It pointed out that “the use of Ashwagandha leaves in crude or extract or any other form is not permitted” under the notified regulations. | Photo Credit: DINESH VALKE

The Food Safety and Standards Authority of India (FSSAI) has cautioned companies to ensure use of Ashwagandha in products is done in compliance with the notified standards. It has directed food business operators to ensure that only roots of Ashwagandha and its extracts are used in their products in compliance with prescribed limits. It emphasised that the use of the herb’s leaves and its extracts is prohibited.

Besides Ayurvedic medicines, Ashwagandha (Withania Somnifera) is used in a variety of products such as nutraceuticals and supplements. In recent times, it is also being used in functional food products such as herbal teas, protein blends, nutrition powders and wellness beverages.

In its latest advisory, the Authority stated that it has come to its attention that certain manufacturers are using Ashwagandha leaves and its extract in their products. It pointed out that “the use of Ashwagandha leaves in crude or extract or any other form is not permitted” under the notified regulations.

FSSAI said it has specified the standards for health supplements, nutraceuticals, food for special dietary use, food for special medical purpose 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. The regulations provide the list of plants or botanicals permitted for use in such products. “As per Schedule IV of the aforesaid regulations, only the roots and their extracts of Ashwagandha are permitted for use in these categories of products, subject to compliance with the prescribed limits,” it added in its advisory.

The Authority added that the Ministry of Ayush has in its recent letter has also directed Ayush drug and product manufacturers to use only Ashwagandha roots and their extracts and not the leaves, in any form. The Ministry in its letter noted that available scientific studies “have reported possible safety concerns for Ashwagandha leaves due to higher concentrations of reactive withanolides, particularly Withaferin-A”.

Published on April 18, 2026