FSSAI Rules for Health Supplements and Nutraceuticals: Categories, Ingredients, Limits and Labelling

In India, health supplements and nutraceuticals are regulated as foods by FSSAI, under the FSSAI regulations for health supplements and nutraceuticals notified in 2022. Those regulations define the product categories, list which ingredients are permitted and at what levels, and add specific label statements on top of general food labelling rules, so every formula and label needs checking against the current text.

For brand founders, the regulations shape almost every early decision: which ingredients you can use, how much of each, how the product is described and what the label must say. Working with an FSSAI-licensed nutraceutical manufacturer in India helps, but the brand owner still carries responsibility for what goes on sale. This guide gives a general overview. It is not legal advice, and the notified regulations, amendments and FSSAI directions should always be checked before you finalise a product.

Food, not medicine: why the distinction matters

Supplements under FSSAI sit in food law. They are intended to supplement the normal diet of healthy people, not to diagnose, treat, cure or prevent any disease. Products that make medicinal claims, or contain substances regulated as drugs, fall outside this framework and into drug or AYUSH regulation, which has its own licences and rules.

That boundary affects ingredient choice, dosage form and language. If your product idea depends on a therapeutic claim, it is probably not a food supplement. Our guide to the AYUSH route versus the FSSAI route for herbal products explains how classification works for botanicals.

Categories covered by the regulations

The 2022 regulations group specialised foods into several categories, each with its own conditions. The main ones relevant to supplement brands are:

• Health supplements. Products that supplement the diet with concentrated sources of nutrients such as vitamins, minerals, amino acids and other permitted substances, in measured dose formats.
• Nutraceuticals. Products built around naturally occurring compounds that have a physiological benefit, whether extracted, purified or made synthetically to the same identity.
• Foods with added probiotic or prebiotic ingredients. Subject to their own lists of permitted strains or ingredients and conditions.
• Specialty foods containing plant or botanical ingredients. Linked to permitted botanical lists and their stated parts and forms.
• Foods for special dietary use and foods for special medical purposes. These carry additional conditions and, in some cases, use under medical advice, so they are not typical starting points for consumer brands.

The category you choose must appear on the label and determines which ingredient lists and limits apply. Choose it at the brief stage, not after artwork is drawn.

Permitted ingredients and limits

Schedules of permitted ingredients

The regulations include schedules listing permitted vitamins and minerals and their approved chemical forms, permitted amino acids, plant and botanical ingredients, and other nutritional or bioactive substances. Additives such as binders, sweeteners, colours and flavours must also come from the permitted lists for that category.

An ingredient that is not on the relevant list cannot simply be added. It may need approval through FSSAI's route for non-specified foods and ingredients, which takes time and requires a safety dossier. If a formula idea relies on an unlisted ingredient, raise it at the start.

How limits work

• Vitamin and mineral levels in health supplements are tied to recommended dietary allowances published for India, with upper bounds that formulas must not exceed per daily serving.
• Botanical ingredients are generally permitted for stated plant parts and forms, sometimes with conditions on extract type or daily level.
• Certain substances are restricted or excluded altogether, for example those regulated as drugs, hormones or steroids.

We do not quote specific limits here because they are set in the notified schedules and can be amended. Your formulation team should check each ingredient, its form and its level against the current text. This is a core part of custom supplement formulation.

Labelling basics for supplements

Supplement labels must meet the general food labelling and display rules plus the specific requirements in the supplement regulations. The table below summarises the elements brands most often need to plan for.

Label element	What to check
Product name and category	Category stated as required, for example "Health Supplement" or "Nutraceutical"
Mandatory statements	Statements such as "Not for medicinal use" and advisories required by the regulations, including not exceeding the recommended daily usage
Ingredients and composition	Full ingredient list and quantity of each nutrient or active per serving
Recommended usage	Serving size, how to take it and any population cautions
Veg or non-veg symbol	Correct symbol, which also depends on capsule shell and gelatin use
Allergen information	Declared where required
FSSAI logo and licence numbers	For the manufacturer and, where applicable, the brand owner or marketer
Net quantity, batch, dates	In line with food and Legal Metrology rules for packaged commodities
Names and addresses	Manufacturer, packer and marketer as required, plus consumer care details

Exact wording, font sizes and placement rules are detailed, so ask your manufacturer to review proofs and confirm with a regulatory adviser. Our label and branding design team builds artwork around the approved label text rather than the other way round.

Claims and advertising

What you say about a supplement, on the label, the website or in a creator's video, is governed by the Food Safety and Standards (Advertising and Claims) Regulations, 2018 alongside the supplement regulations. Disease claims are not allowed on food supplements, and any nutrient-function or general wellbeing statement must be permitted for that ingredient and substantiated. See our guide to what supplement brands can and cannot say.

A practical compliance checklist for brand owners

1. Decide the category before formulating.
2. Check every ingredient, form and level against the current schedules.
3. Confirm additives, flavours and colours are permitted for that category.
4. Write label text first, then design artwork.
5. Review every claim for permission and substantiation.
6. Hold the correct FSSAI licence or registration as the brand owner or marketer.
7. Keep specifications and batch documents on file, and understand what testing and quality checks support each release.
8. Recheck after any regulatory amendment or formula change.

How Harrods Health supports compliance

Harrods Health manufactures nutraceuticals and health supplements in-house under an FSSAI licence for nutraceuticals, in a facility that is also ISO certified, GMP-compliant, Halal certified, AYUSH licensed and US FDA registered. Our team works through ingredient selection, label text and packaging with you, offers samples before you order, and gives you a single account manager throughout. Final regulatory responsibility for marketing and claims stays with the brand owner, so we recommend an independent regulatory check before launch.

Frequently asked questions

Which FSSAI regulations apply to health supplements?

Health supplements and nutraceuticals are covered by the FSSAI regulations for health supplements and nutraceuticals notified in 2022, together with general food labelling, additive and claims rules. Always check the latest amendments before launch.

Can I use any herb or vitamin form in a supplement?

No. Ingredients, their chemical forms or plant parts, and their levels must match the permitted schedules for your category. Unlisted ingredients may need separate approval.

Does a supplement label need to say "Not for medicinal use"?

The supplement regulations require certain statements, including one making clear the product is not for medicinal use, along with usage advisories. Confirm exact wording against the current text.

Is FSSAI approval needed for each new supplement?

Products that use only permitted ingredients within limits generally do not need individual product approval, but they must comply fully. Products with unlisted ingredients may need approval first.

Need a compliant formula and label? Talk to our private label supplement manufacturing team.