I want to talk to you today about black cohosh — Actaea racemosa — and about what happens when a regulatory system responds to case reports without doing the work of finding out whether those cases actually involved the herb they say they did.
Black cohosh is one of the most widely used herbal remedies for menopausal symptoms in the world. There are clinical trials. There is a substantial evidence base. And there is a legitimate hepatotoxicity concern that has been in the scientific literature for over a decade.
Let me give you the regulators' argument in full, because you deserve to hear it.
The concern.
More than fifty case reports in the medical literature link products labelled as black cohosh to clinically apparent liver injury. That number is not trivial. Some of those cases resulted in acute liver failure. Some required transplantation. Pharmacovigilance systems in multiple countries have flagged this. Regulatory bodies in Europe have reviewed the evidence, and the European Heads of Food Safety Agencies have listed black cohosh on their 2024 priority restriction list.
If you hear that, you might reasonably conclude: black cohosh is dangerous. Stay away.
But here is what you are not being told.
The RUCAM analysis that changes everything.
The international standard for assessing whether a herb caused a liver injury is a scoring tool called RUCAM — the Roussel Uclaf Causality Assessment Method. Scores of 6 to 8 mean probable causality; 9 and above means highly probable. 3 to 5 means possible. 1 to 2 means unlikely. Zero or below means excluded.
Professor Rolf Teschke — one of the world's leading authorities on herb-induced liver injury — applied RUCAM formally to nine of the most credible black cohosh hepatotoxicity case reports available for detailed analysis. He was not trying to exonerate black cohosh. He was applying the standard.
The results: four cases excluded. Four cases unlikely. One case possible. Not one case reached probable. Not one reached highly probable.
In nine formally assessed cases, the evidence for black cohosh as the cause of liver injury was, at best, weak.
And then there are the prospective clinical trials. The HALT trial and related clinical studies assessed authenticated black cohosh preparations in over 1,200 patients. No significant changes in liver enzymes. No clinical liver injury. When you use a known, authenticated preparation in a controlled setting, the hepatotoxicity signal essentially disappears.
So what is going on? How do you get fifty-plus case reports on one side and zero hepatotoxicity signal in the clinical trials on the other?
The adulteration issue — and why this is the real story.
One study examining 33 commercial black cohosh products found that approximately 46% were not authentic Actaea racemosa at all. They were adulterated with Asian Cimicifuga species — Cimicifuga dahurica, Cimicifuga foetida, or Cimicifuga heracleifolia — which have different phytochemical profiles and different safety profiles from authentic black cohosh.
The American Botanical Council has documented this adulteration problem in the herbal supplement industry for years. The raw material supply chain is contaminated with misidentified or deliberately substituted Asian species.
What this means for the case reports is devastating: a substantial proportion of the fifty-plus adverse event reports attributed to black cohosh may not involve black cohosh at all. They may involve unlabelled Asian species that do carry genuine hepatotoxicity risk.
The regulatory response — restricting access to black cohosh — does nothing to address this adulteration problem. It punishes the authentic herb for harms caused by mislabelled substitutes. The answer is authentication standards and supply chain quality control. Not prohibition.
The menopausal context.
The pharmaceutical comparator for black cohosh is hormone replacement therapy. HRT carries documented risks of venous thromboembolism, breast cancer, and stroke. These are well-quantified in large population studies. The benefit-risk balance for HRT is accepted as appropriate, and millions of women use it. No one is proposing to restrict HRT. Yet for black cohosh, fifty case reports — the majority of which, under RUCAM analysis, show unlikely or excluded causality — is sufficient to trigger an EU restriction process.
The standard is not being applied equally.
The information vacuum.
Here is the regulatory trap that nobody is talking about. Black cohosh products cannot legally tell you to seek a practitioner's advice before using them. They cannot tell you that the product should be from authenticated Actaea racemosa. They cannot tell you which populations should avoid it. Food supplement law prohibits this kind of safety information on the label. The information vacuum that creates unsafe and uninformed use is regulatory in origin. Prohibition is not the solution to a problem that labelling reform and practitioner oversight would solve.
The constitutional close.
Sign the petition.
https://www.change.org/p/demand-uk-regain-control-over-food-supplements-regulation?recruiter=1403120945&recruited_by_id=ca366360-0a66-11f1-a119-071922cd5010&utm_source=share_petition&utm_campaign=petition_dashboard&utm_medium=copylink&share_id=Qv72WrhZDN
Respond to the EU consultation. Write to your MP at writetothem.com.
Ask them this: the UK Government has committed to align UK food supplement law with EU food supplement law under the SPS Agreement. That commitment is published at GOV.UK — www.gov.uk/government/news/uk-eu-sps-agreement-legislation-in-scope . Parliament was not asked to vote on this. When these restrictions on black cohosh take effect — and they will, if we do not act — they will become UK law without your elected representatives having approved them.
Demand a parliamentary vote before any EU food supplement restriction is transposed into UK law. That is not a radical demand. That is democracy.
#RightToHeal #HerbalAccessNI #SaveOurSupplements
