Andrographis: When Public Safety and Herbal Freedom Collide
There is something about the recent decision to restrict andrographis in Australia that has left me with more questions than answers.
Not because I believe medicinal plants are inherently harmless. Quite the opposite.
As a clinical naturopath, understanding the therapeutic properties of herbal medicines also means understanding their risks, contraindications and limitations. It means recognising that natural substances can have powerful physiological effects, and that those effects are not always beneficial.
But it also means recognising the value of traditional medicine, the importance of informed choice and the need for a regulatory system that evaluates herbal medicines fairly.
So when I received an update from the Naturopaths & Herbalists Association of Australia (NHAA) explaining that Andrographis paniculata had been removed from Australia's list of permissible ingredients for new listed medicines, I was concerned.
The decision followed reports of serious allergic reactions, including anaphylaxis and a fatality.
These are not insignificant findings, and they deserve to be taken seriously.
Yet I found myself asking a question that extends far beyond this particular herb.
At what point does protecting public health begin to restrict informed choice, and how do we determine whether the response is proportionate to the risk?
I don't believe this is a question with a simple answer.
But I do believe it is one worth asking.
First, What Is Andrographis?
Andrographis paniculata, sometimes called the King of Bitters, is a medicinal plant belonging to the Acanthaceae family.
It has a long history of use in traditional Indian and Chinese medicine, particularly for conditions involving fever, respiratory symptoms and inflammation.
Its intensely bitter taste is characteristic of the plant, which contains several biologically active compounds, including andrographolides.
These compounds have attracted scientific interest for their potential effects on inflammatory and immune-related pathways.
In contemporary Western herbal medicine, andrographis has commonly been used in formulations intended to support the management of upper respiratory tract infections, including the common cold.
And unlike many herbs whose therapeutic reputations rest primarily on traditional use, andrographis has also been investigated in human clinical trials.
A 2017 systematic review and meta-analysis examined 33 randomised controlled trials involving 7,175 participants.
The researchers reported improvements in some symptoms of acute respiratory tract infections, including cough and sore throat, compared with placebo.
However, the authors also identified important limitations, including generally poor study quality and considerable differences between the preparations investigated.
In other words, there is evidence suggesting potential therapeutic benefit, but that evidence is not without uncertainty.
And this is an important starting point: a herb can have therapeutic potential without being appropriate or safe for everyone.
The existence of benefit does not eliminate risk.
Equally, the existence of risk does not automatically erase every potential benefit.
Understanding both is fundamental to responsible herbal medicine.
What Actually Happened in Australia?
On 17 September 2026, Australia's Therapeutic Goods Administration (TGA) removed Andrographis paniculata from the list of ingredients permitted in new listed medicines.
To understand the significance of this decision, we first need to understand how medicines are regulated in Australia.
The TGA uses different regulatory pathways depending on the risks associated with a medicine.
Many complementary medicines are supplied as listed medicines, identifiable by an AUST L number.
These products must meet applicable quality and safety requirements, and manufacturers must hold evidence supporting their claims. However, individual listed medicines do not undergo the same pre-market evaluation of effectiveness as registered medicines.
Registered medicines, identified by an AUST R number, undergo a more extensive assessment of quality, safety and effectiveness.
The September decision means that new andrographis-containing medicines can no longer enter the Australian market through the listed-medicines pathway.
It does not constitute an absolute prohibition on the plant itself.
The TGA has indicated that andrographis-containing products could potentially be supplied through the registered-medicines pathway, subject to the relevant assessment requirements.
Existing listed products were not immediately removed when the decision came into effect.
However, manufacturers were subsequently encouraged to withdraw affected products voluntarily, and recalls have since been initiated across a range of consumer and practitioner products.
So while the regulatory distinction matters, the practical implications are significant.
For practitioners and consumers who have historically used andrographis, access is becoming increasingly restricted.
And this is where the discussion becomes more complicated.
The Safety Concerns Are Serious
I want to be very clear about something.
The TGA did not make this decision because andrographis was simply considered ineffective or because herbal medicine lacks scientific legitimacy.
The decision was driven by concerns about severe allergic reactions.
According to the TGA's updated safety assessments, more than 1,300 adverse events associated with andrographis-containing products had been reported, including serious cases of anaphylaxis and a fatal case reported in 2024.
Anaphylaxis is a severe, potentially life-threatening allergic reaction that can develop rapidly and requires emergency medical treatment.
What makes the andrographis findings particularly concerning is the apparent unpredictability of these reactions.
The TGA reported that some individuals experienced severe reactions despite having previously taken andrographis without difficulty.
A history of allergies or asthma was also not a reliable way to identify those at risk.
Furthermore, the review did not establish that a particular dose, extract, preparation type or formulation could consistently be considered safer.
This included liquid herbal extracts, which are commonly used in naturopathic and Western herbal medicine practice.
For practitioners, that finding is particularly relevant.
We cannot simply assume that using a traditional liquid extract rather than a tablet eliminates the risk.
The TGA had previously introduced mandatory allergy warnings, but reports of serious reactions continued.
Following its review, the regulator concluded that the risk could not be adequately managed within the existing listed-medicines framework.
There is another important distinction here.
Adverse-event reports are signals used in medicine safety monitoring. They do not all establish that a particular ingredient definitively caused the reported reaction.
They also cannot, by themselves, tell us the exact likelihood of an adverse event occurring.
The TGA's assessment went beyond simply counting reports, incorporating additional safety data, expert advice and information about product supply.
Its analysis suggested that anaphylaxis was rare or very rare, although the precise frequency remains uncertain.
That distinction matters.
Rare does not mean harmless. But rare also does not mean common.
Both the severity and likelihood of harm are relevant when evaluating a medicine's overall risk.
And both deserve to be communicated accurately.
When Does Precaution Become Restriction?
This is the question I keep returning to.
I understand why a regulatory authority would take action when faced with reports of unpredictable, potentially fatal allergic reactions.
Protecting consumers from preventable harm is an essential responsibility.
But I also believe we should be able to examine whether a particular regulatory response is proportionate.
Could stronger consumer education have been effective?
Could additional restrictions on supply have provided an alternative?
Would practitioner-supervised access have offered meaningful safeguards?
Or was the nature of the risk such that these measures would not adequately protect consumers?
These are not questions I raise to dismiss the TGA's findings.
They are questions about how we translate evidence into public health policy.
The TGA considered earlier warning requirements, further safety information and stakeholder submissions before reaching its decision.
Its conclusion was that the available measures could not sufficiently manage the risk within the listed-medicines system.
That reasoning deserves acknowledgement.
But regulatory decisions also have consequences beyond the immediate safety concern.
When a medicinal ingredient is removed from a widely used regulatory pathway, manufacturers may withdraw products, practitioners may lose familiar therapeutic options, and consumers may experience reduced access.
The registered-medicines pathway technically remains available.
However, it involves more extensive evidence and regulatory requirements, which may present practical and financial challenges for some herbal medicine manufacturers.
Whether that pathway will provide a realistic means of maintaining access to andrographis remains to be seen.
A regulatory pathway existing in principle is not necessarily the same as meaningful access in practice.
And I believe that distinction deserves greater public discussion.
What About Informed Choice?
Informed consent is a principle I value deeply, both as a practitioner and as someone navigating my own healthcare decisions.
To me, informed choice means understanding the available options, their potential benefits, their limitations and their risks.
It means having the opportunity to ask questions and participate meaningfully in decisions affecting your health.
But informed choice is not as simple as allowing unrestricted access to every substance with potential therapeutic properties.
Some risks are difficult to predict.
Some adverse reactions are so severe that even appropriate counselling and careful monitoring may not prevent harm.
And consumers purchasing medicines without professional guidance may not have the information needed to evaluate those risks.
These are legitimate reasons for regulation.
Nevertheless, I think it is worth asking whether our healthcare systems consistently seek to preserve informed choice wherever reasonably possible.
For example, could certain medicinal substances be made available under more controlled conditions rather than becoming practically inaccessible?
What evidence would be required to demonstrate that such an approach is safe?
And who should participate in those discussions?
Regulators, researchers, medical professionals, herbal practitioners, manufacturers and consumers all bring different perspectives.
None should be exempt from scrutiny.
I don't see informed choice and public safety as opposing principles. I see them as responsibilities that should be considered together.
Are Herbal Medicines Held to a Different Standard?
This is perhaps the broader conversation I find most interesting.
As a naturopath, I am accustomed to seeing herbal medicine described as either entirely safe because it is natural or inherently questionable because it is not pharmaceutical.
Neither position reflects the complexity of the evidence.
Medicinal plants contain pharmacologically active compounds.
They can produce measurable physiological effects, interact with medications and cause adverse reactions.
They should therefore be evaluated seriously.
But conventional medicines also carry risks.
Prescription and over-the-counter medicines may cause allergic reactions, gastrointestinal complications, liver injury and other adverse effects.
Some of these risks are serious.
Yet medicines are not regulated solely according to whether an adverse event is possible.
Their benefits, risks, intended uses, available alternatives and the ability to manage potential harm are all relevant.
This does not mean the risks associated with andrographis are directly comparable to those of any particular pharmaceutical medicine.
Such comparisons require appropriate data, including exposure rates, the severity of adverse events, the strength of evidence for benefit and the clinical context.
But it does raise a reasonable question.
Are the principles used to evaluate benefit, risk and acceptable access applied transparently and consistently across different types of medicine?
I would like to see this question explored more openly.
Not because I believe herbal medicines should receive special treatment.
But because I believe they deserve rigorous, fair and scientifically informed consideration.
The Bigger Conversation About Pharmaceutical Influence
I also want to acknowledge a concern that I know exists among many people who value natural medicine.
There is a perception that conventional pharmaceutical products are more readily accommodated within healthcare systems, while traditional and complementary medicines face increasing restrictions.
It is understandable that decisions like this can reinforce that perception.
I have my own questions about the influence of commercial interests on healthcare, research priorities and the availability of different therapeutic options.
But I think we need to be careful about how we approach these concerns.
The fact that a regulatory decision restricts access to a herbal medicine does not establish that pharmaceutical companies influenced or orchestrated that decision.
In the case of andrographis, the publicly available regulatory documents identify specific safety concerns and explain the TGA's reasoning.
I have not seen evidence establishing that pharmaceutical industry pressure was responsible for the September 2026 decision.
And I would not want to suggest otherwise without evidence.
However, that does not mean broader questions about commercial influence are irrelevant.
Healthcare is not separate from economics.
Research funding, regulatory costs, intellectual property, manufacturing requirements and commercial incentives can all influence which therapeutic products are developed, studied and made available.
These structural factors deserve examination.
In particular, I think we should be asking how traditional medicinal plants can be subjected to appropriate scientific evaluation without creating barriers that only the largest manufacturers can realistically overcome.
That is a different argument from suggesting that an individual safety decision was deliberately designed to suppress herbal medicine.
And, in my view, it is a much more constructive one.
We can question the systems that shape healthcare without making assumptions about motives we cannot substantiate.
Traditional Knowledge Still Deserves a Place
One of the things I value most about herbal medicine is its connection to generations of observation, experience and traditional knowledge.
Across different cultures, medicinal plants have been used long before modern clinical trials or pharmaceutical manufacturing existed.
That history is meaningful.
It has also contributed to scientific investigation and the development of modern therapeutics.
But traditional use does not automatically establish safety or effectiveness.
Historical experience may provide valuable clues, yet it cannot reliably identify every uncommon adverse reaction, particularly one that occurs unpredictably.
Modern pharmacovigilance—the ongoing monitoring of medicine safety—can identify risks that may not have been apparent through traditional use or relatively small clinical studies.
This is not a reason to disregard traditional medicine.
It is a reason to bring traditional knowledge and contemporary scientific evidence into conversation.
I believe herbal medicine is strongest when we are willing to learn from both.
We should be able to recognise the historical and therapeutic value of andrographis while acknowledging that newer safety evidence may change how it should be used.
Likewise, we should be able to accept the need for safety regulation while questioning whether the resulting restrictions are proportionate and whether appropriate pathways for continued access exist.
These positions are not mutually exclusive.
They reflect the kind of critical thinking that responsible healthcare requires.
What Does This Mean for Herbal Practitioners?
For practitioners, the andrographis decision is a reminder that our responsibilities extend beyond selecting herbs based on traditional indications or clinical experience.
We must remain informed about emerging safety evidence, regulatory changes and the limitations of the products we recommend.
We must also be willing to reconsider established practices when new information becomes available.
The NHAA has encouraged members to review relevant protocols, dispensary stock and patient communications, while remaining attentive to product recalls and reporting suspected adverse reactions.
These are important responsibilities.
And although alternative medicinal plants may be available for certain therapeutic purposes, replacing one herb with another is not always straightforward.
Different herbs contain different active compounds, have different safety profiles and may not offer equivalent clinical benefits.
Substitution should therefore be guided by the individual's presentation, relevant evidence and safety considerations.
For consumers, it is equally important to understand that an ingredient's natural origin does not guarantee its safety.
Anyone currently using an andrographis-containing product should check the latest TGA recall information and seek appropriate professional advice.
Products subject to recall should not continue to be used.
And symptoms suggestive of anaphylaxis, such as difficulty breathing, throat swelling or collapse, require immediate emergency medical attention.
Responsible herbal medicine is not about defending every herb at all costs. It is about making informed decisions based on the best available evidence.
Perhaps the Most Important Question Is What Happens Next
I don't think the conversation should end with the removal of andrographis from the listed-medicines framework.
In many ways, I think this is where the most meaningful questions begin.
Will further research help us understand why certain individuals experience severe allergic reactions?
Could future investigations identify relevant risk factors or biological mechanisms?
Will manufacturers pursue registration through alternative regulatory pathways?
And how will regulators evaluate the practical consequences of reduced access?
There is also an opportunity to examine how adverse-event monitoring, clinical research and communication between conventional and complementary healthcare professionals might be improved.
These are areas where collaboration could produce meaningful benefits.
Because the ultimate goal should not be to defend one healthcare philosophy over another.
It should be to improve the quality, safety and accessibility of healthcare.
That requires us to be willing to change our minds when evidence changes.
But it also requires us to remain willing to ask whether our systems are working as well as they could.
Sev's Final Thoughts
When I first read about the andrographis decision, my reaction was one of disappointment.
Not because I dismiss the seriousness of the reported adverse reactions.
But because I recognise the value of medicinal plants, the importance of therapeutic choice and the potential consequences when familiar herbal medicines become less accessible.
As a naturopath, I have a responsibility to place patient safety at the centre of my clinical decisions.
That responsibility is not negotiable.
But neither is my belief in critical thinking.
I don't believe that being evidence-informed means accepting every regulatory decision without question.
Nor do I believe that supporting herbal medicine requires us to reject evidence of harm.
We should be capable of holding both perspectives.
We can respect the TGA's responsibility to protect consumers while examining the reasoning and proportionality of its decisions.
We can acknowledge the therapeutic potential of andrographis while recognising that its safety profile warrants serious concern.
And we can advocate for informed choice without pretending that every risk can be adequately managed through individual decision-making alone.
Perhaps what concerns me most is the possibility of these conversations becoming increasingly polarised.
Natural versus pharmaceutical.
Traditional versus scientific.
Freedom versus safety.
I don't believe these divisions serve patients particularly well.
The future of healthcare should make room for traditional knowledge, contemporary research, responsible regulation and meaningful patient participation.
Because ultimately, protecting public health should not mean abandoning informed choice, just as preserving therapeutic freedom should never mean disregarding evidence of harm.
The challenge is finding a responsible balance between the two.
And I believe that balance is worth continuing to question.
Sevim xx
References
TGA — High-moderate risk changes to permissible ingredients: Andrographis paniculata (2026)
TGA — Andrographis paniculata and anaphylaxis: Updated safety review and supplementary report (2026)
NHAA — Andrographis: TGA Decision and NHAA Member Update (2026)
TGA — Andrographis recalls: Concerns over allergy risk (2026)
TGA — Database of Adverse Event Notifications (DAEN): Understanding adverse-event reports
This article presents my personal reflections as a clinical naturopath and does not represent the official position of the NHAA or any other professional association. It is intended for general education and discussion, not as individual medical advice or a recommendation to use andrographis.
