Australian Regulator Bans Popular Cold and Flu Herb Andrographis Over Anaphylaxis Risk

When a pharmaceutical ingredient triggers a severe allergic reaction, the risk is usually tied to a known sensitivity, much like a penicillin allergy where patients can be screened and warned in advance. But the Australian regulator's decision to ban a popular cold and flu herb this week hinges on exactly the opposite: the anaphylactic reactions are striking people with no history of allergies, often within 30 minutes of their very first dose. The Therapeutic Goods Administration (TGA) has formally removed Andrographis paniculata from its list of permissible ingredients for low-risk listed medicines, a regulatory shift that effectively bars the herb from new over-the-counter formulations.

The regulatory action, which took effect on September 17, 2026, follows a sustained pattern of severe adverse events that standard safety measures failed to curb. Up to the end of December 2025, the TGA recorded 287 reports of anaphylaxis linked to the ingredient, culminating in a fatal case reported in June 2024. In total, the agency has logged 1,368 adverse event reports associated with the herb since 2005. The ingredient, native to India and Sri Lanka, has long been used in traditional Ayurvedic and Chinese medicine and is currently found in around 70 to 80 immune-support products on Australian shelves.[1][2]

What makes the andrographis cases particularly difficult to manage is their sheer unpredictability. According to the TGA's updated safety review, the life-threatening responses can occur on the very first use or after a patient has taken the supplement previously without any incident. Most of the affected individuals had no prior history of asthma or allergies, rendering standard self-screening strategies entirely ineffective. "The TGA has decided to remove andrographis from the Permissible Ingredients Determination on the basis that the risk of severe allergic reactions (including anaphylaxis) is not adequately mitigable within the listed medicines framework," the agency stated.[1]

The regulator had previously attempted to manage the risk through consumer education and labeling. In 2019, the TGA mandated warning statements on all andrographis products, and it strengthened those requirements again with a safety alert in early 2024. However, the agency concluded that these measures failed to produce a meaningful reduction in anaphylaxis reports. Regulators noted that because the reaction is so rapid, by the time a consumer reads the label and experiences symptoms, the warning is effectively irrelevant to preventing the medical emergency.[2]

Medical professionals have broadly supported the intervention, weighing the severe risks against the herb's clinical utility. The Royal Australian College of General Practitioners (RACGP) backed the removal, with experts pointing out that the trade-off is difficult to justify for an over-the-counter supplement. "With any medication decision there is always a balance of harms or risks against benefits," said Professor Mark Morgan, Chair of the RACGP Expert Committee for Quality Care. "The evidence of benefits for Andrographis to relieve cold and flu symptoms is limited. I agree with the TGA's approach to remove Andrographis from permitted ingredients."[4]

Immunologists have also voiced long-standing concerns regarding the herb's safety profile. Connie Katelaris, a Professor of Immunology and Allergy at Western Sydney University, noted that specialists have reported seeing numerous cases of severe reactions in emergency settings, emphasizing that the risk is simply incompatible with a product sold freely in supermarkets and health food stores. Furthermore, the data reveals a compounding factor: more than 80 percent of the reported adverse events involved andrographis paired with echinacea, another common herbal ingredient that carries its own recognized history of triggering allergic responses, making combination formulas particularly scrutinised.[2]

For consumers, the transition away from these products will not happen overnight. While new medicines containing the herb can no longer be registered on the Australian Register of Therapeutic Goods, existing stock remains on shelves and has not been subjected to an immediate, mandatory recall. Instead, the TGA has strongly encouraged sponsors to voluntarily cancel their listings, halt manufacturing, and initiate consumer-level recalls of their own accord. If companies do not take voluntary action to remove the products, the regulator has explicitly indicated it will begin compulsory enforcement, including mandatory recalls and ARTG cancellations, starting in mid-October 2026.[2][3]

Some major manufacturers have already begun complying with the new regulatory directive. BioCeuticals, which produces the prominent cold and flu supplement ArmaForce—sold in large combination packs—confirmed it has ceased releasing stock and is working closely with the regulator on a voluntary market withdrawal. In the interim, health authorities advise anyone currently taking an immune-support supplement to check the ingredient list carefully. Consumers are urged to stop use immediately and seek urgent medical treatment if they experience any signs of an allergic reaction, particularly since symptoms can escalate to life-threatening anaphylaxis within 30 minutes of ingestion.[2]