FSSAI FEES AND VALIDITY FOR SUPPLEMENT INDUSTRY ESTABLISHMENTS

Operating a supplement license FSSAI production plant in India requires complete regulatory compliance in addition to creating safe and efficient products. Dealing with the Food Safety and Standards Authority of India, or FSSAI, is one of the fundamental legal obligations. The most recent changes and regulations pertaining to FSSAI for food & health supplements are covered in detail in this Lawfinity article.

WHY FSSAI COMPLIANCE MATTERS FOR SUPPLEMENTS

Consumer trust and safety: People frequently take supplements to improve their health. Consumers are shielded from deceptive or dangerous products by ensuring that manufacturing, packaging, claims, labelling, etc. adhere to FSSAI standards.
Legal requirement: All food business operators (FBOs) that manufacture or handle novel foods, nutraceuticals, or health supplements are required to abide by the Food Safety and Standards Act, 2006. Fines, license suspension, product recalls, and even criminal liability may result from noncompliance.
uniform standards: There are particular product standards, safety limits, and labelling/claim guidelines with regulations like the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 ("Nutraceuticals Regulations").
Market access and export: Exporting or putting goods through major retail chains or e-commerce sites frequently requires proper licensing, registration, and compliance.

FSSAI REGISTRATION VS. LICENSE FOR SUPPLEMENT BUSINESSES

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FSSAI Registration (Basic)

Very small operators, low-volume production, often with turnover below ₹12 lakhs/year.
Local/State food safety authority or FoSCoS portal under state jurisdiction.
Turnover up to 12 lakhs.

State License

Mid-sized operators, higher turnover, state-level operations.
State Licensing Authority.
RS. 12 lakhs up to RS. 20 crores (depending on business kind).

Central License

Large scale manufacturers/suppliers/exporters/importers, operating across multiple states, or under categories such as supplements/nutraceuticals which FSSAI has mandated must obtain central license.
Central Licensing Authority under FSSAI.
Above ₹20 crores, or certain categories (like supplements/nutra) regardless of turnover since recent mandate.

ELIGIBILITY AND DOCUMENTATION FOR SUPPLEMENT FACILITIES

A facility must meet eligibility requirements and provide supporting documentation, usually consisting of the following, in order to be eligible for the proper FSSAI registration or license (particularly the central license for supplements):

Business identity (proprietor/partnership/company), address, contact etc.
Certificate of incorporation / partnership deed etc.
Proof of address of premises.
List of machinery and equipment with capacities.
Layout / plan of the processing or manufacturing unit (dimensions, process flow etc.).
Water analysis report.
Proof of raw material sources / supply chain.
Responsible person details (qualified individual in charge of compliance).
Labelling mock-ups / samples.
Claims or nutritional data backups (if making health claims).
Quality management / hazard control plan (e.g. HACCP, or equivalent).
Details of production capacity / expected throughput.

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

Determine your category and eligibility

Assess your turnover, whether you are manufacturing supplements/nutraceuticals etc., whether you cross the thresholds for central license.
Confirm whether you need registration, state license, or central license under the latest Nutraceuticals Regulations.

Select appropriate form

For small / petty business, basic registration (Form A, registration certificate).
For state/central license (Form B in FoSCoS portal).

Gather documentation as listed above.

Prepare product information

Standardised product classification in FoSCoS.
Nutritional data, ingredient safety, health claim basis etc.

Submit application via FoSCoS portal

For central or state licensing and for basic registration as relevant.

Pay applicable fees (new application, license or registration fee).

Inspection, if required

After submission, FSSAI/State may conduct site inspections.

Receive license or registration certificate

Once satisfied, the 14-digit FSSAI license or registration number/certificate is issued.

Renew before expiry and ensure you maintain compliance during the validity period.

PRODUCT STANDARDS, PROCESSING, PACKAGING, AND LABELING FOR SUPPLEMENTS

Under the 2016 Nutraceuticals Regulations, FSSAI establishes precise guidelines. Supplementary companies need to:

Use only authorized ingredients for vitamins, minerals, botanicals, and additives within the specified ranges.
To guarantee safety, adhere to hygienic processing standards, which include quality checks, clean facilities, and safe water.
Use non-reactive, food-grade materials to safely package supplements, preserving their shelf life and quality.
Product name, ingredient list, net quantity, batch/lot number, MFD & expiry, storage instructions, manufacturer information, and nutritional information per serving should all be properly labelled.
Claims must be accurate; only approved nutritional or health claims are accepted; claims that a disease can be cured are not.

CLAIMS, NUTRITIONAL INFORMATION, AND LABELING REQUIREMENTS

Must display ingredients, nutritional values, batch/expiry, manufacturer, and storage.
Show active ingredient levels and safety warnings.
Only FSSAI-approved health/nutrition claims allowed; no disease-cure claims.

FEES, VALIDITY, AND RENEWAL TIMELINES

Fees: Basic Registration RS.100/year; State License – RS.2,000–5,000/year; Central License – RS. 7,500/year. (Note: Always confirm from official site of FSSAI)
Validity: 1–5 years (as chosen at application).
Renewal: Apply at least 30 days before expiry; late renewal may attract penalty or require fresh application.

COMMON VIOLATIONS IN SUPPLEMENTS AND HOW TO AVOID THEM

Common Violation

Using unapproved ingredients / higher-than-permitted dose of vitamins/minerals.
Misleading health claims or overclaiming benefits.
Poor labelling (missing info, incorrect nutritional table, no manufacturer info).
Failure to migrate state license to central (where required).
Non-renewal or late renewal

How to Avoid

Consult the FSSAI published lists at all times, obtain lab analysis, and consult experts for formulation reviews.
Only use permitted claims; keep up with scientific proof or substantiation; stay away from claims that sound like drugs unless permitted.
Create templates, get the label reviewed, create an internal review checklist, and make sure the packaging complies with regulations.
Use FoSCoS, keep an eye on FSSAI notifications, and make sure the migration happens by the deadline.
Assign responsibilities, maintain a compliance calendar, and renew well in advance of expiration.

AUDITS, INSPECTIONS, AND HOW TO PREPARE

Inspections of your facility, raw materials, process, record-keeping, hygiene, lab testing, packaging, label compliance, etc., may be conducted by the FSSAI or State Food Safety Departments.
Keep track of all documentation, including water and microbiological tests, supplier and ingredient certifications, testing reports, and manufacturing batch records.
Establish SOPs for staff training, cleaning, and pest control.
Prepare for dosage claims, shelf-life/stability information, and label verification.
Make sure the space is tidy, the equipment is kept up to date, and the storage conditions are suitable.

COMPLIANCE CHECKLISTS AND BEST PRACTICES

Maintain current licenses and documentation.
Verify that labels adhere to FSSAI regulations regarding ingredients, nutrition, expiration, and MRP.
Use only ingredients and claims that have been approved.
Perform internal audits and quality checks.
Educate employees on compliance and hygiene.
Keep track of changes and promptly renew licenses.