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Regulation

India FSSAI Supplement Label Requirements (2016 Regs)

Health Supplement (FSSAI), the India FSSAI nutrition label under FSS (Health Supplements, Nutraceuticals, FSDU, FSMP) Regulations, 2016 (as amended 2022); RDA per ICMR-NIN (2020). Generate a compliant label free.

Reviewed against FSS (Health Supplements, Nutraceuticals, FSDU, FSMP) Regulations, 2016 (as amended 2022); RDA per ICMR-NIN (2020) · Page updated August 16, 2026

Jurisdiction
India (packaged food sold at retail)
Regulation
FSS (Health Supplements, Nutraceuticals, FSDU, FSMP) Regulations, 2016 (as amended 2022); RDA per ICMR-NIN (2020)
Effective
23 December 2016
Official source
fssai.gov.in
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Nutrition labelling requirements in India

Packaged food sold in India must carry a nutrition declaration under FSS (Health Supplements, Nutraceuticals, FSDU, FSMP) Regulations, 2016 (as amended 2022); RDA per ICMR-NIN (2020). This page covers the India - Health Supplement (FSSAI) format: Per serving with %RDA (ICMR-NIN 2020) - FSS Nutra Regs 2016. A supplement panel lists whatever the product contains rather than a fixed set, but 23 nutrients have a published reference intake, values are declared per serving and alongside a % RDA* column. 4 statements are mandatory on pack, including "NOT FOR MEDICINAL USE.". The panel carries the footnote "* RDA as per ICMR-NIN (2020) for adult (sedentary) man.". The panel is headed "HEALTH SUPPLEMENT". NFL builds a print-ready India FSSAI nutrition label from your recipe, applying the rounding rules and reference intakes for India automatically, and exports it as PDF, PNG, SVG, JPG or EPS.

Official regulation

Citation
FSS (Health Supplements, Nutraceuticals, FSDU, FSMP) Regulations, 2016 (as amended 2022); RDA per ICMR-NIN (2020)
Effective
23 December 2016
Scope
India (packaged food sold at retail)
Source

Key facts

Panel heading
HEALTH SUPPLEMENT
Reference values defined
23 nutrients with a published reference intake
Column caption
Per serving
Percentage column
% RDA*
Required footnote
* RDA as per ICMR-NIN (2020) for adult (sedentary) man.
Mandatory statements (4)
NOT FOR MEDICINAL USE., Not to exceed the stated recommended daily usage., Not for children, pregnant or lactating women unless recommended. and Keep out of reach of children.

Status of the FSS (Nutra) Regulations, 2022: a draft applied by direction, not a final gazette

The 2022 regulations have been applied for years without a final notification. The sequence, from FSSAI's own documents:

  • The 2016 regulations came into force on gazette publication, with full compliance required by 1 January 2018. Their last amendment took effect on 6 September 2021, compliance by 1 April 2022.
  • On 29 March 2022 FSSAI issued a direction under section 16(5) of the FSS Act operationalising the FSS (Nutra) Regulations, 2022 from 1 April 2022, stating that it supersedes the 2016 regulations and their amendments.
  • The draft was published in the Gazette of India on 28 June 2022 (notification dated 24 June 2022, No. 329, CG-DL-E-28062022-236891) with a 60-day objection period.
  • As finalisation slipped, FSSAI re-operationalised the same text by directions of 18 October 2022, 11 April 2023, 17 November 2023, 5 June 2024 (from 1 January 2024) and 30 August 2024 (from 1 July 2024).

So enforcement follows the 2022 text, yet it remains formally a draft. Print to the 2022 requirements today and check the FSSAI advisories page for a newer direction or a final gazette first. The 2022 title also drops Functional Food and Novel Food; novel ingredients go through the FSS (Approval of Non-Specified Food and Food Ingredients) Regulations, 2017.

Source: FSSAI Direction of 29 March 2022, Gazette draft notification of 24 June 2022, FSSAI Directions of 5 June and 30 August 2024.

Mandatory statements and placement under regulation 5(12) of the 2022 text

Regulation 5(12) sits on top of the FSS (Labelling and Display) Regulations, 2020 and fixes where each extra statement goes.

  • Front of pack: the category word, one of HEALTH SUPPLEMENT, NUTRACEUTICAL, FOOD FOR SPECIAL DIETARY USE, FOOD FOR SPECIAL MEDICAL PURPOSE, PREBIOTIC FOOD or PROBIOTIC FOOD, in capital and bold letters in the immediate proximity of the product or brand name, plus a prominent statement of the target consumer or age group where the product is formulated for one.
  • Front or back of pack: NOT FOR MEDICINAL USE in capital and bold letters; the recommended usage level; duration of usage where applicable; "Not to exceed the recommended daily usage" written prominently; an advisory warning where excess consumption may be dangerous; warnings on precautions, side effects, contraindications and published drug interactions; "product is not to be used as a substitute for a varied diet" (not required for FSDU and FSMP); "product is required to be stored out of reach of children"; and nutrient quantities as a percentage of the relevant recommended daily allowance.
  • Front, back or leaflet: the amount of each nutrient or active substance, plus instructions and precautions.

FSDU and FSMP are exempt from NOT FOR MEDICINAL USE. FSDU packs instead carry FOOD FOR SPECIAL DIETARY USE followed by "Food for ......" naming the condition or user group; FSMP packs carry RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY in capital and bold on the front, "For the dietary management of ......", NUTRITIONALLY COMPLETE where applicable and a warning that the product is not for parenteral use. Probiotic foods must state genus, species and strain, viable numbers at end of shelf life, and the serving size delivering the effective dose.

Source: FSS (Nutra) Regulations, 2022, regulations 5(12) and 6.

RDA limits, % RDA declarations, overages and the minus 10 percent tolerance

The percentage on an Indian supplement label is a share of the Recommended Dietary Allowance, not a Nutrient Reference Value. The FSS (Labelling and Display) Regulations, 2020 apply the current ICMR Nutrient Requirements and Recommended Dietary Allowances for Indians, with Codex or WHO values only where an Indian value is missing. The current edition is ICMR-NIN 2020, which raised most allowances over 2010: calcium from 600 mg to 1000 mg, vitamin C for men from 40 mg to 80 mg (65 mg for women), vitamin D from 400 IU to 600 IU. Values differ by sex and activity, so the label should name the reference group used.

Dose limits under the 2022 text: where FSSAI has not set a level, a nutrient content claim on a health supplement or nutraceutical needs at least 15 per cent of the ICMR RDA, a higher-content claim at least 30 per cent, and the nutrient shall not exceed one RDA in any case. FSDU and FSMP share the one-RDA ceiling, but a higher level in a food format (not tablet, capsule or syrup) may be allowed with prior FSSAI approval.

Overages within Schedule I, Table C are allowed (30 per cent for vitamins A, D and K1, 20 per cent for vitamin C and iodine, 10 per cent for minerals) and the panel must then state "appropriate overages added". Tolerance follows the Labelling and Display Regulations: a declared nutrient may test no lower than minus 10 per cent of the label value within shelf life.

Source: FSS (Labelling and Display) Regulations, 2020, regulations 2(q) and 5(3); FSS (Nutra) Regulations, 2022, regulation 6 and Annexure 2 Schedule I Table C; ICMR-NIN RDA 2020 brief note.

Schedules, age limits and formats: what changed from the 2016 regulations

The 2016 regulations carried eight schedules; the 2022 text uses four, issued by FSSAI as executive orders so they can change without re-notifying the regulation: Schedule I nutrients (vitamins, minerals, amino acids, nucleotides), Schedule II plants and botanicals with the part used and adult daily range, Schedule III molecules, isolates and extracts standardised to marker compounds, and Schedule IV prebiotics and probiotics. A health supplement may use every schedule except III; a nutraceutical is built on Schedule III. Unlisted botanicals with 30 years of safe use abroad or 15 years in India need prior approval.

Other changes that reach the label:

  • Age: the 2016 text allowed health supplements only above five years. The 2022 text covers people above two years, but products for children of two to five must be given only under advice from a doctor, dietician or nutritionist
  • Formats: powders, granules, tablets, capsules, liquids, drops, gummies, jelly, strips, bars, biscuits and candies are recognised, but a conventional-looking format must not be presented as a conventional food. Tablet, capsule, pill and drop formats for prebiotic or probiotic foods need prior approval.
  • Prebiotic foods are capped at 40 g per day for adults; probiotic foods must deliver at least 10 to the power 8 CFU in the recommended daily serving unless a lower count is approved.

Source: Compendium of the 2016 regulations (29 September 2021); FSS (Nutra) Regulations, 2022, regulations 2, 5 and 6.

Enforcement under the FSS Act, 2006: misbranding, advertising and import

Section 22 of the Food Safety and Standards Act, 2006 prohibits making, selling or importing these foods except as the regulations allow, so a pack missing the 2022 statements is misbranded. Under section 52 anyone who manufactures, stores, sells, distributes or imports misbranded food faces a penalty of up to three lakh rupees, and the Adjudicating Officer may order corrective action or destruction of the stock. Section 53 sets a penalty of up to ten lakh rupees for an advertisement that falsely describes a food or misleads as to its nature, substance or quality, the provision used against disease claims. Section 25 bars import of misbranded food, so an imported supplement meets the same label check at the port. The 2022 text also lets FSSAI suspend sale of products not clearly distinguishable from ordinary food and order unsupported claims stopped. Build an India label in the generator.

Source: Food Safety and Standards Act, 2006, sections 22, 25, 52 and 53; FSS (Nutra) Regulations, 2022, regulation 5(15).

Sources

Primary documents this page was written from, checked 2026-09-16.

How NFL handles it

  • Applies the correct rounding rules for every nutrient
  • Uses the right Daily Value / Reference Intake table for this jurisdiction
  • Renders the required front-of-pack warnings automatically when thresholds are hit
  • Handles multilingual labels where required (bilingual EN/FR, EN/ES, Arabic + EN, etc.)
  • Exports print-ready vector PDF, PNG, SVG, JPG, and EPS

Common questions

Are the FSSAI nutraceutical regulations 2022 in force in India?
In practice yes, formally not yet. FSSAI operationalised the FSS (Nutra) Regulations, 2022 by a direction dated 29 March 2022 with effect from 1 April 2022, superseding the 2016 regulations, and published the draft in the Gazette of India on 28 June 2022. Because the final notification kept slipping, FSSAI re-issued the direction on 18 October 2022, 11 April 2023, 17 November 2023, 5 June 2024 and 30 August 2024. Businesses comply with the 2022 text now and should check the FSSAI advisories page for the latest direction or a final gazette.
What must be written on the front of a health supplement pack in India?
The words HEALTH SUPPLEMENT (or NUTRACEUTICAL, FOOD FOR SPECIAL DIETARY USE, FOOD FOR SPECIAL MEDICAL PURPOSE, PREBIOTIC FOOD or PROBIOTIC FOOD as applicable) in capital and bold letters right next to the product or brand name, plus a prominent statement of the target consumer or age group if the product is formulated for one. NOT FOR MEDICINAL USE, the recommended usage level and the other warnings may go on the front or the back.
Which RDA does FSSAI use for the % RDA on supplement labels?
The RDA values in the current ICMR-NIN Nutrient Requirements and Recommended Dietary Allowances for Indians, which is the 2020 edition; Codex or WHO figures apply only where India has no value. The 2020 edition lifted many allowances, for example calcium to 1000 mg and vitamin C for men to 80 mg, so a label carrying 2010-era percentages is out of date. State the reference group used, since values differ for men, women and activity levels.
Can a health supplement in India contain more than 100% RDA of a vitamin?
No. Under the 2022 text a nutrient in a health supplement or nutraceutical shall not exceed one ICMR RDA in any case, and section 22 of the FSS Act also caps vitamins, minerals and amino acids at the RDA for Indians. FSDU and FSMP products in a food format (not tablet, capsule or syrup) may exceed one RDA only with prior FSSAI approval based on scientific evidence.
Is 'NOT FOR MEDICINAL USE' compulsory on every FSSAI supplement label?
It is compulsory, in capital and bold letters, for health supplements, nutraceuticals, prebiotic foods and probiotic foods. Foods for special dietary use and foods for special medical purpose are exempt from that statement; FSDU carries a statement on whether medical advice is needed and FSMP carries RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY on the front of pack instead.
What is the FSSAI tolerance for declared vitamins and minerals on a supplement?
The 2022 text points to the FSS (Labelling and Display) Regulations, 2020, which allow the analysed value to be at most 10 per cent below the declared value at any time within shelf life. To hold that, manufacturers may add overages up to the Schedule I Table C limits (for example 30 per cent for vitamin A, 20 per cent for vitamin C, 10 per cent for minerals) and must then print 'appropriate overages added' in the composition panel.
Can I sell a gummy or protein bar as a health supplement under FSSAI rules?
Yes. The 2022 text recognises powders, granules, tablets, capsules, liquids, drops, gummies, jelly, chewable and mouth dissolving strips, bars, biscuits and candies as delivery formats. If the format looks like a conventional food, the label must not present it as one and must make the distinction clear. Tablet, capsule, pill and drop formats for prebiotic or probiotic foods need prior FSSAI approval.
What is the penalty for a misbranded supplement label in India?
Section 52 of the Food Safety and Standards Act, 2006 provides a penalty of up to three lakh rupees for manufacturing, storing, selling, distributing or importing misbranded food, and the Adjudicating Officer can order the label corrected or the stock destroyed. A misleading advertisement or disease claim falls under section 53, with a penalty of up to ten lakh rupees. Imports are checked against the same rules under section 25.

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