluten
in the finished food (Sec.  101.91(a)(3)(i)(A)(3)). In addition, our
final rule also requires that any unavoidable presence of gluten in the
food be below 20 ppm (see Sec.  101.91(a)(3)(i)(A)(3) and (a)(3)(ii)).
Codex Standard 118-1979 and European Commission Regulation No 41/2009,
in general, require that the gluten content ``not exceed'' 20 mg/kg in
the food.''
    We also note that, in June 2012, Health Canada described its
position on gluten-free claims. Canadian regulations had previously
defined ``gluten,'' in part, as any gluten protein from the grain of,
or the grain of a hybridized strain created from, barley, oats, rye,
triticale, or wheat, kamut, or spelt. In June 2012, however, Health
Canada stated that: ``Based on the available scientific evidence,
Health Canada considers that gluten-free foods, prepared under good
manufacturing practices, which contain levels of gluten not exceeding
20 ppm as a result of cross-contamination, meet the health and safety
intent of [Health Canada regulation] B.24.018 when a gluten-free claim
is made.'' ``Based on the enhanced labeling regulations for allergens
and gluten sources, any intentionally added gluten sources, even at low
levels (e.g. wheat flour as a component in a seasoning mixture which
makes up a small proportion of the final food), must be declared either
in the list of ingredients or in a `Contains' statement. In these
cases, a gluten-free claim would be considered false and misleading.
If, however, a manufacturer using a cereal-derived ingredient includes
additional processing steps which are demonstrated to be effective in
removing gluten, then the food may be represented as gluten-free''
(Ref. 27). The Health Canada position that food labeled ``gluten-free''
not contain more than 20 ppm gluten is comparable to the final rule's
criterion that foods labeled ``gluten-free'' cannot contain 20 ppm
gluten or more gluten.
    However, we recognize that our final rule differs in certain
respects from requirements or positions taken by Health Canada and
other countries or entities. For example, Codex Standard 118-1979,
European Commission Regulation No 41/2009, Australia New Zealand Food
Standards Code standard 1.2.8 (Ref. 28), and Health Canada include oats
as gluten-containing grains, whereas our final rule does not. (We
discuss oats in our response to comment 9.) Codex Standard 118-1979 and
European Commission Regulation No 41/2009 also state that a gluten-free
food is one whose ``gluten level does not exceed'' 20 mg/kg, and Health
Canada's position is that a gluten-free food has a gluten content ``not
exceeding 20 ppm,'' whereas our final rule defines ``gluten-free'' with
respect to a gluten content of < 20 ppm. We do not consider the
difference between ``does not exceed 20 mg/kg or 20 ppm,'' compared to
our ``< 20 ppm'' gluten content criterion, to be significant because,
as indicated in our discussion of comment 19, many foods labeled as
``gluten-free'' have a gluten content well below 20 ppm.
    As another difference, we recognize that European Commission
Regulation No 41/2009 requires foods for those intolerant to gluten to
not contain gluten exceeding 100 mg/kg and to bear the term ``very low
gluten,'' and Australia New Zealand Food Standards Code standard 1.2.8
requires that a food have ``no detectable gluten'' if it claims to be
``gluten free.'' The Australia New Zealand Food Standards Code also
states that a food can be ``low gluten'' if the detectable gluten
content is no more than 20 mg per 100 g of food, which is equivalent to
no more than 200 ppm. Our final rule does not define the use of ``low
gluten'' or ``very low gluten'' claims. If such claims were used in
labeling, we would evaluate such claims on a case-by-case basis as to
whether the claim was truthful and not misleading. We discourage the
use of statements in labeling about the gluten content in foods other
than ``gluten-free.'' (We discuss ``low gluten'' claims in our response
to comment 25.)
    Based on our review of products currently on the market, we do not
believe that the differences between our final rule and standards,
requirements, or positions taken by other countries or entities will
adversely affect the ability of manufacturers to voluntarily use the
``gluten-free'' claim, as appropriate, on many foods.

B. What comments did we receive on the proposed rule?

1. Definitions (Sec.  101.91(a))
    a. Prohibited grains (Sec.  101.91(a)(1)). The proposed rule would
define three terms. Proposed Sec.  101.91(a)(1) would define
``prohibited grain'' as any one of three specific grains (wheat, rye,
and barley) ``or their crossbred hybrids (e.g., triticale, which is a
cross between wheat and rye).''
    (Comment 8) Several comments disagreed with or would revise the
term ``prohibited grain.'' Some comments stated that the term is
misleading because it implies that all consumers, rather than consumers
with celiac disease or consumers who are allergic to those grains,
should avoid the grains. Some comments suggested alternative
terminology; for example, one comment suggested replacing the term
``prohibited grain'' with ``specific grain.''
    (Response 8) We agree in part and disagree in part with the
comments. We agree that the word ``prohibited'' could create the
misimpression that all consumers (rather than solely those individuals
with celiac disease) should avoid these grains. We decline, however, to
use the term ``specific grains'' because it does not provide any
information as to what the term ``specific'' refers. Instead, we have
revised Sec.  101.91(a)(1) and corresponding language elsewhere in
Sec.  101.91(a) to refer to ``gluten-containing grain'' rather than
``prohibited grain.'' The term ``gluten-containing grain'' is simple,
informative, and tied to the rule's definition of ``gluten.'' In
addition, ``gluten-containing grain'' may avoid any misinterpretation
of the rule's intent with respect to the consumption of gluten by
individuals without celiac disease or other medical need to avoid
gluten.
    (Comment 9) Many comments addressed the use of oats as an
ingredient that could be used in a food labeled ``gluten-free.'' Most
comments supported the inclusion of oats as an ingredient in ``gluten-
free''-labeled foods. The comments stated that the scientific evidence
indicates that the majority of individuals who have celiac disease can
tolerate eating oats. The comments added that oats are a whole grain
and contribute essential nutrients and fiber to a gluten-free diet and
that oats add more dietary variety and appeal to following a gluten-
free diet. Many comments favored the use of ``gluten-free'' labeling
for food containing oats only if the food contains less than 20 ppm
gluten. These comments stated that limiting the use of

the ``gluten-free'' claim on these foods would make it easier for
consumers to distinguish these oats from other commercially available
oats that could contain higher levels of gluten due to cross-contact
situations with gluten-containing grains. The comments stated that oats
in food labeled ``gluten-free'' would provide individuals who have
celiac disease and who are oat-tolerant more assurance that the product
has been grown, processed, stored, and handled in a way to prevent
incorporation of gluten.
    Other comments opposed permitting oats in a food labeled ``gluten-
free.'' These comments argued that not all individuals with celiac
disease can tolerate oats and that FDA's definition of ``gluten-free''
should accommodate the needs of everyone who has celiac disease. Some
comments stated that more research is needed to determine whether
individuals with celiac disease should consume oats. Other comments
stated that persons newly diagnosed with celiac disease and elderly
persons with celiac disease are commonly advised not to introduce oats
into their gluten-free diet until their small intestine has fully
healed or that some individuals with celiac disease who are
asymptomatic may be sensitive to oats and not know it. Finally, some
comments said that if we do not prohibit oats in food labeled ``gluten-
free,'' then the label should indicate if the food does or does not
contain oats.
    (Response 9) We agree with the comments that oats may be used as an
ingredient in a food labeled as ``gluten-free'' provided that the food
meets the definition of ``gluten-free.'' In other words, oats that
contain 20 ppm or more gluten due to cross-contact may not bear a
``gluten-free'' claim. While oats are inherently gluten-free, we
recognize that some oats may come in contact with gluten-containing
grains during their production, processing, storage, or other handling
practices. However, as we noted in the preamble to the proposed rule
(72 FR 2795 at 2798), the commingling of oats with other grains appears
to be preventable. At least two manufacturers who submitted written
responses to our 2005 public meeting on gluten-free food labeling
reported that the oats they market in the United States do not contain
gluten from wheat, rye, and barley (Refs. 29 and 30). Other comments
indicated that five brands of gluten-free oats are now commercially
available in the United States.
    We decline to prohibit the use of oats as an ingredient in foods
labeled ``gluten-free.'' As we noted in the proposed rule, data suggest
that the proportion of individuals with celiac disease who cannot
tolerate oats in daily amounts of about 50 g or less dry weight is
probably very low, possibly below 1 percent of the population of
individuals with celiac disease, and there is no general agreement
among experts about the extent to which oats present a hazard for
individuals with celiac disease (72 FR 2795 at 2797 through 2798).
Thus, for most individuals with celiac disease, oats can add whole
grain options, nutrient enrichment, and dietary variety and appeal to a
gluten-free diet. Individuals with celiac disease who cannot tolerate
oats can use food label information to avoid eating foods labeled
``gluten-free'' that are made with oats or oat-derived ingredients.
Examples of oat-derived ingredients include whole oats, rolled oats
(also called oatmeal and oat flakes), steel-cut oats, oat flour, oat
bran, and oat fiber. The term ``oat'' or ``oats'' is a part of the
common or usual name for each of these ingredients and can be found in
the food's ingredient list. For the reasons stated previously in this
document, we also decline to revise the rule to require that foods
labeled ``gluten-free'' bear additional language indicating that the
food does or does not contain oats.
    We recognize that there may be instances in which products could
contain an oat-derived ingredient without ``oats'' in the name, but we
did not receive any data or information on this possibility, and we are
aware of only one such ingredient, a non-starch polysaccharide called
``beta glucan,'' which can be derived from multiple sources, including
oats, and which is used in certain dietary supplements and to a much
lesser extent in conventional foods (Ref. 31).
    Because individuals with celiac disease who are sensitive to oats
may wish to avoid all oat-derived ingredients, we encourage
manufacturers of foods labeled ``gluten-free'' that use an oat-derived
ingredient where the word ``oat'' does not appear in the ingredient
list as part of any ingredient's name (e.g., beta glucans) to indicate
in their labeling that an oat-derived ingredient is present.
    (We understand that beta glucan may also be derived from barley,
which, unlike oats, is a ``gluten-containing grain'' under Sec.
101.91(a)(1). Similar to wheat starch, we consider beta glucan derived
from barley to be an ingredient that has been processed to remove
gluten because the process of deriving this ingredient is designed to
selectively yield the desired polysaccharide and exclude other
naturally occurring components, including protein.)
    b. Gluten (Sec.  101.91(a)(2)). Proposed Sec.  101.91(a)(2) would
define ``gluten'' as ``the proteins that naturally occur in a
prohibited grain and that may cause adverse health effects in persons
with celiac disease (e.g., prolamins and glutelins).''
    (Comment 10) Several comments suggested that FDA revise the
definition of ``gluten'' to mean ``specific amino acid sequences'' that
naturally occur in a prohibited grain and that cause harmful effects by
eliciting an immune response.
    (Response 10) We decline to revise the definition as suggested by
the comments. The comments did not explain how the definition would be
improved by replacing ``proteins'' with ``specific amino acid
sequences'' or by replacing ``may cause adverse health effects'' with
``cause harmful effects by eliciting an immune response.'' We also note
that our definition of ``gluten'' is comparable to those used by Codex
Standard 118-1979 and European Commission Regulation No 41/2009; both
define ``gluten'' as ``a protein fraction from wheat, rye, barley,
oats, or their crossbred varieties and derivatives thereof, to which
some [people] are intolerant and [that] is insoluble in water and
0.5M'' sodium chloride solution. Consequently, except for replacing
``prohibited grain'' with ``gluten-containing grain'' (as we explained
in our response to comment 8), we have finalized the definition of
``gluten'' without change.
    c. ``Gluten-free'' (Sec.  101.91(a)(3)). Proposed Sec.
101.91(a)(3) would define the labeling claim ``gluten-free'' or similar
claims as meaning that the food bearing the claim in its labeling does
not contain any of the following: (1) An ingredient that is a
prohibited grain; (2) an ingredient that is derived from a prohibited
grain and has not been processed to remove gluten (e.g., wheat flour);
(3) an ingredient that is derived from a prohibited grain and has been
processed to remove gluten if use of that ingredient results in a
presence of 20 parts per million (ppm) or more gluten in the food; and
(4) 20 ppm or more gluten. The proposal also cited examples of similar
claims, such as ``free of gluten,'' ``without gluten,'' and ``no
gluten'' that would have to meet the same definition as the term
``gluten-free.''
    (Comment 11) Many comments asked us to develop a clear and
consistent definition for the ``gluten-free'' labeling claim. However,
one comment from a national organization committed to serving the
celiac community noted that it had dietitians with expertise in the
gluten-free diet develop a 15-question online consumer survey designed
to obtain consumer input on the various

questions posed by FDA as they related to consumers and their decisions
and choices related to gluten-free products. The organization executed
the online survey, open to consumers for 45 days, and collected over
5,000 responses. The comment indicated that 95 percent of the
respondents preferred the term ``gluten-free'' to indicate that a
product meets FDA's definition for ``gluten-free,'' as set forth in the
proposed rule. The comment also noted that voluntary label statements,
such as ``may contain'' or ``processed in a plant with,'' currently
restrict consumer use of some foods. The comment said that these types
of voluntary label statements would be unnecessary if consumers could
rely on a ``gluten-free'' label that indicated a product had been
tested to below 20 ppm. The comment suggested that we strive for
``clarity'' in all aspects of the regulation. Another comment suggested
that any definition of ``gluten-free'' should facilitate a reasonable
level of consistency among various products labeled as ``gluten-free''
and should ensure that individuals who are sensitive to or cannot
tolerate gluten can rely on gluten-free products meeting the same
minimum definition.
    Several comments recommended a single labeling definition for
``gluten-free'' foods and believed multiple labels would be too
confusing to the public. As one comment stated, ``only one simple,
clear standard claim like `gluten free' may simplify the identification
of gluten-free products (with a gluten level below 20 ppm).''
    One comment stated that we should expressly prohibit ambiguous
statements, such as ``No Gluten Added'' or ``Made from Gluten Free
Ingredients.'' Other comments expressed similar sentiments about
variations of similarly worded claims. One comment said that
manufacturers use such statements to suggest that the product is
suitable for individuals with celiac disease, while simultaneously
attempting to avoid liability for any gluten in the product that could
result from cross-contact or cross-contamination during the
manufacturing process. Similarly, other comments urged us to prohibit
other claims about the presence or absence of gluten ingredients unless
the food meets FDA requirements for a ``gluten-free'' claim.
    (Response 11) We agree that the final rule should clearly define
the term ``gluten-free.'' Section 206 of FALCPA directs the Secretary
to define and permit use of the term ``gluten-free'' in the labeling of
foods. Although proposed Sec.  101.91(a)(3) would have defined
``gluten-free'' and include ``or similar claim,'' we have revised the
final rule to define the term ``gluten-free'' without referring to
``similar claims.'' A single definition should help individuals with
celiac disease identify foods that they can tolerate, without having to
wonder whether foods bearing different label claims present different
risks, and thus manage their diets more easily. Furthermore, as the
comments suggest, it may be confusing to define ``gluten-free'' in a
manner that also attempts to capture ``similar claims.'' For example,
as the comments indicate, a claim such as ``no gluten added'' might not
be similar to ``gluten-free;'' instead, a ``no gluten added'' claim
could mean that the manufacturer did not increase the food's gluten
content during the manufacturing process beyond whatever level of
gluten the food contained before manufacturing. While another comment
suggested that we prohibit other claims, our experience with lists of
examples, such as listing the products subject to a rule, indicates
that it may be impractical to list more examples of ``similar'' claims.
(See, e.g., 66 FR 59138 at 59144 (November 27, 2001) (``FDA's
experience demonstrates that, despite FDA's intentions to provide
advice or clarity, whenever the agency attempts to provide complete
descriptions of the products that are subject to a particular
regulation or part, the descriptions are either misconstrued as being
exhaustive or definitive (so that persons whose products are not
identified or even slightly different from the products mentioned in
the description claim that they are exempt from the rule) or must be
constantly revised to add new products and to remove old products'').
    Nevertheless, we recognize that some companies use claims that are
similar to our definition of ``gluten-free.'' Our experience with other
content claims on foods suggests that claims that a food contains ``no
gluten,'' is ``free of gluten,'' or is ``without gluten'' (the examples
of ``similar claims'' in proposed Sec.  101.91(a)(3)) would be
misleading if the food does not meet the definition for ``gluten-free''
specified in Sec.  101.91(a)(3) (Ref. 32). Consequently, we have
revised Sec.  101.91(b)(2) to state that, ``A food that bears the claim
`no gluten,' `free of gluten,' or `without gluten,' in its labeling and
fails to meet the requirements of paragraph (a)(3) of this section will
be deemed misbranded.'' In essence, we consider the statements ``no
gluten,'' ``free of gluten,'' and ``without gluten,'' to be equivalent
to a ``gluten-free'' claim. We use the term ``requirements'' to
accurately describe the list of items in this paragraph. We discourage
the use of statements in labeling about the gluten content of foods
other than ``gluten-free'' and would evaluate any such statements under
sections 403(a)(1) and 201(n) of the FD&C Act.
    (Comment 12) Many comments requested that we establish a universal
symbol/logo and/or a standardized print format for all manufacturers
who wish to make a ``gluten-free'' claim on their food labels. The
comments said that symbols, logos, or standardized print formats would
make it easier for consumers to identify gluten-free foods, to reduce
their time shopping, and to reduce possible confusion by having the
same symbol appear in the same place using the same print format on
foods bearing a ``gluten-free'' labeling claim. Comments from
certification organizations suggested that consumers, particularly the
most gluten-sensitive individuals, look for those symbols and
understand what they mean.
    Other comments opposed the use of a universal ``gluten-free''
symbol/logo. Some comments said that some manufacturers and grocery
store chains have designed their own unique symbols/logos for
identifying gluten-free foods and should be able to continue using
these symbols/logos for labeling gluten-free foods or to use these
symbols/logos on printed cards or other signs to call attention to
gluten-free products sold in their stores. Still other comments noted
several third party gluten-free certification programs that have
developed their own specific ``gluten-free'' symbols/logos to identify
foods that comply with particular criteria for a gluten-free food. One
comment noted that some food companies seek independent, third-party
certification for their gluten-free products. The comment urged us to
not restrict the companies' use of certification programs or symbols.
The comment said that inclusion of multiple ``gluten-free'' symbols on
the same food or any restriction against continued use of third-party
``gluten-free'' certification program symbols/logos could make it more
confusing or difficult for consumers to identify foods that met the
criteria of those third-party ``gluten-free'' certification programs.
    (Response 12) The proposed rule did not address the use of a
universal symbol/logo, and we do not have any data indicating that
mandating a universal symbol/logo is necessary to ensure that the claim
is not false or misleading.
    We are aware that some companies or organizations have developed
specific phrases or symbols to indicate adherence to their own
standards or to

the standards of an independent gluten-free certification program for
foods that meet specific criteria. We would review the use of any
gluten-related claim not addressed in the final rule under sections
403(a)(1) and 201(n) of the FD&C Act.
    (Comment 13) One comment noted that the proposed rule would allow a
food to be labeled ``gluten-free'' if it uses an ingredient derived
from a prohibited grain that has been processed to remove gluten, but
would not allow a food to be labeled ``gluten-free'' if it used a
prohibited grain or used an ingredient derived from a prohibited grain,
if the processing of the food (instead of the ingredient) results in
the removal of gluten to below 20 ppm in the final product. The comment
said that processes exist that remove gluten from foods produced with
gluten containing ingredients, and suggested that because the processes
that remove gluten can occur at any stage in production, from the
preparation of the ingredients to the finished product, the final rule
should allow the use of the term ``gluten-free'' regardless of when the
gluten removing process occurs.
    (Response 13) Comments indicate that individuals with celiac
disease search for ``gluten-free'' claims and also review the
ingredient statement for specific ingredients. The final rule limits
the use of gluten-containing ingredients to ensure the food, as
consumed, contains as little gluten as possible. Allowing the ``gluten-
free'' label claim on food whose ingredients have been processed to
remove gluten, but not on food that has been processed to remove gluten
helps ensure that the finished product has the lowest amount of gluten
that is reasonably possible, and consistent with the use of specific
manufacturing practices that can prevent gluten cross-contact
situations. We plan to issue a proposed rule to address our compliance
approach to foods that are, or contain ingredients that are, fermented
or hydrolyzed, as discussed in response to comment 14. We anticipate
that the proposed rule will include a discussion related to the whether
it is feasible, and if so, under what circumstances, to process food to
remove gluten.
    (Comment 14) Several comments responded to analytical methods-
related issues raised in our 2011 notice regarding a scientifically
valid method that can be used to accurately determine if foods that are
or contain ingredients that are fermented or hydrolyzed (i.e., in which
chemical components are decomposed by reaction with water) contain < 20
ppm gluten to support ``gluten-free'' claims. Other comments discussed
whether we also should require these manufacturers to maintain records
on test methods, protocols, and results and to make these records
available to FDA upon inspection.
    Some comments, primarily from manufacturers of gluten detection
test kits or the food industry, asserted that there are some
competitive enzyme-linked immunosorbent assay (ELISA)-based methods
that can accurately detect and measure gluten concentration levels in
fermented and hydrolyzed foods as low as 0.24 mg/100 g or 2.4 ppm.
These comments also maintained that these methods were validated to
ensure that they perform reliably and can report test results in terms
of intact gluten concentration or ppm gluten. Several other comments,
particularly from those with celiac disease, celiac disease
associations, or health professionals, wanted FDA to require records of
test methods, protocols, and results to permit ``gluten-free'' claims
on fermented or hydrolyzed foods. Some comments wanted the
recordkeeping requirements to apply to all foods bearing a ``gluten-
free'' claim.
    (Response 14) We routinely rely upon scientifically valid methods
\1\ in our enforcement programs on food labeling. However, we are aware
that currently available sandwich ELISA-based methods are not effective
in detecting and quantifying intact gluten proteins in fermented and
hydrolyzed foods. The sandwich ELISA-based methods designed to detect
gluten require the presence of two antigenic epitopes and are not
appropriate for fermented and hydrolyzed products.
---------------------------------------------------------------------------

    \1\ As noted in the 2011 notice, a scientifically valid method
for purposes of substantiating a ``gluten-free'' claim for foods
matrices where formally validated methods (e.g., that underwent a
multi-laboratory performance evaluation) do not exist is one that is
accurate, precise, and specific for its intended purpose and where
the results of the method evaluation are published in the peer-
reviewed scientific literature. In other words, a scientifically
valid test is one that consistently and reliably does what it is
intended to do.
---------------------------------------------------------------------------

    In comparison to sandwich ELISA-based methods, competitive ELISA-
based methods need the presence of a single antigenic epitope. However,
without an appropriate reference standard to gauge the response, one
cannot interpret the results on a quantitative basis that equates the
response to intact gluten. Evidence in the scientific literature is
currently lacking about a scientifically valid competitive ELISA method
which confirms that any gluten peptides detected in a food sample can
be accurately quantified in terms of ppm intact gluten protein.
Therefore, we do not consider these methods scientifically valid for
the purposes of analyzing fermented or hydrolyzed foods to determine
compliance with this rule under Sec.  101.91(c). We intend to issue a
proposed rule to address how FDA will evaluate compliance with Sec.
101.91(b) when an evaluation of compliance based on an analysis of the
food using a scientifically valid method under Sec.  101.91(c) is not
available because the food is fermented or hydrolyzed or contains
fermented or hydrolyzed ingredients. We intend to consider the need for
issuing guidance for these foods to the extent the proposed rule does
not issue before the compliance date for this final rule.
    A ``gluten-free'' claim will be permitted on fermented and
hydrolyzed foods or foods containing fermented or hydrolyzed
ingredients that meet all of the requirements for bearing a ``gluten-
free'' claim even though the gluten content of the food cannot be
reliably measured pursuant to Sec.  101.91(c). Until we establish
provisions specifically for these foods, through further rulemaking, as
is true for all food manufacturers who wish to use ``gluten-free''
labeling on their food, manufacturers of fermented or hydrolyzed foods
or foods that use fermented or hydrolyzed ingredients are responsible
for ensuring that the food bearing a ``gluten-free'' claim is not
misbranded for failure to meet all of the requirements of the final
rule. Manufacturers can implement measures that are necessary to
prevent the introduction of gluten into the food during the
manufacturing process to ensure that the finished product will comply
with the provisions in Sec.  101.91.
    (Comment 15) Several comments concerned ``gluten-free'' labeling
claims on beers. Some comments wanted FDA to allow beers to be labeled
``gluten-free'' if the beers contained less than 20 ppm gluten. One
comment stated that, in some European countries, the traditional
brewing processes for barley malt-based beers have been modified to
ensure that beers labeled as ``gluten-free'' contain significantly less
than 20 ppm of gluten.
    In contrast, other comments favored prohibiting the use of a
``gluten-free'' claim on the label of beers made from gluten containing
ingredients but were later ``reduced'' in gluten due to the processing
methods.
    (Response 15) The Alcohol and Tobacco Tax and Trade Bureau (TTB) is
responsible for the issuance and enforcement of regulations with
respect to the labeling of beers that are malt beverages under the
Federal Alcohol Administration Act (FAA Act). Certain beers do not meet
the definition of a malt beverage under the FAA Act (27

U.S.C. 211(a)(7)). These beers are not subject to the labeling
requirements under the FAA Act and are subject to the labeling
requirements administered by FDA (Ref. 33).
    On May 24, 2012, TTB issued an interim policy on gluten content
statements in the labeling and advertising of beverages or beers they
regulate. The ``Interim Policy on Gluten Content Statements in the
Labeling and Advertising of Wines, Distilled Spirits, and Malt
Beverages'' allows the use of the following qualifying statement to
inform consumers: ``Product fermented from grains containing gluten and
[processed or treated or crafted] to remove gluten. The gluten content
of this product cannot be verified, and this product may contain
gluten,'' or ``This product was distilled from grains containing
gluten, which removed some or all of the gluten. The gluten content of
this product cannot be verified, and this product may contain gluten.''
(TTB Ruling No. 2012-2, May 24, 2012, available at http://www.ttb.gov/rulings/2012-2.pdf)
    Beers subject to FDA's labeling requirements are those beers that
are not made from both malted barley and hops but are instead made from
either malted barley and no hops or with substitutes for malted barley
(for example sorghum, millet, rice or buckwheat) with or without hops.
Other beers subject to FDA's labeling requirements not brewed from
gluten-containing grains may contain gluten through cross-contact with
gluten-containing grains or ingredients during processing. (We also
note that, for purposes of this discussion, we do not consider
sak[eacute] and similar products to be ``beers.'' Sak[eacute] and
similar products are treated as wine under the FAA Act and are subject
to FDA's labeling requirements only if they contain less than 7 percent
alcohol by volume.)
    Beers are among the foods subject to fermentation during
manufacturing. As discussed in our response to comment 14, we intend to
issue a proposed rule to address how FDA will evaluate compliance with
Sec.  101.91(b) when an evaluation of compliance based on an analysis
of the food using a scientifically valid method under Sec.  101.91(c)
is not available because the food is fermented or hydrolyzed or
contains fermented or hydrolyzed ingredients.
    We intend to address the ``gluten-free'' labeling of beers subject
to FDA's labeling requirements in that proposed rule. However, the
issues with respect to the labeling of FDA-regulated beers as gluten-
free go beyond the question of how compliance can be verified. First,
we note that consumers might not distinguish between those beers
subject to FDA's labeling requirements and those beers subject to TTB's
labeling requirements. Second, some comments have claimed that beers
made from gluten-containing grains can be processed in a way that
removes gluten. We are aware of a limited number of such products in
the market. As with other fermented foods, we are not aware of any
scientifically valid way to evaluate these claims, and there is
inadequate evidence in the record concerning the effectiveness of the
commenters' gluten removal process. We want to avoid any changes to
labels that may cause further confusion with regard to ``gluten-free''
beer until we issue the separate rule on gluten-free labeling of
hydrolyzed and fermented foods.
    In light of these considerations, we intend to exercise enforcement
discretion with respect to the requirements for ``gluten-free''
labeling for beers subject to FDA labeling requirements. Our
consideration for enforcement discretion would extend to beers that
currently make a ``gluten-free'' claim and that are: (1) Made from a
non-gluten-containing grain or (2) made from a gluten-containing grain,
where the beer has been subject to processing that the manufacturer has
determined will remove gluten. This enforcement discretion pertains
only to these beers subject to our labeling requirements that make a
``gluten-free'' claim as of August 5, 2013 pending completion of the
rulemaking process with respect to fermented or hydrolyzed products. To
the extent that a beer manufacturer wants to make a new gluten-free
claim that is not present on a label as of August 5, 2013, they should
contact FDA regarding the possible expansion of FDA's consideration for
the exercise of enforcement discretion related to such labeling.
    FDA expects beer manufacturers using a ``gluten-free'' claim to
take appropriate measures to prevent cross-contact with gluten-
containing grains during production, processing, storage, or other
handling practices. We note that beer manufacturers, whose beers are
subject to FDA's labeling requirements, that make beer from a gluten-
containing grain or from non-gluten-containing grains are not precluded
from using other statements on the label, such as a gluten statement
consistent with the TTB guidance, about processing of beers to reduce
gluten. However, such statements must be truthful and not misleading.
Beers bearing a ``gluten-free'' claim, or other statements related to
the gluten processing or content other than ``gluten free,'' are still
subject to sections 403(a)(1) and 201(n) of the FD&C Act.
    (Comment 16) Several comments claimed that individuals with celiac
disease are concerned that gluten-containing ingredients used in food
products may not be readily identifiable in the list of ingredients on
food packages. The comments suggested that ingredients declared as
``flavoring'' or ``modified food starch'' could contain gluten or
ingredients derived from gluten-containing grains. Some comments
suggested that we require the source of these ingredients be declared
on the label for foods bearing the ``gluten-free'' labeling claim.
    (Response 16) We recognize that, in some situations, an ingredient
that is a ``flavoring'' or ``modified food starch'' may be derived from
a gluten-containing grain but nonetheless be present in a food bearing
a ``gluten-free'' label. We note that the use of the ``gluten-free''
claim on a food label is voluntary and does not replace or eliminate
any other labeling requirements. Wheat is a major food allergen under
FALCPA and any food that is, or contains an ingredient that bears or
contains, a major food allergen under section 201(qq) of the FD&C Act
must declare either the word ``Contains'' followed by the name of the
food source from which the major food allergen is derived, or the
common or usual name of the major food allergen in the list of
ingredients followed in parentheses by the name of the food source
unless subject to an exception (section 403(w)(1) of the FD&C Act). A
flavoring, coloring, or incidental additive that is, or that bears or
contains, a major food allergen is subject to the labeling requirements
of section 403(w)(4) of the FD&C Act. Section 101.91(b)(1) of the final
rule states that we will consider a food bearing the claim ``gluten-
free'' in its labeling to be misbranded if it fails to meet the
requirements of paragraph (a)(3) of this section, which includes the
requirement that any ingredient derived from a gluten-containing grain
be processed to remove gluten such that its use in the finished product
does not result in 20 ppm or more gluten in the food. Therefore, this
final rule does not change the current labeling requirements for major
food allergens, including wheat. To the extent the comment requests
that we require that all ingredients in flavorings be listed in the
ingredient statement, the request is outside the scope of this
rulemaking.
    (Comment 17) A few comments suggested that we establish a gluten
limit for ingredients derived from gluten-containing grains that have
been

processed to remove gluten. One comment suggested 20 ppm as a
reasonable limit to set for safety and ease of testing. Another comment
suggested that if ingredients derived from gluten-containing grains
must be used, and if the food complies with the maximum gluten content
of 20 ppm, market practice will impose the same requirement at the
ingredient level.
    (Response 17) We decline to revise the rule to establish a specific
gluten limit for ingredients derived from a gluten-containing grain
that have been processed to remove gluten. As we discussed in the
preamble to the proposed rule (72 FR 2795 at 2802), although
ingredients such as wheat starch, are processed to remove gluten, there
may be different methods of deriving these ingredients, and some
methods may remove less gluten than others. The final rule provides
that the use of such ingredients must not result in the presence of 20
ppm or more gluten in the finished food (i.e., 20 mg or more gluten per
kg of food). To use additional adjectives to indicate that these
ingredients have been ``significantly'' or ``substantially'' reduced in
gluten would have little meaning given the variability in the gluten
levels in the starting materials and the various processes used.
Likewise, to establish gluten thresholds for these specific ingredients
would add criteria to the definition of ``gluten-free'' that do not
offer additional benefit to the protection of public health beyond
those provided by the definition of ``gluten-free.''
    We agree that, as more manufacturers use ingredients derived from
gluten-containing grains that have been processed to remove gluten, the
market may respond by producing more ingredients that have been
processed to reduce the gluten content even further and supporting the
use of such ingredients in food products that meet the definition of
``gluten-free.'' Thus, we encourage suppliers of ingredients derived
from a gluten-containing grain to process those ingredients using
appropriate controls to achieve gluten content below 20 ppm.
Manufacturers that are producing ``gluten-free'' foods may be more
inclined to buy ingredients from suppliers that can produce ingredients
with gluten content levels below 20 ppm. We would expect such
manufacturers, as part of good manufacturing practice, to test the
ingredient itself to ensure the gluten level in the ingredient is below
20 ppm. Alternatively, we would expect such manufacturers, as part of
good manufacturing practice, to rely on a certificate of analysis for
the ingredient, and to verify the accuracy and reliability of the
certificate of analysis ensuring that the ingredient contains less than
20 ppm gluten. Such a certificate of analysis would be based on initial
qualification and periodic re-qualification of the supplier through
testing of the ingredient with sufficient frequency or at least once
per year.
    (Comment 18) One comment suggested that any commingling or cross-
contact that may occur should not be evaluated under the < 20 ppm
element of the definition, at least until such time as a safety-based
threshold is established that would justify such inclusion. The comment
asked that the final rule not condition voluntary use of the term
``gluten-free'' on whether a food contains 20 ppm or more gluten ``for
any reason'' or on whether the product does not contain 20 ppm or more
gluten if the product is made from oats.
    (Response 18) The 20 ppm gluten threshold level is just part of the
criteria used to define ``gluten free.'' The < 20 ppm part of the
criteria for the definition of ``gluten-free'' is based on an
analytical methods-based approach, not a safety-assessment-based
approach. We recognize that gluten may be present in a food either
because it is a component of an ingredient used to produce that food or
through cross-contact during production, processing, storage, or other
handling practices. Therefore, it is appropriate to use the same
definition both for foods that have been formulated or processed not to
contain 20 ppm or more gluten and for the presence of gluten in foods
that do not inherently contain gluten, such as oats.
    (Comment 19) Some comments expressed concern about some foods
currently labeled as ``gluten-free'' having gluten content at or above
20 ppm or that many foods labeled ``gluten-free'' would contain the
maximum permissible level of gluten near but still below 20 ppm.
    (Response 19) Under the final rule, foods can no longer be labeled
``gluten-free'' if they contain 20 ppm or more gluten. The final rule
uses an analytical methods-based approach to establish a gluten content
of < 20 ppm as part of the criteria for defining the term ``gluten-
free.'' Given the current unavailability of test methods that can
reliably detect gluten at levels below 20 ppm, we conclude that
``gluten-free'' labeling on a food that contains less than 20 ppm
gluten would be neither false nor misleading, so long as it conforms to
all aspects of the final rule.
    As for the comments expressing concern about some foods currently
labeled as ``gluten-free'' having gluten content at or above 20 ppm,
data submitted in comments to the proposed rule indicate that many
products that are currently labeled as ``gluten-free'' have gluten
content well below 20 ppm gluten. In addition we note that in surveys
that have been conducted for foods labeled as gluten-free, available
for sale in Canada, most samples contained less than 20 ppm of gluten
(Ref. 27 at p. 4).
2. Requirements (Sec.  101.91(b))
    Proposed Sec.  101.91(b) would establish three different
requirements relating to the use of a ``gluten-free'' labeling claims.
    a. Use of the ``gluten-free'' claim or similar claims. Proposed
Sec.  101.91(b)(1) would state that ``A food that bears a ``gluten-
free'' claim or similar claim in its labeling and fails to meet the
conditions specified in paragraph (a)(3) of this section will be deemed
misbranded.''
    As we discussed earlier in our response to comment 11, the final
rule now defines the term ``gluten-free'' without referring to
``similar claims'' or providing examples of similar claims. Section
101.91(b)(2) of the final rule states: ``A food that bears the claim
`no gluten,' `free of gluten,' or `without gluten' in its labeling and
fails to meet the requirements of paragraph (a)(3) of this section will
be deemed misbranded.'' In essence, we consider the statements ``no
gluten,'' ``free of gluten,'' and ``without gluten'' to be equivalent
to a gluten-free claim. We are planning educational efforts to help
consumers learn that when they see foods labeled as being ``gluten-
free,'' the term will have a consistent meaning and, therefore, be a
reliable tool when planning a gluten-free diet.
    On our own initiative, we also have revised Sec.  101.9(b)(1) to
refer to ``the requirements of paragraph (a)(3) of this section''
instead of ``the conditions specified in paragraph (a)(3) of this
section.'' This change corresponds to the language used in Sec.
101.91(b)(2) of the final rule.
    b. Foods that do not inherently contain any gluten. Proposed Sec.
101.91(b)(2) would apply to foods that do not inherently contain any
gluten from a prohibited grain (now referred to as a gluten-containing
grain in the final rule), but would exclude foods made from oats. In
brief, proposed Sec.  101.91(b)(2) would consider such foods that bear
a ``gluten-free'' claim to be misbranded unless the claim ``refers to
all foods of that same type (e.g., `milk, a gluten-free food,' `all
milk is gluten-

free')'' and the food does not contain 20 ppm or more gluten.
    We invited comments and scientific information on whether a
``gluten-free'' claim on an inherently gluten-free food would be
misleading in the absence of additional qualifying language.
    (Comment 20) While a few comments supported proposed Sec.
101.91(b)(2) as written, most comments expressed significant confusion
as to the requirements for labeling foods inherently free of gluten.
Numerous comments expressed concern that the rule would result in foods
inherently free of gluten being deemed misbranded or ``illegal'' if
they claimed to be ``gluten-free.'' The comments did not appear to
understand that the proposed rule would find these foods misbranded
only if they omitted the qualifying language when they claimed to be
``gluten-free'' (assuming they met the other criteria for a ``gluten-
free'' labeling claim).
    Other comments discussed the proposed qualifying language. The
comments expressed concern that, in many instances, it would be
misleading to suggest that a particular food or food category is always
gluten-free. Some comments referred to the issues discussed in our
analysis of oats in the proposed rule (72 FR 2795 at 2801), noting that
cross-contact with gluten-containing ingredients can and does occur in
virtually any facility where gluten-containing ingredients are present.
One comment stated that ``requiring that inherently gluten-free foods
electively labeled `gluten-free,' declare that all such foods are
gluten-free, is to deny the cross-contact risks to which many
inherently gluten-free foods are regularly exposed. Furthermore,
requiring such a statement devalues the efforts of manufacturers who
employ exhaustive measures to remedy those risks of cross-contact. That
type of reference, in effect, tells the consumer that foods labeled
`gluten-free'--and subject to federal regulations--are no more safe
than those bearing no claim at all. Enforcing a requirement of such an
advisory will perpetuate the confusion and risks to individuals with
celiac disease that FALCPA is expected to undo.''
    Other comments noted that certain foods of the same type may be
available in flavored and unflavored forms or with additional
ingredients that may contain traces of gluten. Many comments cautioned
that, if one product used a ``gluten-free'' claim with the qualifying
language (i.e., a statement that all foods of that type are gluten-
free), some consumers may pick a flavored or formulated, gluten-
containing version of the product and mistakenly believe that it also
is inherently free of gluten. A few comments suggested that the
proposed qualifying language for foods that inherently do not contain
gluten would only be appropriate for single ingredient foods which are
not flavored nor have added ingredients. Several comments urged us to
allow an unqualified ``gluten-free'' claim if the food meets the
definition of ``gluten-free.'' They emphasized that this unqualified
labeling would be useful to consumers who are seeking gluten-free
products.
    Other comments explained that the proposed additional clarifying
wording indicating that all foods of the same type, not just the brand
bearing ``gluten-free'' labeling claim, also are free of gluten could
compel manufacturers to make representations about all products in a
given category, including products that the manufacturer does not make
or cannot control. Some comments explained that companies are willing
to support that their own products may bear a ``gluten-free'' claim (<
20 ppm gluten), but do not wish to make a statement suggesting that
other companies have made the same determination or have the same
controls or manufacturing practices to minimize or prevent contact with
gluten.
    Many comments suggested that we establish a simple ``gluten-free''
claim, regardless of whether the product is inherently gluten-free or
formulated to be gluten-free. To minimize consumer confusion, many
comments suggested that the final rule allow a ``gluten-free'' claim on
products that have been processed in a manner that ensures the products
meet the definition of ``gluten-free'' and contain less than 20 ppm
gluten. The comments also suggested that consumers seeking to avoid
gluten do not care if the food is inherently (or ``naturally'') gluten-
free or processed to remove gluten by formulation or ingredient
substitution.
    Other comments explained that the proposed requirements for
qualifying language could have an unintended consequence as it could
cause companies to stop labeling their products as ``gluten-free,''
rather than deal with misbranding issues. The comments indicated that
such a result would frustrate consumers because there would be fewer
foods labeled as ``gluten-free.''
    (Response 20) We understand how the proposal's additional
clarifying language for foods inherently free of gluten could cause
confusion and concern for the consumers seeking foods with a ``gluten-
free'' labeling claim. We agree with the comments stating the
requirement for qualifying language on foods that inherently do not
contain gluten could be interpreted as saying that it is the nature of
the food, rather than the care provided by the company making the
``gluten-free'' claim, that ensures the product meets the definition of
``gluten-free.'' Likewise, we agree with the comments suggesting that,
in this situation, requiring companies using the ``gluten-free'' claim
to add the qualifying language that all foods of the same type are also
gluten-free would, in effect, require the companies to make
representations as to the gluten-free status of products outside of
their control. We agree that such qualified labeling on one brand of
food that inherently does not contain gluten could mislead consumers
into assuming that a flavored or formulated gluten-containing version
of that product is also gluten-free, and could result in an individual
with celiac disease consuming gluten and possibly suffering negative
health consequences as a result.
    Consequently, we conclude that a ``gluten-free'' claim, without
qualifying language, on a food that is inherently free of gluten is not
misleading. We have revised the final rule so that a food labeled as
``gluten-free'' must meet the definition of ``gluten-free'' in Sec.
101.91(a)(3), but will not require additional qualifying language. This
final rule will allow us to determine whether specific ``gluten-free''
labeling claims are misleading on a case-by-case basis. A food bearing
a ``gluten-free'' label must meet each of the relevant criteria in the
``gluten-free'' definition, and qualifying language would not be
necessary for consumers to understand the meaning of the term ``gluten-
free'' with respect to other foods, including those that may also be
inherently free of gluten. There may be inherently gluten-free foods
that still may not meet the definition of ``gluten-free'' due to cross-
contact with gluten that leads to gluten content in the food that are
at or above 20 ppm. There also may be inherently gluten-free foods that
have some cross-contact with gluten-containing products, but are still
able to bear the ``gluten-free'' claim because the presence of gluten
in the food due to cross-contact is less than 20 ppm. Thus, the
approach we have taken in the final rule should result in labeling that
is easier for consumers to understand. We note that, in changing our
approach to ``gluten-free'' claims on inherently gluten free foods we
are making a determination that, in many situations ``gluten-free''
labeling is unlike the ``free'' labeling claims (nutrient content

claims) made for foods inherently free of calories, nutrients such as
sodium or fat, and other food substances such as cholesterol (see 21
CFR 101.13(e)(2) and 72 FR 2795 at 2802). The general rationale behind
the labeling of ``free'' claims is that, as we explained in the
preamble to the proposed rule, ``[i]f a single brand of food inherently
free of the substance that is the subject of its `free' labeling claim
does not also include additional qualifying language, consumers may
mistakenly assume that only the particular brand of the food is free of
the substance and may not understand that other brands of the same type
of food that do not make the `free' labeling claim are also free of the
substance'' (See id.). As noted previously, some comments challenged
the logic of that rationale in the context of gluten-free labeling and
indicated that firms did not want to make representations as to the
gluten-free status of products outside of their control, because it
could result in adverse health consequences to consumers. We concur
with these comments.
    We have removed proposed Sec.  101.91(b)(2) and its subparagraphs
(i) and (ii), and we reorganized the final rule to include Sec.
101.91(a)(3)(i)(B) stating that the definition applies if the food
inherently does not contain gluten and, as stated in Sec.
101.91(a)(3)(ii), any unavoidable presence of gluten in the food is
below 20 ppm gluten.
3. Compliance (Sec.  101.91(c))
    Proposed Sec.  101.91(c) would indicate that, when compliance is
based on an analysis of a food, we would ``use a method that can
reliably detect the presence of 20 ppm gluten in a variety of food
matrices, including both raw and cooked or baked products.'' In the
2011 notice, we stated our tentative conclusion that the analytical
methods we would use to assess compliance with the < 20 ppm gluten
content ``should be specified in codified language'' (76 FR 46671 at
46673). However, the 2011 notice also stated that we recognized that
some food matrices, such as fermented or hydrolyzed foods, may lack
currently available scientifically valid methods that can be used to
accurately determine if these foods contain < 20 ppm gluten (id.). In
such cases, we indicated that we were considering whether to require
manufacturers of such foods to have a scientifically valid method that
will reliably detect gluten at 20 ppm or less before including a
``gluten-free'' claim in the labeling of their foods.
    (Comment 21) Several comments addressed whether the final rule
should specify the analytical methods we would use to assess
compliance. In general, the comments advised against specifying
analytical methods in the rule. One comment, for example, said that a
number of adverse effects could result, including:
     The possibility that the analytical methods we chose would
become outdated quickly. The comment indicated that there are two or
more additional commercially available test kits that offer peer
reviewed performance that is at least equivalent to the analytical
methods (the ELISA R5- Mendez Method and the Morinaga method) we had
identified in the 2011 notice (76 FR 46671 at 46672).
     Limiting the testing options for food manufacturers and
regulatory and commercial laboratories. The comment expressed concern
that identifying specific analytical methods in the final rule could
result in problems when a specific kit becomes unavailable on a
temporary basis or if the kit was changed or removed from market for
any reason.
     Limiting our flexibility to use improved technology as it
becomes available and dissuading test kit manufacturers from developing
improved methods.

Another comment supported our selection of the ELISA R5-Mendez Method,
but stated that ``analysts should be free to use any method that
provides comparable results'' and that ``other methods may be
equivalent.'' Another comment urged us to ``remain flexible as to the
method of test validation'' and added that not specifying analytical
methods would ``permit a more rapid development of dependable and
affordable technologies for testing gluten.'' Additional comments
recommended that FDA develop performance criteria rather than identify
particular analytical methods to enable the widest choice among gluten-
detection methods that the Agency and other entities could consider
using to determine compliance with a ``gluten-free'' claim. However,
the comments did not provide any data or information on performance
criteria that FDA should consider.
    (Response 21) Upon further consideration, we agree that specifying
the analytical methods in the final rule could limit our flexibility
and possibly deter the development of new and better analytical
methods. We also note that specifying the analytical methods we would
use for compliance purposes, as part of the final rule, would not be
binding on food manufacturers because neither the proposed rule nor
this final rule requires them to use the same analytical methods to
determine the gluten content. To the extent that food manufacturers or
other interested parties want to know the specific scientifically valid
method we intend to consider using when determining compliance, we can
identify this method through other means (such as through a guidance
document).
    If we were to specify analytical methods in the final rule that FDA
is to use to determine compliance with the final rule, and the methods
are revised, we would have to, by regulation, change the methods
specified in the rule. The revisions to the methods may be more than a
technical change and require notice and comment rulemaking. As one
comment recognized, if we had to engage in rulemaking to revise or
update analytical methods, we would run the risk that the analytical
methods specified by regulation would become outdated or obsolete
quickly (especially if the methods were revised or updated frequently)
and that we would deter the development of better test methods. We
have, however, revised Sec.  101.91(c) by inserting ``scientifically
valid'' before ``method'' to make clear that we will use a
scientifically valid method for purposes of compliance testing.
    As for the comments regarding the use of performance criteria, the
comments did not provide any data and information on which the Agency
could rely to support such an approach. Therefore, we are not making
changes in response to this comment.
    (Comment 22) Many comments discussed how manufacturers might comply
with the rule. The comments asked that we require foods (including
oats) to be ``certified'' or verified that they do not contain 20 ppm
or more gluten and to meet all other FDA requirements for a gluten-free
food before being labeled ``gluten-free.'' The comments argued that
certification would provide assurance that foods bearing this claim do
not contain levels of gluten at or above 20 ppm. Many comments
expressed the concern that cross-contact with gluten-containing
ingredients could result in the inadvertent presence of gluten in a
food labeled ``gluten-free.''
    (Response 22) We decline to revise the rule to require
certification that foods comply with the definition and requirements
regarding a ``gluten-free'' claim. Under sections 403(a)(1) and 201(n)
of the FD&C Act, manufacturers must ensure that all statements they
include on their food labels are truthful and not misleading. The final
rule defines the term ``gluten-free,'' but does not require
manufacturers to use a

particular test methodology or to certify their products.
    Additionally, given the range of food products and methods of
manufacturing, it would be impractical and an inefficient use of our
resources for us to require, through regulation, a precise manner in
which manufacturers must or should certify or verify the gluten content
of their products. Manufacturers are free to develop their own methods
that best suits their particular needs to determine the gluten content
of their products. In addition, other methods may be used for quality
control, specifications, contracts, surveys, and similar non-regulatory
functions. Some companies may choose, but are not required, to have
third parties certify or verify the gluten content of their product to
ensure their products labeled as ``gluten-free'' are within the
definition of ``gluten-free.''
4. Miscellaneous Comments
    Several comments addressed matters that were not specific to a
particular provision in the proposed rule or issues not covered by the
rule. We address those comments here.
    (Comment 23) In the preamble to the proposed rule, we recognized
that even those foods that comply with the proposed definition of
``gluten-free'' nonetheless could contain some amount of gluten up to
20 ppm (72 FR 2795 at 2803). We questioned whether the potential
presence of some gluten below 20 ppm would be a material fact that
would make a ``gluten-free'' claim potentially misleading. We invited
comments on whether the use of additional qualifying language (e.g.,
``does not contain 20 ppm or more gluten per gram of food'') would be
necessary to inform individuals with celiac disease that a food labeled
as ``gluten-free'' nonetheless may contain the amount of gluten
permitted under whatever threshold level is established in the final
rule. The 2011 notice repeated the invitation for comments and provided
an example of such qualifying language in the form of ``a possible
asterisk after the term `gluten-free' and an associated statement that
says, e.g., `does not contain 20 ppm or more gluten' '' (76 FR 46671 at
46675).
    We received comments both supporting and opposing the addition of
language to indicate that foods labeled ``gluten-free'' could have the
potential presence of less than 20 ppm gluten in the product. Comments
supporting the inclusion of this language on the label explained that
this would inform consumers about the meaning of the ``gluten-free''
claim. Many comments indicated that the public should receive truth in
labeling and therefore the label should indicate the presence of even
trace amounts of gluten.
    In contrast, comments opposing the additional qualifying language
stated that it would likely confuse consumers without providing any
additional benefits. One comment noted that there appears to be no
other health-related claims (e.g., fat-free, sugar-free, low-sodium)
that define or further qualify the regulatory definition via additional
labeling statements and that ``a good labeling regulation does not
distort a valid, established public health standard.'' In addition,
some comments suggested the additional language could discourage
manufacturers from making a ``gluten-free'' claim on products that are
inherently gluten-free and produced under cGMPs. The comments said that
manufacturers whose foods had gluten content well below 20 ppm could
refrain from labeling their food as ``gluten-free'' because the
qualifying language could mislead consumers into assuming most products
contain the maximum levels of gluten.
    (Response 23) We agree with the comments opposing the use of
qualifying language to inform individuals with celiac disease that a
food labeled as ``gluten-free'' nonetheless may contain less than 20
ppm of gluten because the final rule defines the criteria and
requirements for the ``gluten-free'' labeling claim. The lawful use of
the federally defined term ``gluten-free'' on a food label will inform
both consumers and industry of the fact that the food bearing the
``gluten-free'' claim may not contain 20 ppm or more gluten. Education
and outreach programs will be important to ensure that individuals with
celiac disease and other consumers understand the definition and the
changes set forth by these regulations.
    We also agree with the comment that additional qualifying language
that would, in effect, restate Sec.  101.91(a)(3) would be inconsistent
with other FDA regulated labeling claims (e.g., fat-free, sugar-free)
that define the term without the need to further qualify that
regulatory definition elsewhere on the label.
    We also agree with the comments suggesting that additional
qualifying language could create a disincentive for manufacturers to
make a ``gluten-free'' claim. For example, if a manufacturer's food had
less than 5 ppm gluten, but the final rule would require the
manufacturer to state ``does not contain 20 ppm or more gluten'' in
addition to the ``gluten-free'' claim, the manufacturer might decide to
remove the ``gluten-free'' claim rather than risk creating the
misimpression that its food contained up to 20 ppm gluten.
Additionally, if a manufacturer could improve its manufacturing or
processing operations to create a food with less than 5 ppm gluten, but
the final rule would require the statement of ``does not contain 20 ppm
or more gluten,'' the manufacturer might decide to forego those
improvements because the statement would only refer to ``20 ppm or more
gluten.'' Requiring the additional qualifying language, therefore,
could result in fewer ``gluten-free''-labeled foods being available and
limit the ability of individuals with celiac disease to follow a
gluten-free diet.
    We do not agree with the comments supporting the additional
qualifying language. While we acknowledge the desire of some consumers
to know the exact gluten content of foods, we adopted an analytical
methods-based approach, with a threshold level of 20 ppm gluten,
because we determined that this level is appropriate, enforceable, and
practical after considering multiple types of information, including
the scientific literature on the sensitivity of consumers with celiac
disease and information on the methods available to reliably detect and
quantify gluten in a wide variety of foods.
    Therefore, the final rule does not require the use of additional
qualifying language (e.g., ``does not contain 20 ppm or more gluten'')
to inform individuals with celiac disease that a food labeled as
``gluten-free'' nonetheless may contain less than 20 ppm gluten.
    (Comment 24) A few comments asked about the inclusion of wheat
starch in foods labeled ``gluten-free.'' Proposed Sec.
101.91(a)(3)(iii) would allow a food to bear a ``gluten-free'' claim
provided that any ingredient that is derived from a prohibited grain
has been processed to remove gluten (e.g., wheat starch), if the use of
the ingredient does not result in the presence of 20 ppm or more gluten
in the finished food. Wheat starch is an ingredient derived from wheat
(a gluten containing grain) that has been processed to remove gluten.
As discussed in our response to comment 17 (regarding a < 20 ppm gluten
content level applied to individual ingredients), a comment suggested
that if ingredients derived from gluten-containing grains must be used,
and if the food complies with the maximum gluten content of < 20 ppm,
market practice will impose the same requirement at the ingredient
level (in other words, ingredient purchasers will require that the
ingredients contain less than 20 ppm gluten). Several comments
submitted by

individuals with celiac disease indicated that they would not purchase
a product that included the term ``wheat'' within the ingredient list.
The comments noted that because wheat is considered a ``major food
allergen'' under FALCPA the term wheat could appear either in the list
of ingredients or in a separate ``Contains wheat'' statement near the
list of ingredients. One comment said that if wheat must be identified
on the label of a food that also bears a ``gluten-free'' claim,
consumers will not be able to determine whether the food is appropriate
for them to consume and will have to avoid the food. The comment
suggested that the result would be an unnecessary restriction in an
already restrictive diet and also suggested that individuals with
celiac disease will receive a confusing message that wheat starch in
food labeled ``gluten-free'' is acceptable, but wheat starch in other
foods must be avoided.
    (Response 24) We agree that individuals with celiac disease would
receive a confusing message if foods bearing a ``gluten-free'' claim
also include the term ``wheat'' in the ingredient list or in a
``Contains'' statement, as required by FALCPA (Ref. 34). Although we
were unable to identify many products bearing a ``gluten-free'' claim
that also have the term ``wheat'' appearing in the ingredient list, a
food may bear both a ``Contains wheat'' statement under Sec.
101.91(b)(3) of the final rule and a ``gluten-free'' claim or a claim
identified in Sec.  101.91(b)(2) of the final rule and be in compliance
with both section 203 of FALCPA (regarding food labeling for allergenic
substances) and the ``gluten-free'' label regulation arising from
section 206 of FALCPA. In such situations, Sec.  101.91(b)(3) requires
that the labeling also bear the statement that ``The wheat has been
processed to allow this food to meet FDA requirements for gluten-free
foods,'' preceded by an asterisk (*) or other symbol that links this
statement to the word ``wheat,'' either in the ingredient list or the
``Contains wheat'' statement, depending on how the allergen declaration
is made. Without this statement, a food that identifies the presence of
wheat either in the ingredient statement or in a ``Contains wheat''