On August 2, 2013, the FDA issued a final rule defining “gluten-free” for food labeling to help consumers, especially those living with celiac disease, be confident that items labeled “gluten-free” meet a defined standard for gluten content. The final rule’s compliance date was August 5, 2014. To gauge compliance with one of the major requirements of the rule, the agency conducted a sampling assignment of products labeled “gluten free” from July 2015 to August 2016.

The assignment, an important part of the FDA’s strategy to address products labeled on or after the compliance date, centered on the collection and testing of a wide variety of foods labeled “gluten free.” In all, the agency tested 702 individual samples from three commodity groups (cereals, grain bars and flours). More than 250 types of products were analyzed as part of the assignment.

Of the total number tested, five samples from one product source contained gluten in excess of the regulatory limit of 20 parts per million (ppm), for a product-based rate of compliance with that requirement greater than 99.5 percent. A voluntary recall was conducted to address concerns related to the violative samples. In addition to carrying out the recall, the manufacturer conducted an extensive root cause analysis and immediately implemented additional corrective actions to prevent recurrence. Subsequent sampling by the FDA did not find levels of gluten that violated the regulation.

Analytical Results of FY2015/16 Gluten-Free Food Product Sampling