Used for centuries in Asian cultures and Indian traditional medicine systems, the roots of the ashwagandha plant are today recognised in pharmacopoeias and authoritative compendiums the world over for their remarkable therapeutic benefits.

Despite the botanical’s widespread renown, alongside a vast tranche of scientific studies demonstrating its safety, in May 2020 the Danish Food Authorities issued a risk assessment of ashwagandha, recommending against its use due to purported abortifacient activity. Some other European countries have followed, calling for independent risk assessments on its safety when used in pregnancy. Recently, the Danish Veterinary and Food Administration (DVFA) took the decision to ban ashwagandha. However, the report (by the Technology University of Denmark, DTU) upon which the organisation’s concerns were based has been lambasted by numerous scientific researchers and industry players, who further note the substantial body of evidence supporting the root extract’s safety for consumption.

DTU report is “contradictory”, “inconsistent”, and features “irrelevant” studies

One such researcher is Bhushan Patwardhan, who writes in the Journal of Ayurveda and Integrative Medicine that the DTU report “does not seem to be peer-reviewed”, further noting: “the credentials of the authors, funding sources, and conflict of interests are not disclosed”. Patwardhan criticises the English version of the report “for being contradictory”. Somewhat compellingly, he also asserts that while the DVFA’s mandate for the DTU assessment was to focus on ashwagandha roots, the resultant report actually “draws conclusions from studies on whole plants, stems, leaves, fruits/berries clearly irrelevant to this case”. Patwardhan further opines that the DTU report is “far from a critical review or analysis, and inconsistent with the methodology commonly practiced in food and pharmaceutical sciences, making it substandard and misleading”.1

Likewise, Tom Johnsson, founder of Sweden-based herbal remedies company MedicineGarden, says the “flawed” Danish report could not – in even one case – demonstrate a negative effect from consumption of the root. “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 these negative effects also included the root, which is wrong,” he advised.

‘Citation distortion’ and monograph misrepresentation

The American Herbal Pharmacopoeia (AHP) has also weighed in on the ashwagandha safety issue.

Interestingly, the AHP claims its monograph was the source reference of the Danish authorities’ assessment on the herb, but says its own document was misrepresented. It claims the Danish authorities cited an ashwagandha monograph of the World Health Organization (WHO) (2009) – one that, in turn, cited the AHP’s own ‘Ashwagandha Root Monograph and Therapeutic Compendium (2000)’. Yet the WHO monograph – in an example of what is known in medical literature as ‘citation distortion’ – did not fully articulate the AHP review.

Accordingly, the AHP claims that misrepresentation of its monograph is “repeatedly uncritically resulting in the misconception that ashwagandha root is potentially unsafe”.

“While adequate caution when using any substance during pregnancy is warranted, based on a critical and comprehensive review of the traditional and modern literature, as well as the opinion of the majority of experts, there is no evidence of an abortifacient effect of ashwagandha root,” the AHP concludes.

There have also been contradictory reports on hepatotoxicity, thyroid toxicity, and sex hormones regarding ashwagandha use. Nonetheless, multiple clinical studies have been conducted to evaluate the safety of ashwagandha root extract, and no significant alterations or irregularities were detected in several health indices and biochemical parameters, including critical safety metrics, such as liver, kidney, and thyroid
functions. Furthermore, changes in hormonal levels were reported as well within the normal reference ranges.

Indeed, as scientists at best-selling branded botanical KSM-66 note: “Numerous safety studies consistently demonstrate that standardised ashwagandha (Withania somnifera) root extract is safe for human consumption. The scientific data reveals that
ashwagandha root is well-tolerated across a wide range of doses, with no adverse outcomes reported in diverse demographic and clinical cohorts.”

Extensive dossiers support safe use of KSM-66

KSM-66 Ashwagandha recently issued a dossier presenting a comprehensive overview of the safety and efficacy profile of its leading organic ashwagandha root extract, and particularly regarding its effect on liver health, thyroid health, reproductive health, pregnancy, and sex hormones.3

The dossier serves to bring all current evidence-based knowledge surrounding the herb to the attention of academics, researchers, healthcare providers, consumers, and policymakers, thus enabling them to make informed decisions that prioritise safety while recognising the potential benefits of KSM-66 within today's health landscape.

The numerous toxicological and preclinical studies (both in vitro and in vivo) detailed throughout the report serve to significantly support such objectives, as do a vast ream of published clinical studies focused on the safety of ashwagandha root extract, with many more currently under peer review.

The Government of India’s Ministry of AYUSH also released a Safety Dossier earlier this year, noting “the lack of abortifacient activity of ashwagandha root”, and citing all clinical and pre-clinical data that have investigated the use of ashwagandha and its preparations in pregnancy.

KSM-66: Marketed and trusted by major brands worldwide

The outcome of more than 14 years of R&D and on the market for just over 11 years, KSM-66 can today be found in 52 markets globally, and more than 3,000 products, including those of major brands Pfizer, Walmart, Mars, Nature’s Bounty, GNC, GSK, CVS, Nestle, Unilever, and Bayer.

In the last three years alone, over four billion doses of KSM-66 Ashwagandha have been sold worldwide, with no report of adverse events associated with the branded botanical’s usage.

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