The Food Safety and Standards Authority of India (FSSAI) has issued an advisory dated 16 April 2026 clarifying that Ashwagandha leaves are not permitted in crude, extract, or any other form in food products.
This applies to product categories such as health supplements, nutraceuticals, food for special dietary use (FSDU), and food for special medical purpose (FSMP), where only Ashwagandha roots and their extracts are permitted as per existing regulations.
FSSAI also noted that certain manufacturers were using Ashwagandha leaves in their products, which is not allowed under the applicable regulatory framework.
Why This Advisory Matters for Businesses
This update is important for manufacturers, importers, and brands dealing with nutraceuticals and health supplements.
Non-compliance can result in:
- Product rejection
- Regulatory queries
- Delays in approvals
- Possible penalties
Understanding FSSAI regulatory compliance for nutraceuticals & supplement in India is essential to ensure smooth operations and avoid compliance risks.
What Businesses Should Do
Businesses using Ashwagandha should immediately review:
- Product formulation
- Ingredient sourcing
- Label declarations
- Regulatory documentation
- Product category alignment
Ensuring correct usage of permitted plant parts is critical for compliance.
Compliance Takeaway
If your product contains Ashwagandha, ensure that only the roots and their extracts are used in accordance with FSSAI guidelines.
For businesses needing guidance, understanding FSSAI compliance and regulatory services for supplement & nutraceutical products in India is essential.
Failure to comply with regulatory requirements may lead to action under applicable laws and impact product approvals.
How Regacats Solutions Can Help
At Regacats Solutions, we assist businesses with regulatory compliance, documentation, and formulation review to align with FSSAI requirements.
contact@regacats.in
+91 9211921474
About Regacats Solutions
Regacats Solutions is an India-based regulatory consulting firm specializing in CDSCO cosmetic import licensing, medical device import registration, and FSSAI regulatory compliance. With extensive experience supporting Indian importers and global cosmetic brands, we assist with COS-1 and COS-2 registration, labeling compliance, Legal Metrology requirements, and post-approval regulatory obligations. Our team focuses on India-specific compliance frameworks to ensure faster approvals, accurate documentation, and long-term regulatory compliance.
Content Reviewed by
Regulatory Experts at Regacats Solutions
Specialists in CDSCO cosmetic import licensing, Legal Metrology compliance, EPR authorization, medical device import registration, and FSSAI regulatory consultant in India.
Conclusion
The recent FSSAI advisory clearly reinforces the importance of using only permitted ingredients and plant parts in regulated food categories. With Ashwagandha leaves now explicitly not allowed, businesses must ensure that their formulations, sourcing, and labeling are fully aligned with current regulatory requirements.
Proactive compliance not only helps avoid regulatory action and delays but also ensures smoother product approvals and market continuity. Staying updated with regulatory changes and implementing them correctly is essential for long-term business success in the food and nutraceutical sector.
To understand how these changes apply to your products and to ensure full compliance, explore our FSSAI Consultancy Services for Nutraceuticals & Dietary Supplements Import in India and get expert support tailored to your business needs.
