Karnataka High Court Stays FSSAI Advisory Restricting Use Of Ashwagandha Leaves In Health Supplements

The Karnataka High Court has stayed the operation of a Food Safety & Standards Authority of India (FSSAI) advisory arising from a directive issued by Ministry of AYUSH, prohibiting use of Ashwagandha (Withania Somnifera) leaves & its extract in manufacture of health supplements and Nutraceuticals.

The advisory meanwhile permits the use of Ashwagandha roots and root extracts.

The single-judge bench of Justice S.R. Krishna Kumar asked Ministry of AYUSH and FSSAI to file their statement of objections before the next date of hearing on June 8.

“…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 court said. 

Various multinational companies involved in the production of ashwagandha-based supplements through contract manufacturers approached the High Court, challenging the advisory and directive, stating that they have been using extracts from the roots and leaves of Ashwagandha plants in their products for the past 30 years without any objections from the regulatory authorities.

They contended that the respondents have wrongly assume that in Schedule – IV of the 2016 Regulations on Health Supplements and Nutraceuticals, only the roots and extracts of Ashwagandha and not the leaves are permitted to be used as a plant or botanical ingredient, which is contrary to the provisions of Food Safety and Standards Act and Regulations.

It was contended that the FSSAI advisory is violative of Article 19(1)(g) of the Constitution of India, the restriction imposed through the advisory is excessive and fails to meet the proportionality test apart from lack of application of mind by the respondent, who has issued the impugned advisory only on the basis of a mere directive dated 15.04.2026 by AYUSH ministry. 

In the petition, it was submitted by the companies that FSSAI could not prohibit the use of Ashwagandha leaves through an advisory dated April 16, 2026, based on an AYUSH Ministry directive dated April 15, 2026, without amending the 2016 Regulations on Health Supplements and Nutraceuticals.

Ashwagandha is listed at Sl. No. 432 of Schedule IV of the 2016 Regulations, which permits the use of the plant as a botanical ingredient, told the companies' counsel. The incorrect interpretation of the regulations so as to limit the use to the Ashwagandha root and its extract amounted to imposing disproportionate limitations on business activity, the companies told the court.

Moreover, scientific studies conducted also didn't throw sufficient light at the health concerns of using Ashwagandha leaves in supplements, the aggrieved manufacturers told the court.

Accordingly, the court took into account the submission made by the counsel that preventing the usage of leaves of Ashwagandha plant's leaves would severely impact the business and passed the interim order.

Adv. Mayur Shetty, Adv. Rushil Mathur, Adv. Rajarshi Chakrabarti and Adv. Sameena Jahangir represented the companies.

Case Title: Sami-Sabinsa Group Ltd.& Ors vs. Union of India & Ors

Case No: WP 14990/2026

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