In light of recent stories about gluten-free foods in the
Chicago Tribune, you may be questioning whether the gluten-free food you purchase truly is gluten free.
We do not yet have a definition of “gluten-free” for labeling purposes in the United States, although the Food and Drug Administration should be releasing a final rule within the next several months. To read the proposed rule, please
click here.

So until the FDA rule on gluten-free labeling is finalized, what should you ask manufacturers of gluten-free food to ensure that the products you buy contain less than 20 parts per million of gluten?
The first thing that many consumers want to know is whether gluten-free food is produced in a dedicated facility. If it isn’t, ask whether the manufacturer has dedicated production times, uses dedicated equipment, or has scrupulous cleaning standards. Also ask if they have a Hazard Analysis Critical Control Point (HACCP) or Allergen Control Program (ACP) in place.
It is important to keep in mind that just because a gluten-free food was made in a dedicated facility, doesn’t mean all ingredients used to make that product were produced in a dedicated facility. A gluten-free food can only be as “clean” as the ingredients used to make it. This is why it is important that manufacturers have a Certificate of Analysis (that includes gluten) from ingredient vendors and test the ingredients they use in their products for gluten, especially those that are most at-risk for contamination, such as grains, flours, and starches. Ask manufacturers if they test their “raw” ingredients and how frequently.
While gluten testing is important, it must be understood that all tests are not equal — some are better than others.
Two sandwich ELISA tests are frequently used in the United States — the R5 ELISA and the omega-gliadin ELISA. Under current Codex standards the R5 ELISA has been endorsed for gluten analysis. In the Food and Drug Administration’s proposed rule for labeling of foods as gluten-free, the R5 ELISA is being considered for gluten determination.
Neither of these assays is perfect but the R5 ELISA is widely considered to be state-of-the-art. Among other drawbacks, the omega-gliadin ELISA does not accurately assess for barley contamination.
It is important to ask manufacturers what assay they are using to assess gluten and what level of gluten they consider gluten free. No food should be labeled gluten free if it contains 20 parts per million or more gluten. In my opinion, it is very important that manufacturers use the R5 ELISA (the regular and not the fast test) and not the omega-gliadin ELISA to test their final product.
Bia Diagnostics LLC in Burlington, Vermont does a great deal of third ...
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