Gluten Free Watchdog no longer recommends GF Harvest as a source of purity protocol oats

Gluten Free Watchdog no longer recommends GF Harvest as a source of purity protocol oats

Until further notice, Gluten Free Watchdog does not recommend GF Harvest as a source of purity protocol oats.

Gluten Free Watchdog recently analyzed five bags of oat products from GF Harvest. Testing using the sandwich R5 ELISA found gluten in quantifiable levels in both GF Harvest oat flour and GF Harvest organic rolled oats.

Back story: A subscriber to Gluten Free Watchdog reached out about GF Harvest oats due to test results posted to Facebook. The Nima Sensor detected gluten in multiple products tested by multiple users. As you may recall, Nima results are qualitative but not quantitative, either showing a smiling face (for no gluten found) or a gluten found result.

Generally speaking, Gluten Free Watchdog does not test products that test gluten-found using any lateral flow device unless multiple people are getting the same result OR the same person is getting the same result on multiple tests. Test results on GF Harvest oats warranted further investigation.

We had the two consumers send their opened bags to the Gluten Free Certification Organization (both bags had the Certified Gluten-Free mark from GFCO on the label). After testing, GFCO sent what remained of the product to Gluten Free Watchdog. We sent the opened bags as well as additional unopened bags to Bia Diagnostics for testing using the scientifically validated sandwich R5 ELISA.

Note regarding lateral flow devices such as the Nima Sensor and EZ Gluten: Unexpected results should always be confirmed using a fully validated ELISA. In the case of GF Harvest, the positive results using the Nima were confirmed by the R5 ELISA. In the case of Liquid I.V. electrolyte drink mix (see our AOAC International conference poster and abstract available at https://www.glutenfreewatchdog.org/news/the-need-for-a-standardized-sample-portion-when-testing-food-for-gluten-using-an-lfd-a-case-study/), the positive results found with the LFD were false positives.

All impacted parties have been notified about the test results. Please reach out to GF Harvest if you have questions about their oats. Please reach out to GFCO if you have questions about their certification.

If you believe a GF Harvest oat product made you sick, please contact an FDA Consumer Complaint Coordinator at https://www.fda.gov/safety/report-problem-fda/consumer-complaint-coordinators.

Thank you to the consumers who reached out to Gluten Free Watchdog.

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Comments (29)

  • Derek
    Reply

    Do you know of any purity protocol GF oat suppliers that regularly test their own product?

    It would be great to hear from Gluten Free Harvest more about why this is happening, both to build trust back in their brand and inform other purity protocol suppliers of improvements that can be made to their process.

    Also, do you know if these products were bought directly from GF Harvest or through other retailers/marketplaces?

    August 30, 2022 at 2:18 pm
    • Tricia Thompson Reply

      Information provided to Gluten Free Watchdog from suppliers is included in the listing of purity protocol oats available at https://www.glutenfreewatchdog.org/news/oats-produced-under-a-gluten-free-purity-protocol-listing-of-suppliers-and-manufacturers/. GF Harvest has been notified. When we hear back from them, information will be updated. Products purchased by Gluten Free Watchdog were purchased via Amazon (sold by GF Harvest, shipped by Amazon).

      August 30, 2022 at 2:31 pm
      • Dominique Mostafania Reply

        Do u know what the date was on the package? My date is 5/23.

        September 5, 2022 at 3:29 pm
        • Tricia Thompson Reply

          Products tested:
          GF Harvest Flour
          Best by date: 06/23
          Lot #: 0452.001.9.007

          Organic rolled oats
          Best by 12/23
          Lot #: 3101.001.4.002

          Rolled oats (not labeled organic)
          Best by date: 4/24
          Lot #: 0612.001.4.001
          (TESTED < 5 PPM of GLUTEN)

          September 6, 2022 at 12:24 pm
  • sarah Reply

    May we share this information publicly? I know a lot of GF folks rely on GF harvest and this seems like a major potential health issue. I personally just threw my two (EXPENSIVE) bags in the trash and won’t purchase from them again. As someone with gliadin allergy, 80ppm would put me in the hospital.

    August 30, 2022 at 5:46 pm
    • Tricia Thompson Reply

      Yes, thanks for asking. Please post the link back to this page in case the information is updated. Thank you.

      August 30, 2022 at 6:00 pm
  • Rochelle A Villenave Reply

    I Have two unopended bags of these oats, also purchased from Amazon. i wonder if we will be able to return them for a refund. I’ve tried returning other amazon subscription items and they won’t take them. In light of this current problem I may try to get a refund from the company directly. Has GF Harvest been told about the results?

    August 30, 2022 at 7:41 pm
    • Tricia Thompson Reply

      From what we’ve been told, Amazon has been providing some refunds. GF Harvest is aware of the results.

      August 30, 2022 at 7:57 pm
  • Tayler Reply

    Was it quantifiable gluten but still meeting GFCO <10ppm standards? Or is it quantifiable gluten but still meeting FDA <20ppm standards, or is it quantifiable gluten above all safety standards?

    August 30, 2022 at 8:42 pm
    • Tricia Thompson Reply

      Test results have been released to Gluten Free Watchdog subscribers. At this time, we are not publicly releasing any additional information.

      August 30, 2022 at 9:00 pm
    • Lynda Reply

      I was looking for some numbers as well, knowing that just saying they found gluten doesn’t mean it was above what is acceptable. Why would they not mention the actual amount they found?

      September 4, 2022 at 3:02 pm
  • Dianne L Reply

    Does the contamination include the packages of GF Harvest not labeled “Organic”? Are there any identifying codes I can look for? Thank you.

    August 30, 2022 at 9:35 pm
    • Tricia Thompson Reply

      We tested 3 bags of flour, 1 bag of organic rolled oats, and 1 bag of regular rolled oats. The regular rolled oats tested fine (but again, we tested only 1 bag). We do not know at this time if the cross contact is widespread or limited to certain lots. Here are the best by dates and lot numbers for the flour and organic rolled oats:

      GF Harvest Flour
      Best by date: 06/23
      Lot #: 0452.001.9.007

      Organic rolled oats
      Best by 12/23
      Lot #: 3101.001.4.002

      August 31, 2022 at 12:30 pm
      • James Reply

        Could you share lot # and BB for the bag of regular rolled oats that tested negative*? Thank you!

        *below assay quantification; <5ppm I presume.

        September 4, 2022 at 6:04 pm
        • Tricia Thompson Reply

          Rolled oats (not labeled organic)
          Best by date: 4/24
          Lot #: 0612.001.4.001
          Tested < 5 ppm of gluten

          September 6, 2022 at 12:22 pm
  • Diane Reply

    I’ve been using GF Harvest Quick Oats. Is this product having issues too?

    August 31, 2022 at 2:37 am
    • Tricia Thompson Reply

      We do not know at this time if the cross contact is widespread or limited to certain products and lots. Hopefully, GF Harvest will provide consumers with information soon.

      August 31, 2022 at 12:32 pm
  • Sara Reply

    Hi Tricia. Thank you so much for your research on the subject of gluten free oats. Have you by chance tested oats from any of the listed purity protocol oat providers? My kids and I have Celiac disease, and we have been eating GF Harvest oats for the past few years since I learned about the recommendation to use purity protocol certified GF oats, not just certified GF oats. I would just give up oats, but my son has severe food allergies to nuts and seeds as well, and feeding my family has become exceedingly difficult. I’d hate to switch to another oat provider just to learn down the road that I continued to poison my family and myself in the process. Thanks!

    August 31, 2022 at 4:21 pm
    • Tricia Thompson Reply

      We have but not recently. We will be increasing our testing of oats.

      August 31, 2022 at 5:03 pm
  • Derek Reply

    Are oats particularly susceptible to cross-contamination, more than say buckwheat? If so, why? I don’t know of a purity protocol for buckwheat, but it can be grown in rotation with wheat.

    In the past, buckwheat has been implicated as the source of gluten in gluten-free packaged products https://pubmed.ncbi.nlm.nih.gov/32805193/

    Of the gluten free grains, oats and buckwheat are two of the more nutritious, so trying to figure out how these can be safely eaten by Celiacs. Will it require dedicated GF farms, transport, processing?

    August 31, 2022 at 8:11 pm
    • Tricia Thompson Reply

      Oats and barley are very similar in size, shape, and color. Historically, this made it difficult to completely sort out a grain like barley from oats. Buckwheat is a very different looking grain–it is triangular. BUT you are correct, any grain can be subject to gluten cross-contact if grown in rotation with or next to wheat, barley, or rye. This is why at Gluten Free Watchdog we recommend only those grains that are labeled gluten-free. BUT we MUST be able to trust the manufacturers that label products gluten-free. They must test for gluten and not a one-off test or by using a lateral flow device. They need a testing plan with a lab using an ELISA.

      August 31, 2022 at 8:30 pm
  • Derek Reply

    From GF Harvest Purity Protocol – “Gluten testing is conducted on all incoming seed stock and after processing”

    Has GF Harvest disclosed if this is an ELISA test, or lateral flow?

    August 31, 2022 at 8:46 pm
    • Tricia Thompson Reply

      Hopefully we will get more information when GF Harvest releases a statement.

      August 31, 2022 at 8:54 pm
  • Yemin Liu Reply

    Oats are naturally gluten free.
    Grains, gluten containing or not, are harvest as kernel.
    Mingling of gluten-containing kernels into oats can happen in the field (where the focus of purity protocol is) and via shared harvesting machinery, transportation and storage.
    There was research shows that every gluten contain kernel is a gluten bomb, and the presence of one kernel can make a serving size of oat over 20 ppm gluten.

    It has been shown in the following publications that gluten containing kernels were found in oats produced by purity protocol.

    1. Allred, L. K.; Kupper, C.; Quinn, C., The Use of Visual Examination for Determining the Presence of Gluten-Containing Grains in Gluten Free Oats and Other Grains, Seeds, Beans, Pulses, and Legumes. Journal of AOAC International 2018, 10, 1-9.
    2. Chen, Y.; Fritz, R. D.; Kock, L.; Garg, D.; Davis, R. M.; Kasturi, P., A stepwise, ‘test-all-positives’ methodology to assess gluten-kernel contamination at the serving-size level in gluten-free (GF) oat production. Food Chemistry 2018, 240, 391-395.

    The first paper even suggests oats produced by purity protocol still needs the scrutiny of visual examination.

    Could the purity protocol be fundamentally insufficient to produce gluten-free oats?

    September 1, 2022 at 12:46 pm
    • Tricia Thompson Reply

      In a perfect world, it would be ideal to have purity protocol oats that had undergone mechanical/optical sorting. Even the most robust purity protocol can’t control birds flying overhead and dropping seeds or animals in buffer zones wandering onto the field. However, I don’t know that we want to disparage purity protocol oats before we understand what happened with GF Harvest oats.

      The farmers that came up with the original protocols provided a tremendous service to the gluten-free community. At the time, around 2004, I had just published test results for oats sometimes eaten by folks with celiac disease and the picture was bleak. See https://www.nejm.org/doi/full/10.1056/NEJM200411043511924.

      Regarding the study by Allred et al., there are some issue. See https://www.glutenfreewatchdog.org/news/it-isnt-just-oats-that-have-gluten-cross-contact-issues/. The Quaker studies are very good (excellent in fact) and in my opinion the Pepsico/Quaker testing protocol should be industry standard.

      There are a lot of issues with oats and I’m not quite sure where we go from here in terms of recommendations. The only sorted oats we recommended at this time are gluten-free Quaker oats. This is due to their robust testing protocol and transparency.

      September 1, 2022 at 1:15 pm
  • Derek Reply

    Based on this recent study Investigation of Protein and Epitope Characteristics of Oats and Its Implications for Celiac Disease (https://pubmed.ncbi.nlm.nih.gov/34660657/) – is it possible we’re all wrong about Oats and until we figure things out they should be avoided in Celiac Disease?

    September 3, 2022 at 2:12 pm
    • Tricia Thompson Reply

      To get a clear picture of the current state of oats research requires a pretty deep dive going back to at least 1995 and the study by Janatuinen et al. The cited article is interesting. However I have not read the full text. I do find this statement rather concerning: “Using ELISA methodology with the R5 antibody, a high number of the investigated samples were found to be contaminated with wheat, barley, or rye”. It is important to keep in mind that oats have been studied more than any other grain (with the exception of wheat) in relation to celiac disease. The vast majority of studies have found that moderate amounts of oats without gluten cross contact are “safe” to consume by the vast majority of folks with celiac disease. That said, newer research must be factored into our thinking about oats. At this point though, I have far more concern about supply chain issues and cross contact of oats with gluten grains.

      September 6, 2022 at 2:39 pm
  • Sarah Reply

    It has been 3 weeks since GF harvest and GFCO were notified of this issue and there has been no statement made. I’m horrified that these products are still on the shelf and the only warning those with celiac and allergies have received is from this paid subscription service. Personally, I will NEVER purchase anything from GF Harvest again as they have made clear that the new owners DO NOT care about customer safety.

    What’s most concerning is that GFCO seems to be doing nothing as well. I’ve come to completely trust products that carry their label, but it seems they are also not being open with consumers about safety issues. Do you have any suggestions for us to actually feel confident in the brands we are purchasing?

    Personally, if I ate something with 80ppm I would go into full anaphylaxis and require hospitalization. I’d hate to go back to cooking 100% of my food from raw ingredients, but it’s feeling like that is my only avenue to safe eating.

    September 19, 2022 at 3:55 pm

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