FSSAI bans use of Ashwagandha leaves in supplements over safety concerns

Hyderabad: Food Safety and Standards Authority of India (FSSAI) has banned the use of Ashwagandha (Withania somnifera) leaves in food products, health supplements, and nutraceuticals due to safety concerns.

The New Directive

In its latest advisory dated April 16, 2026, the FSSAI has made it clear that only the roots of the Ashwagandha plant are permitted for use in food products.

FSSAI said that manufacturers are strictly forbidden from using leaves, whether in their crude form, as an extract, or in any other processed state. Food Business Operators (FBOs) have been instructed to ensure immediate compliance, as any violation will lead to regulatory action under the Food Safety and Standards Act, 2006.

Why the Ban?

The decision to ban the use of Ashwagandha leaves is rooted in safety concerns identified by scientific research.

Safety Concerns: Scientific studies have suggested that Ashwagandha leaves contain significantly higher concentrations of reactive withanolides, particularly a compound called Withaferin-A.

Health Risks: High exposure to these compounds in leaves may pose potential health risks to consumers.

Proven Benefits of Roots: Following a thorough review by a multidisciplinary expert committee in 2024, the Ministry of Ayush concluded that while the roots are safe and widely used in traditional medicine for health benefits, the leaves do not share the same established safety profile.

Impact on Manufacturers and Labels

This mandate applies to both food product manufacturers regulated by the FSSAI and drug manufacturers governed by the Ministry of Ayush.

Beyond simply removing the leaves from their formulas, manufacturers must also strictly follow labeling regulations. Under Rule 161 of the Drugs Rules, 1945, it is mandatory to clearly mention the specific plant parts used in any product on the packaging.

What This Means for You

The government has directed all State and Union Territory licensing authorities to maintain strict vigilance. Consumers are advised to check product labels to ensure that any Ashwagandha supplements they purchase clearly state “root extract” rather than “leaf extract.” This regulatory shift is a proactive step by authorities to align product manufacturing with the latest safety standards and research findings.