FSSAI License for Nutraceuticals – Online Process, Fees & Documents

 

On 1 September 2021, the Food Safety and Standards Authority of India (FSSAI) issued an order bringing nutraceuticals and supplement food businesses under Central Licensing authority. As per this directive, a Central FSSAI License for Nutraceuticals is mandatory to manufacture, import, distribute, or sell any health or food supplement product in India.

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An FSSAI nutraceutical license ensures that supplement products use only approved ingredients in the prescribed proportions and comply with safety, labeling, and quality standards. The application process for an FSSAI license for supplement products is completely online through the official FSSAI portal. Applicants can submit the required documents and pay the nutraceutical license cost of Rs. 7,500/- + GST. 

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Get your FSSAI Nutraceutical License with Food License India fast & easy:

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FSSAI License for Nutraceuticals - Overview

An FSSAI nutraceutical license is a legal certificate issued by the Food Safety and Standards Authority of India for food businesses dealing in nutraceuticals, health supplements, and food supplements. It is necessary under the Food Safety and Standard Act 2006.

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Applications are accepted for the nutraceutical license online on the official FSSAI website @fosco.fssai.gov.in. This is a central license which gives the freedom to run a business across Indian states. Businesses have to go through a strict checking and compliance process. Food supplements are directly related to the consumer’s health. Therefore FSSAI checks each ingredient against the approved Nutraceutical schedule list.

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FSSAI License for Health Supplements & Food Supplements

Food Supplements are products which support nutrition and physiological well being and do not make medical claims. Products typically eligible under the FSSAI nutraceutical framework include:

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• Multivitamin and mineral tablets

• Protein powders and whey protein supplements

• Amino acid and BCAA formulations

• Herbal and botanical capsules or powders

• Immunity boosters and wellness supplements

• Probiotics and prebiotics

• Collagen powders and joint health supplements

• Functional nutrition drinks and fortified products

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If your product uses commonly accepted nutrients, vitamins, minerals, proteins, or botanicals, it can usually be licensed under the FSSAI nutraceutical category. Approval depends primarily on correct product classification, ingredient scheduling, and dosage amount. 

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In many cases, misclassified or incorrect nutraceutical formulation can cause delay during filing.

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FSSAI regulations for Nutraceuticals

The latest regulation defines the Nutraceutical products classification under the FSS regulation (Food Safety and Standards Regulations). Under FSS regulations, nutraceuticals, health supplements, and food supplements are treated as special food categories and are regulated separately from conventional foods.

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FSSAI has compiled specific schedules that list all the approved nutrients, botanicals, enzymes, probiotics, or other dietary substances. All products applying for FSSAI Nutraceutical License will have to follow the allowed limit and dosage amount. Food supplements are meant to support health and nutrition and not to diagnose, treat, or cure diseases.​

 

Who Needs an FSSAI License for Nutraceuticals

An FSSAI license is required by any individual or entity involved in the nutraceutical supply chain, including:

• Manufacturers and contract manufacturers

• Importers of nutraceutical or supplement products

• Brand owners and marketers

• Online sellers (own website, Amazon, Flipkart, etc.)

• Distributors and wholesalers
   

If your business handles nutraceutical products at any stage, licensing is required before commercial operations begin.

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FSSAI Nutraceuticals License Requirements

To get the FSSAI license for supplement products and clear the application fast businesses need to focus on a few things:

• They should have a valid business registration documents

• Only the approved product formulation as per FSSAI norms should be used

• A clean manufacturing premises following the safety standard (for Manufacturers)

• Proper labeling and packaging standards

• Strict use of ingredient limits and claims. FSSAI rejects any application not following the given limit for ingredients
   

Meeting these requirements at the application stage significantly improves approval chances.

 

Documents Required for FSSAI Nutraceuticals License

To apply successfully, following documents related to the Nutraceutical product and business must be submitted online to FSSAI:

• Business registration and identity proofs

• Address proof of premises

• Product ingredient list and formulation details

• Label artwork as per FSSAI guidelines

• Import-related documents (for importers)
   

Incomplete or incorrect documentation is a common reason for application delays.

 

FSSAI License for Nutraceuticals Cost

Since the Nutraceutical License is made under central license authority of FSSAI, its cost is the same as the FSSAI central license. To get the FSSAI Nutraceutical central license FSSAI asks for a cost of Rs. 7,500/- as the government fee. However, an additional 18% GST is also applicable on this fee. 

 

Application Process for FSSAI Nutraceuticals License

Step 1: Go to the official FSSAI website @foscos.fssai.gov.in.

Step 2: Click on General License. 

Step 3: Select Central License and proceed. 

Step 4: Start filling the application form. 

Step 5: Upload the documents. 

Step 6: Pay the government fee online and wait for 7-10 days. 

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Proper preparation at each step helps avoid unnecessary back-and-forth and future modification.

 

FSSAI Nutraceuticals Application Rejected

Applications are commonly rejected due to:

• Use of non-permitted ingredients

• Incorrect or misleading health claims

• Labeling non-compliance

• Mismatch between business activity and license type

• Incomplete documentation
   

Understanding these risks early helps safeguard your application.

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Our FSSAI License Services for Nutraceuticals Businesses

We help nutraceutical businesses navigate the FSSAI licensing process with clarity and confidence. Our role is not just filing applications, but interpreting regulations, aligning products with compliance norms, and reducing rejection risks.

We assist with:

• Identifying correct license category

• Reviewing formulations and labels

• Ensuring documentation accuracy

• Handling FSSAI queries and follow-ups

• Ongoing compliance support
   

Our services focuses on fast delivery of food licenses, revising the formulations, and compliance consultancy. 

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FAQs

Q: Is FSSAI license mandatory for nutraceuticals in India?
Ans: Yes. Selling nutraceuticals without an FSSAI license is illegal.

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Q: Is product approval required for nutraceuticals?
Ans: Product compliance with regulations is mandatory; certain cases may require additional approvals.

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Q: Can I sell nutraceuticals online without FSSAI?
Ans: No. Online marketplaces require a valid FSSAI license.

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Q: How long does it take to get an FSSAI nutraceutical license?
Ans: After submitting the online fees FSSAI takes up to 15 days to release the Nutraceutical License.