FSSAI Advisory: Mandatory Labelling and Warning Requirements for Plant-Based Ingredients and Extracts

Introduction

FSSAI’s advisory dated 15 October 2026 directs manufacturers of health supplements, nutraceuticals, Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) to immediately comply with mandatory labelling and warning requirements for plant-based ingredients and their extracts. The advisory aims to protect consumer safety and prevent misleading claims under the Food Safety and Standards Regulations, 2016, particularly Schedule IV.

Why Botanical Labelling Compliance Is Essential

Accurate labelling helps consumers identify botanical ingredients and understand associated precautions. Manufacturers must declare the plant part used and include the applicable warning or cautionary statement specified in Annexure I.

Examples of Botanical Ingredients and Their Cautionary Statements

Please Note: These are examples from the advisory, not an exhaustive list. Manufacturers should refer to Annexure I for the applicable botanical ingredient, permitted usage range and exact cautionary statement.

Key Requirements for Food Business Operators

FSSAI directs the manufacturers covered by the advisory to ensure immediate compliance with the following requirements:

1. Declare the plant part used: Clearly indicate the relevant part of the botanical ingredient used, such as the leaf, root, seed, flower or fruit, as applicable.
2. Include mandatory warnings: Display the specific disclaimer, cautionary statement or warning prescribed for the individual botanical ingredient in Annexure I.
3. Follow prescribed usage limits: Ensure that botanical ingredients comply with the applicable permitted usage limits.
4. Ensure accurate labelling and claims: Review product labels and claims to prevent misleading representations and ensure compliance with applicable food regulations.
5. Review existing products: Check current formulations and labels, identify gaps and make the necessary corrections to achieve immediate compliance.

Annexure I: Botanical Ingredients and Cautionary Statements

Annexure I identifies individual botanical ingredients, their botanical and common names, plant parts used, permitted daily usage ranges and applicable cautionary statements.

The uploaded advisory contains 16 numbered entries. 

Examples of cautionary statements visible in the annexure include:

• Not recommended for males and females planning to conceive.
• Not recommended during pregnancy.
• Not recommended for children below 5 years.
• Not recommended for children below 5 years and pregnant women.

Important: These statements apply to specific botanical ingredients as listed in the annexure; they should not be treated as universal warnings for all botanical ingredients.

Monitoring and Regulatory Compliance

The advisory highlights the need for manufacturers to comply with the applicable provisions of the 2016 Regulations and the labelling requirements specified in Schedule IV.

What This Means for Manufacturers

Manufacturers of health supplements, nutraceuticals, FSDU and FSMP should review their botanical ingredients, formulations and product labels against the applicable regulatory requirements