A claim is the fastest way to sell a supplement and the fastest way to trigger a regulatory notice. The Food Safety and Standards (Advertising and Claims) Regulations, 2018 set out which claims are permitted, which require substantiation, and which are prohibited outright for food and health supplements in India.
We assess every claim on your pack, website and campaign material against the regulations, tell you which will stand, and prepare the substantiation dossier where prior approval is required.
Who is this service for?
- Brands preparing a launch campaign with nutrition or health claims
- Manufacturers whose artwork carries functional or structure/function wording
- Businesses that have received a notice about advertising or claims
- Exporters aligning Indian claims with FDA or EU positions
What is included?
- Claim-by-claim classification: nutrition, health, structure/function or prohibited
- Substantiation review against available scientific evidence
- Prior-approval applications where the claim requires them
- Advertising and campaign copy review before publication
- Written opinion referencing the specific clause for each decision
How does the process work?
- 1Share the proposed claims with product composition and evidence
- 2Classification and gap assessment issued in writing
- 3Substantiation dossier prepared where approval is needed
- 4Filing and query handling with the authority
Which documents will you need?
- Proposed claim wording for pack and campaign
- Complete product composition with quantities
- Scientific references or study reports supporting the claim
- Existing artwork and marketing material
How long does it take?
Within one week
Claim classification and a written opinion are typically issued within a week of receiving complete information. Where prior approval is required, the authority timeline governs and varies by claim type.
How long is it valid?
A claim opinion or approval attaches to the exact wording, the product composition and the serving size that were assessed. Reformulate the product or change the wording and the assessment no longer covers it, so claims are re-checked at every artwork revision.
Common mistakes we correct
- Borrowing claim wording from a foreign label that Indian regulations do not permit
- Treating a disease-risk-reduction claim as an ordinary nutrition claim
- Publishing campaign copy that goes further than the approved pack claim
- Holding evidence that supports the ingredient but not the finished product
Frequently Asked Questions
Which claims need prior approval from FSSAI?
Nutrition claims that follow the prescribed conditions generally do not need prior approval, while health claims and any claim not covered by the permitted list typically do. We classify each claim before you commit it to artwork.
What evidence does FSSAI expect to substantiate a health claim?
Substantiation is assessed against the finished product as it is sold, not the ingredient in isolation. That means evidence at the dose and format your product actually delivers, with a clear line from the published literature to the exact wording you intend to print on pack. Holding strong evidence for an ingredient generally, but not for your formulation at your serving size, is the most common reason a claim is refused.
Do claim rules apply to my website and social media?
Yes. The Advertising and Claims Regulations apply to advertising in any medium, not only the pack, so website copy, marketplace listings and campaign creatives are all in scope.
Regulations that apply
- FSS (Advertising and Claims) Regulations, 2018
- FSS (Labelling and Display) Regulations, 2020
- Food Safety and Standards Act, 2006