Australia Just Pulled a Popular Cold and Flu Herb From Its Low Risk Supplement List

What Australia actually did

The TGA removed Andrographis paniculata from the Permissible Ingredients Determination, the list of ingredients that are allowed in "listed" medicines, the low risk tier that includes most supplements sold off a shelf without the product's effectiveness being individually assessed. The change took effect on September 17, 2026, and it was made using an urgent mechanism, on the grounds that waiting would likely pose an imminent or serious risk of injury to consumers.

In practical terms, no new listed medicine containing the herb can be entered on the Australian Register of Therapeutic Goods. Roughly 80 existing Andrographis products are already on that register. They may still be supplied for now, but the TGA says it will strongly recommend that their sponsors cancel the listings or recall the products, and that from mid October it will assess whether to force a cancellation or recall where sponsors do not act. The herb is not gone from Australia entirely. It can still be sold through the higher evidence "registered" medicines pathway, which requires human clinical trial data.

The number, and why warning labels were not enough

The TGA has received 287 reports of anaphylaxis linked to medicines containing Andrographis, counting from the first report in 2005 through December 31, 2025. One of those was fatal, and it was reported in 2024. Anaphylaxis is a sudden, whole body allergic reaction that can close the airway and drop blood pressure, and it is a medical emergency.

What turned this into a regulatory decision is the trend, not the total. Warning labels have been mandatory on these products since 2019 and were strengthened again in 2024. The TGA states that these measures "have not led to a meaningful reduction in the number of reports." So the regulator looked at its other options, stronger warnings, limits on how the herb is formulated, more consumer education, and concluded that none of them were viable ways to reduce the risk.

If you cannot tell who is at risk, you cannot tell anyone to avoid it.

The reason is the shape of the reaction. According to the TGA's review, it can happen the first time someone takes the herb or after a long stretch of uneventful use, most of the people affected had no history of allergies or asthma, symptoms usually start within 30 minutes, and the mechanism is not understood. If you cannot tell who is at risk, you cannot tell anyone to avoid it. The TGA's conclusion is that Andrographis may not be appropriately positioned within the low risk framework of listed medicines.

Legal where you live is not the same as reviewed

Here is the gap that made me want to write this. Andrographis remains freely sold in the US, the UK and the EU. As of this writing I found no parallel action from the FDA, the European Food Safety Authority or the UK's MHRA, so please do not read this as a global withdrawal. It is one national regulator, with a tiered system that separates low risk listed products from assessed and registered ones, reaching a conclusion about one ingredient.

That is still worth your attention, because a US supplement label does not come with an independent safety review of this kind. It also matters because the herb hides under names most people do not scan for: Andrographis paniculata, kalmegh, green chiretta, King of Bitters, and as the partner ingredient in many echinacea combination formulas sold for colds.