FSSAI Claim Approval: Food Claims and Advertisement Compliance
FSSAI claim approval is needed when a food label or advertisement makes a reduction of disease risk claim that the regulations do not already define. Most other claims need no prior approval, but they must meet the 2018 Advertising and Claims Regulations. We review your claims, prepare the dossier and handle FSSAI queries.
What it is
Every claim on a food pack, website or advertisement, from "high protein" to "helps reduce cholesterol", is governed by the Food Safety and Standards (Advertising and Claims) Regulations, 2018. Regulation 4 says claims must be truthful, unambiguous, meaningful and not misleading. Some claims are allowed if you meet the conditions. One kind needs FSSAI's prior approval. Others are banned outright.
Regulation 11 requires prior approval for reduction of disease risk claims beyond those the regulations or other rules already define. Regulation 10 bars claims that a food prevents or treats disease unless specifically permitted. Nutrition claims follow Regulation 5 and Schedule I. Health claims follow Regulation 7. Section 24 of the Food Safety and Standards Act, 2006 prohibits misleading advertisements, and FSSAI also issued an advisory on 31 May 2025 asking operators not to use "100%" on labels.
Who it applies to
Brand owners making health claims
Say a snack brand wants "good for your heart" on its pack. A supplement, snack or beverage brand that wants to say a product supports a body function needs the right words and the right evidence behind them.
Companies planning a disease risk claim
If your pack says a food reduces the risk of a disease, and that claim is not already defined, you must apply to FSSAI under Regulation 11.
Marketers and e-commerce sellers
Website copy, influencer videos and marketplace listings count as advertisements. The same rules apply there as on the pack.
Why it matters
Avoid a penalty
Under Section 53 of the Act, a person who publishes or is party to an advertisement that falsely describes food can face a penalty of up to ₹10 lakh.
Protect your listings
Marketplaces and retail chains often ask for proof behind a claim. A reviewed claim with evidence on file answers that request quickly.
Build a claim that stands
Evidence gathered at the start also supports your label, brochure and distributor material, so you say the same thing everywhere.
Documents required
Product details
- FSSAI licence or registration of the manufacturer
- Full composition and label draft
- Description of the exact claim and where it will appear
Scientific evidence
- Scientific substantiation for the claim
- Validated methods of analysis for the nutrient or ingredient
- Human intervention studies, where a health claim needs them
Test and company papers
- Lab test reports from an accredited laboratory
- Authorisation letter for the applicant
- Marketing copy, artwork and advertisement scripts
Which claims need approval and which do not
| Type of claim | Rule | Prior approval? |
|---|---|---|
| Nutrient content or comparative claim | Regulation 5, Schedule I conditions; a comparative claim needs at least a 30% difference in energy or nutrient, or 10% of RDA for micronutrients | No, if conditions are met |
| Nutrient function or other function claim | Regulation 7, current scientific substantiation | No, but evidence must be on file |
| Reduction of disease risk beyond defined claims | Regulation 11 | Yes |
| Claim that food prevents or treats disease | Regulation 10 | Not permitted unless specifically allowed |
How it works
Audit every claim and label
We list each claim on your pack, website and ads, and sort them into permitted, needs-evidence, needs-approval and not allowed.
Fix the easy ones first
Many claims fail only on wording or a missing disclosure. We redraft them so they fit Regulations 4, 5 and 7 without any application.
Prepare the Regulation 12 dossier
For a claim that needs approval, we assemble the claim description, validated methods, scientific substantiation and, for health claims, human intervention studies.
File and answer FSSAI queries
We submit the application, track it and prepare replies. Under Regulation 12 the Authority has 90 days to point out deficiencies.
Timelines
Review
An audit of a small product range is usually quick. A large catalogue with many claims takes longer.
Deficiency check
The Authority has 90 days under Regulation 12 to identify deficiencies in your application.
Clarifications
Regulation 14 sets a clarification procedure with 30-day response and 90-day determination timelines. Keep your replies ready.
What happens if you make an unapproved claim
Penalty under the Act
Regulation 13 provides penalty under Section 53 of the Food Safety and Standards Act, which can extend to ₹10 lakh for falsely describing food.
Withdrawal of labels and ads
FSSAI has asked operators to pull misleading labels and advertisements. Reprinting packs and pulling campaigns costs far more than a review.
Marketplace takedown
Retail partners can delist products when a claim is challenged. A documented claim file protects you.
Frequently asked questions
What is FSSAI claim approval?
It is FSSAI's prior approval of a reduction of disease risk claim under Regulation 11 of the Advertising and Claims Regulations, 2018. You apply with the claim description, validated analysis methods and scientific evidence. Most other claims need no approval, but must meet the conditions. We review your claims and prepare any application for you.
Which food claims need prior approval from FSSAI?
Regulation 11 requires prior approval for reduction of disease risk claims that go beyond those defined in the regulations or other rules. Nutrient content, comparative and function claims do not need prior approval if you meet the stated conditions and hold the evidence. We sort your claims, so you apply only where you must.
What does an application under Regulation 12 contain?
It contains the description of the claim, validated methods of analysis, scientific substantiation and, for health claims, human intervention studies. The Authority has 90 days to identify deficiencies. A complete dossier reduces back-and-forth. We prepare the file, check each item, and reply to FSSAI's queries on your behalf.
Can I say a food prevents or cures a disease?
No. Regulation 10 bars claims that a food prevents, treats or cures disease unless specifically permitted. It also bars claims that a medical professional recommends the food. If you want to speak about a health benefit, we help you find permitted wording that is accurate and safe to print.
What is the penalty for a misleading food advertisement?
Section 53 of the Food Safety and Standards Act, 2006 provides a penalty that may extend to ₹10 lakh for publishing, or being party to, an advertisement that falsely describes food. Regulation 13 links the Advertising and Claims Regulations to this section. A claim review before printing costs a fraction of that.
Does the rule apply to websites and social media?
Yes. The Act prohibits misleading advertisements in any medium, and the claims rules apply to advertisements for food, whether on a pack, a website, a marketplace listing or a video. We check your online copy alongside your label so that both carry the same, consistent claims.
Can I use the term 100% on my label?
FSSAI issued an advisory on 31 May 2025 asking all food business operators to refrain from using the term 100 per cent on food labels, citing its potential to mislead. If your pack uses it, we suggest a safer wording after checking the facts about your product and label.
Does Taxhint certify the science behind my claim?
No. The scientific evidence comes from your product studies and accredited laboratories, and any scientific expert opinion you rely on is theirs. Taxhint reviews your claims against the regulations, prepares the dossier, files the application and answers FSSAI queries, so you have one team handling the paperwork.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
FSSAI may charge a fee for an approval application, and laboratory and study costs are separate. We confirm the current fee from FSSAI before quoting.
Ready to begin?
Send us your label, website copy and the claim you want to make, and we will tell you what needs approval.