FSSAI licence for nutraceuticals and supplements.
Making health supplements, nutraceuticals or protein supplements, or having them made for you, needs a Central Licence at any turnover: ₹7,500 a year. Selling someone else’s supplements, including as a direct seller for a network brand, is trade and goes by turnover, starting with a ₹100 Registration.
Manufacturers of food or health supplements and nutraceuticals need a Central Licence whatever their turnover, at ₹7,500 a year (KoB table, 01.04.2026). Direct sellers and retailers of supplements apply under Trade/Retail: Registration up to ₹1.5 crore turnover (₹100), State Licence to ₹50 crore (₹5,000), Central above. Energy drinks are a separate beverage standard.
Which FSSAI licence a nutraceutical or supplement business needs.
| Annual turnover | You need | Government fee (to FSSAI) | Our filing fee |
|---|---|---|---|
| Any turnover | Central Licence | ₹7,500 a year | ₹19,500 |
Per FSSAI’s kind-of-business table updated 01.04.2026. Our fee is one-time plus GST. Operating in two or more States/UTs adds a head-office Central Licence (₹7,500 a year).
What to choose on FoSCoS
- Food or Health Supplements and Nutraceuticals etc. (Manufacturer section) — Central Licence, no turnover threshold; product sub-categories 13.3 to 13.6 as applicable
- Relabeller — if a third-party unit makes your supplement under your brand. How the Central-at-any-turnover row applies to a relabeller is a point we confirm with the licensing authority on your file
- Direct Seller (Trade/Retail) — a person appointed by a direct selling entity under a written contract; turnover bands
- Retailer, Distributor or Wholesaler (Trade/Retail) — gyms, chemists and shops reselling packed supplements; turnover bands
- E-Commerce (Central) — if you sell through your own website or app; Importer (Central) — if you import
2026 tablePer FSSAI’s table updated 01.04.2026. We confirm your kind of business before filing.
What a nutraceutical or supplement business has to get right.
Each point comes with the regulation, order or FSSAI document behind it. Where FSSAI hasn’t spelt something out, we say it’s our reading.
Central Licence at any turnover for makers
The kind-of-business table updated 01.04.2026 puts "Food or Health Supplements and Nutraceuticals etc." on a Central Licence with no turnover threshold, at ₹7,500 a year. A start-up with ₹10 lakh of sales is in the same tier as a large brand. Special nutritional foods are a high-risk category, so Central-licensed manufacturers also face an annual third-party audit.
KoB table 01.04.2026; Auditing Regulations 2018, reg. 8; FSSAI order 02.05.2022Know which regulation you're reading
The gazetted instrument is the Health Supplements and Nutraceuticals Regulations 2016, as amended in 2021. The 2022 text most people cite was notified as a draft and is kept operative by FSSAI directions under section 16(5). The latest in the chain are dated 05.06.2024 and 30.08.2024. The two number their schedules differently, so a bare "Schedule IV" can mean either.
FSS (HS, Nutraceuticals…) Regulations 2016; directions u/s 16(5), 05.06.2024 and 30.08.2024No disease claims — that's drug territory
FSSAI's FAQ says products that claim to prevent, treat or cure a human disease "are more akin to drugs which do not fall under the ambit of FSSAI". The label and the advertising must not make such claims. The boundary is FSS Act section 22 against section 3(b)(ii) of the Drugs and Cosmetics Act.
FSSAI FAQs on Nutraceutical Regulations, FAQ 10; FSS Act s.22New ingredients need approval before the licence
Novel foods, and ingredients with a history of safe use that aren't included in the regulations, need approval under the Non-Specified Food Regulations 2017 before you take the licence.
FSSAI FAQs on Nutraceutical Regulations, FAQs 59–60; NSF Regulations 2017Warnings, side effects, interactions
Every product under these regulations has to carry warnings or precautions for use, known side effects, contraindications and published product-drug interactions, as applicable. Nutrient levels have to stay within the limits the regulations set against the Indian RDA.
FSSAI FAQs on Nutraceutical Regulations; FSSAI notice on RDA levels, 12.05.2023Direct sellers need their own registration
FSSAI's FAQ says direct sellers are not exempt. The only exception is where the direct selling entity has taken responsibility for its sellers in writing. Direct sellers apply under Trade/Retail, and since 2026 the table has a dedicated Direct Seller row on the turnover bands.
FSSAI Licensing FAQs Q81, Q132 (21.07.2022); KoB table 01.04.2026, Direct Seller rowEnergy drinks follow a beverage standard
A caffeinated beverage has to contain between 145 and 300 mg of caffeine per litre. The label declares the caffeine per serving and warns "Not recommended for children, pregnant or lactating women, persons sensitive to caffeine", and tells the consumer to have no more than 500 ml a day. It's a beverage, licensed under General Manufacturing, not a nutraceutical.
FSSR 2011, 2.10.6(2) (Chapter 2.10, Version 4, 01.08.2025)What you’ll be asked for.
On top of the owner’s photo ID and address proof. FoSCoS asks per kind of business, so we send you the exact list for yours before you gather anything.
Full documents checklist- Product-wise composition: each ingredient, its quantity per serving and the regulation schedule it relies on
- NSF approval letter, for any ingredient or product not covered by the regulations
- Layout plan, equipment list with installed capacity, water analysis report and FSMS plan (manufacturing units, Annexure 2)
- Agreement with the third-party manufacturer and their licence, plus the manufacturer's NOC (relabellers)
- Recall plan with details of who the product is distributed to
- Direct sellers: the written contract with the direct selling entity, and any written undertaking in which it takes responsibility for you
The authorities around this business.
FSSAI isn’t the only door you’ll knock on. These are the bodies that usually matter for this kind of business — each links to what it does and when you’ll meet it.
See the full regulatory map
Food Safety and Standards Authority of IndiaFoSCoSCommissioner of Food SafetyDesignated Officer and Food Safety Officers
FSSAI-notified, NABL-accredited food laboratoriesFoSTaC training partnersFSSAI-recognised auditing agenciesLegal Metrology DepartmentCPCBAdjudicating Officer and Food Safety Appellate TribunalMunicipal corporation or local bodyState Pollution Control BoardCDSCO and State drug controllersCommon mistakes with nutraceutical or supplement business licences.
Turnover doesn't matter for this row. A supplement brand on a Registration or State Licence is on the wrong licence, and FSSAI counts that as trading without one.
Health and function claims were the largest single group in the 552 FSSAI enforcement cases we have analysed. A disease claim takes the product out of food law altogether.
It covers you only if the direct selling entity has taken responsibility for its sellers in writing. Otherwise every distributor who sells food needs their own registration.
Naming is where many beverage cases start. "Energy drink" and "electrolyte" are names FSSAI has written up, so check the product against the standard before you use the word.
Your nutraceutical or supplement business licence in three steps.
Most of the work is ours. Where something needs you, it says so — and nothing is filed without your approval.
- 1
Book a free 10-minute check
Tell us what you do. We confirm the exact kind of business, the licence and the full cost — including the exceptions most people miss.
Free · no obligation - 2
We file it on your login
You get a checklist for your business, we check every document, and we file on your own FoSCoS account. The government fee goes from you to FSSAI.
Fixed fee, in writing - 3
We keep you licensed
Fees, returns, tests, medicals, labels and inspections — dated, tracked and handled, with a short status note each month.
Ready any day
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.
FSSAI licence for nutraceutical or supplement business: questions
Which FSSAI license is needed for protein powder?
If you make it or have it made and sell it as a health supplement, you need a Central Licence at any turnover, ₹7,500 a year. A protein supplement sold as a health supplement belongs in sub-category 13.6. If you only resell sealed tubs, as a gym or shop does, you apply as a Retailer by turnover, starting at Registration. Check the product's category on FoSCoS before filing.
What is the FSSAI license for nutraceuticals and health supplements?
A Central Licence under the Food or Health Supplements and Nutraceuticals kind of business, with no turnover threshold, at ₹7,500 a year. Product sub-categories run from 13.3 (special medical purpose) to 13.6 (health supplements, nutraceuticals, probiotics and prebiotics). Our fee to file a Central Licence is ₹19,500 plus GST, and the licence is filed on your own FoSCoS login.
Do I need FSSAI registration as an Amway distributor?
Usually yes. FSSAI's FAQ says direct sellers are not exempt unless the direct selling entity has taken responsibility for them in writing. Direct sellers apply under Trade/Retail: Registration up to ₹1.5 crore turnover at ₹100 a year, a State Licence to ₹50 crore, Central above. Ask your company whether it has given a written undertaking before you rely on one.
Which FSSAI license is required for direct selling of food supplements?
The 2026 table has a Direct Seller row under Trade/Retail. A direct seller is someone appointed by a direct selling entity under a legally enforceable written contract. It follows the turnover bands: ₹100 Registration up to ₹1.5 crore, ₹5,000 State Licence to ₹50 crore, ₹7,500 Central above. The direct selling entity itself, if it manufactures or has products made, is on the nutraceutical row.
Do food supplements need FSSAI product approval?
Not if every ingredient and level is within the regulations. Ingredients not covered, and novel foods, need approval under the Non-Specified Food Regulations 2017 before you apply for the licence. A product that claims to treat or prevent disease isn't a food supplement at all in FSSAI's view. It falls under drug law.
Which FSSAI license is needed for energy drinks?
Energy drinks are caffeinated beverages under standard 2.10.6(2), made under General Manufacturing on the turnover bands, not the nutraceutical row. The drink must contain 145–300 mg of caffeine per litre and carry the mandatory warning and the 500 ml a day consumption statement. An importer of energy drinks needs a Central Licence.
Why do energy drinks get FSSAI notices?
FSSAI's enforcement files show naming ("energy drink", "electrolyte") and health claims as recurring findings for beverages. Notices quote the claim, name the provision and usually give 30 days to reply, or 7 where an earlier letter went unanswered. They are sent to every business in the chain at once. Getting the name and the caffeine warning right avoids most of them.
Get your nutraceutical or supplement business licensed — and keep it that way.
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.