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.

Proposed Rules Federal Register

2795 

Vol. 72, No. 14 

Tuesday, January 23, 2007 

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: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

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 http:// 

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 http:// 

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 


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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 


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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 

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 


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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.’’

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 

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 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, 


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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 GlutenFree 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 ‘‘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 

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) 


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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 

(http://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 

(http://www.cfsan.fda.gov/~dms/ 

alrgcom.html). FDA also posted the 

revised Thresholds Report (Ref. 69) 

(http://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 (http:// 

www.fda.gov/ohrms/dockets/ac/ 

cfsan05.html). Copies of the transcript 

materials that specifically address the 

topics of celiac disease and a gluten 

threshold level are also available 

through the 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 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 


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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 ‘‘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. 

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 


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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 

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 

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 


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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. 

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 ‘‘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. 

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 


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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 

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 

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 


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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 

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 

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 


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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 

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 

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 


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Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules 2807 

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 

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. 

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. 


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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 

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 

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 


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Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules 2809 

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 

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 

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 


jlentini on PROD1PC65 with PROPOSAL
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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 

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 

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 


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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 

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. 

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 


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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. 

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 

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 

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. 


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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. 

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 

that complied with our existing 

position. Therefore, we estimate that 

this option would also generate minimal 

or no costs for small entities. 

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 

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. 

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 

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. 

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 1- 

year 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 


jlentini on PROD1PC65 with PROPOSAL
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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 

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, 

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 http:// 

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 http:// 

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. 


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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. Ma ̈ki, M. and P. Collin, ‘‘Coeliac 

Disease,’’ Lancet, 349:1755–1759, 1997. 

9. Fasano, A., ‘‘Celiac Disease—How to 

Handle a Clinical Chameleon,’’ New England 

Journal of Medicine, 348:2568–2570, 2003. 

10. Catassi, C. and A. Fasano, ‘‘Celiac 

Disease as a Cause of Growth Retardation in 

Childhood,’’ Current Opinion in Pediatrics, 

16:445–449, 2004. 

11. Catassi, C., E. Fabiani, G. Corrao, et al., 

‘‘Risk of Non-Hodgkin Lymphoma in Celiac 

Disease,’’ Journal of the American Medical 

Association, 287(11):1413–1419, 2002. 

12. Peters, U., J. Askling, G. Gridley, et al., 

‘‘Causes of Death in Patients With Celiac 

Disease in a Population-Based Swedish 

Cohort, ‘‘ Archives of Internal Medicine, 

163:1566–1572, 2003. 

13. Green, P.H.R. and B. Jabri, ‘‘Coeliac 

Disease,’’ Lancet, 362:383–391, 2003. 

14. Pietrzak, M.M., C. Catassi, S. Drago, et 

al., ‘‘Celiac Disease: Going Against the 

Grains,’’ Nutrition in Clinical Practice, 

16:335–344, December 2001. 

15. Corrao, G., G.R. Corazza, V. Bagnardi, 

et al., ‘‘Mortality in Patients With Coeliac 

Disease and Their Relatives: A Cohort 

Study,’’ Lancet, 358:356–361, 2001. 

16. Rostom, A., C. 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 http:// 

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 http://www.fda.gov/ 

ohrms/dockets/dockets/05n0279/05n-0279- 

tr00001-02-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 

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 http://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 

http://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. 

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 http:// 

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 

http://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. Ho ̈gberg, 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. Pera ̈aho, 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 


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 

http://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 http:// 

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 

http://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 http://www.fda.gov/ 

ohrms/dockets/dockets/05n0279/05n-0279- 

tr00001-02-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 http://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 http:// 

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 http://www.fda.gov/ohrms/ 

dockets/dockets/05n0279/05n-0279-EC1482- 

Attach-1.pdf on June 22, 2006. 

61. U.S. Department of Agriculture, 

‘‘Official United States Standards for Grain, 

Subpart A–General Provisions,’’ pp. A1–A5, 

June 1999, accessible at http://151.121.3.117/ 

reference-library/standards/810101.pdf on 

June 2005. [Note standards for specific grains 

are accessible at http://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 http://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 http://www.fda.gov/ 

ohrms/dockets/dockets/05n0231/05n-0231- 

rpt0001.pdf and http://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 http://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 http:// 

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, 

2005, accessible at http://www.fda.gov/ 

ohrms/dockets/ac/05/minutes/2005- 

4160m1_summary%20minutes.pdf and 

http://www.fda.gov/ohrms/dockets/ac/ 

cfsan05.html on June 22, 2006. 

71. St<rsrud, S., L.R. Hulthe ́n, and R.A. 

Lenner, et al., ‘‘Beneficial Effects of Oats in 

the Gluten-Free Diet of Adults With Special 

Reference to Nutrient Status, Symptoms and 

Subjective Experiences,’’ British Journal of 

Nutrition, 90:101–107, 2003. 

72. Burke, S.J., S.J. Milberg, and W.W. Moe, 

‘‘Displaying Common but Previously 

Neglected Health Claims on Product Labels: 

Understanding Competitive Advantages, 

Deception, and Education,’’ Journal of Public 

Policy & Marketing, 16(2):242–255, Fall 1997. 

73. Gendel, S.M., Memorandum to the 

Administrative Record for the Gluten-Free 

Food Labeling Proposed Rule, pp. 1–5 (with 

31 attachments), May 12, 2006. 

74. Me ́ndez, E., V. Carmen, U. Immer, et 

al., ‘‘Report of a Collaborative Trial to 

Investigate the Performance of the R5 

Enzyme Linked Immunoassay to Determine 

Gliadin in Gluten-Free Food,’’ European 

Journal of Gastroenterology & Hepatology, 

17(10):1053–1063, 2005. 

75. Johnson, K., Personal Communication, 

March 16, 2006. 

76. Matsuda, R., Y. Yoshioka, H. Akiyama, 

et al., ‘‘Interlaboratory Evaluation of Two 

Enzyme-Linked Immunosorbent Assay Kits 

for the Detection of Egg, Milk, Wheat, 

Buckwheat, and Peanut in Foods,’’ Journal of 

AOAC INTERNATIONAL, 89(6):1600–1608, 

November/December 2006. 

77. AOAC INTERNATIONAL, Official 

Method 991.19: ‘‘Gliadin as a Measure of 

Gluten in Foods.’’ Chapter 32, Cereal Foods, 

Official Methods of Analysis of AOAC 

INTERNATIONAL, 18th Ed., AOAC 

INTERNATIONAL, Gaithersburg, MD, pp. 

15–17, 2005. 

78. Fielder, R., Personal Communication, 

May 10, 2006. 

79. Food Standards Australian New 

Zealand, ‘‘Australian New Zealand Food 

Standards Code: Chapter 1—General Food 

Standards, Part 1.2—Labelling and Other 

Information Requirements, Standard 1.2.8—

Nutrition Information Requirements,’’ pp. 1 

and 16–17, 2006, accessible at http:// 

www.foodstandards.gov.au/ 

foodstandardscode June 27, 2006. 

80. Fasano, A., Personal Communication, 

November 22, 2004. 

81. Catassi, C., E. Fabiani, G. Iacono, et al., 

‘‘Toxicity of Gluten Traces in Patients on 

Treatment for Celiac Disease. Results of a 

Prospective, Placebo-Controlled, DoubleBlind, Randomized Study,’’ Presentation 

Abstract No. S1775, Digestive Disease Week, 

May 14–19, 2005, accessible at http:// 

precis.preciscentral.com/files/source/67/ 

html/45832.htm on June 22, 2006. 

82. Collin, P., L. Thorell, K. Kaukinen, et 

al., ‘‘The Safe Threshold for Gluten 

Contamination in Gluten-Free Products. Can 

Trace Amounts Be Accepted in the 

Treatment of Coeliac Disease?’’ Alimentary 

Pharmacology & Therapeutics, 19(12):1277–

1283, June 2004. 

83. Chartrand, L.J., P.A. Russo, A.G, 

DuHaime, et al., ‘‘Wheat Starch Intolerance 

in Patients With Celiac Disease,’’ Journal of 


jlentini on PROD1PC65 with PROPOSAL
Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Proposed Rules 2817 

the American Dietetic Association, 

97(6):612–618, June 1997. 

84. Fasano, A., I. Berti, T. Gerarduzzi, et 

al., ‘‘Prevalence of Celiac Disease in At-Risk 

and Not-At-Risk Groups in the United States. 

A Large Multicenter Study,’’ Archives of 

Internal Medicine, 163:286–292, 2003. 

85. U.S. Census Bureau, Population 

Division, ‘‘U.S. POPClock Projection,’’ Web 

page, accessible at http://www.census.gov/ 

population/www/popclockus.html on August 

18, 2005 

86. Blast, A., National Foundation for 

Celiac Awareness, Public Statement, 

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. 287, August 19, 2005, accessible at http:// 

www.fda.gov/ohrms/dockets/dockets/ 

05n0279/05n-0279-tr00001-01-vol16.doc June 

22, 2006. (Also see errata sheet for transcript 

accessible at http://www.fda.gov/ohrms/ 

dockets/dockets/05n0279/05n-0279-tr00001- 

02-erratta-vol16.doc June 22, 2006.) 

87. Schluckebier, M., ‘‘Food Labeling 

Concerns for CD/DH,’’ 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. 200, August 19, 2005, accessible at http:// 

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 http://www.fda.gov/ 

ohrms/dockets/dockets/05n0279/05n-0279- 

tr00001-02-erratta-vol16.doc on June 22, 

2006.) 

88. Bureau of Labor Statistics, U.S. 

Department of Labor (USDL), ‘‘Employer 

Costs for Employee Compensation 

Summary,’’ USDL: 05–2279, December 9, 

2005. 

89. Kaukinen, K., P. Collin, K. Holm, et al., 

‘‘Wheat Starch-Containing Gluten-Free Flour 

Products in the Treatment of Coeliac Disease 

and Dermatitis Herpetiformis. A Long Term 

Follow-Up Study,’’ Scandinavian Journal of 

Gastroenterology, 34:163–169, 1999. 

90. McCrae, W.M., M.A. Eastwood, M.R. 

Martin, et al., ‘‘Neglected Coeliac Disease,’’

Lancet, 1:187–190, 1975. 

91. Sdepanian V.L., I.C.A. Scaletsky, U. 

Fagundes-Neto, et al., ‘‘Assessment of 

Gliadin in Supposedly Gluten-Free Foods 

Prepared and Purchased by Celiac Patients,’’

Journal of Pediatric Gastroenterology and 

Nutrition, 32:65–70, January 2001. 

92. Codex Alimentarius Commission, Food 

and Agriculture Organization (FAO) of the 

United Nations, World Health Organization 

(WHO), Joint FAO/WHO Food Standards 

Programme, Codex Committee on Nutrition 

and Foods for Special Dietary Uses, Twentyfifth Session, ‘‘Proposed Draft Revised 

Standard for Gluten-Free Food At Step 7,’’

Comments from Sweden, Finland, AOECS–

Association of European Coeliac Societies, 

IWGA–International Wheat Gluten 

Association, CX/NFSDU 03/4–Add. 1, pp. 1–

11, October 2003. 

93. Lohiniemi, S., M. Ma ̈ki, K. Kaukinene, 

et al., ‘‘Gastrointestinal Symptoms Rating 

Scale in Coeliac Disease Patients on Wheat 

Starch-Based Gluten-Free Diets,’’

Scandinavian Journal of Gastroenterology, 

September, 35(9):947–949, October 2000. 

94. Pera ̈aho, 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 

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 

AGENCY: Federal Bureau of Investigation 

(FBI), Department of Justice. 

ACTION: Notice of proposed rulemaking 

with request for comments. 

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 


jlentini on PROD1PC65 with PROPOSAL