India · Supplements

Claims Substantiation in India

A practical guide to Claims Substantiation for supplements sold in India: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Health and nutrition claims must be authorised and supported by evidence; Online sellers listing supplements for buyers in India

Authority

Food Safety and Standards Authority of India

Legal basis

FSSAI nutraceutical regulations

Local representative

A local notifying entity is required

Timeline

Before sale; notification review takes weeks

Cost

Dossier and testing costs vary by ingredient

If you do not comply

Seizure, fines, and listing removal

Who needs this

Health and nutrition claims must be authorised and supported by evidence
Online sellers listing supplements for buyers in India

Documents you need

Claims substantiation file
Ingredient and dosage review
Product information file
GMP certificate

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Claims substantiation file
Ingredient and dosage review
Product information file
GMP certificate

How to comply

Check each claim against the permitted list
Check whether ingredients are permitted locally
Prepare the product information file
Register or notify where required

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: Claims Substantiation — India
Product category: Supplements
Authority: Food Safety and Standards Authority of India
Legal basis: FSSAI nutraceutical regulations

Documents we already have:
  1. Claims substantiation file
  2. Ingredient and dosage review
  3. Product information file
  4. GMP certificate

Questions:
  1. Does our product fall under Claims Substantiation in India?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before sale; notification review takes weeks.

Dossier and testing costs vary by ingredient.

Common rejection reasons

Disease prevention claim without authorisation
Ingredient not permitted
Claims too strong for the category
Label missing required warnings

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.