FDA Drug Product Gluten Recommendations

FDA has issued a draft guidance, Gluten in Drug Products and Associated Labeling Recommendations, to give drug manufacturers agency recommendations on how certain drug products should be labeled regarding gluten. “Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten,” the document says. “Confronted by uncertainty, some patients may forego important medication rather than risk an adverse reaction to gluten. Thus, even if gluten is not present at levels that would harm a typical individual with celiac disease, that individual may be harmed through uncertainty and lack of information.”

The guidance pertains to human drug products that pass through the small intestine: orally ingested drug products, topical drug products applied to or near the lips, and drug products applied inside the mouth.

FDA says that while the guidance was developed with celiac disease in mind, the recommendations may be of interest to patients with other conditions that are treated with a gluten-free diet. It does not apply to food, including dietary supplements, and products regulated solely as cosmetics.

Following an Introduction, the document contains a Discussion on possible sources and amounts of gluten in oral drug products and on labeling, and Recommendations on voluntary statements regarding gluten, submission and adoption, and placement of a voluntary gluten labeling statement.