How do you report a supplement side effect in South Africa?

What should you do first?

If you have a serious reaction (trouble breathing, chest pain, fainting, seizures, confusion, severe vomiting or yellow skin), go to an emergency unit or call emergency services. Reporting comes second. For milder symptoms, stop the product and speak to a doctor or pharmacist.

Where do you report in South Africa?

SAHPRA, the regulator for medicines, accepts reports of suspected side effects from the public through two channels, both accessed from its website: the MedSafety mobile app (launched in 2021) and the eReporting portal. SAHPRA also publishes a paper form for complementary medicines, "Adverse Drug Reactions and Quality Problem Reporting Form" (GLF CEM PV 06A, version 3, November 2023), which covers vitamins, minerals, amino acids and other Category D products. Check the SAHPRA website for the current links before you submit, because addresses change.

Which regulator covers which product?

South Africa regulates supplements differently depending on how they are sold:

The boundary between "food" and "health supplement" is not settled in law after the 2022 Supreme Court of Appeal ruling, so if you are unsure, a SAHPRA report is still worthwhile.

What information should you include?

• Product name, brand, size, batch number and expiry date (photograph the label)
• Dose, how often you took it and the date you started
• Your symptoms, when they began, and how they resolved after stopping
• Other medicines and supplements you take
• Any test results or diagnosis from your doctor

Keep the container; do not throw it away. R146 requires the manufacturer or importer's name and South African address on the label, so you can write to them directly.

Why does reporting matter?

Supplement side effects are under-reported, and regulators rely on case reports to spot patterns. Signals for ashwagandha liver injury, for example, built up through case series (see supplements and liver injury). Your report also helps flag contaminated batches.

Should athletes do anything else?

If you are drug-tested and suspect contamination, keep the sealed unopened pack from the same batch, tell your doctor, and contact SAIDS. See what third-party tested means.

For background on how the system works, read are supplements regulated in South Africa and what SAHPRA Category D means. This is general information, not medical advice.