Court Issues Interim Stay
A significant interim order has been issued by the Karnataka High Court, placing a hold on an advisory from the Food Safety and Standards Authority of
India (FSSAI). This advisory had previously banned the incorporation of Ashwagandha leaves or their extracts into health supplements. The High Court's decision, presided over by Justice S R Krishna Kumar, specifically applies to the petitioners involved in the case, namely Sami-Sabinsa Group Ltd and Kerry Inc. The stay is effective until the next scheduled court hearing, providing a temporary reprieve for the companies that challenged the FSSAI's directive. The move comes after the Union Ministry of Ayush flagged potential safety issues associated with the use of Ashwagandha leaves.
Concerns Over Leaf Compounds
The FSSAI's advisory was prompted by safety concerns highlighted by the Ministry of Ayush, particularly relating to compounds found in Ashwagandha leaves. It is understood that Ashwagandha leaves may contain elevated levels of reactive withanolides, with a notable mention of withaferin-A. These specific compounds have been linked to potential adverse health effects, including toxicity to the liver, digestive discomfort, and even possible neurotoxic impacts. Ashwagandha itself is widely recognized as an adaptogen and is commonly used in supplements aimed at enhancing strength and sexual well-being, predominantly for men. The debate centers on whether the benefits of using the entire plant, including leaves, outweigh these identified risks.
Manufacturers' Legal Arguments
Representing the petitioners, Senior Advocate K G Raghavan presented key arguments before the court. He emphasized that the companies involved manufacture their products through contract manufacturers specializing in Ashwagandha. Crucially, Raghavan pointed out that the production of Ashwagandha, utilizing roots, extracts, and including leaves, adheres to the established guidelines set forth in the Food Safety and Standards (Health Supplements, Neutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations of 2016. These regulations were formulated under Section 92 of the Food Safety and Standards Act, 2006. Furthermore, he argued that a blanket prohibition on specific plant parts within a health supplement cannot be enacted through a mere advisory notice; it necessitates an amendment to the existing 2016 Regulations. The companies also highlighted their long-standing practice, having utilized Ashwagandha leaves in their product manufacturing for over three decades.
Impact and Future Proceedings
The advisory issued in April had instructed Ayush drug manufacturers, exporters, and sellers to refrain from using Ashwagandha leaves in any form—whether crude, extracted, or otherwise—in their products. Raghavan's submission underscored the significant business repercussions such a prohibition would have on the petitioner companies. In response to these arguments, the counsels representing the Union Government and the FSSAI requested additional time to formally submit their objections to the petitions. Following this exchange, the court delivered its interim order, granting the stay, and has scheduled the next hearing for June 8 to further deliberate on the matter.
