The regulatory body that supervises all food-related claim approvals in India is the Food Safety and Standard Authority of India (FSSAI). The purpose of this service is to provide a claim approval before launching any product into the market. The claim could be related to disease risk reduction but is not limited to this or other claims that might not be listed under schedule 3 of the Food Safety Standards (Advertisement & Claims) Regulations, 2018.
The claim approval is a Government process and could take approximately 180 days.
The process involved in this claim approval is as follows:
Any importers, producers, marketers, or re-labelers of food products based in India who want to make claims about the efficacy of their products, disease risk reduction claim, ingredient-led health benefits claim, product-led claim, enhanced function claim, etc. can apply through this service.
|Step 1: Checking the feasibility of the claim approval for the substance, nutrient, or product.|
|Step 2: Preparing a claim support dossier (CSD) with the necessary information, including published scientific data from in-vitro, in-vivo, human studies, and cause-and-effect studies with all the details of the study. The CSD should be made in the prescribed format|
|Step 3: Fill out the Application form for “Approval of Claims on Food Products” in Annexure A with all the required information, including Name, Address, License No., License Category, Product Category, Claim Statement & Justification, and Claim Support Dossier. It should be signed by the authorized signatory.|
|Step 4: Preparation of a demand draft (DD) of INR 50,000.|
|Step 5: Submission of the duly filled Application form along with DD and CSD to FSSAI for max. three claim statements per application.|
|Step 6: The Expert Committee at FSSAI will scrutinize the claim. On scrutiny, deficiencies, if any, shall be informed to the applicant within 90 days from the date of receipt of the claim application.|
|Step 6: Within 30 days of receiving the letter, the applicant (FBO) must submit the information requested by the food authority; otherwise, the application will be denied without further discussion.|
|Step 8: The Food Authority may accept, deny, or advise a modification for the relevant claims following additional examination.|
|Step 9: Within 30 days, the revised statement from the FBO may include the revised claim that FSSAI recommended and be submitted to the Food Authority for reconsideration.|
|Step 10: Application approval or rejections by Expert Committee.|
|Step 11: In case of rejection, following 30 days after the issuance of the Rejection Letter, FBO may appeal to the Appellate Authority.|
|Step 12: In case of rejection by the Appellate Authority disapproves, thirty days after the Appellate Authority’s refusal, the FBO may submit a review petition to the Chairperson of the FSSAI.|
|Step 13: The Chairperson’s decision is final and binding.|
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.
Government timeline is 180 days approx.
The expert professionals at CliniExperts have some essential tips that can be kept in mind before going for claim approval to FSSAI:
Applicant should not fill more than 3 claim statements in one application.
The claim should refer to the nutritional components, or the mix of nutritional components, in the specific product.
Applicant should adequately mention the quantity of all the nutrients for the respective claim.
Potential potholes that could be faced while filling out the application and that can be easily avoided by are -
The summary of the in-vitro data needs to be included with he claims statement, such as tested Material, purity, standardisation/ marker compound/activity tested.
In in-vitro data, the details of the NTCC/ACCN no./Cell lines/organ culture/tissue culture/or any other system should be clearly defined.
In addition, the details of the concentrations tested and positive and negative controls used in the experiment need to be mentioned.
If the aforementioned information is not supported by documentation, the application or claim statement risk being further questioned or rejected.
The professional team of CliniExperts advices to-
Complete reference journals with confirmatory evidence are required to support the references listed as confirmatory evidence for the claim statements.
It is preferable to provide details of the study report with the name of the institute or lab where the study was undertaken along with its accreditation status and a confirmatory authenticated copy of the same, if the reference journal is not published in a peer-reviewed publication.
Considering that this is the most current and complex approval requirement detailed by the FSSAI, it is possible that FBOs might make mistakes unintentionally. Therefore, it is always advisable to seek the guidance and support of regulatory experts when putting this dossier together.
The FSSAI must approve any claims, not on the Schedule III list or that address disease risk reduction; otherwise, a penalty of about INR 10 lakh per misleading claim may be compounded up to INR 25 lakhs imposed. Therefore, seeking advertisement claim clearance is advised to protect your business and goods from these fines.
The mode of application is through a manual submission process. The application should be addressed to the CEO, FSSAI, FDA Bhawan, New Delhi or to Advisor (Science and Standards) FSSAI, FDA Bhawan, New Delhi.
The Government charges a fee of INR 50,000 per application (per product or ingredient) that can be submitted through a demand draft payable to the Senior Account Officer, FSSAI.
A maximum of three claim statements can be addressed in one application.
The claims approved by FSSAI should not be usedto promote the sale, supply, use and consumption of food articles, explicitly attributing it to the FSSAI logo or license number in any way.