Gluten Free Watchdog, LLC was founded by Tricia Thompson, MS, RD, to make state-of-the-art gluten-free food testing data available directly to you, the consumer. Gluten Free Watchdog, LLC tests labeled gluten-free foods.
Study authors have affiliations with ImmunogenX and Biomedal/Glutenostics
Gluten Free Watchdog has no affiliation with either Biomedal/Glutenostics or ImmunogenX.
The study, “Determination of gluten consumption in celiac disease patients on a gluten-free diet” was recently published in the American Journal of Clinical Nutrition. In the opinion of Gluten Free Watchdog this is one of the more significant studies published on celiac disease and the gluten-free diet in recent memory. It is the first study that attempts to analytically determine the actual amount of gluten consumed by a sub-group of individuals with celiac disease.
What researchers did: Researchers analyzed prior clinical data to determine how much gluten is accidentally consumed while on a gluten-free diet. They conducted a meta-analysis on data from studies involving measurements of gluten in stool and urine and trials for the investigational drug latiglutenase.
What researchers found: Mean daily consumption for adult participants on a gluten-free diet were determined to be 244 mg (stool analysis), 363 mg (urine analysis) and >228 mg (ALV003-1221 trial analysis). According to the study, “There is a general consistency in these analyses and the potentially higher value for the latter case may reflect that this trial enrolled a more symptomatic CD population.”
Keep in mind that in the US, it is recommended that folks with celiac disease consume no more than 10 mg of gluten per day. This is approximately equivalent to 17 one ounce servings of labeled gluten-free food containing just under 20 parts per million of gluten.
What researchers concluded: Many individuals following a gluten-free diet regularly consume sufficient gluten to trigger symptoms and perpetuate intestinal histologic damage.
Note from Francisco Leon (one of the study authors): Not all recurrent symptoms while on a GFD are due to gluten. Many cases are due to other co-morbidities (bacterial overgrowth, pancreatic enzyme deficiency… and even true refractory celiac disease) or dietary causes (low fiber intake, for example, see recent article https://www.ncbi.nlm.nih.gov/pubmed/29505551 – these patients are not the patients we studied, these have healed mucosa yet persistent symptoms).
Assessing gluten consumption is a first step in the evaluation of recurring symptoms by patients and clinicians. If there is clearly no gluten consumption yet symptoms persist, more invasive exploration is warranted to identify the cause of the symptoms.
If you have been diagnosed with celiac disease and continue to have persistent symptoms, it is the recommendation of Gluten Free Watchdog that you speak with your dietitian or physician about stool testing using Glutenostics Gluten Detective at-home stool test. Gluten Free Watchdog recommends using the stool test (versus the urine test) as it reportedly has a lower limit of detection of approximately 50 milligrams gluten as compared to the urine test with a lower limit of detection of 500 milligrams gluten. While these tests are available to consumers it is best to use them under medical supervision. Please see our previous post on the Gluten Detective stool and urine tests for more information https://www.glutenfreewatchdog.org/news/gluten-detective-consumer-test-kits-for-detecting-gluten-in-stool-and-urine/
Q&A with Study Authors
Gluten Free Watchdog reached out to Francisco Leon, one of the study authors and the co-founder of Glutenostics and Jack Syage, corresponding author and CEO and co-founder of ImmunogenX. What follows is a Q&A with Dr. Leon and Dr. Syage.
What is the main strength of the study?
FL: The medical community has known for a long time that patients with celiac disease are frequently exposed to gluten. In most studies, 30 to 50% of patients on a gluten-free diet have intestinal mucosal atrophy, and these patients heal completely if monitored closely. This proves they were getting contaminated. The article’s strength is that it quantifies the amount, and that is extremely valuable not just for patients but also for companies developing medications. Now we know how much gluten we need to counteract.
What is the main weakness of the study?
FL: The calculation is indirect. It’s a meta-analysis and relies on a mathematical model. Directly measuring gluten in food, stool and urine will give us more direct information. Such a study is currently underway.
JS: On the whole it should be realized, and I hope we make this clear in the paper, that there are many assumptions and approximations in determining consumed gluten so this can only be considered a semi-quantitative analysis at best. It is the best we can do with the available data. I think the model is sound and hopefully new data can be generated with this model in mind to refine the analysis.
In one of the studies used in the meta-analysis about 30 to 40 % of participants were classified as having moderate to severe symptoms (based on various criteria including frequency of diarrhea, constipation, etc.). Do you believe this percentage in generalizable to the entire population of folks with celiac disease?
FL: Yes, I believe the percent of 30-40 is extrapolable to the general population based on all of the studies available to us.
JS: In the Alvine/AbbVie ALV003-1221 trial about 2000 patients were screened and about 30-40% had moderate to severe symptoms as measured by a CD-specific symptom patient reported outcome questionnaire. These patients were further screened for histologic damage that reduced this number to about 25% of the screened patients entering into the trial.
Were the participants with high levels of gluten in their stool and urine considered non-compliant with the gluten-free diet?
FL: Yes, by definition, these patients are eating gluten (in small amounts), so they are not compliant, but they are not necessarily “cheaters”. It’s contamination for the most part.
JS: Keep in mind if an average non-gluten-free diet is say 15 g then 99% success at compliance is still 150 mg of gluten sneaking in, an amount considered unsafe.
Had the participants who were considered non-compliant received counseling services from a dietitian on the gluten-free diet?
FL: This is the worst part; most of these patients were followed at some of the best centers in the US and abroad, so it’s likely many of them had received counseling.
Do we know how much gluten is consumed by folks with celiac disease reporting mild symptoms?
FL: Celimmune looked at gluten in stool in celiac patients with no or mild symptoms in our NRCD-001 study, using a different definition. About 20 % of the patients in this study had mucosal atrophy, and of those we detected gluten in 20 % only – suggesting they were eating gluten only occasionally, but enough to trigger atrophy. We did not get a precise quantification, only positive/negative.
Members of the Gluten Free Watchdog community asked the following two questions due to interest in transparency.
Were patients advised during the study enrollment period that researchers had various relationships with the manufacturers of the drug and test kits prior to enrollment?
FL: Patients were of course informed of the sponsorship by Biomedal and Alvine of the respective original studies. The meta-analysis study is retrospective, and patients had consented to let researchers use their data in future celiac research by the sponsors and their collaborators. Then Immunogenx bought Alvine and Biomedal partnered with Glutenostics (companies which did not exist at the time of the original studies).
How might the interpretation of the data by study authors be influenced by relationships with these companies and the desire to illustrate the importance of monitoring stool and urine for gluten and the importance of developing drug treatment for celiac disease?
FL: Of course, there is bias in everything we do, but ImmunogenX (who drove the study) would in any case be interested in finding as low a contamination as possible (to claim their drug will be able to treat) so the bias -had it existed- may have been to minimize the amount of gluten – and yet we found a lot. Certainly Biomedal and Glutenostics are interested in showing there is contamination, but that’s well known already.
JS: In our minds there were two motivating factors behind this study: (i) how much gluten is being consumed on a gluten-free diet so we know how to design our real-world trials to provide doses that are sufficient to protect against these unintended exposures and (ii) in gluten challenge trials are the gluten intakes representative of real-world intrusions so that if these trials are successful one is confident it will have real therapeutic value. This is an interest of the FDA as well.
Thank you to Francisco Leon and Jack Syage!
Personal note from Tricia Thompson, Founder of Gluten Free Watchdog: Admittedly, this study has shaken me up a bit. If the gluten levels reported in this meta-analysis are reasonably accurate and can be corroborated by additional studies, this raises so many questions–in my mind at least. I need time to digest it all but some of the questions rattling around in my brain include:
How does this analysis change my opinion about drug therapy for celiac disease?
What does this analysis say about how folks with celiac disease are being counseled to follow the gluten-free diet? How can we do better?
What might this analysis mean about the foods folks with celiac disease are eating?
What might this analysis say about the levels of cross contact in naturally gluten-free foods, such as grains and legumes?
What might this analysis say about foods that are the trickiest to test for gluten? Are we not detecting gluten when it is present?
What might this analysis say about gluten levels in food—might levels be higher than gluten test results indicate?
What can we do to make eating outside of the home less likely to result in cross contact with gluten?
We will continue to watch for future studies. In the meantime, please adhere to the gluten-free diet to the best of your ability.
Note: If you are a subscriber to Gluten Free Watchdog, summary test reports for both arsenic and mercury will be reposted with minor updates. Reposting these reports allows the entire community of current subscribers (and all new subscribers if they subscribe before May 28, 2018) to access this information regardless of subscription level (Watchdog or Premium). Please wait until you receive email notification that the reports have posted before trying to access them.
The researchers from Dartmouth College who tested rice products for arsenic and mercury for Gluten Free Watchdog have just published a new article in the journal Food Chemistry entitled, “Essential micronutrient and toxic trace element concentrations in gluten containing and gluten-free foods” (abstract available at https://www.sciencedirect.com/science/article/pii/S0308814618301341). Among other micronutrients and trace elements, they assessed rice and rice-based products for arsenic and mercury.
Arsenic findings: Researchers found that “the total arsenic concentration in whole grain rice, rice flour and processed foods containing rice was significantly higher than non-rice flours and processed foods based on other grains.” In addition, brown rice and enriched white rice had significantly higher concentrations of total arsenic than white rice that was not enriched. The amount of inorganic arsenic was also significantly higher in brown rice than white rice—both enriched and unenriched varieties. According to the researchers, “inorganic arsenic accumulation in bran layers of the rice grain is a likely explanation for the higher inorganic arsenic concentrations measured in brown rice. However, the reason why enriched white rice grain contains higher organic arsenic concentrations than brown or non-enriched white rice is not clear and may be an artifact of the small sample size of each grain type.”
Mercury findings: Results were low for all foods tested, including rice. However, researchers found that “food containing rice had significantly higher mercury concentrations than those based on wheat or other grains.” Mercury concentrations did not differ significantly between rice types—brown, unenriched white, and enriched white.
Why does arsenic and mercury accumulate in rice? According to the researchers, “Like arsenic, the presence of methylmercury in rice is due to the practice of growing rice in flooded soils.”
Bottom line: Gluten Free Watchdog asked Tracy Punshon, one of the researchers for her main take away points from the study:
Eat as wide a variety of gluten-free grains as possible
Pay attention to the rice and rice ingredient content of gluten-free foods
At Gluten Free Watchdog we echo the above recommendations.
The FDA has issued an interim response to Gluten Free Watchdog’s petition requesting that the agency establish a specific protocol for increased surveillance, investigation and enforcement of potential facial misbranding violations under the gluten-free labeling rule. The agency response reads in part, “…we have not reached a decision on your petition within the first 180 days due to competing priorities. However, be advised that your petition is currently under active evaluation by our staff.”
At Gluten Free Watchdog, Kaki and I will be giving the FDA what we believe to be a reasonable amount of time (until the end of April) to get back to us with additional information on the status of our petition. If the agency continues to delay their decision, we will begin exploring other options.
In the meantime, it is important for all of us to document potential misbranding violations. Please do the following if you come across a product either in the store or after purchase that you believe is misbranded:
Take photos of the label that clearly show:
Contains statement if present
Wording about gluten-free status printed after the Contains statement
Gluten Free Watchdog has tested three artisanal sourdough breads for gluten. We will not be testing any additional varieties. As the test results prove, wheat-based sourdough bread, including those made in small bakeries by artisanal bakers contains a lot of gluten and should not be eaten by anyone with a gluten related disorder. Full Stop.
Product: Dan the Baker Country Sourdough Bread
Test date: April 2015
Why product was tested: At the time of testing the bakery website included a page entitled “Sourdough for Celiacs”which as of April 6, 2015 stated: “A recent study based out of Italy shows that 80% of those with doctor-confirmed celiac disease can eat sourdough bread every day and experience no adverse symptoms. In sourdough bread, the concentration of gluten is decreased by about 97% …Eating sourdough can be a safe and healthy way to consume grains for nearly everyone, even 80% of those diagnosed with celiac disease as evidenced by the Italian study.”*
Test results using the sandwich R5 ELISA (measures intact gluten): 104,000parts per million of gluten
Product: Purbread Gluten Neutralized Bread
Test date: March 2016
Why product was tested: At the time of testing, literature in the bread display area read: Neutralized is defined by the manufacturer as making something ineffective or harmless. “Gluten now has been neutralized.” The manufacturer was also claiming that “celiacs” enjoy his bread without reaction.
Ingredients: Sour dough starter, Gluten neutralized white winter wheat, Raw pure honey, Pure maple syrup, Pure canola oil, Sea salt
Test results using the sandwich R5 ELISA: > 84 ppm gluten
Test results using the competitive R5 ELISA (used to detect gluten protein fragments): > 283 ppm gluten
Note: The actual gluten level of this bread is likely much higher. We did not have the lab dilute the sample to bring the results in line with the standard curve as we did with the loaf of sourdough bread from Dan the Baker. It is not necessary to have the lab run additional tests to know that this bread is not safe for individuals with celiac disease or other gluten-related disorders.
Product: Leaven Breads 100% Sourdough Bread
Test date: February 2018
Why product was tested: At the time of testing the website read, “There is a growing body of science showing how the sourdough process produces bread that can be handled by those with gluten-sensitivities, even though the bread isn’t gluten-free. If diagnosed with celiac disease, you should avoid this and all bread made with wheat flour. For more information, check out this article on the history of sourdough and celiac disease.” At the time of testing the homepage also read, “All our breads our sourdough, but they are not sour. We believe in the power of local fermentation to leaven our doughs without the use of commercial yeast. This creates a more complex flavor with a long proofing process and breaks down the gluten in flour naturally.”
Ingredients: Flour, Water, Salt
Test results using the sandwich R5 ELISA: > 84 ppm gluten
Test results using the competitive R5 ELISA: > 283 ppm gluten
Note: As with Purbread, the actual gluten level of this bread is likely much higher. We did not have the lab dilute the sample to bring the results in line with the standard curve as we did with the loaf of sourdough bread from Dan the Baker. It is not necessary to have the lab run additional tests to know that this bread is not safe for individuals with celiac disease or other gluten-related disorders.
* The study referenced on the Dan the Baker website is a 2011 study by researchers Greco et al.
What the researchers actually report: When two study participants ate baked goods made using extensively hydrolyzed flour (gluten reduced 97% and containing 2,480 ppm gluten) no clinical complaints were reported BUT they developed SUBTOTAL ATROPHY of their intestinal mucosa. In other words (and not surprisingly) these products are NOT safe for people with celiac disease. The researchers write, “Two CD patients consumed 200 g of S1BG that contained ~ 2480 +/- 86 ppm of residual gluten. They had no clinical complaints during the 60 days. One showed increased antibodies and both showed increased CD3 and gamma-delta intraepithelial lymphocytes with subtotal atrophy after challenge.”
The products that the study researchers believe may have potential use in gluten-free diets are those that have been fully hydrolyzed (8 parts per million of gluten) through sourdough lactobacilli and fungal proteases.
To read the full article, click HERE.
Please feel free to share this post with any bakers who claim their artisanal wheat-based sourdough bread is okay for folks with a gluten related disorder.
The comment period for this proposed guidance closes at 11:59 pm eastern time TODAY February 12, 2018.
This is the text of the email sent to Gluten Free Watchdog subscribers:
Dear Gluten Free Watchdog community,
As most of you know, FDA issued draft guidance for industry on gluten in drug products and associated labeling recommendations. The comment period closes on Monday, February 12 (yes, tomorrow!). Please see the comment pasted below that we just submitted to the docket. Please consider commenting and feel free to use any (or all) of the information posted below. To comment go to https://www.regulations.gov/docket?D=FDA-2017-D-6352.
Tricia Thompson, MS, RD
Founder, Gluten Free Watchdog, LLC
Gluten Free Watchdog supports the comment submitted by the Celiac Community Foundation of Northern California (FDA-2017-D-6352-0075) and raises an additional scientific concern.
First, we agree with the conclusion of the Celiac Community Foundation of Northern California:
“Issuing industry guidance on the voluntary labeling of gluten in drugs leaves the burden primarily on consumers to research and analyze whether a drug is safe for those with celiac disease and other gluten-related disorders. Voluntary labeling does not resolve uncertainty when most drugs remain unlabeled for gluten. The approach is inadequate and unlikely to have a significant impact on the problem.”
Second, we raise a concern about the research on which the proposed guidance is in part based. If the FDA plans to proceed with the industry guidance despite widespread objection to this approach in the national celiac disease community, the guidance should be based on sound scientific research in accordance with FDA standards. Therefore, we ask the FDA to publicly release the raw data that was used to determine that the amount of gluten in a unit dose of an oral drug product is expected to be less than 0.5 mg, and then reopen the proposed guidance for comments.
In this proposed guidance (Gluten in Drug Products and Associated Labeling Recommendations, FDA-2017-D-6352) you state the following:
“If a drug included an ingredient derived from wheat, barley, or rye, the ingredient would most likely be wheat-derived. The amount of gluten potentially contributed by a wheat-derived ingredient to a unit dose of an oral drug product (unless that ingredient is wheat gluten itself or wheat flour) is expected to be less than 0.5 mg, as a high estimate.” 11
Reference 11 is the following:
“11 Our estimate is based on assumptions regarding gluten content and ingredient usage that favor a high estimate (i.e., we considered high levels of use for each inactive ingredient potentially derived from wheat, and we considered the high end of the range at which gluten is reasonably expected to be present in each ingredient).”
However, in an FDA citizen petition (FDA-2008-P-0333, Citizen petition to remove gluten ingredients from medications) a different reference is cited for the assumption that the amount of gluten in a unit dose of an oral drug product is expected to be less than 0.5 mg.
On page 18 of FDA’s response to Mr. Weber (FDA-2008-P-0333) the following is written:
“3. Overall Conclusion Regarding Quantities of Gluten in Oral Drug Products We recognize there is some uncertainty in our analysis regarding quantities of gluten potentially present in oral drug products. But we believe based on this analysis that oral drug products marketed in the United States today- apart from exceedingly rare oral drug products that contain and should be labeled as containing wheat gluten as an ingredient- are very unlikely to contain more than 0.5 mg gluten per unit dose. 39”
Reference 39 is an FDA funded study in which 39 drugs were tested for gluten.
http://www.regulations.gov/#!documentDetail;D=FDA-2008-P-0333-0030 (see bottom of page 18).
The study cited appears to have flaws. At issue is the apparent belief of the study authors that the part per million gluten contamination value changes based on medication dosage. As FDA knows, ppm is a proportion/percentage. One pill, 1/2 pill, or the entire bottle has the same ppm value. What obviously changes based on dosage and ppm contamination level is the milligram amount of gluten ingested.
The study authors’ apparent confusion regarding parts per million is illustrated in the following passage from the study:
“Testing Methods: Four drugs (esomeprazole capsules, tramadol tablets, diphenhydramine HCL tablets and chlorthalidone tablets) tested positive in the Competitive ELISA when their gluten concentrations were examined in raw form. Since the Competitive assay protocol required taking 1000 mg of sample, we had to use 4.58 tablets for esomeprazole, 4 tablets for tramadol, 3.88 tablets for diphenhydramine and 7.09 tablets for chlorthalidone for the assay. Adjusting the assay result for a subsample of 1 tablet/capsule resulted in the ppm for these drugs to be below 10ppm, the level of quantification. For this reason, we are reporting that these drugs tested below the LOQ, and therefore negative for gluten.”
FDA may very well be correct in its conclusion that medications are unlikely to contain more than 0.5 mg gluten per unit dose but this conclusion must be based on accurate testing data.
In the interest of transparency, please release what the authors of the FDA commissioned study term “raw “ part per million test results for all drugs tested. This would be the ppm gluten result before the researchers appear to have erroneously recalculated the ppm amount based on dosage size.
On Sunday January 14, Kaki and I submitted a supplement to our FDA citizen petition requesting that the FDA establish a specific protocol for increased surveillance, investigation and enforcement of potential facial misbranding violations under the gluten-free labeling rule.
The supplement has not yet posted to the docket so we are posting it here for your information. Please take the time to read this supplement paying particular attention to page 3 and the listing of 17 misbranded products discovered in circulation in 2017. The petition supplement is available at this linkGFWDPetitionSupplementFinal
If you have not yet commented on the petition, please take the time to do so. Trust me, this is exceedingly important to do. FDA needs to hear from YOU. The comment period closes on February 19th.
To all companies and advertisement agencies planning to poke fun at people on a gluten-free diet during your Super Bowl ads: Take a very hard look at this photograph*. It is of a 2 year old child with celiac disease diagnosed BEFORE the discovery that gluten was the causative agent in this disease. Do you know what happened to these children? Many of them died. A gluten-free diet is a medical necessity for children and adults with celiac disease. It is the ONLY treatment for this disease.
*Photo of my personal copy of the article “The Value of the Banana in the Treatment of Celiac Disease” by Dr. Sidney Haas. Published in 1924 in the American Journal of Diseases of Children.
If you would like to learn more about the history of the dietary treatment for celiac disease, see the following articles:
Early Dietary Treatment for Celiac Disease: The Banana Diet
Note: Gluten Free Watchdog purchased the tests shown in the photo from Glutenostics. All conversations with Glutenostics have been “on the record.”
There are two new consumer tests for monitoring gluten intake on the market from Glutenostics—Gluten Detective stool test and Gluten Detective urine test. According to the manufacturer these tests can be used to monitor “major transgressions” related to gluten intake (urine test) and “total weekly gluten consumption” (stool test). What follows is information about the amount of gluten (and what this looks like) that has to be eaten for either test to detect gluten.
Please note that this discussion is not about whether these tests work or whether they should be used. Both tests are based on the 33-mer peptide. This peptide is considered immunogenic to folks with celiac disease and according to Romer labs (not affiliated with Glutenostics), “is highly resistant to digestive degradation and is therefore well suited as an analytical marker.” Research assessing the stool and urine tests has been published in the scientific peer review literature.
Urine test (from the manufacturer):
Minimum intake 500 mg
Per manufacturer: 2 bites of bread
Optimal window 6 to 16 hours (full window 1 to 24 hours)
Stool test (from the manufacturer):
Minimum intake: 50+mg
Per manufacturer: a crumb of bread
Optimal window: 2 to 4 days (full window 1 to 7 days)
Question: Will the stool test detect gluten eaten from labeled gluten-free food or food that appears to be free of gluten-containing ingredients when the gluten level is greater than 20 ppm gluten?
Keep in mind the following:
1 ounce of a product with a gluten level of 2,000 ppm contains approximately 50 mg of gluten.
2 ounces of a product with a gluten level of 1,000 ppm contains approximately 50 mg of gluten.
4 ounces of a product with a gluten level of 500 ppm contains approximately 50 mg of gluten.
10 ounces of a product with a gluten level of 200 ppm contains approximately 50 mg of gluten.
20 ounces of a product with a gluten level of 100 ppm contains approximately 50 mg of gluten.
40 ounces of a product with a gluten level of 50 ppm contains approximately 50 mg of gluten.
80 ounces of a product with a gluten level of 25 ppm contains approximately 50 mg of gluten.
Based on the above information, it seems unlikely that gluten will be detected from a food labeled gluten-free that is not in compliance with the gluten-free labeling rule (< 20 ppm gluten) unless the food is highly contaminated and/or a lot of the food is eaten over the course of 2 to 4 days.
Question: Will the stool test detect gluten cross contact, such as from breadcrumbs on a cutting board?
Assuming the crumbs are from wheat bread that has a gluten level of 124,000 ppm, the equivalent of 1/70th of a one-ounce slice of wheat bread crumbs would have to be eaten to ingest 50 mg of gluten.
What does this look like?
Measuring 1/70th of one ounce of my husband’s bread, it looks a bit smaller than a dime (see photo).
1/70th of a one-ounce slice of bread amounts to quite a few crumbs. But it is plausible that accidental cross contact with wheat-based bread, pasta, or flour could result in this level of intake, especially over 2 to 4 days. However, characterizing 50 mg of gluten as “a crumb of bread” (as is done by the manufacturer) is not quite accurate.
How much gluten would you have to eat for the urine test to be positive?
About 1/7 of an ounce of wheat bread, assuming a gluten level of 124,000 ppm.
The urine test seems more useful for assessing whether or not regular bread or pasta was accidentally eaten (as is insinuated by the manufacturer).
What I would like to see
In the US, we tend to use 10 mg of gluten per day as the “safe” threshold for folks with celiac disease. If the optimal window for the stool test is 2 to 4 days, it would be useful if the lower limit of detection for this test could be reduced from 50 mg to 20 to 40 milligrams of gluten.
If you are concerned that you have been regularly exposed to cross contact from gluten over a period of days then you may find the stool test useful (assuming the test works as the manufacturer claims). However, if you are concerned that a single food or meal may have contained a level of gluten above 20 ppm, this test will likely not provide you with an answer (unless the food/meal is highly contaminated).
Statement from Glutenostics
A draft of this post was shared with Glutenostics prior to publication. They were invited to provide a comment for publication. Their statement is posted in full.
“The FDA has determined the safe level of gluten concentration in food to qualify as ‘gluten-free’ to be 20 ppm (20 mg gluten per 1 kg food). Based on the fact that the average American eats 4.5 pounds = 2.5 kg of food per day, the maximum amount of gluten that the average American could consume while eating foods labeled ‘gluten-free’ is 50 mg of gluten per day (20 ppm x 2.5 kg food = 50 mg gluten). Gluten Detective recognizes that the definition of a ‘crumb’ is subjective, and is dependent on the density of the bread, which may be ‘fluffy’ resulting in a bigger crumb such as that shown in the image here, or more dense resulting in a smaller crumb (not shown).”
At least two varieties of the brand Jane Bakes cookies are labeled gluten-free yet list whole wheat flour as the first ingredient—Hazelnut & Chocolate and Coconut & Caramel. If you currently have any variety of labeled gluten-free cookies from this manufacturer in your pantry, please read the ingredients list carefully before eating.
A consumer first notified Gluten Free Watchdog about this product on December 26th. The cookies were a gift to the consumer. The person purchasing the cookies relied on the gluten-free label. GFWD was in touch with the manufacturer on December 27th. At this time, the manufacturer stated in email correspondence that they would alert their distributor to remove product from store shelves and that they would contact the FDA. According to the manufacturer the incorrect gluten-free labeling was due to “printer” error.
The consumer contacted GFWD again on December 31st to alert us to a second variety of cookie labeled gluten-free yet listing whole wheat flour as the first ingredient. The consumer also stated that both varieties of cookies remained on store shelves.
GFWD sent a follow-up email to the manufacturer on December 31st. We have not heard back.
The consumer contacted GFWD again on January 6th stating that a new delivery of cookies arrived at a local store. Coconut & Caramel cookies labeled gluten-free yet listing whole wheat flour as the first ingredient remain on store shelves. The consumer has advised the store manager that the incorrectly labeled cookies should be removed.
Thank you to the consumer who continues to update us.
It is inexcusable that labeled gluten-free cookies listing wheat flour in the ingredients remain on store shelves. If you are reading this and you have not yet commented in support of our citizen petition requesting that the FDA establish a specific protocol for increased surveillance, investigation and enforcement of potential facial misbranding violations under the gluten-free labeling rule, please do so now at https://www.regulations.gov/docket?D=FDA-2017-P-5118
Thank you to the almost 1,200 consumers who have already commented. Thank you to the national consumer groups, Center for Science in the Public Interest, Beyond Celiac, and National Celiac Association for their support of this petition.
We would also love to have the support of the other two national celiac disease consumer groups. It isn’t too late for them to join us. On behalf of everyone with celiac disease and other gluten-related disorders who require properly labeled gluten-free foods, we urge them to comment in support of this petition today.
Note: If you do not follow Gluten Free Watchdog on Facebook or Twitter please do so. Product warnings such as this one tend to be posted on social media so that they can be quickly shared.
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