The Ministry of AYUSH has issued a recent advisory regarding the use of Ashwagandha. As per this notification, only the root of Withania Somnifera is permitted for use. The use of leaves is strictly prohibited in any form.
This restriction applies to crude material, extracts, and compound products. The advisory is based on scientific evaluation. The root is considered safe and effective, while the leaves may raise safety concerns due to higher levels of Withaferin A.
The advisory has also been shared with the Food Safety and Standards Authority of India, making it relevant for food businesses.
FSSAI regulatory perspective
The Food Safety and Standards Act, 2006 requires businesses to use safe and suitable ingredients. Companies must ensure that each ingredient meets safety standards.
Further, the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2016 require that ingredients used in nutraceuticals must be safe, scientifically validated, and appropriately described. Any deviation, such as using a non recommended plant part, may be treated as non compliance.
The Food Safety and Standards (Labelling and Display) Regulations, 2020 also require clear declaration of ingredients. This includes specifying the nature and source of botanical ingredients used in the product.
What businesses need to do
- Use only Ashwagandha root in formulations
- Avoid the use of leaves in any form
- Ensure accurate declaration of plant part on the label
Non compliance may lead to regulatory action, including product recall or license level consequences. Businesses should review formulations and documentation to ensure alignment with both AYUSH and FSSAI requirements.
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