US vs EU drug label comparison — starch source disclosure for 86 molecules

Same molecule, two regulators, two answers

For 86 medicines authorised in both the United States and the European Union, we hold the starch excipient terms exactly as each regulator's label states them. The comparison is worth making because the result runs opposite to the rules.

US drug labelsas of April 2026EU drug labelsApril 2026 snapshot

88.4% US labels naming the starch source

38.4% EU leaflets naming it

43 labels that disagree — all favouring the US

The mandate is not the outcome. EMA guidance (CHMP/704219/2013) requires wheat starch to be declared on the leaflet when used. The US has no equivalent requirement. Yet US labels name the botanical source more than twice as often, because US labels draw on a controlled vocabulary that carries the source inside the ingredient name itself. A rule that mandates disclosure of one grain does less work than a naming convention that makes every source explicit.

Every paired molecule

How current is this?

This is a April 2026 snapshot, and it is deliberately not refreshed on a schedule. A census is point-in-time by definition — the measurement describes the labels as they stood when they were captured, and re-running it later produces a new measurement rather than a correction of this one.

Drug labels change without notice, so treat any individual row as a pointer to check the current label, not as a live status. The screening tool reads the US label catalogue; for the specific product in your hand, the NDC on the bottle is what matters.

By Ned Walsch

Founder and maintainer of Gluten Screen

Updated August 19, 2026

Not clinically reviewed — verify with your pharmacist

Gluten Screen is a label-reading tool, not medical advice, and is not a pharmacist, physician or dietitian. Never stop, switch or substitute a prescribed medication because of something you read here. Bring the question to your pharmacist or prescriber.