Takeaways: Debate on Ashwagandha Leaf Ban
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Updated May 8, 2026, at 9:32 a.m. EDT: This article was updated with additional comments and industry perspectives.
In April, Indian regulatory authorities with India’s Ministry of Ayush and the Food Safety and Standards Authority of India (FSSAI) issued directives on the use of ashwagandha leaves in supplements and food products, permitting only the root and root extracts of ashwagandha (Withania somnifera), which is one of the most widely used botanicals in global dietary supplements. The Government of India's move to restrict ashwagandha to root-only use is being hailed by some as a long-overdue step toward transparency and safety, while others contend it ignores a growing body of research supporting the responsible use of leaf-containing extracts. At the center of the debate: questions around withaferin-A safety, analytical standards, and whether the real issue is adulteration and not plant part. While proponents frame the directive as a necessary correction, others argue it oversimplifies a far more nuanced scientific and quality discussion. Ashwagandha ingredient suppliers on both sides of the issue weigh in.
The Case for Root-Only
Proponents Cheer a Return to Tradition
The root of Withania somnifera is traditionally used in Ayurveda, and the Ministry of Ayush has emphasized the safety of root-based ashwagandha when used as directed, with much of the existing clinical research focused on root extracts. Studies have explored its role in stress, immune support, and general well-being, contributing to its long-standing use in traditional and modern applications.
“The coordinated directives send a clear signal that Ashwagandha’s regulatory future is rooted, literally, in the root," says Suresh Lakshmikanthan, Ph.D., B.Pharm, Chief Business Officer, Natural Remedies, which offers the root-only branded ingredient Ashwa.30. "By banning leaf-based extracts often used as low-cost 'fillers' to artificially spike withanolide counts, regulators are forcing a long-overdue shift toward transparency and consumer safety."
Dr. Lakshmikanthan adds that, in his view, this aligns with what traditional Ayurveda has practiced for millennia: "The root is the good part, not the leaf." Leaves contain higher levels of Withaferin-A, which Dr. Lakshmikanthan says raises a concern. "This ban isn’t just about safety; it’s about transparency and doing the right thing. Using leaves as a low-cost 'filler' to spike withanolide counts has misled consumers.”
Ixoreal, maker of the root-only branded ingredient KSM-66 Ashwagandha, also emphasized in communications around the directive that it supports the ban. The company has worked to educate on key differences of ashwagandha extracts, stressing that "root only extraction of ashwagandha adheres to thousands of years of traditional usage, and modern clinical validation, delivering what matters: potency and purity."
The Case for Leaves
Opponents Offer a Scientific Critique
"From an operational perspective, Sabinsa and its partners are not affected by these changes," says Shaheen Majeed, Global CEO and Managing Director, Sabinsa. "Our Shagandha extract has always been produced exclusively from roots and standardized to 2.5% withanolides using a USP-aligned HPLC method. Withaferin-A is carefully controlled at 0.25%, and all results can be independently verified. These advisories do not alter our sourcing, production, or supply commitments. However, we have profound concerns about both the ban and the process used to decide upon it."
Notably, though Sabinsa itself produces root-only extracts, the company opposes the regulatory approach behind the ban. A key issue, according to Majeed: "Given the body of published research supporting the safe use of ashwagandha leaves, this ban does not make sense. It doesn’t appear that these directives were grounded in a full and objective assessment of the science. If regulators were concerned about Withaferin-A levels, a more appropriate response would have been to define clear, evidence-based limits for dietary supplement use rather than impose an outright ban, which has far-reaching and harmful implications. That kind of framework would have strengthened the category. What has been issued instead does not reflect that level of scientific rigor, and it raises legitimate questions about the underlying rationale."
Also stating that the directive is misguided, Nipen Lavingia, Brand Innovation Advisor at Arjuna Natural, which offers Shoden ashwagandha root and leaf extract, maintains: "The directive is not supported by the science, and we want to be direct about that. The safety signals cited in support of the directive are largely drawn from in vitro work on isolated withaferin-A and from a toxicity study on a single root-only branded ingredient. Comparable studies on standardized root-and-leaf extracts, including Shoden, have not shown the same findings. Generalizing from one ingredient’s toxicology to an entire class of preparations is not a defensible scientific position."
Assertions about withaferin-A toxicity are viewed by some stakeholders, including Lavingia, as largely theoretical and based on in vitro data. Lavingia says such assertions do not reliably translate to oral consumption in humans, "and a substantial body of published research actually points to protective effects."
Lavingia contends that if a regulator had genuine concerns about specific constituents, the appropriate response would be to establish withaferin-A specifications and dose limits, which is the path global regulators take when a constituent warrants oversight. "A blanket prohibition is not that. It removes legitimate, well-characterized ingredients from the market while doing little to address the underlying problem the directive appears to be reacting to."
Economic & Supply Chain Impact
"The implications extend well beyond regulatory policy," Majeed stresses. He says the impacts are immediate and measurable: "Ashwagandha cultivation in India spans roughly 25,000 acres annually, with production of about 5,000 metric tons of roots and 7,500 metric tons of aerial parts. An estimated 20,000 farmers rely directly on this crop, along with approximately 80,000 family members. When the full value chain is considered, including processing and manufacturing, the number of people whose livelihoods depend on ashwagandha may approach 300,000. Aerial biomass represents a significant portion of what is produced per acre. Limiting use to roots effectively reduces what farmers can bring to market, lowers overall productivity of the land, and places added strain on already vulnerable rural economies. These are immediate, measurable impacts, and policies with this level of consequence should be supported by equally robust scientific and economic justification, which they are not."
There is also a historical dimension that should not be overlooked, Majeed continues. "Ashwagandha has been cultivated and used in the United States for decades by health-focused communities, long before its current global prominence. For much of that period, India was not actively shaping the international narrative around the ingredient. As the market has expanded, the regulatory approach has shifted in ways that are difficult to explain based on science alone. In 2021, my father, Sabinsa founder Dr. Muhammed Majeed, challenged a comparable restriction and was able to preserve a more science-based outcome. That precedent is worth revisiting. Withaferin-A should not be viewed solely as a compound to restrict; it is an area of active scientific interest, including in oncology research. Broad limitations on access may ultimately slow progress rather than protect consumers."
The Transparency Gap in Testing
This situation highlights a persistent issue within the category, Majeed adds. "Withanolide content is frequently used as a marketing benchmark, often with increasingly high claims, yet the analytical methods used to generate those figures are rarely disclosed and seldom reproducible. Without methodological transparency, a percentage has limited value. Pharmacopeial methods, such as the USP HPLC monograph Sabinsa follows, are publicly defined and can be validated by any qualified laboratory. In contrast, proprietary methods lack that level of scrutiny. If results cannot be independently confirmed, they should not be treated as meaningful specifications."
Adulteration vs. Formulation
Is the Problem the Ashwagandha Plant—or the Label?
Despite their disagreements, stakeholders on both sides point to a shared underlying issue: Transparency is essential.
At a dedicated session on ashwagandha held alongside the WHO Global Traditional Medicine Summit in December 2025, participants discussed scientific validation, safety assessment, and quality standardization necessary for ashwagandha's responsible global adoption. At that event, Roy Upton, of the American Herbal Pharmacopoeia, stressed that overcoming Western skepticism requires addressing quality concerns, particularly leaf adulteration, which remains an industry challenge requiring rigorous identification and quality control standards.
Majeed stresses: "At a minimum, this moment should prompt a more serious discussion about what constitutes credible standardization in the ashwagandha market. While current attention is focused on plant part, the more consequential issue for quality and consumer confidence is whether labeled claims are accurate and supported by validated testing. Transparency in both methodology and reporting should be expected across the category, not positioned as a point of differentiation."
The underlying problem is real, Lavingia says, but it has been mischaracterized. "Leaf material introduced, undisclosed, into products marketed as root-only is an adulteration and labeling issue, and it deserves regulatory attention. That is not the same as the deliberate, transparent, clinically studied use of leaf in a standardized extract like Shoden, where plant parts are disclosed, characterized, and reproducible batch to batch. The directive has conflated the two and produced a regulatory response aimed at the wrong target."
Lavingia says a properly designed root-and-leaf extract is not a root extract with leaf added for cost. "In Shoden’s case, the combination was selected through bioactivity-guided fractionation—the plant parts were chosen because the resulting phytochemical matrix delivered the clinical effect. Shoden has a documented safety and tolerability record, with published human studies showing significant reductions in stress, anxiety, and cortisol at low daily doses. It is approved by Health Canada as a Natural Health Product, with permitted claims for sleep, stress, cortisol, and male testosterone support. Its safety profile is not theoretical—it is peer-reviewed and reproducible."
What This Means for the North American Industry
For the North American market, viewpoints diverge, but a main issue is that quality and transparency are key.
"The responsible manufacturers already use only the authenticated root extracts; this is business as usual for them," says Dr. Lakshmikanthan. "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."
Lavingia offers another view: "First, this is an India-only directive. It does not change the legal or regulatory status of ashwagandha root-and-leaf extracts in the United States, Canada, the EU, or other markets where Shoden is sold. Arjuna’s supply of Shoden to North American customers is uninterrupted and fully compliant with applicable regulations in those markets. Brands currently using Shoden do not need to reformulate, relabel, or adjust their supply plans. Second, the conversation the industry needs to have is not root versus leaf. It is standardized versus unstandardized, characterized versus uncharacterized, transparency versus non-transparency. Ashwagandha’s success has attracted both serious science and opportunistic supply. Our hope is that regulators ultimately move toward specifications-based oversight, where the question is not which part of the plant was used, but whether the finished ingredient meets a defined, reproducible safety and quality standard."
The American Herbal Products Association (AHPA) also commented on the advisory on ashwagandha leaves. “This has been a longstanding point of discussion within the botanical industry, and we are engaged with our Ayurvedic Products Committee to evaluate the technical nuances of the FSSAI's advisory,” said AHPA President & CEO Graham Rigby. “AHPA is working to determine how this clarification might impact the global supply chain. AHPA's focus remains on ensuring that any regulatory policies potentially impacting international supply chains are grounded in sound science and that U.S. consumers continue to have access to safe, high-quality dietary supplements that meet all domestic compliance standards.”
Looking ahead
Actions are being taken to work with the Indian regulatory authorities to adjust their current stance. "Arjuna is engaging through industry associations and direct technical submissions to share the safety and clinical data on standardized root-and-leaf extracts," says Lavingia. "Our position is constructive: We are advocating for science-based specifications and use limits as an alternative framework. We are also urging the broader sector to align around transparent analytics and clear plant-part labeling—which is the right way to address adulteration without removing legitimate, well-characterized ingredients from the toolkit."
The debate over ashwagandha leaves highlights a broader industry focus on transparency, standardized testing, and evidence-based regulation in botanical supplements. The outcome of this debate may determine not just the future of ashwagandha globally, but also how the broader botanical category defines quality, safety, and trust.
LATEST UPDATE: Karnataka High Court Issues Interim Stay on Ashwagandha Leaf Ban
FAQ: India’s Ashwagandha Leaf Ban
What did India ban in ashwagandha products?
The Government of India has issued directives prohibiting the use of ashwagandha leaves in supplements and food products, restricting formulations to root-only extracts.
Why are ashwagandha leaves controversial?
Leaves are known to contain higher levels of withaferin-A, a compound that some stakeholders argue has a narrower safety margin, while others say existing research does not support safety concerns at typical usage levels.
What is the issue with the safety of ashwagandha leaf extracts?
The answer is debated. Some industry experts cite safety concerns based on compound concentration, while others point to clinical studies showing safe use in standardized root-and-leaf formulations.
Does this affect supplements in the United States?
No. The directive currently applies only within India and does not change regulations in the U.S., Canada, or Europe.
What is the bigger issue in the ashwagandha market?
Many experts say the core issue is lack of transparency in sourcing, standardization, and testing methods—not whether root or leaf is used.
