In April, the Food Safety and Standards Authority of India (FSSAI) issued an advisory that manufacturers are prohibited from using leaves of the ashwagandha (Withania somnifera) plant in domestically-sold dietary supplements, extracts, or crude forms; the use of leaves, the government agency stated, are in violation of India’s Food Safety and Standards Act.

However, in May, the Karnataka High Court in India granted an interim stay in response to petitions filed by Sami-Sabinsa Group Ltd and Kerry Inc. A hearing was scheduled for June 8.

FSSAI cited a 2024 safety dossier produced by the Ministry of AYUSH, a government department focused on traditional medicine, in its determination. That review concluded that leaves contain higher levels of reactive withanolides, like withaferin A, compared to roots, and that most of the safety data on ashwagandha formulations is tied to root-only products.

“In the year 2024, Ministry through a multidisciplinary expert committee, published an updated Ashwagandha safety dossier and its report, which categorically recommended that Ashwagandha roots should be used for health benefits,” FSSAI reported. 

While the safety data cited by the Ministry of AYUSH are still emerging, ashwagandha formulations containing leaves have a significantly different chemical profile than those containing roots. Importantly, while there’s no conclusive evidence that withaferin A is inherently toxic, no universal safety thresholds have been established for either this compound or for leaf-containing ingredients, which was cited as a concern.

Because withanolide concentrations are high in ashwagandha leaves, suppliers of standardized extracts sometimes rely on leaf material to create low-dose ingredients that meet high withanolide content claims. There’s also an economic incentive; leaves are faster-growing than roots, and can be harvested more frequently, enabling a more scalable supply and cost stability during root shortages.

Why Ban Leaves Now?

There wasn’t a single, catalyzing event that compelled FSSAI to act now, but mounting regulatory scrutiny in the global market likely instilled a sense of urgency, said Jane Wilson, director of program development at the American Herbal Products Association (AHPA).

“Increased market presence often leads to heightened scrutiny and a natural progression toward modernization of regulatory oversight,” she said. “As use of the botanical has expanded from simple preparations for traditional use to more modern standardized ashwagandha extracts that may incorporate other parts of the plant, some regulatory authorities, particularly in Europe, have restricted its use, issued advisories, or mandated warning labels on ashwagandha products due to safety concerns out of an abundance of caution.”

“The pressure has been building for some time,” said Paras Kumar Jain, chief operating officer at Ixoreal Biomed, which makes KSM-66 Ashwagandha. “Denmark moved to a ban in 2023, the Netherlands is on a similar path, and the UK’s Food Standards Agency has opened its own risk assessment … The 2024 safety dossier prepared by the AYUSH expert committee, the published HPLC and HPTLC studies documenting widespread adulteration, and the sheer global scale at which ashwagandha is now sold all came together at the same time.”

Notably, the ban is coordinated across FSSAI and Ministry of AYUSH, covering food, supplements, and drugs, leaving no clear pathway for leaf material under any product category, Jain said. “The phrase ‘in crude, extract, or any other form’ is deliberately sweeping,” removing any ambiguity about how the existing rules will be applied moving forward.

It’s important to note that FSSAI’s April advisory was enforcement of existing policy, rather than new rulemaking, said Rajat Mittal Shah, co-founder and director of Nutriventia. A 2021 advisory from the Ministry of AYUSH already directed manufacturers to refrain from using leaves, “noting that Withania somnifera root is the widely used drug in Ayurveda, Siddha, and Unani systems since ancient times, and the Ayurvedic Pharmacopoeia of India defines ashwagandha as consisting of dried mature roots,” Shah said.

“What compelled the 2026 action was the observed persistence of non-compliance,” she added. “Regulators also cited industry practices in which lower-cost leaf material was used in place of root, sometimes in extracts, while products were labeled generically … The pattern of advisory, non-compliance, and enforcement escalation is a familiar one in Indian food and supplement regulation.”

Traditional Use and Safety Data

Shah said the precedent set by traditional usage more heavily influenced India’s decision to ban leaves than recent safety data. Regulators are particularly concerned about the undisclosed inclusion of leaf material in ingredients and products, constituting economic adulteration. “A 2014 study found that eight of 10 commercially available standardized Withania somnifera extracts labeled as derived from roots contained aerial-part-specific marker constituents.”

Shah noted that ashwagandha’s 3,000-year history of use is supported with classical texts such as the Charaka Samhita and the Ayurvedic Pharmacopoeia of India, which call for root-only usage. The latter arrived at the conclusion that the dried mature root should be reserved for therapeutic use centuries ago, “and this is the primary and longstanding basis. Emerging safety data adds contemporary context, but the advisory, in our opinion, is most clearly directed at undisclosed substitution and adulteration, not at disclosed root-and-leaf products, per se.”

“Safety evidence supporting root use is centuries deep,” said Jain. “The leaf does not have the same foundation, either in traditional internal use or in modern safety dossiers,” and both tradition and safety data converge on the root. “That is the position India has chosen to stand on. It is the soundest position for consumers, for practitioners, and for the industry as a whole.”

The published literature on specific compounds like withaferin A alone wouldn’t justify a blanket prohibition, said Shaheen Majeed, global CEO and managing director of Sabinsa, who disagreed with the flat-out ban on leaf material. “The scientific approach would have been to establish evidence-based limits, not to eliminate an entire plant part from permissible use … Policy decisions with this level of economic and scientific consequence must be grounded in transparent review, validated analytical methods, and honest assessment of the downstream effects on farmers, processors, and manufacturers throughout the supply chain.”

Withaferin A should be managed through rigorous testing and clear specifications, rather than being treated as a blanket disqualifier, he added.

Impact on Global Supply

Experts noted that while FSSAI’s decision applies to ingredients and products being marketed in India, the impact on the global supply of ashwagandha ingredients that incorporate leaf material could be profound, and the industry is divided over whether that’s a good or a bad thing.

Majeed noted that companies serving global customers would need to maintain two separate supply chains, manufacturing controls, and product documentation procedures, adding cost and complexity.

“The impact on farmers cannot be overstated,” he said. “Restricting use to roots effectively reduces the market value of the entire plant and lowers farm income per acre. Estimates from the industry suggest that approximately 20,000 farmers, 80,000 family members, and as many as 300,000 people across the broader value chain could be affected. As a company that has sourced from Indian farmers for decades, we understand this is not an abstract number.”

Jain, by contrast, said that early market signals are already positive. If raw material is restricted by India, “no manufacturer can credibly maintain a leaf-and-root formulation for export markets while the domestic chain operates root-only … The industry will, and should, converge on a single global root-only standard. That’s also what international buyers are increasingly asking for, particularly in markets where the regulatory mood is already cautious … The shift restores fair value to the farmer cultivating roots, which is where the genuine value of the plant has always rested.”

India has more than enough authentic root supply to meet world demand, Jain added, “and we see no reason for concern on the manufacturing side. Since the leaf ban, root prices have already improved, which directly strengthens the farmers’ livelihoods and gives growers a reason to invest further in quality cultivation … Consumers receive products that are authentic and aligned with traditional use.”

It’s still too early to project the full scope of the advisory’s impact on raw material sourcing and downstream manufacturing, Wilson said. “AHPA will continue to prioritize the availability of safe, high-quality ashwagandha products that remain accessible to consumers while meeting all relevant compliance standards through our engagement with members and the wider industry.”

Even though exports aren’t subject to the leaf ban, there’s genuine supply chain exposure for brands that source from India if they can’t independently verify the plant parts in their products through ISO/IEC 17025-accredited third-party certificates of analysis (CoA) specific to the plant part, Shah said.

Could this Lead to Better Standardization?

As a result of the ruling, distinguishing between ashwagandha root and leaf material will become a much stronger baseline expectation, observers said. 

“Robust analytical methodologies and established industry monographs already exist to support standardized testing,” said Wilson. Critical application is needed to use them to distinguish between root and leaf material, but “leading analytical laboratories are well-equipped with the necessary tools and expertise to verify these materials.”

The total-withanolide HPLC readings used as first-line tests on ingredients shouldn’t be accepted, Jain noted. “HPTLC methods that detect chlorophyll and flavonol glycoside markers indicating aerial parts, supported by DNA-based identity testing where appropriate, are mature and well-documented … This is not specialized or exclusive infrastructure,” and NABL/ISO17025-accredited labs are capable.

“What is needed next is wider adoption across the supply chain and the updating of monographs by standards bodies,” he added. “Given the regulatory pressure now in place, this is a matter of months rather than years. Part-specific testing will quickly become the norm rather than the exception.”

Major pharmacopeial monographs, such as the USP, British Pharmacopoeia, Indian Pharmacopoeia, and the Ayurvedic Pharmacopoeia of India, are root-specific by design with 10 withanolide compounds used for reference standards, said Shah, “enabling individual identification of all 10 and quantification of 8. An extract that contains leaf-derived material carries a fundamentally different distribution profile … The practical implication for brands is that a generic total withanolides percentage, derived by an unspecified method, cannot be independently reproduced or verified. A USP-methodology CoA can. Specifying which test method was used, and whether it was conducted by an independent ISO/IEC 17025-accredited laboratory, is the difference between a label claim a regulator or retailer can verify, and one they simply have to accept.”

Reducing enforcement down to a ban on a plant part doesn’t remedy the issue of companies using testing methodologies that can’t be reproduced, Majeed concurred; as a result, the FSSAI ban’s potential to improve product quality may be overestimated.

“Sabinsa’s Shagandha extract, for example, is produced exclusively from roots and standardized to 2.5% withanolides using a USP-aligned HPLC method, with withaferin-A controlled at 0.25%,” he said. “The real-world consequences of methodological inconsistency are significant. We have tested a leading roots-only ashwagandha brand and found that even at high concentration, the intensity of the actives was very low … That gap is a direct result of their proprietary testing method versus the USP method. Pharmacopeial methods can be independently verified and reproduced; proprietary methods may produce numbers that look strong on a label but can’t withstand external scrutiny.”

Supply Chain Stability

For many reasons, it’s hard to anticipate the ripple effects of FSSAI’s advisory on global supply chains.

“AHPA is not aware of similar advisories that have been issued by FSSAI in the past,” said Wilson. “While the potential global impact is currently being assessed, AHPA will engage with any impacted members and international partners to mitigate possible supply chain disruptions.”

However, it’s safe to say that the impact “will be most acute for brands that have not closely examined their ingredient documentation, and minimal for those that have,” Shah said. The call for greater documentation at the sourcing stage in India, combined with increased regulatory scrutiny in Europe, presents an inflection point for the global ashwagandha market, she noted.

“Published pharmacokinetic and clinical data, GRAS, and toxicology reports, covering dose, delivery format, and plasma half-life is increasingly the standard that separates ingredients able to navigate regulatory scrutiny from those that cannot. The net effect globally is likely to be a bifurcation.”

“Even if export markets remain legally separate, uncertainty alone can affect sourcing decisions, formulation planning, and customer confidence,” Majeed said. While Sabinsa isn’t scrambling to reformulate since its extract is roots-only, ripple effects on sourcing, manufacturing, and exports will take time to fully surface.

“We also have some institutional experience here. Sabinsa’s founder, Dr. Muhammed Majeed, challenged a 2021 restriction on ashwagandha through scientific and regulatory engagement, and that challenge contributed to a more evidence-based conversation. We believe that constructive engagement, grounded in data, is what the industry needs now as well.”

Understated Nuances

Shah noted that the advisory isn’t simply about a product’s contents but also applies to labeling. “A brand that labels a product as a root extract but cannot produce an independent CoA stating the botanical source is exposed on documentation grounds independently of what the product contains … Brands with generic Withania somnifera extract labeling that does not specify plant part are technically non-compliant on this basis alone.”

The enforcement truly sits in labeling, said Jain. “Misstating the plant part used is now a documentary offense, and the burden of proof sits squarely on the seller. Compliance now turns on what the documentation can prove, not what the product claims.”

Targeting a single naturally-occurring compound like withaferin A in botanical formulations, rather than imposing testing and specification requirements, could have unintended broader consequences, noted Majeed, “not just for the supplement industry, but for future pharmaceutical and research applications, as well. The science supports management, not prohibition.”

Setting specifications for products would distinguish risk management from market restriction, he added. “Sabinsa has long held that pharmacopeial-grade standardization is the path forward for the entire adaptogens category,” and the industry would be proactive to move in that direction, rather than reacting to what has been restricted.