[Federal Register: July 19, 2005 (Volume 70, Number 137)]
[Proposed Rules]               
[Page 41356-41358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Chapter I

[Docket No. 2005N-0279]

Food Labeling; Gluten-Free Labeling of Foods; Public Meeting; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to obtain expert comment and consultation from stakeholders to 
help the agency to define and permit the voluntary use on food labeling 
of the term ``gluten-free''. The meeting will focus on food 
manufacturing, analytical methods, and consumer issues related to 
reduced levels of gluten in food. We request that those who wish to 
speak at the meeting, or otherwise provide FDA with their written or 
oral comments, focus on the questions set out in this document.

DATES: The public meeting will be held on Friday, August 19, 2005, from 
8:30 a.m. to 5 p.m. All those attending the meeting must register by 
August 12, 2005. See the ``Registration'' heading of the SUPPLEMENTARY 
INFORMATION section of this document for details on how to register. 
Submit written or electronic comments by September 19, 2005.

ADDRESSES: The public meeting will be held at the Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5100 
Paint Branch Pkwy., Harvey W. Wiley Auditorium, College Park, MD 20740.
    You may submit written comments, identified with Docket No. 2005N-
0279, to the Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments

    For general questions about the meeting, to register, to request 
permission to speak at the meeting, to request onsite parking, or if 
you need special accommodations due to a disability: Marion V. Allen, 
Center for Food Safety and Applied Nutrition (HFS-32), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1584, FAX: 301-436-2605, e-mail: marion.allen@fda.hhs.gov.
    For technical questions: Rhonda R. Kane, Center for Food Safety and 
Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-2371, FAX: 301-436-2636, 
e-mail: rhonda.kane@fda.hhs.gov.


I. Background

    Celiac disease (also known as celiac sprue) is a chronic 
inflammatory disorder of the small intestine triggered by ingesting 
certain storage proteins that naturally occur in cereal grains. Celiac 
disease is genetically inherited, and its prevalence in the United 
States is estimated to be slightly less than 1 percent of the general 
population (Ref. 1).
    The grains that are considered to cause problems for persons with 
celiac disease are wheat, barley, and rye, their related species (e.g., 
durum wheat, spelt, kamut) and crossbred hybrids (e.g., triticale), and 
possibly oats (Ref. 2). The scientific literature includes reports of 
celiac disease patients who can tolerate oats (Refs. 3 through 5) and 
others who cannot (Refs. 6 and 7). This intolerance may be due to the 
possible presence in commercially available oat products of trace 
amounts of other grains that are harmful to persons who have celiac 
disease (e.g., wheat, rye, or barley) (Refs. 2 and 8). However, there 
is also some evidence that naturally occurring proteins in 
uncontaminated oats may cause adverse effects in some celiac disease 
patients (Ref. 7).
    Technically, the term ``gluten'' applies to the combination of 
storage proteins found in wheat, the prolamin proteins called 
``gliadins'' and the glutelin proteins called ``glutenins'' (Ref. 9). 
However, in the context of celiac disease, the term ``gluten'' is often 
used to refer collectively to any of the proteins in the grains that 
may cause harm. Currently, to prevent severe and sometimes life-
threatening complications of celiac disease, sensitive individuals need 
to avoid all offending sources of gluten (Refs. 10 through 12). Life-
threatening complications can affect multiple organs of the body (Refs. 
10 through 12).
    The Food Allergen Labeling and Consumer Protection Act of 2004 
(FALCPA) (Title II of Public Law 108-282) at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/alrgact.html
 requires FDA to issue, within 2 years of the enactment 

date, a proposed rule to define, and permit the use of, the term 
``gluten-free'' on food labeling and a final rule within 4 years of 
enactment. FALCPA requires FDA to

[[Page 41357]]

consult with appropriate experts and stakeholders during the agency's 
development of the proposed rule. Establishing a definition of 
``gluten-free'' that is both protective of the celiac population and 
that uniformly applies to ``gluten-free'' labeling statements for foods 
marketed in the United States will assist Americans with celiac disease 
to make more informed food consumption decisions.

II. Purpose and Scope of Meeting

    FDA is holding this meeting to solicit comments from appropriate 
experts and stakeholders to assist us in developing a proposed rule to 
define and permit the use of the term ``gluten-free,'' as required by 
FALCPA. The agency is interested in gathering information from the 
public, particularly the food industry on how ``gluten-free'' foods are 
manufactured, the analytical methods used to verify that foods are 
``gluten-free,'' and related costs of manufacturing ``gluten-free'' 
foods. The agency is also interested in receiving research data or 
findings on the food purchasing practices of consumers with celiac 
disease and their caregivers related to packaged products labeled or 
marketed as ``gluten-free,'' compared to their purchasing practices of 
packaged products that are not so labeled.
    The public meeting will not address issues regarding a threshold 
level of gluten (i.e., the amount of gluten below which it would be 
unlikely to elicit harmful effects in celiac disease patients) and the 
medical implications of celiac disease. These two issues were addressed 
at a meeting of FDA's Food Advisory Committee (FAC) on July 13 through 
15, 2005 (70 FR 29528, May 23, 2005). The meeting agenda provided that 
the FAC would review and evaluate the Center for Food Safety and 
Applied Nutrition Threshold Working Group draft report entitled 
``Approaches to Establish Thresholds for Major Food Allergens and for 
Gluten in Food,'' which may be found on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/alrgn.html.
 FDA will consider all pertinent 

information, including the recommendations of the FAC and comments from 
this public meeting, in developing a definition and establishing the 
permissible use of the term ``gluten-free'' in food labeling.

III. Questions

    FDA has drafted a series of questions to help focus the comments 
presented at the public meeting or otherwise communicated to the 
agency. Those who comment are invited to address any or all of these 
questions. FDA is particularly interested in receiving related 
technical, scientific, and cost data from the food industry as well as 
research data or findings about the food purchasing practices of 
consumers with celiac disease or their caregivers. For the purpose of 
the list of questions in this document, FDA is using the following 
     ``Gluten'' refers to the proteins found in any of the 
grains that can cause harm to persons with celiac disease;
     ``Grains of concern'' refers to wheat, rye, barley, and 
oats, and their related species (e.g., durum, spelt, kamut) or 
crossbred hybrids (e.g., triticale); and
     ``Gluten-free foods'' refers to foods currently marketed 
in the United States that are either represented to be free of gluten 
or that contain statements or symbols on their labeling that identify 
the products as ones that do not contain gluten.

A. Definitions of ``Gluten-Free''

    1. How do food manufacturers define ``gluten-free''? What is the 
generally accepted definition in the food industry of ``gluten-free''? 
Please identify any entities that ``certify'' finished foods or raw 
ingredients to be ``gluten-free''. Describe how they define ``gluten-
free'' and how they determine whether a food product satisfies this 

B. ``Gluten-Free'' Product Development

    2. How are ``gluten-free'' foods produced? For example, are 
``gluten-free'' foods made by using only ingredients that do not 
contain any gluten (i.e., they are inherently ``gluten-free'') or are 
they made by processing ingredients or the finished food to remove 
gluten? What methods are most commonly used to remove gluten from food?
    3. Due to potential grain cross-contact situations, is it 
technologically feasible to produce ``gluten-free'' flour from grains 
other than those of concern (e.g., corn, millet)? Is it technologically 
feasible to produce oat-based products that do not contain gluten from 
grains of concern other than oats (e.g., wheat)? If so, what additional 
measures in the milling or manufacturing process would be needed to 
produce these products? Is it economically feasible to produce such 
products, and if so, what would be the incremental costs?

C. Good Manufacturing Practices and Analytical Methods

    4. What measures do you have in place during the manufacturing, 
packaging, or holding of ``gluten-free'' foods to prevent them from 
coming into contact with any grains of concern? For example, do you use 
dedicated facilities, dedicated equipment, or dedicated production 
    5. What analytical method(s) do you use to evaluate your ``gluten-
free'' products? How often to do you perform these analyses? For 
example, do you test every batch of finished product? Do you test bulk 
containers of each ingredient? What is the cost of such testing?
    6. The following questions seek data and information about 
available gluten detection test kits or analytical methods to detect 
     In what grains can the test kit or method detect gluten?
     What specific mechanism is used to indicate the presence 
or absence of gluten?
     What is the sensitivity or lowest level of detection of 
your test kit or method?
     Is your test kit or method qualitative (i.e., establishes 
only the presence or absence of gluten) or quantitative?
     If quantitative, what is the limit of quantification of 
your test kit or method?
     What is the false positive rate of your test kit or 
method? What is its false negative rate?
     Is the effectiveness of your test kit or method affected 
by the nature of the processing of the ``gluten-free'' food, and if so, 
how? Is it affected by the food matrix, and if so, how? (FDA is 
especially interested in information that addresses the influence of 
the presence of fermented or hydrolyzed proteins, of xanthan gum, of 
guar gum, or of any other dietary fibers.)
     If your test kit or method has been validated, please 
indicate by whom it was validated and the level (e.g., parts per 
million) of detection at which it was validated.
     If your test kit or method has not been validated, have 
the results of its performance or an evaluation of its performance been 
published in a peer-reviewed scientific journal?
     What is the cost of your test kit or the cost to perform 
your method of analysis?
    7. What analytical methods are currently available or under 
development to detect the presence of oat proteins in food? Please 
specify which proteins. What is the cost to conduct such analyses? Have 
any of these methods been validated or published in a peer-reviewed 
scientific journal?

D. Foods Marketed as ``Gluten-Free''

    8. Are there available research data or findings on what consumers 
with celiac disease or their caregivers believe the term ``gluten-
free'' means? For example,

[[Page 41358]]

do the research data or findings show consumers' beliefs as to which 
specific grains or other ingredients are not present in foods labeled 

E. Consumer Purchasing Practices

    9. Are there available research data or findings on how consumers 
with celiac disease or their caregivers identify packaged foods that do 
not contain gluten? Do the data establish how much time these consumers 
devote to identifying such foods?
    10. Are there available research data or findings on whether the 
packaged foods consumers with celiac disease or their caregivers 
currently purchase or consume are primarily or exclusively those foods 
labeled ``gluten-free''? Do the research data or findings identify the 
types of ``gluten-free'' packaged foods (e.g., breads, dairy foods, 
canned vegetables) purchased or consumed by persons with celiac disease 
or their caregivers? Do the research data or findings show whether a 
``gluten-free'' label influences the purchasing decision of persons 
with celiac disease or their caregivers when presented with products 
having identical ingredient lists?

IV. Registration

    Please submit your registration information (including name, title, 
firm name (if applicable), address, telephone number, fax number (if 
available), and e-mail address (if available)) by August 12, 2005. We 
encourage you to register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/comm/register.html
 or by fax to Marion V. Allen at 301-436-2605. We will 

also accept registration onsite; however, space is limited and 
registration will be closed when the maximum seating capacity is 
reached. If you need special accommodations due to a disability (e.g., 
sign language interpreter), please inform Marion V. Allen (see FOR 
FURTHER INFORMATION CONTACT) no later than August 12, 2005, when you 
register. Please also specify whether you need onsite parking when you 
    If you wish to make a presentation, indicate this desire when 
registering and submit the following information by August 12, 2005: 
(1) A brief written statement about the general nature of the views you 
wish to present and (2) the names of any copresenters who must also 
register to attend. The amount of time allowed for each oral 
presentation at the public meeting may be limited (e.g., 5 minutes 
each), depending upon the number of persons who request to speak. 
Individuals and organizations that do not preregister to make a 
presentation may have the opportunity to speak if time permits.
    Persons preregistered or wishing to register onsite should check in 
between 7:30 and 8:30 a.m. Because the meeting will be held in a 
Federal building, meeting participants must present photo 
identification and plan adequate time to pass through the security 

V. Comments

    In addition to attending or presenting oral comments at the 
meeting, interested persons may submit to the Division of Dockets 
Management (see ADDRESSES) written or electronic comments related to 
the questions and the focus of this public meeting. All relevant data 
and information should be submitted with the written comments. 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 with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. Meeting Transcript

    A transcript will be made of the meeting's proceedings. You may 
request a copy in writing from FDA's Freedom of Information Office 
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, 
Rockville, MD 20857, approximately 30 working days after the public 
meeting at a cost of 10 cents per page. The transcript of public 
meeting and all comments submitted will be available for public 
examination at the Division of Dockets Management (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA 
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.

VII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSESS) and may be viewed 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. National Institutes of Health, Consensus Development 
Conference Statement, Celiac Disease, June 28 through 30, 2004, 
accessible on June 2005 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://consensus.nih.gov/cons/118/118celiacPDF.pdf.
 (FDA has verified the Web site address, but is not 

responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    2. Kasarda, D.D., ``Grains in Relation to Celiac Disease,'' 
Cereal Foods World, 46(5):209-210, 2001.
    3. 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.
    4. 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.
    5. 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.
    6. Lundin, K.E., E.M. Nilsen, H.G. Scott, et al., ``Oats Induced 
Villous Atrophy in Coeliac Disease,'' Gut, 52(11):1649-1652, 2003.
    7. 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, 2004.
    8. Thompson, T., ``Gluten Contamination of Commercial Oat 
Products in the United States,'' New England Journal of Medicine, 
351(19):2021-2022, 2004.
    9. Brown A., Understanding Food Principles and Preparation, 
Second Edition, Wadsworth/Thomson Learning, Belmont CA, USA, pp. 
402-403, 2004.
    10. 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.
    11. Dewar, D., S.P. Pereira, and P.J. Ciclitira, ``The 
Pathogenesis of Coeliac Disease,'' International Journal of 
Biochemistry & Cell Biology, 36:17-24, 2001.
    12. Fasano, A. and C. Catassi, ``Current Approaches to Diagnosis 
and Treatment of Celiac Disease: An Evolving Spectrum,'' 
Gastroenterology, 120(3):636-651, 2001.

    Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14196 Filed 7-14-05; 4:31 pm]