Gluten threshold testing: Why GFCO tests below FDA’s 20 ppm standard

On January 21, 2026, the Food and Drug Administration announced it was taking steps to increase transparency surrounding food labels and gluten through a Request for Information (RFI). While providing insights into the FDA’s move, Laura Allred, PhD, regulatory manager at the Gluten Free Certification Organization (GFCO), also discusses the scientific and regulatory considerations behind gluten threshold levels in packaged foods. Allred explains why GFCO requires certified products to test below 10 ppm of gluten, even as the FDA maintains its 20 ppm standard, highlighting analytical variability in gluten testing methods.

Transcript

Erin McEvoy: Speaking of looking at research and data, the GFCO requires products to test below 10 ppm of gluten, while the FDA standard remains at 20 ppm. So based on clinical research and data, do you believe the FDA should lower the federal threshold to 10 ppm to better protect this community?

Laura Allred: We’ve never really advocated for the 10 ppm as a permanent threshold reduction. We do know there are some certifications out there that go down to 5 as well. You know, the 20 ppm threshold from FDA was always an analytical threshold. It was what the testing capabilities were at the time. There are some methods out there, they're validated down to 5 PPM now. But FDA has done some evaluation and some longitudinal data look to see how the 20 ppm threshold is working. They haven't seen a reason to change it. There was the recent FAO and WHO [Food and Agriculture Organization and World Health Organization] expert consultation on gluten reference doses. They also considered the 20 ppm threshold again and didn't see a reason to change it. So we wouldn't be advocating so much for them to lower the FDA threshold. It also matches the threshold in most of the world, so, nice to keep it the same where we can.

But for us, the 10 ppm threshold, again, because it's an analytical threshold, one of the things we took into account is if I have a test method and I say it can see 20 ppm of gluten, and I'm going to validate that method and tell you this is fit for purpose for gluten testing. Acceptable recovery levels are typically 50 to 150% so you could see a 20 ppm sample as low as 10 and as high as 30, and that kit, that test method, would be considered acceptable. So for us, that's some of the reason we dropped the threshold little lower is to take that analytical variability into account.