FSSAI Advertisement & Claims Approval for Food Supplements and Nutraceuticals in India - FSSAI Advertisement & Claims Approval
CliniExperts is an Authorised Regulatory Solution Provider in India. They facilitate end-to-end solutions for clients and assist them in launching their products. Further, CliniExperts is engaged in procuring and enabling claim approvals for different products. It has a well-committed team who walks with its client in every step of its journey. This makes the regulatory process easier and faster with minimal paperwork. They also help in obtaining the claim approvals for Supplements and Nutraceuticals products.
FSSAI Advertisement & Claims Approval - For Food Supplements & Nutraceuticals – Overview
The Food Safety and Standards Authority of India (FSSAI) regulates Claims and Advertisements. Manufacturers or importers of nutritional and health products must obtain approval before making any health, nutritional, or risk reduction claims. This is essential to prevent misleading advertisements and protect consumers. The FSS Regulations, 2018 aims to develop fairness in claims and advertisements of food products. A penalty of Rs. 10 lakh will be charged per misleading claim and may be compounded up to Rs. 25 lakhs. Thus, it is essential to obtain claim approval to protect the food business from these fines.
To apply for FSSAI Advertisement & Claims Approval, applicant must follow this process:
- The applicant must submit a dossier with a duly filled application form and pre-requisite government fees of Rs. 50,000.
- Food Authority will appoint an expert committee to conduct scrutiny of application to approve the claims.
- If any deficiency is found in the application, applicant will be informed within ninety days from the date of receiving.
- The applicant is responsible for providing the query response within thirty days. Otherwise, the application may get rejected.
- Food Authority may pass the order either for approval/rejection of claims or suggest amendment for the mentioned claim.
- The amended claim should be submitted to the Food Authority within thirty days for reconsideration.
- 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.
- If Appellate Authority also rejects the claim, FBO may file a review petition before the FSSAI Chairperson within thirty days. The decision of the Chairperson is final.
- The timeline for obtaining the FSSAI Advertisement & Claims Approval is approximately one-eighty days.
Who Can Apply?
Any Indian manufacturer, importer, marketer or re-labeller of Food Supplements can apply.
How To Apply?
The Applicant must follow the following process:
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The applicant must check for the feasibility of claim approval associated with the product.
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The applicant must prepare the Claim Support Dossier (CSD) in prescribed formats along with data suggested by FSSAI.
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As a pre-requisite charge, the applicant must prepare a demand draft of Rs. 50,000.
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The applicant must submit the duly filled application form, CSD, and demand draft to the FSSAI Office.
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The maximum claim per application is three claims.
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Finally, the applicant must wait until the application scrutiny/query/approval/rejection is done.
Important Documents
The following is the list of documents and details required during the application process:
- Applicant name and address
- Applicant should provide the name, email address and contact number of the authorized signatory
- Category of license should be provided
- License number
- Validated method of analysis of ingredient/substance for which the claim has to be made.
- The name of the ingredient/ nutrient/ substance for which the claim is to be made.
- Claim statement along with justification.
- Interaction/Possible Adverse Effects/Contraindications /Advisories on the food products etc.
Timeline to get
FSSAI Advertisement & Claims Approval
from FSSAI
180
DAYSEssential Tips
The following are some essentials tips:
- The applicant must ensure a valid method of analysis of the ingredient or substance for which the claim is to be made is mentioned.
- The applicant should mention the quantity of all the nutrients for the respective claim.
- The claim should mention the nutritional components in the specific product.
- The applicant should ensure the Scientific backup substantiation for the claim is made.
- A complete Claim Support Dossier (CSD) with all the details must be submitted. Some roadblocks faced during the application process can be easily avoided by keeping these points in mind:
- The study parameters and designs should be relevant to the claim. The Authority may raise queries or reject the claim if the same is absent.
- If CSD submission is incomplete, the application may be rejected.
Expert Advise
CliniExperts provides some advice for its client:
If a claimed health benefit is directly related to food product, it must be based on statistical results from well-designed intervention studies. These studies should be conducted under the guidance of research institutions. It should comply with the principles of Good Clinical Practices and be published in a reputed scientific journal.
The claims in advertisements need to be consistent with the information on the label of the food products or beverages.
In-vitro, in-vivo and human studies data must include comprehensive details. These include material tested, test system used, biomarkers, performance indicators, results obtained etc.
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Frequently Asked Questions
How many claims can be applied for per application?
A maximum of three claims can be applied per application for advertisement and claims approvals for Food Supplements and Nutraceuticals.
Is the application fee of INR 50,000 refundable?
No. Once the fee is submitted along with the application, it is not refundable.
To whom does the application need to be addressed, and what is the mode of application?
The application must be addressed to the CEO, FSSAI, FDA Bhawan, Kotla Road, New Delhi -110002 or Advisor (Science & Standards). The current mode of application is offline. However, this mode of application may be shifted to online mode on the ePAAS portal.