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  • Scott Adams
    Scott Adams

    Critical Review of GFCO Gluten-Free Certification in Light of Recent Findings

    Reviewed and edited by a celiac disease expert.

    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.

    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.

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    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:

    Quote

    The annual audit report will always provide the highest, baseline level of Product testing that is expected from a Plant. Plants that have a documented history of testing with no positive test results in Products have the option of decreasing their Product testing level according to the following schedule. Plants that have a confirmed positive (greater than the Applicable Gluten-Free Threshold) gluten result in any Product should remain at or return to the higher, baseline level of testing described on their most recent audit report. This step-down schedule only applies to Products, and not to Ingredients.

    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 

    Quote

    Testing Methods, Documentation and Submission Testing can only be done using test kits found on the GFCO Approved Kit list. Alternatively, the plant may choose to have testing done by an outside lab that is accredited to ISO 17025 for gluten testing, again using a GFCO-approved method. In either case, test results should be completed and reviewed prior to the release/sale of certified Product.

    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.



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    Scott Adams

    In an email I received two days ago John Fagan, Ph.D., Chief Science Officer, Health Research Institute regarding the Trader Joe's Everything Gluten-Free Bagels:

    Quote

    We have the exact sample that we tested before, and have retested it and it still came out positive.

    and from 8/2/2024:

    Quote

    To reiterate, we used the Romer 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. Health Research Institute is an ISO17025 accredited laboratory and is approved by the FDA as a high-complexity clinical laboratory.

     

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    GardeningForHealth

    Gluten Free Watchdog has issued an update: https://www.glutenfreewatchdog.org/news/correcting-the-record-gluten-free-watchdogs-testing-of-trader-joes-gluten-free-almost-everything-bagels/

    So now the issue seems to be boiling down to R5 Elisa testing method vs G12 Elisa testing method, which are producing different results under different conditions.

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    Scott Adams

    Actually the issue is why isn't Gluten Free Watchdog playing it safe with their followers/members, and instead going after the lab? Are they working for Trader Joe's or celiacs?

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    Scott Adams

    Also, the Romer AgraQuant Gluten G12 tests are approved by the GFCO for use to determine levels of gluten in foods--R5 vs G12 should therefore not be an issue, otherwise they would not be on their own list of approved testing methods:

    https://gfco.org/341235-2/ 

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    GardeningForHealth

    GFW is claiming in their link here https://www.glutenfreewatchdog.org/product/trader-joes-gluten-free-almost-everything-bagels-2024/1348 that the G12 test without milk additive was the only positive test and then they are claiming here https://www.glutenfreewatchdog.org/news/correcting-the-record-gluten-free-watchdogs-testing-of-trader-joes-gluten-free-almost-everything-bagels/ that this result may have been a false positive.

    But is this assumption correct? 

    The R5 vs G12 ELISA tests and the subject of "non-specific binding" are outside of my knowledge, but I wonder why the G12 test needs milk to match the results of the R5 test.

    Is one test more accurate than the other?

    What antibodies are these tests using? Where did the antibodies come from? 

    If the R5 and G12 tests do not match each other, are we to trust one over the other? And if so, why? And if we are to trust "with milk" or "without milk," why is that? 

    Why should we interpret the positive G12 "without milk" test as a false positive? 

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    Scott Adams

    Exactly, and is GFWD saying that with the additive the test result would have gone down from nearly 300 ppm to zero? I doubt this, even if it were lower than 300 ppm I suspect that it would have been above 20 ppm. The entire argument they are making just doesn't serve the gluten-free community at all. I say avoid the product just to be on the safe side--why would an organization designed to protect celiacs go down this path at all? 

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    GardeningForHealth

    TLDR: It seems that this phenomenon of different tests getting different results is common, and gluten testing should be using more than one type of ELISA test to detect gluten anyway. 

    In light of the info in the rest of this post, my own curiosity on this matter is now satisfied; to me, all the results are accurate, including the G12 without-milk-positive result, and this means that those brands found by Moms Across America, and confirmed by GFWD via their G12 without-milk ELISA test (although GFWD erroneously suggested it was a false positive) are correct--they contain gluten, and those products must now be viewed with caution.

    ------------------------------------------------------------

    Some info I dug up for context:

    Quote

    A significant difference (p < 0.05) in gluten content was observed for these gluten-containing food products. Reproducibility issues suggest that it is necessary to use several ELISA kits for the accurate detection and quantification of gluten in various food products rather than using one ELISA kit.

    https://www.mdpi.com/2304-8158/10/1/108

     

    A brochure from Romer Labs, maker of the G12 ELISA test:

    Quote

     

    Over the years, a few different antibodies became standard in gluten testing. Initially, the Skerritt antibody was most commonly used and tests based on it had Type 1 method status. It was replaced by the R5 antibody, an antibody developed in cooperation with the PWG. The R5 antibody was raised against rye secalin, but showed strong cross reactivity to wheat gliadin. It became quickly the “consensus antibody”, seen by many as the one, giving the correct answers. However, the change of the concept, detecting the immunotoxic peptides playing a role in the pathogenesis of celiac disease, instead of detection of prolamins, led to the development of a next generation of antibodies. The G12 antibody belongs to this new generation.

    The G12 antibody specifically recognizes the toxic fragment of the gliadin protein present in gluten. This fragment (called 33-mer) was identified by the University of Stanford and published in a paper 2002 in Science. Using the knowledge from this publication, the G12 antibody was raised against this 33-mer peptide. In contrast, the R5 antibody was raised against a secalin extract. The epitope it reacts with was later identified as the QQPFP pentapeptide. The distinction between the two antibodies relates to the fact that the G12 antibody specifically targets the toxic fragment that triggers the auto-immune reaction in celiac patients, rather than a peptide sequence unrelated to clinical outcomes.

    Detection of Oats
    There is an ongoing debate concerning the presence or absence of gluten in oat. In fact, current antibodies were not recommended for the detection of gluten in oat. The G12 antibody has shed light on this debate due to its specificity for potentially immunotoxic sequences. G12 shows also a higher affinity to these sequences, which makes it much more sensitive, compared to other antibodies. It seems, that G12 can recognize oat varieties which trigger response in celiacs, while other oat varieties which are not causing any celiac response are not detected.

     

    https://foodriskmanagement.com/wp-content/uploads/2014/05/AQ-Gluten-G12-Brochure-13.pdf

     

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    Scott Adams

    We published a new article related to this discussion here, as we believe that it's important to try to clear up confusion that is now being created within the celiac disease community:

     

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  • About Me

    Scott Adams

    Scott Adams was diagnosed with celiac disease in 1994, and, due to the nearly total lack of information available at that time, was forced to become an expert on the disease in order to recover. In 1995 he launched the site that later became Celiac.com to help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives.  He is co-author of the book Cereal Killers, and founder and publisher of the (formerly paper) newsletter Journal of Gluten Sensitivity. In 1998 he founded The Gluten-Free Mall which he sold in 2014. Celiac.com does not sell any products, and is 100% advertiser supported.


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