I just received the attached gluten lab results for our manufactured bulk lot no. 41426500, which was used in our packaged lot no. 41458701 (see attached Certificate of Analysis). The lab results came back as between 3-10 ppm of gluten.
I am just waiting for confirmation from the lab that the ELISA test method is an AOAC/CODEX approved method that detects gluten from barley. I will let you know as soon as I get this information.
If you would like us to test a sample from the tub you purchased, we will need you to send the entire tub to us (to my attention) at:
33 -1833 Coast Meridian Road
Port Coquitlam, BC V3C 6G5
Attn: Michele Gurney
Please advise if you have any other suggestions on how you would like us to investigate this further so that you are satisfied with the conclusion.
I’m leaving the office at noon today but you can reach me next week if you want to discuss this further.
I wrote back:
"I just talked to Thomas Grace from Bia Diagnostics. He says that it makes sense that two samples from different areas of the same lot could test at different levels. It's called hotspotting. He says it should throw up a big red flag that both tested samples contained gluten. He is also concerned that an exact level was not reported and suspects that they are not using the gold standard method. He has worked with the FDA in developing the standards in the US. He is giving the company you used a call to find out what method they use. He gave me the number of the guy he works with at the FDA. The lab is actually very close to my house.
Is it my understanding from your email that you don't intend to investigate further unless I do something? Even though you found gluten in a product that is not supposed to have any? Did you test the other lot that I tested with EZ Gluten? Several other people with Celiac and gluten intolerance have reported having problems on your forum. I'm a little confused that you seem to be willing to let this drop."
And this was from Thomas Grace about the method used by the lab Sequel uses:
"I have not heard back from them but they seem to be using the “Old” AOAC method from Neogen which does not detect Barley unless it is above 200ppm. This method was first recognized by AOAC in the early 1990”s but is no longer considered an Official AOAC method. Seehttp://www.neogen.com/FoodSafety/pdf/ProdInfo/Page_802002Y_1209.pdf and check the cross reactivity for Barley. "
So the upshot seems to be that there is indeed gluten in their product, which has tested as high as 30.5ppm by the gold standard of tests, and as low as 3-10ppm by an out of date test that would not detect the gluten from barley. I'm not sure what the company is going to do about it. By law, a product only needs to test under 20ppm to be listed as gluten free.There is a push to get this lowered to 5ppm which still might be too high for people with celiac. Sequel seems to be willing to accept the result of their lab as final word and let it rest. If I want to press matters they want me to ship my bottle to them at my own expense.
If you have Celiac or gluten intolerance, I advise that you stop taking Sequel products and email the company that you want them to fix the gluten contamination, whether it is 30ppm or 5ppm. I'm sure most people who take these products do not read this forum and thus have no way of knowing that they are being glutened. We have a responsibility to protect them. If you have been having digestive problems using the products, you should get yourself tested for celiac disease and gluten intolerance.