Ashwagandha is one of the most researched adaptogens in herbal medicine. It is used across the world for stress, fatigue, hormonal balance, and cognitive support. It has been a cornerstone of Ayurvedic medicine for over three thousand years. And it is now on a list of 117 substances flagged by European food safety regulators for prohibition or restriction in food supplements. I want to be clear with you about why that's happened — because if I dismiss the regulatory concern entirely, I lose credibility, and so does this campaign.
The concern — stated fairly.
There are published case reports — approximately 25 to 50 worldwide, depending on how you count them across different registries — linking ashwagandha supplementation to liver injury. That includes cases drawn from pharmacovigilance databases in the United States, the Netherlands, India, and elsewhere. Multiple independent systems in multiple countries have flagged this signal. That is not nothing. I am not here to tell you there is no safety concern with ashwagandha. There is a genuine signal, and responsible practitioners take it seriously.
Some of those cases have been severe. A small number have required liver transplantation, and there are rare reports of fatalities. When you read that, it sounds alarming. But the detail matters enormously here, and regulators are not providing that detail to the public.
The clinical distinction.
When the severity cases are examined carefully, virtually all of them occurred in patients who had pre-existing liver disease — particularly cirrhosis. The mechanism in those cases is a different clinical picture from someone with a healthy liver taking ashwagandha at a standard supplement dose. The NIH's own LiverTox database — which is about as authoritative as it gets — makes this clear in its December 2024 update. The majority of published case reports have been formally scored using RUCAM — the Roussel Uclaf Causality Assessment Method — which is the international gold standard for assessing whether a herb actually caused the liver injury. RUCAM scores range from excluded to highly probable. Across the published literature, ashwagandha case reports score in the possible to probable range. No published case in the peer-reviewed literature carries a RUCAM score of highly probable. That doesn't mean the herb is innocent — possible and probable causality is still causality. But it means the signal is weaker than the regulatory response implies.
And here is what the regulators have not told you. There are confounders in many of these case reports that haven't been adequately excluded. A significant proportion involve Ayurvedic formulations that may carry heavy metal contamination — arsenic, mercury, lead — that are themselves hepatotoxic. Many cases involved people taking multiple other medications whose liver toxicity hadn't been fully ruled out. Most reports involve concentrated, withanolide-standardised root extracts — not the traditional whole-root preparations that herbalists like me actually use.
The reproductive concern and the DTU problem.
The EU-level concern was partly triggered by a Danish risk assessment from the Technical University of Denmark that flagged ashwagandha as a potential abortifacient — something that causes miscarriage. That's a frightening claim. But here is what you are not being told: the DTU report based that concern on animal studies at doses far exceeding anything a human would take, and on an ethnobotanical survey of traditional use. The peer-reviewed scientific literature has since published a specific critique of that methodology — the leap from animal reproductive toxicity data to human abortifacient risk is not supported by direct clinical evidence.
Appropriate clinical guidance is: avoid ashwagandha in pregnancy. That is different from banning it entirely.
The proportionality argument.
Let me put those 25 to 50 case reports in context. The global ashwagandha supplement market is valued at between USD 693 million and USD 778 million annually. Tens of millions of individual doses are consumed every year. Against that consumption volume, we are talking about a case count you can count on the fingers of both hands, sometimes twice.
Now let me tell you about paracetamol — which you can buy in any supermarket in any quantity, without a prescription, without any consultation, without any safety screening. Paracetamol is responsible for approximately 56% of severe acute liver injury cases presenting to specialist liver units in this country. There are approximately 47,500 accident and emergency attendances every year in England for paracetamol overdose. Paracetamol can and does kill people. It is not under restriction. It is not on a list of 117 dangerous substances.
I am not saying paracetamol should be banned. What I am saying is: apply the same standard. The regulatory response to ashwagandha's safety signal — which is real but small — is disproportionate to the level of threat it represents when measured against substances that are freely available without any oversight at all.
What a proportionate response looks like.
A practitioner-supervised framework for ashwagandha achieves everything legitimate safety concern requires. Baseline liver function assessment for patients with pre-existing liver disease. Avoidance in pregnancy and concurrent hepatotoxic medication regimens. Prompt cessation and monitoring if symptoms arise. This is what I do in clinical practice. This is what the evidence supports. It does not require removing ashwagandha from the shelves of every health food store in Europe. One more thing regulators won't tell you.
Food supplement labels cannot legally tell you what a safe dose is. They cannot tell you what interactions to watch for. They cannot tell you who should avoid the product. That is prohibited under food law. So the regulatory system has created a situation where you cannot legally provide the information that would make safe use possible — and then cites unsafe use as the justification for prohibition. The information vacuum is regulatory in origin. The answer is better labelling law and practitioner oversight — not prohibition.
The constitutional close.
Here is what I need you to do. And I need you to understand why it matters constitutionally, not just practically.
The UK Government signed a commitment to align UK food supplement law with EU food supplement law as part of the SPS — Sanitary and Phytosanitary — Agreement with the European Union. That commitment was published on GOV.UK. There was no parliamentary vote. Parliament was not asked. Your elected representatives did not approve this change.
That means that EU decisions about ashwagandha — decisions made by European food safety agencies, applying European risk assessments, including the flawed DTU reproductive toxicity assessment — will become UK law without your MPs ever having had a say. This is the fight. Not just for ashwagandha. For the constitutional principle that Parliament votes on laws that affect you.
Sign the petition — link below. Respond to the EU public consultation — link below. Write to your MP at writetothem.com. Ask them directly: did you know food supplements are in scope of the SPS alignment agreement? What parliamentary scrutiny is planned before these restrictions take effect? Share this page: www.gov.uk/government/news/uk-eu-sps-agreement-legislation-in-scope
#RightToHeal #HerbalAccessNI #SaveOurSupplements
