Regulator Clarifies Permitted Plant Parts
The Food Safety and Standards Authority of India (FSSAI) has directed food business operators to discontinue the use of ashwagandha leaves in food products, nutraceuticals, health supplements, and related categories.
The regulator clarified that existing regulations permit only the use of ashwagandha roots and root extracts, subject to prescribed limits. The advisory follows findings that certain manufacturers were using leaf-derived ingredients despite the regulatory restriction.
Compliance Requirements for Industry
FSSAI stated that Schedule IV of 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 permits only root-based ashwagandha ingredients.
Manufacturers using leaf extracts, leaf powders, or other leaf-derived forms in regulated food and nutraceutical products have been instructed to cease their use. Non-compliance may attract action under the Food Safety and Standards Act, 2006.
The advisory applies to health supplements, nutraceuticals, foods for special dietary use, and foods for special medical purposes.
Implications for Nutraceutical and Ingredient Manufacturers
Ashwagandha (Withania somnifera) remains one of India’s most widely used Ayurvedic botanicals. However, the regulatory clarification reinforces the importance of ingredient traceability and plant-part verification within product development and quality systems.
For nutraceutical manufacturers, contract manufacturers, and ingredient suppliers, the development may require formulation reviews, supplier audits, and documentation updates to ensure regulatory compliance.
The move also highlights increasing regulatory scrutiny of botanical ingredients and the need for alignment between traditional usage claims and approved ingredient specifications.