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As per Schedule IV of these regulations, only roots and root extracts of Ashwagandha (Withania somnifera) are permitted
The Food Safety and Standards Authority of India has laid down standards for health supplements, nutraceuticals, Food for Special Dietary Use (FSDU), Food for Special Medical Purpose (FSMP), Functional Food, and Novel Food under the Food Safety and Standards (Health Supplements, Nutraceuticals, FSDU, FSMP, Functional Food and Novel Food) Regulations, 2016.
As per Schedule IV of these regulations, only roots and root extracts of Ashwagandha (Withania somnifera) are permitted for use in such products, subject to prescribed limits.
However, it has come to FSSAI’s notice that some manufacturers are using Ashwagandha leaves and leaf extracts in their formulations.
In this regard, FSSAI has clarified that use of Ashwagandha leaves, in crude form, extract form, or any other form, is not permitted under the current regulations. The Ministry of AYUSH, through its communication dated April 15, 2026, has also directed AYUSH drug manufacturers to use only roots and root extracts, and not leaves, in any form.
All Food Business Operators (FBOs) are advised to ensure strict compliance with the above provisions.
Avoid any use of non-permitted plant parts such as leaves. Any violation will attract action under the Food Safety and Standards Act, 2006 and related regulations.
Commissioners of Food Safety across States/UTs Regional Directors of FSSAI have been instructed to ensure strict monitoring and enforcement action against non-compliance by licensing authorities and food safety officers.