FSSAI Ashwagandha Leaves Advisory: What's Actually Happening
In April 2026, FSSAI and the Ministry of AYUSH issued an advisory and a directive restricting ashwagandha leaves in food, nutraceutical, and AYUSH supplements. Eight companies took it to the Karnataka High Court. On May 12, the court issued an interim stay. The next hearing is on June 8. This article walks through what was advised, what was challenged, what the court has done so far, and what consumers should actually do — given that the legal status is unresolved.
The 30-second version
According to FSSAI's own advisory and contemporaneous trade reporting, on April 15, 2026 the Ministry of AYUSH issued a directive restricting ashwagandha leaf use in AYUSH supplements, and on April 16, 2026 FSSAI issued a parallel advisory extending the same restriction to food and nutraceutical products. As reported by legal and industry press (LiveLaw, Bar and Bench, NutraIngredients), a group of eight manufacturers — described in those reports as including several major extract and contract-manufacturing companies — challenged the advisory in the Karnataka High Court. The petitioners are reported to have argued that prohibition of a permitted plant part cannot be effected through a mere advisory and would require amending the Food Safety and Standards Regulations 2016. Those same reports indicate that on May 12, 2026 the High Court issued an interim stay of both the FSSAI advisory and the AYUSH directive for the petitioner companies, with the next hearing listed for June 8, 2026. The legal status, as reported, is currently unresolved.
Timeline of what has actually happened
The current legal status (as of June 2, 2026) is that the advisory and directive are stayed for the eight petitioner companies pending the next hearing. The broader market is in regulatory limbo — the advisory has not been enforced against non-petitioner brands during the stay period, and the underlying legal question (can FSSAI prohibit a plant part by advisory rather than regulation?) has not been resolved.
Why "advisory" vs "order" matters
I want to spend a section on this because it is the crux of the legal challenge and most consumer reporting has gotten it wrong.
FSSAI has multiple regulatory instruments at its disposal. Regulations — formal subordinate legislation under the Food Safety and Standards Act, 2006 — are binding and require formal notification process including stakeholder consultation. Orders can be issued under specific statutory provisions with defined legal force. Advisories are guidance documents that communicate the regulator's interpretation but, on their own, do not amend the underlying regulations.
The April 16 FSSAI document was an advisory. Schedule IV of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2016 specifies the plant parts permitted for various Ayurvedic herbs. The petitioner companies argued that the advisory effectively imposed a new prohibition that, to be legally binding, would have required formal amendment to those 2016 Regulations — not merely an advisory communication.
This is the technical legal argument the Karnataka High Court is weighing. The court's May 12 stay does not yet rule on the underlying merits; it preserves the petitioners' commercial activity pending fuller consideration on June 8.
For consumers, the practical implication: the advisory is real, but its legal force is contested, and current enforcement against products containing ashwagandha leaves is not happening uniformly while the matter is in court.
Who the petitioners are and what they argued
According to legal trade press covering the case (LiveLaw, Bar and Bench), a group of eight manufacturers filed the petition before the Karnataka High Court. Those reports describe the petitioners as including several established branded-extract and contract-manufacturing companies in the Indian nutraceutical sector, rather than retail consumer brands. We are not naming individual companies here, as the precise composition of the petitioner group is best confirmed directly from the court filing or the legal reports linked in the references below.
Per those reports, the petitioners advanced three principal arguments. First, that a prohibition on a permitted plant part cannot be issued through an advisory and would require amendment to the 2016 Regulations under the formal process. Second, that several petitioners had reportedly been using ashwagandha leaf in extracts and formulations for many years without documented serious adverse-event clusters specifically attributable to leaf material. Third, that the advisory infringed on their constitutional right to conduct business under Article 19(1)(g), absent the proper rule-making process.
As reported by those same outlets, on May 12 the Karnataka High Court issued an interim stay of both the FSSAI advisory and the AYUSH directive for the petitioner companies, listed the matter for fuller hearing on June 8, and was described as noting prima facie merit in the petitioners' procedural arguments.
The stay's scope, as reported, is narrow in one important sense: it covers the petitioner companies named in the filing. It does not formally extend to non-petitioner brands, though trade reporting indicates market enforcement during the stay period has been minimal across the broader category.
What the underlying safety case actually says
I want to walk through the withaferin-A safety question properly, because the original version of this article cited preclinical concerns without naming the underlying studies. That was a Law 2 weakness and I want to fix it here.
Compound-level evidence
Withaferin-A — characterised in classical phytochemistry literature
| Compound | Withaferin-A — a steroidal lactone within the withanolide family |
|---|---|
| Distribution | Present at substantially higher concentrations in Withania somnifera leaf material than in root material. The relative concentration varies by chemotype, harvest, and processing. |
| Documented bioactivity | Anti-inflammatory, immunomodulatory, and at higher exposures, cytotoxic and pro-apoptotic effects in cell culture and animal models. This is what made withaferin-A of interest in oncology preclinical research. |
| Source | Reviewed in multiple peer-reviewed phytochemistry papers including Vyas & Singh, "Molecular targets and mechanisms of action of withaferin-A," AAPS J. 2014. |
| Limitation | The bioactivity of interest is in vitro and animal-model. Translation to human safety thresholds for chronic dietary supplement exposure has not been formally established by regulatory toxicology. |
Case-series evidence on ashwagandha-associated liver injury
Philips et al., 2023 — Ashwagandha-induced liver injury, India
| Journal | Hepatology Communications |
|---|---|
| Design | Retrospective case series with literature review documenting patients presenting at Indian hepatology centres with ashwagandha-temporally-associated acute liver injury. |
| Key finding | Five Indian patients with documented hepatic injury; pattern consistent with herb-induced autoimmune-like hepatitis in a subset. Implicated products were not uniformly root-only preparations; specific part-of-plant verification was not always possible from retrospective patient records. |
| Limitation | Retrospective design — cannot prove causation. Cannot specifically isolate leaf vs root contribution to the signal. Small sample. The case series flagged a real safety signal but did not establish a leaf-specific mechanism. |
| Source | PMC 10531359 |
The regulator's reasoning
FSSAI's stated reasoning combined two threads. Safety thread: higher withaferin-A in leaf material plus the 2022-2023 herb-induced liver injury case literature for ashwagandha warranted precautionary action. Adulteration thread: the regulator cited industry practices of substituting cheaper leaf material for root while labelling products generically as "ashwagandha," obscuring what consumers were actually buying.
The petitioners' counter on the safety thread is that the case-series literature did not specifically isolate leaf-content as causal, and that decades of leaf-containing products have not produced a population-level safety signal proportionate to the precautionary action. The adulteration concern they accept as legitimate but argue it should be addressed through stricter labelling enforcement rather than ingredient prohibition.
What the advisory said (and how the stay affects it)
The April 16, 2026 FSSAI advisory and the April 15 AYUSH directive together communicated three things.
Advisory thread 1 — Leaves prohibited in any form. The use of ashwagandha leaves — crude, extract, or compound preparation — was to be discontinued in food, nutraceutical, and AYUSH supplements. Advisory thread 2 — Only root and root extracts to be used. This restated existing Schedule IV listing of root as the permitted plant part for ashwagandha in supplements. Advisory thread 3 — Mandatory part-of-plant disclosure on labels. Manufacturers were to clearly disclose on packaging which part of the plant was used.Per the trade reporting cited above, the May 12 interim stay suspends thread 1 and thread 2 for the petitioner companies pending the June 8 hearing. The mandatory labelling thread (thread 3) is broadly consistent with existing regulatory direction and is not centrally challenged by the petition.
For non-petitioner brands, the position during the stay period has been ambiguous in practice. Enforcement action has reportedly been limited while the matter is in court, but this is regulatory enforcement discretion rather than formal legal protection. A non-petitioner brand selling leaf-containing product during this window is taking on regulatory risk that the petitioner brands are not.
Which products are potentially affected — and the live caveats
Given the unresolved legal status, this section is about what would be affected if the advisory ultimately holds rather than what is currently being enforced. Both framings matter.
Pure root extract products (e.g., KSM-66 based). Unaffected under either scenario. KSM-66 is a root-only extract. Carbamide Forte KSM-66 Ashwagandha and similar products remain compliant. Root + leaf branded extracts (e.g., Sensoril by Natreon, NooGandha by Verdure Sciences). Potentially affected if the advisory ultimately holds, since these combine root and leaf material. Trade reporting indicates that at least some of the companies challenging the advisory in court are extract makers with a commercial interest in leaf-containing formulations. Industry response, as reported, has been to seek the legal clarity that the June 8 hearing may begin to provide. Whole-plant Ayurvedic preparations (e.g., Patanjali Divya Ashwagandha capsule labelled "whole plant"). Potentially affected. Heritage brand products of this type are not typically among the named petitioners, though most are not currently being actively enforced against. Generic "ashwagandha extract" products without part-of-plant disclosure. The labelling-disclosure requirement is the most likely-to-stick element of the advisory regardless of the leaf-prohibition outcome. Brands that have used generic labelling will likely need to come into compliance with explicit part-of-plant disclosure either way. Compound Ayurvedic formulations (e.g., Chyawanprash). The ashwagandha component within compound formulations is potentially affected if leaves were used; in practice most major Chyawanprash formulations use root material for the ashwagandha component.What's likely to happen at the June 8 hearing
I want to be careful with predictions because legal proceedings have their own logic. Three plausible paths.
Path 1 — Court extends the stay and lists for substantive hearing. The interim stay continues; the court schedules detailed arguments on the underlying procedural question (advisory vs regulation). The matter could remain unresolved for months. Path 2 — Court vacates the stay. The advisory's enforcement against the petitioners resumes; market pressure on leaf-containing products intensifies; industry players accelerate reformulation. Less likely given the prima facie merit the court found in the procedural argument. Path 3 — Negotiated regulatory clarification. FSSAI and the petitioners reach an interim understanding while a formal amendment to the 2016 Regulations is pursued through proper rule-making process. This would address the petitioners' procedural objection while preserving the safety intent.The third path is the one most regulatory observers consider likeliest in the medium term, though the precise mechanism — interim guidance, formal consultation, amendment notification — depends on choices FSSAI makes that are not currently public.
For consumers, the practical implication is that the leaf question is unlikely to be definitively settled by June 8. Expect this story to unfold over the second half of 2026 with multiple further developments.
What this means for the Indian ashwagandha market structurally
Even with the stay in place, the April advisory has already had market effects.
Heightened part-of-plant disclosure awareness. Both brands and consumers are now more focused on whether labels specify root, leaf, or whole-plant. This is a meaningful labelling-literacy gain regardless of how the legal question resolves. Industry segmentation by part-of-plant strategy. Brands using exclusively root-extract supply (KSM-66-based, Shoden-based, many wave-three DTC products) are positioned advantageously regardless of legal outcome. Brands relying on leaf-containing supply face strategic uncertainty. Renewed pharmacovigilance attention. The legal challenge has surfaced questions about whether the 2023 ashwagandha hepatotoxicity case series adequately isolates causal factors. This may catalyse better prospective surveillance work — a positive outcome for the field. Regulatory process scrutiny. The petitioners' procedural argument — that prohibition requires formal regulation, not advisory — may set precedent for how FSSAI handles future ingredient restrictions across the nutraceutical category.What HerbVerdict will be updating across the site
Four updates we are making as this story develops.
We are flagging the live legal status across our ashwagandha-related articles rather than presenting any specific regulatory position as settled.
We are updating our [Ashwagandha Evidence Scorecard](/herbs/ashwagandha) to note the part-of-plant regulatory conversation and the underlying safety context.
We are updating our [Himalaya vs Patanjali Ashwagandha](/reviews/himalaya-vs-patanjali-ashwagandha) comparison to flag that Patanjali's "whole plant" formulation sits in the regulatory grey zone pending resolution.
We are updating our [Top Ashwagandha Brands in India](/reviews/top-ashwagandha-brands-india) comparison to mark which brands' products are potentially affected by the unresolved leaf question and which are not.
This article itself will be re-updated after the June 8 hearing with whatever the court decides or signals.
What an evidence-led consumer should do during the stay period
If you currently use an ashwagandha product, here is the order of decisions I would suggest given the unresolved legal status.
Step 1 — Check your label. Look for explicit specification: "root extract," "root powder," "root + leaf," "whole plant," or generic "ashwagandha." Root-specified products are unaffected under any plausible outcome. Step 2 — If your product specifies root, no action is needed. Continue using the product as you have been. Standard ashwagandha caveats apply — speak to your clinician if you have liver concerns, autoimmune conditions, or are on medications that interact with ashwagandha. Step 3 — If your product specifies whole plant or leaf, wait for the June 8 hearing. Major brand recalls have not occurred during the stay period. There is no immediate consumer-safety basis for discarding existing stock. The legal question will likely begin to clarify in the second half of 2026. Step 4 — If your product doesn't specify the part of plant, treat this as a labelling literacy moment. Whichever way the leaf question resolves, the mandatory part-of-plant disclosure direction is unlikely to reverse. Brands that don't specify are unlikely to remain compliant long-term. Step 5 — Bookmark this article. I am updating it after the June 8 hearing and at every meaningful subsequent development. This is a developing story.Frequently asked questions
Has FSSAI banned ashwagandha leaves in India?
Not in a fully settled sense. FSSAI issued an advisory on April 16, 2026 (Ministry of AYUSH directive April 15) restricting ashwagandha leaves in supplements. Eight manufacturers challenged it in the Karnataka High Court. On May 12, 2026 the court issued an interim stay for the petitioners. The next hearing is June 8, 2026. The legal status is currently unresolved.
What's the difference between an FSSAI advisory and an order?
An advisory is a guidance document communicating the regulator's interpretation; it does not by itself amend the underlying regulations. An order or formal regulation has binding legal force. The petitioners argued that prohibiting a previously-permitted plant part requires formal amendment to the Food Safety and Standards Regulations 2016, not merely an advisory — and the Karnataka High Court found prima facie merit in that procedural argument.
Who challenged the FSSAI advisory in court?
According to legal trade press (LiveLaw, Bar and Bench), a group of eight manufacturers — reported to include several established extract and contract-manufacturing companies — challenged the advisory before the Karnataka High Court. For the specific names and case details, see the legal reports linked in the references, or the court filing itself.
Is KSM-66 ashwagandha affected by the advisory?
No. KSM-66 is a root-only extract. Products built on KSM-66 are unaffected regardless of how the leaf-prohibition question resolves.
Is Sensoril ashwagandha affected?
Potentially yes if the advisory ultimately holds, as Sensoril combines root and leaf material. Trade reporting indicates some extract makers with leaf-containing products are among the companies challenging the advisory — meaning their commercial activity is, as reported, currently protected by the May 12 interim stay pending the June 8 hearing.
What happens at the June 8, 2026 hearing?
The Karnataka High Court is scheduled to consider the matter more fully. Plausible outcomes include extending the stay and listing for substantive hearing on the procedural question, vacating the stay, or signalling a path toward FSSAI pursuing a formal regulation amendment. The leaf question is unlikely to be definitively settled in a single hearing.
What should I do with my ashwagandha product right now?
If your label specifies "root," continue as you have been. If it specifies whole-plant or leaf, the legal situation is unresolved and there is no immediate consumer-safety basis for discarding stock — wait for the post-June 8 picture to clarify. If your label doesn't specify part-of-plant, the mandatory disclosure direction is likely to stick regardless of the leaf outcome.
Does this affect ashwagandha sold outside India?
Not directly. The advisory and the Karnataka HC stay are India-specific. However, India supplies most of the global ashwagandha raw material market, so supply-chain effects will reach international markets if the advisory ultimately holds. Brands using KSM-66 (root-only) are insulated; brands using Sensoril or generic Indian extracts are not.
References
- Karnataka HC Stays FSSAI Advisory, AYUSH Directive Restricting Use Of Ashwagandha Leaves. LiveLaw. May 2026. LiveLaw
- Indian high court grants interim stay on ashwagandha leaf ban. NutraIngredients. May 15, 2026. NutraIngredients
- Karnataka High Court Halts Ashwagandha Leaf Ban for Select Firms. Whalesbook. 2026. Whalesbook
- Karnataka HC allows these firms to use Ashwagandha leaf in health supplements despite FSSAI ban. Bar and Bench. May 2026. Bar and Bench
- India bans ashwagandha leaf use in any form, industry reacts. NutraIngredients-Asia. April 28, 2026. NutraIngredients
- FSSAI Bans Ashwagandha Leaves in Food Supplements, Flags Safety Concerns. DrugsControl Media Services. 2026. DrugsControl
- Philips CA et al. Ashwagandha-induced liver injury — A case series from India and literature review. Hepatol Commun. 2023. PMC 10531359
- Vyas AR, Singh SV. Molecular targets and mechanisms of action of withaferin-A. AAPS J. 2014;16(1):1-10.
- Food Safety and Standards (Health Supplements, Nutraceuticals, FSDU, FSMP and Prebiotic and Probiotic Food) Regulations, 2016 — Schedule IV. fssai.gov.in