The Food Safety and Standards Authority of India (FSSAI) has released a new advisory concerning the incorporation of Ashwagandha (Withania somnifera) in food items. This advisory delineates standards for various categories, including health supplements, nutraceuticals, and foods aimed at special dietary or medical use. These guidelines fall under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.

The advisory specifically references Schedule IV of these regulations, which enumerates the botanicals that are permissible in such products. Under these stipulated guidelines, only the roots and extracts of Ashwagandha are sanctioned for use in defined categories like health supplements and special dietary foods, provided they adhere to specified limits.

FSSAI has emphasised the importance of compliance, particularly concerning the parts of the Ashwagandha plant that can be utilised. The authority has identified that some manufacturers have been incorporating leaves and their extracts into their products, a practice that is explicitly prohibited by existing regulations.

Clarification on Product Composition

The advisory further elaborates that manufacturers should not use Ashwagandha leaves in any form, including crude or extract. This point has been reiterated due to reports that some companies were violating this guideline. The FSSAI stated, “It has been brought to the notice of FSSAI that certain manufacturers of these products are using ashwagandha leaves and their extracts in their products. In this regard, it is clarified that the use of Ashwagandha leaves in crude or extract or any other form is not permitted under the said regulations.”

This clarification aligns with earlier directives from the Ministry of Ayush, which explicitly instructed manufacturers in the Ayush sector to restrict their use to Ashwagandha roots and their extracts. The intention behind these regulations is to ensure the safety and efficacy of products formulated for health and dietary purposes.

Moreover, the FSSAI has advised all Food Business Operators (FBOs) to adhere rigorously to these provisions. The authority indicated that any deviations from the stated rules would incur repercussions under the Food Safety and Standards Act, 2006, and the regulations created in accordance with it.

Compliance and Monitoring Measures

To bolster compliance, the FSSAI has directed the Commissioners of Food Safety across all States and Union Territories, as well as Regional Directors, to engage licensing authorities and food safety officers. These officials have been asked to maintain stringent oversight to ensure adherence to the established guidelines for Ashwagandha usage.

The advisory underscores the necessity of adherence to these regulations, suggesting that any observed non-compliance would trigger appropriate action under the Food Safety and Standards Act, 2006. The approach taken by FSSAI reflects a commitment to consumer safety and the integrity of food products available in the market.

Given the increasing popularity of herbal products, the FSSAI’s advisory marks an essential step in regulating the use of botanicals in food products. It aims to protect consumer interests while promoting responsible formulation practices in the industry.

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