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. Of 26 non-TGA Andrographis products CMA found for sale online to Australians, 23 carried no allergy warning at all and 3 only carried a partial warning. These products contain the same kinds of Andrographis extracts that were used in Australia.
The risk of overseas products is real. International testing of 40 Andrographis products from 13 countries last year found serious quality failures – one product contained mercury above safe European limits, two contained contaminants including a pesticide and the poison strychnine, and two had been bulked out with a substitute ingredient to disguise their true strength.
CMA is also concerned about the process behind this decision. The Australian Government’s Impact Analysis Framework is designed to ensure regulators consider genuine alternatives, who would bear the costs and risks of each option, any unintended consequences, and how stakeholder feedback shaped the final decision. Whether or not a formal Impact Analysis was required, it remains unclear why this intermediate step of a stronger mandatory front-of-pack warning was not considered through a consultative approach.
Nor is it clear how the foreseeable shift of a significant number of Australians to overseas products without Australian warnings and safeguards was weighed, or how unresolved questions about dose and product type were addressed. A decision with consequences of this scale should have answered those questions before setting in motion the decision to effectively remove every Andrographis product from sale in Australia.
Cancellation of the ingredient from Australian listed medicines removes the only regulatory pathway by which Andrographis-using consumers can be supplied a TGA GMP-controlled medicine with effective warnings at the time of use. The decision to remove Andrographis drives potentially hundreds of thousands of consumers into an unregulated pathway of purchasing the offshore products without any anaphylaxis warnings that remain freely available online through e-commerce platforms and are widely advertised to Australian consumers.
This is particularly concerning in context of 42% of respondents already indicating that they have increased their online purchases of supplement products in the last two years.
For years now, Complementary Medicines Australia has been calling on the TGA to protect Australian consumers by directly addressing the serious health risks associated with overseas online products. Instead, this decision drives consumers to take them in the absence of any warning statement at all. We are deeply concerned that this decision significantly increases the safety risk for a meaningful proportion of Australian consumers.
CMA is calling on the Government to reconsider whether consumers would be better protected if Andrographis remains within the listed-medicines pathway, where strong, mandatory Australian warning requirements and other enforceable safety controls can apply. That assessment should take into account the foreseeable risk that many consumers will instead turn to overseas products without equivalent Australian quality, labelling and pharmacovigilance safeguards.
Disclaimer: CMA makes no representation as to the suitability of the information in this article/publication for any purpose. It is provided ‘as is’ without implied or express warranty. This publication is provided for general information purposes only. You should not rely on this information as a substitute for, nor does it replace, professional medical advice, diagnosis, or treatment. If you have any concerns or questions about your health, you should always consult with a healthcare professional. When taking medicines, always read the label and follow the directions for use.
CMA does not accept any liability for any injury, loss or damage caused by use of the contents of this article/publication or this website including links to other websites. While CMA endeavours to provide quality information in this publication, CMA does not provide any guarantees, and assumes no legal liability or responsibility for the accuracy, currency or completeness of the information. You should obtain advice relevant to your particular circumstances from a health or other relevant professional.
