Health supplements & nutraceuticals.
Nutraceuticals are Central-licensed at any turnover and checked ingredient by ingredient. The category you choose decides which schedules, formats and limits apply.
A supplement that fits its category, its schedules and its limits — before a single batch is made.
What’s at stakeNutraceutical makers are Central-licensed at any turnover; labels and claims are held to the Claims Regulations — misleading claims up to ₹10 lakh (s.53).
Where the rule comes from
FSSAI regulations for health supplements, nutraceuticals, FSDU, FSMP and prebiotic/probiotic foods (2022 direction)
ICMR-NIN Nutrient Requirements 2020
We quote the regulation behind every requirement. Where FSSAI hasn’t specified something, we tell you it’s our reading, not the law.
You need this if…
- Health supplements, nutraceuticals, foods for special dietary use, FSMP, probiotics and prebiotics
- Gummies, powders, capsules, tablets and functional beverages
- Brands importing supplements
Exactly what you’re paying for.
Included
- Category decision — health supplement, nutraceutical, FSDU, FSMP, probiotic/prebiotic
- Every ingredient checked against its schedule and level against one RDA
- Format checked against what the category allows
- Mandatory label statements for the category
- Central Licence under the right kind of business
Not included
- Contract-manufacturer audits (available separately)
- Clinical studies
Anything outside scope is quoted in writing before we do it.
Who does what, in order.
Most of the work is ours. Where something needs you, it says so.
After it’s done
- Product testing every six months
- Claims register for marketing
- YouShare the formulation
Ingredients, quantities per serving, format, target group.
- WePlace the category
The category decides schedules, formats and limits.
- WeCheck every ingredient
Schedule fit, extract ratios, one-RDA ceilings (ICMR 2020).
- WeLabel and licence
Statements, claims and the Central Licence.
The mistakes we see most.
A nutraceutical must use Schedule III ingredients; a health supplement must not.
The prior-approval route exists only in food formats, not tablets, capsules or syrups.
Words that treat, cure or prevent are among the most-cited findings.
The authorities behind this service.
Logos are shown only to identify each body and remain the property of their owners. FoodRaksha is an independent consultancy and is not endorsed by, accredited by or affiliated with any of these authorities.
Our promises, in writing
You get the fee before we start. If the scope changes, you hear it from us before it costs you.
We file on your own FoSCoS account with your approval. Nothing to hand back if you ever leave.
Straight to FSSAI on FoSCoS. It never passes through us.
Each requirement comes with the regulation behind it — and our readings are marked as ours.
Common questions
Can I exceed one RDA?
Only by prior approval of the Food Authority, and only in food format — not in a tablet, capsule or syrup.
Do I need a Central Licence for a small supplement brand?
Yes. Health supplement and nutraceutical manufacturers are licensed centrally at any turnover.
Can I sell gummies as an FSMP?
No — gummies, tablets, capsules and similar formats are prohibited for FSMP.
Do imports need anything extra?
Nutraceuticals and health supplements are high-risk categories that may only enter through designated ports.
Often needed alongside.
Label review
Every mandatory element, size and claim — before the print run.
See the serviceClaims & advertising review
Front-of-pack claims, ads, social posts and influencer copy — checked before FSSAI reads them.
See the serviceProduct & ingredient approval (NSF)
Novel ingredients, non-standardised foods and new formulations — the prior-approval route.
See the serviceGet a fixed quote — in writing, before we start.
Book a free 10-minute check. A person — not a bot — calls you back within working hours, tells you exactly which licence you need and what it costs, before you commit to anything.
- Government fee paid by you, directly to FSSAI
- Filed under your own FoSCoS login
- Fixed fee, confirmed in writing before we start
Not ready to talk? Get the free 2026 checklist or find your licence yourself.