The market for nutraceuticals in India is growing rapidly, but this growth is accompanied by strict regulations. FSSAI is a mandatory legal requirement for nutraceutical manufacturers, marketers, importers, and sellers. It is crucial to understand whether you need an FSSAI license or FSSAI registration for nutraceuticals in order to avoid penalties, product recalls, or business closures.

This guide explains the difference, eligibility, application process, product standards, labelling rules, audits, and best practices in a clear and practical manner.

WHY FSSAI COMPLIANCE MATTERS FOR NUTRACEUTICALS

Nutraceuticals are regulated as food or health supplements under the Food Safety and Standards Act, 2006. Since these products directly affect consumer health, FSSAI for nutraceuticals

nutraceuticals license FSSAIensures:

Safety of ingredients and formulations
Standardized manufacturing practices
Truthful labelling and health claims
Consumer protection and traceability

Without a valid nutraceutical license FSSAI, products can be banned, seized, or delisted from e-commerce platforms such as Amazon and Flipkart.

FSSAI REGISTRATION VS. LICENSE FOR NUTRACEUTICALS

Choosing between FSSAI Registration and an FSSAI License for nutraceuticals depends on your business size, turnover, and nature of operations.

FSSAI Registration (Basic Registration)

Suitable for:

Small nutraceutical sellers or traders
Annual turnover up to Rs. 12lakh
Retailers or marketers without manufacturing

This is the entry-level approval under FSSAI for nutraceuticals, but it is not sufficient for manufacturing or large-scale operations.

FSSAI License for Nutraceuticals

Mandatory for:

Nutraceutical manufacturers
Importers and exporters
Businesses with turnover above Rs.12 lakh

Types of licenses:

State License: Turnover between Rs.12 lakh and Rs.20 crore
Central License: Turnover above Rs.20 crore or import/export activities

A valid FSSAI license for nutraceutical manufacturers is essential for lawful production and nationwide distribution.

ELIGIBILITY AND DOCUMENTATION FOR NUTRACEUTICAL FACILITIES

To obtain FSSAI for nutraceuticals, the following eligibility and documents are required:

Eligibility

Premises compliant with Schedule 4 of FSSAI regulations
Approved nutraceutical ingredients only
Qualified technical personnel for manufacturing

Key Documents

Form A (Registration) or Form B (License)
PAN, Aadhaar, and address proof
Food Safety Management System (FSMS) plan
Product composition and ingredient list
Label artwork as per FSSAI norms

STEP-BY-STEP: HOW TO APPLY FOR FSSAI REGISTRATION OR LICENSE

If you are wondering how to apply for FSSAI for nutraceuticals, follow these steps:

Determine whether Registration, State License, or Central License applies
Create an account on the FoSCoS portal
Fill Form A or Form B accurately
Upload required documents
Pay applicable government fees
Respond to queries or inspection requests
Receive FSSAI certificate with 14-digit number

The process for nutraceuticals license FSSAI usually takes 15–60 days depending on category and inspections.

PRODUCT STANDARDS, PROCESSING, PACKAGING, AND LABELING FOR NUTRACEUTICALS

Under FSSAI for nutraceuticals, products must comply with the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use) Regulations.

Key requirements include:

Use of permitted vitamins, minerals, botanicals, amino acids
GMP-compliant manufacturing processes
No pharmaceutical ingredients allowed
Hygienic packaging to prevent contamination

Non-compliance may result in cancellation of the FSSAI license for nutraceutical manufacturers.

CLAIMS, NUTRITIONAL INFORMATION, AND LABELING REQUIREMENTS

Labeling is one of the most sensitive areas under FSSAI for nutraceuticals.

Mandatory label declarations:

FSSAI logo and license number
Nutritional information per serving
Ingredient list with quantities
Recommended usage and warnings

Claims Restrictions

Only structure/function claims are allowed
Disease cure or prevention claims are prohibited
Claims must be supported by scientific evidence

Incorrect claims are a common reason for suspension of a nutraceuticals license FSSAI.

FEES, VALIDITY, AND RENEWAL TIMELINES

Government Fees

Basic Registration: Rs.100 per year
State License: Rs. 2,000–Rs.5,000 per year
Central License: Rs.7,500 per year + 18% GST

Validity

Licenses can be taken for 1 to 5 years

Renewal

Apply for renewal at least 30 days before expiry
Late renewal attracts penalty of Rs.100 per day

Continuous validity of FSSAI for nutraceuticals is crucial to avoid operational disruptions.

COMMON VIOLATIONS IN NUTRACEUTICALS AND HOW TO AVOID THEM

Frequent violations under FSSAI for nutraceuticals include:

Unauthorized health claims
Use of non-permitted ingredients
Incorrect labelling format
Operating with expired license

Avoid these by conducting internal compliance checks and keeping your FSSAI license for nutraceutical manufacturers updated.

AUDITS, INSPECTIONS, AND HOW TO PREPARE

FSSAI authorities may conduct scheduled or surprise inspections.

To prepare:

Maintain batch records and test reports
Keep raw material purchase invoices
Ensure hygiene and sanitation standards
Train staff on food safety practices

A well-prepared facility strengthens your standing under FSSAI for nutraceuticals.

COMPLIANCE CHECKLISTS AND BEST PRACTICES

Best practices for nutraceutical businesses:

Conduct regular label and claim reviews
Update product formulations as per new regulations
Maintain proper documentation and traceability
Engage professionals for compliance audits

These steps ensure long-term sustainability of your nutraceuticals license FSSAI.