Food Labeling; Gluten-Free Labeling of Foods, 2795-2817 [E7-843]
Download as PDF
2795
Proposed Rules
Federal Register
Vol. 72, No. 14
Tuesday, January 23, 2007
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 101
[Docket No. 2005N–0279]
RIN 0910–ZA26
Food Labeling; Gluten-Free Labeling of
Foods
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with PROPOSAL
ACTION:
Proposed rule.
SUMMARY: The Food and Drug
Administration (FDA) is proposing to
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 (all noted grains are collectively
referred to 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 parts per
million (ppm) or more gluten in the
food; or 20 ppm or more gluten. A food
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’’
would be deemed misbranded. FDA also
is proposing to deem misbranded a food
bearing 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’’). In addition, a food made
from oats that bears a gluten-free claim
in its labeling would be deemed
misbranded if the claim suggests that all
such foods are gluten-free or if 20 ppm
or more gluten is present in the food.
Establishing a definition of the term
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
Submit written or electronic
comments by April 23, 2007.
ADDRESSES: You may submit comments,
identified by Docket No. 2005N–0279,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described in the
Electronic Submissions portion of this
paragraph.
Instructions: All submissions received
must include the agency name and
Docket No(s). and Regulatory
Information Number (RIN) (if a RIN
number has been assigned) for this
rulemaking. All comments received may
be posted without change to https://
www.fda.gov/ohrms/dockets/
default.htm, including any personal
information provided. For detailed
instructions on submitting comments
and additional information on the
rulemaking process, see the
‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
DATES:
Food and Drug Administration
AGENCY:
‘‘gluten-free’’ and uniform conditions
for its use in the labeling of foods is
needed 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 proposed action is in
response to the Food Allergen Labeling
and Consumer Protection Act of 2004
(FALCPA).
PO 00000
Frm 00001
Fmt 4702
Sfmt 4702
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
number(s), found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Rhonda R. Kane, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD, 301–
436–2371, FAX: 301–436–2636, e-mail:
rhonda.kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Celiac Disease
B. Prevalence of Celiac Disease in the
United States
C. Gluten and the Grains of Concern
for Individuals with Celiac Disease
1. Meaning of the Term ‘‘Gluten’’
2. Grains of Concern to Individuals
with Celiac Disease
3. Uncertainty About Including Oats
in the Diet of Individuals with
Celiac Disease
D. FDA’s Prior Statements on GlutenFree Food Labeling
E. Food Allergen Labeling and
Consumer Protection Act of 2004
and Related Activities
1. Food Allergen Labeling and
Consumer Protection Act of 2004
2. FDA’s Threshold Working Group
and Its Report on Approaches to
Establish Thresholds
3. Food Advisory Committee Meeting
of July 13–15, 2005
4. Gluten-Free Food Labeling Public
Meeting of August 19, 2005
II. Proposed Rule
A. Legal Basis
B. Definitions and Criteria for the Use
of the Term Gluten-Free in Food
Labeling
1. Definitions of the Terms
‘‘Prohibited Grains’’ and ‘‘Gluten’’
2. Definition of the Term ‘‘GlutenFree’’
3. Use of the Term Gluten-Free in the
Labeling of Foods That Inherently
Do Not Contain Gluten
4. Use of the Analytical MethodsBased Approach in this Proposed
Rule to Set a Threshold Level of 20
ppm to Define the Term GlutenFree
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
2796
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
C. Compliance and Enforcement of an
FDA Gluten-Free Food Labeling
Claim
III. Preliminary Regulatory Impact
Analysis
A. Need for This Regulation
B. Proposed Regulatory Options
C. Impacts of the Proposed Regulatory
Options
1. Option One: Take No Action
2. Option Two: Take the Proposed
Action—Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing the Prohibited Grains or
Ingredients That Have Been Derived
From Those Grains and Have Not
Been Processed to Remove the
Gluten; Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing Ingredients Derived
From the Prohibited Grains That
Have Been Processed to Remove the
Gluten, If the Level of Gluten Is 20
ppm or Greater; Do Not Permit
Firms to Make Gluten-Free Claims
on Foods Containing 20 ppm or
More Gluten, Regardless of How the
Gluten Got Into the Food; and
Restrict Wording of Gluten-Free
Claims on Foods That Inherently Do
Not Contain Gluten
a. Overview
b. Costs
c. Benefits
d. Summary
3. Option Three: Take the Proposed
Action, Except Do Not Permit Firms
to Make Gluten-Free Claims on
Foods Containing Ingredients
Derived From the Prohibited Grains
That Have Been Processed to
Remove The Gluten, If the Level of
Gluten Is Some Specified Level
Other Than 20 ppm, and Do Not
Permit Firms to Make Gluten-Free
Claims on Foods If the Level Of
Gluten Is Some Specified Level
Other Than 20 ppm, Regardless of
How the Gluten Got Into the Food
a. Overview
b. Costs
c. Benefits
d. Summary
4. Option Four: Do Not Permit Firms
to Make Gluten-Free Claims on
Foods Containing 20 ppm or More
Gluten, Regardless of the
Ingredients They Use to Make
Them, and Restrict the Wording of
Gluten-Free Claims on Foods That
Inherently Do Not Contain Gluten
5. Option Five: Take the Proposed
Action, Except Delete Wording
Requirements for Gluten-Free
Claims on Foods That Inherently Do
Not Contain Gluten
6. Option Six: Take the Proposed
Action, but Also Define the Food
Labeling Claim ‘‘Low Gluten’’
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
7. Option Seven: Take Proposed
Action, Except Include Oats in the
List of Grains That We Propose to
Prohibit in Foods That Firms Label
as Gluten-Free
IV. Regulatory Flexibility Analysis
A. Proposed Regulatory Options
B. Impacts of the Proposed Regulatory
Options on Small Entities
1. Option One: Take No Action
2. Option Two: Take the Proposed
Action—Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing the Prohibited Grains or
Ingredients That Have Been Derived
From Those Grains and Have Not
Been Processed to Remove the
Gluten; Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing Ingredients Derived
From the Prohibited Grains That
Have Been Processed to Remove the
Gluten, If the Level of Gluten Is 20
ppm or Greater; Do Not Permit
Firms to Make Gluten-Free Claims
on Foods Containing 20 ppm or
More Gluten, Regardless of How the
Gluten Got Into the Food; and
Restrict Wording of Gluten-Free
Claims on Foods That Inherently Do
Not Contain Gluten
3. Option Three: Take the Proposed
Action, Except Do Not Permit Firms
to Make Gluten-Free Claims on
Foods Containing Ingredients
Derived From the Prohibited Grains
That Have Been Processed to
Remove the Gluten, If the Level of
Gluten Is Some Specified Level
Other Than 20 ppm, and Do Not
Permit Firms to Make Gluten-Free
Claims on Foods If the Level of
Gluten Is Some Specified Level
Other Than 20 ppm, Regardless of
How the Gluten Got Into the Food
4. Option Four: Do Not Permit Firms
to Make Gluten-Free Claims on
Foods Containing 20 ppm or More
Gluten, Regardless of the
Ingredients They Use to Make
Them, and Restrict the Wording of
Gluten-Free Claims on Foods That
Inherently Do Not Contain Gluten
5. Option Five: Take the Proposed
Action, Except Delete Wording
Requirements for Gluten-Free
Claims on Foods That Inherently Do
Not Contain Gluten
6. Option Six: Take the Proposed
Action, but Also Define the Food
Labeling Claim ‘‘Low Gluten’’
7. Option Seven: Take Proposed
Action, but Include Oats in the List
of Grains That We Propose to
Prohibit in Foods That Firms Label
as Gluten-Free
V. Unfunded Mandates
VI. Executive Order 13132: Federalism
VII. Environmental Impact Analysis
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
VIII. Paperwork Reduction Act of 1995
IX. Comments
X. References
I. Background
A. 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 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 who have celiac disease,
leading to a lack of absorption of
nutrients and 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 age and
immunological status of the individual,
the amount, duration or timing of the
exposure to gluten, and the specific area
and extent of the gastrointestinal tract
involved by disease (Ref. 5). Symptoms
of celiac disease may be: (1) ‘‘Classical,’’
affecting the digestive tract (e.g.,
abdominal bloating; cramping and pain;
chronic diarrhea; vomiting;
constipation) and resulting in
gastrointestinal malabsorption; or (2)
‘‘atypical,’’ affecting mainly other parts
of the body (e.g., fatigue; irritability;
behavior changes; bone or joint pain;
tingling numbness in the legs; ulcers in
the mouth; tooth discoloration or loss of
enamel; itchy skin rash with blisters
called dermatitis herpetiformis) (Refs. 1,
4, 6, and 7).
A large portion of the subpopulation
that has celiac disease may not
experience any symptoms at all and are
classified as having ‘‘silent’’ or ‘‘latent’’
forms 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
E:\FR\FM\23JAP1.SGM
23JAP1
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
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 but not limited to:
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 nonHodgkin’s lymphomas (Refs. 7 and 11
through 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 all
sources 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. Prevalence of Celiac Disease in the
United States
Precise prevalence data for celiac
disease are not available. The overall
prevalence of celiac disease in the U.S.
is currently estimated to range 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). However,
the number of Americans with
physician-diagnosed celiac disease is
estimated at between 40,000 (Ref. 17)
and 60,000 (Ref. 18).
This discrepancy between estimated
prevalence and diagnosed cases has
been linked primarily to the fact that
celiac disease can be silent or latent.
Some researchers have suggested that
the true prevalence is underreported
(Ref. 8). Silent and latent forms of celiac
disease may go undetected in
individuals for years before they
develop symptoms causing them to seek
medical attention (Ref. 13). 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
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
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. Gluten and the Grains of Concern for
Individuals with Celiac Disease
1. Meaning of the Term ‘‘Gluten’’
There is no single definition of the
term ‘‘gluten.’’ Technically, the term
‘‘gluten’’ refers to a specific complex of
proteins that forms when wheat flour is
mixed with a liquid and physically
manipulated, such as in the kneading of
a bread (Ref. 20). This complex of
proteins is composed of both ‘‘gliadins’’
and ‘‘glutenins,’’ which are found in
approximately equal proportions in
most wheat varieties (Refs. 21 through
23). The gliadins belong to a category of
proteins called ‘‘prolamins’’ and the
glutenins belong to a category of
proteins called ‘‘glutelins’’ (Refs. 20 and
24).
Although, strictly speaking, ‘‘gluten’’
pertains only to wheat proteins, this
term is frequently used to refer to the
combination of prolamin and glutelin
proteins naturally occurring in other
grains, including those that have not
been demonstrated to cause harmful
effects in individuals with celiac disease
(e.g., ‘‘corn gluten’’ and ‘‘rice gluten’’)
(Ref. 25). However, in discussions of
celiac disease in the medical literature,
the term ‘‘gluten’’ is used to refer to
either gluten in wheat or collectively to
the proteins (e.g., prolamins and
glutelins) in just those grains that have
been demonstrated to cause harmful
health effects in individuals who have
celiac disease (Refs. 3 and 25).
2. Grains of Concern to Individuals With
Celiac Disease
The grains that are reported to contain
gluten that can cause harmful health
effects in individuals with celiac disease
and should be avoided by them are as
follows: Wheat (including durum wheat,
spelt wheat, and kamut), rye, barley,
and crossbred hybrids of these grains
(e.g., triticale, which is a cross between
wheat and rye), and possibly oats (Refs.
26 through 30). Rye, barley, and triticale
are taxonomically very closely related to
wheat and contain peptides structurally
similar to those found in wheat (Refs. 30
and 31). Although oats are not as closely
related to wheat (Ref. 30), they are
reported to contain some peptides
similar to those found in wheat, which
may help to explain why some
individuals with celiac disease are
sensitive to oats (Ref. 32). In contrast,
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
2797
the cereal grains believed to be well
tolerated by individuals with celiac
disease and which are not
taxonomically as closely related to
wheat and are not reported to contain
similar peptides to those found in wheat
include: Amaranth, buckwheat, corn
(maize), Indian ricegrass, Job’s tears,
millet, quinoa, ragi, rice, sorghum, teff
(tef), and wild rice (Refs. 26, 27, 29
through 31, 33, and 34).
There is evidence that both the
prolamins (i.e., gliadins) and glutelins
(i.e., glutenins) in wheat adversely affect
individuals with celiac disease (Refs. 2,
27, and 35 through 37). Wheat gliadin
subtypes alpha, beta, gamma, and omega
have been shown to cause damage to the
intestinal tract of individuals with
celiac disease (Refs. 38, 39, and 40, p.
41). Moreover, it is also believed that
the prolamins in rye (i.e., secalins) and
the prolamins in barley (i.e., hordeums)
are responsible for causing adverse
health effects in individuals with celiac
disease (Refs. 13, 23, 28, 41, and 42).
Oats also have prolamins (i.e., avenins)
that have some amino acid sequences
similar to those occurring in wheat and
are believed to be harmful to a small
subset of individuals with celiac disease
(Ref. 32). Although the prolamins of the
aforementioned grains and the wheat
glutelins are recognized to cause
adverse health effects in individuals
with celiac disease, all cereal grains
contain other types of proteins,
including albumins and globulins,
which are not currently associated with
celiac disease (Refs. 20 and 21). There
is still much unknown about all the
specific proteins in the different grains
that can affect individuals with celiac
disease (Ref. 43).
3. Uncertainty About Including Oats in
the Diet of Individuals With Celiac
Disease
Currently, there is no general
agreement among experts about the
extent to which oats present a hazard for
individuals with celiac disease.
Whether oats should or should not be
consumed by individuals with celiac
disease has been the subject of
controversy for more than 50 years (Ref.
44). There are inconclusive and
conflicting results from research on the
effects of oat consumption on
individuals with celiac disease.
Some of this research, in particular
early research, suggests that oat
consumption is harmful to individuals
with celiac disease (Refs. 26 and 28).
More recent studies found that 1 of 19
study participants (Ref. 45) and 4 of 9
participants (Ref. 32) could not tolerate
an average of about 50 grams dry weight
of oats. The oats used in both studies
E:\FR\FM\23JAP1.SGM
23JAP1
2798
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
were tested to ensure that they did not
contain gluten proteins from wheat, rye,
or barley.
However, multiple studies in the last
10 years have shown that the ingestion
of oats in the diet of individuals who
have celiac disease, in both children
and adults, does not necessarily lead to
increased intestinal or skin symptoms or
to altered intestinal pathology, and
appears to be preferred to a diet without
oats (Refs. 46 through 51). The average
amount of oats consumed by
participants in each of these studies
differed, ranging from about 15 grams to
60 grams dry weight per day. A longterm study that lasted 5 years concluded
that individuals with celiac disease
prefer and can tolerate without harmful
effects a daily average consumption of
34 grams dry weight of oats (Ref. 49).
Although the total number of
individuals with celiac disease who are
sensitive to oats is unknown, the
findings of many of the contemporary
studies suggest that the proportion of
individuals with celiac disease who
cannot tolerate oats in daily amounts of
about 50 or less grams dry weight is
probably very low. One celiac expert
suggests that the size of this
subpopulation is likely to be less than
one percent of individuals with celiac
disease (Ref. 52).
Despite the evidence that the
consumption of oats does not present a
risk for most individuals with celiac
disease, a major obstacle impeding
general acceptance of oats in the diet of
individuals with celiac disease is the
concern about the commingling1 of oats
with wheat, rye or barley that can occur
during grain production, transport,
storage, or processing (Refs. 44 and 53).
Due to this concern, Farrell and Kelly
(Ref. 7) advise individuals with newly
diagnosed celiac disease not to consume
oats until their disease is in remission
(e.g., intestinal tract has healed). Some
celiac disease treatment or research
centers in the United States report that
they do not support the inclusion of oats
in the diet of individuals with celiac
disease, whereas other centers do,
stating that oats can enhance the
nutrient density and fiber content of a
diet that avoids all sources of gluten and
possibly improve compliance with this
very restrictive diet (Refs. 54 through
56).
Thompson (Ref. 57) conducted a
small, non-randomized mail survey
using a questionnaire about the
1The cited references use the term
‘‘contamination,’’ but other references use the term
‘‘commingling.’’ For purposes of this proposed rule,
FDA has opted to use the term ‘‘commingling,’’ and
considers that term to mean ‘‘the process of
mixing.’’
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
acceptability of several foods in diets
that do not contain gluten. Thirty seven
questionnaires, completed by celiac
disease organizations (United States and
foreign), physicians, and dietitians/
nutritionists, were submitted in
response to the survey. Only five (i.e.,
1 foreign celiac association and 4
physicians) of the 33 respondents who
answered the question about oats
considered oats to be an acceptable
food, and none of the four U.S. celiac
disease associations that responded to
the survey considered oats to be an
acceptable food for individuals with
celiac disease. The reasons given by
respondents for their lack of acceptance
of oats included concerns about the
possibility that oats may cause adverse
health effects in individuals with celiac
disease either directly or due to the
presence of gluten from another grain
(e.g., wheat, rye, or barley), and about
the insufficiency of long-term research
that identifies the amount of oats that
can be tolerated by individuals with
celiac disease.
According to more recent position
statements of 3 of the 4 major celiac
associations in the United States that
responded to the earlier survey
conducted by Thompson (Ref. 57), one
of these associations continues to take
the position that oats are not an
acceptable food for individuals with
celiac disease; but, the other two of
these associations are not opposed to
the inclusion of oats in the diets of
individuals with celiac disease,
provided that the oats do not contain
gluten from other grains and that the
daily amount of oats consumed is
limited to 1 cup cooked (Ref. 56). Both
of the latter associations state that oats
can add soluble fiber and nutrients to a
diet that avoids all sources of gluten;
but, direct individuals with celiac
disease to consult with their health care
providers before introducing oats into
their diet. Also, both of these
associations recommend that
individuals with celiac disease who
consume oats should have their levels of
antibodies specific to celiac disease
monitored periodically.
The recent National Institutes of
Health Consensus Conference Statement
on Celiac Disease (Ref. 1) does not
identify oats as being one of the grains
that individuals with celiac disease
should avoid. Instead, this statement
indicates that it appears that most
individuals with celiac disease can
include oats in their diet without
harmful health effects, but that it may
not be practical to do so because oats
may contain gluten from other grains
due to commingling during their
processing. Similarly, the 2006 edition
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
of the American Dietetic Association
(ADA) Nutrition Care Manual (ADA
Manual) recommends that individuals
with celiac disease avoid wheat
(including wheat in all of its varieties,
such as spelt, and in all of its forms,
such as wheat starch), rye, barley and
their crossbred hybrid varieties (e.g.,
triticale), but does not advise
individuals with celiac disease to
presumptively exclude oats from their
diet (Ref 58). Instead, the ADA Manual
states: ‘‘* * *Findings from in vivo
research on the safety of oats suggest
that most persons with celiac disease
can safely consume moderate amounts
of uncontaminated oats without
adversely affecting the intestinal
mucosa * * *.’’ (Ref. 59). However, the
ADA Manual acknowledges that ‘‘* *
*limited evidence suggests that in some
persons with celiac disease, the
consumption of uncontaminated oats
may result in mucosal inflammation* *
*.’’ Further, the ADA Manual advises
that individuals with celiac disease
consult with their physicians and
dietitians before deciding to consume
oats and that any daily intake should be
limited to about 50 grams of dry oats
that ideally have been tested to ensure
that they do not contain gluten from
wheat, rye, or barley. The ADA Manual
also reports that some oat millers have
established comprehensive clean-out
procedures and control programs to
address the problem of commingling of
oats with wheat, rye, and barley. In
addition, in a letter submitted in
response to FDA’s 2005 public meeting
on gluten-free (see section I.E.4 of this
document for details about this
meeting), ADA expressed support for
FDA establishing a definition of glutenfree for oats that is tied to testing that
ensures that those oats do not contain
gluten from other grains, so that those
oats could bear a gluten-free labeling
claim (Ref. 60).
The commingling of oats with wheat,
rye, barley or their crossbred hybrids or
with the grains generally considered to
be acceptable for individuals with celiac
disease (e.g., corn and rice) can occur at
any step in the farm-to-table continuum.
This is due to the common practices of
growing crops in rotation and in close
proximity to one another as well as
using the same equipment and storage
bins to harvest and hold different grains
(Ref. 53). Accordingly, the official U.S.
standard for a given grain typically
allows for the presence of a small
percentage of other grains (Ref. 61).
It is believed that most oat products
commercially available in the United
States contain some gluten from wheat,
rye, or barley as a result of commingling
during the oats’ growth, harvesting,
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
transport, storage, or processing (Refs.
43, 44, 53, 62, and 63). In 2004,
Thompson reported that in a recent
study 4 samples of each of 3 brands of
oat products marketed in the United
States were analyzed in duplicate for
gluten from wheat, rye, and barley using
an enzyme-linked immunosorbent assay
(ELISA)-based method (Ref. 63). Ten of
the 12 samples, representing all 3
brands of oat products, were reported to
contain an amount of gluten ranging
from 12 to 1861 ppm, depending upon
the individual sample and brand tested.
Thompson concluded that none of these
brands could be considered a reliable
source of oats free of potentially harmful
gluten from other grains.
In another study, Hernando and
colleagues (Ref. 64) collected 108
samples of commercial oat products
(e.g., rolled oats, oat flakes, and oat
flours) from Europe, the United States
and Canada. The samples were analyzed
for gluten from wheat, rye, and barley
using an ELISA-based method. In
addition, analysis of the samples by
polymerase chain reaction (PCR) was
used to identify the particular grains
present. Consistent with the previous
findings of Thompson, the presence of
gluten from other grains was found to be
widespread. Seventy-nine percent of the
oat samples were reported to contain
gluten from wheat, rye, and/or barley at
a level ranging from less than 3 to 8,000
ppm gluten (Ref. 64). Sixty-one percent
of the samples contained more than 200
ppm gluten. Hernando and colleagues
also reported barley to be the
predominant grain present.
Although there appears to be
widespread commingling of oats with
other grains, it appears that this
commingling is preventable. Two
manufacturers who submitted written
responses to FDA’s 2005 public meeting
on gluten-free food labeling report that
the oats they market in the United States
do not contain gluten from wheat, rye,
and barley (Refs. 65 and 66). Examples
of the types of special measures
reported by one or both manufacturers
to ensure that their oats do not contain
gluten from wheat, rye, and barley are
as follows: (1) Contracting with farmers
who are experienced with growing
crops to ensure their purity; (2) using
only oat seed certified to be pure; (3)
planting oats only in fields that have not
produced wheat, rye, or barley in either
2 or 3 years; (4) establishing a 25- or 30–
foot buffer zone separating their oat
crops from other crops; (5) conducting
periodic inspections to remove any stray
wheat, rye, or barley plants growing in
their fields; (6) using only dedicated or
thoroughly cleaned equipment and
facilities to harvest, transfer, store, and
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
2799
process their oats; (7) having an
independent lab test samples of their
freshly harvested and milled oats, using
an ELISA-based method designed to
detect gluten naturally occurring in
wheat, rye, and barley; and (8) milling
their oats in dedicated facilities that
either only mill oats or only mill oats
and soy.
brand of food bearing the gluten-free
claim, are also free of gluten.
As discussed elsewhere in this
preamble, FDA proposes to define
prohibited grain to include all species of
wheat, rye, barley, and their crossbred
hybrids. FDA’s proposed definition of
prohibited grain would exclude all other
grains, including oats and millet.
D. FDA’s Prior Statements on GlutenFree Food Labeling
E. Food Allergen Labeling and
Consumer Protection Act of 2004 and
Related Activities
Currently, there is no FDA regulation
that specifically defines the term
‘‘gluten-free.’’ In the preamble to a final
rule on the declaration of ingredients on
food packaging published in the Federal
Register of January 6, 1993 (58 FR 2850
at 2864), FDA advised that the term
‘‘gluten-free’’ can be used in the labeling
of foods, provided that when such claim
is used, it is truthful and not
misleading. Generally, and absent
regulations to the contrary, FDA would
regard a claim that a food is ‘‘free’’ of
a substance as false or misleading if the
food contains that substance. FDA also
noted that the term ‘‘gluten-free’’ may be
misleading when the food ordinarily
does not contain gluten. Although FDA
did not define the term ‘‘gluten,’’ FDA
referred to the grains wheat, barley, rye,
oats and millet as those ‘‘which
commonly contain gluten’’ (FR 2850 at
2863).
FDA’s view that the term ‘‘glutenfree’’ may be misleading when a food is
inherently free of gluten is consistent
with FDA regulations governing the use
other ‘‘free’’ claims. FDA has issued
regulations that establish requirements
for a ‘‘free’’ labeling claim made about
a food inherently free of calories
(§ 101.60(e)(ii) (21 CFR 101.60(e)(ii)), of
nutrients (e.g., sodium,
§ 101.61(b)(1)(iii) (21 CFR
101.61(b)(1)(iii)) and fat,
§ 101.62(b)(1)(iii) (21 CFR
101.62(b)(1)(iii)), and of other food
components (e.g., cholesterol,
§ 101.62(d)(1)(ii)(E)). FDA considers
‘‘calorie-free,’’ ‘‘sodium-free,’’ ‘‘fat-free,’’
and ‘‘cholesterol-free’’ labeling claims
made for a food that inherently does not
contain these substances to be
misleading to consumers without
additional clarifying wording indicating
that all foods of the same type, not just
the brand of food bearing that ‘‘free’’
labeling claim, are also free of the stated
substance. Consistent with how FDA
has regulated other ‘‘free’’ claims, the
agency would consider a gluten-free
labeling claim made for a food that
inherently does not contain gluten to be
misleading if it is not accompanied by
additional wording to clarify that all
foods of the same type, not just the
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
1. Food Allergen Labeling and
Consumer Protection Act of 2004
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), 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.
FALCPA directs the issuance of a
proposed rule by no later than 2 years
after the law’s enactment date, and a
final rule by no later than 4 years after
the law’s enactment date. FDA is
publishing this proposed rule in
response to this directive.
2. FDA’s Threshold Working Group and
Its Report on Approaches to Establish
Thresholds
FALCPA does not require FDA to
establish a threshold level for gluten.
Nonetheless, an important scientific
issue associated with the issuance of
this proposed rule is the potential
existence of a threshold level below
which it is unlikely that an individual
with celiac disease would experience an
adverse health effect.
To address this issue, among others,
FDA 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 draft report, Approaches to
Establish Thresholds for Major Food
Allergens and for Gluten in Food (the
draft Thresholds Report) (Ref. 67),
summarized the current state of
scientific knowledge with respect to a
dose-response relationship for gluten,
and presented the following four
potential approaches that FDA might
consider in establishing such a
threshold level, if the agency chose to
do so (Ref. 67, pp. 2 and 38 through 41):
• 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)
E:\FR\FM\23JAP1.SGM
23JAP1
2800
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
from available human challenge studies,
applying an appropriate ‘‘uncertainty
factor’’ multiplier to account for
knowledge gaps.
• Risk assessment-based—examines
known or potential adverse heath 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.
The report also noted that any
decisions on approaches to establish a
threshold for gluten likely would
require consideration of additional
factors not addressed in the 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.
A notice of availability for the draft
Thresholds Report was published in the
Federal Register (70 FR 35258, June 17,
2005) and the report was made available
through FDA Docket No. 2005N–0231
and the Center for Food Safety and
Applied Nutrition (CFSAN) Web site
(https://www.cfsan.fda.gov/~dms/
alrgn.html). FDA requested that
interested persons submit comments
and any scientific data or other
information relevant to the draft
Thresholds Report to the docket during
a 60-day comment period ending
August 16, 2005. The Threshold
Working Group considered the
comments, data, and information
submitted, and made appropriate
revisions to the Thresholds Report. On
May 25, 2006, FDA posted its response
(Ref. 68) to the comments, data, and
other information that the agency
received on its draft Thresholds Report
(https://www.cfsan.fda.gov/~dms/
alrgcom.html). FDA also posted the
revised Thresholds Report (Ref. 69)
(https://www.cfsan.fda.gov/~dms/
alrgn2.html). Both of these documents
are dated March 2006.
3. Food Advisory Committee Meeting of
July 13 through 15, 2005
In the Federal Register of May 23,
2005 (70 FR 29528), FDA announced
that FDA’s Food Advisory Committee
(FAC) would be holding a public
meeting on July 13 through 15, 2005, to
evaluate the draft Thresholds Report.
One purpose of the meeting was for the
FAC to determine whether the four
approaches considered in the draft
Thresholds Report for establishing a
threshold level for gluten were
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
scientifically sound. FDA invited
experts to address a number of specific
issues related to sensitivities to gluten.
In addition, FDA invited interested
members of the general public to
present their 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 standards 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.
Approximately 140 persons attended
the FAC meeting. 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 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 (https://
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 FDA Docket No. 2005N–
0279 pertaining to this rulemaking. A
summary of the FAC responses to the
questions is provided in the Summary
Minutes (Ref. 70).
The FAC concluded that the draft
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.
70, p. 1). The FAC also identified the
risk-assessment approach as the
strongest of the four approaches
proposed in the draft Thresholds
Report, assuming the availability of
sufficient data (Ref. 70, p. 1).
FDA received about 20 public
responses, each containing one or more
comments, to the FAC meeting and to
the notice of availability and request for
comments on the draft Thresholds
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
Report. (Some of these responses
concerned food allergens and are not
relevant to this proposal.)
Approximately half of the total number
of responses mentioned wheat or gluten,
and the majority of the responses
submitted about gluten addressed issues
or provided data directly related to the
report’s suggested approaches to
establishing a threshold level for gluten.
Pertinent comments were considered by
FDA in the development of this
proposed rule. All written responses
submitted to FDA about the FAC
meeting and the draft Thresholds Report
are available through FDA Docket No.
2005N–0231, and copies of those
responses that specifically mentioned
wheat or gluten are also available
through FDA Docket No. 2005N–0279.
4. Gluten-Free Food Labeling Public
Meeting of August 19, 2005
In the Federal Register of July 19,
2005 (70 FR 41356), FDA announced
that it would be holding a public
meeting on August 19, 2005, to discuss
the topic of gluten-free food labeling.
Interested persons were given 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, FDA
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.’’
More than 80 persons attended the
public meeting on gluten-free food
labeling. In response to the notice and
public meeting, FDA received more than
2,400 responses, each containing one or
more comments, about the public
meeting or the list of questions cited in
the notice announcing the meeting. The
vast majority of these responses were
from individuals with celiac disease,
their caregivers, and celiac disease
associations, with a much smaller
number of responses being from the
food industry. All written responses
submitted to FDA in response to the
gluten-free public meeting and the
questions posed in the corresponding
Federal Register meeting notice are
available through the FDA Docket No.
2005N–0279.
Most of the consumers’ comments
said that they appreciate and use glutenfree 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 grocery shop, saving the
consumers both time and the frustration
E:\FR\FM\23JAP1.SGM
23JAP1
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
experienced when reading often lengthy
and complicated ingredients lists that
they stated they do not understand.
Many consumers also stated that they
currently purchase only or primarily
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 provide them with 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, opinions
expressed in comments from these
individuals and organizations varied
with respect to whether oats should be
excluded from any products labeled as
gluten-free.
Industry comments 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 assist industry by promoting 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.
Based upon comments that FDA
received during this public meeting or
that were submitted in writing to the
related FDA Docket No. 2005N–0279,
FDA believes that a uniform definition
of the term gluten-free would prevent
confusion and uncertainty among both
consumers and food manufacturers
about what this food labeling claim
means.
jlentini on PROD1PC65 with PROPOSAL
II. Proposed Rule
A. Legal Basis
Section 206 of FALCPA directs the
Secretary of HHS, in consultation with
appropriate experts and stakeholders, to
issue a proposed rule to define, and
permit use of, the term ‘‘gluten-free’’ on
the labeling of foods. FDA has authority
to issue this proposed rule under
sections 403(a)(1), 201(n), and 701(a) of
the act (21 U.S.C. 343(a)(1), 321(n), and
371(a). Section 403(a)(1) of the act states
that, ‘‘A food shall be deemed to be
misbranded if its labeling is false or
misleading in any particular.’’ In
determining whether food labeling is
misleading, section 201(n) explicitly
provides for consideration of the extent
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
to which the labeling fails to reveal facts
‘‘material with respect to the
consequences which may result from
the use of the [food] to which the
labeling * * *relates under * * *such
conditions of use as are customary or
usual.’’ Section 701(a) of the act vests
the Secretary (and by delegation, FDA)
with authority to issue regulations for
the efficient enforcement of the act.
As directed by FALCPA, FDA is
proposing to define the term ‘‘glutenfree’’ for voluntary use in the labeling of
foods. FDA is also proposing to define
various terms corresponding to certain
specified grains and proteins that would
be prohibited from use as ingredients or
sources of ingredients used to make a
food bearing a ‘‘gluten-free’’ labeling
claim. Further, FDA is proposing to
specify how a voluntary gluten-free
labeling claim must be worded for oats
and for other foods that inherently do
not contain any gluten. Any use of the
term ‘‘gluten-free’’ in the labeling of
food that does not conform to the
proposed regulatory definitions and
requirements would render that food
misbranded.
In enacting FALCPA, Congress
recognized the importance to
individuals with celiac disease of
avoiding gluten (FALCPA, section
202(6)(B)). To address this issue, section
206 of FALCPA directs FDA to issue a
regulation to define and permit use of
the term ‘‘gluten-free.’’ As discussed
elsewhere in this preamble, currently
there is neither a regulatory definition of
the term ‘‘gluten-free,’’ nor is there
agreement among manufacturers or
consumers as to what this term means.
In the course of consulting with experts
and stakeholders, FDA has learned that
different manufacturers have different
and inconsistent definitions of the term
‘‘gluten-free.’’ Consumers with celiac
disease and their caregivers, who rely
on ‘‘gluten-free’’ labeling claims to make
purchasing decisions, believe that a
standardized definition of the term is
needed to ensure that those consumers
know what to expect when purchasing
foods labeled as gluten-free. Therefore,
FDA believes that establishing a
definition of the term ‘‘gluten-free’’ and
uniform conditions for its use in the
labeling of foods is needed to ensure
that individuals with celiac disease are
not misled and are provided with
truthful and accurate information with
respect to foods so labeled.
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
2801
B. Definitions and Criteria for the Use of
the Term Gluten-Free in Food Labeling
1. Definitions of the Terms ‘‘Prohibited
Grains’’ and ‘‘Gluten’’
To facilitate proposing a definition of
the term ‘‘gluten-free,’’ FDA proposes to
also define the terms ‘‘gluten’’ and
‘‘prohibited grains.’’ FDA proposes in
§ 101.91(a)(2) to define the term
‘‘gluten’’ to mean 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). FDA
proposes in § 101.91(a)(1) to define the
term ‘‘prohibited grain’’ to mean any of
the following grains or their crossbred
hybrids (e.g., triticale, which is a cross
between wheat and rye): (1) Wheat,
meaning any species belonging to the
genus Triticum; (2) rye, meaning any
species belonging to the genus Secale;
and (3) barley, meaning any species
belonging to the genus Hordeum. As
discussed in section I.C of this
document, the scientific literature
reports general agreement among celiac
disease experts that naturally occurring
prolamins or glutelins in wheat, rye,
barley, and their crossbred hybrids can
cause serious adverse health effects in
individuals with celiac disease and
should be excluded from their diet.
FDA is not proposing to include oats
in the definition of a prohibited grain.
As discussed in section I.C.3 of this
document, the unconditional exclusion
of oats from the diet of individuals with
celiac disease is not supported by the
National Institutes of Health Conference
Development Conference Statement on
Celiac Disease (Ref. 1) or by the
American Dietetic Association (Ref. 58).
FDA recognizes that a small percentage
of individuals with celiac disease may
not be able to tolerate some of the
proteins that naturally occur in oats.
However, it appears that a great majority
of individuals with celiac disease can
tolerate a daily intake of a limited
amount (e.g., 50 grams) of oats that are
free of gluten from wheat, rye, barley or
their crossbred hybrids. Oats are
reported to add variety, taste, satiety,
dietary fiber, and other essential
nutrients to the diet of individuals with
celiac disease; thereby making their diet
more nutritious and appealing (Refs. 44,
51, 56, and 71). Inclusion of oats in the
diet of individuals with celiac disease
who can tolerate oats may therefore
result in the improved nutritional and
health status of those individuals (Refs.
55 and 71).
According to comments FDA received
in response to its August 2005 public
meeting on gluten-free labeling, at least
two food manufacturers can produce
E:\FR\FM\23JAP1.SGM
23JAP1
2802
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
oats that do not contain gluten from
wheat, rye, barley, or any of their crossbred hybrids. Allowing such oats to bear
a gluten-free labeling claim would make
them easier to identify and perhaps
would encourage other manufacturers to
produce such oats. Conversely,
including oats in the definition of
prohibited grain could eliminate any
incentive for manufacturers to produce
oats free of gluten from other grains
because those manufacturers would
have no way of distinguishing their
products in the marketplace. FDA
requests comments on whether the
agency should include oats in the
definition of a prohibited grain.
2. Definition of the Term ‘‘Gluten-Free’’
FDA proposes in § 101.91(a)(3) to
define the claim ‘‘gluten-free’’ to mean
that a 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
that has not been processed to remove
gluten; (3) an ingredient that is derived
from a prohibited grain and that has
been processed to remove gluten, if the
use of that ingredient results in the
presence of 20 ppm or more gluten in
the food (i.e., 20 micrograms or more
gluten per gram of food); or (4) 20 ppm
or more gluten.
Examples of a prohibited grain
include, but are not limited to, barley,
common wheat, durum wheat, einkorn
wheat, emmer wheat, kamut, rye, spelt
wheat, and triticale. Examples of
ingredients that are derived from a
prohibited grain and that have not been
processed to remove gluten include, but
are not limited to:
• Farina, flour made from any of the
proposed prohibited grains, graham, and
semolina;
• Hydrolyzed wheat protein, vital
gluten, wheat bran, and wheat germ;
and
• Barley malt extract or flavoring and
malt vinegar.
Because these ingredients are derived
from a prohibited grain and have not
been processed to remove gluten, they
are presumed to contain gluten.
Examples of ingredients that are or are
sometimes derived from a prohibited
grain and processed to remove gluten
include, but are not limited to:
• Food starch—modified (modified
food starch); and
• Wheat starch.
Although these ingredients have been
processed to remove gluten, FDA
recognizes that there may be different
methods of deriving these ingredients,
and that some methods may remove less
gluten than others. Therefore, FDA
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
proposes to prohibit a food that contains
one of these ingredients from bearing a
gluten-free labeling claim if the use of
the ingredient results in the presence of
20 ppm or more gluten in the food.
A food may contain 20 ppm or more
gluten even though the food does not
contain an ingredient derived from a
prohibited grain. For example, a food
that contains an ingredient derived from
oats may contain 20 ppm or more gluten
if the oats were commingled with a
prohibited grain during their harvest,
transport, or storage. FDA believes that
manufacturers who elect to use the
labeling claim ‘‘gluten-free’’ should
make certain that foods so labeled do
not contain 20 ppm or more gluten,
regardless of whether or not those foods
contain an ingredient that is derived
from a prohibited grain. Under proposed
§ 101.91(b)(1), a food 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’’ would be
deemed misbranded.
3. Use of the Term Gluten-Free in the
Labeling of Foods That Inherently Do
Not Contain Gluten
FDA proposes in § 101.91(b)(2) to
deem misbranded any food, with the
exception of a food made from oats, that
does not inherently contain any gluten
from a prohibited grain and that bears
the claim ‘‘gluten-free’’ in its labeling,
unless the food complies with the
following two requirements: (1) The
wording of the claim in the labeling of
the food clearly indicates that all foods
of the same type, not just the brand
bearing this labeling claim, are glutenfree (e.g., ‘‘milk, a gluten-free food,’’ ‘‘all
milk is gluten-free’’) and (2) the food
does not contain 20 ppm or more gluten.
Examples of foods that inherently do
not contain gluten include, but are not
limited to:
• Different types of milk not flavored
with ingredients that contain gluten
(e.g., fresh fluid whole, low fat and
nonfat milks; evaporated milk; nonfat
dry milk; sweetened condensed milk);
• 100 percent fruit or vegetable juices;
fresh fruits and vegetables that are not
coated with a wax or resin that contains
gluten; and frozen or canned fruits and
vegetables not made with added
ingredients that contain gluten; and
• A variety of single ingredient foods,
e.g., butter; eggs; lentils; legumes like
dried beans and peas, peanuts, and
soybeans; seeds like flax, poppy and
sesame; tree nuts like almonds, pecans,
and walnuts; non-gluten containing
grains like corn, millet and rice; fresh
fish like cod, flounder and haddock;
fresh shellfish like clams, lobster, and
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
octopus; honey; and water, including
bottled waters like distilled and spring.
FDA’s proposed requirement for the
labeling of foods, other than foods made
from oats, that inherently do not contain
gluten is consistent with the general
principles established at § 101.13(e)(2)
(21 CFR 101.13(e)(2)) for existing FDA
regulations on ‘‘free’’ labeling claims
made for foods inherently free of
calories, nutrients (e.g., sodium, fat),
and other food substances (e.g.,
cholesterol). If 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 that
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 a ‘‘free’’ labeling claim
are also free of the substance (Ref. 72).
Therefore, FDA views the use of a
gluten-free labeling claim for a food
inherently free of gluten to be
potentially misleading without the
inclusion of additional qualifying
language.
Although oats are inherently free of
gluten as defined in this proposed rule,
FDA proposes in § 101.91(b)(3) to deem
misbranded a food made from oats that
bears a gluten-free labeling claim if the
claim refers to all such foods as being
gluten-free or if it contains 20 ppm or
more gluten. By ‘‘food made from oats,’’
FDA means oats, any food that contains
oats, and any food that contains any
ingredient derived from oats. The
proposed gluten-free labeling claim
restriction in § 101.91(b)(3) is based on
evidence of the presence of gluten from
prohibited grains in a number of
commercially available brands of foods
made from oats, as discussed in section
I.C.3 of this document. In light of that
evidence, FDA believes that a glutenfree labeling claim that suggests that all
foods made from oats are gluten-free
would be misleading.
The agency is interested in receiving
comments and scientific information on
whether a gluten-free claim on an
inherently gluten-free food, other than
foods made from oats, would be
misleading in the absence of additional
qualifying language. In addition, FDA is
interested in receiving comments and
scientific information on whether the
proposed examples of how a claim
should be worded in the labeling of a
food inherently free of gluten (e.g.,
‘‘milk, a gluten-free food,’’ ‘‘all milk is
gluten-free’’) would effectively inform
consumers that all brands of the same
type of food are also free of gluten, or
whether there are more appropriate
ways to communicate this message to
E:\FR\FM\23JAP1.SGM
23JAP1
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
consumers. Further, FDA requests
comments on the agency’s proposal to
restrict the types of gluten-free labeling
claims that can be made for oats.
4. Use of the Analytical Methods-Based
Approach in This Proposed Rule to Set
a Threshold Level of 20 ppm to Define
the Term Gluten-Free
As discussed in section I.E.2 of this
document, the draft Thresholds Report
describes four approaches FDA could
use to establish a threshold level for
gluten that could be the basis for
decisions on whether to use the term
‘‘gluten-free’’ on product labels (Refs.
67, pp. 2, 38 through 41, and 54 through
61). The draft Thresholds Report
concludes that it currently is not
possible for FDA 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 (Refs. 67, pp. 4, 60,
and 61). The draft Thresholds Report
concludes that two approaches are
viable for FDA to establish a threshold
level for gluten: (1) The safety
assessment-based approach and (2) the
analytical methods-based approach (Ref.
67, pp. 4 and 57 through 60). The
revised Thresholds Report identifies the
same four approaches and conclusions
(Ref. 69, pp. 2, 4, 42 through 45, and 61
through 65).
FDA is planning to conduct a safety
assessment for gluten that is consistent
with the safety assessment-based
approach described in the draft and
revised Thresholds Reports (Ref. 67, pp.
38, 39, and 58 through 60 and Ref. 69,
pp. 42, 43, and 62 through 64). FDA
requests comments providing data
relevant to the planned safety
assessment, including in particular
clinical research and studies designed to
measure chronic exposure, that satisfy
the data quality criteria discussed in the
revised Thresholds Report. We intend to
publish a notice in the Federal Register
seeking comment on the draft safety
assessment and its potential use in the
final rule, and will consider public and
peer-review comments in revising the
safety assessment, as appropriate. In
developing a final rule on gluten-free
labeling, we intend to consider the
safety assessment as well as comments
received in response to this proposed
rule and the notice concerning the
safety assessment. Further, as noted in
both the draft and revised Thresholds
Reports, FDA’s establishment of a
threshold level for gluten may require
consideration of other factors not
addressed in that report, such as ease of
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
compliance and enforcement,
stakeholder concerns, economics, trade
issues, and legal authorities (Ref. 67, p.
41 and Ref. 69, p. 45). This may be true
regardless of which approach FDA uses
to establish a threshold level for gluten
in the final rule (e.g., an analytical
methods-based approach or a safety
assessment-based approach).
Pending the receipt of comments
submitted in response to this
rulemaking and the outcome of the
planned safety assessment, FDA is
currently proposing to use the analytical
methods-based approach to establish a
threshold level of 20 ppm gluten (i.e., a
food labeled gluten-free cannot contain
20 ppm or more gluten) as one of the
criteria for defining the term ‘‘glutenfree.’’ Given the current unavailability
of appropriate test methods that can
reliably and consistently detect gluten at
levels below 20 ppm,2 FDA tentatively
concludes 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
other pertinent requirements of this
proposed rule.
Based upon the current state of
technology concerning available and
appropriate analytical methods that can
detect one or more gluten proteins
naturally occurring in wheat, rye, and
barley, FDA has tentatively determined
that ELISA-based methods can be used
to reliably and consistently detect
gluten at a level of 20 ppm in a variety
of food matrices, including both raw
and cooked or baked foods (Ref. 73).
ELISA-based methods detect the
prolamins in wheat, rye, and barley,
which can serve as a biomarker for the
presence of those grains, their crossbred hybrids, or their other naturally
occurring proteins. FDA is tentatively
considering using an ELISA-based
method that has been validated in
Europe at the 20 ppm gluten detection
level and has been published in the
peer-reviewed scientific literature (Ref.
74). FDA has been advised that this
method is currently under review by
AOAC INTERNATIONAL (Ref. 75). In
addition, we are aware that an
evaluation of other ELISA-based
methods that detect gliadin, a gluten
protein, was recently published in the
peer-reviewed scientific literature (Ref.
2The revised Thresholds Report (Ref. 69, pp. 59
and 60) identifies specific criteria for evaluating
gluten detection analytical methods that are
appropriate for establishing a gluten threshold level
based upon an analytical methods-based approach.
In reviewing the available methods that meet all of
the stated criteria (Ref. 73), FDA has tentatively
concluded that currently there are no available and
appropriate test methods that can reliably and
consistently detect gluten in a variety of food
matrices at levels below 20 ppm.
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
2803
76). FDA requests comments on the
appropriateness of 20 ppm gluten as the
proposed threshold level as determined
using an ELISA-based method.
As new, more sensitive methods of
detection are developed, use of a
methods-based approach, if not
tempered by consideration of other
factors, could result in a threshold level
that is lower than the proposed
threshold level of 20 ppm gluten. For
example, the manufacturer of a test kit
that uses an ELISA-based method that
has been validated at the 160 ppm
gluten detection level (Ref. 77) is
seeking validation of that method at the
5 ppm gluten detection level (Ref. 78).
Given the possibility that new, more
sensitive methods of detection will be
developed in the near future, FDA
requests comments on what effects the
adoption of a lower threshold level
would have on individuals with celiac
disease and on industry. FDA is
interested in receiving scientific data or
other information that addresses the
question of whether the adoption of a
lower threshold level would be of
benefit to individuals with celiac
disease. FDA is also interested in
receiving comments and supporting
data on whether the use of a lower
threshold level could reduce the
commercial availability in the United
States of foods labeled gluten-free and
whether that reduced availability could
negatively impact individuals with
celiac disease (e.g., by making it more
difficult for them to comply with dietary
restrictions, perhaps leading to
increased health risks).
In addition, FDA requests comments
on whether a safety assessment or risk
assessment that addresses gluten
threshold levels for individuals with
celiac disease has been conducted by
other entities. FDA also requests
information on any gluten tolerance
studies that have been published in the
scientific literature since March 2006
when FDA posted the revised
Thresholds Report.
FDA recognizes that even those foods
that comply with the proposed
threshold level of 20 ppm gluten
nonetheless may contain some gluten
up to 20 ppm. FDA questions whether
the potential presence of some gluten up
to 20 ppm would be a material fact that,
if omitted, would make a ‘‘gluten-free’’
claim potentially misleading. FDA
requests 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
E:\FR\FM\23JAP1.SGM
23JAP1
2804
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
whatever threshold level is established
in the final rule.
FDA is aware that at least one other
regulatory body outside the United
States has developed a two-tiered
approach to gluten-related food labeling.
Australia and New Zealand have
established standards for ‘‘gluten-free’’
(meaning no detectable gluten) and
‘‘low-gluten’’ (meaning no more than 20
milligrams gluten per 100 grams of the
food, which is equivalent to no more
than 200 ppm gluten in the food) (Ref.
79). As discussed in section III.C.6 of
this document, one regulatory option
(Option Six) was to develop a 2–tiered
approach to a gluten-related food
labeling in the United States. However,
it is unclear what the scientific basis for
such an approach would be; a safety
assessment could provide a basis for a
threshold, as described in the draft and
revised Thresholds Reports, but would
not provide a basis for a two-level
approach. Thus, FDA tentatively
concludes that this approach is not
feasible because we do not have
sufficient scientific data to recommend
a specified level of gluten to define the
term ‘‘low gluten.’’ In the absence of
such information, use of the term ‘‘low
gluten’’ in the labeling of food could
make that labeling potentially
misleading. FDA requests comment on
this tentative conclusion, including
comment on a possible scientific basis
for setting a level of gluten to be defined
as ‘‘low gluten.’’
Also, in the absence of a regulatory
definition of ‘‘low-gluten,’’ FDA is
concerned that different and
inconsistent definitions of that term
may be developed and used by industry,
and that use of the term under such
circumstances could mislead
consumers. Therefore, FDA is
considering whether it is necessary to
prohibit use of the claim ‘‘low-gluten’’
and similar claims in the labeling of
foods. FDA requests comment on this
potential prohibition.
C. Compliance and Enforcement of an
FDA Gluten-Free Food Labeling Claim
As previously discussed, FDA has
identified 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.
However, determinations of compliance
with the proposed regulation need not
be based on analysis of a food. In the
enforcement of FDA-regulated food
labeling claims, the agency routinely
uses a variety of techniques, such as
label reviews, onsite inspections of food
manufacturers, and analysis of food
samples. FDA does not necessarily
analyze a food when other information
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
or evidence exists that would enable the
agency to determine that the food is
misbranded. For example, if flour
derived from spelt or kamut, which are
species of wheat, is declared in the
ingredient list for a bread labeled
gluten-free, FDA would not have to
analyze the product to deem it
misbranded. This is because all flours
made from cereal grains contain those
grains’ naturally occurring proteins.
Likewise, if an FDA inspector were to
observe the manufacturing of such a
bread with spelt or kamut flour, the
agency would not have to analyze the
product to deem it misbranded.
There are circumstances when FDA
may seek to analyze a food to determine
if it is misbranded, such as in cases
when FDA investigates complaints from
consumers who report experiencing
adverse health effects after eating a
product, and an FDA label review or
onsite inspection of the manufacturing
facility is insufficient to identify
whether there is a problem with the
food. For example, an ingredient may
not have been declared on the food label
or a declared ingredient may
inadvertently contain an undeclared
substance. In such cases, an analysis of
the food may be the only way to identify
the presence of the substance that is the
subject of the ‘‘free’’ labeling claim.
III. Preliminary Regulatory Impact
Analysis
FDA has examined the impacts of this
proposed rule under Executive Order
12866, the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs 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 believe that
this proposed rule is not a significant
regulatory action under the Executive
Order.
A. Need for This Regulation
FALCPA directs the Secretary of HHS
to issue, in consultation with
appropriate experts and stakeholders, a
rule to define and permit use of the term
‘‘gluten-free’’ on the labeling of foods.
B. Proposed Regulatory Options
We considered several regulatory
options or alternatives: (1) Take no
action; (2) take the proposed action—
i.e., do not permit firms to make glutenfree claims on foods containing (a) the
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
prohibited grains; (b) ingredients
derived from the prohibited grains that
have not been processed to remove the
gluten; (c) ingredients derived from the
prohibited grains that have been
processed to remove gluten, if the use of
such ingredients results in the presence
of gluten in the food at a level of 20 ppm
or more; or (d) 20 ppm or more gluten
from any source. We are also proposing
as part of this option to restrict the
wording of gluten-free claims on foods
that inherently do not contain gluten;
(3) take the proposed action, except
enforce the prohibition when the level
of gluten exceeds some specified level
other than 20 ppm in situations in
which the gluten that is present in the
food is (a) from ingredients derived from
a prohibited grain that have not been
processed to remove the gluten or (b)
from commingling; (4) do not permit
firms to make gluten-free claims on
foods containing 20 ppm or more
gluten, regardless of the ingredients they
use to make them, and restrict the
wording of gluten-free claims on foods
that inherently do not contain gluten;
(5) take the proposed action, except
delete the wording requirements for
gluten-free claims on foods that
inherently do not contain gluten; (6)
take the proposed action, but also define
the food labeling claim ‘‘low gluten;’’
and (7) take the proposed action, except
include oats in the list of grains that we
propose to prohibit in foods that firms
label as gluten-free. We request
comments on these options as well as
suggestions for other regulatory policy
options that we should consider. We
will address any significant comments
or suggestions in the analysis of the
final rule.
C. Impacts of the Proposed Regulatory
Option
The primary impacts of the regulatory
alternatives that we discuss in the
following analysis are costs for firms to
make any necessary changes to food
labels and the impact of any label
changes on consumer search costs. A
decrease in search costs is a benefit; an
increase in search costs is a cost.
1. Option One: Take No Action
We can only define costs and benefits
relative to a baseline. We usually select
the option of taking no action as the
baseline because it helps readers
identify the costs and benefits of actions
that change the status quo. By
definition, the baseline itself has no
costs or benefits. This does not mean
that we ignore the costs and benefits of
taking no action. Instead, it means that
we express the costs and benefits of
E:\FR\FM\23JAP1.SGM
23JAP1
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
taking no action in the costs and
benefits of the other regulatory options.
2. Option Two: Take the Proposed
Action—Do Not Permit Firms to Make
Gluten-Free Claims on Foods
Containing the Prohibited Grains or
Ingredients That Have Been Derived
From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not
Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients
Derived From the Prohibited Grains
That Have Been Processed to Remove
the Gluten, if the Level of Gluten Is 20
ppm or Greater; Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing 20 ppm or More Gluten,
Regardless of How the Gluten Got Into
the Food; and Restrict Wording of
Gluten-Free Claims on Foods That
Inherently Do Not Contain Gluten
a. Overview. We are proposing to
prohibit firms from making gluten-free
claims on the labels of foods that
contain any of the following: (1)
Ingredients that are any of the species of
the grains wheat, rye, barley, or a
crossbred hybrid of these grains (e.g.,
triticale) (these grains are collectively
referred to as ‘‘prohibited grains,’’ a
term we propose to define in this rule);
(2) ingredients that have been derived
from a prohibited grain and have not
been processed to remove the gluten; (3)
ingredients that have been derived from
a prohibited grain and have been
processed to remove the gluten, if the
use of such ingredients results in the
presence of gluten in the food at a level
of 20 ppm or more; and (4) 20 ppm or
more gluten from any source. We do not
specify a particular level for the first
two categories of substances because we
would not need to test such products to
determine the presence of gluten.
Instead, we would be able to determine
the presence of gluten by (1) reading the
labels of the foods bearing gluten-free
claims to determine if firms declared
any of the prohibited grains or
ingredients derived from the prohibited
grains that have not been processed to
remove the gluten in the ingredient list
or (2) by conducting onsite inspections
of manufacturing facilities to observe if
firms were using any of the prohibited
grains or ingredients derived from the
prohibited grains that have not been
processed to remove the gluten to make
a food labeled gluten-free. Specifying a
level of 20 ppm for the third and fourth
categories of substances enables us to
test food containing those substances to
determine if they contained gluten. The
third category of substances refers to
ingredients that have been derived from
a prohibited grain but have been
processed to remove the gluten. Some
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
common examples from among the
many ingredients in this category are
wheat starch, malt extract, and malt
vinegar. Depending on the effectiveness
of the procedures used, people may be
able to remove all the gluten from those
ingredients. Thus, we would not be able
to determine if food that firms made
using those ingredients contained gluten
by simply reading the ingredient list.
The fourth category of substances refers
to gluten from any source including
commingling with any of the prohibited
grains. We would not be able to
determine if food contained gluten due
to commingling by reading the
ingredient list.
Not permitting gluten-free claims on
foods that firms make using the
prohibited grains and ingredients that
have been derived from them and have
not been processed to remove the gluten
would have no impact on current
labeling because we already do not
permit firms to make gluten-free claims
on foods that contain gluten, and any
product that firms make using
prohibited grains and ingredients that
have been derived from them and have
not been processed to remove the gluten
would contain gluten. Similarly,
specifying 20 ppm or more gluten as the
amount of gluten that would cause a
food bearing a gluten-free labeling claim
to be misbranded, if the gluten that is
present in the food is from ingredients
that have been derived from a
prohibited grain and have been
processed to remove the gluten or from
any other source, would have no impact
on current food labeling. Although to
date we have not identified a maximum
level of gluten that would be
permissible in a food bearing a glutenfree claim, we generally would regard a
claim that a food is ‘‘free’’ of a substance
as false or misleading if the food
actually contains that substance. As we
discussed earlier in this preamble, a
method exists that can reliably and
consistently detect the presence of
gluten at a level of 20 ppm. If we were
to take enforcement action against a
product with a gluten-free claim under
our existing regulations and policies, we
would use this test to determine
whether a food bearing a gluten-free
claim is misbranded. Therefore, these
two elements of the proposed rule do
not change the status quo and cannot
generate costs or benefits.
We recognize that some firms may
currently be making gluten-free claims
on the labels of products that contain
gluten at levels of 20 ppm or more. Any
costs to these firms from changing
product labels are not costs of this rule
but of the existing statute that prohibits
false or misleading labeling. We are also
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
2805
proposing to restrict how firms may
word gluten-free claims that appear on
inherently gluten-free food. In addition
to the requirement that such food not
contain 20 ppm or more gluten from any
source, we also propose that if a food,
other than a food made from oats, that
inherently does not contain gluten bears
a gluten-free labeling claim, then the
wording of the claim must clearly
indicate that all foods of the same type,
not just the brand bearing this labeling
claim, are gluten-free. Two examples of
the wording of a claim that would meet
both criteria are ‘‘milk, a gluten-free
food’’ and ‘‘all milk is gluten-free.’’
Currently, we determine whether a
gluten-free claim on an inherently
gluten-free product is misleading on a
case-by-case basis. Therefore, this
element could generate both costs and
benefits. We also propose that a food
made from oats can bear a gluten-free
labeling claim if the wording of the
claim does not refer to all foods of the
same type as gluten-free. This element
could also generate both costs and
benefits.
b. Costs. Restricting the wording of
gluten-free claims on inherently glutenfree foods could generate compliance
costs because it would require firms to
remove or change current gluten-free
claims on inherently gluten-free foods
that use wording that does not meet our
proposed requirements. We searched
the Food Labeling and Packaging Survey
2000 (FLAPS 2000) database for foods
bearing gluten-free claims and found the
following types of foods: Yeast,
enriched rice drink, pad Thai noodles
(rice noodles and sauce), and rice
pudding. In addition, we found ‘‘wheat
gluten-free’’ claims on yeast and a soy
protein shake. We would not classify as
inherently gluten-free any of the foods
that we identified in FLAPS as bearing
gluten-free claims because firms could
formulate or manufacture those types of
foods to contain gluten. Based on this
information, we estimate that this
element of the proposed rule would
generate minimal or no relabeling costs.
In addition, this element might
generate increased search costs for some
consumers by suppressing the use of
gluten-free claims on inherently glutenfree food other than foods made from
oats. The incentive for firms to use these
claims increases with the ability of the
claims to increase profits. Gluten-free
claims that consumers interpret to refer
to a particular brand probably increase
that particular firm’s profits more than
gluten-free claims that consumers
interpret to refer to general product
types because such brand-specific
claims provide consumers a reason to
buy a particular brand of product while
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
2806
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
product-type claims only provide
consumers a reason to buy any product
within a given product-type category.
Therefore, requiring firms to use
wording that refers to general product
types would reduce to some degree the
incentives for firms to use gluten-free
claims and, therefore, would probably
reduce the number of such claims
appearing on inherently gluten-free
food. However, some firms may still use
gluten-free claims to influence
consumers choosing between general
product-type categories. The cost
generated by this potential reduction in
the use of gluten-free claims on
inherently gluten-free food depends on
the usefulness of such claims for
consumers. Reducing the use of glutenfree claims would not generate costs for
consumers who are already aware of
inherently gluten-free foods because
they would not need such claims to
identify those foods. However, reducing
the use of gluten-free claims could
generate costs for consumers who are
not aware that some inherently glutenfree foods are gluten-free because they
might currently use such claims to help
identify those foods as foods they can
eat when following a diet that does not
include gluten. We do not have
sufficient information to estimate this
potential cost.
c. Benefits. Restricting the wording of
gluten-free claims on inherently glutenfree foods other than foods made from
oats might generate benefits for some
consumers by making any gluten-free
claims that do appear on inherently
gluten-free food more informative.
These benefits would depend on the
usefulness of such information for
consumers. The wording restrictions
would not benefit consumers who
already know that inherently gluten-free
foods are gluten-free either from prior
knowledge or because they infer it from
the existence of gluten-free claims on
multiple foods within a given product
category. However, the wording
restrictions would benefit consumers
who are unaware that certain inherently
gluten-free foods are inherently free of
gluten. The optimal level of informative
labeling would balance the
countervailing impacts of the potential
reduction in the number of gluten-free
claims and the increase in the
information content of each gluten-free
claim. We do not have sufficient
information on consumers’ knowledge
of inherently gluten-free food or on the
number of such foods that firms might
choose to identify as inherently glutenfree in the future to estimate these
benefits.
Restricting the wording of gluten-free
claims on foods made from oats might
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
generate benefits for some consumers by
making any gluten-free claim that does
appear on those foods less likely to
mislead consumers by implying that
those foods cannot contain gluten via
commingling with the prohibited grains.
We do not have sufficient information
on the impact on consumers of avoiding
potential confusion about the possibility
that foods made from oats may contain
gluten via contact with the prohibited
grains or on the number of foods made
from oats that firms might choose to
label as gluten-free in the future to
estimate these benefits.
d. Summary. Not permitting glutenfree claims on foods that firms make
using the prohibited grains or
ingredients that have been derived from
them and have not been processed to
remove the gluten would not generate
costs or benefits. Similarly, not
permitting gluten-free claims on foods
that firms make using ingredients that
have been derived from prohibited
grains and have been processed to
remove the gluten and on foods that
contain gluten from any other source, if
those foods contain 20 ppm or more
gluten, would also not generate costs or
benefits. Both of these proposed
requirements are consistent with how
we would currently enforce our existing
statute that prohibits false or misleading
labeling statements. Restricting the
wording of gluten-free claims on foods
that inherently do not contain gluten
might require some firms to change
product labels. However, we were
unable to identify any such foods.
Therefore, we estimate that these costs
would be minimal. Restricting the
wording of gluten-free claims on
inherently gluten-free foods may also
generate future costs and benefits by
changing the incentives to use such
claims and changing the information
content of gluten-free claims on affected
foods. We do not have sufficient
information to quantify these potential
costs and benefits.
3. Option Three: Take the Proposed
Action, Except Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing Ingredients Derived From
the Prohibited Grains That Have Been
Processed to Remove The Gluten, if The
Level of Gluten Is Some Specified Level
Other Than 20 ppm, and Do Not Permit
Firms to Make Gluten-Free Claims on
Foods If the Level Of Gluten Is Some
Specified Level Other Than 20 ppm,
Regardless of How the Gluten Got Into
the Food
a. Overview. Under this option, we
could specify a threshold level that was
either higher or lower than 20 ppm
gluten for deeming a food labeled
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
gluten-free to be misbranded, when the
gluten that is present in that food is
from ingredients that have been derived
from the prohibited grains and have
been processed to remove the gluten or
from any other source. However, we
have chosen to analyze alternative
levels higher than 20 ppm gluten
because we do not know of any
currently available and appropriate test
methods that can reliably and
consistently detect gluten at levels
below 20 ppm. Specifying a level higher
than the proposed level of 20 ppm
gluten would expand the number of
foods that would be eligible to bear
gluten-free claims and would generate
both costs and benefits. We do not need
to specify precisely a level above the
proposed level of 20 ppm in order to
analyze this option. We note that if we
were to choose this option, then we
would need additional scientific data to
analyze the costs and benefits of
whatever level we chose.
Specifying a level higher than 20 ppm
gluten would not generate compliance
costs for industry because gluten-free
claims are voluntary and no firms
would need to remove existing labeling
claims that are appropriate under the
statute. However, it could generate
search costs for some consumers. As we
discussed in section I.A of this
document, the symptoms of celiac
disease are highly variable among
affected individuals. We don’t know the
reasons for this variability. Some
individuals with celiac disease may be
unable to tolerate whatever level of
gluten we might specify. Individuals
who cannot tolerate whatever level of
gluten we might specify might
nevertheless continue to rely on glutenfree claims to identify appropriate foods
and might suffer adverse health
consequences from doing so. However,
we assume that most consumers who
use gluten-free claims to identify
appropriate foods will have been
diagnosed with celiac disease and will
be under a physician’s care for that
condition. Therefore, sensitivity to
whatever level of gluten we might allow
would probably be detected within a
short time and these individuals would
probably not continue to rely on glutenfree claims to identify appropriate
foods. The more likely consequence,
and the consequence that we base the
remainder of our analysis upon, is that
consumers who are sensitive to gluten at
this higher level would no longer be
able to rely on gluten-free claims to
identify foods that are safe for them to
eat and would need to take other steps
to identify these foods. This would
increase the cost for these consumers to
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
find appropriate foods. The increased
search costs might cause these
consumers to conduct fewer searches for
appropriate foods, which could lead
them to reduce their compliance with a
diet that does not include gluten and
increase their risk of various adverse
health effects. In addition, increased
search costs for some consumers would
tend to discourage firms from
continuing to produce or develop new
foods that contain no gluten because it
could reduce their ability to inform
consumers of such foods using glutenfree labeling claims, although they
could continue to inform consumers
about these foods in other ways. This
might further reduce the compliance of
these consumers with a diet that does
not include gluten and generate
additional adverse health effects.
Under this option, the potential
benefits of specifying a level greater
than 20 ppm gluten, when the gluten
that is present in the food is from
ingredients that have been derived from
a prohibited grain and have been
processed to remove the gluten or from
any other source, are similar in nature
but opposite in effect to the costs and
would accrue to different consumers.
Consumers who can tolerate whatever
level we specify would value our
adopting that level because it might
allow them to use gluten-free claims to
identify a greater range of appropriate
foods. This reduction in search costs
could lead these consumers to conduct
additional searches for appropriate
foods, which could lead to them to
increase their compliance with diets
that do not include gluten and lower
their risk of adverse health effects. In
addition, the decreased search costs for
these consumers would tend to
encourage firms to produce or develop
foods with up to the specified level of
gluten, which could increase these
consumers’ compliance with a diet that
does not include gluten and further
reduce their risk of adverse health
effects.
We do not know how much some
consumers and firms would value our
specifying a level higher than 20 ppm
gluten. The potential value for
consumers who would benefit from this
option is probably lower on a perperson basis than the corresponding
potential loss for consumers who would
be unable to tolerate the level of gluten
allowed under the specified level
because the incremental effect on a
given individual’s search costs of
gluten-free claims appearing on some
additional foods is smaller than the
incremental effect of losing the use of
gluten-free claims on all foods.
However, we do not know how many
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
consumers can and cannot tolerate
particular levels of gluten. Therefore, we
cannot draw any conclusions on the net
benefits of specifying different levels.
This option would include the
provisions restricting the wording of
gluten-free claims on inherently glutenfree food. Therefore, it would also
generate the costs and benefits that we
associated with those provisions in our
discussion of Option Two (the proposed
action) previously discussed.
b. Costs. As we discussed in the
preceding overview, this option would
increase search costs for consumers who
are unable to tolerate the specified level
of gluten. However, as we discussed in
section I of this document, accurately
estimating the prevalence of celiac
disease in the United States is difficult
for a variety of factors. These factors
also demonstrate that individuals vary
for many reasons in their sensitivity to
gluten. One researcher who did attempt
to identify a level that all celiac patients
can tolerate was Fasano (Ref. 80), who,
based on data from Catassi, et al., (Ref.
81) and Collin, et al., (Ref. 82),
suggested that all individuals with
celiac disease may be able to tolerate
between 20 and 100 ppm. (See Ref. 69
at pp. 39 and 40 for further discussion
of this literature.) Some researchers
address this issue in the context of
wheat starch because wheat starch is a
common ingredient that contains
varying and sometimes very low levels
of gluten (Refs. 41, 82, and 83). In
general, as we discussed in both the
draft and revised Thresholds Reports
(Ref. 67, pp. 35 and 36 and Ref. 69, pp.
39 and 40) , the studies are inconclusive
about the safety and subjective
acceptability of foods that contain 20
ppm or more gluten for individuals with
celiac disease. To reflect this
uncertainty, we assume that 0 percent to
100 percent of consumers with celiac
disease are unable or unwilling to
tolerate 20 ppm or more gluten over the
long term and, therefore, would be
unable to continue to use gluten-free
claims to identify appropriate foods
under this option.
Physicians have diagnosed
approximately 40,000 to 60,000 people
as having celiac disease in the United
States (Refs. 17 and 18). We assume that
physicians have prescribed a diet that
does not include gluten for all
consumers they have diagnosed with
celiac disease. If 0 to 100 percent of
these consumers cannot tolerate 20 ppm
or more gluten, and if all of these
consumers currently use gluten-free
claims to identify appropriate foods,
then 0 to 60,000 people who currently
use gluten-free claims would be unable
to continue to do so.
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
2807
We assume that only consumers who
have been diagnosed with celiac
disease, or those who buy food for such
consumers, are currently using glutenfree claims to find appropriate foods.
However, some consumers who have
not been diagnosed as having celiac
disease may also follow a diet that does
not include gluten on their own
initiative if they are experiencing
symptoms of gluten intolerance. We
consider this group to illustrate the
consequences of our assumption that
only those consumers who have been
diagnosed with celiac disease use
gluten-free claims on product labels.
As we explained in section I.B of this
document, the prevalence of celiac
disease in the United States, including
both symptomatic and asymptomatic
individuals, ranges from about 0.4
percent to about 1.0 percent (Refs. 1 and
16), although the actual prevalence may
be higher or lower. Based on this
information, we assume that 0.4 percent
to 1.0 percent of the United States
population may have celiac disease.
One study found that 40 percent of
children and 60 percent of adults who
were newly diagnosed with celiac
disease were symptomatic (Ref. 84).
Therefore, we assume the overall rate of
new celiac patients who are
symptomatic is between 40 percent and
60 percent.
The U.S. population in August 2005
was approximately 297 million (Ref.
85). If the overall prevalence of celiac
disease is between 0.4 percent and 1
percent, then approximately 1.2 million
to 3.0 million people in the United
States have celiac disease. If 40 percent
to 60 percent of people with celiac
disease have symptoms of that disease,
then between 500,000 and 1.8 million
people in the United States have
symptoms associated with celiac
disease. Earlier we noted that only
40,000 to 60,000 people in the United
States have been diagnosed with celiac
disease. Subtracting this number of
people from the estimated number of
people in the United States who have
symptoms associated with celiac disease
and rounding to the nearest tenth of one
million implies that approximately 0.4
million to 1.8 million people have
undiagnosed celiac disease and exhibit
some symptoms of that disease. If some
of these consumers, or those who buy
food for these consumers, are currently
using gluten-free claims to identify
appropriate foods, then the
consequences of revising the criteria for
using those claims would be much
greater than we have estimated based
only on consumers who have been
diagnosed with celiac disease.
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
2808
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
Any consumers who currently rely on
gluten-free claims to identify
appropriate foods and who would be
unable to continue to use those claims
because they cannot tolerate the level of
gluten allowed under the specified level
would probably need to spend
additional time identifying appropriate
foods. In the comments that we received
during the public meeting on gluten-free
food labeling, some comments said they
spent up to an extra 10 hours per week
shopping, while other comments said
they spent five times as much time
shopping as they did before they started
a diet that does not include gluten. One
consumer group reported that some
consumers on a diet that does not
include gluten said they spent an extra
30 minutes per week shopping, while
other consumers said they spent twice
as much time shopping as they did
before they started a diet that does not
include gluten (Ref. 86). This group did
not report how much time the
consumers spent shopping before they
started a diet that does not include
gluten. However, in the analysis of a
previous and unrelated rule, we
estimated that the average shopping
time for all grocery store purchases was
46.2 minutes per week (68 FR 51738 at
51744, August 28, 2003). This average
would have included those on special
diets such as diets that do not include
gluten. However, most people are not on
special diets. Therefore, we interpret the
information from this consumer group
to mean that some consumers on a diet
that does not include gluten who
reported spending twice as much time
shopping spent about 90 minutes
shopping per week. This group did not
report on the smallest amount of extra
time that these consumers spent
shopping; but, we assume that all
consumers on a diet that does not
include gluten would spend at least
some extra time shopping. We have
chosen 10 minutes per week as a
reasonable estimate of this minimum
amount of extra shopping time. We
assume that the results reported by the
consumer group are more representative
of the average consumer on a diet that
does not include gluten than the results
reported by these individual consumers,
who might not be typical of the average
consumer on a diet that does not
include gluten. Based on this
information, we assume that being on a
diet that does not include gluten
increases food shopping time by 10 to
46 minutes per week.
We do not know the difference in
search times for those who can use
gluten-free labels and those who cannot.
The range in search costs that we
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
reported previously probably includes
consumers who make considerable use
of gluten-free claims to identify foods
and consumers who do not. Many
consumers who can make considerable
use of gluten-free claims probably still
need to expend at least some additional
time searching for foods relative to the
average consumer because relatively few
foods bear gluten-free claims. In
addition, some consumers who use
gluten-free claims to identify acceptable
foods may also read ingredient lists to
confirm the absence of gluten (Ref. 87).
Therefore, the ability to use gluten-free
claims probably leads to a relatively
small reduction in extra shopping time
for consumers on diets that do not
include gluten. We do not have
sufficient information to estimate the
time savings associated with being able
to use existing gluten-free claims; but,
we have chosen a range of 10 to 50
percent of the difference between the
low end and the high end of the range
of total extra shopping time, or 0 minute
to 18 minutes per week, as the extra
shopping time that the ability to use
gluten-free claims could reasonably be
expected to eliminate. We request
comments on this assumption.
Consumers who cannot rely on
gluten-free claims and who buy foods in
conventional grocery stores probably
expend the most extra time shopping
because they would have to rely on
ingredient lists or take other approaches
to identifying appropriate foods. These
consumers might need to learn more
about food ingredients or use references
on food ingredients. In addition, some
of these consumers may call or write
manufacturers to ask about ingredients.
Some consumers may look up
information on foods on the Internet.
Finally, some of these consumers may
refer to reference lists of gluten-free
foods that some celiac organizations
publish for this purpose. Consumers
who cannot rely on gluten-free claims
and who buy gluten-free foods in
specialty stores or from mail order firms
probably have lower search costs
because some of these sources may
identify foods that do not contain
gluten. However, gluten-free foods are
typically more expensive when
purchased in specialty stores or from
mail order firms than when purchased
in conventional grocery stores; so, the
reduction in search cost is offset by
increased product prices.
Based on this information, we assume
that losing the ability to rely on the
relatively small number of existing
gluten-free labels may increase search
costs by 0 to 18 minutes per week.
Multiplying this range by the number of
consumers who we estimated might lose
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
the use of gluten-free labeling, 0 to
60,000, results in a potential increase in
search costs of 0 to 18,000 hours per
week. The average value of 1 hour of
leisure time should be similar to the
average value of 1 hour of working time,
which was $26.05 in September 2005
for nonfarm private and State and local
Government workers in the United
States (Ref. 88). Therefore, we estimate
the cost associated with potential
increases in search costs for some
consumers to be $0 to $24 million per
year.
If specifying a level higher than 20
ppm gluten increases product search
costs for some consumers, then it may
also lead those consumers to conduct
fewer searches for appropriate foods,
which could reduce their compliance
with diets that do not include gluten.
Some consumers already have difficulty
following a diet that does not include
gluten. One recent study said that the
literature suggests that only 17 percent
to 65 percent of patients who are
prescribed a diet that does not include
gluten manage to adhere to that diet
(Ref. 89). An earlier study found that
only 2 percent of 130 patients who had
been diagnosed with celiac disease
managed to adhere to a diet that does
not include gluten (Ref. 90). One article
said that poor compliance with diets
that do not include gluten was at least
partially due to the inconvenience of
purchasing and preparing gluten-free
food and the higher prices of gluten-free
foods (Ref. 46). Search costs are one
measure of the inconvenience of
purchasing gluten-free food and
probably also play a role in the higher
cost of such foods.
Some studies have found relatively
high compliance rates for diets that do
not include gluten that allow
ingredients that may have trace amounts
of gluten, such as wheat starch. This
suggests that compliance with diets that
do not include gluten that allow such
ingredients may be higher than
compliance with diets that do not
include gluten that do not allow such
ingredients. One article noted that 85
percent of celiac patients in Finland
manage to adhere over the long-term to
a diet that does not include gluten that
allows wheat starch (Ref. 82). Similarly,
one study that was conducted in
Finland found that 88 percent of the
patients in that study adhered to a diet
that does not include gluten that
allowed wheat starch (Ref. 89). These
percentages are higher than the 2
percent to 65 percent compliance rates
for diets that do not include gluten that
we mentioned in the preceding
paragraph, which were from articles that
appear to have interpreted any gluten
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
intake as a failure to comply with a diet
that does not include gluten. If there is
a difference in compliance rates, then
part of this difference may be because
gluten-intolerant consumers who can
tolerate foods made with ingredients
that may contain trace amounts of
gluten, such as wheat starch, can more
easily find appropriate and acceptable
foods. For example, one study found
that 13 of the 17 consumers in that
study preferred a product made with
wheat starch containing approximately
15 ppm gluten to foods made with rice
flour or cornstarch that were entirely
gluten-free (Ref. 83). On the other hand,
Thompson (Ref. 41) contended that
there is no evidence that compliance is
higher among patients following diets
that do not include gluten that allow
foods made with wheat starch than
among those following diets that do not
include gluten that do not allow foods
made with wheat starch. For example,
some of the differences in the
compliance rates that appear in different
articles may be due to differences in the
usual diets of various countries or other
factors that are unrelated to whether the
diet includes products that contain trace
amounts of gluten such as wheat starch.
Of course, factors other than search
costs and product costs may affect
compliance with a diet that does not
include gluten. For example, one article
that looked at 55 cases of persisting
celiac disease caused by noncompliance with a diet that does not
include gluten found that 73 percent of
those patients were not aware of the
continuing nature of the disease and
thought they had recovered from a
temporary illness, while 27 percent
were aware of the continuing nature of
the disease but were unable to maintain
compliance without additional dietary
counseling (Ref. 90). The authors
suggested that the principal reason for
non-compliance with a diet that does
not include gluten might be the lack of
morbidity associated with chronic
untreated celiac disease. They noted
that although a few patients had
experienced lassitude, abdominal
discomfort, or occasional diarrhea, the
symptoms were not compelling.
Another study also suggested that one
potential reason for intentional noncompliance with a diet that does not
include gluten is that many noncompliant patients have no symptoms
and normal hematological and
biochemical profiles despite notable
mucosal villous atrophy and
inflammation (Ref. 83).
Based on this information, we assume
that if this option raised search costs for
some consumers, then it could lead
them to decrease their compliance with
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
a diet that does not include gluten.
However, we do not have sufficient
information to estimate the incremental
change in compliance rates.
If this option reduced some
consumers’ compliance with a diet that
does not include gluten, then it could
generate adverse health effects for those
consumers. The adverse health effects
associated with celiac disease are highly
variable among affected individuals. We
do not know the reasons for this
variability, but it may depend on the age
and immunological status of the
individual; the amount, duration, or
timing of the exposure to gluten; and the
specific area and extent of the
gastrointestinal tract involved by
disease (Ref. 5). We discussed the
adverse health effects associated with
gluten consumption by celiac patients
in section I.A of this document.
Although decreased compliance with a
diet that does not include gluten would
probably generate some adverse health
effects, the literature is not clear on the
effect of changes in compliance on
health outcomes. Based on this
information, we conclude that any
decrease in compliance with a diet that
does not include gluten could generate
additional cases of various adverse
health effects. However, we cannot
estimate the number of cases from this
effect because we do not have sufficient
information on the impact of this option
on product search costs, the impact of
product search costs on compliance
rates, or the impact of changes in
compliance rates on the risk of various
adverse health effects.
Finally, any reduction in the
usefulness of gluten-free claims for
some consumers might discourage firms
from continuing to produce or
developing foods with a level of gluten
below the specified level. Firms could
use other truthful and not misleading
wording on food labels to inform
consumers that a product was not made
with gluten-containing ingredients or
contained less than the specified level
of gluten. However, these other types of
label statements might not be as
effective as gluten-free claims. This
potential reduction in the number of
foods with a level of gluten below the
specified level might further increase
search costs for consumers who desire
such foods and might further reduce
their compliance with diets that do not
include gluten. We do not have
sufficient information to estimate these
potential costs.
This option would also generate the
costs that we associated with restricting
the wording of gluten-free claims on
inherently gluten-free food in our
discussion of Option Two. We do not
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
2809
have sufficient information to estimate
these costs.
c. Benefits. As we discussed in the
preceding overview, specifying a level
higher than 20 ppm gluten might
generate benefits because it would
enable firms to use gluten-free claims on
additional foods. Consumers who can
tolerate the specified level of gluten
could use gluten-free claims to more
easily identify appropriate foods.
We do not know how many existing
foods contain particular levels higher
than 20 ppm because no information is
available on the amount of gluten in
different grain-derived food ingredients
or finished food (Ref. 69, p. 37).
However, the gluten in many foods that
contain trace amounts of gluten comes
from ingredients such as wheat starch,
malt extract, or malt vinegar. The level
of gluten in wheat starch varies between
14 ppm and 740 ppm (i.e. 7 ppm to 370
ppm prolamin, which corresponds to 14
ppm to 740 ppm gluten) (Ref. 41). One
small survey of 24 wheat-starch derived
flours in Finland found levels of less
than 20 ppm up to 160 ppm gluten (Ref.
82). The gluten levels in these products
were distributed approximately as
follows: 58 percent had 20 ppm or less,
13 percent had more than 20 ppm up to
40 ppm, 13 percent had more than 40
ppm up to 60 ppm, 0 percent had more
than 60 ppm up to 80 ppm, 8 percent
had more than 80 ppm up to 100 ppm,
0 percent had more than 100 ppm up to
140 ppm, and 8 percent had more than
140 ppm up to 160 ppm. One study
analyzed gluten levels in 2 brands of
wheat starch and found levels of
approximately 15 ppm (0.75mg/100g)
and 560 ppm (28mg/100g) (Ref. 83). One
article noted that improved gluten
detection techniques have demonstrated
that some food made with wheat starch
contains more gluten than the current
Codex standard for gluten-free foods
would allow (Ref. 91). Codex Standard
118–1981 (amended 1983) for glutenfree foods that is in effect today defines
‘‘gluten-free’’ to mean that the total
nitrogen content of gluten-containing
cereal grains used to make a product
cannot exceed 0.05 gram nitrogen per
100 grams dry cereal grain (Ref. 92).
However, some authors have attempted
to estimate what this Codex restriction
means in terms of ppm of gluten. One
study estimates that the current Codex
standard allows gluten-free products to
contain up to 500 ppm (50 mg/100 g)
(Ref. 93). Other studies estimate that the
current Codex standard allows glutenfree products to contain up to 600 ppm
gluten (60 mg/100 g) (Refs. 94 and 89).
Based on this information, we assume
wheat starch contains between 14 ppm
and 740 ppm gluten. The level of gluten
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
2810
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
in products made with wheat starch
would be significantly lower, depending
upon the amount of wheat starch used
in proportion to the other ingredients to
make the products. However, we do not
have data on the level of gluten in
products made with wheat starch. Foods
made with malt extract may also contain
low levels of gluten (Ref. 95). Firms
produce malt extract from malt grain
derived from barley. Depending on the
extraction technique, malt extract may
contain residual amounts of gluten. One
study tested some foods containing malt
extract and found gluten in some
samples of chocolate powder, chocolate
milk, and chocolate bars, but not in
breakfast cereals (Ref. 91). Foods that
firms manufacture using other
ingredients, such as oats, may also
contain gluten if these other ingredients
are commingled with grains like wheat,
rye, barley, or triticale (Refs. 63 and 64).
Some individuals with celiac disease
may be able to tolerate levels of gluten
higher than 20 ppm in ingredients such
as wheat starch, malt extract, and malt
vinegar. These consumers may be able
to use current ingredient labeling to
identify appropriate foods if firms list
these types of ingredients on product
labels and no other potential sources of
gluten appear on the ingredient lists.
However, these consumers would not
always be able to use ingredient lists to
determine whether a product contains
gluten because some ingredients’
common or usual names do not identify
their food sources and some ingredients
can be derived from grains that contain
gluten or from grains that do not contain
gluten. In some cases, firms may include
ingredients containing trace amounts of
gluten in other listed ingredients that
have collective names such as flavors
and colors. Other consumers may be
able to tolerate the lower but not the
higher levels of gluten that might occur
in foods that contain these ingredients.
These consumers would not be able to
rely on current ingredient labeling
because some foods that contain these
ingredients could contain more than
whatever amount of gluten higher than
20 ppm those consumers can tolerate.
These consumers would need to take
additional steps to identify foods that
contain gluten at the levels they can
tolerate. These additional steps might
involve using references on gluten
levels in different foods, calling
manufacturers, or buying foods through
specialty vendors that select appropriate
foods or provide advice on acceptable
foods. Using a level higher than 20 ppm
gluten could decrease search costs for
both groups of consumers, but the effect
would be larger for consumers who
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
cannot use the ingredient list to identify
appropriate foods.
We do not know how many
consumers can tolerate any particular
level of gluten. In the preceding
discussion of costs, we estimated that 0
to 100 percent of the 40,000 to 60,000
consumers who we estimated to be
currently on a diet that does not include
gluten cannot tolerate an amount of
gluten higher than 20 ppm. The
corresponding estimate of the
percentage of consumers who can
tolerate a level of gluten higher than 20
ppm also ranges from 0 percent to 100
percent, which corresponds to 0 to
60,000 consumers.
We also do not know the impact on
search costs for these consumers. In the
preceding cost discussion, we estimated
that being on a diet that does not
include gluten increases product search
time by 10 to 46 minutes per week. We
do not know how much of this
increased time cost comes from reading
ingredient labels to identify ingredients
that may contain low levels of gluten or
taking other steps to determine the
gluten levels of foods that have these
ingredients as the only sources of
gluten. However, a reasonable estimate
of the increased time cost is 10 to 50
percent of the difference between the
low end and high end of the range of
total extra shopping time, or 0 minute
to 18 minutes per week after rounding.
Therefore, we assume that allowing
gluten-free claims to appear on foods
with levels of gluten higher than 20
ppm could reduce consumers’ search
costs by 0 to 18 minutes per week. We
request comments on this assumption.
Multiplying the estimated number of
consumers who have been diagnosed
with celiac disease by the number of
minutes results in a potential search
cost savings of 0 to 18,000 hours per
week. The average value of one hour of
leisure time should be similar to the
average value of 1 hour of working time,
which was $26.05 in September 2005
(Ref. 88). Therefore, we estimate the
potential benefit of reduced product
search costs to be $0 to $18 million per
year.
Any decrease in search costs for some
consumers could lead those consumers
to conduct additional searches for
appropriate foods, which might increase
their compliance with a diet that does
not include gluten. If these consumers
increased their compliance with a diet
that does not include gluten, then they
may reduce their risk of adverse health
effects. This option might also
encourage firms to develop new foods
with the specified level of gluten
because it would improve the ability of
firms to signal to consumers through the
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
use of gluten-free labeling claims that a
given product contains less than the
level of gluten. The development of new
foods might also further facilitate
compliance with a diet that does not
include gluten for consumers who can
tolerate the specified level of gluten,
which could lead to additional health
benefits. We do not have sufficient
information to estimate these benefits.
This option would also generate the
benefits that we associated with
restricting the wording of gluten-free
claims on inherently gluten-free food in
our discussion of Option Two. We do
not have sufficient information to
estimate these benefits.
d. Summary. The element of this
option that specifies a level higher than
20 ppm gluten, when the gluten that is
present in the food is from ingredients
that have been derived from a
prohibited grain and have been
processed to remove the gluten or from
any other source, would allow firms to
make gluten-free claims on the labels of
some foods that contain less than this
level of gluten and would generate both
costs and benefits. The costs would
accrue to consumers who cannot
tolerate the specified level of gluten and
the benefits would accrue to consumers
who can tolerate the specified level of
gluten. We do not have sufficient
information to compare the impact of
this option on these two groups of
consumers. Using the full range of 0
percent to 100 percent of consumers
diagnosed with celiac disease as
potentially falling into either group
gives countervailing search costs and
benefits of $0 to $18 million per year.
Changes in search costs could also
generate countervailing health effects
for these two groups of consumers. The
optimal rule from a cost-benefit
perspective would balance the cost of
reducing the usefulness of gluten-free
claims for consumers who have a
relatively high degree of sensitivity to
gluten with the benefit of making
gluten-free claims as useful as possible
for consumers who are attempting to
control their intake of gluten but are
relatively less sensitive to gluten.
However, we do not have sufficient
information to quantify these effects or
to estimate the optimal level of gluten.
The element of this option that would
restrict the wording of gluten-free
claims on inherently gluten-free food
could also generate costs and benefits.
Costs would result from a potential
reduction in the likelihood that firms
will use gluten-free claims on inherently
gluten-free food, while the benefits
would result from the greater
information content or the reduced
potential for misleading consumers of
E:\FR\FM\23JAP1.SGM
23JAP1
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
any such claims that do appear on these
foods. We do not have sufficient
information to determine the net effect
of these countervailing influences.
4. Option Four: Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing 20 ppm or More Gluten,
Regardless of the Ingredients They Use
to Make Them, and Restrict the Wording
of Gluten-Free Claims on Foods That
Inherently Do Not Contain Gluten
Under this option, we would allow
firms to make gluten-free claims on food
that they make from any type of
ingredient if the food does not contain
20 ppm or more gluten. This option
would generate the same costs and
benefits as Option Two except that
applying the 20 ppm level to food that
contains one or more of the prohibited
grains or that contains ingredients that
have been derived from them and have
not been processed to remove the gluten
would represent a change from our
current approach to such claims. Our
current approach to claims of the form
‘‘substance X-free’’ is that a product that
bears such a claim on its label cannot
contain any level of substance X.
Applying this approach to gluten-free
claims implies that we do not allow
firms to use gluten-free claims on foods
they make from these substances
regardless of the level of gluten in that
food. Option Two maintains our current
approach for these foods. Therefore,
applying the level of 20 ppm to this
food would generate costs and benefits
that we did not discuss under Option
Two.
As a practical matter, any product that
firms make from one or more of the
prohibited grains will contain 20 ppm
or more gluten. Therefore, the impact of
applying the level to food that contains
one or more of the prohibited grains is
the same as the impact of our current
position of prohibiting gluten-free
claims on the labels of food containing
these grains. Therefore, this change will
not generate costs or benefits relative to
the baseline.
In contrast, a food that contains
ingredients that have been derived from
a prohibited grain and have not been
processed to remove the gluten may
contain less than 20 ppm gluten.
Therefore, applying the level to this
category of food would result in costs
and benefits relative to the baseline of
our current position. These costs and
benefits would be in addition to the
costs and benefits that we discussed
under Option Two.
The cost of applying the level to food
that contains ingredients that have been
derived from a prohibited grain and
have not been processed to remove the
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
gluten is that we would need to test the
food to determine if it can bear a glutenfree claim. Enforcement actions that
require testing are significantly more
costly for us than enforcement actions
that only require us to read ingredient
lists on food labels. However, we have
not analyzed the difference in costs for
enforcement actions that require testing
and those that do not. In addition, we
cannot estimate how many times we
would need to take enforcement actions
against this type of food. Therefore, we
cannot estimate this additional cost.
This provision would not generate
costs for consumers because consumers
who cannot tolerate 20 ppm gluten are
unable to rely on gluten-free claims to
identify acceptable products under our
current approach and would also be
unable to do so under the proposed
requirements of Option Two. This is
because both our current approach to
claims of the general form ‘‘substance Xfree’’ and the approach expressed in
Option Two allow firms to make glutenfree claims on products that contain less
than 20 ppm gluten if the gluten that is
present in the food is from a source
other than an ingredient that is a
prohibited grain or that has been
derived from a prohibited grain and has
not been processed to remove the
gluten.
The benefit of applying the level of 20
ppm to food that contains ingredients
that have been derived from a
prohibited grain and have not been
processed to remove the gluten is that
firms would be able to begin using
gluten-free claims on this type of food,
provided that the food did not contain
20 ppm or more gluten. This would
generate benefits for consumers who can
tolerate up to 20 ppm gluten because
they would be able to rely on gluten-free
claims to identify additional products.
We do not have sufficient information to
estimate this benefit.
In summary, this option would have
the same costs and benefits as Option
Two except for the costs and benefits of
applying the level of 20 ppm to food
that contains ingredients that have been
derived from a prohibited grain and
have not been processed to remove the
gluten. We do not have sufficient
information to quantify these
countervailing costs and benefits.
Therefore, we cannot compare the net
benefits of this option to the net benefits
of Option Two.
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
2811
5. Option Five: Take the Proposed
Action, Except Delete Wording
Requirements for Gluten-Free Claims on
Foods That Inherently Do Not Contain
Gluten
We could take the proposed action
but delete the requirements relating to
the wording of gluten-free claims on
foods that inherently do not contain
gluten. In that case, we would continue
the status quo approach of determining
whether such claims are misleading on
a case-by-case basis. This would
eliminate the costs and benefits of the
proposed requirements that we
discussed under Option Two. Therefore,
this option would not generate any costs
or benefits.
6. Option Six: Take the Proposed
Action, But Also Define the Food
Labeling Claim ‘‘Low Gluten’’
Under this option, we would specify
requirements for a ‘‘gluten-free’’ labeling
claim as directed by FALCPA and also
specify requirements for a less
restrictive ‘‘low gluten’’ labeling claim
that firms could use on foods that
contained a relatively low level of
gluten at some specified level higher
than 20 ppm. Firms can already use
‘‘low gluten’’ claims if those claims are
truthful and not misleading. However,
we currently do not have a position on
the level of gluten that renders a ‘‘low
gluten’’ claim truthful and not
misleading. Determining an appropriate
level of gluten to use in defining ‘‘low
gluten’’ on a cost benefit basis would
require, among other things, doseresponse data on the health impacts of
various levels of gluten on those with
celiac disease. We do not have sufficient
scientific data to recommend a specified
level of gluten to define the term ‘‘low
gluten.’’ Nevertheless, we address
significant regulatory options in
regulatory impact analyses irrespective
of their feasibility.
This two-tier approach could generate
higher benefits than Option Two in two
ways. First, by establishing explicit
criteria for using ‘‘low gluten’’ claims,
we might encourage firms to use such
claims. Second, by basing the use of
‘‘low gluten’’ claims on a particular
level of gluten, we would standardize
the meaning of ‘‘low gluten’’ claims and
make them more useful for consumers.
Encouraging the use of ‘‘low gluten’’
claims and standardizing the level of
gluten in foods bearing such claims
might generate benefits because a
combination of ‘‘gluten-free’’ claims and
‘‘low gluten’’ claims would provide
claims that might be useful for both
more sensitive and less sensitive
consumers, which would increase the
E:\FR\FM\23JAP1.SGM
23JAP1
2812
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
number of consumers who find such
claims useful and decrease the number
of consumers who might be unable to
continue to use these claims to identify
appropriate foods.
However, this option may also
generate costs beyond those we
discussed under Option Two. First,
some firms may already be using ‘‘low
gluten’’ claims. If we define that term
relative to a particular level of gluten,
then some of these firms may need to
change product labels. We were unable
to identify any foods bearing ‘‘low
gluten’’ labels in the FLAPS database.
Therefore, we estimate that any labeling
costs would be minimal. Second, the
presence of two claims corresponding to
different levels of gluten might confuse
some consumers and lead them to
consume foods with more gluten than
they intend to consume. Encouraging
the use of ‘‘low gluten’’ claims might
exacerbate this potential problem. While
many consumers may be familiar with
‘‘free’’ and ‘‘low’’ content claims in the
context of nutrients, we have not
previously defined ‘‘low’’ claims for
other food substances that some
consumers may need to totally avoid.
We do not have sufficient information to
estimate the costs and benefits of this
option.
jlentini on PROD1PC65 with PROPOSAL
7. Option Seven: Take Proposed Action,
Except Include Oats in the List of Grains
That We Propose to Prohibit in Foods
That Firms Label as Gluten-Free
We could also expand the list of
prohibited grains to include oats. Some
consumers with celiac disease may be
unable to tolerate some of the proteins
that naturally occur in oats and may
prefer to avoid oats in addition to
avoiding the proposed prohibited grains
and ingredients people make from those
grains discussed in Option Two.
However, other consumers with celiac
disease may be able to tolerate the
proteins that naturally occur in oats
and, therefore, may wish to consume
oats when following a diet that does not
include gluten. This option could
generate some relabeling costs because
we currently allow firms to use glutenfree claims on foods that contain oats
but do not contain gluten from
commingling with a prohibited grain.
These firms would need to remove the
gluten-free claims from foods made from
oats if we were to include oats in the list
of prohibited grains. We do not know
how many foods are made from oats and
do not contain gluten, nor do we know
the percentage of such foods that bear
gluten-free claims. We searched the
FLAPS 2000 database and did not find
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
any foods that contained oats and had
a gluten-free claim. Therefore, we
estimate that any labeling costs would
be minimal.
In addition, if we included oats in the
list of prohibited grains, then we would
reduce the usefulness of those claims for
consumers who wish to avoid gluten but
can tolerate the naturally occurring
proteins in oats. The increase in search
costs for these consumers could be
considerable because oats are a common
food ingredient that can be particularly
important for celiac patients who wish
to avoid wheat, rye, barley, and their
crossbred hybrids. An increase in search
costs for these consumers may decrease
their compliance with a diet that does
not include gluten and possibly increase
their risk of adverse health effects.
However, this option would generate
benefits for consumers who wish to
avoid gluten and also wish to avoid oats
because, if we include oats in the list of
prohibited grains, then these consumers
would be able to use gluten-free claims
to identify appropriate foods. Expanding
the usefulness of gluten-free claims for
these consumers would reduce their
search costs, possibly increase their
compliance with a diet that does not
include gluten, and possibly reduce
their risk of adverse health effects.
As we discussed in detail at section
I.C.3 of this document, the literature is
divided on the percentage of consumers
with celiac disease who can tolerate
oats, even when steps have been taken
to prevent commingling with prohibited
grains such as wheat and rye. Based on
this information, we assume that some
consumers with celiac disease may wish
to avoid oats and that the usefulness of
gluten-free claims for these consumers
could depend on whether or not we
include oats in the list of proposed
prohibited grains. However, we do not
have sufficient information to estimate
the number of such consumers or the
net impact of including oats in the
proposed prohibited list of grains.
IV. Regulatory Flexibility Analysis
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. We are not proposing to change
our current position with respect to the
grains or proteins that we associate with
gluten or the level of gluten that we
would use to determine compliance
with the requirements for using glutenfree claims. Further, we know of no
foods that inherently do not contain
gluten and that bear gluten-free claims
that do not meet our proposed wording
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
restrictions and that are produced by
small entities. Therefore, the agency
certifies that the proposed rule would
not have a significant economic impact
on a substantial number of small
entities.
A. Proposed Regulatory Options
We considered the following
regulatory options: (1) Take no action;
(2) take the proposed action—do not
permit firms to make gluten-free claims
on foods containing the prohibited
grains or ingredients that have been
derived from them and have not been
processed to remove the gluten; do not
permit firms to make gluten-free claims
on foods containing ingredients derived
from the prohibited grains that have
been processed to remove the gluten, if
the level of gluten is 20 ppm or greater;
do not permit firms to make gluten-free
claims on foods containing 20 ppm or
more gluten, regardless of how the
gluten got into the food (i.e. declared
ingredient, undeclared ingredient,
contaminant, etc.); and restrict the
wording of gluten-free claims on foods
that inherently do not contain any
gluten; (3) take the proposed action,
except do not permit firms to make
gluten-free claims on foods containing
ingredients derived from the prohibited
grains that have been processed to
remove the gluten, if the level of gluten
is greater than some specified level
higher than 20 ppm, and do not permit
firms to make gluten-free claims on
foods if the level of gluten is greater
than some specified level higher than 20
ppm, regardless of how the gluten got
into the food; (4) do not permit firms to
make gluten-free claims on foods
containing 20 ppm or more gluten,
regardless of the ingredients they use to
make them, and restrict the wording of
gluten-free claims on foods that
inherently do not contain gluten; (5)
take the proposed action, except delete
the wording requirements for gluten-free
claims on foods that inherently do not
contain gluten; (6) take the proposed
action, but also define the food labeling
claim ‘‘low gluten;’’ and (7) take the
proposed action, except include oats in
the list of grains that we propose to
prohibit in foods that firms label as
gluten-free.
B. Impacts of the Proposed Regulatory
Options on Small Entities
1. Option One: Take No Action
Taking no action would have no
impact on small entities.
E:\FR\FM\23JAP1.SGM
23JAP1
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSAL
2. Option Two: Take the Proposed
Action—Do Not Permit Firms to Make
Gluten-Free Claims on Foods
Containing the Prohibited Grains or
Ingredients That Have Been Derived
From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not
Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients
Derived From the Prohibited Grains
That Have Been Processed to Remove
the Gluten, if the Level of Gluten Is 20
ppm or Greater; Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing 20 ppm or More Gluten,
Regardless of How the Gluten Got Into
the Food; and Restrict Wording of
Gluten-Free Claims on Foods That
Inherently Do Not Contain Gluten
We are not proposing to change how
we currently enforce our existing statute
that prohibits false or misleading
labeling other than instituting new
wording requirements for gluten-free
claims on foods that inherently do not
contain gluten. This element may
generate compliance costs for small
entities. However, as we discussed in
the preceding regulatory impact
analysis, we know of no such foods.
Therefore, we estimate that this
proposed rule would generate minimal
or no costs for small entities. We request
information on the impact of the
proposed action and all other options on
small entities.
3. Option Three: Take the Proposed
Action, Except Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing Ingredients Derived From
the Prohibited Grains That Have Been
Processed to Remove the Gluten, If the
Level of Gluten Is Some Specified Level
Other Than 20 ppm, and Do Not Permit
Firms to Make Gluten-Free Claims on
Foods If the Level of Gluten Is Some
Specified Level Other Than 20 ppm,
Regardless of How the Gluten Got Into
the Food
This option would have the same
minimal impact on small entities as
Option Two. As we discussed in the
preceding preliminary regulatory impact
analysis, we could analyze levels either
higher or lower than 20 ppm, but we
have chosen to analyze levels higher
than 20 ppm because we do not know
of any currently available and
appropriate test methods that can
reliably and consistently detect gluten at
levels below 20 ppm. Under Option
Three, specifying a level higher than 20
ppm gluten would not generate
additional compliance costs for small
entities because gluten-free claims are
voluntary and no small firms would
need to remove existing labeling claims
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
2813
that complied with our existing
position. Therefore, we estimate that
this option would also generate minimal
or no costs for small entities.
7. Option Seven: Take Proposed Action,
but Include Oats in the List of Grains
That We Propose to Prohibit in Foods
That Firms Label as Gluten-Free
4. Option Four: Do Not Permit Firms to
Make Gluten-Free Claims on Foods
Containing 20 ppm or More Gluten,
Regardless of the Ingredients They Use
to Make Them, and Restrict the Wording
of Gluten-Free Claims on Foods That
Inherently Do Not Contain Gluten
Including oats in the list of prohibited
grains may generate relabeling costs for
some small firms because we currently
allow firms to make gluten-free claims
on foods that contain oats but do not
contain any of the prohibited grains or
ingredients derived from those grains
provided that any gluten present is less
than 20 ppm. We do not know how
many small firms produce foods that
contain oats but do not contain any of
the prohibited grains or ingredients
derived from those grains and that bear
gluten-free claims. We searched the
FLAPS 2000 database and did not find
any foods that contained oats and bore
gluten-free claims. Therefore, we
estimate that any costs that might accrue
to small entities from this option would
be minimal.
This option would have the same
minimal impact on small entities as
Option Two. Under Option Four,
applying the level of 20 ppm to all
foods, regardless of the ingredients firms
use to make them, would not generate
additional compliance costs for small
entities because gluten-free claims are
voluntary and no small firms would
need to remove existing labeling claims
that they would not already have had to
remove under our existing approach to
regulating gluten-free food labeling.
Therefore, we estimate that this option
would also generate minimal or no costs
for small entities.
5. Option Five: Take the Proposed
Action, Except Delete Wording
Requirements for Gluten-Free Claims on
Foods That Inherently Do Not Contain
Gluten
Taking the proposed action except
deleting the wording requirements for
gluten-free claims would eliminate any
impact on small entities.
6. Option Six: Take the Proposed
Action, but Also Define the Food
Labeling Claim ‘‘Low Gluten’’
Establishing requirements for ‘‘low
gluten’’ claims might generate
compliance costs for small entities. As
we discussed in the preceding
regulatory impact analysis, we currently
allow ‘‘gluten-free’’ claims that are
truthful and not misleading. If we define
‘‘low gluten’’ based on a particular level
of gluten, then some small firms might
need to change their product labels.
However, we were unable to identify
any foods bearing ‘‘low gluten’’ claims
in the FLAPS database. Therefore, we
estimate that any labeling costs
associated with this provision would be
minimal. In addition, the provision
dealing with gluten-free claims on foods
that inherently do not contain gluten
would have a minimal impact on small
entities. Therefore, we estimate that this
option would have minimal or no
impact on small entities.
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
V. Unfunded Mandates
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 $115
million, using the most current (2003)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this proposed rule to result in any 1year expenditure that would meet or
exceed this amount.
VI. Executive Order 13132: Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. Section
4(a) of the Executive order requires
agencies to ‘‘construe * * * 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.’’3
Here, FDA has determined that the
exercise of State authority would
3Because we have determined that the act
preempts State law because the exercise of State
authority conflicts with the exercise of Federal
authority under that statute, we need not construe
our statutory rulemaking authority as required by
section 4(b) of the Executive order.
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
2814
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
conflict with the proposed exercise of
Federal authority under the act.
FDA is the expert Federal agency
charged by Congress with ensuring that
food labeling is truthful and not
misleading. Under section 403(a)(1) of
the act, a food is deemed misbranded if
its labeling is false or misleading in any
particular. In determining whether
labeling is misleading, FDA takes into
account not only representations made
or suggested by statement, word, design,
device, or any combination thereof, but
also the extent to which the labeling
fails to reveal facts material in the light
of such representations or material with
respect to consequences which may
result from the use of the article to
which the labeling relates under the
conditions of use prescribe in the
labeling thereof or under such
conditions of use as are customary or
usual (section 201(n) of the act).
In section 206 of FALCPA, Congress
directs FDA 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. As discussed
elsewhere in this preamble, FDA has
consulted with numerous experts and
stakeholders in the development of this
proposed rule. FDA has learned that
different manufacturers currently have
different and inconsistent definitions of
the term ‘‘gluten-free,’’ and that
individuals with celiac disease need a
standardized definition of the term
‘‘gluten-free’’ to help them make
purchasing decisions that will support
their need to avoid consumption of
gluten. Therefore, FDA believes that
establishing a definition of the term
‘‘gluten-free’’ and uniform conditions
for its use in the labeling of foods is
needed to ensure that individuals with
celiac disease are not misled and are
provided with truthful and accurate
information with respect to foods so
labeled. If State authorities were
permitted to impose labeling
requirements that are inconsistent with
those proposed in this rule, the federal
objective of standardizing use of the
term ‘‘gluten-free’’ in the labeling of
foods to ensure that such labeling is
neither false nor misleading would be
frustrated.
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.’’
This proposed rule would meet the
preceding requirement because it would
preempt state law only to the extent
required to preserve Federal interests.
Section 4(d) of Executive Order 13132
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
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 the Executive order
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
intends to invite the States’
participation in this rulemaking by
providing notice via fax and e-mail
transmission to State health
commissioners, State agriculture
commissioners, and food program
directors as well as FDA field personnel
of FDA’s publication of this proposed
rule. The notice would provide the
States with further opportunity for input
on the rule. It would advise the States
of FDA’s possible action and encourage
the States and local governments to
review the notice and to provide any
comments to the FDA Docket Number
2005N–0279, opened in the [enter date]
Federal Register by [enter date]. FDA is
providing an opportunity for State and
local officials to comment on this
proposed rule. The agency intends to
comply with all of the applicable
requirements under Executive Order
13132 to ensure that this proposed rule
is consistent with the Executive order.
FDA’s Division of Federal-State
Relations intends to invite the States’
participation in this rulemaking by
providing notice via fax and e-mail
transmission to State health
commissioners, State agriculture
commissioners, and food program
directors as well as FDA field personnel
of FDA’s publication of this proposed
rule. The notice would provide the
States with further opportunity for input
on the rule. It would advise the States
of FDA’s possible action and encourage
the States and local governments to
review the proposed rule and to provide
any comments to the FDA Docket No.
2005N–0279, opened in the July 19,
2005, Federal Register, by April 23,
2007. FDA is providing an opportunity
for State and local officials to comment
on this proposed rule.
VII. Environmental Impact Analysis
FDA has tentatively determined under
21 CFR 25.30(k) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
PO 00000
Frm 00020
Fmt 4702
Sfmt 4702
neither an environmental assessment
nor an environmental impact statement
is required.
VIII. Paperwork Reduction Act of 1995
FDA has tentatively concluded that
this proposed rule contains no
collection of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required.
IX. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified by Docket
No. 2005N–0279. If you base your
comments on scientific evidence or
data, please submit copies of the
specific information along with your
comments. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
X. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. FDA has verified the
cited Web site addresses, but is not
responsible for subsequent changes to
them 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 Development Conference
Statement,’’ NIH, Bethesda, MD, pp. 1–15,
June 28–30, 2004, accessible at https://
consensus.nih.gov/2004/
2004CeliacDisease118html.htm on June 22,
2006.
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. 06–4269, pp. 1–11.
October 2005, accessible at https://
digestive.niddk.nih.gov/ddiseases/pubs/
celiac/ on June 22, 2006.
5. Dewar, D., S.P. Pereira, and P.J. Ciclitira,
‘‘The Pathogenesis of Coeliac Disease,’’
International Journal of Biochemistry & Cell
Biology, 36:17–24, 2004.
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
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. Maki, 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. Dube, 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. Hamilton, F., ‘‘Celiac Disease–A Not So
Uncommon Disorder,’’ Presentation,
Transcript of the Center for Food Safety and
Applied Nutrition, Food and Drug
Administration Public Meeting on GlutenFree Food Labeling held in College Park, MD,
p. 33, August 19, 2005, accessible at https://
www.fda.gov/ohrms/dockets/dockets/
05n0279/05n-0279-tr00001-01-vol16.doc on
June 22, 2006. (Also see errata sheet for
transcript accessible at https://www.fda.gov/
ohrms/dockets/dockets/05n0279/05n-0279tr00001-02-erratta-vol16.doc on June 22,
2006.)
18. Peterson, T., ‘‘Goodbye to Gluten,’’ The
Salt Lake Tribune, September 12, 2005.
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. Brown, A., Understanding Food
Principles and Preparation, Second Ed.,
Wadsworth/Thomson Learning, Belmont,
CA, pp. 402–403 and 420–421, 2004.
21. Pomeranz, Y., Modern Cereal Science
and Technology, VCH Publishers, Inc., New
York, NY, pp. 40–42, 44, and 53, 1987.
22. Skerritt, J.H. and A.S. Hill, ‘‘Enzyme
Immunoassay for Determination of Gluten in
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
Foods: Collaborative Study,’’ Journal of the
Association of Official Analytical Chemists,
74(2):257–264, 1991.
23. Hischenhuber, C., R. Crevel, B. Jarry, et
al., ‘‘Review Article: Safe Amounts of Gluten
for Patients With Wheat Allergy or Coeliac
Disease,’’ Alimentary Pharmacology &
Therapeutics, 23(5):559–575, March 1, 2006.
24. Shewry, P.R., N.G. Halford, P.S Belton,
et al., ‘‘The Structure and Properties of
Gluten: An Elastic Protein From Wheat
Grain,’’ Philosophical Transactions of the
Royal Society of London. Series B, Biological
Sciences, 357:133–142, 2002.
25. Kasarda, D.D., Personal
Communication, January 22, 2005.
26. Dicke, W.K., H.A. Weijers, and J.H van
de Kamer, ‘‘Coeliac Disease. II. The Presence
in Wheat of a Factor Having a Deleterious
Effect in Cases of Coeliac Disease,’’ Acta
Paediatricia, 42:34–42, January 1953.
27. van de Kamer, J.H., H.A. Weijers, and
W.K. Dicke, ‘‘Coeliac Disease. IV. An
Investigation Into the Injurious Constituents
of Wheat in Connection With Their Action
on Patients With Coeliac Disease,’’ Acta
Paediatrica, 42:223–231, May 1953.
28. Baker, P.G. and A.E. Read, ‘‘Oats and
Barley Toxicity in Coeliac Patients,’’
Postgraduate Medical Journal, 52:264–268,
May 1976.
29. Anand, B.S., J. Piris, and S.C. Truelove,
‘‘The Role of Various Cereals in Coeliac
Disease,’’ Quarterly Journal of Medicine, New
Series 47(185):101–110, 1978.
30. Kasarda, D.D., ‘‘What We Know About
Grain Safety,’’ Paper Presented at the
Columbia University Celiac Disease and
Other Food Intolerances Conference,
Columbia University Medical Center, New
York, NY, Program Description & Objectives,
pp. 23–33, October 22, 2004.
31. Kasarda, D.D., ‘‘Grains in Relation to
Celiac Disease,’’ Cereal Foods World,
46(5):209–210, 2001.
32. Arentz-Hansen, H., B. Fleckenstein, O.
Molberg, et al., ‘‘The Molecular Basis for Oat
Intolerance in Patients With Celiac Disease,’’
PLoS Medicine, 1:84–92, October 2004.
33. Johnson, D.L., D. Sands, and A.
Pilgeram, ‘‘Indian Ricegrass: A Gluten-Free
Cereal,’’ Presentation Abstract, The
Association for the Advancement of
Industrial Crops Annual Meeting, Saskatoon,
Saskatchewan, Canada, Program and
Abstracts, p. 16, August 25–28, 2002,
accessible at https://www.aaic.org/
02progrm.htm on June 22, 2006.
34. Kupper, C., ‘‘Dietary Guidelines for
Celiac Disease and Implementation,’’
Presentation Abstract, National Institutes of
Health (NIH), NIH Consensus Development
Conference on Celiac Disease, Bethesda, MD,
pp. 91–95, June 28–30, 2004, accessible at
https://consensus.nih.gov/2004/
2004CeliacDisease118Program.pdf on June
22, 2006.
35. van de Wal, Y., Y.M.C. Kooy, P. van
Veelen, et al., ‘‘Glutenin Is Involved in the
Gluten-Driven Mucosal T Cell Response,’’
European Journal of Immunology,
29(10):3133–3139, 1999.
36. Vader, W., Y. Kooy, P. van Veelen, et
al., ‘‘The Gluten Response in Children With
Celiac Disease is Directed Toward Multiple
Gliadin and Glutenin Peptides,’’
Gastroenterology,122(7):1729–1737, 2002.
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
2815
37. Molberg, O., N.S. Flaete, T. Jensen, et
al., ‘‘Intestinal T-Cell Responses to HighMolecular-Weight Glutenins in Celiac
Disease,’’ Gastroenterology, 125(2):337–344,
2003.
38. Ciclitira, P.J., D.J. Evans, N.L.K. Fagg,
et al., ‘‘Clinical Testing of Gliadin Fractions
in Coeliac Patients,’’ Clinical Science,
66:357–364, 1984.
39. Ellis, H.J., E.L. Pollock, W. Engel, et al.,
‘‘Investigation of the Putative
Immunodominant T Cell Epitopes in Coeliac
Disease,’’ Gut, 52:212–217, 2003.
40. European Food Safety Agency (EFSA),
‘‘Opinion of the Scientific Panel on Dietetic
Products, Nutrition and Allergies on a
Request from the Commission Relating to the
Evaluation of Allergenic Foods for Labelling
Purposes,’’ EFSA-Q–2003–016, EFSA
Journal, 32:40–45, 146, 147, 152, 155–157,
159, 160, 167, 169, 171, 174, 181, 187, 189,
192, 193, and 195, 2004, accessible at https://
www.efsa.europa.eu./en/science/nda/
nda_opinions/341.html on June 27, 2006.
41. Thompson, T., ‘‘Wheat Starch, Gliadin,
and the Gluten-Free Diet,’’ Journal of the
American Dietetic Association,
101(12):1456–1459, December 2001.
42. Kagnoff, M.F., ‘‘Overview and
Pathogenesis of Celiac Disease,’’
Gastroenterology, 128:S10–S18, April
Supplement, 2005.
43. Kasarda, D.D., ‘‘Celiac Disease and Safe
Grains,’’ Web page, July 2003, accessible at
https://wheat.pw.usda.gov/ggpages/topics/
Celiac.vs.grains.html on June 22, 2006.
44. Thompson, T., ‘‘Oats and the GlutenFree Diet,’’ Journal of the American Dietetic
Association, 103(3):376–379, March 2003.
45. Lundin, K.E.A., E.M. Nilsen, H.G. Scott,
et al., ‘‘Oats Induced Villous Atrophy in
Coeliac Disease,’’ Gut, 52(11):1649–1652,
2003.
46. Janatuinen, E.K., P.H. Pikkarainen, T.A.
Kemppainen, et al., ‘‘A Comparison of Diets
With and Without Oats in Adults With Celiac
Disease,’’ New England Journal of Medicine,
333(16):1033–1037, 1995.
47. Hardman, C.M., J.J. Garioch, J.N.
Leonard, et al., ‘‘Absence of Toxicity of Oats
in Patients With Dermatitis Herpetiformis,’’
New England Journal of Medicine,
337(26):1884–1887, 1997.
48. Janatuinen, E.K., T.A. Kemppainen,
P.H. Pikkarainen, et al., ‘‘Lack of Cellular and
Humoral Immunological Responses to Oats
in Adults With Coeliac Disease,’’ Gut,
46(3):327–331, 2000.
49. Janatuinen, E.K., T.A. Kemppainen, R.J.
Julkunen, et al., ‘‘No Harm From Five Year
Ingestion of Oats in Coeliac Disease,’’ Gut,
50(3):332–335, 2002.
¨
50. Hogberg, L., P. Laurin, K. FaithMagnusson, K., et al., ‘‘Oats to Children With
Newly Diagnosed Celiac Disease: A
Randomized Double Blind Study,’’ Gut,
53:649–654, 2004.
¨
51. Peraaho, M., P. Collin, K. Kaukinen, et
al., ‘‘Oats Can Diversify a Gluten-Free Diet in
Celiac Disease and Dermatitis
Herpetiformis,’’ Journal of the American
Dietetic Association, 104(7):1148–1150, July
2004.
52. Kelly, C., Public comment number EC4
submitted on July 28, 2005 to Docket No.
2005N–0231 pertaining to Center for Food
E:\FR\FM\23JAP1.SGM
23JAP1
jlentini on PROD1PC65 with PROPOSAL
2816
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules
Safety and Applied Nutrition, Food and Drug
Administration Draft Report entitled
‘‘Approaches to Establish Thresholds for
Major Food Allergens and for Gluten in
Food,’’ pp. 1–2, June 2005, accessible at
https://www.fda.gov/ohrms/dockets/dockets/
05n0231/05N-0231-EC4.htm on June 22,
2006.
53. Kasarda, D.D., Agricultural Research
Service, Western Regional Research Center,
U.S. Department of Agriculture, ‘‘Grains in
Relation to Celiac (Coeliac) Disease,’’ Web
page, updated 1999, accessible at https://
wheat.pw.usda.gov/ggpages/topics/
celiac.html on June 22, 2006.
54. Cureton, P., ‘‘Celiac Consumer: Survey
Results,’’ Presentation and Remarks During
Question and Answer Period, Transcript of
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. 214–215 and
236–237, August 19, 2005, accessible at
https://www.fda.gov/ohrms/dockets/dockets/
05n0279/05n-0279-tr00001-01-vol16.doc on
June 22, 2006.. (Also see errata sheet for
transcript accessible at https://www.fda.gov/
ohrms/dockets/dockets/05n0279/05n-0279tr00001-02-erratta-vol16.doc on June 22,
2006.)
55. Lee, A., Remarks During Question and
Answer Period, Transcript of 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. 237–238, August 19, 2005,
accessible at https://www.fda.gov/ohrms/
dockets/dockets/05n0279/05n-0279-tr0000101-vol16.doc on June 22, 2006. (Also see
errata sheet for transcript accessible at https://
www.fda.gov/ohrms/dockets/dockets/
05n0279/05n-0279-tr00001-02-errattavol16.doc on June 22, 2006.)
56. Case, S., Gluten-Free Diet: A
Comprehensive Guide, Expanded Edition,
Case Nutrition Consulting, Regina,
Saskatchewan, Canada, pp. 21–24, 28, and
29, 2006.
57. Thompson, T., ‘‘Questionable Foods
and the Gluten-Free Diet,’’ Journal of the
American Dietetic Association, 100(4):463–
465, April 2000.
58. American Dietetic Association (ADA),
‘‘Celiac Disease–Nutrition Care–Grains to
Avoid,’’ ADA Nutrition Care Manual,
American Dietetic Association, Chicago,
Illinois, 1 electronic page, 2006, accessible at
www.nutritioncaremanual.org on June 26,
2006.
59. American Dietetic Association (ADA),
‘‘Celiac Disease–Nutrition Care–Oats,’’ ADA
Nutrition Care Manual, American Dietetic
Association, Chicago, Illinois, 2 electronic
pages, 2006, accessible at
www.nutritioncaremanual.org on June 26,
2006.
60. Hager, M., American Dietetic
Association, Public comment letter EC–1482
submitted on September 20, 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,
accessible at https://www.fda.gov/ohrms/
dockets/dockets/05n0279/05n-0279-EC1482Attach-1.pdf on June 22, 2006.
VerDate Aug<31>2005
16:24 Jan 22, 2007
Jkt 211001
61. U.S. Department of Agriculture,
‘‘Official United States Standards for Grain,
Subpart A–General Provisions,’’ pp. A1–A5,
June 1999, accessible at https://151.121.3.117/
reference-library/standards/810101.pdf on
June 2005. [Note standards for specific grains
are accessible at https://www.gipsa.usda.gov/
GIPSA/
webapp?area=home&subject=grpi&topic=sqous on June 22, 2006.]
62. American Gastroenterological
Association, ‘‘Medical Position Statement:
Celiac Sprue,’’ Gastroenterology, 120:1522–
1525, 2001.
63. Thompson, T., ‘‘Gluten Contamination
of Commercial Oat Products in the Unites
States,’’ New England Journal of Medicine,
351(19):2021–2022, 2004.
64. Hernando A., J.R. Mujico, D. Juanas, et
al., ‘‘Confirmation of the Cereal Type in Oat
Products Highly Contaminated With Gluten,’’
Journal of the American Dietetic Association,
106(5):665, May 2006.
65. Armour, B. and T.B. Perry, Cream Hill
Estates Ltd., Public comment letter EMC299
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,
accessible at https://www.fda.gov/ohrms/
dockets/dockets/05n0279/05n-0279_emc000299-03.pdf on June 22, 2006.
66. 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 GlutenFree Food held in College Park, MD, pp. 1–
2, August 19, 2005.
67. 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, accessible at https://www.fda.gov/
ohrms/dockets/dockets/05n0231/05n-0231rpt0001.pdf and https://www.cfsan.fda.gov/
~dms/alrgn.html on June 22, 2006.
68. Food and Drug Administration, ‘‘FDA’s
Responses to Public Comments on the Draft
Report ‘Approaches to Establish Thresholds
for Major Food Allergens and for Gluten in
Food,’’’ Web site posting, March 2006,
accessible at https://www.cfsan.fda.gov/
~dms/alrgcom.html on June 22, 2006.
69. 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, accessible at https://
www.cfsan.fda.gov/~dms/alrgn2.html on
June 22, 2006.
70. Food Advisory Committee, Center for
Food Safety and Applied Nutrition, Food and
Drug Administration, ‘‘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,
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
2005, accessible at https://www.fda.gov/
ohrms/dockets/ac/05/minutes/20054160m1_summary%20minutes.pdf and
https://www.fda.gov/ohrms/dockets/ac/
cfsan05.html on June 22, 2006.
´
71. St2005
17:57 Jan 22, 2007
Jkt 211001
Scandinavian Journal of Gastroenterology,
September, 35(9):947–949, October 2000.
¨
94. Peraaho, M., K. Kaukinen, K. Paasikivi,
et al., ‘‘Wheat-Starch-Based Gluten-Free
Products in the Treatment of Newly Detected
Coeliac Disease: Prospective and
Randomized Study,’’ Alimentary
Pharmacology & Therapeutics, 17(4):587–
594, February 2003.
95. Faulkner-Hogg, K.B., W.S. Selby, and
R.H. Loblay, ‘‘Dietary Analysis in
Symptomatic Patients With Coeliac Disease
on a Gluten-Free Diet: The Role of Trace
Amounts of Gluten and Non-Gluten
Products,’’ Scandinavian Journal of
Gastroenterology, 34(38):784–789, August
1999.
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 proposes to amend 21
CFR part 101 as follows:
PART 101—FOOD LABELING
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.
2. Section 101.91 is added to subpart
F to read as follows:
§ 101.91
Gluten-free labeling of food.
(a) Definitions. (1) The term
‘‘prohibited 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
prohibited grain and that may cause
adverse health effects in persons with
celiac disease (e.g., prolamins and
glutelins).
(3) The labeling claim ‘‘gluten-free’’ or
similar claim (e.g., ‘‘free of gluten,’’
‘‘without gluten,’’ ‘‘no gluten’’) means
that the food bearing the claim in its
labeling does not contain any of the
following:
(i) An ingredient that is a prohibited
grain (e.g., spelt wheat);
(ii) An ingredient that is derived from
a prohibited grain and that has not been
processed to remove gluten (e.g., wheat
flour);
(iii) 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 parts per
PO 00000
Frm 00023
Fmt 4702
Sfmt 4702
2817
million (ppm) or more gluten in the
food (i.e., 20 micrograms or more gluten
per gram of food);
(iv) 20 ppm or more gluten.
(b) Requirements. (1) A food that
bears the claim ‘‘gluten-free’’ or similar
claim in its labeling and fails to meet
the conditions specified in paragraph
(a)(3) of this section will be deemed
misbranded.
(2) With the exception of foods made
from oats, a food that does not
inherently contain any gluten from a
prohibited grain (e.g., milk, corn, frozen
concentrated orange juice) and that
bears the claim ‘‘gluten-free’’ in its
labeling will be deemed misbranded
unless:
(i) The claim refers to all foods of that
same type (e.g., ‘‘milk, a gluten-free
food,’’ ‘‘all milk is gluten-free’’); and
(ii) The food does not contain 20 ppm
or more gluten.
(3) A food made from oats that bears
the claim ‘‘gluten-free’’ or similar claim
in its labeling will be deemed
misbranded if the claim refers to all
foods of the same type (e.g., ‘‘all oats are
gluten-free’’) or if the food contains 20
ppm or more gluten.
(c) Compliance. When compliance
with paragraph (b) of this section is
based on an analysis of the food, FDA
will 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.
Dated: January 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–843 Filed 1–22–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Federal Bureau of Investigation
28 CFR Part 20
[Docket No. FBI 113; AG Order No. 2855–
2007]
RIN 1110–AA24
Carriage of Concealed Weapons
Pursuant to Public Law 108–277; the
Law Enforcement Officers Safety Act
of 2003
Federal Bureau of Investigation
(FBI), Department of Justice.
ACTION: Notice of proposed rulemaking
with request for comments.
AGENCY:
SUMMARY: The Department of Justice
(the Department) is amending Title 28 of
the Code of Federal Regulations to
authorize access to FBI-maintained
criminal justice information systems for
E:\FR\FM\23JAP1.SGM
23JAP1
Agencies
[Federal Register Volume 72, Number 14 (Tuesday, January 23, 2007)]
[Proposed Rules]
[Pages 2795-2817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-843]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 /
Proposed Rules
[[Page 2795]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2005N-0279]
RIN 0910-ZA26
Food Labeling; Gluten-Free Labeling of Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to 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 (all noted grains are collectively referred to
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
parts per million (ppm) or more gluten in the food; or 20 ppm or more
gluten. A food 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'' would be deemed misbranded. FDA also is
proposing to deem misbranded a food bearing 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''). In addition, a food made from
oats that bears a gluten-free claim in its labeling would be deemed
misbranded if the claim suggests that all such foods are gluten-free or
if 20 ppm or more gluten is present in the food. Establishing a
definition of the term ``gluten-free'' and uniform conditions for its
use in the labeling of foods is needed 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 proposed
action is in response to the Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA).
DATES: Submit written or electronic comments by April 23, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0279, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to https://www.fda.gov/ohrms/dockets/
default.htm, including any personal information provided. For detailed
instructions on submitting comments and additional information on the
rulemaking process, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Rhonda R. Kane, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD, 301-436-2371, FAX: 301-436-
2636, e-mail: rhonda.kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Celiac Disease
B. Prevalence of Celiac Disease in the United States
C. Gluten and the Grains of Concern for Individuals with Celiac
Disease
1. Meaning of the Term ``Gluten''
2. Grains of Concern to Individuals with Celiac Disease
3. Uncertainty About Including Oats in the Diet of Individuals with
Celiac Disease
D. FDA's Prior Statements on Gluten-Free Food Labeling
E. Food Allergen Labeling and Consumer Protection Act of 2004 and
Related Activities
1. Food Allergen Labeling and Consumer Protection Act of 2004
2. FDA's Threshold Working Group and Its Report on Approaches to
Establish Thresholds
3. Food Advisory Committee Meeting of July 13-15, 2005
4. Gluten-Free Food Labeling Public Meeting of August 19, 2005
II. Proposed Rule
A. Legal Basis
B. Definitions and Criteria for the Use of the Term Gluten-Free in
Food Labeling
1. Definitions of the Terms ``Prohibited Grains'' and ``Gluten''
2. Definition of the Term ``Gluten-Free''
3. Use of the Term Gluten-Free in the Labeling of Foods That
Inherently Do Not Contain Gluten
4. Use of the Analytical Methods-Based Approach in this Proposed
Rule to Set a Threshold Level of 20 ppm to Define the Term Gluten-Free
[[Page 2796]]
C. Compliance and Enforcement of an FDA Gluten-Free Food Labeling
Claim
III. Preliminary Regulatory Impact Analysis
A. Need for This Regulation
B. Proposed Regulatory Options
C. Impacts of the Proposed Regulatory Options
1. Option One: Take No Action
2. Option Two: Take the Proposed Action--Do Not Permit Firms to
Make Gluten-Free Claims on Foods Containing the Prohibited Grains or
Ingredients That Have Been Derived From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients Derived From the Prohibited
Grains That Have Been Processed to Remove the Gluten, If the Level of
Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the
Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on
Foods That Inherently Do Not Contain Gluten
a. Overview
b. Costs
c. Benefits
d. Summary
3. Option Three: Take the Proposed Action, Except Do Not Permit
Firms to Make Gluten-Free Claims on Foods Containing Ingredients
Derived From the Prohibited Grains That Have Been Processed to Remove
The Gluten, If the Level of Gluten Is Some Specified Level Other Than
20 ppm, and Do Not Permit Firms to Make Gluten-Free Claims on Foods If
the Level Of Gluten Is Some Specified Level Other Than 20 ppm,
Regardless of How the Gluten Got Into the Food
a. Overview
b. Costs
c. Benefits
d. Summary
4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on
Foods Containing 20 ppm or More Gluten, Regardless of the Ingredients
They Use to Make Them, and Restrict the Wording of Gluten-Free Claims
on Foods That Inherently Do Not Contain Gluten
5. Option Five: Take the Proposed Action, Except Delete Wording
Requirements for Gluten-Free Claims on Foods That Inherently Do Not
Contain Gluten
6. Option Six: Take the Proposed Action, but Also Define the Food
Labeling Claim ``Low Gluten''
7. Option Seven: Take Proposed Action, Except Include Oats in the
List of Grains That We Propose to Prohibit in Foods That Firms Label as
Gluten-Free
IV. Regulatory Flexibility Analysis
A. Proposed Regulatory Options
B. Impacts of the Proposed Regulatory Options on Small Entities
1. Option One: Take No Action
2. Option Two: Take the Proposed Action--Do Not Permit Firms to
Make Gluten-Free Claims on Foods Containing the Prohibited Grains or
Ingredients That Have Been Derived From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients Derived From the Prohibited
Grains That Have Been Processed to Remove the Gluten, If the Level of
Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the
Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on
Foods That Inherently Do Not Contain Gluten
3. Option Three: Take the Proposed Action, Except Do Not Permit
Firms to Make Gluten-Free Claims on Foods Containing Ingredients
Derived From the Prohibited Grains That Have Been Processed to Remove
the Gluten, If the Level of Gluten Is Some Specified Level Other Than
20 ppm, and Do Not Permit Firms to Make Gluten-Free Claims on Foods If
the Level of Gluten Is Some Specified Level Other Than 20 ppm,
Regardless of How the Gluten Got Into the Food
4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on
Foods Containing 20 ppm or More Gluten, Regardless of the Ingredients
They Use to Make Them, and Restrict the Wording of Gluten-Free Claims
on Foods That Inherently Do Not Contain Gluten
5. Option Five: Take the Proposed Action, Except Delete Wording
Requirements for Gluten-Free Claims on Foods That Inherently Do Not
Contain Gluten
6. Option Six: Take the Proposed Action, but Also Define the Food
Labeling Claim ``Low Gluten''
7. Option Seven: Take Proposed Action, but Include Oats in the List
of Grains That We Propose to Prohibit in Foods That Firms Label as
Gluten-Free
V. Unfunded Mandates
VI. Executive Order 13132: Federalism
VII. Environmental Impact Analysis
VIII. Paperwork Reduction Act of 1995
IX. Comments
X. References
I. Background
A. 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 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 who have celiac disease, leading to a
lack of absorption of nutrients and 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 age
and immunological status of the individual, the amount, duration or
timing of the exposure to gluten, and the specific area and extent of
the gastrointestinal tract involved by disease (Ref. 5). Symptoms of
celiac disease may be: (1) ``Classical,'' affecting the digestive tract
(e.g., abdominal bloating; cramping and pain; chronic diarrhea;
vomiting; constipation) and resulting in gastrointestinal
malabsorption; or (2) ``atypical,'' affecting mainly other parts of the
body (e.g., fatigue; irritability; behavior changes; bone or joint
pain; tingling numbness in the legs; ulcers in the mouth; tooth
discoloration or loss of enamel; itchy skin rash with blisters called
dermatitis herpetiformis) (Refs. 1, 4, 6, and 7).
A large portion of the subpopulation that has celiac disease may
not experience any symptoms at all and are classified as having
``silent'' or ``latent'' forms 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
[[Page 2797]]
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 but not limited to: 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 and 11 through 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 all sources 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. Prevalence of Celiac Disease in the United States
Precise prevalence data for celiac disease are not available. The
overall prevalence of celiac disease in the U.S. is currently estimated
to range 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). However, the number of Americans with physician-diagnosed celiac
disease is estimated at between 40,000 (Ref. 17) and 60,000 (Ref. 18).
This discrepancy between estimated prevalence and diagnosed cases
has been linked primarily to the fact that celiac disease can be silent
or latent. Some researchers have suggested that the true prevalence is
underreported (Ref. 8). Silent and latent forms of celiac disease may
go undetected in individuals for years before they develop symptoms
causing them to seek medical attention (Ref. 13). 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. Gluten and the Grains of Concern for Individuals with Celiac Disease
1. Meaning of the Term ``Gluten''
There is no single definition of the term ``gluten.'' Technically,
the term ``gluten'' refers to a specific complex of proteins that forms
when wheat flour is mixed with a liquid and physically manipulated,
such as in the kneading of a bread (Ref. 20). This complex of proteins
is composed of both ``gliadins'' and ``glutenins,'' which are found in
approximately equal proportions in most wheat varieties (Refs. 21
through 23). The gliadins belong to a category of proteins called
``prolamins'' and the glutenins belong to a category of proteins called
``glutelins'' (Refs. 20 and 24).
Although, strictly speaking, ``gluten'' pertains only to wheat
proteins, this term is frequently used to refer to the combination of
prolamin and glutelin proteins naturally occurring in other grains,
including those that have not been demonstrated to cause harmful
effects in individuals with celiac disease (e.g., ``corn gluten'' and
``rice gluten'') (Ref. 25). However, in discussions of celiac disease
in the medical literature, the term ``gluten'' is used to refer to
either gluten in wheat or collectively to the proteins (e.g., prolamins
and glutelins) in just those grains that have been demonstrated to
cause harmful health effects in individuals who have celiac disease
(Refs. 3 and 25).
2. Grains of Concern to Individuals With Celiac Disease
The grains that are reported to contain gluten that can cause
harmful health effects in individuals with celiac disease and should be
avoided by them are as follows: Wheat (including durum wheat, spelt
wheat, and kamut), rye, barley, and crossbred hybrids of these grains
(e.g., triticale, which is a cross between wheat and rye), and possibly
oats (Refs. 26 through 30). Rye, barley, and triticale are
taxonomically very closely related to wheat and contain peptides
structurally similar to those found in wheat (Refs. 30 and 31).
Although oats are not as closely related to wheat (Ref. 30), they are
reported to contain some peptides similar to those found in wheat,
which may help to explain why some individuals with celiac disease are
sensitive to oats (Ref. 32). In contrast, the cereal grains believed to
be well tolerated by individuals with celiac disease and which are not
taxonomically as closely related to wheat and are not reported to
contain similar peptides to those found in wheat include: Amaranth,
buckwheat, corn (maize), Indian ricegrass, Job's tears, millet, quinoa,
ragi, rice, sorghum, teff (tef), and wild rice (Refs. 26, 27, 29
through 31, 33, and 34).
There is evidence that both the prolamins (i.e., gliadins) and
glutelins (i.e., glutenins) in wheat adversely affect individuals with
celiac disease (Refs. 2, 27, and 35 through 37). Wheat gliadin subtypes
alpha, beta, gamma, and omega have been shown to cause damage to the
intestinal tract of individuals with celiac disease (Refs. 38, 39, and
40, p. 41). Moreover, it is also believed that the prolamins in rye
(i.e., secalins) and the prolamins in barley (i.e., hordeums) are
responsible for causing adverse health effects in individuals with
celiac disease (Refs. 13, 23, 28, 41, and 42). Oats also have prolamins
(i.e., avenins) that have some amino acid sequences similar to those
occurring in wheat and are believed to be harmful to a small subset of
individuals with celiac disease (Ref. 32). Although the prolamins of
the aforementioned grains and the wheat glutelins are recognized to
cause adverse health effects in individuals with celiac disease, all
cereal grains contain other types of proteins, including albumins and
globulins, which are not currently associated with celiac disease
(Refs. 20 and 21). There is still much unknown about all the specific
proteins in the different grains that can affect individuals with
celiac disease (Ref. 43).
3. Uncertainty About Including Oats in the Diet of Individuals With
Celiac Disease
Currently, there is no general agreement among experts about the
extent to which oats present a hazard for individuals with celiac
disease. Whether oats should or should not be consumed by individuals
with celiac disease has been the subject of controversy for more than
50 years (Ref. 44). There are inconclusive and conflicting results from
research on the effects of oat consumption on individuals with celiac
disease.
Some of this research, in particular early research, suggests that
oat consumption is harmful to individuals with celiac disease (Refs. 26
and 28). More recent studies found that 1 of 19 study participants
(Ref. 45) and 4 of 9 participants (Ref. 32) could not tolerate an
average of about 50 grams dry weight of oats. The oats used in both
studies
[[Page 2798]]
were tested to ensure that they did not contain gluten proteins from
wheat, rye, or barley.
However, multiple studies in the last 10 years have shown that the
ingestion of oats in the diet of individuals who have celiac disease,
in both children and adults, does not necessarily lead to increased
intestinal or skin symptoms or to altered intestinal pathology, and
appears to be preferred to a diet without oats (Refs. 46 through 51).
The average amount of oats consumed by participants in each of these
studies differed, ranging from about 15 grams to 60 grams dry weight
per day. A long-term study that lasted 5 years concluded that
individuals with celiac disease prefer and can tolerate without harmful
effects a daily average consumption of 34 grams dry weight of oats
(Ref. 49).
Although the total number of individuals with celiac disease who
are sensitive to oats is unknown, the findings of many of the
contemporary studies suggest that the proportion of individuals with
celiac disease who cannot tolerate oats in daily amounts of about 50 or
less grams dry weight is probably very low. One celiac expert suggests
that the size of this subpopulation is likely to be less than one
percent of individuals with celiac disease (Ref. 52).
Despite the evidence that the consumption of oats does not present
a risk for most individuals with celiac disease, a major obstacle
impeding general acceptance of oats in the diet of individuals with
celiac disease is the concern about the commingling\1\ of oats with
wheat, rye or barley that can occur during grain production, transport,
storage, or processing (Refs. 44 and 53). Due to this concern, Farrell
and Kelly (Ref. 7) advise individuals with newly diagnosed celiac
disease not to consume oats until their disease is in remission (e.g.,
intestinal tract has healed). Some celiac disease treatment or research
centers in the United States report that they do not support the
inclusion of oats in the diet of individuals with celiac disease,
whereas other centers do, stating that oats can enhance the nutrient
density and fiber content of a diet that avoids all sources of gluten
and possibly improve compliance with this very restrictive diet (Refs.
54 through 56).
---------------------------------------------------------------------------
\1\The cited references use the term ``contamination,'' but
other references use the term ``commingling.'' For purposes of this
proposed rule, FDA has opted to use the term ``commingling,'' and
considers that term to mean ``the process of mixing.''
---------------------------------------------------------------------------
Thompson (Ref. 57) conducted a small, non-randomized mail survey
using a questionnaire about the acceptability of several foods in diets
that do not contain gluten. Thirty seven questionnaires, completed by
celiac disease organizations (United States and foreign), physicians,
and dietitians/nutritionists, were submitted in response to the survey.
Only five (i.e., 1 foreign celiac association and 4 physicians) of the
33 respondents who answered the question about oats considered oats to
be an acceptable food, and none of the four U.S. celiac disease
associations that responded to the survey considered oats to be an
acceptable food for individuals with celiac disease. The reasons given
by respondents for their lack of acceptance of oats included concerns
about the possibility that oats may cause adverse health effects in
individuals with celiac disease either directly or due to the presence
of gluten from another grain (e.g., wheat, rye, or barley), and about
the insufficiency of long-term research that identifies the amount of
oats that can be tolerated by individuals with celiac disease.
According to more recent position statements of 3 of the 4 major
celiac associations in the United States that responded to the earlier
survey conducted by Thompson (Ref. 57), one of these associations
continues to take the position that oats are not an acceptable food for
individuals with celiac disease; but, the other two of these
associations are not opposed to the inclusion of oats in the diets of
individuals with celiac disease, provided that the oats do not contain
gluten from other grains and that the daily amount of oats consumed is
limited to 1 cup cooked (Ref. 56). Both of the latter associations
state that oats can add soluble fiber and nutrients to a diet that
avoids all sources of gluten; but, direct individuals with celiac
disease to consult with their health care providers before introducing
oats into their diet. Also, both of these associations recommend that
individuals with celiac disease who consume oats should have their
levels of antibodies specific to celiac disease monitored periodically.
The recent National Institutes of Health Consensus Conference
Statement on Celiac Disease (Ref. 1) does not identify oats as being
one of the grains that individuals with celiac disease should avoid.
Instead, this statement indicates that it appears that most individuals
with celiac disease can include oats in their diet without harmful
health effects, but that it may not be practical to do so because oats
may contain gluten from other grains due to commingling during their
processing. Similarly, the 2006 edition of the American Dietetic
Association (ADA) Nutrition Care Manual (ADA Manual) recommends that
individuals with celiac disease avoid wheat (including wheat in all of
its varieties, such as spelt, and in all of its forms, such as wheat
starch), rye, barley and their crossbred hybrid varieties (e.g.,
triticale), but does not advise individuals with celiac disease to
presumptively exclude oats from their diet (Ref 58). Instead, the ADA
Manual states: ``* * *Findings from in vivo research on the safety of
oats suggest that most persons with celiac disease can safely consume
moderate amounts of uncontaminated oats without adversely affecting the
intestinal mucosa * * *.'' (Ref. 59). However, the ADA Manual
acknowledges that ``* * *limited evidence suggests that in some persons
with celiac disease, the consumption of uncontaminated oats may result
in mucosal inflammation* * *.'' Further, the ADA Manual advises that
individuals with celiac disease consult with their physicians and
dietitians before deciding to consume oats and that any daily intake
should be limited to about 50 grams of dry oats that ideally have been
tested to ensure that they do not contain gluten from wheat, rye, or
barley. The ADA Manual also reports that some oat millers have
established comprehensive clean-out procedures and control programs to
address the problem of commingling of oats with wheat, rye, and barley.
In addition, in a letter submitted in response to FDA's 2005 public
meeting on gluten-free (see section I.E.4 of this document for details
about this meeting), ADA expressed support for FDA establishing a
definition of gluten-free for oats that is tied to testing that ensures
that those oats do not contain gluten from other grains, so that those
oats could bear a gluten-free labeling claim (Ref. 60).
The commingling of oats with wheat, rye, barley or their crossbred
hybrids or with the grains generally considered to be acceptable for
individuals with celiac disease (e.g., corn and rice) can occur at any
step in the farm-to-table continuum. This is due to the common
practices of growing crops in rotation and in close proximity to one
another as well as using the same equipment and storage bins to harvest
and hold different grains (Ref. 53). Accordingly, the official U.S.
standard for a given grain typically allows for the presence of a small
percentage of other grains (Ref. 61).
It is believed that most oat products commercially available in the
United States contain some gluten from wheat, rye, or barley as a
result of commingling during the oats' growth, harvesting,
[[Page 2799]]
transport, storage, or processing (Refs. 43, 44, 53, 62, and 63). In
2004, Thompson reported that in a recent study 4 samples of each of 3
brands of oat products marketed in the United States were analyzed in
duplicate for gluten from wheat, rye, and barley using an enzyme-linked
immunosorbent assay (ELISA)-based method (Ref. 63). Ten of the 12
samples, representing all 3 brands of oat products, were reported to
contain an amount of gluten ranging from 12 to 1861 ppm, depending upon
the individual sample and brand tested. Thompson concluded that none of
these brands could be considered a reliable source of oats free of
potentially harmful gluten from other grains.
In another study, Hernando and colleagues (Ref. 64) collected 108
samples of commercial oat products (e.g., rolled oats, oat flakes, and
oat flours) from Europe, the United States and Canada. The samples were
analyzed for gluten from wheat, rye, and barley using an ELISA-based
method. In addition, analysis of the samples by polymerase chain
reaction (PCR) was used to identify the particular grains present.
Consistent with the previous findings of Thompson, the presence of
gluten from other grains was found to be widespread. Seventy-nine
percent of the oat samples were reported to contain gluten from wheat,
rye, and/or barley at a level ranging from less than 3 to 8,000 ppm
gluten (Ref. 64). Sixty-one percent of the samples contained more than
200 ppm gluten. Hernando and colleagues also reported barley to be the
predominant grain present.
Although there appears to be widespread commingling of oats with
other grains, it appears that this commingling is preventable. Two
manufacturers who submitted written responses to FDA's 2005 public
meeting on gluten-free food labeling report that the oats they market
in the United States do not contain gluten from wheat, rye, and barley
(Refs. 65 and 66). Examples of the types of special measures reported
by one or both manufacturers to ensure that their oats do not contain
gluten from wheat, rye, and barley are as follows: (1) Contracting with
farmers who are experienced with growing crops to ensure their purity;
(2) using only oat seed certified to be pure; (3) planting oats only in
fields that have not produced wheat, rye, or barley in either 2 or 3
years; (4) establishing a 25- or 30-foot buffer zone separating their
oat crops from other crops; (5) conducting periodic inspections to
remove any stray wheat, rye, or barley plants growing in their fields;
(6) using only dedicated or thoroughly cleaned equipment and facilities
to harvest, transfer, store, and process their oats; (7) having an
independent lab test samples of their freshly harvested and milled
oats, using an ELISA-based method designed to detect gluten naturally
occurring in wheat, rye, and barley; and (8) milling their oats in
dedicated facilities that either only mill oats or only mill oats and
soy.
D. FDA's Prior Statements on Gluten-Free Food Labeling
Currently, there is no FDA regulation that specifically defines the
term ``gluten-free.'' In the preamble to a final rule on the
declaration of ingredients on food packaging published in the Federal
Register of January 6, 1993 (58 FR 2850 at 2864), FDA advised that the
term ``gluten-free'' can be used in the labeling of foods, provided
that when such claim is used, it is truthful and not misleading.
Generally, and absent regulations to the contrary, FDA would regard a
claim that a food is ``free'' of a substance as false or misleading if
the food contains that substance. FDA also noted that the term
``gluten-free'' may be misleading when the food ordinarily does not
contain gluten. Although FDA did not define the term ``gluten,'' FDA
referred to the grains wheat, barley, rye, oats and millet as those
``which commonly contain gluten'' (FR 2850 at 2863).
FDA's view that the term ``gluten-free'' may be misleading when a
food is inherently free of gluten is consistent with FDA regulations
governing the use other ``free'' claims. FDA has issued regulations
that establish requirements for a ``free'' labeling claim made about a
food inherently free of calories (Sec. 101.60(e)(ii) (21 CFR
101.60(e)(ii)), of nutrients (e.g., sodium, Sec. 101.61(b)(1)(iii) (21
CFR 101.61(b)(1)(iii)) and fat, Sec. 101.62(b)(1)(iii) (21 CFR
101.62(b)(1)(iii)), and of other food components (e.g., cholesterol,
Sec. 101.62(d)(1)(ii)(E)). FDA considers ``calorie-free,'' ``sodium-
free,'' ``fat-free,'' and ``cholesterol-free'' labeling claims made for
a food that inherently does not contain these substances to be
misleading to consumers without additional clarifying wording
indicating that all foods of the same type, not just the brand of food
bearing that ``free'' labeling claim, are also free of the stated
substance. Consistent with how FDA has regulated other ``free'' claims,
the agency would consider a gluten-free labeling claim made for a food
that inherently does not contain gluten to be misleading if it is not
accompanied by additional wording to clarify that all foods of the same
type, not just the brand of food bearing the gluten-free claim, are
also free of gluten.
As discussed elsewhere in this preamble, FDA proposes to define
prohibited grain to include all species of wheat, rye, barley, and
their crossbred hybrids. FDA's proposed definition of prohibited grain
would exclude all other grains, including oats and millet.
E. Food Allergen Labeling and Consumer Protection Act of 2004 and
Related Activities
1. Food Allergen Labeling and Consumer Protection Act of 2004
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), 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. FALCPA directs the issuance of a
proposed rule by no later than 2 years after the law's enactment date,
and a final rule by no later than 4 years after the law's enactment
date. FDA is publishing this proposed rule in response to this
directive.
2. FDA's Threshold Working Group and Its Report on Approaches to
Establish Thresholds
FALCPA does not require FDA to establish a threshold level for
gluten. Nonetheless, an important scientific issue associated with the
issuance of this proposed rule is the potential existence of a
threshold level below which it is unlikely that an individual with
celiac disease would experience an adverse health effect.
To address this issue, among others, FDA 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 draft report, Approaches to Establish
Thresholds for Major Food Allergens and for Gluten in Food (the draft
Thresholds Report) (Ref. 67), summarized the current state of
scientific knowledge with respect to a dose-response relationship for
gluten, and presented the following four potential approaches that FDA
might consider in establishing such a threshold level, if the agency
chose to do so (Ref. 67, pp. 2 and 38 through 41):
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)
[[Page 2800]]
from available human challenge studies, applying an appropriate
``uncertainty factor'' multiplier to account for knowledge gaps.
Risk assessment-based--examines known or potential adverse
heath 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.
The report also noted that any decisions on approaches to establish
a threshold for gluten likely would require consideration of additional
factors not addressed in the 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.
A notice of availability for the draft Thresholds Report was
published in the Federal Register (70 FR 35258, June 17, 2005) and the
report was made available through FDA Docket No. 2005N-0231 and the
Center for Food Safety and Applied Nutrition (CFSAN) Web site (https://
www.cfsan.fda.gov/~dms/alrgn.html). FDA requested that interested
persons submit comments and any scientific data or other information
relevant to the draft Thresholds Report to the docket during a 60-day
comment period ending August 16, 2005. The Threshold Working Group
considered the comments, data, and information submitted, and made
appropriate revisions to the Thresholds Report. On May 25, 2006, FDA
posted its response (Ref. 68) to the comments, data, and other
information that the agency received on its draft Thresholds Report
(https://www.cfsan.fda.gov/~dms/alrgcom.html). FDA also posted the
revised Thresholds Report (Ref. 69) (https://www.cfsan.fda.gov/~dms/
alrgn2.html). Both of these documents are dated March 2006.
3. Food Advisory Committee Meeting of July 13 through 15, 2005
In the Federal Register of May 23, 2005 (70 FR 29528), FDA
announced that FDA's Food Advisory Committee (FAC) would be holding a
public meeting on July 13 through 15, 2005, to evaluate the draft
Thresholds Report. One purpose of the meeting was for the FAC to
determine whether the four approaches considered in the draft
Thresholds Report for establishing a threshold level for gluten were
scientifically sound. FDA invited experts to address a number of
specific issues related to sensitivities to gluten. In addition, FDA
invited interested members of the general public to present their
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 standards 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.
Approximately 140 persons attended the FAC meeting. 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 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
(https://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 FDA
Docket No. 2005N-0279 pertaining to this rulemaking. A summary of the
FAC responses to the questions is provided in the Summary Minutes (Ref.
70).
The FAC concluded that the draft 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. 70, p. 1). The FAC also
identified the risk-assessment approach as the strongest of the four
approaches proposed in the draft Thresholds Report, assuming the
availability of sufficient data (Ref. 70, p. 1).
FDA received about 20 public responses, each containing one or more
comments, to the FAC meeting and to the notice of availability and
request for comments on the draft Thresholds Report. (Some of these
responses concerned food allergens and are not relevant to this
proposal.) Approximately half of the total number of responses
mentioned wheat or gluten, and the majority of the responses submitted
about gluten addressed issues or provided data directly related to the
report's suggested approaches to establishing a threshold level for
gluten. Pertinent comments were considered by FDA in the development of
this proposed rule. All written responses submitted to FDA about the
FAC meeting and the draft Thresholds Report are available through FDA
Docket No. 2005N-0231, and copies of those responses that specifically
mentioned wheat or gluten are also available through FDA Docket No.
2005N-0279.
4. Gluten-Free Food Labeling Public Meeting of August 19, 2005
In the Federal Register of July 19, 2005 (70 FR 41356), FDA
announced that it would be holding a public meeting on August 19, 2005,
to discuss the topic of gluten-free food labeling. Interested persons
were given 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, FDA 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.''
More than 80 persons attended the public meeting on gluten-free
food labeling. In response to the notice and public meeting, FDA
received more than 2,400 responses, each containing one or more
comments, about the public meeting or the list of questions cited in
the notice announcing the meeting. The vast majority of these responses
were from individuals with celiac disease, their caregivers, and celiac
disease associations, with a much smaller number of responses being
from the food industry. All written responses submitted to FDA in
response to the gluten-free public meeting and the questions posed in
the corresponding Federal Register meeting notice are available through
the FDA Docket No. 2005N-0279.
Most of the consumers' comments 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 grocery shop, saving the consumers
both time and the frustration
[[Page 2801]]
experienced when reading often lengthy and complicated ingredients
lists that they stated they do not understand. Many consumers also
stated that they currently purchase only or primarily 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 provide them with 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, opinions expressed in comments from these individuals and
organizations varied with respect to whether oats should be excluded
from any products labeled as gluten-free.
Industry comments 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 assist industry by
promoting 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.
Based upon comments that FDA received during this public meeting or
that were submitted in writing to the related FDA Docket No. 2005N-
0279, FDA believes that a uniform definition of the term gluten-free
would prevent confusion and uncertainty among both consumers and food
manufacturers about what this food labeling claim means.
II. Proposed Rule
A. Legal Basis
Section 206 of FALCPA directs the Secretary of HHS, in consultation
with appropriate experts and stakeholders, to issue a proposed rule to
define, and permit use of, the term ``gluten-free'' on the labeling of
foods. FDA has authority to issue this proposed rule under sections
403(a)(1), 201(n), and 701(a) of the act (21 U.S.C. 343(a)(1), 321(n),
and 371(a). Section 403(a)(1) of the act states that, ``A food shall be
deemed to be misbranded if its labeling is false or misleading in any
particular.'' In determining whether food labeling is misleading,
section 201(n) explicitly provides for consideration of the extent to
which the labeling fails to reveal facts ``material with respect to the
consequences which may result from the use of the [food] to which the
labeling * * *relates under * * *such conditions of use as are
customary or usual.'' Section 701(a) of the act vests the Secretary
(and by delegation, FDA) with authority to issue regulations for the
efficient enforcement of the act.
As directed by FALCPA, FDA is proposing to define the term
``gluten-free'' for voluntary use in the labeling of foods. FDA is also
proposing to define various terms corresponding to certain specified
grains and proteins that would be prohibited from use as ingredients or
sources of ingredients used to make a food bearing a ``gluten-free''
labeling claim. Further, FDA is proposing to specify how a voluntary
gluten-free labeling claim must be worded for oats and for other foods
that inherently do not contain any gluten. Any use of the term
``gluten-free'' in the labeling of food that does not conform to the
proposed regulatory definitions and requirements would render that food
misbranded.
In enacting FALCPA, Congress recognized the importance to
individuals with celiac disease of avoiding gluten (FALCPA, section
202(6)(B)). To address this issue, section 206 of FALCPA directs FDA to
issue a regulation to define and permit use of the term ``gluten-
free.'' As discussed elsewhere in this preamble, currently there is
neither a regulatory definition of the term ``gluten-free,'' nor is
there agreement among manufacturers or consumers as to what this term
means. In the course of consulting with experts and stakeholders, FDA
has learned that different manufacturers have different and
inconsistent definitions of the term ``gluten-free.'' Consumers with
celiac disease and their caregivers, who rely on ``gluten-free''
labeling claims to make purchasing decisions, believe that a
standardized definition of the term is needed to ensure that those
consumers know what to expect when purchasing foods labeled as gluten-
free. Therefore, FDA believes that establishing a definition of the
term ``gluten-free'' and uniform conditions for its use in the labeling
of foods is needed to ensure that individuals with celiac disease are
not misled and are provided with truthful and accurate information with
respect to foods so labeled.
B. Definitions and Criteria for the Use of the Term Gluten-Free in Food
Labeling
1. Definitions of the Terms ``Prohibited Grains'' and ``Gluten''
To facilitate proposing a definition of the term ``gluten-free,''
FDA proposes to also define the terms ``gluten'' and ``prohibited
grains.'' FDA proposes in Sec. 101.91(a)(2) to define the term
``gluten'' to mean 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). FDA proposes in Sec.
101.91(a)(1) to define the term ``prohibited grain'' to mean any of the
following grains or their crossbred hybrids (e.g., triticale, which is
a cross between wheat and rye): (1) Wheat, meaning any species
belonging to the genus Triticum; (2) rye, meaning any species belonging
to the genus Secale; and (3) barley, meaning any species belonging to
the genus Hordeum. As discussed in section I.C of this document, the
scientific literature reports general agreement among celiac disease
experts that naturally occurring prolamins or glutelins in wheat, rye,
barley, and their crossbred hybrids can cause serious adverse health
effects in individuals with celiac disease and should be excluded from
their diet.
FDA is not proposing to include oats in the definition of a
prohibited grain. As discussed in section I.C.3 of this document, the
unconditional exclusion of oats from the diet of individuals with
celiac disease is not supported by the National Institutes of Health
Conference Development Conference Statement on Celiac Disease (Ref. 1)
or by the American Dietetic Association (Ref. 58). FDA recognizes that
a small percentage of individuals with celiac disease may not be able
to tolerate some of the proteins that naturally occur in oats. However,
it appears that a great majority of individuals with celiac disease can
tolerate a daily intake of a limited amount (e.g., 50 grams) of oats
that are free of gluten from wheat, rye, barley or their crossbred
hybrids. Oats are reported to add variety, taste, satiety, dietary
fiber, and other essential nutrients to the diet of individuals with
celiac disease; thereby making their diet more nutritious and appealing
(Refs. 44, 51, 56, and 71). Inclusion of oats in the diet of
individuals with celiac disease who can tolerate oats may therefore
result in the improved nutritional and health status of those
individuals (Refs. 55 and 71).
According to comments FDA received in response to its August 2005
public meeting on gluten-free labeling, at least two food manufacturers
can produce
[[Page 2802]]
oats that do not contain gluten from wheat, rye, barley, or any of
their cross-bred hybrids. Allowing such oats to bear a gluten-free
labeling claim would make them easier to identify and perhaps would
encourage other manufacturers to produce such oats. Conversely,
including oats in the definition of prohibited grain could eliminate
any incentive for manufacturers to produce oats free of gluten from
other grains because those manufacturers would have no way of
distinguishing their products in the marketplace. FDA requests comments
on whether the agency should include oats in the definition of a
prohibited grain.
2. Definition of the Term ``Gluten-Free''
FDA proposes in Sec. 101.91(a)(3) to define the claim ``gluten-
free'' to mean that a 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
that has not been processed to remove gluten; (3) an ingredient that is
derived from a prohibited grain and that has been processed to remove
gluten, if the use of that ingredient results in the presence of 20 ppm
or more gluten in the food (i.e., 20 micrograms or more gluten per gram
of food); or (4) 20 ppm or more gluten.
Examples of a prohibited grain include, but are not limited to,
barley, common wheat, durum wheat, einkorn wheat, emmer wheat, kamut,
rye, spelt wheat, and triticale. Examples of ingredients that are
derived from a prohibited grain and that have not been processed to
remove gluten include, but are not limited to:
Farina, flour made from any of the proposed prohibited
grains, graham, and semolina;
Hydrolyzed wheat protein, vital gluten, wheat bran, and
wheat germ; and
Barley malt extract or flavoring and malt vinegar.
Because these ingredients are derived from a prohibited grain and
have not been processed to remove gluten, they are presumed to contain
gluten.
Examples of ingredients that are or are sometimes derived from a
prohibited grain and processed to remove gluten include, but are not
limited to:
Food starch--modified (modified food starch); and
Wheat starch.
Although these ingredients have been processed to remove gluten,
FDA recognizes that there may be different methods of deriving these
ingredients, and that some methods may remove less gluten than others.
Therefore, FDA proposes to prohibit a food that contains one of these
ingredients from bearing a gluten-free labeling claim if the use of the
ingredient results in the presence of 20 ppm or more gluten in the
food.
A food may contain 20 ppm or more gluten even though the food does
not contain an ingredient derived from a prohibited grain. For example,
a food that contains an ingredient derived from oats may contain 20 ppm
or more gluten if the oats were commingled with a prohibited grain
during their harvest, transport, or storage. FDA believes that
manufacturers who elect to use the labeling claim ``gluten-free''
should make certain that foods so labeled do not contain 20 ppm or more
gluten, regardless of whether or not those foods contain an ingredient
that is derived from a prohibited grain. Under proposed Sec.
101.91(b)(1), a food 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'' would be deemed misbranded.
3. Use of the Term Gluten-Free in the Labeling of Foods That Inherently
Do Not Contain Gluten
FDA proposes in Sec. 101.91(b)(2) to deem misbranded any food,
with the exception of a food made from oats, that does not inherently
contain any gluten from a prohibited grain and that bears the claim
``gluten-free'' in its labeling, unless the food complies with the
following two requirements: (1) The wording of the claim in the
labeling of the food clearly indicates that all foods of the same type,
not just the brand bearing this labeling claim, are gluten-free (e.g.,
``milk, a gluten-free food,'' ``all milk is gluten-free'') and (2) the
food does not contain 20 ppm or more gluten. Examples of foods that
inherently do not contain gluten include, but are not limited to:
Different types of milk not flavored with ingredients that
contain gluten (e.g., fresh fluid whole, low fat and nonfat milks;
evaporated milk; nonfat dry milk; sweetened condensed milk);
100 percent fruit or vegetable juices; fresh fruits and
vegetables that are not coated with a wax or resin that contains
gluten; and frozen or canned fruits and vegetables not made with added
ingredients that contain gluten; and
A variety of single ingredient foods, e.g., butter; eggs;
lentils; legumes like dried beans and peas, peanuts, and soybeans;
seeds like flax, poppy and sesame; tree nuts like almonds, pecans, and
walnuts; non-gluten containing grains like corn, millet and rice; fresh
fish like cod, flounder and haddock; fresh shellfish like clams,
lobster, and octopus; honey; and water, including bottled waters like
distilled and spring.
FDA's proposed requirement for the labeling of foods, other than
foods made from oats, that inherently do not contain gluten is
consistent with the general principles established at Sec.
101.13(e)(2) (21 CFR 101.13(e)(2)) for existing FDA regulations on
``free'' labeling claims made for foods inherently free of calories,
nutrients (e.g., sodium, fat), and other food substances (e.g.,
cholesterol). If 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 that 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 a ``free'' labeling claim are also free of the
substance (Ref. 72). Therefore, FDA views the use of a gluten-free
labeling claim for a food inherently free of gluten to be potentially
misleading without the inclusion of additional qualifying language.
Although oats are inherently free of gluten as defined in this
proposed rule, FDA proposes in Sec. 101.91(b)(3) to deem misbranded a
food made from oats that bears a gluten-free labeling claim if the
claim refers to all such foods as being gluten-free or if it contains
20 ppm or more gluten. By ``food made from oats,'' FDA means oats, any
food that contains oats, and any food that contains any ingredient
derived from oats. The proposed gluten-free labeling claim restriction
in Sec. 101.91(b)(3) is based on evidence of the presence of gluten
from prohibited grains in a number of commercially available brands of
foods made from oats, as discussed in section I.C.3 of this document.
In light of that evidence, FDA believes that a gluten-free labeling
claim that suggests that all foods made from oats are gluten-free would
be misleading.
The agency is interested in receiving comments and scientific
information on whether a gluten-free claim on an inherently gluten-free
food, other than foods made from oats, would be misleading in the
absence of additional qualifying language. In addition, FDA is
interested in receiving comments and scientific information on whether
the proposed examples of how a claim should be worded in the labeling
of a food inherently free of gluten (e.g., ``milk, a gluten-free
food,'' ``all milk is gluten-free'') would effectively inform consumers
that all brands of the same type of food are also free of gluten, or
whether there are more appropriate ways to communicate this message to
[[Page 2803]]
consumers. Further, FDA requests comments on the agency's proposal to
restrict the types of gluten-free labeling claims that can be made for
oats.
4. Use of the Analytical Methods-Based Approach in This Proposed Rule
to Set a Threshold Level of 20 ppm to Define the Term Gluten-Free
As discussed in section I.E.2 of this document, the draft
Thresholds Report describes four approaches FDA could use to establish
a threshold level for gluten that could be the basis for decisions on
whether to use the term ``gluten-free'' on product labels (Refs. 67,
pp. 2, 38 through 41, and 54 through 61). The draft Thresholds Report
concludes that it currently is not possible for FDA 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 (Refs. 67, pp.
4, 60, and 61). The draft Thresholds Report concludes that two
approaches are viable for FDA to establish a threshold level for
gluten: (1) The safety assessment-based approach and (2) the analytical
methods-based approach (Ref. 67, pp. 4 and 57 through 60). The revised
Thresholds Report identifies the same four approaches and conclusions
(Ref. 69, pp. 2, 4, 42 through 45, and 61 through 65).
FDA is planning to conduct a safety assessment for gluten that is
consistent with the safety assessment-based approach described in the
draft and revised Thresholds Reports (Ref. 67, pp. 38, 39, and 58
through 60 and Ref. 69, pp. 42, 43, and 62 through 64). FDA requests
comments providing data relevant to the planned safety assessment,
including in particular clinical research and studies designed to
measure chronic exposure, that satisfy the data quality criteria
discussed in the revised Thresholds Report. We intend to publish a
notice in the Federal Register seeking comment on the draft safety
assessment and its potential use in the final rule, and will consider
public and peer-review comments in revising the safety assessment, as
appropriate. In developing a final rule on gluten-free labeling, we
intend to consider the safety assessment as well as comments received
in response to this proposed rule and the notice concerning the safety
assessment. Further, as noted in both the draft and revised Thresholds
Reports, FDA's establishment of a threshold level for gluten may
require consideration of other factors not addressed in that report,
such as ease of compliance and enforcement, stakeholder concerns,
economics, trade issues, and legal authorities (Ref. 67, p. 41 and Ref.
69, p. 45). This may be true regardless of which approach FDA uses to
establish a threshold level for gluten in the final rule (e.g., an
analytical methods-based approach or a safety assessment-based
approach).
Pending the receipt of comments submitted in response to this
rulemaking and the outcome of the planned safety assessment, FDA is
currently proposing to use the analytical methods-based approach to
establish a threshold level of 20 ppm gluten (i.e., a food labeled
gluten-free cannot contain 20 ppm or more gluten) as one of the
criteria for defining the term ``gluten-free.'' Given the current
unavailability of appropriate test methods that can reliably and
consistently detect gluten at levels below 20 ppm,\2\ FDA tentatively
concludes 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 other pertinent requirements of this proposed rule.
---------------------------------------------------------------------------
\2\The revised Thresholds Report (Ref. 69, pp. 59 and 60)
identifies specific criteria for evaluating gluten detection
analytical methods that are appropriate for establishing a gluten
threshold level based upon an analytical methods-based approach. In
reviewing the available methods that meet all of the stated criteria
(Ref. 73), FDA has tentatively concluded that currently there are no
available and appropriate test methods that can reliably and
consistently detect gluten in a variety of food matrices at levels
below 20 ppm.
---------------------------------------------------------------------------
Based upon the current state of technology concerning available and
appropriate analytical methods that can detect one or more gluten
proteins naturally occurring in wheat, rye, and barley, FDA has
tentatively determined that ELISA-based methods can be used to reliably
and consistently detect gluten at a level of 20 ppm in a variety of
food matrices, including both raw and cooked or baked foods (Ref. 73).
ELISA-based methods detect the prolamins in wheat, rye, and barley,
which can serve as a biomarker for the presence of those grains, their
cross-bred hybrids, or their other naturally occurring proteins. FDA is
tentatively considering using an ELISA-based method that has been
validated in Europe at the 20 ppm gluten detection level and has been
published in the peer-reviewed scientific literature (Ref. 74). FDA has
been advised that this method is currently under review by AOAC
INTERNATIONAL (Ref. 75). In addition, we are aware that an evaluation
of other ELISA-based methods that detect gliadin, a gluten protein, was
recently published in the peer-reviewed scientific literature (Ref.
76). FDA requests comments on the appropriateness of 20 ppm gluten as
the proposed threshold level as determined using an ELISA-based m