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Andrographis removal fails to balance consumer safety and access
September 18, 2026
The Government’s decision to ban products containing Andrographis is disappointing news for the hundreds of thousands of Australians that rely on them every cold and flu season.
Every adverse reaction matters. But all medicines carry risk and what matters is how those risks are best managed. A blanket ban that denies hundreds of thousands of Australians access to a product they have used safely is not the right approach, and there is strong evidence to show a significant number of consumers will turn to online products that do not contain any warning at all.
The question is not whether additional regulatory action was warranted. It is whether removal was proportionate before a mandatory, standardised and prominent front-of-pack warning had been implemented across the category, supported by targeted controls, consumer education and more effective monitoring of contributing factors.
Paracetamol, antibiotics, aspirin, ibuprofen and peanut-containing foods all carry rare but serious risks. These are managed with warnings, not bans. Andrographis should be treated the same way, given reactions to Andrographis are very rare.
Andrographis isn’t a new or uncommon product. It has been recommended by health practitioners for decades and most consumers buy the products in pharmacies. It’s been used widely for over two thousand years in Ayurvedic and Traditional Chinese Medicine, and it’s important to Australia’s Asian communities and practitioners who recommend it in clinical practice.
Consumers will understandably be very disappointed that they are being denied access products that they and their family have used safely for many, many years.
Unlike common over-the-counter cold remedies, which mainly relieve symptoms, Andrographis is valued by Australians for the significant and noticeable immune support that they experience from it. Removing it takes away a self-care therapy that hundreds of thousands of Australians have come to rely on.
The Therapeutic Goods Administration (TGA) has an important role in managing risk while supporting consumer access. On this occasion we believe the TGA has not balanced these appropriately.
Australians who understand the very low risk of a potential anaphylactic reaction, and the actions required if any allergy symptoms occur, should be allowed to exercise their fundamental right to choose this medicine for themselves.
The TGA’s own Advisory Committee on Complementary Medicines advised that further consideration of
dose, preparation type, and single-ingredient versus combination products was needed before the risk of Andrographis as a single listed ingredient could be clearly determined.
Rather than banning the ingredient from complementary medicines, a workable alternative was put to the Government months ago – with industry calling for stronger, mandatory warnings on the front of every pack, backed by monitoring over a full cold and flu season or two.
A strong, mandatory warning can influence who uses the product, strongly improves awareness before use and helps consumers act quickly if symptoms occur – the period the TGA’s review identifies as decisive. None of that has ever been required of Andrographis – prominently, on the front of pack – and none of it has been properly tested.
Australian and international regulators already have a proportionate, established regulatory approach for managing rare but serious allergy risks in all medicines – strong, mandatory front of pack warnings, rather than removal. Royal jelly is the clearest example for Australian complementary medicines. Despite historical reports of fatal anaphylaxis, royal jelly remains legally available today because the TGA required a bold front-of-pack warning instead of taking it off the market.
Andrographis has never been given that test. Current warnings are small, have never been required on the front of the pack, and have never described the symptoms expected or that it may occur unexpectedly. Consumer research found around two-thirds of users did not recall noticing any warning at all. Where one brand voluntarily trialled a clearer front-of-pack warning box, recognition rose substantially. Throughout the consultation, CMA has actively supported a prominent label warning that identifies the risk, explains that reactions may occur despite previous safe use, describes the symptoms and tells consumers to seek emergency assistance immediately.
Instead, the Government has gone straight to a ban without demonstrating why the less restrictive option would not have worked, contrary to Australian Government guidance on regulation.
The decision also ignores the evidence about what consumers will do next. A survey of almost 1000 Andrographis consumers found around 35% of people would buy Andrographis online from overseas if it wasn’t available in Australia, and a quarter were unsure. Only 40% ruled out purchasing overseas products.
This is a serious safety concern because overseas products carry no Australian quality controls, no mandated warning label, have no Australian sponsor, and no mandated obligation to report side effects.