India’s Food Safety Watchdog Restricts Ashwagandha to Roots Only, Citing Liver Safety Concerns

New Delhi, April 22, 2026

The Food Safety and Standards Authority of India (FSSAI) has issued a sweeping advisory to the nutraceutical industry, mandating the immediate removal of Ashwagandha leaves from all food products and health supplements. The directive, issued on April 16, 2026, clarifies that only the roots of Withania somnifera (Ashwagandha) and their specific extracts are permitted for human consumption in food formats. This regulatory pivot follows growing concerns from the Ministry of Ayush and global health researchers regarding the potential toxicity of the plant’s aerial parts, marking a significant intervention in India’s multi-million-dollar herbal supplement market.

A Divide Between Root and Leaf

Ashwagandha has long been celebrated as the “King of Ayurvedic Herbs,” acting as an adaptogen that helps the body manage stress, much like a natural shock absorber. However, while traditional Ayurvedic texts have focused almost exclusively on the root for internal use, modern commercial interests have increasingly turned toward the leaves as a cheaper source of raw material.

Under the Food Safety and Standards Regulations (2016), Ashwagandha was already listed as a permitted botanical, but the FSSAI recently observed a surge in manufacturers using leaf extracts to bolster “withanolide” content—the active compounds in the plant. The new advisory explicitly shuts this door, stating that leaves lack a history of safe use in food and are not endorsed by classical Ayurvedic medicine for oral consumption.

“The regulatory framework is clear: Schedule IV of the 2016 regulations specifies roots,” the FSSAI stated in its communication to State Food Safety Commissioners. “Non-compliance by Food Business Operators (FBOs) using leaves or leaf-based extracts is a violation of the Act and poses a potential risk to public health.”

The Science of Safety: Withaferin-A and Liver Health

The primary driver behind this crackdown is a chemical disparity between the plant’s parts. While the roots contain beneficial withanolides that support cognitive and physical health, the leaves possess high concentrations of Withaferin-A.

While Withaferin-A is currently being studied for its cytotoxic properties in cancer research—meaning its ability to kill cells—those same properties can be hazardous when ingested daily in a supplement. High doses of leaf extract have been linked in peer-reviewed studies to:

• Hepatotoxicity: Liver injury characterized by jaundice and elevated liver enzymes.

• Gastrointestinal Distress: Severe irritation of the stomach lining.

• Cytotoxic Stress: Unintended damage to healthy cells.

A 2025 AI-driven safety analysis published in a leading pharmacological journal reviewed 79 molecules found in the Ashwagandha root and found zero predictors for liver toxicity. In contrast, non-root parts, particularly the leaves, showed a significantly higher risk profile.

“The safety record of Ashwagandha roots is robust, backed by over 70 clinical trials showing high tolerability,” says Dr. Rajesh Kumar, a hepatologist at AIIMS New Delhi. “However, the leaves are a different biological entity. Their chemical signature mirrors certain herbal toxins that can strain the liver, especially in individuals with underlying conditions. This FSSAI move is a necessary step to prioritize clinical evidence over industrial marketing.”

Market Impact and Enforcement

The timing of this advisory is critical. India’s Ashwagandha supplement market was valued at approximately USD 62 million in 2024 and is projected to surge to USD 148 million by 2033. As millions of consumers turn to these products for “natural” stress relief, the risk of herb-induced liver injury (HILI) becomes a significant public health concern.

The FSSAI has empowered regional directors to conduct rigorous audits. Manufacturers found using leaves face:

1. Immediate Product Recalls: Removal of non-compliant batches from retail and e-commerce platforms.

2. Heavy Fines: Financial penalties under the Food Safety and Standards Act, 2006.

3. License Suspension: For habitual offenders or those misrepresenting ingredients on labels.

The Ayurvedic Perspective

The move has found unexpected support from traditional practitioners. Dr. Vaidya Priya Sharma, a researcher with the Central Council for Research in Ayurvedic Sciences (CCRAS), notes that the “roots-only” rule actually restores the herb’s traditional integrity.

“In classical texts like the Charaka Samhita, Ashwagandha root is used for Rasayana (rejuvenation) therapy,” Dr. Sharma explains. “The leaves were occasionally used topically for skin issues or wounds, but they were never intended to be brewed into teas or concentrated into pills for daily intake. Science is finally catching up with what our ancestors practiced for centuries.”

Counterpoints and Industry Limitations

Despite the safety concerns, some industry insiders argue that a total ban on leaves in food may be premature. Critics point out that many reported cases of liver injury involve “poly-supplements,” where consumers are taking multiple herbs simultaneously, making it difficult to isolate Ashwagandha leaves as the sole culprit.

Furthermore, because roots take longer to harvest and are more expensive to process, there are concerns that the price of high-quality Ashwagandha supplements may rise, potentially making them less accessible to low-income consumers.

What This Means for Consumers

For the average health-conscious reader, the FSSAI’s directive serves as a reminder that “natural” does not always mean “safe in any form.” To navigate this change, experts recommend the following:

• Read the Supplement Facts: Look for labels that specifically state “Withania somnifera root extract” or “root powder.” Avoid products that simply list “Ashwagandha aerial parts” or “whole plant.”

• Standardization Matters: High-quality extracts are usually standardized to 2.5% to 5% withanolides from the root.

• Watch for Symptoms: If you are currently taking an Ashwagandha supplement, monitor for signs of liver strain, such as unusual fatigue, yellowing of the eyes (jaundice), or dark urine.

• Consult Professionals: If you are on thyroid medication or are pregnant, consult a doctor, as even root extracts can interact with certain hormonal treatments.

The Path Forward

This regulatory crackdown represents a maturing of the Indian nutraceutical industry. By weeding out the use of unverified plant parts, the FSSAI aims to build a global reputation for Indian herbal products as both potent and safe. For now, the message is clear: if you’re reaching for Ashwagandha to calm your nerves, make sure you’re getting back to the roots.

Medical Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.

References

• FSSAI Advisory: “Advisory on non-use of ashwagandha leaves in crude or extract or any other form in food products,” April 16, 2026. fssai.gov.in