Currently we have a proposed government definition of the term “gluten-free” for food labeling purposes but no final rule. Under the proposed rule, a labeled gluten-free food has to contain less than 20 parts per million of gluten. When the final rule is released this number could stay the same, go up, or go down—a little or a lot.
The amount of gluten a labeled gluten-free food is allowed to contain is only part of the story. Another part is testing. The FDA stated in its proposed rule that it is tentatively considering using the standard sandwich R5 ELISA and the Morinaga wheat protein ELISA to test food products for gluten when necessary to assess misbranding. In contrast, FDA did not include the omega-gliadin (Skerritt) ELISA among the methods it was considering. One of the limitations discussed in the scientific literature regarding this ELISA is its underestimation of barley protein.
At the present time the R5 ELISA (Ridascreen Gliadin R7001) is widely regarded as the best available validated ELISA for assessing final food product for gluten. In my opinion, all labeled gluten-free foods should be periodically tested using (more…)