09 May 2026, New Delhi: The Food Safety and Standards Authority of India (FSSAI) has issued an advisory directing Food Business Operators (FBOs) not to use Ashwagandha (Withania somnifera) leaves in crude, extract, or any other form in food products regulated under nutraceutical and health supplement categories.
The advisory, issued by the Regulatory Compliance Division of FSSAI on April 16, 2026, clarified that under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, only Ashwagandha roots and their extracts are permitted for use in such products, subject to prescribed limits.
According to the regulator, it has come to its notice that certain manufacturers are using Ashwagandha leaves and their extracts in food products despite the existing provisions. FSSAI stated that the use of Ashwagandha leaves in crude, extract, or any other form is not permitted under the current regulations.
The advisory also referred to a communication from the Ministry of Ayush dated April 15, 2026, which directed Ayush drug and product manufacturers to use only Ashwagandha roots and their extracts and strictly avoid the use of leaves in any form.
The Ministry of Ayush noted that updated scientific assessments and the Ashwagandha safety dossier published in 2024 recommended the use of Ashwagandha roots for health benefits. The ministry further cited scientific studies indicating possible safety concerns associated with Ashwagandha leaves due to higher concentrations of reactive withanolides, particularly Withaferin-A.
FSSAI has advised all FBOs to ensure strict compliance with the provisions of the Food Safety and Standards Act, 2006, and warned that any deviation may attract regulatory action. The authority has also requested Food Safety Commissioners of all States and Union Territories, along with Regional Directors and Licensing Authorities, to maintain vigilance and initiate action against non-compliance.
The advisory was issued with the approval of the Competent Authority and signed by Dr. Amit Sharma, Executive Director (Compliance Strategy), FSSAI.
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