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Ashwagandha has been making headlines recently — and for once, the news is actually useful to the average supplement buyer. India's food safety authority issued a regulatory clarification in April 2026 that drew a hard line between the two parts of the ashwagandha plant most commonly used in supplements: the root and the leaf.
If you've never thought about which part of the plant is in your capsule, you're not alone. Most supplement labels don't make it obvious. But it matters — not as a scare story, and not because ashwagandha is suddenly dangerous. It matters because the root and the leaf are chemically different in ways that are relevant to safety and efficacy. And given that ashwagandha is consistently one of the top five selling herbal supplements in the US, this is worth understanding properly.
Ashwagandha (Withania somnifera) is a small shrub native to India, North Africa, and parts of the Mediterranean. It has been used in Ayurvedic medicine for over 3,000 years — almost always in the form of preparations made from the dried root. The root is where the traditional knowledge base sits, and where the modern clinical research has been conducted.
The active compounds in ashwagandha are a family of steroidal lactones called withanolides. These compounds are found throughout the plant — in the roots, leaves, berries, and stem. But the profile and concentration of those withanolides vary enormously depending on which part of the plant you're looking at. The root and the leaf are not interchangeable sources of the same compounds. They're different materials with different chemistry.
This is the core of what the current regulatory discussion is really about.
Within the withanolide family, one compound has attracted particular attention: Withaferin-A. It's a potent bioactive molecule that has been the subject of significant research for its anti-inflammatory properties and — more controversially — its cytotoxic (cell-killing) effects. There are researchers investigating Withaferin-A as a potential anti-cancer agent in preclinical models. It's genuinely interesting science.
Here's the number that changes the conversation: Withaferin-A is present at approximately 0.5–1 mg/g in ashwagandha roots. In ashwagandha leaves, it's present at approximately 8–22 mg/g. That's not a small difference — that's a 10 to 40-fold increase.
The same property that makes Withaferin-A interesting for cancer research — its potency as a cytotoxic compound — is what raises a flag for daily oral supplementation. Preclinical data has flagged potential hepatotoxic (liver-damaging) signals at higher exposures in animal models. Whether those signals translate to harm in humans at typical supplement doses is an open question, but it's precisely the kind of uncertainty that regulatory bodies use to justify precautionary restrictions.
This isn't a case of "leaf ashwagandha has been proven dangerous." It's a case of "we don't have the same depth of safety and efficacy data for leaf that we do for root, and the phytochemical profile gives us reason for caution." That's a reasonable position.
In April 2026, India's Food Safety and Standards Authority (FSSAI), in coordination with the Ministry of AYUSH, issued a regulatory advisory clarifying which parts of the ashwagandha plant are permitted in health supplements and nutraceuticals. The ruling is unambiguous: only dried mature roots and root-derived extracts of Withania somnifera are permitted. Leaf material — in any form, crude or extracted — is not.
This isn't a new ban on ashwagandha. Ashwagandha root supplements remain fully permitted in India. What the advisory targets is a practice that had developed among some manufacturers: using leaf material, which is cheaper to produce and higher in certain withanolides, as a way to hit standardisation percentages on labels without the cost of proper root extraction.
The advisory builds on a 2021 AYUSH advisory and a comprehensive 2024 expert committee safety dossier that reviewed all available clinical, phytochemical, and traditional use data. Their conclusion: roots are well-supported by evidence; leaves are not.
Manufacturers in India are now required to declare the plant part used on supplement labels. That requirement is good for consumers everywhere, because it puts pressure on the global supply chain to be transparent — a supply chain that feeds the US supplement market.
You may have also seen coverage of Denmark banning ashwagandha outright — not just the leaf, but the root extracts that are the standard form sold everywhere else. This is a separate issue and a more controversial one.
Denmark's 2023 ban stems from a 2020 risk assessment by the Danish Technical University (DTU) that cited potential effects on sex hormones, thyroid function, and metabolism under the precautionary principle. The assessment reviewed animal data and some human clinical data and concluded there was no clearly safe dose.
The scientific community has widely pushed back on this conclusion. There are hundreds of human clinical trials on ashwagandha root extract, and the weight of that evidence shows it to be well-tolerated in healthy adults at standard doses (300–600mg/day). The specific concerns about thyroid and hormone effects are noted in the literature but are typically relevant only to people with pre-existing thyroid conditions or hormone-sensitive diagnoses — and are addressed through precautionary labelling, not a blanket ban.
No other country has followed Denmark's lead. The United States, United Kingdom, European Union (except Denmark), Canada, Australia, and Japan all continue to permit ashwagandha root extracts as supplements. The Denmark decision is best understood as an outlier application of the precautionary principle rather than a signal that ashwagandha root is broadly unsafe.
The important distinction: India's leaf restriction is evidence-based and scientifically grounded. Denmark's root ban is precautionary and not broadly endorsed by the scientific community. These are two different conversations.
This is worth stating clearly because it sometimes gets lost in the noise: every major randomised controlled trial on ashwagandha for stress, cortisol, sleep, and cognitive function has used root extract. Not leaf. Not whole plant. Root.
The two most studied branded extracts — KSM-66 (Ixoreal Biomed) and Sensoril (Natreon) — are both root-only preparations. KSM-66 is the most clinically studied ashwagandha extract in the world, with a robust portfolio of randomised controlled trials on stress, cortisol, sleep quality, and physical performance. Sensoril uses root and root-bark. Both have comprehensive safety and efficacy data.
When you see headlines that say "studies show ashwagandha reduces cortisol" or "ashwagandha improves sleep quality," those studies are referring to root extract. It is not accurate to extrapolate those findings to leaf-based products, because the phytochemical profiles are different and the leaf has not been subject to the same clinical scrutiny.
This takes 30 seconds. Pick up your ashwagandha supplement and look for the following:
The honest answer: not particularly — but it's worth checking your label.
The vast majority of ashwagandha supplements sold in the United States use root extract. KSM-66 and Sensoril dominate the premium end of the market. Many mid-range products specify "root" on the label or use the same root-extract supply chains. The leaf issue is more prevalent in the budget end of the market and in some regions with less stringent labelling requirements.
The US supplement industry is not without its problems, but this particular issue — undisclosed leaf material — is more of a label transparency problem than an emergency safety crisis. The India FSSAI ruling will push the global supply chain toward better labelling, which ultimately benefits US consumers who currently have to actively look for the "root" designation to confirm quality.
The National Center for Complementary and Integrative Health (NCCIH) continues to note promising preliminary evidence for ashwagandha root in stress, fatigue, and sleep support, while acknowledging that research quality varies and more large-scale trials are needed. None of the major health agencies in the US have issued any warnings about ashwagandha root at standard supplement doses for healthy adults.
If you're taking a KSM-66 or Sensoril product, or any product that explicitly specifies root extract at 300–600mg/day — you're using the most studied, most validated form of ashwagandha that exists. Keep taking it. The regulatory news doesn't change the evidence base for root extract, which remains solid.
If your label is vague or says "whole plant," the precautionary approach is to switch to a root-specified product or a recognised branded extract. Given that root extracts aren't more expensive and are considerably better documented, there's no good reason to use a less transparent product.
The bigger picture is this: the India FSSAI ruling is good for the ashwagandha category as a whole. It creates pressure for transparent labelling, it validates the traditional and clinical evidence base for the root, and it signals that regulatory bodies are distinguishing between different forms of the same plant rather than banning categories wholesale. That's the kind of nuanced regulation the supplement industry needs more of — not blanket bans, but form-specific requirements backed by evidence.
Ashwagandha root extract has 3,000 years of traditional use and hundreds of modern clinical trials behind it. It works for stress, cortisol support, and sleep quality when taken consistently at 300–600mg/day, and its safety record at those doses is well established. None of that has changed.
What has changed is that regulators are now formally distinguishing between the root — which has all of that evidence — and the leaf, which has a different chemical profile, dramatically higher Withaferin-A concentrations, and almost none of the clinical safety and efficacy data that makes ashwagandha worth taking in the first place.
Check your label. Look for "root." If it says root — or if it says KSM-66 or Sensoril — you're using the right product. If it doesn't specify, find one that does. That's the entire action item here.
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