FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
Nutraceuticals & health supplements
Can I sell this as a supplement, and what am I allowed to say about it?
How this sector is regulated
Health supplements, nutraceuticals and foods for special dietary use are regulated by FSSAI under the Food Safety and Standards Act, 2006 and the 2016 regulations made under it, which set the permitted categories, the ingredients allowed in each and the applicable limits.
Where a product is positioned as Ayurvedic or herbal rather than as a supplement, it may fall under AYUSH and the Drugs and Cosmetics Act instead — a different authority, a different licence and a different evidence expectation. Which one applies is determined by the formulation and the claim, not by how the product is marketed.
Where programmes usually lose time
The claim decides the regulator
A supplement claim describes nutrition or maintenance of normal function. The moment wording implies preventing, treating or curing a condition, the product is a drug — with a different authority, a far higher evidence bar and a timeline measured in years rather than months. This is the most common and most expensive mistake in the category, and it is usually made on the label after the formulation is finished.
Your route
Regulatory routes that apply here
Which one governs your product depends on its composition, its intended use and what you intend to claim.
AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
BIS certification
Does my product need a BIS licence, and against which Indian Standard?
Delivery
The services behind that work
The route sets what has to be produced. These are the teams that produce it — the same functional capability we have run for CROs and sponsors for years.
Medical Writing
Protocol/IB, CSR, narratives and statistical sections aligned to TA context.
Biostatistics & Programming
SAP, SDTM/ADaM mapping, TLF programming & QC; submission-ready outputs.
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Quality Assurance & Audits
Internal/vendor/site audits support, TMF health, deviation/CAPA tracking, inspection readiness.
When people call us
Typical situations
Launching a new supplement
You have a formulation and a marketing concept, and need to know whether both survive contact with the regulations before you print packaging.
A claim you want to keep
Marketing has written a claim that sells. You need to know whether it is defensible, and what evidence would make it so.
Ayurvedic or supplement?
The formulation could be positioned either way, and the two routes have different licences, timelines and constraints on what you can say.
Human study for substantiation
A claim needs evidence behind it, and the study has to be designed so the result actually supports the wording you intend to use.
Other sectors we work in
Medical Devices
Classification, risk management, technical documentation and quality systems for CDSCO and EU routes.
Cosmetics
COS-1 and COS-2 import registration, State licensing, labelling and claim control for the Indian market.
Pharmaceuticals
Clinical trial approval, study execution and the full functional stack — our longest-running capability.
Working on a nutraceutical product?
Send us the product, the claims you want to make and the market you are going to. We will come back on the route and the evidence it needs — before anyone commissions a test.