FDA issued draft guidance: Gluten in Drug Products and Associated Labeling Recommendations

The FDA issued draft guidance today, Gluten in Drug Products and Associated Labeling Recommendations, that provides drug manufacturers with the agency’s recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease or other gluten sensitivities. As part of this effort, the FDA is providing drug manufacturers with a recommended labeling statement to indicate that their products do not contain ingredients derived from gluten-containing grains (wheat, barley or rye).  Additionally, the draft guidance describes where to place that statement in the product labeling and informs manufacturers about the supporting product information that FDA would expect them to include in the submission or have available for agency examination at their manufacturing facility to support the statement. This guidance does not apply to food (including dietary supplements) or products regulated as cosmetics. For more information: CDER page on gluten in drug products.