TGA Proposes to Ban Andrographis from Australian Cold and Flu Supplements

For a 51-year-old Perth mother with a known bee-sting allergy, a popular cold and flu supplement was meant to soften a winter cold. Within minutes of swallowing a tablet of ArmaForce, a BioCeuticals product combining Andrographis paniculata with Echinacea, Kerry Smith's throat began to close and her skin felt as though it was on fire [1]. She survived only because two EpiPens prescribed for her insect allergy were already at home. Her case now sits at the centre of an updated safety review released by Australia's Therapeutic Goods Administration (TGA) on 8 April 2026, which opened a formal consultation on removing Andrographis paniculata from the Permissible Ingredients Determination used for low-risk listed medicines [2]. The window closed on 30 April 2026. A final decision is expected imminently.

What the TGA is proposing, and why now

The proposal is narrow but consequential. The TGA is consulting on removing Andrographis paniculata from the Permissible Ingredients Determination, the list of ingredients permitted for use in "listed" medicines, a category that allows products to be sold over the counter in Australian pharmacies, health food stores and supermarkets without individual pre-market efficacy review [2][3]. If removed, Andrographis would not vanish from the Australian market. It would remain available in registered, that is, prescription, medicines. It would simply no longer be permitted in the low-risk listed pathway that covers most retail supplements.

The trigger is a sustained spike in anaphylaxis reports, the most severe form of allergic reaction, that has not been brought under control by label warnings alone. As of 31 December 2025, the TGA had received 287 reports of anaphylaxis associated with Andrographis-containing medicines since 2005, including at least one fatal case in Queensland in June 2024 [4][5]. Across the full dataset, 1,368 adverse event reports have been logged since 2005, and 217 of the 287 anaphylaxis cases, or 76 percent, were received between 2019 and 2025 [4][6]. The TGA's own conclusion, now on the public record, is unambiguous.

"The sustained high reporting pattern since 2019 indicates that Andrographis is associated with risk of life-threatening anaphylaxis which is inconsistent with the low-risk regulatory framework for listed medicines." [4]

The TGA's updated safety review, published on the agency's website in April 2026, lays the regulatory case out plainly. For consumers, the immediate step is clear. Anyone holding a box of an Andrographis-containing product, particularly multi-ingredient formulas such as ArmaForce, ArmaForce Cold Care and similar pharmacy brands, should treat it as a potential anaphylaxis trigger. Until the final ruling, the TGA's August 2024 safety advisory remains the active guidance: do not take these products if you have a history of allergy or asthma. Anyone who develops throat tightening, breathing difficulty or facial swelling after a dose should call 000 immediately. For non-urgent advice after a suspected reaction, the Australian Poisons Information Centre can be reached on 13 11 26 [3].

The cases behind the numbers

The clinical signal is reinforced by a small set of well-documented cases, two of which capture the breadth of the harm.

Kerry Smith's story is the most cited. In early January 2026, she took a single ArmaForce tablet for what she described as a minor cold [1][5]. Within minutes she developed a reaction severe enough to require her pre-existing EpiPens before paramedics arrived. She has since been quoted saying: "I knew I had the EpiPens for the bees, but I never thought I'd be using them for a vitamin tablet" [1]. Of the 287 anaphylaxis reports on the TGA's file, 188 specifically named an ArmaForce product, making it by some margin the most-implicated brand on the Australian Register of Therapeutic Goods (ARTG), according to TGA pharmacovigilance data reported by the ABC [5].

The second case is slower, but no less instructive. Carmen Wells, a Queensland patient, took an Andrographis-containing supplement in 2019 and subsequently developed drug-induced liver injury, later rediagnosed as drug-induced autoimmune hepatitis. Six years on, she remains on regular blood testing to monitor her liver function. Her account, recorded by the ABC in December 2024, is a reminder that hypersensitivity to Andrographis is not limited to acute anaphylaxis [7].

"I'm having to manage my health still … so I'm back on regular blood testing. It's always in the background, it's always something I have to think about." [7]

Wells, speaking through the ABC's December 2024 reporting, framed her ongoing monitoring as a permanent change to her health. The pharmacovigilance specialists who have reviewed this casefile are clear about its meaning. Professor Connie Katelaris AM, an immunologist and allergist at Western Sydney University, has publicly backed the TGA's proposed removal, arguing that stronger warnings have proven inadequate [4]. The TGA's own safety review notes that anaphylaxis can occur on first use, or after previous uneventful use, and in people with no history of allergies, which makes consumer self-screening unreliable [2].

The clinical message is clear: anaphylaxis from Andrographis can be minutes-fast, fatal at home without adrenaline, and unpredictable by prior history. There is no patient subgroup that can be reliably told they are safe.

Why label warnings have failed

The TGA has already tried the soft regulatory path. In 2015 it published a public safety alert. In 2019 it mandated warning labels about allergic reaction risk, with the change rolled out between December 2019 and May 2020 [8][9]. BioCeuticals, the manufacturer of ArmaForce, took the additional step in August 2024 of updating its label to specifically warn of anaphylaxis [4]. The 2024 strengthened warning has not worked. According to the TGA's review, the number of anaphylaxis reports for ArmaForce in 2025 remained consistent with 2022 and 2023 levels [6]. Across all Andrographis products, 53 anaphylaxis cases were reported in 2024 and 33 in 2025, with 2024 marking the highest annual count on record [6].

The agency's reasoning is clinical, not administrative. A label warning only helps a consumer who reads it, registers that they carry an allergy risk, retains the information at the moment of dosing, and has rapid access to adrenaline. The TGA's own safety review makes the point starkly.

"For consumers experiencing these symptoms, the label warning becomes irrelevant. A label warning is also not helpful for people who did not have quick access to emergency treatment including adrenaline." [4]

The TGA's safety review draws the line through the consumer behaviour data, and the agency's conclusion is that warning-led mitigation has run its course. A viral illness, the very reason most consumers reach for an Andrographis product in the first place, can independently amplify allergic reactivity, narrowing the safety margin further [7].

The regulatory lesson is straightforward. Once a regulator concludes that risk cannot be reliably mitigated at the consumer level, the remaining levers are restricted availability, behind-the-counter status, or removal from the listed-medicines pathway. The TGA has now chosen the strongest of those.

The co-formulation question: is Echinacea to blame?

A common counter-argument, raised in industry submissions, is that the harm signal is driven by Echinacea rather than Andrographis. The TGA's data does not support that reading. Eighty-three percent of all anaphylaxis reports involved products containing both Andrographis and Echinacea, but the agency has separately tracked Echinacea-only products, and only 10 anaphylaxis cases have been reported to the TGA involving Echinacea without Andrographis [6]. Five ArmaForce products from a single sponsor account for 66 percent of all anaphylaxis cases named in the dataset, a concentration consistent with a specific formulation rather than a class effect of herbal cold and flu ingredients [6].

International data point in the same direction. Health Canada has recorded hypersensitivity reactions, including anaphylaxis, suspected of being associated with oral ingestion of Andrographis paniculata-containing products, and flagged the issue in its September 2020 Health Product InfoWatch [10]. Reporting elsewhere is described by the TGA as "disproportionately high" for Andrographis relative to Echinacea [6].

For clinicians, the priority is to be specific when taking an allergy history. "Do you take any herbal supplements?" is not enough. "Do you take ArmaForce, Andrographis, or any cold and flu product combining Andrographis with Echinacea?" is the question that surfaces the risk.

What Andrographis actually is, and what the evidence shows

Andrographis paniculata, sometimes sold under the common name "King of Bitters," is an annual herb in the Acanthaceae family, native to India and Sri Lanka and used for centuries in Ayurveda, Traditional Chinese Medicine, and Thai traditional medicine for fever, inflammation, and upper respiratory tract infections [11]. Its principal active constituent is andrographolide, a labdane diterpenoid with documented immunomodulatory and anti-inflammatory activity in vitro. The herb's modern reputation as a cold and flu remedy rests on small, heterogeneous trials, mostly conducted outside Australia, with mixed results.

The pharmacology writer Ian Musgrave of the University of Adelaide has summarised the evidence base bluntly.

"Andrographis is often used to treat and prevent cold and flu symptoms, upper respiratory tract infections, inflammation and fever. However, despite its popularity, there is a gap in empirical evidence to support these benefits." [9]

Musgrave, a pharmacologist who has tracked herbal safety for years, makes the evidentiary case in plain terms. The Royal Australian College of General Practitioners (RACGP) has reached a similar conclusion. Professor Mark Morgan, chair of the RACGP Expert Committee on Quality Care, has stated:

"With any medication decision there is always a balance of harms or risks against benefits. 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." [7]

Morgan's framing, from inside Australia's peak general practice body, shifts the regulatory question from "is it risky?" to "is it worth the risk at all?". In other words, the regulatory case is not only that the risk is high, but that the demonstrated benefit is modest at best. The risk-benefit calculation that supports most listed medicines does not hold for Andrographis.

For consumers weighing the next cold and flu season, the calculus is straightforward: the evidence for Andrographis in shortening or preventing upper respiratory tract infections is thin, the anaphylaxis risk is real, and the safer alternatives, including rest, fluids, intranasal saline, paracetamol or ibuprofen for symptom relief, and pharmacist review for red-flag symptoms, do not carry this risk profile.

What happens next, and what to do at home

The TGA's consultation closed on 30 April 2026. A final decision on whether to amend the Permissible Ingredients Determination is expected imminently [4]. If the TGA proceeds with removal, existing listed medicines containing Andrographis will need to be reformulated or withdrawn. BioCeuticals, asked for comment, has said it is "reviewing the consultation and will take any steps required following the outcome of the TGA consultation" [7].

For now, the regulatory position is unchanged. Andrographis remains permitted in listed medicines, with mandatory warning labels about anaphylaxis risk in place since 2020. Until the TGA publishes its final decision, the August 2024 safety advisory stands [3]. Consumers and clinicians should treat Andrographis-containing products, especially multi-ingredient ArmaForce formulas, as carrying a risk that is low in absolute per-dose terms but real and potentially fatal, with reactions that can develop within minutes. Anyone who has experienced any hypersensitivity symptom after an Andrographis dose, even mild, should not take the product again. Anyone with a personal or family history of severe allergy, or who does not have rapid access to adrenaline, should think carefully before starting one. In an emergency, call 000. For non-urgent advice, the Australian Poisons Information Centre is on 13 11 26.

The clinical signal is now large, sustained, and pharmacologically plausible. The TGA's own view, plainly stated in the safety review, is that further labelling will not fix it.

"Current risk mitigation strategies, including stronger label warnings, have not reduced the risk of anaphylaxis from Andrographis for it to be suitable for use in listed medicines." [4]

The TGA's updated safety review makes the regulatory position explicit, and the agency's final decision will determine whether Andrographis remains on Australian supplement shelves at all. Whether the final ruling removes the ingredient entirely or restricts it further, the threshold question has already been answered. The evidence no longer supports this herb in the low-risk supplement aisle.

This article is journalism, not medical advice. It reports on the TGA's safety review and proposed regulatory action. Anyone with concerns about a supplement or a reaction should speak to a doctor or pharmacist, and call 000 in an emergency.