Exploring Functional Food Supplements: A Manufacturer's Handbook

Regulatory Body Requirement

FSSAI Food Product compliance ensures that products adhere to the essential requirements set forth by FSSAI through directives, standards, and regulations. It applies to manufacturers, marketers, sellers, and FBOs involved in storing and distributing food supplements and nutraceuticals. Compliance with FSSAI Product regulations is overseen by FSSAI and related bodies like Legal Metrology, where applicable. The service aims to verify that product formulations and labels align with FSSAI standards, involving an analysis of the formulation to ensure compliance with regulations.

Essential Tips

Here are some key tips for achieving FSSAI food compliance:

1. Ensure accurate listing of all ingredients and additives.
2. Adhere to the quality standards set by FSSAI for the product.
3. Ensure compliance with the latest Food Safety and Standards (Labelling and Display) Regulations, 2020, for the product label.
4. Consider reformulating the product, if necessary, to eliminate non-compliant ingredients or to enhance its value and potentially bypass the need for NSF approval.
5. Step 5: After the review, the State Licensing Authority will grant the manufacturer permission and the manufacturing license in Form MD-5

Regulatory Body Requirement

The Food Safety and Standards Authority of India (FSSAI) oversees Claims and Advertisements for Food Supplements and Nutraceuticals in India. Manufacturers of nutritional and health products must obtain prior approval before making any health or nutritional claims, or claims related to the reduction of disease risk, to ensure consumers are not misled by advertisements. The FSS (Claims and Advertisements) Regulations, 2018, aim to promote fairness in the claims and advertisements of food products.

How to Apply

1. Step 1: The applicant must check for the feasibility of claim approval associated with the ingredient/nutrient/product.
2. Step 2: The applicant must prepare the Claim Support Dossier (CSD) in prescribed formats along with data suggested by FSSAI.
3. Step 3: As a pre-requisite charge, the applicant must prepare a demand draft of Rs. 50,000.
4. Step 4: The applicant must submit the duly filled application form, CSD, and demand draft to the FSSAI Office.
5. Step 5: The maximum claim per application is three claims.
6. Step 6: Finally, the applicant must wait until the application scrutiny/query/approval/rejection is done.

Regulatory Body Requirement

The Food Safety and Standards Authority of India (FSSAI) oversees food-related licensing in India. Manufacturers of functional food supplements are required to possess a valid FSSAI License. This license ensures that Food Business Operators (FBOs) are registered with FSSAI, facilitating compliance with regulations such as food safety audits, annual returns, product testing, and recalls. It serves as a mechanism for FBOs to ensure adherence to FSSAI licensing guidelines.

How to Apply

1. Step 1: Visit the FoSCoS website for food licensing and registration.
2. Step 2: Register and log in on FoSCoS with a username, password, and captcha.
3. Step 3: Select "Apply for New License/Registration" from the dashboard.
4. Step 4: Provide necessary details regarding premises and types of businesses (KoBs).
5. Step 5: Complete Form B and attach required documents like Aadhaar Card, Form IX, and proof of premises.
6. Step 6: Preview and submit the application, then proceed with payment.
7. Step 7: Upon payment completion, receive a receipt with a 17-digit reference number for future use.
8. Step 8: The Food Authority grants the license after scrutinizing the application and documents.

Regulatory Body Requirement

The Food Safety and Standards Authority of India (FSSAI) is the governing body responsible for approving all food products in India. This service aims to grant approvals for Non-Specified Ingredients/Products - for Food Supplements to manufacturers prior to product launch. The approval process typically spans from six to twelve months.

How to Apply

The applicant must follow these steps:

1. Step 1: Prepare the dossier in the specified format, including necessary scientific information and study details.
2. Step 2: Fill out Form-I, upload required documents, and pay the online fee of 50,000 rupees, GST inclusive.
3. Step 3: The expert committee appointed by the Food Authority will conduct an initial review of the application and provided data. Any deficiencies will be notified to the applicant within 45 days of application receipt.
4. Step 4: The FBO should address any required information within 30 days of receiving the notification.
5. Step 5: After further evaluation and in accordance with FORM-II, the Food Authority may approve or reject the application.
6. Step 6: Upon approval, the FBO must conduct and submit post-market surveillance data on relevant safety and efficacy parameters within one year of product placement.
7. Step 7: If the application is rejected, the FBO may appeal to the CEO within thirty days of receiving the rejection notice.
8. Step 8: In case of rejection by the appellate Authority, the FBO may file a review petition before the Chairperson of FSSAI within thirty days of the appellate order issuance.
9. Step 9: The decision of the Chairperson shall be final.