On April 16, India’s regulatory agency, Food Safety and Standards Authority of India (FSSAI), banned products containing ashwagandha leaves, stating only ashwagandha roots and their extracts are permitted for use in health supplements, nutraceuticals and certain food products as per government regulations.

“It has been brought to the notice of FSSAI that certain manufacturers of these products are using ashwagandha leaves and its extract in their products,” the notice reads. “In this regard, it is clarified that use of ashwagandha leaves in crude or extract or any other form is not permitted under the said regulations.”

The Indian Ministry of Ayush also sent a letter (No. L. 11011/9/2021-DCC) advising Ayush drug manufacturers, exporters and sellers not to use ashwagandha leaves in either crude or extract or any form in Ayush drugs and products.

The natural products industry responded to the ban, expressing mixed opinions.

“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. While India’s regulatory framework for ashwagandha has historically prioritized the root, 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,” said Graham Rigby, president and CEO of the American Herbal Products Association (AHPA).

Dr. Suresh Lakshmikanthan, chief business officer at Natural Remedies (India), explained by banning leaf-based extracts, which are often used as “low-cost fillers” to artificially spike withanolide counts, regulators are now forcing a long overdue shift toward transparency and consumer safety. He added the root is the good part—leaves contain higher levels of Withaferin-A, which has a much narrower safety margin than the root.

“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. The responsible manufacturers already use only the authenticated root extracts; this is business as usual for them. 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,” Lakshmikanthan said.

According to Rajat Shah, co-founder of India-based Nutriventia, ashwagandha’s therapeutic value has always resided in the root, which is explicitly stated in ayurvedic texts.

“What FSSAI has done is formalize what responsible ingredient science already knew: that the leaf carries a meaningfully different phytochemical profile, including significantly higher concentrations of compounds with safety concerns when consumed over extended periods,” Shah explained. “At the same time, the broader body of research on leaf-derived extracts remains relatively limited, particularly with respect to long-term safety, efficacy, and consistency of results. The regulatory body has listened to the science. We think that deserves respect, not resistance. For Nutriventia, nothing changes operationally. For the broader market, it raises the floor, and we think a higher floor is good for consumers, good for brands, and good for the long-term credibility of the ashwagandha category.”

Blake Ebersole, founder of Fearless Naturals and NaturPro Scientific (Carmel, IN), and co-founder of the Ashwagandha Standards Alliance, said many people are interpreting the FSSAI action “differently than it actually is.”

“It is a regulatory decision within India’s own traditional medicine and food framework, and should not be misread anywhere else as a global scientific verdict that ashwagandha leaf is unsafe in all forms,” Ebersole said. “On a practical level, it is entirely unclear to me whether the new rule will be enforced, considering the level of corruption we know is associated at the highest levels of Indian government—much less how it would ever be practically enforced.”

He added the action is “misguided” for a few main reasons: it conflates legitimate use of root and leaf with adulteration, neglects the body of evidence which shows a record of safety for both root and leaf products, is based on a foundation of “flawed and incomplete” reports which omit a large amount of verified evidence, and incorrectly claims that leaf was not used traditionally.

There is also a critical photochemistry aspect—root and leaf share withanolide chemistry including withaferin A, withanolide A, withanone and 12-deoxywithastramonolide, but in different ratios depending on chemotype, tissue, growing conditions, extraction process and method of analysis, he said.

“The right regulatory response is not ‘root good, leaf bad.’ It is basic GMP’s—plant-part disclosure, validated identity testing, fit-for-purpose analytical methods, and clinical and safety substantiation tied to the actual commercial material. And acknowledging that the large body of evidence now includes both root-only, as well as root-and-leaf products,” Ebersole said.

Shaheen Majeed, global CEO and managing director of Sabinsa (East Windsor, NJ) argued the implications extend well beyond regulatory policy.

Limiting use to roots effectively lowers what farmers can bring to market, lowers overall productivity of the land and places added strain on already vulnerable rural economies. He said at minimum the announcement should prompt a more serious discussion about what constitutes “credible standardization” for ashwagandha.

“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,” Majeed said. “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.”