In India, the founders of functional beverage brands fight with the FSSAI Nutraceutical Regulations every day. The misunderstanding in licensing levels, ingredient restrictions and health-related assertions causes expensive mistakes and postponements.
- Regulatory confusion: Especially the lack of clarity of state and central licenses, as well as the constant updates of the regulations in 2026, brings about uncertainty in compliance.
- Issues with Labelling and Claims: There are no such things as disease-cure claims; obligatory Nutraceutical tags and warnings discourage innovative branding.
- Market Risks: Recalls, bans and reduction in sales destroy the market share.
Lack of Clarity on FSSAI Rules for Nutraceutical Beverages
The main problem that functional beverage founders encounter regarding FSSAI compliance is the ever-changing rules regarding nutraceuticals, the complex makeup of ingredients, and a lack of regulatory expertise.
- Continuous Revisions: Founder adaptations are overtaken by the frequent changes in FSSAI, which is compelled by the necessity to present evidence in claims in 2026.
- Complicated Recipes: Finding a compromise between the ICMR nutrient limits and attractive recipes requires the skills of an expert.
- Knowledge Dispensation: Most people do not know a lot about licensing levels and labelling prohibitions.
Navigating FSSAI Nutraceutical Regulations
- Ingredient Confusion: Confusion about nutraceuticals that are both approved by the FSSAI and permitted in their products, and safe levels of caffeine/sugars.
- Labelling & Claims Uncertainty: There are no claims made about disease-cure; all the brands are required to have an NUTRA tag and warnings, as this negatively affects branding.
- Delay in the approvals: The FSSAI licensing and approval take up a lot of time, delaying the introduction of new products.
Launch a Fully Compliant Nutraceutical Beverage
From formulation review and stability validation to FSSAI approval strategy and compliant label drafting —
we ensure your nutraceutical beverage is market-ready, legally secure, and built for long-term brand credibility.
Understanding FSSAI Rules for Nutraceutical Beverages Made Easy
- Ingredients: Approved vitamins/herbs should be used only. Max caffeine 75mg/250ml, sugars <15g/100ml. No steroids/hormones.
- Claims: Can say health benefits. Does not make claims of curing illnesses.
- Labelling: Writes Nutraceutical. Insert dosage and notices, such as Not for medicine
- Approvals: Obtain FSSAI license (central in case of big turnover). Follow GMP (Good Manufacturing Practice) rules.
Violate them, pay fines or recall. Keeps drinks safe for buyers.
Proven Steps to Meet FSSAI Regulations for Nutraceutical Beverages India
These 5 steps would assist in achieving FSSAI compliance of functional beverages. This practical guide guarantees successful start-ups.
Step 1: Classify Your Product
Select the appropriate category in the regulations of Health Supplements by FSSAI, 2016. Improper classification prevents licensing.
| Category | Examples | Key Rules |
| Health Supplements | Protein shakes, vitamin drinks | RDA limits: general wellness |
| Nutraceuticals | Herbal extracts, probiotic beverages | Schedules I-VI ingredients only |
| Speciality Plant/Botanicals | CBD-infused (if approved), ginseng drinks | Botanical extracts validated |
| Probiotic/Prebiotic Foods | Gut-health fermented drinks | Viable cultures; claim restrictions |
Step 2: Rubric Grading: Inventory check
- Check all the components with the schedules of FSSAI.
- Equivalent of Schedules I- VI (vitamins, minerals, botanicals).
- Remain as ICMR RDAs (e.g., caffeine, 145-300mg/L; sugars <15g/100ml).
- No contrabands: steroids, hormones, unlisted probiotics.
- Source COAs from suppliers.
Step 3: Labelling & Claims
- Labels of the designs that hold.
- Breaking Declaration: Nutraceutical/Health Supplement.
- Dose by dose includes the store.
- Barnabas Waning: not to be used as medicine; be sure you see the doctor.
- Claims Only supports immunity- no cures diabetes.
Step 4: Documentation & Licensing
Use this checklist for FoSCoS (Food Safety Compliance System) portal submission.
| Checklist Item | Required? |
| Form B (signed) + layout plan | Yes |
| Ingredient list + COAs | Yes |
| FSMS plan; equipment details | Yes |
| Turnover proof (central if >₹20Cr) | Yes |
| GMP self-declaration | Yes |
Step 5: Testing & Quality Assurance
Validate before launch.
- Third-party NABL (National Accreditation Board for Testing and Calibration Laboratories) lab tests for contaminants and nutrients.
- Batch-wise microbial/heavy metal checks.
- Retain records 2 years post-expiry; audit-ready FSMS.
- Annual self-audit; renew license timely.
Implement now to avoid recalls.
Foodsure’s Role in Navigating FSSAI Nutraceutical Regulations
FSSAI, with its nutraceutical maze, overwhelms founders, but Foodsure comes in as a reliable guide to functional beverages. Our compliance is made simple when we are not being pushed.
- Guidance Formulation: Modified ingredients to match ingredient limits and Schedules I- VI.
- Labelling & Claims Check: Check the safe health claims and compulsory warnings.
- Support of the license: Automate the applications of FoSCoS, between the state and central licensing.
- Testing & Audits: Organise NABL labs and GMP audits to launch new ready-to-use products.
We partner with you to be business-ready.
Key Lessons for Founders Under Functional Drinks Regulations
The success of a functional beverage cannot be achieved outside of the FSSAI compliance, as it not only keeps your brand safe but also the consumers’ trust. Earlike start to reduce delays, fines and reformulation costs.
- Act Now: Compare Ingredients with Schedules I-VI and ICMR limits.
- Label Smart: Include the tags, dosages and no disease claims under the Nutraceutical label.
- Checklist Ready: License, COAs, GMP and lab tests: Check pre-launch.
Launch worry-free.
New functional beverage? Foodsure makes headaches easy with skip FSSAI.
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FAQs
Nutraceutical regulators FSSAI. What are these?
The nutraceutical regulations of the FSSAI specify safety, labelling, and ingredient standards of the nutraceutical beverages in India.
Is there a need to have nutraceutical beverages approved by FSSAI in India?
Yes, any nutraceutical beverage should be in line with FSSAI requirements on nutraceutical beverages in India before being introduced on the market.
What do functional drinks entail under the FSSAI rules?
The regulation of functional drinks encompasses the approved ingredients, dose restrictions, label pillars, and authorised health assertions.
Would my health nutraceutical statements be allowed according to FSSAI?
Only health claims that are specifically authorised in the FSSAI requirements concerning nutraceutical drinks are allowed.
What is a compliance checklist of a functional drink?
A functional drink compliance checklist will guarantee the compliance of your formulation, labelling, testing, and licensing in accordance with the FSSAI nutraceutical regulations.
What components can be used under the FSSAI regulations of functional drinks?
Nutraceutical drinks can only use ingredients that are approved by the FSSAI nutraceutical regulations.
What is the importance of adhering to the FSSAI regulations of functional beverage brands?
Adherence to the FSSAI nutraceutical laws safeguards your brand against legal liabilities and ensures secure product commercialisation in India.
