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USA: FDA Releases Draft Guidance on Gluten Labelling for Drugs

Thursday, December 14, 2017: The US Food and Drug Administration (FDA) has released draft guidance which encourages drug manufacturers to provide detailed labelling regarding whether their products are made from ingredients that contain gluten.

Individuals with celiac disease may face difficulty when trying to determine whether specific drug products contain gluten and thus they may decide to do without the medication rather than risking an adverse reaction to gluten. Therefore, in this guidance the FDA provides recommendations to drug manufactures on how certain drug products should be labelled regarding gluten, thus reducing the uncertainty about the presence of wheat gluten in oral drugs.

The guidance applies to all human drugs that pass through the small intestine, for example, drugs that are taken orally, topical drugs applied on or near the lips and drugs that are applied to the inside of the mouth.

The FDA states that “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)”.

Drugs that contain intentionally added wheat gluten will have to be labelled stating this, however the FDA is not aware of any currently marketed oral drugs that contain wheat gluten as an intentionally added inactive ingredient. If a drug has been substantiated to contain no gluten, the FDA recommends manufacturers include a statement that their drug “contains no ingredient made from a gluten-containing grain (wheat, barley or rye)” in the description section of the drug’s prescribing information.

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