[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Rules and Regulations]
[Pages 47154-47179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 301-436-2636, email: 
[email protected].

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

[[Page 47155]]

``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
------------------------------------------------------------------------
 
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

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

[[Page 47156]]

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.

[[Page 47157]]

    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'').

[[Page 47158]]

     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

[[Page 47159]]

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

[[Page 47160]]

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

[[Page 47161]]

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

[[Page 47162]]

(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

[[Page 47163]]

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

[[Page 47164]]

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

[[Page 47165]]

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

[[Page 47166]]

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

[[Page 47167]]

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-

[[Page 47168]]

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

[[Page 47169]]

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

[[Page 47170]]

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

[[Page 47171]]

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'' 
statement under Sec.  101.91(b)(3) and bears a ``gluten-free'' claim 
under Sec.  101.91(a)(3)(i)(A)(3) will be deemed misbranded.
    We also included ``or a claim identified in paragraph (b)(2) of 
this section'' in Sec.  101.91(b)(3) to clarify that this disclaimer is 
also needed when a food bears the term ``wheat'' in the ingredient list 
or a separate ``Contains wheat'' statement and also contains a ``no 
gluten,'' ``free of gluten,'' or ``without gluten'' claim.
    (Comment 25) The preamble to the proposed rule acknowledged that at 
least one other regulatory body outside the United States has developed 
a two-tiered approach to gluten-related food labeling (72 FR 2795 at 
2804). Australia and New Zealand have established standards for 
``gluten-free'' (meaning no detectable gluten) and a less restrictive 
standard for ``low-gluten'' (meaning no more than 20 mg gluten per 100 
g of the food, which is equivalent to no more than 200 ppm gluten in 
the food) (Ref. 28). The preamble to the proposed rule also discussed 
the possible development of a similar 2-tiered approach to gluten-
related food labeling in the United States (72 FR 2795 at 2811 through 
2812). At the time we issued the proposed rule, we tentatively had 
concluded that a two-tiered approach was not feasible because we do not 
have sufficient scientific data to recommend a specified level of 
gluten to define the term ``low gluten.'' We invited comments on this 
tentative conclusion, including comments on a possible scientific basis 
for setting a level of gluten to be defined as ``low gluten.''
    Several comments addressed the issue of ``low-gluten,'' ``very low-
gluten'' or other tiered gluten labeling claims. Most comments opposed 
tiered gluten labeling claims. The comments agreed with us that there 
is no scientific basis for these claims and such claims would not 
benefit individuals with celiac disease. For example, many comments 
noted a preference for a single definition of ``gluten-free,'' stating 
that a dual definition of ``gluten-free'' and ``low-gluten'' would be 
confusing. The comments suggested that terms implying various gluten 
content levels may confuse individuals with celiac disease who are 
advised to follow a gluten-free diet rather than one that is low in 
gluten or gluten-reduced. Comments opposed to the use of ``low-gluten'' 
claims or tiered gluten labeling also expressed concerns that these 
other claims may influence individuals with celiac disease to 
substitute such foods for foods labeled ``gluten-free'' and thereby 
jeopardize their health.
    Other comments said we should establish a tiered gluten labeling 
system allowing individuals with celiac disease, especially those very 
sensitive to gluten, to distinguish between foods that do not have any 
gluten and those that contain a trace amount of gluten. Most comments 
expressing this opinion favored defining ``gluten-free'' to mean either 
zero, no detectible, or < 5 ppm gluten and defining the term ``low-
gluten'' to mean a greater amount of gluten than allowed for a 
``gluten-free'' food, but no more than 20 ppm (e.g., < 5 ppm or < 10 
ppm for a ``low-gluten'' claim). Some comments said we should consider 
allowing ``low-gluten'' claims consistent with those used in other 
countries. Several comments expressed support for the two-tiered gluten 
labeling system in effect in Australia and New Zealand. One comment 
suggested the term ``celiac safe'' to mean < 20 ppm and another comment 
suggested the terms ``Gluten-0'' for no gluten, ``Gluten-5'' or ``Lo 
Gluten 5'' for no more than 5 ppm gluten, and ``Gluten-20'' or ``Lo 
Gluten 20'' for no more than 20 ppm gluten).
    (Response 25) We decline to define the terms ``low-gluten,'' 
``very-low gluten,'' or other terms mentioned by the comments or to 
adopt a tiered gluten labeling system. We agree with comments that 
stated that tiered labeling claims would likely be confusing to those 
with celiac disease if there was a proliferation of ``low-gluten'' or 
``very-low-gluten'' claims on food labels. With respect to the other 
terms suggested by the comments, we continue to lack a scientific 
foundation for developing definitions for these terms. We also decline 
to define terms for gluten content below 20 ppm because, as of the date 
of this final rule, given the current unavailability of appropriate 
test methods that can reliably and consistently detect gluten at levels 
below 20 ppm.
    Because it is currently not known what amount of gluten would be 
appropriate for foods bearing a ``low-gluten'' or a ``very-low-gluten'' 
claim, we have decided only to define ``gluten-free'' as described in 
Sec.  101.91(a)(3).
    (Comment 26) Many comments asked that we require the labels of food 
bearing a ``gluten-free'' claim to state on the label the total amount 
of gluten contained in the food (e.g., based upon a gluten analysis of 
the food). Some comments suggested that we require food labels to 
declare the amount of gluten present per serving of food in the 
Nutrition Facts label. Some comments asserted that consumers want to be 
able to compare ``gluten-free''-labeled foods and choose those with the 
lowest gluten content to reduce their potential health risks or to 
estimate their total daily cumulative gluten intake as a way to manage 
their gluten-free diet. Some comments stated that many consumers do not 
understand the meaning of a < 20 ppm gluten criterion for a ``gluten-
free'' food. Other comments argued that this information is necessary 
for the label to be truthful and not misleading, or that consumers view 
the declaration

[[Page 47172]]

of gluten within the Nutrition Facts label to be consistent with the 
manner in which we require nutrients to be declared on food labels.
    (Response 26) We decline to require an analysis of the food and 
resulting declaration on the label of the total amount of gluten 
contained in a food bearing a ``gluten-free'' claim as discussed in our 
response to comment 4. Declaring the results of such testing would not 
be consistent with the purpose of developing a consistent definition of 
the term ``gluten-free'' to mean that the food contains < 20 ppm gluten 
and conforms to the final rule's other elements.
    To the extent comments seek to add a gluten declaration as part of 
the Nutrition Facts label, such a request is outside the scope of this 
rule. However, whether or not a ``gluten-free'' labeling claim is made, 
we will not object if manufacturers voluntarily provide the amount of 
gluten present in their food elsewhere on the food label, as long as 
such a statement is truthful and not misleading. Such voluntary 
information must comply with all other rules regarding labeling.
    (Comment 27) Several comments requested that we permit ``gluten-
free'' claims on foods in the form in which they are consumed rather 
than foods as packaged. The comments noted that certain foods (e.g., 
dried soup mixes), when prepared according to package directions (e.g., 
prepared with water), would meet the definition of a ``gluten-free'' 
food.
    In contrast, other comments stated that a ``gluten-free'' claim 
should apply to the food ``as packaged'' instead of the food ``as 
prepared.'' The comments said that individuals with celiac disease 
might consume a food bearing a ``gluten-free'' claim in ways other than 
those specified in the preparation directions. The comments wanted the 
assurance that foods, ``as packaged'' and bearing a ``gluten-free'' 
claim, meet all FDA requirements for a ``gluten-free'' food.
    (Response 27) The ``gluten-free'' claim applies to foods ``as 
packaged'' and not ``as prepared'' according to package directions. 
This requirement is consistent with our other statutory labeling 
requirements and implementing regulations. While we understand that 
setting the criteria for ``gluten free'' claims based on a food ``as 
packaged'' may not allow certain foods to bear a ``gluten-free'' claim, 
we agree that some individuals with celiac disease who purchase 
``gluten-free'' labeled foods may wish to consume those foods in ways 
other than those stated in the package directions. For example, instead 
of reconstituting a dried soup mix according to instructions, a 
consumer may wish to use that mix in a concentrated form to flavor 
other foods or to prepare a vegetable dip. If a food sold in a 
concentrated form were dependent upon food preparation using package 
directions to ensure the prepared food conforms to this final rule and 
contains less than 20 ppm gluten, errors in preparation or alternative 
use of the packaged food product could result in persons with celiac 
disease consuming foods with gluten content higher than that permitted 
by our definition of ``gluten-free.''
    (Comment 28) Some comments expressed concern that individuals with 
celiac disease also are exposed to gluten in drugs, dietary 
supplements, or cosmetics. A few comments wanted us to develop a rule 
that would be applicable to the labeling of drugs, dietary supplements, 
and cosmetics in addition to foods.
    (Response 28) The final rule does apply to dietary supplements. We 
are issuing the final rule under FALCPA. FALCPA's requirements apply to 
all packaged foods sold in the United States that are regulated under 
the FD&C Act, including both domestically manufactured and imported 
foods. Section 201(ff) of the FD&C Act states that ``Except for 
purposes of section 201(g) [definition of drug], a dietary supplement 
shall be deemed to be a food within the meaning of this Act.'' 
Accordingly, the final rule applies to dietary supplements. The use of 
a ``gluten-free'' claim in food labeling including the labeling of 
dietary supplements is voluntary and does not replace or eliminate any 
other labeling requirements.
    Requirements related to ``gluten-free'' labeling on drugs and 
cosmetics are outside the scope of this rule. We note that, in the 
Federal Register of December 21, 2011, we published a notice inviting 
information and comments about ways to help individuals with celiac 
disease avoid the presence of gluten in drug products (76 FR 79196). 
The notice also invited information on ingredients in human drug 
products that are currently derived from wheat, barley, or rye. The 
comment period closed on March 20, 2012, and FDA's Center for Drug 
Evaluation and Research is reviewing those comments. As for cosmetics, 
should we receive data or information indicating that cosmetics present 
a concern for individuals with celiac disease, we may consider whether 
further action is warranted.
    Additionally, we wish to clarify that this rule pertains to food 
intended for human use. Although we are aware of gluten claims with 
respect to food intended for animals, our rulemaking activities have 
focused on defining the term ``gluten-free'' in a manner that would 
help humans concerned about managing the gluten in their diet.
    (Comment 29) A few comments asked how our definition of ``gluten-
free'' would apply to individuals who have an immunoglobulin E-mediated 
(IgE-mediated) food allergy to wheat, or other non-celiac disease 
conditions related to consumption of gluten. The comments asked us to 
consider their needs in defining ``gluten-free.''
    (Response 29) We considered a number of factors, including the 
needs of individuals who have a food allergy to wheat or are sensitive 
to gluten, in developing this final rule. We are issuing the final rule 
under, in part, section 206 of FALCPA. In general, FALCPA's 
requirements apply to all packaged foods sold in the United States that 
are regulated under the FD&C Act, including both domestically 
manufactured and imported foods. Additionally, section 203 of FALCPA 
requires food manufacturers to declare, on the label, if a product 
contains an ingredient that is one of the eight major food allergens or 
that contains protein from a major food allergen.
    The use of ``gluten-free'' on a food label is voluntary and does 
not replace or eliminate any other labeling requirements. Therefore, 
any food containing an ingredient that is a major food allergen under 
section 201(qq) of the FD&C Act must declare the presence of that 
ingredient as described in section 403(w)(1) of the FD&C Act.
    As we discussed in our response to comment 24, the labeling of 
wheat as a major food allergen would present the potential for 
confusion with the ``gluten-free'' claim. Rather than prohibit the use 
of the ``gluten-free'' claim on products that have used ingredients 
derived from wheat that have been processed to remove gluten and comply 
with the definition of ``gluten-free,'' and considering the potential 
for individuals with an IgE-mediated wheat food allergy to experience 
adverse health effects in response to servings of food containing 
residual wheat protein levels below 20 ppm, we have added another 
requirement for additional qualifying language in Sec.  101.91(b)(3) of 
the final rule. Section 101.91(b)(3) provides that a food that bears 
the term ``wheat'' in the ingredient list or in a separate ``Contains 
wheat'' statement in its labeling as required by section 403(w)(1)(A) 
of the FD&C Act and also bears the claim ``gluten-free'' will be deemed 
misbranded unless its labeling

[[Page 47173]]

also bears additional language (set forth in the rule) clarifying that 
the food complies with FDA requirements for a ``gluten-free'' claim.
    (Comment 30) A few comments addressed farmers, food companies, and 
restaurants making ``gluten-free'' claims about their grains/crops, 
food products, or menu items, respectively. The comments were concerned 
that these foods could contain gluten due to common cross-contact 
situations. Other comments expressed the concern that food service 
personnel may not be thoroughly trained and knowledgeable about the 
need to segregate gluten-free and non- gluten-free products, and the 
dietary needs of the celiac population.
    (Response 30) Under the final rule, manufacturers making a 
``gluten-free'' claim on their labeling must ensure that such foods, in 
addition to meeting the other criteria, do not contain 20 ppm or more 
gluten, including the unavoidable presence of gluten due to gluten 
cross-contact situations or migration from packaging materials.
    With respect to restaurants, FDA guidance suggests that any use of 
an FDA-defined food labeling claim (e.g., ``fat free'' or ``low 
cholesterol'') on restaurant menus should be consistent with the 
respective regulatory definitions (Ref. 35).
    As for food service personnel, issues regarding the training of 
food service personnel are beyond the scope of this rulemaking.
    (Comment 31) A few comments asked if we intend to issue guidance to 
industry regarding ``gluten-free'' labeling.
    (Response 31) Section 206 of FALCPA directs us to engage in 
rulemaking to define and permit the use of the term ``gluten-free'' on 
the labeling of foods. We anticipate that manufacturers wishing to 
label their products as ``gluten-free'' will be able to understand and 
comply with the final rule without difficulty. We intend to issue 
guidance about the ELISA-based methods (Refs. 36 and 37) FDA will use 
when analysis of a food would be necessary in order to determine 
regulatory compliance with FDA's definition of ``gluten-free'' for a 
food bearing such a labeling claim. If, upon further experience with 
the rule, we find that it would be helpful to issue additional 
guidance, whether such guidance would be directed at industry or at FDA 
itself (such as discussion of a new test method), we will consider 
developing such guidance.
    (Comment 32) Some comments urged that we fund research to learn 
more about potential treatment for celiac disease beyond the avoidance 
of gluten or about oat sensitivity in some people with celiac disease. 
Other comments suggested we also support research to determine the 
impact of low levels of gluten in gluten-sensitive individuals.
    (Response 32) Although we agree that these issues are of interest 
to FDA, the funding of any research activities is beyond the scope of 
this rulemaking. The final rule is limited to defining the term 
``gluten-free'' and to describing how such a claim is permitted in the 
labeling of foods.
    (Comment 33) Several comments expressed concerns about foods 
containing some level of gluten due to contact with gluten sources 
(i.e., through cross-contact), and suggested that we require specific 
manufacturing conditions for foods bearing a ``gluten-free'' claim. In 
the context of this rule, cross-contact occurs when a food without 
gluten comes in contact with a gluten-containing food or ingredient, 
resulting in the presence of gluten in the food not intended to contain 
gluten. The comments suggested that multi-product facilities do not 
have sufficient means to minimize the introduction of gluten in 
products and therefore believed that these foods could not be without 
gluten. The comments suggested the use of dedicated facilities or 
dedicated production lines to exclude the unavoidable contact with 
gluten with foods bearing a ``gluten-free'' claim.
    Some comments were particularly concerned that foods inherently 
free of gluten (e.g., rice or dried fruits) could be processed in 
facilities or on equipment that also manufacture gluten-containing 
foods. Because of cross-contact concerns, these comments requested that 
we require foods bearing a ``gluten-free'' claim to be manufactured on 
equipment or in facilities that only produce foods that are inherently 
free of gluten. Some comments asked that we require, when appropriate, 
that foods labeled ``gluten-free'' also disclose on the label that they 
were not produced in dedicated facilities (i.e. ``this food 
manufactured in a facility that also processes foods containing 
gluten''). However, many other comments said these additional label 
declarations would be useless and frustrating to individuals with 
celiac disease who are seeking foods for their gluten-free diets. Still 
other comments noted that products can be produced in mixed product 
facilities and still comply with the final rule's definitions and 
requirements through the use of controls designed to avoid cross-
contact of foods with gluten sources during food manufacturing.
    (Response 33) We agree with the comments stating that manufacturers 
that adhere to specific manufacturing practices that can prevent gluten 
cross-contact situations can produce foods that meet the final rule's 
definition of ``gluten-free.'' The < 20 ppm level is only one of the 
criteria used to define ``gluten free.'' We determined that this level 
is appropriate, enforceable, practical, and protective of the public 
health. We expect foods bearing the ``gluten-free'' claim to be 
manufactured using whatever controls are necessary to prevent cross-
contact with all gluten sources and to ensure that any amount of gluten 
that may be present in the food from cross-contact is as low as 
possible and that the food has less than 20 ppm gluten.
    We disagree with comments asking us to require labels to disclose 
whether foods are not produced in dedicated facilities or on dedicated 
equipment because such a disclosure would suggest that those foods have 
necessarily come in contact with gluten and do not comply with the 
definition of ``gluten-free.'' Nevertheless, manufacturers may disclose 
voluntarily whether their foods are produced in dedicated facilities or 
on dedicated equipment, provided that such statements are truthful and 
non-misleading.
    We also disagree with comments requesting that we require foods 
bearing a ``gluten-free'' claim be manufactured on dedicated equipment 
or in dedicated facilities because limitations due to cost, equipment 
utilization needs, and space would make it impractical for many 
manufacturers to produce gluten-free foods. Some data show that large 
companies are more likely than their medium-size or small-size 
counterparts to dedicate facilities to avoid cross-contact (Ref. 38). 
Facilities should be able to avoid cross-contact during production by 
using, for example, physical barriers (such as walls, curtains, or 
distance) or air handling as a means of isolating the production line 
and by cleaning and sanitation of equipment between production runs. 
Also, the requirement sought by the comments likely would discourage 
manufacturers from labeling their products as ``gluten-free'' and 
result in fewer foods labeled ``gluten-free'' available for persons 
with celiac disease.
    Accordingly, the final rule does not require foods bearing a 
``gluten-free'' claim to be manufactured in dedicated facilities or on 
dedicated equipment, or require any form of disclosure on the label 
that the foods were not produced in dedicated facilities or on 
dedicated equipment. We expect these facilities to take proper 
precautions to reduce the potential for cross-contact of food, food 
ingredients, food-contact surfaces,

[[Page 47174]]

finished foods, or food-packaging materials from gluten sources. The 
potential for this cross-contact may be reduced by adequate controls 
and operating practices, effective design, and the separation of 
operations in which such contact is likely to occur, by one or more of 
the following means: Location, time, partition, air flow, enclosed 
systems, cleaning and sanitation, or other effective means.
    (Comment 34) Several comments urged us to strictly enforce our rule 
to ensure that foods bearing a ``gluten-free'' claim comply with the 
final rule.
    (Response 34) We enforce our regulations primarily through 
inspections of food processing facilities, examination of imports, 
collection and testing of food products on the market, and imposition 
of enforcement measures as required to protect consumers. Manufacturers 
are responsible for ensuring that food bearing a ``gluten-free'' claim 
is not misbranded for failure to meet the final rule.
    (Comment 35) One comment asked how we will enforce the rule against 
foods already in the marketplace. The comment explained the concern 
that the consumer will not be able to trust the labeling initially and 
the rule will be less effective than anticipated.
    (Response 35) The final rule becomes effective on September 4, 
2013. We recognize that manufacturers of foods currently bearing a 
``gluten-free'' claim may need time to review their products to ensure 
that these foods comply with this final rule, or to remove ``gluten-
free'' or similar claims from the label if their foods do not comply. 
Consequently, we are establishing a compliance date of August 5, 2014.
    Although we are issuing the final rule after January 1, 2013, there 
is sufficient justification for establishing the compliance date of 
August 5, 2014, to enforce the provisions of this final rule, rather 
than January 1, 2016, which FDA established as the next uniform 
compliance date for other food labeling changes for food labeling 
regulations issued between January 1, 2013, and December 31, 2014 (77 
FR 70885; November 28, 2012).
    We believe that 12 months from the date of publication is 
sufficient time for manufacturers to review their products to ensure 
that these foods comply with this final rule, or to remove ``gluten-
free'' or similar claims from the label if their foods do not comply. 
This period of 12 months is consistent with what FDA has used in the 
past for compliance with the requirements of voluntary food labeling 
claims. We believe that waiting until FDA's next uniform compliance 
date of January 1, 2016, would create an unnecessary delay in the 
enforcement of this final rule, as foods bearing the voluntary label 
claim ``gluten-free'' that do not comply with FDA's regulatory 
definition of ``gluten-free'' could have an adverse public health 
impact on persons with celiac disease who may be consuming those foods.
    Therefore, we are establishing the compliance date to enforce the 
provisions of this final rule at August 5, 2014. By that time, 
manufacturers of foods labeled with the ``gluten-free'' claim must 
comply with the requirements of the final rule.
    In the interim, if manufacturers want to use stickers as a short-
term measure to amend their labels, we would not object provided that 
the stickered products are in compliance with all of FDA's labeling 
requirements. If a manufacturer chooses this option, the sticker should 
adhere to the package under customary storage conditions throughout the 
shelf life of the product, and the corrected label must comply with all 
applicable laws and regulations.
    (Comment 36) Some comments expressed concern that distilled 
vinegar, as a food product or ingredient, could contain gluten. The 
comments said we should not allow distilled vinegar to be labeled as 
``gluten-free.'' Other comments expressed concern about gluten in malt 
vinegar and malt extract. One comment stated that information contained 
in the preamble to the proposed rule is contradictory regarding malt 
vinegar and malt extract. The comment noted that, in some places, the 
preamble to the proposed rule listed these foods together with wheat 
starch. The comment said that listing malt vinegar and malt extract 
with wheat starch could create the misimpression that malt vinegar and 
malt extract have been processed to remove gluten.
    (Response 36) As the comments suggest, there are different types of 
vinegars. For example, there is distilled vinegar (also known as spirit 
vinegar or grain vinegar) and other vinegars that are not distilled 
like cider vinegar (also known as apple vinegar or simply ``vinegar''), 
wine vinegar (also known as grape vinegar), malt vinegar, sugar 
vinegar, and glucose vinegar to mention a few. All vinegars undergo a 
fermentation process during their production, but can be derived from 
different substances. For example, cider vinegar is made by the 
alcoholic and subsequent acetous fermentations of the juice of apples; 
whereas, wine vinegar is made by the alcoholic and subsequent acetous 
fermentations of the juice of grapes. In addition, as the comments 
noted, some vinegars may be made from gluten-containing grains, such as 
malt vinegar, which is the product made by the alcoholic and subsequent 
acetous fermentations, without distillation, of an infusion of barley 
malt or cereals whose starch has been converted by malt. For a fuller 
discussion see Food and Drug Administration, Compliance Policy Guide 
Sec. 525.825, ``Vinegar, Definitions--Adulteration With Vinegar Eels'' 
(available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074471.htm).
    As we indicated 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 consider the comments received on vinegars, including 
distilled vinegar, in that proposed rule.
    (Comment 37) Many comments urged FDA to coordinate with the U.S. 
Department of Agriculture (USDA) so that FDA and USDA have the same 
standard for foods labeled ``gluten-free.'' Other comments indicated 
that the same definition of ``gluten-free'' should apply to all foods 
and that ``gluten-free'' labeling of foods should be mandatory and not 
voluntary to be protective of individuals with celiac disease.
    (Response 37) We have been in contact with both the Food Safety and 
Inspection Service (FSIS, which is an Agency within USDA) and TTB 
concerning our gluten-free rulemaking and related issues. USDA 
regulates the labeling of all poultry, most meats, and certain egg 
products, and TTB regulates the labeling of most alcoholic beverages. 
We expect to continue working with both FSIS and TTB on matters 
relating to use of the term ``gluten-free.''
    Regarding the comments to make gluten-free labeling ``mandatory,'' 
section 206 of FALCPA directed us to establish a definition for the 
term ``gluten-free'' and ``permit'' use of this term in the labeling of 
food. We consider the use of the word ``permit'' instead of 
``require,'' to mean that manufacturers may, but are not required to, 
label their food products ``gluten-free'' provided that they comply 
with our rule.

III. What is the legal authority for this rule?

    We received no comments on the legal basis, as set forth in the 
proposed

[[Page 47175]]

rule, to define the term ``gluten free'' for voluntary use in the 
labeling of foods.
    Consistent with section 206 of FALCPA and sections 403(a)(1), 
201(n), and 701(a) of the FD&C Act, we are issuing requirements for the 
use of the term ``gluten free'' for voluntary use in the labeling of 
foods. A food bearing the claim ``gluten-free'' that does not conform 
to the requirements in the final rule would result in the food being 
misbranded within the meaning of sections 403(a)(1) and 201(n) of the 
FD&C Act.
    We include requirements in Sec.  101.91(b)(2) of the final rule for 
the use of the terms ``no gluten,'' ``free of gluten,'' and ``without 
gluten'' in the labeling of food in order for such food to not be 
misbranded under sections 403(a)(1) and 201(n) of the FD&C Act. 
Specifically, food that bears such a claim in labeling must meet the 
requirements for the use of the ``gluten-free'' claim because the use 
of ``no,'' ``free of,'' and ``without'' gluten connote the same meaning 
to consumers as ``gluten-free'' (Ref. 32). Thus, it would be misleading 
to consumers to use such terms if the food bearing the claim did not 
meet the same requirements as a food bearing a ``gluten-free'' claim.
    In addition, Sec.  101.91(b)(3) of the final rule requires a food 
that bears a ``gluten-free'' claim (as well as a ``no gluten,'' ``free 
of gluten,'' or ``without gluten'' claim) in addition to a statement 
regarding wheat content on the label required by section 403(w) of the 
FD&C Act, to also bear additional language to clarify that the wheat 
has been processed to allow this food to meet FDA requirements for a 
gluten-free food in order for the food not to be misbranded under 
sections 403(a)(1) and 201(n) of the FD&C Act. Because consumers would 
see two seemingly contradictory terms in the labeling based on separate 
statutory and regulatory requirements for each, this additional 
language is necessary to prevent consumers from being misled (Ref. 32).
    The legal basis for federal preemption is discussed in the 
Federalism section, section VII.

IV. Analysis of Impacts--Final Regulatory Impact Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). We have developed a detailed Regulatory Impact Analysis (RIA) 
that presents the benefits and costs of this final rule (Ref. 39) which 
is available at http://www.regulations.gov (enter Docket No. FDA-2005-
N-0404). The full economic impact analyses of FDA regulations are no 
longer (as of April 2012) published in the Federal Register but are 
submitted to the docket and are available at http://www.regulations.gov. We believe that the final rule is a significant 
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Additional costs per entity of this final rule are 
small, but not negligible, and as a result we conclude that the final 
rule could have a significant economic impact on a substantial number 
of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The analyses that we have performed to examine the impacts of this 
final rule under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 
1995 are included in the RIA (Ref. 39).

V. How does the Paperwork Reduction Act of 1995 apply to this final 
rule?

    We conclude that the labeling provisions of this final rule set 
forth in this document are not subject to review by the Office of 
Management and Budget because they do not constitute a ``collection of 
information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). Rather, the ``gluten-free'' labeling claims are ``public 
disclosure of information originally supplied by the Federal Government 
to the recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

VI. What is the environmental impact of this rule?

    We have determined under 21 CFR 25.30(h) and (k) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VII. What are the federalism impacts of this rule?

    We have analyzed the final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of Executive Order 
13132 requires Agencies to ``construe . . . a Federal statute to 
preempt State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Here, we have determined that certain narrow 
exercises of State authority would conflict with the exercise of 
Federal authority under the FD&C Act.
    In section 206 of FALCPA, Congress directed us to issue a proposed 
rule to define and permit use of the term ``gluten-free'' on the 
labeling of foods, in consultation with appropriate experts and 
stakeholders, to be followed by a final rule for the use of such term 
in labeling. In the preamble to the proposed rule (72 FR 2795 at 2813 
through 2814), we proposed preemption of State requirements and 
indicated that we had consulted with numerous experts and stakeholders 
in the proposed rule's development. Different and inconsistent amounts 
of gluten in foods with ``gluten-free'' labeling result in the 
inability of those individuals with celiac disease who adhere to a 
gluten-free diet to avoid exposure to gluten at levels that may result 
in adverse health effects. There is a need for national uniformity in 
the meaning of the term ``gluten-free'' so that most individuals with 
celiac disease can make informed purchasing decisions that will enable 
them to adhere to a diet they can tolerate without causing adverse 
health effects and can select from a variety of available gluten-free 
foods. If States were able to establish different definitions of the 
term ``gluten-free,'' then individuals with celiac disease would not be 
able to rely on that term to understand the amount of gluten the food 
may contain and thereby use the

[[Page 47176]]

term to identify appropriate dietary selections. As a result, 
individuals with celiac disease may unnecessarily limit their food 
choices, or conversely, select foods with levels of gluten that are not 
tolerated and that may cause adverse health effects. Food 
manufacturers, if confronted by a State or various State requirements 
that adopted a different gluten threshold than what the final rule 
establishes, might decide to remove the ``gluten-free'' label, and such 
a result would make it more difficult for individuals with celiac 
disease to identify foods that they can tolerate and achieve a dietary 
intake from a variety of foods to meet an individual's nutrient needs. 
Moreover, a consistent definition of ``gluten-free'' enables the Agency 
to more efficiently enforce the definition across all foods through the 
use of a reliable scientifically valid method to detect gluten and 
ensure labels bearing a ``gluten-free'' claim are truthful and not 
misleading.
    Therefore, the objective of this rule is standardizing use of the 
term ``gluten-free'' in the labeling of foods so that foods with this 
claim in labeling, and foods with a claim of ``no,'' ``free of,'' and 
``without'' gluten, which connote a similar meaning to that of ``gluten 
free,'' are used in a consistent way and will therefore prevent 
consumer confusion and assist individuals with celiac disease to make 
purchasing decisions.
    Section 4(c) of Executive Order 13132 instructs us to restrict any 
Federal preemption of State law to the ``minimum level necessary to 
achieve the objectives of the statute pursuant to which the regulations 
are promulgated.'' The final rule meets the preceding requirement 
because it preempts State law narrowly, only to the extent required to 
achieve uniform national labeling with respect to the requirements 
related to the use of the term ``gluten-free,'' as well as the terms 
``no gluten,'' ``free of gluten,'' or ``without gluten.'' As we explain 
later in this section, we are preempting State or local requirements 
only to the extent that they are different from the requirements in 
this section related to the use of the terms ``gluten-free,'' ``no 
gluten,'' ``free of gluten,'' or ``without gluten.'' In addition, we 
cannot foresee every potential State requirement and preemption may 
arise if a State requirement is found to obstruct the federal purpose 
articulated in this rule. We do not intend the final rule to preempt 
other State or local labeling requirements with respect to other 
statements or warnings about gluten. For example, a State would not be 
preempted from requiring a statement about the health effects of gluten 
consumption on persons with celiac disease or information about how the 
food was processed.
    Section 4(d) of Executive Order 13132 states that when an Agency 
foresees the possibility of a conflict between State law and federally 
protected interests within the Agency's area of regulatory 
responsibility, the Agency ``shall consult, to the extent practicable, 
with appropriate State and local officials in an effort to avoid such a 
conflict.'' Section 4(e) of Executive Order 13132 provides that ``when 
an agency proposes to act through adjudication or rulemaking to preempt 
State law, the agency shall provide all affected State and local 
officials notice and an opportunity for appropriate participation in 
the proceedings.'' FDA's Division of Federal and State Relations 
invited the States' participation in this rulemaking by providing 
notice via fax and email transmission to State health commissioners, 
State agriculture commissioners, and State food program directors as 
well as FDA field personnel of the publication of the proposed rule. 
The notice gave the States further opportunity for input on the rule, 
advised the States of FDA's possible action, and encouraged State and 
local governments to provide any comments. We did not receive any 
comments from State or local authorities.
    After we had published the proposed rule in the Federal Register, 
the President issued a memorandum entitled ``Preemption'' (74 FR 24693 
(May 22, 2009)). The memorandum, among other things, instructs Agencies 
to ``not include in regulatory preambles statements that the department 
or agency intends to preempt State law through the regulation except 
where preemption provisions are also included in the codified 
regulation'' and ``not include preemption provisions in codified 
regulations except where such provisions would be justified under legal 
principles governing preemption, including the principles outlined in 
Executive Order 13132'' (id.).
    Because of the May 22, 2009, memorandum and because the final rule 
differs from the proposed rule in several respects, we explain in 
detail here the principles underlying our conclusion that the final 
rule may result in preemption of State and local laws under a narrow 
set of circumstances and describe the final rule's codified provision 
regarding preemption.
    Under the Supremacy Clause of the Constitution (U.S. Constitution; 
Art. VI, clause 2), State laws that interfere with or are contrary to 
Federal law are invalid. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 
211 (1824).) Federal preemption can be express (stated by Congress in 
the statute) or implied. Implied preemption can occur in several ways. 
For example, Federal preemption may be found where Federal law 
conflicts with State law. Such conflict may be demonstrated either when 
``compliance with both federal and state [law] is a physical 
impossibility'' (Florida Lime and Avocado Growers, Inc. v. Paul, 373 
U.S. 132, 142-143 (1963)), or when State law ``stands as an obstacle to 
the accomplishment and execution of the full purposes and objectives of 
Congress'' (Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-74 
(2000) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). State law 
is also preempted if it interferes with the methods by which a Federal 
law is designed to reach its goals. (See International Paper Co. v. 
Ouellette, 479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n 
v. Agricultural Marketing & Bargaining Bd., 467 U.S. 461, 477-478 
(1984).)
    Additionally, `` `a federal agency acting within the scope of its 
congressionally delegated authority may preempt state regulation' and 
hence render unenforceable state or local laws that are otherwise not 
inconsistent with federal law'' (City of New York v. FCC, 486 U.S. 57, 
63-64 (1988) (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S. 
355, 369 (1986)). ``Federal regulations have no less preemptive effect 
than federal statutes'' (Fidelity Federal Savings and Loan Ass'n v. de 
la Cuesta, 458 U.S. 141, 153 (1982)).
    When an Agency's intent to preempt is clearly and unambiguously 
stated, a court's inquiry will be whether the preemptive action is 
within the scope of that Agency's delegated authority (Capital Cities 
Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal 
Savings, 458 U.S. at 154). If the Agency's choice to preempt 
``represents a reasonable accommodation of conflicting policies that 
were committed to the agency's care by the statute [the regulation will 
stand] unless it appears from the statute or its legislative history 
that the accommodation is not one that Congress would have sanctioned'' 
(United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough 
County, the Supreme Court stated that FDA possessed the authority to 
promulgate regulations preempting local laws that compromise the supply 
of plasma and could do so (Hillsborough County, Fla. v. Automated 
Medical Laboratories, Inc., 471 U.S. 707, 721 (1985)). We believe we 
have similar authority to preempt State and local laws and regulations 
to the limited extent that they define and permit use of ``gluten-

[[Page 47177]]

free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' 
differently from our final rule because different State or local 
requirements would be contrary to the Congressional directive for us to 
define and permit use of the term ``gluten-free.''
    State or local laws or regulations that define and permit use of 
``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without 
gluten'' differently from our final rule could frustrate the ability of 
most consumers to identify gluten-free foods and avoid adverse health 
effects and deter manufacturers from applying a ``gluten-free'' label 
to their foods. As discussed previously, currently, individuals with 
celiac disease do not know what the term ``gluten-free'' on a product 
means because there is no consistent or established definition of 
``gluten-free'' in the United States. For example, a product currently 
labeled gluten-free could contain 10 ppm gluten or 100 ppm gluten. 
Therefore, consumers with celiac disease cannot have confidence to 
identify and purchase gluten-free products they can tolerate and that 
can provide a variety of foods in their diets. With a uniform federal 
definition, consumers throughout the United States can understand what 
the term ``gluten-free'' means on a packaged food. A uniform definition 
of gluten-free will also allow the Agency to more efficiently enforce 
the definition on product labels and manufacturers will be able to 
comply with a single set of requirements which may lead to greater use 
of this voluntary labeling. Consequently, we have added a new Sec.  
101.91(d) entitled ``Preemption'' to the final rule. Section 101.91(d) 
declares that a State or political subdivision of a State may not 
establish or continue into effect any law, rule, regulation, or other 
requirement that is different from the requirements in Sec.  101.91 for 
the definition and use of the term ``gluten-free,'' as well as the 
terms ``no gluten,'' ``free of gluten,'' or ``without gluten.'' 
Preemption may also arise with regard to other labeling language 
regarding gluten if a state requirement is found to obstruct the 
federal purpose articulated in this rule.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852, and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (We have verified all the Web site addresses in 
the References section, but we are not responsible for any subsequent 
changes to the Web sites after this document publishes in the Federal 
Register.)

1. National Institutes of Health (NIH), NIH Consensus Development 
Conference on Celiac Disease, ``National Institutes of Health 
Consensus Statement on Celiac Disease,'' NIH, Bethesda, MD, pp. 1-
15, June 28-30, 2004, available at http://consensus.nih.gov/2004/2004CeliacDisease118PDF.pdf.
2. Shan, L., O. Molberg, I. Parrot, et al., ``Structural Basis for 
Gluten Intolerance in Celiac Sprue,'' Science, 297:2275-2279, 2002.
3. Jabri, B., D.D. Kasarda, and H.R Green, ``Innate and Adaptive 
Immunity: The Yin and Yang of Celiac Disease,'' Immunological 
Reviews, 206:219-231, 2005.
4. National Digestive Disease Information Clearinghouse, National 
Institute of Diabetes and Digestive and Kidney Diseases, National 
Institutes of Health (NIH), ``Celiac Disease,'' NIH Publication No. 
08-4269, September 2008, available at http://digestive.niddk.nih.gov/ddiseases/pubs/celiac/.
5. Dewar, D., S.P. Pereira, and P.J. Ciclitira, ``The Pathogenesis 
of Coeliac Disease,'' International Journal of Biochemistry and Cell 
Biology, 36:17-24, 2004.
6. Fasano, A. and C. Catassi, ``Current Approaches to Diagnosis and 
Treatment of Celiac Disease: An Evolving Spectrum,'' 
Gastroenterology, 120(3):636-651, 2001.
7. Farrell, R.J. and C.P. Kelly, ``Celiac Sprue,'' New England 
Journal of Medicine, 346(3):180-188, 2002.
8. M[auml]ki, M. and P. Collin, ``Coeliac Disease,'' Lancet, 
349:1755-1759, 1997.
9. Fasano, A., ``Celiac Disease--How to Handle a Clinical 
Chameleon,'' New England Journal of Medicine, 348:2568-2570, 2003.
10. Catassi, C. and A. Fasano, ``Celiac Disease as a Cause of Growth 
Retardation in Childhood,'' Current Opinion in Pediatrics, 16:445-
449, 2004.
11. Catassi, C., E. Fabiani, G. Corrao, et al., ``Risk of Non-
Hodgkin Lymphoma in Celiac Disease,'' Journal of the American 
Medical Association, 287(11):1413-1419, 2002.
12. Peters, U., J. Askling, G. Gridley, et al., ``Causes of Death in 
Patients With Celiac Disease in a Population-Based Swedish Cohort,'' 
Archives of Internal Medicine, 163:1566-1572, 2003.
13. Green, P.H.R. and B. Jabri, ``Coeliac Disease,'' Lancet, 
362:383-391, 2003.
14. Pietrzak, M.M., C. Catassi, S. Drago, et al., ``Celiac Disease: 
Going Against the Grains,'' Nutrition in Clinical Practice, 16:335-
344, December 2001.
15. Corrao, G., G.R. Corazza, V. Bagnardi, et al., ``Mortality in 
Patients with Coeliac Disease and Their Relatives: A Cohort Study,'' 
Lancet, 358:356-361, 2001.
16. Rostom, A., C. Dub[eacute], A. Cranney, et al., ``Celiac 
Disease,'' Evidence Report/Technology Assessment Number 104, 
Prepared by the University of Ottawa Evidence-Based Practice Center 
Under Contract No. 290-02-0021 for the Agency for Healthcare 
Research and Quality (AHRQ), U.S. Department of Health and Human 
Services, Rockville, MD, AHRQ Publication No. 04-E029-2, p. 140, 
September 2004.
17. Centers for Disease Control and Prevention (CDC), National 
Center for Health Statistics (NCHS), ``National Health and Nutrition 
Examination Survey Questionnaire,'' Question MCQ082, Hyattsville, 
MD: U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, 2011, available at http://www.cdc.gov/nchs/nhanes/nhanes2009-2010/MCQ_F.htm#MCQ082.
18. Rubio-Tapia, A., J.F. Ludvigsson, T.L. Brantner, et al., ``The 
Prevalence of Celiac Disease in the United States,'' 
Gastroenterology, 142(5):S181-S182, May 2012.
19. Sanders, D.S., M.J. Carter, D.P. Hurlstone, et al., 
``Association of Adult Coeliac Disease With Irritable Bowel 
Syndrome: A Case-Control Study in Patients Fulfilling ROME II 
Criteria Referred to Secondary Care,'' Lancet, 358:1504-1508, 2001.
20. The Threshold Working Group, ``Approaches to Establish 
Thresholds for Major Food Allergens and for Gluten in Food,'' Draft 
Report, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, College Park, MD, pp. 1-103, June 2005, available at 
http://www.fda.gov/ohrms/dockets/dockets/05n0231/05n-0231-rpt0001.pdf.
21. The Threshold Working Group, ``Approaches to Establish 
Thresholds for Major Food Allergens and for Gluten in Food,'' 
Revised Report, Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, College Park, MD, pp. 1-106, March 2006, 
available at http://www.fda.gov/downloads/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/UCM192048.pdf.
22. FDA, ``FDA's Responses to Public Comments on the Draft Report 
`Approaches to Establish Thresholds for Major Food Allergens and for 
Gluten in Food,' '' March 2006, available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106042.htm.
23. Food Advisory Committee, CFSAN/FDA, ``Summary Minutes for the 
Food Advisory Committee Meeting on `Advice on CFSAN's Draft Report: 
Approaches to Establish Thresholds for Major Food Allergens and for 
Gluten in Food,' '' Greenbelt, MD, pp. 1-11, July 13-15, 2005, 
available at http://www.fda.gov/ohrms/dockets/ac/05/minutes/2005-4160m1_summary%20minutes.pdf.
24. FDA, ``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,' '' December 2012, available at http://
www.fda.gov/downloads/Food/

[[Page 47178]]

FoodScienceResearch/RiskSafetyAssessment/UCM362401.pdf.
25. Codex Alimentarius Commission, ``Codex Standard for Foods for 
Special Dietary Use for Persons Intolerant to Gluten (Codex Standard 
118-1979),'' Rome, Italy, pp. 1-3, 2008; available at http://www.codexalimentarius.net/download/standards/291/cxs_118e.pdf.
26. The Commission of the European Communities, ``Commission 
Regulation (EC) No 41/2009,'' Official Journal of the European 
Union, Brussels, Belgium, pp. L 16/3-L 16/5, January 20, 2009; 
available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:016:0003:0005:EN:PDF.
27. Health Canada, Bureau of Chemical Safety, Food Directorate, 
Health Products and Food Branch ``Health Canada's Position on 
Gluten-Free Claims,'' dated June 2012, available at http://www.hc-sc.gc.ca/fn-an/alt_formats/pdf/securit/allerg/cel-coe/gluten-position-eng.pdf.
28. Government of Australia, ``Australian New Zealand Food Standards 
Code: Chapter 1--General Food Standards, Part 1.2--Labelling and 
Other Information Requirements, Standard 1.2.8--Nutrition 
Information Requirements,'' pp. 2 and 14, 2012, available at http://www.comlaw.gov.au/Details/F2012C00218.
29. Armour, B., and T.B. Perry, Cream Hill Estates Ltd., Public 
comment letter Document ID: FDA-2005-N-0404-0399, submitted on 
November 19, 2005, to Docket No. 2005N-0279 pertaining to the Center 
for Food Safety and Applied Nutrition, Food and Drug Administration 
Public Meeting on Gluten-Free Food Labeling held in College Park, 
MD, pp. 1-3, August 19, 2005, available at http://www.regulations.gov/#!documentDetail;D=FDA-2005-N-0404-0399.
30. Smith, S., Gluten Free Oats LLC, Public comment letter EMC301 
submitted on March 20, 2006, to Docket No. 2005N-0279 pertaining to 
the Center for Food Safety and Applied Nutrition, Food and Drug 
Administration Public Meeting on Gluten-Free Food held in College 
Park, MD, pp. 1-2, August 19, 2005.
31. Daou, C. and H. Zhang, ``Oat Beta-Glucan: Its Role in Health 
Promotion and Prevention of Diseases,'' Comprehensive Reviews in 
Food Science and Food Safety, 11: 355-365, 2012.
32. Verrill, L., Y. Zhang, and C.T.J. Lin, Memorandum, ``Consumer 
Studies' Comments on Alternative Terms for `Gluten-Free' on The Food 
Label,'' Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, College Park, MD, July 8, 2013.
33. FDA, ``Guidance for Industry: Labeling of Certain Beers Subject 
to the Labeling Jurisdiction of the Food and Drug Administration; 
Draft Guidance,'' August 2009, available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm166239.htm.
34. Verrill, L. and C.-T.J. Lin, Memorandum, ``Consumer Studies' 
Comments on a Proposed Codicil in the `Gluten-Free' Labeling Final 
Rule,'' Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, College Park, MD, July 8, 2013.
35. FDA/CFSAN, ``Guidance for Industry: A Labeling Guide for 
Restaurants and Other Retail Establishments Selling Away-From-Home 
Foods,'' April 2008, available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm053455.htm.
36. AOAC Research Institute, ``Certificate of Performance Tested\SM\ 
Status, Certificate No. 120601,'' AOAC International, Gaithersburg, 
MD, 2013; available at http://www.aoac.org/iMIS15_Prod/AOAC_Docs/RI/RI_MethodsCert/2013_120601_certificate.pdf.
37. Morinaga Institute of Biological Science, Inc., ``Product: Food 
Allergen Kits: Food Allergen ELISA Kits,'' available at http://www.miobs.com/english/product/food_allergen_elisa_kits/index.html, and Information Sheet Download ``Wheat Protein ELISA Kit 
(Gliadin),'' available at http://www.miobs.com/english/product/food_allergen_elisa_kits/dl/gdrev1.pdf.
38. FDA/CFSAN, ``Report to The Committee on Health, Education, 
Labor, and Pensions United States Senate and the Committee on Energy 
and Commerce United States House of Representatives, Food Allergen 
Labeling and Consumer Protection Act of 2004 Public Law 108-282,'' 
available at http://www.fda.gov/downloads/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/UCM179390.pdf.
39. FDA/CFSAN, ``Gluten-Free Labeling of Foods, Final Regulatory 
Impact Analysis and Regulatory Flexibility Analysis,'' 2013.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    For the reasons discussed in the preamble, the Food and Drug 
Administration amends 21 CFR part 101 as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Section 101.91 is added to subpart F to read as follows:


Sec.  101.91  Gluten-free labeling of food.

    (a) Definitions. (1) The term ``gluten-containing grain'' means any 
one of the following grains or their crossbred hybrids (e.g., 
triticale, which is a cross between wheat and rye):
    (i) Wheat, including any species belonging to the genus Triticum;
    (ii) Rye, including any species belonging to the genus Secale; or
    (iii) Barley, including any species belonging to the genus Hordeum.
    (2) The term ``gluten'' means the proteins that naturally occur in 
a gluten-containing grain and that may cause adverse health effects in 
persons with celiac disease (e.g., prolamins and glutelins).
    (3) The labeling claim ``gluten-free'' means:
    (i) That the food bearing the claim in its labeling:
    (A) Does not contain any one of the following:
    (1) An ingredient that is a gluten-containing grain (e.g., spelt 
wheat);
    (2) An ingredient that is derived from a gluten-containing grain 
and that has not been processed to remove gluten (e.g., wheat flour); 
or
    (3) 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
    (B) Inherently does not contain gluten; and
    (ii) Any unavoidable presence of gluten in the food bearing the 
claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten 
per kg of food).
    (b) Requirements. (1) A food that bears the claim ``gluten-free'' 
in its labeling and fails to meet the requirements of paragraph (a)(3) 
of this section will be deemed misbranded.
    (2) 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.
    (3) A food that bears the term ``wheat'' in the ingredient list or 
in a separate ``Contains wheat'' statement in its labeling, as required 
by 21 U.S.C. 343(w)(1)(A), and also bears the claim ``gluten-free'' or 
a claim identified in paragraph (b)(2) of this section will be deemed 
misbranded unless the word ``wheat'' in the ingredient list or in the 
``Contains wheat'' statement is followed immediately by an asterisk (or 
other symbol) that refers to another asterisk (or other symbol) in 
close proximity to the ingredient statement that immediately precedes 
the following: ``The wheat has been processed to allow this food to 
meet the Food and Drug Administration (FDA) requirements for gluten-
free foods.''
    (c) Compliance. When compliance with paragraph (b) of this section 
is based on an analysis of the food, FDA will use a scientifically 
valid method that can reliably detect the presence of 20 ppm gluten in 
a variety of food

[[Page 47179]]

matrices, including both raw and cooked or baked products.
    (d) Preemption. A State or political subdivision of a State may not 
establish or continue into effect any law, rule, regulation, or other 
requirement that is different from the requirements in this section for 
the definition and use of the claim ``gluten-free,'' as well as the 
claims ``no gluten,'' ``free of gluten,'' or ``without gluten.''

    Dated: July 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18813 Filed 8-2-13; 8:45 am]
BILLING CODE 4160-01-P