“There are two ways to be deceived: one consists in believing in what is not true, and the other in refusing to believe what is true.” - Søren Kierkegaard, Danish philosopher
The ban on Ashwagandha by Denmark invites scientific scrutiny as this decision may have far reaching consequences. Therefore, as a scientific journal, it is our duty to take its due cognizance.
Ashwagandha, botanically classified as Withania somnifera (L.) Dunal, Family Solanaceae, is also known as Indian ginseng or winter cherry. Ashwagandha roots have been used for centuries in Asian cultures and Indian traditional medicine systems, including Ayurveda, Siddha, Unani, and Sowa Rigpa. It is widely known for its health benefits and has attracted more attention during COVID-19 pandemic. It is readily available as a dietary supplement in many countries. It is recognized in several pharmacopoeia and authoritative compendiums worldwide, such as the Ayurvedic Pharmacopoeia of India, Indian Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia, American Herbal Pharmacopoeia, Japanese Pharmacopoeia, Pharmacopoeia of the People's Republic of China, and the World Health Organization's Monographs. Despite its widespread global recognition, the Danish Veterinary and Food Administration (DVFA) decided to ban Ashwagandha based on a 2020 report by the Technology University of Denmark (DTU).
1. Concerns with the DTU report
The DTU report has several technical, scientific, and ethical pitfalls. This report does not seem to be peer-reviewed, the credentials of the authors, funding sources, and conflict of interests are not disclosed. The English version of the DTU report is a bit unusual. The reasoning is hardly convincing, in fact, it contradicts itself at several points. The DTU report on Ashwagandha discusses its ingredients, general toxicity, effects on sex hormones and reproduction, metabolism, immune system, and central nervous system. Unfortunately, the report refers to a few articles from predatory journals in its sketchy literature review. Although the mandate from DVFA is on Ashwagandha roots, it draws conclusions from studies on whole plants, stems, leaves, fruits/berries clearly irrelevant to this case. Generally, 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.
It is not clear what prompted the DVFA to commission this report to the DTU. The report lacks systematic evidence synthesis to support the decision to ban Ashwagandha. Some of the serious gaps in DTU report have been critically discussed in the context of chemistry and biological effects of Ashwagandha [1]. Generally, the conclusions drawn by the DTU report are far from truth, rather closer to deception.
The DTU report has not considered several clinical studies including those demonstrating female fertility promotion and the absence of mutagenecity or genotoxicity [2]. A 2018 systematic review has reported that Ashwagandha roots enhance spermatogenesis and improve sperm-related indices [3]. The DTU report cites an ethnobotanical survey and pre-clinical animal studies to claim abortifacient effects in humans [4]. However, the ethnobotanical survey has been challenged and disproved by subsequent research reporting no evidence of maternal or fetal toxicity even from high doses of Ashwagandha root extract [5]. Also, traditional use, clinical studies, and pharmacovigilance data do not support these claims regarding abortifacient effects. Agreeably, a few sporadic reports have raised concerns about possible adverse events related to liver, thyroid, and gastrointestinal system. However, no conclusive causal relation with Ashwagandha has been established [6,7]. In addition, several studies have reported no observed adverse effect level (NOAEL) for Ashwagandha roots even at high doses. Ashwagandha is traditionally used only as root powder 3–5 gm per day or equivalent aqueous or hydro-ethanolic extracts. Despite numerous studies showing feto-maternal safety of Ashwagandha root, it is not known why the DTU report has cited poorly conducted studies, that too on methanol and other solvent extracts, and ignored scholarly scientific literature. Claims regarding hormonal, reproductive, immunological, and neurological risks pointed out in the DTU report are similarly flawed.
2. DVFA's ban on Ashwagandha
The DVFA's official website states: “Do not eat Ashwagandha or supplements containing Ashwagandha because its root has negative effects on sex hormones and reproduction for both men and women. In addition, the plant can affect the metabolism, the immune system, and the central nervous system.” Having researched and used Ashwagandha for over three decades, we find that the statement is far from truth.
The DTU report fails on scientific and ethical aspects. Regulatory agencies, especially in the food and drug domains, typically have stringent procedures for approving substances/products for health benefits. The DVFA should have followed a similar stringent procedure for banning Ashwagandha. However, this is not the case.
3. Flawed report, flawed decisions
The primary reference for the DTU report's conclusion regarding abortifacient effects is the World Health Organization's (WHO) Monograph on Selected Medicinal Plants on Ashwagandha (2009) that in turn refers to the American Herbal Pharmacopoeia (AHP) Ashwagandha Root Monograph and Therapeutic Compendium (2000). However, this reference chain perpetuates citation distortion. The report does not correctly interpret the AHP monograph in claiming abortifacient effect; rather, the monograph highlights Ashwagandha's traditional use to prevent miscarriage and stabilize pregnancies. The AHP editor has issued a clarification that defeats the DTU report's foundation [8].
The American Herbal Products Association's Botanical Safety Handbook (BSH) affirmed the reproductive safety of Ashwagandha in 2022 and reclassified its safety Class from 2d to 1 based on new studies. BSH Class 1 signifies that a plant is considered safe when used appropriately. It is generally well-tolerated and suitable for use in herbal products or remedies.
The DTU report and its findings are contradictory to the scientific literature that has emerged over the past few decades. PubMed search for Ashwagandha yields over 1100 papers published during 2013–2024 (as on June 2024), which indicates growing interest in Ashwagandha and its health and well-being potential. It must be noted that no clinical trials in the last ten years have reported any serious adverse events associated with Ashwagandha roots. More than 500 scientific papers have been published on the safety and activity of Ashwagandha since the DTU report of 2020. This new body of evidence shows that the DTU report is redundant, irrational and calls for its update.
4. International perspectives
Outlooks on safety and use of Ashwagandha vary globally. For instance, Ashwagandha root use is permitted as a food or dietary supplement in the United States of America and the United Kingdom. The American National Center for Complementary and Integrative Health of the National Institutes of Health informs of the safety of Ashwagandha for short-term use. The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK has permitted the ongoing APRIL Trial which is a randomized, placebo-controlled trial using Ashwagandha led by researchers at the London School of Hygiene & Tropical Medicine, UK, and the All India Institute of Ayurveda, India. About 320 medicines listed in the Australian Register of Therapeutic Goods (ARTG) include Ashwagandha.
Several European and Scandinavian countries also have taken a balanced approach. For instance, Poland allows the use of Ashwagandha roots but not leaves or other parts. It further specifies that the content of withanoloids should be less than 10mg in the daily portion of the product. Germany has expressed concerns about Ashwagandha probably based on the DTU report; however, it continues to be available there. Sweden permits local authorities to take decisions on such matters rather than depriving people of its health benefits. These decisions are rational, scientific, and in the public interest. However, Denmark seems to have overlooked these facts.
We are afraid that the DTU report might influence the decisions of some countries in this regard. It is necessary to undertake a systematic situation analysis on the status of Ashwagandha in different countries. In this context, the Ministry of AYUSH, Government of India has released a Ashwagandha Safety Dossier 2024. This dossier synthesizes data and presents robust scientific evidence on safety and efficacy of Ashwagandha roots.
5. Risk-benefit analysis
The DTU report is titled "Risk assessment of the root of Withania somnifera." A ′risk assessment' approach is typically used for environmental or occupational hazards, whereas for pharmacological purposes, a 'safety assessment' that includes toxicity and ‘risk-benefit analysis’ are more appropriate. Ashwagandha is known as Rasayana, which means beneficial for rejuvenation, immunomodulation, and longevity. Substantial scientific evidence supports the benefits of Ashwagandha in inflammation, stress, cancer, neurodegeneration, musculoskeletal diseases, and healthy aging [9,10].
The DTU report entirely ignores the 'benefit' component, raising serious questions about its conclusions. Most drugs have some adverse effects but are used based on risk-benefit assessments. For example, toxic drugs like Taxol are used in cancer treatment because their benefits outweigh the risks. Proper health advice along with essential information consisting precautions, contraindications, and dosage of Ashwagandha will help maximize its therapeutic benefits. Banning Ashwagandha roots based on the data on the toxicity of leaves or berries is akin to banning apples because their seeds contain amygdalin which is a precursor to cyanide.
6. Responsible regulatory mechanisms
There is no denying that regulators must be careful about the safety and quality of any product for human consumption. However, for this purpose, robust mechanisms are necessary. Decision-making must be based on scientific evidence and not influenced by political, economic, or other factors. The DVFA is a responsible regulatory agency from a progressive country like Denmark. The DVFA decision could have cascading consequences, potentially extending beyond the ambit of science and regulation into geopolitics or economics.
The case of the ban on Ashwagandha underscores the importance of transparency in evidence-based regulations. A prestigious institution like DTU should have exercised greater caution in preparing this report, given its potential impact on public health. The DVFA should reconsider the ban in the light of the extensive scientific literature supporting safety and efficacy of Ashwagandha roots. This incidence invokes the value of truth in Kierkegaardian words of wisdom!
India's rich heritage of traditional medicine offers the potential for planetary well-being in the spirit of Vasudhaiva Kutumbakam, the world as one family. Scientific exploration, guided by ethics and international collaboration, should serve a higher purpose – a world where advancements promote solidarity, and harmony. As the Vedas teach us, ‘Sarve Santu Niramaya - Sarve Bhavantu Sukhinah’ – let everyone be free from illness and find peace and happiness. This is the true purpose of science. Scientific community shall collaborate for the pursuit of a healthier, and happier world.
Funding sources
No funding was received for this work.
Conflicts of interest
BP, GT, and SC are involved in research on Ashwagandha. BP is a National Research Professor-Ayush, which is a non remunerative honorary position and GT has an honorary association with the World Ashwagandha Council (a non-profit academic platform for research and propagation of Ashwagandha). SD, and BMH declare no conflicts of interest.
Author contributions
BP conceptualized and wrote the first draft with SC. BP, GT, SC together revised the draft with inputs from SD and BMH. All authors reviewed and approved the final draft.
Declaration of Generative AI and AI-assisted technologies in the writing process
The authors did not use generative AI for drafting the manuscript.
Acknowledgements
The authors thank Darshan Shankar for the review and Roy Upton for useful documents.
Footnotes
Peer review under responsibility of Transdisciplinary University, Bangalore.
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