Gluten in medicines & supplements



Medicines and supplements are regulated differently from food, and gluten labelling rules do not apply to them in the same way.

In Australia, foods labelled gluten free must meet strict standards. Medicines and supplements, however, are regulated by the Therapeutic Goods Administration (TGA), not food authorities, and ingredient disclosure follows medicines-specific requirements.


GLUTEN LABELLING IN MEDICINES

According to the TGA, prescription and non-prescription (over-the-counter) medicines must declare when ingredients are derived from gluten if gluten is present at 20 parts per million (ppm) or more. This includes when gluten is present naturally as part of an ingredient such as wheat starch.

Coeliac Australia considers medicines that contain less than 20 ppm of gluten to be suitable for people with coeliac disease.

This means that:

  • Medicines containing 20 ppm or more of gluten must declare it
  • Medicines with less than 20 ppm of gluten are considered suitable
  • Gluten may not be mentioned if it is not present at a level that requires declaration

People with coeliac disease are advised to:

  • Advise the pharmacist that your medicines need to be gluten free because you have coeliac disease
  • Examine the packaging of over-the-counter medicines
  • Check the Consumer Medicine Information (CMI) leaflet for prescription medicines

If gluten is not mentioned on the packaging or CMI, Coeliac Australia considers the medicine suitable for people with coeliac disease under current labelling rules.


GLUTEN-RELATED CLAIMS ON SUPPLEMENTS

Unlike food labelling, gluten-related claims on supplements are often voluntary and can be used as marketing terms.

A claim such as “no added gluten” means gluten has not been intentionally added as an ingredient. It does not necessarily confirm that:

  • Ingredients are free from gluten contamination, or
  • The product meets Australian gluten free standards

For this reason, Coeliac Australia advises that people with coeliac disease should not rely on marketing claims alone and should still check ingredient sources and suitability, particularly for supplements taken regularly.


IMPORTANT PRACTICAL CONSIDERATIONS

Although this guidance provides reassurance, medicines are intentionally ingested and may be taken regularly or long-term. For this reason, it is still important to check each time you are buying medicine or a supplement.

In addition:

  • Gluten is not always clearly labelled on medicines or supplements
  • Ingredients may be listed under inactive ingredients or starch sources that are unfamiliar
  • Many medicines and supplements do not state gluten status at all, even when they are gluten free

People with coeliac disease are encouraged to:

  • Check the gluten status of all prescribed and over-the-counter medicines and supplements
  • Ask a pharmacist to confirm ingredient sources and inactive ingredients
  • Contact the manufacturer if gluten status is unclear
  • Avoid making assumptions based on food labelling rules or the absence of warnings
  • Seek professional advice if symptoms occur after starting a new medicine or supplement

Pharmacists are often the best first point of contact, as they can access detailed formulation information and liaise with manufacturers when needed.


TRUSTED INFORMATION


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