Gluten in Cosmetics: Is There a Reason for Concern?

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DOI: 10.1016/j.jand.2012.07.011 · Source: PubMed
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Gluten in Cosmetics: Is There a Reason for Concern?
ONE OF THE PRESS RELEASES
from the 76th Annual
Scientific Meeting of the
American College of Gast-
roenterology reads, “Celiac Patients
Face Potential Hazard as Information
on Cosmetic Ingredients Difficult to
Find.”
1
The release discusses the lack of
readily available information about
cosmetic ingredients on the websites of
cosmetics manufacturers and how this
may result in the inadvertent use of
gluten-containing cosmetics and the
exacerbation of celiac disease if gluten-
containing products are used on the face
and lips. Investigators were prompted to
review cosmetic ingredient information
because of a patient who experienced a
skin rash and gastrointestinal symptoms
after using a body lotion. When use of
the body lotion was stopped, the symp-
toms went away. It was never deter-
mined whether the lotion contained
any ingredients derived from wheat,
barley, or rye, and the product was not
tested for gluten. The press release sug-
gests that cosmetics manufacturers
should indicate when their products
are gluten-free and safe to use by per-
sons with celiac disease.
This press release was picked up by
the wire services and resulted in nu-
merous articles with titles such as
“Your Makeup Could Be Making You
Sick” and “Unidentified Gluten in Cos-
metics May Pose Threat to Celiac Pa-
tients.” These headlines caused a flurry
of Twitter posts, Facebook discussions,
and blogs, not to mention e-mails to
registered dietitians from concerned
patients. The primary question being
asked was whether patients with celiac
disease need to worry about the ingre-
dients in cosmetics.
DESCRIPTION OF EVALUATION
To the authors’ knowledge, there has
never been any published test reports
in the scientific literature on the gluten
content of cosmetics made using ingre-
dients derived from wheat, barley, or
rye. Neither have there been published
studies in the scientific literature indi-
cating the harmful nature of cosmetics
containing ingredients derived from
wheat, barley, or rye. To provide a pre-
liminary assessment on whether lip-
sticks and lotions contain quantifiable
gluten, a convenience sample of prod-
ucts from four different manufacturers
was purchased in Massachusetts or by
mail order in January and February of
2012, including four lipsticks/balms
and two body/face lotions. The only cri-
terion for testing was that the product
contains at least one ingredient derived
from wheat, barley, rye, or oats. Oats
were included not because they inher-
ently contain gluten but because they
may be contaminated with gluten.
2,3
In-
gredients in the products tested included
triticum vulgare (wheat) germ oil, hor-
deum vulgare (barley) extract, triticum
vulgare (wheat) germ extract, triticum
vulgare (wheat) bran extract, and avena
sativa (oat) kernel flour.
Products were sent unopened to the
allergen testing facility, Bia Diagnostics,
in Burlington, VT. Each product sample
was tested in duplicate using both the
sandwich R5 enzyme-linked immu-
nosorbent assay (ELISA) and competi-
tive R5 ELISA (R-biopharm). The assays
were run according to manufacturer in-
structions. The competitive R5 ELISA
was used because it detects hydrolyzed
gluten that may be found in products
containing wheat and barley extracts.
The lower limit of quantification for
gluten for the sandwich R5 ELISA is 5
parts per million (ppm). The lower limit
of quantification for gluten for the com-
petitive R5 ELISA is 10 ppm. These test-
ing methods have been discussed pre-
viously in the Journal.
4,5
LESSONS LEARNED
As is illustrated in the Table, there was
no quantifiable gluten in any of the
products tested. In addition, a spiked
recovery was run on three samples to
make sure that any gluten contained in
the product at or above the lower limit
of quantification was being extracted
and that there was no matrix effect.
There was 100% recovery of gluten from
the spiked samples. Therefore, nothing
in the product overtly interfered with
the ability of the assay to extract gluten.
FURTHER IMPLICATIONS FOR
DIETETICS PRACTITIONERS
Ingredients Labeling of
Cosmetics
The Food and Drug Administration
(FDA) defines a cosmetic as “a product,
except soap, intended to be applied to
the human body for cleansing, beauti-
fying, promoting attractiveness, or al-
tering appearance.”
6
Ingredients labels
for cosmetics are required to be in-
cluded on the outer container of prod-
ucts sold at retail establishments.
6
If
the surface area of the cosmetic is too
small to allow for an ingredients list,
off-package ingredient labeling is al-
lowed. With few exceptions, ingredi-
ents must be declared in order of pre-
dominance. Fragrance, flavor, and trade
secrets may be named at the end of the
ingredients list as “fragrance,” “flavor,”
and “and other ingredients.” All other
ingredients must be identified by the
name established by the FDA. If a name
has not been established, then terms
used in a variety of publications, in-
cluding the Cosmetic Ingredient Dic-
tionary, must be used. If the ingredient
name does not appear in one of the
publications identified by the FDA, then
the ingredient should be identified us-
ing the name familiar to the consumer
or the technical name.
In general, ingredients containing
gluten can be identified in the ingredi-
ents list of cosmetics. For example:
Ingredients derived from wheat
generally include the terms
“wheat” or “triticum vulgare” in
the name.
This article was written by Tricia
Thompson, MS, RD, founder, Gluten
Free Watchdog, LLC, Manchester, MA,
and Thomas Grace, CEO Bia Diag-
nostics, Burlington, VT.
doi: 10.1016/j.jand.2012.07.011
PRACTICE APPLICATIONS
Topics of Professional Interest
1316 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS © 2012 by the Academy of Nutrition and Dietetics.
Ingredients derived from barley
generally include the terms “bar-
ley,” “malt,” or “hordeum vul-
gare” in the name.
Ingredients derived from rye
generally include the terms
“rye,” or “secale cereale” in the
name.
Ingredients derived from oats
generally include the terms “oat”
or “avena sativa” in the name.
Gluten Labeling of Cosmetics
The FDA hopes to release its final rule
regarding labeling of food as gluten-
free in 2012.
7
Food manufacturers may
voluntarily label products gluten-free if
the product meets the criteria of the
gluten-free labeling rule.
8
This rule
covers food under the jurisdiction of
the FDA. It does not cover cosmetics.
Based on correspondence with the
FDA (D.C. Havery, written communica-
tion, November 2011), the presence of
gluten does not need to be definitively
declared on cosmetic labels and there are
no rules or guidance documents specifi-
cally addressing the use of the term glu-
ten-free in the labeling of cosmetics reg-
ulated by the FDA. The FDA does not,
however, prohibit cosmetics companies
from labeling products gluten-free. If a cos-
metics company does label a product glu-
ten-free and this labeling distinction is
found to be inaccurate or misleading, the
product may be declared misbranded.
Table. Gluten content of four lip products and two lotions containing ingredients derived from wheat, barley, rye, and oats
Product Ingredients of concern
Sandwich ELISA
a
Competitive ELISA
Extractions1&2 Extractions1&2
Lip balm Wheat germ oil 5 ppm gluten; 5 ppm gluten 10 ppm gluten; 10 ppm gluten
Lip balm Barley extract; wheat germ extract 5 ppm gluten; 5 ppm gluten 10 ppm gluten; 10 ppm gluten
Lip gloss Wheat germ extract; barley extract 5 ppm gluten; 5 ppm gluten 10 ppm gluten; 10 ppm gluten
Lipstick Wheat bran extract 5 ppm gluten; 5 ppm gluten 10 ppm gluten; 10 ppm gluten
Lotion Wheat germ oil 5 ppm gluten; 5 ppm gluten 10 ppm gluten; 10 ppm gluten
Lotion Oat kernel flour 5 ppm gluten; 5 ppm gluten 10 ppm gluten; 10 ppm gluten
a
ELISAenzyme-linked immunosorbent assay.
PRACTICE APPLICATIONS
September 2012 Volume 112 Number 9 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS 1319
Absorption and Ingestion of
Gluten from Cosmetics
There is currently no scientific evidence
that gluten used in cosmetics that are
not ingested is harmful to individuals
with celiac disease, including those
with dermatitis herpetiformis (the skin
form of celiac disease). According to
Alessio Fasano, MD, Medical Director of
the Center for Celiac Research, Univer-
sity of Maryland, “If you have celiac dis-
ease, then the application of gluten-
containing products to the skin should
not be a problem, unless you have skin
lesions that allow gluten to be absorbed
systemically in great quantities. The
reason why this should not be a prob-
lem is that, based on what we know
right now, it is the oral ingestion of glu-
ten that activates the immunological
cascades leading to the autoimmune
process typical of celiac disease.”
9
As a consequence, it appears that
consumers with celiac disease do not
need to worry about products applied
to the skin, such as body lotion, sun-
screen, shaving cream, deodorant,
makeup, and perfume, especially if
hands are washed after use. It also ap-
pears that consumers do not need to
worry about products applied to the
hair such as shampoo and conditioner.
Hand lotion has been considered one
of those in-between cases. If a lot is
used and hands are not washed before
eating then theoretically some hand lo-
tion could be ingested.
Products used in and around the
mouth, such as lipstick, have been con-
sidered more suspect. However, even if
they do contain gluten derivatives it is
unlikely they will contribute much glu-
ten to the diet. If a lipstick weighing
0.13 oz (3.8 g or 3,800 mg) contains less
than 10 ppm of gluten, it contains less
than 0.001% gluten. This means that if
the entire tube of lipstick was somehow
ingested, less than 0.038 mg of gluten
would be consumed.
PRACTICE TIPS FOR DIETITICS
PRACTITIONERS
Preliminary test results on a small
number of cosmetics containing glu-
ten-derived ingredients found them
to contain below-quantifiable levels
of gluten. A much larger formal study
on the gluten content of cosmetics
containing ingredients derived from
wheat, barley, rye, and oats is needed
to draw any definitive conclusions on
the gluten content of cosmetics that
may be used on the lips and hands.
Consumers may be concerned about
using products containing ingredi-
ents derived from wheat, barley, rye,
and oats that may inadvertently be in-
gested. If this is the case, consumers
can be advised to:
Read the ingredients listed on
cosmetics looking for the words
“wheat,” “barley,” “malt,” “rye,”
“oat,” “triticum vulgare,” “hor-
deum vulgare,” “secale cereale,”
and “avena sativa.”
Look for off-packaging ingredi-
ent lists when the product pack-
aging is too small to include this
information on the label. This
may be in the form of tear sheets
located next to the product dis-
play case.
PRACTICE APPLICATIONS
September 2012 Volume 112 Number 9 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS 1321
Contact cosmetic companies
when ordering products by mail
order and ask whether their
products contain any derivatives
of wheat, barley, rye, or oats.
Use cosmetics labeled gluten-free.
An increasing number of manufac-
turers are labeling their products.
SUGGESTED RESOURCES
Food and Drug Administration
(www.fda.gov/cosmetics): This
website provides a wealth of in-
formation on cosmetics, includ-
ing labeling information.
Mayo Clinic (www.mayoclinic.com/
health/celiac-disease/AN01623):
This resource contains advice on
gluten in cosmetics.
Cosmeticsinfo.org: This website
provides information on ingredi-
ents, including their sources.
Canadian Celiac Association (www.
celiac.ca/index.php/about-celiac-
disease/celiac-news-articles/cosme
tic-regulations/): This resource pro-
vides guidance on the issue of glu-
ten in cosmetics.
References
1. American College of Gastroenterology. Ce-
liac patients face potential hazard as infor-
mation on cosmetic ingredients difficult to
find: Products used on lips and face can re-
sult in unexpected exposure to gluten
[press release]. http://d2j7fjepcxuj0a.
cloudfront.net/wp-content/uploads/2011/
10/2011acg_Celiac-Cosmetics__FINAL-OCct-
26.pdf. Published October 31, 2011. Accessed
May 30, 2012.
2. Thompson T. Gluten contamination of com-
mercial oat products in the United States. N
Engl J Med. 2004;351(19):2021-2022.
3. Koerner TB, Cleroux C, Poirier C, Cantin I,
Alimkulov A, Elamparo H. Gluten contami-
nation in the Canadian oat supply. Food Ad-
ditives & Contaminants: Part A. 2011;28(6):
705-710.
4. Thompson T, Mendez E. Commercial assays
to assess gluten content of gluten-free
foods: Why they are not created equal. JAm
Diet Assoc. 2008;108(10):1682-1687.
5. Thompson T, Lee AR, Grace T. Gluten con-
tamination of grains, seeds, and flours in
the United States: a pilot study. J Am Diet
Assoc. 2010;110(6):937-940.
6. Food and Drug Administration. Cosmetic
labeling guide: ingredient labeling. http://
www.fda.gov/cosmetics/cosmeticlabeling
labelclaims/cosmeticlabelingmanual/ucm
126444.htm#clgl. Updated May 4, 2012.
Accessed May 30, 2012.
7. Verrill L, Kane R, Thompson T. FDA’s gluten-
free rulemaking—Implications for your cli-
ents with celiac disease [teleseminar].
Academy of Nutrition and Dietetics web-
site. http://www.eatright.org/Shop/Product.
aspx?id6442466994. Published December
8, 2011. Accessed December 8, 2012.
8. Food and Drug Administration. Federal
Register proposed rule - 72 FR 2795 January
23, 2007: Food labeling; gluten-free lab-
eling of foods. http://www.fda.gov/
Food/ LabelingNutrition/ FoodAllergens
Labeling/GuidanceComplianceRegulatory
Information/ucm077926.htm. Updated
May 20, 2009. Accessed May 30, 2012.
9. Thompson T. Personal care products: Do
you need to worry about gluten. Gluten
Free Dietitian website. http://www.
glutenfreedietitian.com/newsletter/personal-
care-products-do-you-need-to-worry-about-
gluten/. Published July 14, 2009. Accessed May
30, 2012.
PRACTICE APPLICATIONS
September 2012 Volume 112 Number 9 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS 1323
  • ... Type Remarks Memon [7] Dental prostheses One case report Verma [8] Toothpaste, lipstick Borderline amount in only 4 of 62 oral hygiene and care products Sharma [4] Burnett [5] Lauriere [10] Pecquet [11] Nakamura [12] Tammaro [13] Thompson [14] Topical cosmetics Some contain gluten or hydrolyzed wheat proteins (shown to illicit allergic reactions). The impact on people with CD unclear El-Wakil [15] Wheat starch-based food wrap ...
    Article
    Full-text available
    The management of coeliac disease involves the life-long adherence to a strict gluten free diet. There have been concerns about exposure to gluten or other cereal components that are not contained in foods. This manuscript reviews the available literature focused on the potential for exposure to non-food-based gluten and the potential relevance of this to the ongoing management of individuals with coeliac disease. The products of consideration included dental and oral hygiene products, cosmetics and packaging products. Each of these items has been considered, with caution noted in regards to dental products and potential concern about novel packaging applications. Accidental ingestion by younger children of items such as play-dough during play also requires care. In conclusion, there is currently little firm data to guide individuals with coeliac disease, other than caution about specific items.
  • ... powder, body lotions, etc) may contain gluten in different forms (thicker and preservatives) or gluten-derived ingredients (11)(12)(13). Although such products should not be ingested, some amounts of these products can inadvertently be swallowed, particularly in the form of lipsticks or lip balms and toothpastes, thus leading to the possible ingestion of gluten traces (in the case of contamination) and eventually contributing to a persistent intestinal damage in CD patients. ...
  • ... powder, body lotions, etc) may contain gluten in different forms (thicker and preservatives) or gluten-derived ingredients (11)(12)(13). Although such products should not be ingested, some amounts of these products can inadvertently be swallowed, particularly in the form of lipsticks or lip balms and toothpastes, thus leading to the possible ingestion of gluten traces (in the case of contamination) and eventually contributing to a persistent intestinal damage in CD patients. ...
    Article
    Objectives: The only available treatment for celiac disease (CD) is the gluten-free diet. It is unclear whether the presence of gluten in oral hygiene products and cosmetics that are applied on the mouth is a reason of concern for CD patients. The aim of this study was to test the level of gluten contamination in oral hygiene and cosmetic products available in the Italian market. Methods: A total of 66 products (toothpastes = 37; dental tablets = 2; mouthwashes = 5; lip-balms = 10; lipsticks = 12) labelled gluten-free or with unknown gluten content were randomly collected from different supermarkets and pharmacies. The gluten quantification was determined by the R5 ELISA method approved by EU regulations. Results: Out of 66 oral hygiene and cosmetics, 62 products (94%) were found to be gluten-free (gluten level <20 ppm), while 4 (6%) (toothpastes = 3; lipsticks = 1) showed a gluten level >20 ppm (toothpastes: 20.7 ppm, 31.4 ppm, and 35 ppm; lipstick: 27.4 ppm). None of the selected products had ingredient derived from wheat, barley, or rye. Conclusions: Gluten contamination is currently not an issue in a wide array of cosmetic and oral hygiene products that are commonly on the market.
  • Article
    Full-text available
    Background: Therapy for coeliac disease (CD) mainly relies on following a gluten-free diet (GFD); however, a serum marker for gluten intake has yet to be established. Aims: To evaluate the utility of alkylresorcinol concentrations for detecting gluten intake in studies of human and mouse. Methods: Alkylresorcinol concentrations were compared among treated patients with coeliac disease (n = 34), untreated coeliac disease patients (n = 36) and controls (n = 33). Furthermore, seven additional coeliac disease patients whose serum samples were available at diagnosis and after GFD were evaluated. In mice studies, alkylresorcinol concentrations were compared in the serum of five mice fed a regular chow and 10 mice fed lifelong with a gluten-free chow. In addition, the effect of adding gluten on changes of alkylresorcinol concentrations was also evaluated. Results: Total alkylresorcinol concentrations were significantly lower in treated with coeliac disease [median (IQR), 3 (2-8) nmol/L], compared to untreated patients [median (IQR), 32 (11-74) nmol/L; P < 0.0001] or healthy controls [median (IQR), 54 (23-112) nmol/L; P < 0.0001]. Moreover, alkylresorcinol concentrations in coeliac disease patients significantly decreased after introduction of a GFD (median, 34 nmol/L at diagnosis vs. 5 nmol/L after GFD, P = 0.02). In the mice, median (IQR) total alkylresorcinol concentrations in serum samples of mice fed lifelong with a gluten-free chow was 1.8 (1.6-2.3) nmol/L, which was further significantly increased to 16 (11-22) nmol/L after 8 days of feeding with the gluten-free chow that had gluten added to it. (P = 0.008). Conclusion: Serum alkylresorcinol concentrations could be a useful marker for dietary gluten in coeliac disease.
  • Article
    Gluten-free diets are increasing in popularity among consumers and fueling a global market of gluten-free products. A gluten-free diet is the only treatment for celiac disease (CD). However, many patients are self-reporting and suspecting “gluten sensitivity” after gastrointestinal symptoms, such as bloating, abdominal pain, or diarrhea, resolve on a gluten-free diet without formal evaluation testing for food allergies or CD. The terms related to gluten and/or wheat intolerance, nonceliac gluten sensitivity or wheat sensitivity, CD, and wheat allergy can be confusing. These forms of intolerance combined affect approximately 10% of the United States population. In this article we clarify the range of gluten and/or wheat disorders, clinical features, diagnosis, and management.
  • Article
    There are ten things that all gastroenterologists should know about celiac disease. The IgA TTG is the single best serologic test to use for the detection of celiac disease (CD). Celiac disease can be recognized endoscopically, and water immersion enhances villi detection, although a normal endoscopic appearance does not preclude the diagnosis. It is recommended that four biopsies be taken from the second part of the duodenum, and two bulb biopsies taken at the 9 and 12-o’clock positions to maximize the sensitivity for histologic confirmation of CD. Consider serologic testing of first-degree relatives, patients with type 1 diabetes, Down’s, Turner’s and William’s syndromes, as well as those with premature osteoporosis, iron deficiency, abnormal liver biochemistries and other manifestations of CD. Patients already on a prolonged gluten-free diet (GFD) should be tested for the presence of HLA DQ2 or DQ8, thereby avoiding the need for further evaluation of CD in non-allelic carriers. The basic treatment of CD is a strict, life-long GFD, enabled by an expert dietitian. Newly-diagnosed adults with CD should be assessed for micronutrient deficiencies (iron, B12, folate, zinc, copper), fat soluble vitamins deficiencies (vitamin D) and bone densitometry. All patients diagnosed with CD should have clinical follow-up to ensure response and adherence to a GFD. In those with persistent or relapsing symptoms, the robustness of the original diagnosis should be reviewed, gluten exposure sought, and a systematic evaluation for alternative and associated diseases. Evaluate those with refractory disease for malignant transformation.
  • Cosmetic labeling guide: ingredient labeling
    • Drug Food
    • Administration
    Food and Drug Administration. Cosmetic labeling guide: ingredient labeling. http:// www.fda.gov/cosmetics/cosmeticlabeling labelclaims/cosmeticlabelingmanual/ucm 126444.htm#clgl. Updated May 4, 2012. Accessed May 30, 2012.
  • FDA's gluten-free rulemaking—Implications for your cli-ents with celiac disease [teleseminar]. Academy of Nutrition and Dietetics web-site
    • Kane L R Verrill
    • Thompson
    Verrill L, Kane R, Thompson T. FDA's gluten-free rulemaking—Implications for your cli-ents with celiac disease [teleseminar]. Academy of Nutrition and Dietetics web-site. http://www.eatright.org/Shop/Product. aspx?idϭ6442466994. Published December 8, 2011. Accessed December 8, 2012.
  • Celiac patients face potential hazard as information on cosmetic ingredients difficult to find: Products used on lips and face can result in unexpected exposure to gluten
    • American College
    • Gastroenterology
    American College of Gastroenterology. Celiac patients face potential hazard as information on cosmetic ingredients difficult to find: Products used on lips and face can result in unexpected exposure to gluten [press release]. http://d2j7fjepcxuj0a. cloudfront.net/wp-content/uploads/2011/ 10/2011acg_Celiac-Cosmetics__FINAL-OCct-26.pdf. Published October 31, 2011. Accessed May 30, 2012.
  • Gluten contamination in the Canadian oat supply. Food Additives & Contaminants: Part A
    • T B Koerner
    • C Cleroux
    • C Poirier
    • I Cantin
    • A Alimkulov
    • H Elamparo
    Koerner TB, Cleroux C, Poirier C, Cantin I, Alimkulov A, Elamparo H. Gluten contamination in the Canadian oat supply. Food Additives & Contaminants: Part A. 2011;28(6): 705-710.
  • FDA's glutenfree rulemaking-Implications for your clients with celiac disease
    • L Verrill
    • R Kane
    • T Thompson
    Verrill L, Kane R, Thompson T. FDA's glutenfree rulemaking-Implications for your clients with celiac disease [teleseminar].
  • Article
    The Food and Drug Administration (FDA or we) is issuing a final rule to define the term "gluten-free'' for voluntary use in the labeling of foods. The final rule defines the term "gluten-free'' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim "no gluten,'' "free of gluten,'' or "without gluten'' in its labeling and fails to meet the requirements for a "gluten-free'' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term "wheat'' in the ingredient list or in a separate "Contains wheat'' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim "gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a "gluten-free'' claim. Establishing a definition of the term "gluten-free'' and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
  • Article
    Full-text available
    A growing body of evidence suggests that a majority of people with celiac disease and on a gluten-free diet can safely consume pure oats in moderate amounts; however, previous studies have indicated that the commercial oat supply in other countries, and in Canada to some extent, is contaminated with other grains. This study has confirmed that the commercial oat supply in Canada is heavily contaminated with gluten from other grains. Approximately 88% of the oat samples (n = 133) were contaminated above 20 mg kg(-1) and there were no differences between the oat types tested. Only one gluten-free variety of oats was analysed and it consistently provided negative results in all analyses. It is difficult to determine where the contamination originates, but there are possibilities for cross-contamination in the field, in the transport of the grain, in the storage of the grain, and in the milling and packaging facilities. It is clear from this study that only those products that have been certified 'pure' oats would be appropriate for a gluten-free diet.
  • Article
    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.
  • Article
    A standardized method of analysis is needed to quantitatively determine the gluten content of food and provide the basis for enforcing regulations regarding use of the term gluten-free in food labeling. People with celiac disease should feel confident that foods labeled "gluten-free" have been assessed for gluten using the same "best available" methodology. The Association of Analytical Communities and the Codex Alimentarius Commission endorse different methods. Both are used by manufacturers in the United States to determine the gluten-free status of food. The sandwich omega-gliadin enzyme-linked immunosorbent assay (ELISA) is the official method of the Association of Analytical Communities. It is able to quantify native and heated gluten. It is unable to accurately detect and quantify barley prolamins, can over- or underestimate gluten content, and cannot accurately quantify hydrolyzed gluten. The sandwich R5 ELISA was endorsed by Codex for gluten determination. It is able to quantify native and heated gluten. One criticism is that it overestimates barley hordein. It also is unable to accurately quantify hydrolyzed gluten. Foods that can be reliably assessed for gluten using a validated commercially available ELISA are those contaminated with native and heated proteins from wheat, barley, and rye. The degree of confidence that can be placed in a manufacturer's assertion that a product is gluten-free is based on the assay used to determine the gluten content and the specific food analyzed.
  • Article
    Full-text available
    To the Editor: Research published in the Journal 1 and elsewhere2 strongly suggests that persons with celiac disease can consume moderate amounts of uncontaminated oats. Nonetheless, celiac disease organizations in the United States continue to advise against the consumption of oats because of concern that commercial oat products may be contaminated with wheat, barley, or rye during harvesting, transporting, milling, and processing.2 However, little information is available on the contamination of oat products in the United States. Here I report an assessment of selected brands of oats for gluten contamination. Twelve containers of rolled or steel-cut oats, representing four different lots . . .