Abstract
Under the Food Allergen and Consumer Protection Act, the Food and Drug Administration
(FDA) must issue a rule for the voluntary labeling of food as gluten-free. In the
proposed rule, many single-ingredient foods, such as millet, are considered inherently
free of gluten. Inherently gluten-free grains will be considered misbranded if they
carry a gluten-free label and do not also state that all foods of the same type are
gluten-free (eg, “all millet is gluten free”). Twenty-two inherently gluten-free grains,
seeds, and flours not labeled gluten-free were purchased in June 2009 and sent unopened
to a company who specializes in gluten analysis. All samples were homogenized and
tested in duplicate using the Ridascreen Gliadin sandwich R5 enzyme-linked immunosorbent
assay with cocktail extraction. Thirteen of 22 (59%) samples contained less than the
limit of quantification of 5 parts per million (ppm) for gluten. Nine of 22 (41%)
samples contained more than the limit of quantification, with mean gluten levels ranging
from 8.5 to 2,925.0 ppm. Seven of 22 samples (32%) contained mean gluten levels ≥20
ppm and would not be considered gluten-free under the proposed FDA rule for gluten-free
labeling. Gluten contamination of inherently gluten-free grains, seeds, and flours
not labeled gluten-free is a legitimate concern. The FDA may want to modify their
proposed rule for labeling of food as gluten-free, removing the requirement that gluten-free
manufacturers of inherently gluten-free grains, seeds, and flours must state on product
labels that all foods of that type are gluten-free.
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References
- Food Allergen Labeling and Consumer Protection Act of 2004.(Title II of Public Law 108-282) (Published August 2, 2004. Accessed November 17, 2009)
- 21 CFR Part 101. Docket No. 2005N-0279. Food labeling: Gluten-free labeling of foods. Proposed rule.(Published July 19, 2005. Accessed November 17, 2009)
- Gluten contamination of commercial oat products in the United States.N Engl J Med. 2004; 351: 2021-2022
- Oats and the gluten-free diet.J Am Diet Assoc. 2003; 103: 376-379
- PWG collaborative trial of gluten in gluten-free food through “Cocktail ELISA.”.in: Stern M. Proceedings of the 17th Meeting of the Working Group on Prolamin Analysis and Toxicity. October 3-6, 2002, London, England. Verlag Wissenschaftliche Scripten, Zwickau, Germany2003: 23-33
- Report of a collaborative trial to investigate the performance of the R5 enzyme linked immunoassay to determine gliadin in gluten-free food.Eur J Gastroenterol Hepatol. 2005; 17: 1053-1063
- Towards a new gliadin reference material isolation and characterization.J Cereal Sci. 2006; 43: 331-334
- Innovative approach to low-level gluten determination using a novel sandwich enzyme-linked immunosorbent assay protocol.Eur J Gastroenterol Hepatol. 2003; 15: 465-474
- A monoclonal antibody that recognizes a potential coeliac-toxic repetitive pentapeptide epitope in gliadins.Eur J Gastroenterol Hepatol. 2001; 13: 1189-1193
- Monoclonal antibody R5 for detection of putatively coeliac-toxic gliadin peptides.Eur Food Res Technol. 2006; 222: 78-82
- Commercial assays to assess gluten content of gluten-free foods: Why they are not created equal.J Am Diet Assoc. 2008; 108: 1682-1687
- Take new routes and make new tracks.(R-Biopharm AG Web site) (Accessed November 17, 2009)
- Codex Alimentarius.(FAO/WHO Food Standards Web site) (Accessed November 17, 2009)
- Report of the Twenty-Seventh Session of the Codex Committee on Methods of Analysis and Sampling. Food and Agriculture Organization of the United Nations and World Health Organization, Rome, Italy2006: 8
- Grain inspection, packers & stockyard administration. Grain, rice & pulses. Official US Standards. US Standards for Grains.(US Department of Agriculture Web site) (Updated July 20, 2009. Accessed November 17, 2009)
US Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition. Food Allergen Labeling and Consumer Protection Act of 2004 Public Law 108-282 Report to The Committee on Health, Education, Labor, and Pensions United States Senate And The Committee on Energy and Commerce United States House of Representatives. July 2006.
- Economic burden of a gluten-free diet.J Hum Nutr Dietet. 2007; 20: 423-430
- Gluten contamination of cereal foods in Canada.Int J Food Sci Technol. 2007; 43: 1245-1252
Biography
T. Thompson is a nutrition consultant on celiac disease, Manchester, MA
Biography
A. R. Lee is director of nutritional services, Schar USA, Santa Fe, NM
Biography
T. Grace is CEO and director of Bia Diagnostics, Burlington, VT
Article info
Publication history
Accepted:
December 29,
2009
Identification
Copyright
© 2010 American Dietetic Association. Published by Elsevier Inc. All rights reserved.
