Is my product a food supplement or a medicine?

The two tests

• By presentation: a product presented as treating or preventing disease in people is a medicine. Claims, the name, pictures, the website and even where it's sold all count.
• By function: a product that restores, corrects or modifies body functions through a pharmacological, immunological or metabolic action is a medicine, even if it makes no claims.

These come from the Human Medicines Regulations 2012. The MHRA decides borderline cases, and its guidance on what counts as a medicinal product explains its approach.

What tips a product over the line

• Disease words: “treats”, “cures”, “prevents”, or naming conditions such as arthritis, depression or diabetes.
• Ingredients that are medicines in the UK, such as melatonin, which is prescription-only.
• Doses at a level that has a drug-like effect.
• Medical-looking presentation, such as dosage instructions for symptoms, “clinically proven to treat”, or packs that copy medicine styling.

Herbal products

Some herbal products are sold as traditional herbal medicines under a Traditional Herbal Registration (THR), which allows limited traditional-use indications. If you want to make that kind of claim, the product needs that registration rather than being sold as a supplement.

If the MHRA decides it's a medicine

It can tell you to stop selling the product, change it, or apply for a licence. Avoid that by keeping claims within the authorised health claims, and by checking ingredients and doses before launch.

Every ProofMyLabel check flags disease and medicinal wording. Look up the claims you can use in the health claim finder.