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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
ELISA⫽enzyme-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?id⫽6442466994. 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