Announcing the ban, the country’s Food Safety and Standards Authority (FSSAI) referred to schedule IV of the Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose regulation, which provides the list of plants or botanicals permitted for use in such products.
“In view of the above, all Food Business Operators (FBOs) are hereby advised to ensure strict compliance with the aforementioned provisions,” the notice reads. “Any deviation shall attract action under the Food Safety and Standards Act, 2006 and regulations made thereunder.”
This latest advisory follows a letter published by the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy (Ayush), directing product manufacturers to use root only—not leaf—and requiring that all plants parts used be identified on product labels.
It cites a 2024 updated ashwagandha safety dossier and its reports, which categorically recommends root use for health benefit, as well as two studies shared by the ministry identifying “possible safety concerns for ashwagandha leaves due to higher concentrations of reactive withanolides, particularly withaferin A.”
India is the world’s primary producer and exporter of ashwagandha, controlling the vast majority of the global market.
Considering the root cause
Soon after the April 16 announcement, market-leading ashwagandha root supplier Ixoreal Biomed posted to LinkedIn reassuring its over 4,500 customers that it was “already compliant before the directive existed” and that its KSM-66 Ashwagandha supply would not be disrupted.
“When we created KSM-66, we made one foundational choice: build it from the root alone,” the post reads. “No leaves. No aerial parts. No blends. It was the slower, more traceable path. We took it because we wanted to build something that would stand the rest of time. Last week, it did.”
Kartikeya Baldwa, CEO of Ixoreal Biomed, described the directives as a needed market correction that aligns with milennia of traditional Ayuvedic use and an important outcome for public health globally, not just in India.
“The era of using leaf material or undisclosed whole-plant material under the ashwagandha name, because it is cheaper and more readily available than the root, is over,” he said.
“When India defines what ashwagandha must be at the point of origin, that definition travels with every consignment. In practical terms this means the root-only standard now shapes not just products sold domestically but the raw material feeding finished products on shelves in North America, Europe and dozens of other markets. That is the significance of acting at source rather than waiting for importing countries to act at the retail end.”
He added that, like any company conducting pre-clinical and clinical research, Ixoreal Biomed makes its studies available in peer-reviewed journals.
“If a regulator reviewing the evidence landscape finds our data useful alongside the broader body of scientific literature, that is how science is supposed to work,” he said. “But the ’2024 safety dossier on ashwagandha root’ that underpins this directive was assembled by the government, reviewed by the government and acted upon by the government on public health grounds. A decision that carries this kind of authority needs to belong entirely to the regulator, and it does.”
Dr. Thomas Brendler, founder of consultancy Plantaphile, has been leading a team of experts in a year-long review of the efficacy and safety evidence of ashwagandha from close to 140 clinical trial reports to provide regulators with a well-curated data set to support informed decisions about the future of the adaptogenic herb.
The team’s work includes an evaluation of both leaf and root products as part of a series of publications for a special issue of Phytotherapy Research. According to Dr. Brendler, the research found insufficient evidence to establish causality for ashwagandha in the body of adverse event reports, regardless of the plant part used.
“This is backed up by a favorable clinical safety profile and the fact that all major branded ingredient manufacturers have now published OECD-conforming batteries of toxicological investigations demonstrating absence of toxicity equally for root, leaf or mixed extracts—all facts that I had the opportunity to communicate to the secretary of Ayush, Vaidya Rajesh Kotecha, at the recent International Conference on the Science of Botanicals (ICSB) in Oxford, MS,” he said. “A ban of manufacture and export of leaf and leaf products seems disproportionate, unless it were a politically motivated trade-off to dissuade EU regulators from further scrutiny.”
The Indian government ban sits on an increasingly compressed timeline of mounting pressure on ashwagandha and all its parts due to concern in Europe over signals of liver injury and hormonal, abortifacient and immunological effects.
This led to prohibitions in Denmark in 2023 and subsequent warnings and restrictions in other countries including France, Germany, Poland and Sweden, with a ban currently under consideration in the Netherlands and safety under active review in the UK.
Ashwagandha is also facing a prioritized Article 8 procedure—the European Union’s formal process for restricting or banning substances in reaction to safety concerns. If approved, it could turn the current patchwork into a single Europe-wide endgame ban.
Voicing his disagreement with the Indian government’s root-only directives, Shaheen Majeed, global CEO of ingredient supplier Sabinsa, stated that he does not believe that science was the deciding factor in their issuance.
“Published research supports the safe use of ashwagandha leaves, and if regulators had genuine concerns about withaferin A concentrations, the scientifically sound response would have been to establish acceptable limits for dietary supplement use, not a blanket prohibition. That would have been a meaningful contribution to the field. What was issued instead falls short of that standard, and I think the global ashwagandha industry deserves a more honest conversation about why.”
He added that Sabinsa’s customers are unaffected by the ban as its root-only Shagandha extract is standardized to 2.5% withanolides by HPLC using the USP pharmacopeial method, with withaferin A independently controlled and measured at 0.25%.
Is ashwagandha leaf unsafe?
Regarding the research referenced to substantiate the FSSAI ban, Dr. Brendler said that the publication referenced on toxicity studies was conducted with gold standard and root-only KSM-66 Ashwagandha produced by Ixoreal Biomed but that identical studies show no signs of toxicity for other branded and standardized ingredients. These include Shoden by Arjuna Naturals (root and leaf), Shagandha by Sabinsa (root only), Sensoril by Kerry (root and leaf), Witholytin by Verdure Sciences (root only) and LongeFera by Phytoveda (root only), among others.
“Assertions related to the safety of withaferin A are at best theoretical and largely based on in vitro studies that may not translate to toxicity in vivo after oral consumption,” he added. “In fact, the body of data published on the effects of withaferin A contains a significant number of studies demonstrating protective effects. Looking at the entirety of the available data, vilification of withaferin A appears arbitrary and unfounded.”
For Majeed, withaferin A is not only a variable to be managed for safety but one of the most promising compounds in cancer biology.
“Restricting access to it categorically is a loss for science, not a victory for it,” he said.
Discussing the significantly higher concentrations of withaferin A found in the leaf compared to the root, Baldwa noted that the compound has demonstrated cytotoxic and pro-apoptotic properties in laboratory and animal studies at concentrations achievable through regular supplementation.
“In recent years, case reports and pharmacovigilance signals have begun to associate hepatotoxic effects in human consumers with ashwagandha supplement use, and when those cases are examined carefully, the pattern correlates with products derived from leaf material, whole plant extracts or products where the plant part was simply not disclosed, rather than verified root-only preparations,” he said.
While he does not assert that the leaf will cause liver damage in all consumers, he emphasized that KSM-66 root extract’s safety record across 18 dedicated safety studies and over 70 clinical investigations, covering thousands of participants across diverse populations and durations up to 12 months, does not extend to the leaf.
“When you have a material with the safety record that KSM-66 root extract has established over a decade of rigorous clinical research and you place it alongside a material derived from the same plant whose safety profile is both unstudied at any comparable depth and raising early concern signals, the right answer for public health is not to treat them as interchangeable,” he said. “The Indian regulators recognized that. I believe the rest of the world will reach the same conclusion.”
Natural Remedies, which introduced its Ashwa.30 root extract last year for enhanced energy, endurance and stress resilience, welcomed India’s coordinated directives as formalizing millennia-old Ayurvedic practices. It also stated that the higher level of withaferin A in the leaves “carries a much narrower safety margin than the root.”
“The responsible manufacturers already use only the authenticated root extracts, this is business as usual for them,” said Suresh Lakshmikanthan, PhD, B.Pharm, chief business officer at Natural Remedies. “For everyone else this is a wake-up call to audit their supply chains and ensure they source authenticated root material that meets these new, stringent compliance standards.”
Combining root and leaf extracts
Dr. Mukesh Summan, former FDA toxicologist and current global director of toxicology at Kerry, which supplies the Sensoril-branded leaf and root extract, noted that the ingredient is backed by 15 human clinical trials without any reports of adverse events or safety concerns.
“Kerry uses a standardized root and leaf extract as it allows us to offer a high degree of bioactives at a low dose,” he said. “Ashwagandha leaf also provides additional anti-inflammatory benefits, which are not available in root-only products. Product safety is a non-negotiable for Kerry, and we firmly stand by the clinical and pre-clinical studies attesting to the safety and efficacy of our ashwagandha root and leaf extract.”
Kerry also contributed a paper on the safety of its aqueous root and leaf extract to the Phytotherapy Research special issue, showing that Sensoril is safe up to 4,000 mg/kg/day—equivalent to 19 times the standard dose—during a 90-day mouse trial.
Dr. Summan said the company is actively engaging with Indian regulators and relevant industry stakeholders to provide scientific evidence and seek clarification and a reconsideration of the position on leaf use, particularly since components named as those of concern in the leaf are also present in the root.
“Kerry and many other manufacturers wholly refute the basis for this decision and are appealing it,” he said, noting that discussions must center on evidence-based science or risk setting a poor precedent for regulation.
“Ashwagandha leaf has a long history of use and is cited in classical Ayurvedic texts,” he added. “The conversation around ashwagandha has increasingly been influenced by modern myths and misinformation.”
Arjuna Naturals launched its Shoden-branded root and leaf extract in 2018, backed by a study published in the International Journal of Pharmacy and Pharmaceutical Sciences reporting the ingredient’s strong tolerability and safety profile.
The supplier, headquartered in Kerala on the southwestern coast of India, shared that its rationale for combining root and leaf in its ashwagandha formulations is grounded in a bioactivity-guided fractionation approach rather than a raw-material–driven or commercially convenient selection of plant parts.
“In our internal R&D workflow, the process begins with whole-plant phytochemical mapping and activity screening—not extraction," said Nipen Lavingia, brand innovation advisor at Arjuna Natural. “Multiple fractions derived from different plant parts (root, leaf and their combinations) are systematically evaluated across relevant biological models (e.g., stress modulation, anti-inflammatory pathways, neuroprotection). Only after identifying fractions that demonstrate consistent, mechanism-linked bioactivity do we proceed to optimize extraction and standardization. This establishes proof of concept up front, ensuring that what is being extracted is biologically meaningful—not just chemically abundant."
For Arjuna, restricting formulation to a single plant part of a chemically complex botanical like ashwagandha risks narrowing the therapeutic window—where roots are rich in withanolide glycosides associated with adaptogenic effects and leaves containing compounds like withaferin A that contribute to broader pharmacological activity.
“Arjuna’s philosophy is therefore plant-centric, not part-centric—aiming to capture a synergistic phytochemical matrix that reflects the functional potential of the entire plant, while still maintaining safety and consistency," he added. “In short, the root + leaf strategy is not an arbitrary combination—it is the result of a structured, evidence-led discovery pipeline designed to deliver maximum efficacy from the plant, without compromising safety, by leveraging the full phytochemical intelligence of ashwagandha."
In 2025, the supplier also introduced Shoden-R, a water-soluble root-only version for advanced formulation, with improved organoleptic profiles.
Considering withanolide content and what is at stake
Beyond plant part origin, Sabinsa’s Majeed says that brand owners and formulators should verify how the withanolide content is measured by their supplier, whether the method used is pharmacopeial or proprietary and if results can be reproduced by an independent laboratory.
“This moment should prompt a serious and long-overdue conversation in the ashwagandha category about what standardization actually means and who is being held accountable for it,” he said. “The regulators focused on plant part. The harder question, and the one that more directly affects product quality and consumer safety, is whether what is printed on the label reflects what is in the extract, measured by a method anyone can audit. In our category, transparency is not a differentiator. It should be the baseline.”
A paper included in the special issue of Phytomedicine Research authored by researchers at the National Center for Natural Product Research (NCNPR) in Oxford, MS compares British and U.S. pharmacopeia standards for detecting adulteration and verifying the quality of ashwagandha dietary supplements. It notes that crucially, neither pharmacopeia provides official, standardized analytical methods for evaluating blends of root and leaf materials.
“The post-COVID surge in adaptogens, such as ashwagandha, underscores the urgency of these issues,” the researchers wrote. “The commercial use of aerial parts—despite traditional root-only use and phytochemical variability—raises concerns about quality and safety. The situation necessitates rigorous source verification and re-evaluation of current pharmacopeial methods.”
This aligns with the American Botanical Council’s Laboratory Guidance Document (LGD) on the authentication and detection of adulteration of ashwagandha root and root extracts published last October.
“While sales of ashwagandha continue to grow, there have been reports that undeclared ashwagandha aerial parts (plant leaves and stems) have been added to root powders or root extracts, even when certificates of analysis and finished herbal product labels claimed the contents were root material only,” the council shared in accompanying the guidance document.
“The aerial parts are available at a lower cost and contain some of the same phytochemical compounds (notably, withanolides) as the roots. This makes test methods intended to authenticate ingredients based solely on the presence of withanolides inadequate and unsuitable to detect adulteration of ashwagandha root with undisclosed aerial parts.”
Mark Blumenthal, founder and executive director of ABC and founder of the Botanical Adulterants Prevention Program (BAPP), emphasized that products properly labeled to contain ashwagandha leaf would not be considered adulterated or misbranded but rather that adulteration and fraud occur when lower-cost ingredients are added to a product and intentionally concealed by the seller for unfair economic gain.
The NCNPR analysis revealed substantial variations in steroidal lactone (withaferin A, withanolide A and withanoside IV) content in ashwagandha samples and commercial products evaluated. In response, the paper called for the development of “robust analytical methods and revisiting existing pharmacopeial guidelines for assessing the quality and safety of ashwagandha products, including novel formulations.”
Majeed also said that more broadly the FSSAI regulation requires reflection on the “predictable, immediate and severe” consequences and “deserved far more scientific and economic deliberation than it appears to have received.”
“Consider what is actually at stake,” he said. “Approximately 25,000 acres in India are dedicated to ashwagandha cultivation annually, producing an estimated 5,000 metric tons of roots and 7,500 metric tons of aerial parts. Roughly 20,000 farmers and 80,000 of their family members depend on that cultivation directly, and when you account for workers across the full supply chain, processing, manufacturing and marketing, the total number of people whose livelihoods connect to this plant may be as high as 250,000 to 300,000.”
As such, he highlights that restricting use to the root affects not only a product category but decreases rural employment, reduces what farmers can harvest and sell from their land, undermines land-use efficiency and ultimately cuts into household income for some of India’s most economically vulnerable agricultural communities.
