FSSAI License for Nutraceuticals and Health Supplements: Process, Fees, and Documents

Updated on March 24, 2025 05:58:52 PM

An FSSAI License is the necessary certification required by business entities engaged in nutraceutical and health supplement manufacturing or distributing, retailing, and exporting from India. Nutrition or nutraceutical foods that involve dietary supplements, functional foods, and fortified items contribute to health and provide disease resistance. As such direct implications on consumer health must be ensured safety, quality, and regulatory compliance.

The Food Safety and Standards Authority of India (FSSAI) regulates this segment under the Food Safety and Standards Act, 2006. These products need to conform to established guidelines for ingredients, labeling, and manufacturing practices. Businesses must apply for the correct FSSAI license based on the annual turnover and operational scale—Basic Registration for smaller businesses, a State License for medium-sized operations, and a Central License for large-scale manufacturers or those involved in interstate trade or exports.

It is, therefore, not just compliance but a testament to consumer trust since FSSAI assures that the product has maintained safety and efficacy. The licenses ensure the business's legal protection as well as give credibility in the market while also opening a door for opportunities in such a growing industry. This is very crucial for any individual carrying out any form of activity in the sector.

FSSAI License For Nutraceuticals and Health Supplements [Sample]

  • Central License
Fssai Central License

What is FSSAI License for nutraceutical and health supplement?

FSSAI License for Nutraceuticals and Health Supplements: The Food Safety and Standards Authority of India issues this certification for those companies involved in nutraceutical and health supplements production, distribution, and sales under the safety and quality of foods. These include vitamins, minerals, herbal extracts, and functional foods. They provide benefits in health rather than just providing nutrients. Such products affect the health of the consumers directly and therefore require proper regulation for their safety and efficacy.

This license will apply to nutraceutical manufacturers, wholesalers, nutraceutical and health supplements, and exporters. There are three types of licenses, based on the amount of turnover and the type of business. The smallest-sized enterprise would be granted Basic Registration, medium enterprises would need a State License, while large-scale manufacturers or the companies involved in interstate trade and exports need Central License.

Obtaining an FSSAI license shows a commitment to food safety and adherence to legal standards. It allows businesses to create trust with their consumers, market credibility, and prevent legal complications.

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Benefits of FSSAI License for Nutraceutical and Health Supplement

Obtaining an FSSAI License offers numerous advantages for nutraceutical and health supplements, ensuring not only legal compliance but also operational efficiency, customer trust, and business growth. Here are the key benefits:

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Documents Required for FSSAI License for Nutraceutical and Health Supplement

FSSAI Registration For nutraceutical and health supplements, it is mandatory to have various documents that depend on the type of registration or license applied.

Document Type Details
Central License Mandatory
Identity Proof Aadhar Card, PAN Card, or Voter ID
Address Proof Rent agreement, utility bill, or property ownership
Business Registration Proof GST Certificate, Partnership Deed, or Incorporation Certificate
Photographs Passport-sized photograph of the applicant
List of Food Products Mandatory
Food Safety Management Plan Required
Proof of Turnover Financial documents showing turnover above ₹20 crore
Manufacturing Unit Details Required
NOC from Local Authority May be required based on local regulations
Form IX (Nomination of Person) Required
Water Testing Report Required if water is used in production
Testing Report of Ingredients Required
Import/Export Code Mandatory for import/export businesses
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How to Apply for FSSAI License for Nutraceutical and Health Supplements?

Acquiring an FSSAI License for nutraceutical and health supplement: A Step-by-Step Guide

Step 1: Access the FoSCOS Official Website

The first thing that the applicant needs to do is to access the official website of FoSCOS, the Food Safety Compliance System.

Step 2: Choose License Type

Before applying, it is very important to decide whether a Central or State License is to be obtained. Each location should be separately entered to decide on its eligibility.

Step 3: Registration on FoSCOS

Once the website is loaded, click "Sign-up" for the desired license type. Fill in the registration form with contact details, whereby the phone number and email address provided will be active and accessible.

Step 4: Create Username and Password

Choose a unique username and set up a password during registration. Upon completion of the form, click 'Register' to finalize the sign-up.

Step 5: Confirmation of Account Activation

Confirmation of account activation via an SMS and email to the applicant after successful registration.

Step 6: Log in and Submit the FSSAI Registration Application Form

Use your new credentials to log into the system and fill out the FSSAI Registration online Application Form. All details should be correct and complete.

Step 7: Print and Submit an Application

Before submitting online, print a copy of it. Once submitted online, a reference number would appear on the screen, very important for tracking the application process.

Step 6: Offline Submission

Within 15 days of applying online, a photocopy of the filled application form should be sent to the respective regional or state FSSAI office. This is so that the application is considered and processed.

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FSSAI License for Nutraceutical and Health Supplement Fees

If you're planning to start a Nutraceutical and Health Supplement in India, getting an FSSAI license is essential. The FSSAI License Fees for Nutraceutical and Health Supplement include a government fee of ₹7,500 for a Central License, Additionally, professional fees for application processing and documentation are ₹15,000 for a Central License

License Type Government Fee (INR) Professional Fee(INR)
Central License ₹7,500 ₹15,000

Note: The aforementioned fees are exclusive of GST

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Conclusion

An FSSAI License is a must requirement for all businesses that are engaged in the manufacturing, distribution, or sale of nutraceutical and health supplements. The license assures that the business complies with the food safety and quality standards, thus securing both consumers and businesses. Getting the right FSSAI license helps businesses build trust and increase their market credibility while showcasing a commitment to delivering safe and effective products.

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Frequently Asked Questions (FAQs)

What is an FSSAI License for nutraceutical and health supplements?

An FSSAI License is a mandatory certification for businesses manufacturing, distributing, or selling nutraceutical and health supplements. It ensures compliance with food safety and quality standards.

Who needs an FSSAI License for nutraceutical and health supplements?

Manufacturers, distributors, wholesalers, retailers, importers, and exporters of nutraceuticals and health supplements must obtain an FSSAI license.

Is a Food Safety Management Plan mandatory?

Yes, it is compulsory for State and Central Licenses but not for Basic Registration.

Is it possible to run without an FSSAI License?

No, running without an FSSAI license is illegal and can lead to heavy penalties or business closure.

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