Study: 8% of Gluten-Free Products Test Over 20ppm, and 15% of "Gluten-Free" Products Certified by GFCO Contain Gluten at Over 10ppm

[Scott Adams]

5 hours ago, RMJ said:

Here is an update from Gluten Free Watchdog, indicating that the high results on at least one item may be false positive.  I am a scientist and used to develop ELISAs, the type of test used.  Non-specific binding such as is described can be a real problem with these tests, so this is a scientifically reasonable explanation.

possibly false positive

I've sent an email to Dr. John Fagan, Chief Scientist at Health Research Institute, asking for his comments on that article, and I'll share any response. In his initial reply he doesn't say one way or the other whether or not he used blocking agents like non-fat dry milk (NFDM), bovine serum albumin (BSA), or casein, but since he's at an accredited lab I must assume that he would know the protocol for such testing, and would follow it. If he didn't follow the protocol for the tests then it seems like he would likely have had a lot more false positive results in his report, but hopefully I'll hear back from him soon.

[Scott Adams]

4 hours ago, trents said:

Thanks for this input and the link, RMJ. As I said some time ago in this discussion, I fear the celiac community may have gone off half-cocked in their reaction to these claims. Having said that, I still think random, unannounced drop in testing added to the mix of protocols would be a good idea.

I think the GFCO step down process is far too aggressive--it ends up where a company only needs to test a single gluten-free product per quarter? What if the company makes millions of boxes per week, for example a major cereal company? To me, the amount of testing done to retain certification must be consistent over time, done on every batch, and must be done in proportion to production run sizes--you need to test 1 of every 5,000 products for example--rather than a one size fits all approach where the total number of tests a company must do is the same no matter what their production size is.

[Lotte18]

Trents, Thanks for your comment.  Like so many, I was completely unaware of the GFCO step down testing process.  I assumed they were testing on a consistent, perpetual basis.  My understanding is that companies pay a minimum of $10,000 a year for this certification.  You and I pay a premium for that certified product.  Testing should be consistent.  The FDA doesn't step down testing beef, poultry, etc. do they?  Which begs the question, why isn't the FDA certifying our food?  Again, thanks for your input!

[Scott Adams]

The FDA sets the guidelines for certain things that can appear on food labels, and they also do some random testing and enforcement. You can, for example, report a company if you get sick from a product due to gluten. Ultimately it comes down to funding--and like many federal agencies the FDA is underfunded in comparison with the task at hand--keeping the USA food supply safe.

[Lotte18]

Thanks for clarifying Scott.  The FDA does have an enormous job.  

Looking forward to seeing what else you uncover from this evolving story.  Many thanks for keeping us informed.

[Scott Adams]

On 7/23/2024 at 10:20 AM, RMJ said:

Here is an update from Gluten Free Watchdog, indicating that the high results on at least one item may be false positive.  I am a scientist and used to develop ELISAs, the type of test used.  Non-specific binding such as is described can be a real problem with these tests, so this is a scientifically reasonable explanation.

possibly false positive

So far I've not heard anything more from the Moms Across America folks about their test protocols, and it's possible that due to the class action lawsuit against Trader Joe's spawned by their article,  I may not get a reply. 

I think Gluten-Free Watchdog's position on this is a bit strange, given the normal angle they take of protecting their paying members from possible gluten contamination. In this case they are jumping to a conclusion, without any evidence, that the lab MAY not have followed standard protocol for gluten-free product testing, but they have no evidence of this--zero evidence of such a lapse was presented in their article. The article is pure speculation at this point--WHAT IF they didn't follow protocol--but how does this approach serve their gluten-free members and the broader gluten-free community? Are they telling them it's ok to eat those bagels because the lab MAY have made a mistake? Did Trader Joe's approach them and encourage them to do this critical article?

Gluten-Free Watchdog, as far as I know, to this day doesn't believe that Cheerios are gluten-free and safe for people with celiac disease, and their reasoning for this position was their claim that there could be hot spots where some boxes of Cheerios might have higher levels than others, even though General Mills invented and patented technology they developed which removes wheat grains from oats, thus removing the contamination before they are processed. To date I'm not aware of any individual box of Cheerios testing over 20ppm, yet Gluten-Free Watchdog, as far as I know, hasn't changed their position on this.

In the case of the Trader Joe's bagels, we have an accredited lab that ran two standard tests on a batch of Trader Joe's Everything Gluten-Free Bagels which registered at nearly 300ppm--yet Gluten-Free Watchdog is taking a position here that the lab might not know what they are doing--and the bagels might actually be gluten-free? It's exactly the opposite position to their position on Cheerios, where they seem to want to err on the side of caution, even though they have no evidence that any boxes of Cheerios exist that are over 20ppm--in this case they seem to want to ignore scientific lab results and attack the lab and doctor who runs it, rather than warn their users to avoid the bagels and err on the side of caution.

Just my two cents here, but I must say that at this point I believe Gluten-Free Watchdog's position is irresponsible (but it is fair for them to ask the lab questions about their protocols), and they would do better in serving the gluten-free community by erring on the side of caution. Making the assumption that the bagels actually could be safe given the shared test results could get people sick.

[RMJ]

Actually, in both cases they are criticizing the testing laboratory.

A big issue they had with the Cheerios testing was that the company said they took 12 samples (good) but then mixed them together prior to testing such that if there were a slight hot spot it would be diluted and possibly not detected. Mixing samples like that is NOT considered good in an analytical laboratory and it surprised me that the Cheerios manufacturer did that.

In the current case, as you say, they’re guessing at a laboratory problem which could explain the results, but they don’t know how the testing was actually done, so it remains to be seen if the criticism is valid.

 

[Scott Adams]

Anyone can make a statement like that about any gluten-free company--that there could be hot spots out there about any of their products, but you need a lot more evidence to make such a claim--in this case we have a lab that ran the accepted gluten tests which found high gluten content in a product, yet, instead of Gluten-Free Watchdog warning people not to eat the product they do an article speculating on possible failed protocol by the lab. They test the same bagels as evidence for this, yet not from the same batch. 

In the case of General Mills, they would be a huge target for a big class action lawsuit. If you could buy 100 boxes of Cheerios and find 1-2 that were above 20ppm, then any attorney could bring a major case against them. The fact that this hasn't happened in over 10 years--and with millions of boxes per week manufactured--tells me that their technology is working as designed, and is effectively removing wheat kernels, yet Gluten-Free Watchdog has never changed their stance on Cheerios.

Their positions on issues seems to shift with the wind--there is no consistency. There is no warning in Gluten-Free Watchdog's article to play it safe and avoid the product until we know more. One analogy I think of here is that it is like reading an article in the paper about Joe Blow getting in a car accident caused by him driving too fast, and the article doesn't mention anything at all about drunk driving or alcohol being involved--but then someone writes another article about the accident wherein it doesn’t mention driving too fast at all, but instead mentions the risks of drunk driving, and cites lots of statistics about drunk driving, and how to best detect high blood alcohol in drunk drivers—and speculates that maybe Joe blow was drunk.

Of course Joe Blow could have been drunk and gotten away with it, just like this lab might have done their gluten tests incorrectly--but is it fair to make such assumptions without any evidence, and then not play it safe with the facts that we actually have? My personal reaction was to warn consumers first about the study to prevent possible injury, and see how things pan out later. I'll be happy to report anything that is learned going forward, including if the tests were done incorrectly, but the more I think about Gluten-Free Watchdog's article the more I must scratch my head. Who is their article trying to protect?

[Eleanor McGinn]

How credible is Mom’s Across America? I never heard of them until they made news regarding unacceptable gluten content in so many foods that claim to be gluten free. As a celiac, that’s worth investigating. I did and heard reports from a company and a  credible gluten certification organization that contradicted MAA. Could this be any more confusing? Should we be looking for hidden agendas? Are all certification labs equally credible? Do they use different techniques resulting in different outcomes? Is there any truly reliable source of information on this issue? Must one’s gut be the ultimate testing ground? If so, that’s a recipe for disaster. Just asking……

EBM

[Scott Adams]

I am sure that there are many other organizations that you have not heard of, and the fact that you haven't heard of them does not detract from how credible they might be.

But Celiac.com is indeed investigating their report, and have been one of the only organizations who has reached out to them and received direct replies from them regarding their study, which we've shared here in this thread and in the comments under our original article, as well as direct replies from Dr. John Fagan, Chief Scientist at Health Research Institute, regarding their tests.

We won't, however, run speculative articles without any evidence to support them that question the lab that was used to run the tests, as I think this approach could potentially be harmful to the people we're trying to help here--I believe it's best to play it safe, rather than ignore the message and try to kill the messenger. Until I hear more from Dr. John Fagan, Chief Scientist at Health Research Institute, I will assume that his lab understands the test protocols, as he earned his Ph.D. in molecular biology, biochemistry, and cell biology from Cornell University:
https://www.linkedin.com/in/drjohnfagan/

Also, one can ask the same question about Gluten-Free Watchdog--how credible is that organization? They have a paywall separating their test results from the public--which is a model that I disagree with--especially if their goal is to help people celiac disease, and not just those who can afford to pay. 

[RMJ]

The best way to investigate the unexpected results would be at the laboratory that got those results. An accredited laboratory likely has a procedure for laboratory investigations which would involve reviewing how the tests were run, and possibly redoing tests on retain samples if procedures were not correct. Such an investigation takes time and dollars. However, to HRI the higher gluten results aren’t necessarily unexpected, so such an investigation would have to be by request of the person or organization who contracted to have the samples run (MMA), and HRI would likely not be able to make the results of the investigation public without permission from MMA.

We may never know if the high results were hot spots or analytical issues. Either is theoretically possible. As Scott said, the safest thing is to assume the results are correct.

 

[Scott Adams]

I am also not terribly surprised by the results of the MMA study, given the number of recalls I see on gluten-free products, even ones that are certified gluten-free:

This is even less surprising to me now that I understand the step down testing granted to companies that have GFCO certification, which I don't agree with regardless of what comes about about the lab tests in this case:

 

[Scott Adams]

On 7/31/2024 at 1:16 PM, RMJ said:

The best way to investigate the unexpected results would be at the laboratory that got those results. An accredited laboratory likely has a procedure for laboratory investigations which would involve reviewing how the tests were run, and possibly redoing tests on retain samples if procedures were not correct. Such an investigation takes time and dollars. However, to HRI the higher gluten results aren’t necessarily unexpected, so such an investigation would have to be by request of the person or organization who contracted to have the samples run (MMA), and HRI would likely not be able to make the results of the investigation public without permission from MMA.

We may never know if the high results were hot spots or analytical issues. Either is theoretically possible. As Scott said, the safest thing is to assume the results are correct.

 

I received this reply from John Fagan, Ph.D. or Health Research Institute regarding the Romer G12 ELISA tests that were run by his lab for the MMA study, and it includes his response to the Gluten-Free Watchdog article. His reply makes me even more suspicious about the article Gluten-Free Watchdog, as he even offered to send them a sample from the same batch that they tested, which they refused (they tested a different batch to somehow try to prove that the tests done by Health Research Institute may have been done incorrectly).

Quote

Hi Scott,

Sorry for the delay in responding. I have been traveling.

I read your article. Wisely put! I agree with your proposal for GFCO to increase the frequency of testing. The cost of testing is not so great to put a serious financial burden on manufacturers and that will protect people with gluten sensitivities and celiac disease and it will protect the GFCO standard. A gluten-free claim carries with it a big responsibility for brand owners and for GFCO, and your article positions your organization to remind everyone of that responsibility.

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. 

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.

I am happy to answer any additional questions by phone or email.

Sincerely,
John Fagan, Ph.D.
Chief Science Officer
Health Research Institute
505 Dimick Drive, Suite 111
Fairfield, IA 52556

 

[Scott Adams]

I am sharing here the GFCO's official response to Celiac.com's request for comment (which evidently ended up in their spam folder):

Quote

Hi Scott,

Thank you for getting back to us. We just wanted to be sure you were aware that we have investigated the MAA claims and found that they were not reproducible - our complete response can be found at https://gluten.org/consumer-notice-gluten-free-product-testing-results/ 

Best regards, 
Laura
 
Laura K. Allred, Ph.D.  |  Regulatory Manager
My Office Hours: M – Th 8:00am to 5:00pm, F 8:00am to 12:00pm Eastern
Corporate Office: 31214 124th Ave SE, Auburn WA 98092

 

[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:

 

[Rachwertz]

I quit eating these bagels years ago when my Celiac Service Dog began alert to  these bagels. Checked by several other gluten detection dogs they all alerted on different samples and batches over several years. This just confirms I was right to not trust their products. Check the cinnamon muffins also alerted to them for gluten contamination. 

[trents]

There is such a thing as a Celiac Service Dog? How do you get these and what does it take to qualify for one? Can you share your story with us. I imagine you must have severe reactions to gluten. This might be a better option than a Nima gluten sensor!

[Scott Adams]

We've done some articles on this:

@Rachwertz than you for sharing this!

Has your dog ever detected gluten in McDonald's French Fries?