The Karnataka High Court has granted interim relief to a set of Petitioners inter alia engaged in the manufacture of Ashwagandha-based products by staying an advisory and directive issued by Food Safety and Standards Authority of India (FSSAI) and the AYUSH Ministry, respectively, that sought to restrict the use of Ashwagandha leaves in health supplements.
The Petitions were filed by companies engaged in manufacturing products containing Ashwagandha (Withania Somnifera), a botanical ingredient listed as a permissible item under Schedule IV of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Functional Food and Novel Food) Regulations, 2016.
The Petitioners submitted that the companies manufacture products using extracts from the roots as well as leaves of the Ashwagandha plant and have been doing so for over 30 years without objection from the regulators. The Petitioners further contended that the FSSAI could not prohibit the use of Ashwagandha leaves merely through an advisory dated April 16, 2026 (based on a AYUSH Ministry directive dated April 15, 2026) without amending the 2016 Regulations, which was beyond the statutory ambit. The Petitioners primarily argued that i) the advisory was ultra vires the Food Safety and Standards Act, 2006; ii) the authorities had incorrectly interpreted the regulations as permitting only roots and root extracts; iii) the restriction violated Article 19(1)(g) of the Constitution by imposing disproportionate limitations on business activities; and iv) the directive relied on scientific studies that did not conclusively establish safety concerns regarding Ashwagandha leaves.
According to the Petitioners, enforcement of the advisory would cause severe financial and operational hardship to manufacturers using Ashwagandha leaf extracts in their products. Opposing the plea, the Central Government Counsels appearing for the Respondents raised certain defences and sought time to file objections.
After hearing both sides, the High Court directed the Respondent authorities to file their statement of objections before the next hearing date and listed the matter for further consideration on June 8, 2026.
Pending further proceedings, the Court stayed the operation of the Impugned Advisory dated April 16, 2026 and the AYUSH directive dated April 15, 2026 insofar as they apply to the Petitioners.
The Kochhar & Co. team comprised of Mayur Shetty, Partner (Litigation); Rushil Mathur, Associate Partner (Litigation); Rajarshi Chakrabarti, Senior Partner (Corporate); and Sameena Jahangir, Partner (Corporate).
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