Compliance assessment of US gluten-free labeled oatmeal produced under a "Purity Protocol" indicates "Serving Level Compliance" not attained

Abstract

Oats are naturally gluten-free, but are commonly contaminated with gluten-containing kernels of wheat, barley, and rye. Gluten compliance (FDA, gluten <20 ppm) when managed at the serving level (40-50 g) is believed to provide the best protection to consumers. In this recent in-market survey, a third-party laboratory tested 166 servings of oatmeal manufactured with oats produced under a "Purity Protocol." Results indicated gluten at noncompliant levels in five servings (spanning 20.4-229 ppm). This equates to a noncompliance rate of 1 in 33 servings. This new finding is comparable to a noncompliant rate of 1 in 57 servings uncovered by our previous in-market survey, where the gluten-free (GF) oatmeal was manufactured with oats produced by mechanical/optical cleaning. These new findings, substantiated by the previous ones, show that GF oats not managed for gluten compliance at the serving level may introduce an intermittent bolus of gluten to consumers with celiac disease.