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Selling health supplements in India

In India, health supplements and nutraceuticals are food under section 22 of the Food Safety and Standards Act, 2006, not medicines. FSSAI's regulations set the permitted ingredients, cap nutrients at the ICMR recommended daily allowance, and require the words "HEALTH SUPPLEMENT" and "NOT FOR MEDICINAL USE" on the label.

Updated · Each section links to the official source it comes from

Regulator
Food Safety and Standards Authority of India (FSSAI)
Legal basis
Section 22, Food Safety and Standards Act, 2006
Who it is for
People above the age of five years (2016 text)
Nutrient ceiling
The ICMR recommended daily allowance
Label words
"HEALTH SUPPLEMENT" and "NOT FOR MEDICINAL USE"
Disease claims
Not allowed

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a health supplement or nutraceutical, rather than a drug or a standardised food? Read more
  2. 2Are its ingredients and additives on FSSAI's schedules, at levels within the RDA? Read more
  3. 3What does the label have to say? Read more
  4. 4Can the claims be made? Read more
  5. 5Who holds the licence, and how does it come into India? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

What counts as a health supplement

Where FSSAI draws the line between a supplement, a nutraceutical, a drug and an ordinary food.

  • Section 22 of the FSS Act covers health supplements, nutraceuticals, functional foods and novel foods.
  • As notified in 2016, a health supplement supplements the normal diet of a person above the age of five years.
  • It contains concentrated sources of nutrients or other substances with a known nutritional or physiological effect, such as amino acids, enzymes, minerals, proteins, vitamins, botanicals, prebiotics and probiotics, and is not a drug under the Drugs and Cosmetics Act, 1940.
  • It is sold in measured units, such as capsules, tablets, pills, sachets, gels, liquids or powders.
  • A food for which a specific standard exists elsewhere in the regulations is not a health supplement.
  • These points are from the regulations as notified in 2016; check FSSAI's current text for later changes.

How we help: Compliant Always keeps the product's specification and category with the regulation it was read against, dated, and watches FSSAI for changes. Ask about this

Ingredients and nutrient levels

Which ingredients may be used, and how much.

  • Health supplements use ingredients in Schedules I, II, IV, VII and VIII, and enzymes only from Schedule VI (2016 text).
  • Nutrients may not exceed the recommended daily allowance set by the Indian Council of Medical Research; where ICMR sets none, Codex Alimentarius standards apply.
  • Additives are limited to those in Schedules VA, VE and VF.
  • A business applies to FSSAI to include a new nutrient or substance with no history of use in India.
  • Where a nutrient content claim is made, the nutrient is at least 15% of the RDA, or 30% for a "high" claim.
  • Tablets, capsules and syrups meet the general quality requirements of the Indian, British or United States Pharmacopoeia.

How we help: Compliant Always reads the formula and certificates of analysis against the schedules and RDA limits, and shows which ingredients need a closer look. Ask about this

Label

What a health supplement label shows, in addition to the general food label.

  • The words "HEALTH SUPPLEMENT" and the common name, or a description of its true nature.
  • The amount of each nutrient or substance with a nutritional or physiological effect, with nutrients as a percentage of the ICMR RDA.
  • The warnings "NOT FOR MEDICINAL USE", shown prominently, and "Not to exceed the recommended daily usage".
  • A statement that it is not to be used as a substitute for a varied diet, and that it is to be stored out of reach of children.
  • Precautions, known side effects, contraindications and known product or drug interactions, as applicable.
  • The general particulars of the Labelling and Display Regulations, 2020 and the declarations of the Legal Metrology (Packaged Commodities) Rules, 2011 also apply.

How we help: Compliant Always reads your label against the supplement wording and the general particulars, and lists what is missing. Ask about this

Claims

What a supplement may and may not say.

  • The label, presentation and advertising may not claim that the supplement prevents, treats or cures a human disease.
  • Statements on structure, function or general well-being may be allowed where generally accepted scientific data support them.
  • Under the Advertising and Claims Regulations, 2018, claims are truthful, unambiguous and scientifically substantiated.
  • A health claim without established scientific support, or one for a novel ingredient, needs FSSAI's prior approval based on scientific evidence.

How we help: Compliant Always sets each claim beside the evidence on file for it, so unsupported wording shows up before the pack is printed. Ask about this

Licensing and import

The FSSAI licence, and how imported supplements are cleared.

  • Food businesses making or selling supplements hold an FSSAI licence or registration under section 31 of the FSS Act.
  • Schedule 1 of the Licensing Regulations places importers of food, and food made from novel ingredients, with the Central Licensing Authority.
  • Imports are cleared by FSSAI at the port under the Import Regulations, 2017, after document checks, inspection and sampling.

How we help: Compliant Always keeps licences, certificates of analysis and import papers with each lot, and shows what is expiring. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Brand ownerThe formula, the label wording and the claims.Label and claims read against the regulations, with the evidence beside them.
ManufacturerIngredients from the schedules, within RDA limits, under its FSSAI licence.Specifications and certificates of analysis kept with each batch.
ImporterA central import licence, the importer's details on the label, and port clearance.Supplier documents read and dated before shipment.

Central and state rules

Most product rules in India are central: FSSAI for food, CDSCO for imported cosmetics, BIS for standards and the Department of Consumer Affairs for packaged-goods declarations.

States license cosmetics manufacture, enforce food and legal metrology rules through their own officers, and run excise on alcohol.

Questions businesses ask

Are dietary supplements regulated as food or medicine in India?
As food. Section 22 of the Food Safety and Standards Act, 2006 covers health supplements and nutraceuticals, and FSSAI regulates them, provided they are not drugs under the Drugs and Cosmetics Act, 1940.
What must a health supplement label say in India?
"HEALTH SUPPLEMENT", the common name, the amounts of nutrients and %RDA, "NOT FOR MEDICINAL USE", "Not to exceed the recommended daily usage", that it is not a substitute for a varied diet, precautions and side effects, and to store it out of reach of children.
Is there a maximum vitamin or mineral level for supplements in India?
Yes. Nutrients may not exceed the recommended daily allowance set by the Indian Council of Medical Research; where ICMR sets none, Codex Alimentarius standards apply.
Can a supplement claim to treat a disease in India?
No. The label, presentation and advertising may not claim that a health supplement prevents, treats or cures a human disease.
Can I make structure or function claims for a supplement?
Statements on structure, function or general well-being may be allowed where generally accepted scientific data support them. Claims without established support need FSSAI's prior approval.
Can supplements be sold for children in India?
As notified in 2016, health supplements are for people above the age of five years. Check FSSAI's current regulations for any change.
Can I use an ingredient that is not on FSSAI's list?
Not without FSSAI. A business applies to the Food Authority to include a new nutrient or substance with no history of use in India, and FSSAI evaluates it.
Do supplement tablets need to meet pharmacopoeia standards?
Yes. Tablets, capsules and syrups meet the general quality requirements of the Indian, British or United States Pharmacopoeia under the 2016 regulations.
Do I need an FSSAI licence to import supplements?
Yes. Importers of food hold a central licence from FSSAI, and each consignment is cleared at the port under the Import Regulations, 2017.
Does the MRP rule apply to supplements?
Yes. As pre-packed commodities they carry the Legal Metrology declarations, including the retail sale price in Indian currency inclusive of taxes and consumer care details.
How does Compliant Always help with selling in India?
Our team reads the rules for the markets you sell in, including India's central regulators and the state rules that sit beside them. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in India and what your paperwork needs to show.

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