The Karnataka High Court has issued an interim stay on the Food Safety and Standards Authority of India (FSSAI) advisory that restricted the use of ashwagandha in health supplements. This decision provides temporary relief to manufacturers and suppliers of products containing this popular herbal ingredient.
Background of the Advisory
The FSSAI had issued an advisory in early 2025, directing that ashwagandha (Withania somnifera) should not be used as an ingredient in health supplements due to safety concerns. The regulatory body cited potential adverse effects on certain individuals, including liver toxicity and hormonal imbalances. This move had sparked widespread concern among Ayurvedic practitioners and the nutraceutical industry.
Court's Intervention
Hearing a petition filed by the Ayurvedic Drug Manufacturers Association and other stakeholders, the Karnataka High Court observed that the FSSAI advisory lacked scientific backing and was issued without adequate consultation. The court noted that ashwagandha has been used safely for centuries in traditional medicine and that the advisory could cause irreparable harm to the industry.
The bench, comprising Justice Krishna S. Dixit and Justice V. Srishananda, stated that the FSSAI must provide substantive evidence to justify the restriction. Until then, the advisory stands stayed. The court also directed the central government to respond within four weeks.
Industry Reaction
The stay order has been welcomed by manufacturers and exporters of ashwagandha-based products. Industry representatives argued that the FSSAI advisory was arbitrary and could have crippled a sector that contributes significantly to India's economy. They emphasized that ashwagandha is a well-researched adaptogen with numerous health benefits, including stress reduction and immune support.
Dr. P. M. Unnikrishnan, a senior Ayurvedic physician, commented, "Ashwagandha has been a cornerstone of Ayurveda for millennia. The court's decision respects traditional knowledge while demanding scientific rigor."
Next Steps
The matter is scheduled for further hearing in March 2025. The court has asked the FSSAI to submit a detailed report on the scientific basis for its advisory. Meanwhile, the stay allows the continued manufacture and sale of ashwagandha supplements, provided they comply with existing labeling and quality standards.
This case highlights the ongoing tension between modern regulatory frameworks and traditional medicine practices. As the legal process unfolds, stakeholders await a balanced resolution that ensures consumer safety without stifling heritage-based industries.
