After thousands of years as a cornerstone of Ayurvedic medicine, the adaptogenic herb is facing growing regulatory scrutiny over the safety of its bioactive compounds.
European regulators are considering whether it should be subject to an “Article 8” review under EU food law. If initiated, that process could eventually lead to restrictions or even a ban on its use in food supplements across the European Union if the evidence indicates an unacceptable health risk.
But how did ashwagandha, the revered rejuvenator and king of Ayurvedic herbs, become the focus of an increasingly complex debate over safety, evidence and proportionate regulation?
2009: The WHO monograph
In 2009, the World Health Organization published its monograph on ashwagandha, which documented reported historical uses and reviewed literature evidence. It concluded that the herb is a well-established traditional medicinal plant with growing scientific support, particularly for stress adaptation, fatigue and general health maintenance.
As with any botanical, it highlighted that ashwagandha is chemically variable, stressing the importance of authenticated raw materials, purity standards and appropriate chemical assays to ensure consistent quality and safety.
Although it concluded that ashwagandha was generally considered safe, it also documented adverse reactions, contraindications and potential herb–drug interactions, particularly with medications that affect the central nervous system. In addition, it identified “inducing abortion” as one of the plant’s reported uses in traditional medicine.
2013: First major European risk assessment
The German Federal Institute for Risk Assessment (BfR) published a level A risk assessment on the use of certain botanicals in 2013, recommending inclusion of ashwagandha in Article 8 procedure.
This recommendation was based on multiple safety concerns, such as the possibility of undesirable endocrinological effects, apparent documented use as an abortifacient, the absence of toxicological and safety data and the lack of data on safe dosing and exposure.
These were not enacted by EU regulators at the time because there was no consensus on whether and how Article 8 procedures should be conducted among member states.
2016: India approves ashwagandha root
In 2016, the Food Safety and Standards Authority of India (FSSAI) established a dedicated regulatory framework to govern the safety, manufacturing and labeling of health supplements and nutraceuticals, including a positive list of permitted botanical ingredients and approved plant parts.
For ashwagandha, the regulations permitted use of the root and its extracts, a position that would underpin future regulatory actions.
2020: Danish conduct risk assessment
Amid rising consumption of ashwagandha supplements, in 2019 the Danish Veterinary and Food Administration (DVFA) commissioned The Technical University of Denmark (DTU) to conduct a risk assessment and determine whether a safe intake level could be established.
The DTU report, published in 2020, identified studies suggesting possible effects on reproductive function and sex hormones, thyroid function, the immune system, metabolism and the central nervous system.
It concluded that there was insufficient evidence to establish a safe lower intake limit for ashwagandha root or root extracts. Under Denmark’s precautionary approach to food safety, that uncertainty was considered a cause for concern.
In 2020, the Therapeutic Goods Administration (TGA) identified concerns that ashwagandha may have abortifacient effects based on international monographs and evidence of traditional use.
After public and industry stakeholder consultation, a mandatory warning statement (“If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional”) was introduced. The warning did not apply to products that contain 12 grams or less of equivalent dry root from extracts that are only water, ethanol or methanol based, in line with a 2015 reproductive and developmental toxicology study in rats.
2021: Ministry of Ayush advises against leaf
On October 6, 2021, the Ministry of Ayush (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) in India, the world’s primary producer and exporter of the herb, issued an advisory directing drug manufacturers, exporters and sellers to refrain from using ashwagandha leaves in any crude, extract, or product form.
The advisory stated ashwagandha root had been used traditionally and that the Ayurvedic Pharmacopoeia of India defines ashwagandha extract as containing dried mature roots.
But after receiving significant ‘representations’ from Ayurveda, Siddha, and Unani (ASU) Drugs Manufacturing Industry partners and other industry stakeholders, the Ministry announced in November 2021 that it would re-examine the advisory by setting up an Expert Group.
The Expert Group would make appropriate recommendations to the Government of India on the use of ashwagandha leaves based on scientific evidence.
2023: Denmark’s total ban, snowball effect
The 2020 DTU report prompted Denmark to impose a total ban on ashwagandha in food supplements, with the Danish authorities also using the EU’s Rapid Alert System for Food and Feed (RASFF) to notify other Member States about dozens of ashwagandha-containing products marketed online.
This triggered a wave of regulatory scrutiny across Europe, with member states including Sweden, Finland and France initiating their own investigations.
The response was met with criticism from members of industry and experts in botanical, toxicology and public health, who expressed concern that the herb could be restricted across Europe under Article 8 of the Food Supplements Directive.
As authorities scrambled to assess the herb’s safety, industry rallied to reject the DTU report and defend ashwagandha’s safety.
Critics argued that the assessment did not adequately distinguish between roots and other plant parts and misinterpreted study findings, including the apparent conflation of the normalization of sex hormones with damage to sex hormones.
Internationally-reputed ethnobotanist Chris Kilham backed the safety of the ingredient, calling many of the concerns a result of poor monitoring of adulteration.
“Supplements can contain ashwagandha with other agents that may act as irritants, like piperine, and the ashwagandha gets blamed,” he said at the time. “Adulteration also has zero to do with safety of ashwagandha and everything to do with failure to monitor supplements in an intelligent and responsible way.”
2024: Netherlands flags toxicity and interaction concerns
In the spring of 2024, the National Institute for Public Health and the Environment in the Netherlands published its Risk Analysis Tracker, advising against the use of ashwagandha based on toxicity and hormone interaction concerns.
“Little scientific research has been conducted into the harmful effects of ashwagandha,” the report stated. “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 cited the WHO monograph as part of its review of historical data and potential safety risks, including the statement that ashwagandha had been used to induce abortion. Industry stakeholders emphasized that the plant had, in fact, been used traditionally to support fertility.
2024: A special issue to address HoA concerns
Aiming to improve harmonization on botanical safety and regulation in the EU, the Heads of Food Safety Agencies (HoA) in Europe proposed banning or restricting 12 botanicals classified as “critical” ingredients.
“Making food supplements safer is an important component of our daily work to protect the health of citizens in Europe,” said Friedel Cramer, president of the Federal Office for Consumer Protection and Food Safety (BVL). “The working group is making a significant contribution to this by developing the list of critical substances.”
In response to international concerns, the UK’s Food Standards Agency (FSA) launched a call for evidence on the use of the herb in food supplements. The aim was to create an evidence package to be assessed through the FSA’s risk analysis process to decide whether a ban was necessary.
Recognizing the need for scientific clarity, Thomas Brendler, PhD, founder of botanical consultancy Plantaphile, and Professor Jo Barnes of the University of Auckland, New Zealand, issued a call for papers in September 2024 for a special edition of Phytotherapy Research to pool scientific evidence and review safety concerns.
Aswagandha market set to double
Valued at $725 milion in 2024, the global ashwagandha market is expected to grow to roughly $1.4 billion by 2033 at a compound annual growth rate (CAGR) of 8.2%. Over the past 10 years, it has expanded from a niche Ayurvedic herb market into a global wellness category, growing several times in size due to rising demand for natural stress, sleep and immunity supplements.
2025: Reviewing the data
In September 2025, Dr. Brendler discussed initial results of the call for papers during the Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA).
He reported that the data revealed safety and good tolerance with up to 24,000 mg of raw material for up to 52 weeks. Addressing concerns about potential abortifacient effects, he described them as “pure myth with no backing”.
That same month, a scientific review highlighting critical knowledge gaps in ashwagandha’s effects on pregnancy and fertility was published in the journal Phytotherapy Research to analyze all available safety studies on ashwagandha.
Dr. Mark Tallon, managing partner of the food law firm Legal Foods and co-author on the review, said that findings suggested that concerns among some regulators about the use of the herb during pregnancy may stem from older research that has been repeatedly misquoted.
2026: Indian ban announced and stayed
While the industry was busy conducting safety research and keeping its eye on European decisions, India announced a ban on ashwagandha leaf use in any form.
This advisory followed a letter published by the Ministry of Ayush, directing product manufacturers to use root only.
It cited its 2024 ashwagandha safety dossier 2.0 which recommended root use and two studies identifying “possible safety concerns for ashwagandha leaves due to higher concentrations of reactive withanolides, particularly withaferin A.”
But just one month later, the Karnataka High Court in Bangalore announced an interim stay on the prohibition after industry stakeholders—including Sami-Sabinsa Group, K Patel Phyto Extractions, SA Herbal Bioactives, Sakti Naturals, OmniActive Health Technologies, Konark Herbals & HealthCare and Unicorn Natural Products—challenged the rationale behind the blanket ban.
Two further stays were granted by the High Court in Kerala in the following weeks. A total of 16 international and Indian companies petitioned Indian courts, with three separate stays granted.
Petitioners argued that the Government failed to establish that ashwagandha leaves posed a safety concern and overlooked the vast body of scientific evidence demonstrating their safety. They claimed the ban was disproportionate and invalid because the government had wrongly interpreted the regulations as limiting ashwagandha extracts to root only while they contain no such limitation, and that the restrictions unfairly affected business activities and farmers.
Finally, they argued that the government could not legally ban ashwagandha leaf overnight as it would require a formal amendment to the Food Safety and Standards Act, 2006.
Since April, the increased global regulatory activity has also prompted suppliers to form coalitions to promote science-based standards and accurate public communication in defense of ashwagandha—including the Ashwagandha Standards Alliance, which incoporated Sabinsa, Arjuna Naturals and Cepham as founding members, and the Safeguard Ashwagandha initiative led by Kerry Group, which has spearheaded the upcoming meeting at the European Parliament.
