Making All Medications Gluten Free

Gluten is found in food containing wheat, rye, and barley, and it may be introduced into medicines through the use of starch or any modified form of starch derived from these grains. The ingestion of gluten poses serious health hazards to people with celiac disease and non-celiac gluten sensitivity, and they must avoid the oral ingestion of gluten. In 2011, the Food and Drug Administration solicited information and public comments on 'gluten in drug products.' However, the 'final rule' that the Agency issued in 2013 involved only the voluntary 'gluten-free' labeling of food, and it did not include drug products. In this commentary, we are proposing that all drug products can and should be made gluten free. This is especially important since there is currently a global trade in medicines, and patients and health care providers do not know whether a product is gluten free or not unless they are labeled as such. All drug products can be made gluten free as there are many alternatives to gluten-containing starch that can be used as excipients during their formulation. Global collaborative efforts of regulatory agencies, pharmaceutical companies, and excipient manufacturers will be needed to implement a gluten-free medication policy and new regulatory guidelines.