FDA Issues Draft Guidance on Gluten Labeling for Drugs

FDA Issues Draft Guidance on Gluten Labeling for Drugs

The draft guidance encourages drugmakers to provide detailed labeling about whether their products are made from ingredients that contain gluten.

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December 19, 2017
Edited by QA Staff
Food Safety
The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance encouraging drugmakers to provide detailed labeling about whether their products are made from ingredients that contain gluten.

FDA says the guidance is meant to reduce uncertainty about the presence of wheat gluten in oral drugs, and that unless a drug specifically contains wheat gluten or wheat flour as an ingredient, that it expects that most drugs would contain less wheat gluten than a gluten-free cookie.

"The amount of gluten estimated to be potentially present in a unit dose of an oral drug product (less than 0.5mg) is significantly less than the range at which gluten is estimated to be present in a gluten-free diet (5 to 50mg)," FDA writes, noting that 0.5mg is the high end of its estimate.

FDA also says it is not aware of any currently marketed oral drugs that contain wheat gluten as an intentionally added inactive ingredient, and that drugs that contained intentionally added wheat gluten would have to be labeled as such.
FDA