A single-judge bench of the Karnataka High Court, presided over by Justice S.R. Krishna Kumar, has granted interim relief to manufacturers of Ashwagandha-based health supplements, staying an advisory issued by the Food Safety and Standards Authority of India (FSSAI) on April 16, 2026, and an accompanying directive by the Ministry of AYUSH dated April 15, 2026, which sought to restrict the use of Ashwagandha (Withania Somnifera) leaves in food and health supplement products.
The petitioners include Kerry Inc, Sami-Sabinsa Group Ltd, K Patel Phyto Extractions Pvt Ltd, SA Herbal Bioactives LLP, Sakti Naturals Pvt Ltd, Unicorn Natural Products Pvt Ltd, OmniActive Health Technologies Ltd and Konark Herbals and Healthcare Pvt Ltd.
The FSSAI Advisory and AYUSH Directive
The regulatory action has its origins in a Ministry of AYUSH directive dated October 6, 2021, which had first advised Ayush drug manufacturers, exporters, and sellers not to use Ashwagandha leaves, in crude, extract, or any other form, in Ayush drugs and products. In 2024, a multidisciplinary expert committee convened by the Ministry of AYUSH published an updated safety dossier, recommending the exclusive use of Ashwagandha roots for health benefits. Building on this, the Ministry of AYUSH issued a fresh directive on April 15, 2026, strictly prohibiting the use of Ashwagandha leaves in any form across all Ayush drugs and products and mandating that labels clearly mention the plant part used, in compliance with Rule 161 of the Drugs Rules, 1945.
FSSAI followed this on April 16, 2026, issuing an advisory clarifying that under Schedule IV of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Functional Food and Novel Food) Regulations, 2016, only the roots and root extracts of Ashwagandha are permitted for use in food and health supplement products. The advisory directed all Food Business Operators to ensure strict compliance, warning that any deviation would attract action under the Food Safety and Standards Act, 2006.
The Challenge
The petitions were filed by companies engaged in the manufacture of products containing Ashwagandha, a botanical ingredient listed at Sl. No. 432 of Schedule IV of the 2016 Regulations. The petitioners, who have manufactured products using both root and leaf extracts of the Ashwagandha plant for over 30 years, argued that the FSSAI advisory was issued without amending the 2016 Regulations and therefore fell outside the statutory authority of the regulator.
The petitioners contended that the advisory was ultra vires the Food Safety and Standards Act, 2006; second, that the authorities had incorrectly interpreted the 2016 Regulations as permitting only roots and root extracts, which was contrary to the provisions of the Act and Regulations.
The petitioners also contended that prohibition of use through a mere advisory simpliciter, without amending the 2016 Regulations, was sufficient to vitiate the impugned advisory and that enforcement of the directive would severely and substantially impact the businesses of the petitioners, resulting in irreparable injury and hardship.
The Order
After hearing both sides, the High Court passed a common oral order directing the respondents to file their statement of objections before the next date of hearing. The Court stayed the operation of the FSSAI advisory dated April 16, 2026, and the AYUSH directive dated April 15, 2026, insofar as they apply to the petitioners, until the next date of hearing.The Court also reserved liberty to the respondents to seek vacation or modification of the order and listed the matter for further hearing on June 8, 2026.
“In the meanwhile, the impugned Advisory dated 16.04.2026 and the impugned Directive dated 15.04.2026 issued by respondent Nos.1 and 2 respectively, are hereby stayed only insofar as it relates to the petitioners in W.P.No.14990/2026 and W.P.No.15010/2026 are concerned, till the next date of hearing. Liberty is reserved in favour of respondents to seek vacation/modification of this order,” the bench ordered.
The petitioners were represented by Kochhar & Co., with a team comprising partner – litigation Mayur Shetty, associate partner – litigation Rushil Mathur, senior partner – corporate Rajarshi Chakrabarti, partner – corporate and Sameena Jahangir.
