The TGA announced its decision to ban the use of Andrographis (Andrographis paniculata) in listed medicines on Sept. 18, citing concerns of allegic reactions, including anaphylaxis. Also known as the “King of Bitters” or Indian echinacea, the leafy green herb is native to South Asia and has a long history of use in traditional Ayurvedic and Chinese medicine to treat colds, flus and sore throat.
As of 2025, the TGA noted that it had received 287 reports of anaphylaxis associated with Andrographis-containing supplements, including one fatal reaction reported in June 2024.
The authority is now strongly advising companies to cancel Australian Register of Therapeutic Goods (ARTG) listings of their Andrographis products and recall them from the market. While Andrographis can no longer be used in new listed medicines as of Sept. 17, products containing the herb can still enter the Australian market through the registered medicines pathway, subject to TGA assessment of their quality, safety and efficacy before approval.
“I think a lot of us were surprised at the severity of the decision,” said Jon Wardle, professor of public health at the Southern Cross University and foundation director of the university’s National Centre for Naturopathic Medicine (NCNM).
While there is a cause for further regulatory action and investigation, he believes that completely removing Andrographis from listed medicines is unwarranted.
“The decision seems to be based on signal tracing of adverse events alone, but that itself does not provide the story you need. The TGA seems to have made a complete and rather drastic decision based on only half the story,” he said.
He pointed out that Andrographis use has increased significantly since COVID-19, which could have translated to a commensurate increase in adverse events in recent years.
However, this does not necessarily mean that the product itself has become riskier, as it is unclear what the rate or proportion of Andrographis-related adverse events is, unless sales data is accounted for.
Calls for stronger warnings, practitioner-only model
Commenting on TGA’s announcement, Complementary Medicines Australia (CMA) questioned why the government did not explore implementing stronger front-of-pack warnings as a more moderate approach rather than an outright ban.
“The question is not whether additional regulatory action was warranted,” John O’Doherty, CEO at CMA, shared in a statement following the announcement. “It is whether removal was proportionate before a mandatory, standardized 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.”
He noted that paracetamol, antibiotics, aspirin, ibuprofen and peanut-containing foods all manage rare but serious risks through warnings rather than bans, arguing the same approach should apply to Andrographis given the rarity of reported reactions. He pointed to royal jelly as an example, noting that despite historical reports of fatal anaphylaxis, it remains legally available, with the TGA instead requiring a bold front-of-pack warning.
Andrographis-containing listed medicines sold in Australia have carried a mandatory allergy warning since 2019. However, O’Doherty said that the current warnings were inadequate because most were not displayed on the front of the pack.
“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,” he said, highlighting consumer research indicating that around two-thirds of users did not recall noticing any warning at all. In contrast, when one brand voluntarily trialed 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,” O’Doherty added. “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 association maintains that the removal fails to balance consumer safety with access to Andrographis-listed medicines and is urging the government to reconsider the decision, retain Andrographis in listed medicines and introduce stronger mandatory warnings and other enforceable safety controls.
In its response, the Australian Register of Naturopaths and Herbalists (ARONAH) has called for a practitioner-only model to maintain safe access to Andrographis, rather than banning its use in listed medicines.
In a submission to the TGA as part of the industry consultation process in May, ARONAH outlined a staged approach that would allow suitably qualified practitioners to continue providing Andrographis, while removing products from general retail and self-selection.
More needs to be uncovered
The regulator could also have considered whether certain dosages, types or formulations of Andrographis are causing adverse effects, as well as whether certain populations are more susceptible to Andrographis use due to factors such as genetic polymorphism.
“Andrographis’ increasing popularity in the marketplace has led to different forms and doses being sold, and it is not made clear whether this is a product-specific issue where one type of extract or formulation is riskier, or it cuts across Andrographis more generally...” said Prof Wardle. “The curiosity of what’s causing the allergenicity is not there.”
Like the CMA, he is also of the view that bolder, stronger warning labelings would be a better option to regulate Andrographis.
Aside from the TGA, New Zealand’s MEDSAFE and Health Canada are some of the regulators that have published safety alerts and adverse event reports associated with Andrographis use.
MEDSAFE, for instance, published an alert about the potential risk of allergic reactions with andrographis in 2017 and last year. In its statement last year, it also said that it had received three cases of hypersensitivity reactions each year since 2023.
As of April 30, 2020, Health Canada reported that it had received three reports of hypersensitivity reactions suspected of being associated with a product containing Andrographis. Two cases were deemed serious, including a case where anaphylactic shock was reported within 10 minutes of taking a health supplement containing Andrographis. The other case reported abdominal and chest pain, diarrhea, dyspnea, erythema, seizure, urticaria and vomiting three hours after taking Andrographis.
Still, Health Canada noted that all three reports were “deemed unassessable for the relatedness to Andrographis paniculata,” due to limited information or the presence of other suspect ingredients.
Ban could lead to purchase of unregulated products online
CMA warned that banning Andrographis in listed medicines could drive consumers to purchase unregulated supplements elsewhere.
Citing a survey of nearly 1,000 Andrographis consumers, the association said around 35% of respondents would consider buying the products online from overseas if they were not available in Australia. A further quarter were unsure if they would purchase Andrographis overseas, and 40% said they would not.
“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,” O’Doherty said.
CMA also confirmed that of 26 non-TGA Andrographis products identified for sale online to Australians, 23 carried no allergy warning and three carried only a partial warning. These products contain the same kinds of Andrographis extracts used in Australia.
O’Doherty also highlighted findings from a study published in Swiss Medical Weekly last December, showing that Andrographis products purchased online were found to contain heavy metals like mercury or pesticides like strychnine and butralin.
As with medicinal cannabis and Ayurvedic medicines like Shilajit, melatonin and kava, Prof Wardle believes the ban on Andrographis in listed medicines means that Australian consumers would similarly turn to online channels for easy access to overseas-made Andrographis.
This could also lead to less reporting of adverse events data, he said, since a significant proportion come from Australian companies themselves.
“Unfortunately, I think what the TGA has done is to inadvertently hand over safety and quality assessments for Andrographis to the online marketplace, which is not really going to protect anyone,” he said.
Andrographis products on the market
As of Sept. 21, there were 75 Andrographis-containing medicines on the Australian Register of Therapeutic Goods (ARTG), including both practitioner-only and direct-to-consumers products. These include ArmaForce from FIT-BioCeuticals Pty Ltd, which claims to relieve common cold/flu and mild upper respiratory tract infection (URTI), as well as Mediherb Andrographis Complex from Integria Healthcare Australia Pty Ltd. Both are practitioner-only products. There are also Andrographis supplements directly available to consumers without a practitioner’s prescription, such as Nature’s Sunshine Andrographis and Immune Active NK 40 Tablets by Metagenics.
Regulations elsewhere
In the United States, Andrographis is commercially available as an ingredient in dietary supplements under the regulatory framework established by the Dietary Supplement Health and Education Act.
In Canada, Health Canada granted a product license to the Andrographis extract AP-Bio/KalmCold by Natural Remedies in 2022. The license allows brands containing 200 mg of AP-Bio to make the claim that it “helps to reduce symptoms of common cold and upper respiratory tract infections (such as sore throat, cough, runny nose, fatigue, plugged nose and fever) and ”helps to reduce/relieve the severity of symptoms associated with upper respiratory tract infections (eg., common cold and flu)."
In Europe, Andrographis is considered non-novel in food supplements and therefore does not require pre-market authorization under Regulation (EU) 2015/2283. However, its use in retail food supplements could still be restricted in individual European Union Member States under national legislation.
