Ashwagandha concerns branded pure ‘horse s**t’: On-trend herb thrives despite authority unease

The UK Food Standards Agency (FSA) revealed to NutraIngredients that it has logged ashwagandha on its Risk Analysis Tracker​ in order to identify and assess any potential risks the herb may have.  

The news comes as a result of NI's investigation into a report from the National Institute for Public Health and the Environment​ (RIVM, published in March 2024) in the Netherlands advising against the use of the ingredient, based on toxicity and hormone interaction concerns.

Although industry experts from across the globe have criticized the "complete fantasy" of the report, a growing number of governments have been taking a cautious approach to this ingredient. 

"Our risk analysis process helps us to protect consumers by ensuring high standards of food and feed safety are upheld," Steve Adie, head of standards policy from the UK FSA told NutraIngredients.  "At present, the FSA is not considering a ban on ashwagandha, which would be a decision for the Minister to make, however, we do want to find out more about ashwagandha and its use in food supplements.   

"On this basis, we have taken the decision to log it on our Risk Analysis Tracker, so that it can be considered by the Committee on Toxicity. This will help us identify and assess any potential risks the product may have and whether there should be set limits for its use, and this information will help ensure consumer safety."

RIVM Report 

The Netherlands RIVM report, which sparked outcry from experts and industry alike, stated: “Little scientific research has been conducted into the harmful effects of ashwagandha. However, physicians in the Netherlands and other countries have reported cases of poisoning among people who had consumed these supplements. This included harmful effects in the liver.” 

It continued: “In some countries, such as China and India, ashwagandha was used in the past to induce abortion, among other things. It is not known how often this was done or whether ashwagandha is still being used for this purpose. This particular effect of ashwagandha has not been studied. 

“Given that the effects can be serious and may occur even when people use the product as instructed on the packaging, RIVM advises against consuming food supplements that contain ashwagandha. For lack of further information, it is assumed that this conclusion also applies to tea that contains ashwagandha.” 

U.S.-based ethnobotanist Chris Kilham, aka The Medicine Hunter, responded in shock, taking issue with the suggestion that people have taken this ingredient to induce abortion when it has traditionally been used to support fertility.

“This is one hundred percent made up, smoldering horse s**t,” he said. “It is apparent there is some extravagant sloppiness here that has nothing to do with actual health science.” 

He added that if it has been the case that products labelled as ashwagandha have been found to be toxic then this would be due to them containing toxic adulterants—an issue​ which has long plagued the herbals market due to substitution, dilution or improper extraction methods. 

But Kilham said the report does not provide any indication of adulteration analysis.  

“This is a fog of complete misinformation which does not have a basis in science,” he concluded. 

'Relying on research designed to discredit a product' 

Shaheen Majeed, global CEO at Sabinsa, which supplies Shagandha ashwagandha across the globe, agreed that any toxicity issues found in these supplements must have arisen from contaminants.  

"Denmark banning ashwagandha is, in our view, misguided given the lack of legitimate scientific substantiation—but is no surprise,” he told NutraIngredients. "They did the same with curcumin, relying on research designed to discredit a product, while ignoring a vast body of safety data that didn’t support the conclusion they wanted."

Sabinsa has contributed to the growing body of science demonstrating the safety of ashwagandha extract when used as a dietary supplement, he added.

"Given that millions of people worldwide have used ashwagandha for many years, it would have been known long ago if toxicity was a risk," he said. "If you see what’s missing from the research they relied upon and the opaque process used, the appearance of an agenda emerges. The paper omits details on the formulation they studied and doesn’t reveal if the product was tested to identify what else may have been in it besides ashwagandha.  

"If people have been harmed, it’s far more likely that there is a specific product that is adulterated, and that should be the focus of an investigation."

He added: "The real loss is to Danish consumers, who have lost access to a safe and effective herb." 

'They do not understand the concept of adaptogen'

NutraIngredients reported in May last year​ that a number of Nordic countries​ were showing signs of concern after Denmark’s ashwagandha ban resulting from a negative risk assessment by the Technical University of Denmark (DTU).  

The conclusion of the assessment was that the root or extract of the root can have a negative effect on thyroid and sex hormones. Danish authorities then used the EU’s Rapid Alert System for Food and Feed (RASFF)​ to flag dozens of products containing ashwagandha marketed online across multiple countries, judging the breach to be "potentially serious". 

Authorities in the other countries started to take note of this report and questioned if the same action is needed locally, hence the recent report in the Netherlands. 

Industry experts took issue with the studies included in the DTU report, noting they were old and performed on the leaves and stems of the ashwagandha plant, not the root—which have extremely different impacts on the body. 

Tom Johnsson, founder of the Swedish herbal remedies firm MedicineGarden, created to bring KSM-66 ashwagandha to the Swedish market, explained the latest Netherlands health report is based on the flawed DTU report plus a German report from 2013, and it misinterprets findings

"Not even the Danish report could in one single case show negative effect on root," he said. "All conclusions were based on high concentrations of other parts of the plant. But since they could not differentiate between different parts, they concluded that this negative effects also included root, which is wrong.

"What is interesting with the Dutch report is that, when they add new studies, they could not find any adverse events. So what they did was to interpret al changes on immune system, hemoglobin and thyroid as adverse effects, showing that they do not understand the concept of adaptogen. The changes were normalizations, bringing the body to homeostasis."

Johnsson confirmed that the Swedish Food Authority has reassured him that MedicineGarden can continue to supply KSM-66 in the country.  

He further shared a letter sent to suppliers of the ingredient by the Finnish Food Authority in April 2024. It stated that the authority had reviewed the Danish risk assessment and concluded the safety of ashwagandha should be examined more extensively at the community level but, importantly, it assured suppliers that the ingredient, "may continue to be on the market with food business operators responsible for their safety and other legality."

Swedish experts weigh-in

Dr. Stefan Branth, a specialist in internal medicine and clinical nutrition at the Clinic of internal medicine Lindesbergs hospital and University of Uppsala, Sweden, agreed that the Dutch report relies partly on the misleading DTU report and, "contains many methodological flaws and relies on older, often small-scale studies that do not reflect the current scientific landscape".

"Numerous recent studies contradict the conclusions and comments made in the DTU report," he told NutraIngredients. "The Danish report, conducted in 2020 is based on studies up to September 2019, overlooks since then many well-conducted much more reliable new studies and trustworthy reviews, including some meta-analyses, which do not support DTU's conclusions.

"There are several instances in the report where misunderstandings of the data lead to incorrect conclusions and comments. In its current form and content, I doubt that the DTU report would have passed a scientific peer review for publication in a scientific journal."

He concluded the authorities should revisit and re-evaluate their conclusions. 

Professor Åke Nilsson, a retired gastroenterologist/hepatologist and translational medical scientist and teacher at Lund University, Sweden, has also looked into the ingredient from a liver safety point of view.  

His conclusion was that ashwagandha may, very rarely, cause liver disease similar to that which can be caused by popular OTC medicines which are considered safe. Communicating with NutraIngredients, he assured that he saw no reason to ban sales of well-defined formulations of ashwagandha. 

"Such idiosyncratic liver reactions, which may be lethal or require liver transplantation, may be caused by common drugs as ibuprofen, diclofenac and other NSAIDs, paracetamol and antifungal drugs etc., many of which are sold over the counter,” he told NutraIngredients.   

“They may also be caused by herbal medicines, often combinations, and this proportion has increased with increased use of such formulations in Japan, Korea and the West. So, from this perspective, the probably very rare severe idiosyncratic liver reactions on ashwagandha are probably a small part of a larger problem, and I found from a liver perspective no reason to ban sales of well-defined formulations of ashwagandha which have so far not been reported to cause severe liver damage."

Innovation across Europe 

Despite these isolated concerns, ashwagandha continues to attract a lot of commercial and consumer attention. New ashwagadha innovations continue to appear on the UK market, with brain health supplement startup Noggin​ launching the ingredient in a stress supporting capsule named Pause.  

B-Yond Performance​, formally known as CBD performance, also recently extended its range beyond its flagship ingredient to provide new botanical products including a line called Focus, containing ashwagandha, gotu kola, reishi and turmeric to support cognitive function, memory and mood.  

And the athlete and performance nutritionist backed start-up Hibern8​ just launched its sleep supporting drinks range formulated with the extract.     

But it is certainly not only the UK where this ingredient is increasingly inspiring consumers and brands alike. At Vitafoods Geneva this month, several suppliers were showcasing a range of cognitive health focused concepts​ containing the herb, with s​leep health being reiterated​ as a key consumer demand.