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Celiac.com 08/13/2024 - Gluten Free Watchdog, an advocacy site for people with celiac disease, recently responded to a study by Moms Across America, which claimed that Trader Joe's Everything Gluten-Free Bagels contained nearly 300 ppm of gluten—a controversy that has already led to a class action lawsuit against Trader Joe's. The gluten testing was performed by Health Research Institute (HRI), an ISO17025 accredited lab approved by the FDA, and examined 46 products, including 32 GFCO-certified ones. It found that nearly 15% of the certified products exceeded the 10 ppm gluten-free standard, with nearly 10% surpassing the FDA's 20 ppm gluten-free limit, meaning they cannot be labeled gluten-free and should be subject to a product recall. A recent analysis by Celiac.com uncovered potential issues with GFCO's certification process, which may have contributed to the high failure rate found in the study, and suggests ways to improve the certification program. Gluten Free Watchdog, however, suggests that these findings might be false positives, possibly due to HRI not using an extra protein to prevent non-specific binding during testing. Gluten Free Watchdog tested three different batches of Trader Joe's bagels using two different assays (R5 ELISA and G12 ELISA) with and without a milk additive for protein blocking. They argue that the inconsistent results—depending on whether the milk additive was used—indicate that HRI should rerun their tests with the additive, as their original results might have been false positives. HRI's Response Celiac.com reached out by email to John Fagan, Ph.D., Chief Science Officer at HRI for comment about Gluten Free Watchdog's article, and according to him: "(W)e used the Romer (AgraQuant) G12 ELISA test, exactly according to the Romer protocol. The person who did the lab work is a highly experienced scientist who has decades of experience in conducting ELISA tests. The Romer G12 ELISA is recommended by GFCO as a reliable method. There was nothing about the Trader Joe’s sample that was strange or out of the ordinary and it contained no chocolate and therefore extra protein was not called for." When describing their testing procedure he explained: "We tested, first, the undiluted extract in duplicate. Those tests exceeded the calibration curve. We then made two dilutions of the extract and tested those in duplicate. Duplicates matched in both cases and the two dilutions were quantitatively consistent. That was the value that we reported." Further: "We have the exact sample that we tested before, and have retested it and it still came out positive." Romer, the manufacturer of the AgraQuant G12 ELISA test, supported Dr. Fagan's claims, stating that while the milk additive is an option, it is not mandatory for all tests, and while certain ingredients like chocolate, soy, and oats, may require adding an extra protein during the testing procedure to prevent non-specific binding, they confirmed that no such ingredients were present in the Trader Joe's bagels. Tara J. Miller, Vice President of Marketing at Trader Joe's, however, claims that their tests on the same batch tested by HRI showed the bagels met FDA and GFCO standards for gluten-free labeling (below 10 ppm). When Celiac.com asked Dr. Fagen how his lab could find high gluten in a batch where Trader Joe's found none, he concurred with the possibility of "hot spots" within the sample, which could explain the discrepancy. Why Did Gluten Free Watchdog Test Different Batches? Gluten Free Watchdog's testing did not involve the same batches of bagels tested by HRI. When Celiac.com asked Dr. Fagan for his comment on the Gluten Free Watchdog article he replied with: "I was surprised at the Gluten Watchdog’s article. And the fact that the product contained no chocolate raises questions about their explanation. The obvious explanation for the discrepancy between the Gluten Watchdog’s results and ours is not even considered in their article, namely that they did not test the same sample that we tested. They didn't ask for that sample but we told them that we would be quite happy to set up an opportunity for them to test that sample. I suspect they would have confirmed our result. Also, during our phone call with Watchdog, they did not suggest the modification of the method where extra protein is added." (a recent post by Gluten Free Watchdog disputes this characterization of their contact) The last email we received from Dr. Fagan on this topic further emphasized his position: "We would be willing to share that lot with any lab that wants to test it. We would send multiple blinded samples, one of which would be the sample we tested as being positive and there would be other samples that would be indistinguishable but would be positive and negative. This would test their ability to detect the level of gluten that we found present in the sample and verify whether the sample we tested as positive was positive with their test method. We have decades of experience dealing with conflicting results on lab tests and it is this kind of routine that clarifies things definitively." Unfortunately, Gluten Free Watchdog's posts do not address how HRI found zero detectable gluten in most of the products they tested, including three types of bagels similar to Trader Joe's bagels, one of which also contained brown rice flour and sorghum flour (Canyon Bakehouse Plain Bagels). If HRI's testing required extra protein for accuracy, shouldn't these very similar products have also shown false positives? Every Romer AgraQuant® Gluten G12 ELISA Test Kit Includes Fish Gelatin to Prevent Non-Specific Binding According to the product documentation for the Romer AgraQuant® Gluten G12 ELISA Test Kit, the kits include the following: Package Insert Certificate of Performance 5 standards (0, 4, 20, 80, 200 ppm), calibrated to the Prolamin Working Group (PWG) Gliadin. Gluten G12 antibody coated microwells Ready to use Extraction Solution 5x concentrated Diluent Buffer 10x concentrated Wash Buffer Ready to use Conjugate, Substrate and Stop Solutions 1 sachet of Fish Gelatin The fish gelatin included in the AgraQuant® Gluten G12 ELISA test kit is likely used to prevent non-specific binding. In ELISA assays, non-specific binding can occur when proteins or other molecules in the sample adhere to the microwells in an undesired manner, potentially leading to inaccurate results. Fish gelatin is a commonly used blocking agent in such assays. It coats the surfaces of the microwells that are not already occupied by the specific antibodies, reducing the likelihood that other proteins or molecules from the sample will bind non-specifically to the microwells. This helps ensure that the only significant interactions are between the specific antibodies and the target gluten proteins, leading to more accurate and reliable test results. Do We Accept or Reject the Results of an FDA Accredited Laboratory? Celiac.com believes that Gluten Free Watchdog's recent stance is misguided and deviates from its mission to protect people with celiac disease from gluten exposure. Instead of cautioning people to avoid the products found to contain high gluten levels and possibly calling for their recall and reassessing GFCO's certification standards, Gluten Free Watchdog is creating confusion by questioning HRI's testing protocol and results. Given Celiac.com's understanding of the Romer AgraQuant G12 ELISA test and its testing protocol, and the fact that the Romer test is on GFCO's Approved Kit List, we see no reason to doubt the validity of HRI's results or their testing competence. We continue to recommend that people with celiac disease avoid all products in the study that tested at or above 20 ppm of gluten, and for those who are highly sensitive, products that tested at or above 10 ppm. Read more at: foodriskmanagement.com Join our forum discussion on this topic, and feel free to comment below. 08/19/2024 - Added the section: "The Romer AgraQuant® Gluten G12 ELISA Test Kit Includes Fish Gelatin to Prevent Non-Specific Binding."

Celiac.com 07/02/2024 - Trader Joe's Co. is being sued for allegedly mislabeling its "Almost Everything Gluten-Free Bagels" as "gluten-free," after a recent study conducted by Moms Across America found that a batch of the bagels (KLR1 24030031) may contain significant levels of gluten. This consumer class action was recently filed by Plaintiff Shaianne Starks in the Central District of California under docket number 2:24-cv-05543, Shaianne Starks v. Trader Joe’s Company. According to the complaint filed on June 28, testing conducted by Moms Across America, a nonprofit organization focused on raising awareness about toxins in food, revealed that the bagels contain 269.8 parts per million (ppm) of gluten. The US Food and Drug Administration (FDA) stipulates that products labeled as gluten-free must contain less than 20 ppm of gluten. According to Dr. John Fagan, Chief Scientist at Health Research Institute, their lab used the AgraQuant Gluten G12 test: "We tested, first, the undiluted extract in duplicate. Those tests exceeded the calibration curve. We then made two dilutions of the extract and tested those in duplicate. Duplicates matched in both cases and the two dilutions were quantitatively consistent. That was the value that we reported." Celiac.com Reaches Out to Trader Joe's Celiac.com also reached out to Trader Joe's regarding the high gluten levels was found by the Moms Across America study, and we received the following responses from them: After obtaining and sending them the lot number (KLR1 24030031), we received this response from Trader Joe's: How Could Both Trader Joe's and Moms Across America's Lab Tests be Correct? The conflicting test results from Moms Across America and Trader Joe’s may both be accurate due to the presence of gluten "hot spots" within a single batch of bagels. These hot spots can occur when gluten is unevenly distributed in the manufacturing process, leading to some parts of a batch containing significantly higher levels of gluten than others. This inconsistency can result in different gluten levels being detected depending on which part of the batch is tested. Therefore, while Trader Joe’s regular testing might show gluten levels within acceptable limits, Moms Across America's tests could have encountered a hot spot, revealing higher concentrations of gluten. Understanding this potential issue highlights the importance of comprehensive and varied sampling methods to ensure the accuracy of gluten-free labeling, thereby protecting consumers who rely on such products for their health. A Voluntary Recall is Recommended by Celiac.com Whether or not Trader Joe's found any gluten in the samples they tested from this batch, we at Celiac.com still believe that it would be prudent to initiate a voluntary recall with the FDA in the hope that some people with celiac disease will not inadvertently ingest such high levels of gluten. An FDA voluntary recall for Trader Joe's Everything Gluten-Free Bagels would involve the company notifying the FDA of the issue and then working to remove the affected products from shelves and supply chains. This process includes identifying and communicating with customers who may have purchased the product, offering refunds or replacements, and publicly announcing the recall through various channels. Trader Joe's would also need to investigate the cause of the gluten contamination, take corrective actions to prevent future occurrences, and provide regular updates to the FDA on the recall's progress and resolution. Join the lively discussion on this topic in our forum. Stay tuned for more updates on this story, and be sure to subscribe to our email updates. Read more at: bloomberglaw.com Edited on 07/05/2024 - Added Plaintiff Shaianne Starks.

Celiac.com 07/12/2024 - The Gluten-Free Certification Organization (GFCO) has long been considered a gold standard for gluten-free certification, offering rigorous testing and certification processes to ensure that products meet strict gluten-free criteria. However, a recent study conducted by Moms Across America has raised significant concerns about the reliability of GFCO's certification. The study found that 15% of randomly tested GFCO-certified products contained gluten levels above the organization's threshold of 10 parts per million (ppm), prompting a re-evaluation of GFCO’s procedures and standards. Understanding GFCO Certification The Gluten-Free Certification Organization (GFCO) is a program under the Gluten Intolerance Group (GIG) and is dedicated to certifying gluten-free products. The GFCO certification mark is a symbol of trust for consumers with celiac disease and gluten sensitivity, ensuring that products meet stringent gluten-free standards. According to the GFCO Manual Rev. 2024, the certification process involves several steps: Application: Companies must submit detailed information about their products and manufacturing processes. Audit and Testing: GFCO performs thorough audits and rigorous testing of products to detect gluten presence, using methods such as enzyme-linked immunosorbent assay (ELISA). Approval and Licensing: Products that pass the audit and testing phases receive GFCO certification and can display the certification mark. Ongoing Compliance: Certified companies must undergo annual audits and regular testing to maintain certification. GFCO sets a strict gluten threshold of less than 10 ppm, which is more rigorous than the 20 ppm threshold set by the FDA. Findings from Moms Across America Study The recent study by Moms Across America has challenged the perceived reliability of GFCO's certification. The study tested 46 products, 32 of which were GFCO-certified, and found that 5 of these certified products contained gluten levels exceeding 10 ppm. This translates to 15% of the tested GFCO-certified products failing to meet the advertised 10 ppm certified gluten-free standard. Even more concerning, 3 of the 5 products that were GFCO certified contained gluten above the FDA's gluten-free limit of 20 ppm—so nearly 10% of them cannot even be labeled as gluten-free! The study's findings have already spawned a class-action lawsuit against Trader Joe's for the gluten content found in their Everything Gluten-Free Bagels. Analysis by Celiac.com - Possible Issues with Step-Down Testing Procedure Celiac.com conducted an in-depth analysis of the Moms Across America study and scrutinized the GFCO Manual Rev. 2024. Our findings suggest that the compliance issues may stem from the "step-down" testing procedure allowed under GFCO guidelines. According to the manual, companies with a history of negative test results are permitted to reduce the frequency of their product testing. This "step-down" approach can lead to decreased vigilance over time, potentially allowing gluten contamination to go undetected: The specific testing schedule outlined in the manual is as follows: Initial Testing: Test 40 consecutive lots three times per lot. Step Down 1: If all tests are negative, reduce to testing once per lot for 40 consecutive lots. Step Down 2: If negative, test any one certified product on 40 consecutive production days. Step Down 3: If negative, test any one certified product during 40 consecutive production weeks. Step Down 4: If negative, test any one certified product during 40 consecutive production months. Final Step Down: If negative, test any one certified product during each production quarter. Additional testing schedules are provided for products initially tested less frequently: Once per day: Follow the same step-down process, reducing to weekly, then monthly, and finally quarterly if all results are negative. Once per week: Reduce to monthly testing after 40 consecutive weeks of negative results, then quarterly if all remain negative. Once per month: After 40 consecutive months of negative results, testing can be reduced to once per quarter. If any product tests positive for gluten at any stage, the company must return to the higher level of testing frequency immediately. No plant is permitted to test less frequently than once per calendar quarter, ensuring a minimum level of ongoing scrutiny. Allowing Self Testing Poses a Conflict of Interest On page 26 of: https://gfco.org/wp-content/uploads/2024/05/GFCO-Manual.pdf The companies themselves, as opposed to an independent laboratory, can perform all GFCO certification testing, as long as they use a "GFCO-approved method." This model seems to open the door for an obvious conflict of interest issue where a company could send in false results, or test a different batch than one which might test over 10ppm. Any company could have a financial motivation to avoid a product recall, which is a very expensive process, or to avoid destroying a batch of products rather than selling them. Given that companies can run all certification testing themselves, which can present potential conflicts of interest, the best solution would be for all testing to be done by an independent laboratory who would report the results directly to the GFCO, and those results should be publicly available on the GFCO website. Implications for the Gluten-Free Community The study's findings are particularly concerning for individuals with celiac disease, who rely on accurate gluten-free labeling to manage their health. Ingesting even small amounts of gluten can cause severe health issues for those with celiac disease, making reliable certification critical. The discovery that 15% of randomly selected GFCO-certified products contained gluten above the 10 ppm threshold undermines consumer confidence in GFCO's gluten-free certification. Call for Stricter Testing Protocols In light of these findings, there is a pressing need for GFCO to re-evaluate its testing protocols. The step-down approach, while offering companies less hassle and expense after passing a certain threshold, may not provide the consistent oversight necessary to ensure that all products remain gluten-free over time. Increased frequency of testing, even for companies with a history of compliance, could help mitigate the risk of gluten contamination and maintain the reputation of the GFCO gluten-free certification. Conclusion The recent study by Moms Across America highlights significant gaps in the current GFCO certification process. While the GFCO has set a high standard for gluten-free certification, the allowance for reduced testing frequency has revealed vulnerabilities that may need to be addressed. For individuals with celiac disease, the reliability of gluten-free certification is not just a matter of preference but a critical component of their health and well-being. Strengthening testing protocols and maintaining rigorous standards are essential steps toward restoring consumer trust and ensuring the safety of gluten-free products. Note: Celiac.com reached out to the GFCO for comment about our article, but did not receive a response. Join our forum discussion on this topic, and feel free to comment below. 08/08/2024 - Article updated to add "Allowing Self Testing Poses a Conflict of Interest" section.