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For Food Business Operators, Manufacturers & Brand Owners

In India’s competitive food industry, making compelling health claims can be a powerful differentiator for your products. However, the line between persuasive marketing and regulatory non-compliance is razor-thin. A single unapproved or misleading claim could cost you up to Rs. 10 lakh in penalties, or worse, damage your brand reputation irreparably.
The Food Safety and Standards Authority of India (FSSAI) has established a comprehensive framework through the Food Safety and Standards (Advertising and Claims) Regulations, 2018, to ensure all health and nutritional claims made by Food Business Operators (FBOs) are scientifically substantiated, truthful, and not misleading. For claims that go beyond standardized nutrition content statements, specifically disease risk reduction (DRR) claims and novel health benefit claims, prior approval from FSSAI is mandatory.
This guide provides food manufacturers, brand owners, and FBOs with an in-depth, factual roadmap to navigate the FSSAI prior claim approval process successfully in 2026.

Understanding FSSAI Claims Regulations: What You Need to Know

Types of Claims Under FSSAI

The Food Safety and Standards (Advertising and Claims) Regulations, 2018, categorize food claims into several types, including:

1. Nutrition Content Claims: Claims about the presence or absence of specific nutrients (e.g., “High in protein,” “Low fat,” “Rich in Vitamin C”)
2. Nutrition Comparative Claims: Claims comparing nutritional content between products
3. Health Claims: Claims suggesting a relationship between a food and health benefit
4. Disease Risk Reduction Claims: Claims that consumption of a food may reduce disease risk
5. Non-Addition Claims: Claims about not adding certain additives or ingredients

When Prior Approval is Mandatory

You must seek FSSAI’s prior approval when:

• Making Disease Risk Reduction (DRR) Claims that are not already defined and listed in Schedule III of the Advertising and Claims Regulations
• Introducing Novel Health Claims not covered under existing FSSAI regulations
• Using New Ingredients or Substances for health benefit claims that lack established safety data
• Making Claims on Non-Specified Food Products that don’t have standardized definitions under FSSAI regulations

FSSAI prior approval is mendatory if any claims not on the Schedule III list or that address disease risk reduction. Failure to obtain approval can result in penalties and enforcement action.

The Cost of Non-Compliance

False advertisements and claims are punishable offences under Section 53 of the Food Safety and Standards Act, 2006. Non-compliance penalties include:

• Fines up to ₹10 lakh per misleading claim
• Compounding of penalties up to ₹25 lakh for repeat offenses
• Product recall from the market
• License suspension or cancellation
• Mandatory corrective advertising at your expense
• Legal action under the Food Safety and Standards Act, 2006

The FSSAI Prior Claim Approval Process: Step-by-Step Guide

Step 1: Determine If Your Claim Requires Approval

Before initiating the approval process, verify whether your intended claim:

• Falls under Schedule III (which lists approved health claims, no prior approval needed if your claim matches these)
• Is a standard nutrition content claim meeting Schedule I criteria (no prior approval needed)
• Is a novel claim or DRR claim not listed in regulations (requires prior approval)

Please go through the complete Schedule III in the Food Safety and Standards (Advertising and Claims) Regulations, 2018, available on the official FSSAI website: https://shorturl.at/6dMWy

Step 2: Prepare Your Scientific Dossier

The application must be submitted with a dossier according to the checklist of specific claims and associated ingredients. Your Claim Support Dossier (CSD) must include:

Essential Components:

1. Detailed Product Information

• Product name, category, and formulation
• Complete ingredient list with quantities
• Nutritional composition per serving
• Manufacturing process details

2. Scientific Substantiation

• Human intervention studies demonstrating the claimed effect
• Studies should be well-designed, randomized, controlled trials
• Statistical significance of results
• Studies conducted following Good Clinical Practice (GCP) principles
• Publications in reputed, peer-reviewed scientific journals

3. Safety Data

• Toxicological studies
• Adverse effects profile
• Contraindications and interaction studies
• Safe dosage limits

4. Analytical Methods

• Validated method of analysis of ingredient/substance for which the claim has to be made
• Quality control protocols
• Stability data

5. Supporting Documentation

• NABL-accredited laboratory test reports
• Certificate of analysis
• Literature review and meta-analyses (if applicable)

Step 3: Complete the Application Form

The application should be addressed to the CEO, FSSAI, FDA Bhawan, New Delhi or to Advisor (Science and Standards) FSSAI, FDA Bhawan, New Delhi.

Application Details Required:

• Name and address of the applicant (FBO license details)
• Product name and category
• The name of the ingredient/nutrient/substance for which the claim is to be made
• Exact claim statement with justification
• Quantity of nutrients supporting the claim
• Scientific backup for substantiation
• Number of servings per day for claimed benefit

Important Restrictions:

• A maximum of three claims can be applied per application for advertisement and claim approvals
• Each claim must be scientifically distinct and separately justified

Step 4: Fee Submission

The Government charges a fee of INR 50,000 plus GST, per application (per product or ingredient).

Payment Method:

• Demand draft payable to “Senior Account Officer, FSSAI”
• Fee is non-refundable once submitted with the application
• You can Use Online Process too, and for error free submission you can also hire an reputed expert regulatory consultant to make the process smooth.

Step 5: Application Submission

Current Process:
The mode of application is through manual submission as of January 2026. Always verify the latest submission procedures on the official FSSAI website before submitting.

Step 6: FSSAI Scrutiny and Review

Scrutiny of the application thoroughly by the FSSAI claim approval panel follows these steps:

1. Initial Review (Within 90 days)

• If any deficiency is found in the application, applicant will be informed within ninety days from the date of receiving
  Expert committee appointed by Food Authority reviews scientific evidence

2. Query Response (30-day window)

• The applicant is responsible for providing the query response within thirty days. Otherwise, the application may get rejected
• Respond comprehensively to all queries raised

3. Final Decision

• Food Authority may pass the order either for approval/rejection of claims or suggest amendment for the mentioned claim
• Amended claims must be resubmitted within 30 days for reconsideration

Step 7: Post-Approval or Appeal

If Approved:

• There is no fixed date of maturation of this claim license. It is approved for a lifetime; however, subjected to any changes made in the regulations
• Implement the approved claim exactly as worded in the approval order
• Maintain all scientific documentation for future reference

If Rejected:

• If the claim application gets rejected, the FBO should not use the claim. However, they may appeal to the Appellate Authority within thirty days of the issue of the rejection letter
• Review rejection reasons and determine if amendment is possible
• File an appeal with proper justification if warranted

Critical Success Factors for Approval

1. Robust Scientific Evidence

If a claimed health benefit is directly related to food product, it must be based on statistical results from well-designed intervention studies conducted under the guidance of research institutions and comply with the principles of Good Clinical Practices.

Common Pitfalls:

• Using only in-vitro or animal studies without human clinical data
• Insufficient sample sizes in clinical trials
• Studies not published in peer-reviewed journals
• Conflicts of interest not disclosed

2. Accurate Claim Formulation

The claims in advertisements need to be consistent with the information on the label of the food products.

Best Practices:

• Keep claims specific, measurable, and verifiable
• Avoid superlatives like “best,” “perfect,” or “100% cure”
• Don’t promise outcomes beyond what studies demonstrate
• Ensure consistency between labels, advertisements, and claim applications

3. Complete Dossier Submission

If CSD submission is incomplete, the application may be rejected.

Checklist Before Submission:

• All study parameters and designs relevant to the claim
• Comprehensive in-vitro, in-vivo, and human studies data
• Validated analytical methods
• Safety and interaction studies
• Quality assurance documentation

4. Regulatory Alignment

Ensure your product also complies with:

• Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 (if applicable)
• Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016
• Food Safety and Standards (Packaging and Labelling) Regulations, 2020

Timeline and Expectations

The claim approval is a Government process and could take approximately 6 to 12 months, though actual timelines can vary based on complexity and completeness of the application.

Recent Updates and Developments (2025-2026)

Key Regulatory Changes

1. Standardized Implementation Dates: On January 3, 2025, India’s Food Safety and Standards Authority (FSSAI) published order setting July 1 of each year as the date of implementation for any new or amended labeling and display requirement.

2. Enhanced Monitoring: FSSAI has strengthened its Advertising Monitoring Committee to actively monitor claims on social media and e-commerce platforms.

3. Updated Status Tracking: FSSAI regularly updates the list of applications Approved/Rejected/Closed/Withdrawn under regulations as of December 4, 2025, providing transparency in the approval process.

Important Notices

• FSSAI has issued specific notices regarding applications for products formulated with vitamins and/or minerals above one RDA level
• Fee refund policy established for non-specified food applications (November 2022)
• Special guidelines for genetically modified (GM) food applications

Common Mistakes to Avoid

1. Inadequate Clinical Evidence: Relying solely on testimonials, traditional knowledge, or minimal scientific backing
2. Overstating Benefits: Making absolute claims like “cures,” “prevents,” or “treats” diseases
3. Incomplete Applications: Missing critical documents or partial scientific data
4. Ignoring Schedule III: Failing to check if the claim is already approved under existing schedules
5. Poor Quality Studies: Study parameters and designs should be relevant to the claim. The Authority may raise queries or reject the claim if the same is absent
6. Non-Compliance with Label Regulations: Claims that contradict or aren’t supported by label information
7. Missing Deadlines: Not responding to FSSAI queries within 30-day windows
8. Using Unapproved Claims While Awaiting Decision: Marketing products with pending claims before approval