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Nutraceutical Label Compliance in India: FSSAI Rules Made Practical

Selling supplements in India means labelling under FSSAI nutraceutical regulations. A practical walkthrough of mandatory declarations, claims rules, format requirements and the print decisions that keep you compliant.

  • Uma, Senior Sales Executive
  • Updated
  • 4 min read
  • Since 2010
  • 1000+ brands
  • 25+ export countries
  • Quote within 24 hours
Nutraceutical Label Compliance in India: FSSAI Rules Made Practical

A health supplement or nutraceutical label in India must carry the words HEALTH SUPPLEMENT or NUTRACEUTICAL, the advisory NOT FOR MEDICINAL USE, nutrient quantities against ICMR recommended daily allowances where applicable, and the prescribed safety statements, and regulators are watching these labels closely. FSSAI’s framework for health supplements and nutraceuticals sets out exactly what your label must declare, how claims may be worded, and what gets products pulled from shelves. Here is the practical version for brand owners preparing artwork.

This guide is an orientation, not legal advice, so always validate final artwork against the current regulations and your product’s specific approval.

Which Rules Apply to You?

Health supplements, nutraceuticals, foods for special dietary use and similar categories fall under FSSAI’s nutraceutical regulations, layered on top of the general food labelling rules. Practical consequence: your label must satisfy both the general food labelling requirements and the category-specific ones below.

Two recent updates matter for artwork planning. On 15 October 2026 FSSAI issued an advisory on warning statements for plant and botanical ingredients, directing makers of health supplements, nutraceuticals and similar foods to indicate the plant part used and carry the prescribed cautionary statements, and warning that non-compliance can lead to regulatory action, including suspension or cancellation of licences and penalties. Separately, the Labelling and Display First Amendment Regulations, 2026 were notified on 24 March 2026 and come into force on 1 July 2027. As reproduced in published gazette text, they amend Regulation 5(3)(c) of the 2020 labelling rules, the list of foods exempted from mandatory nutritional labelling, with a clause on health supplements, nutraceuticals and foods for special dietary use in tablet, pill and capsule format. Check the gazette text before your next reprint.

The Mandatory Declarations Checklist

  1. Product name + category words: HEALTH SUPPLEMENT or NUTRACEUTICAL, as applicable, stated clearly.
  2. “NOT FOR MEDICINAL USE” prominently written: the advisory warning regulators look for first.
  3. Complete ingredient list with quantities of nutrients/actives per serving, and % RDA where applicable.
  4. Recommended usage/serving and the advisory not to exceed it.
  5. Target consumer and warnings: “not for children below…”, pregnancy and lactation cautions, known side effects, contraindications and drug interactions where relevant, and, for health supplements, a statement that the product is not a substitute for a varied diet.
  6. FSSAI license number and logo of the brand owner and manufacturing unit, as applicable.
  7. Veg/non-veg mark at prescribed size and placement.
  8. Batch/lot, MFG and EXP/best-before dates, printed legibly, not as a dot-matrix smudge.
  9. Net quantity, MRP, customer-care details per Legal Metrology rules.
  10. Storage instructions matched to the product’s stability data, plus a statement that the product must be stored out of reach of children.

Need labels like these for your products?

Tell us your product, quantity and market. Our team replies with a clear quote within 24 hours, for orders in India and for export.

Claims: Where Brands Get Into Trouble

  • Permitted: nutrient-content and approved health/function claims consistent with the schedules and your formulation evidence.
  • Prohibited: disease treatment/cure/prevention claims, such as “cures diabetes”, “fights cancer” and softer versions of the same idea.
  • The grey zone: implied claims via imagery and testimonials count as claims. Regulators read pictures too.

Format & Legibility Requirements

Minimum font sizes scale with pack size; declarations must contrast with the background; the veg mark has fixed size rules. Cramming is the enemy, so our label sizing guide shows how to establish the area your mandatory text actually needs before design begins.

  • Print batch/expiry into the label via variable data printing instead of line overprinting: crisp, verified, never misaligned or missing.
  • Serialized QR verification defends against the counterfeit supplements plaguing the category, exactly what we built in this nutraceutical case study.
  • Durable materials: bathroom-cabinet humidity and oil contact demand film faces or laminated stocks, so see the nutraceutical labels page for constructions we recommend.
  • Tamper evidence: induction seals plus tamper-evident labels reassure both regulators and customers.

Preparing a supplement launch? Send Sai Impression your draft artwork and we will quote it, printing batch-coded variable data; your compliance team still signs off sizes, marks and placements. Get a compliance-aware quote →

FAQ

Is “NOT FOR MEDICINAL USE” mandatory on supplements in India?

Yes. Health supplements and nutraceuticals must carry this advisory warning prominently written under the FSSAI nutraceutical regulations. Its absence is one of the fastest routes to enforcement action.

Can supplement labels claim to cure or treat diseases?

No. Disease treatment, cure or prevention claims are prohibited for this category, including implied versions through images or testimonials. Only permitted nutrient and function claims consistent with the schedules may be used.

Do imported supplements need Indian labels?

Yes. Imported food must meet FSSAI labelling requirements, including the importer’s name and address, the importer’s FSSAI logo and licence number, and the country of origin, with the Food Safety and Standards (Import) Regulations, 2017 applying in addition. Importers commonly handle this with compliant labels applied before sale.

What font size is required for supplement label text?

Under the FSSAI Labelling and Display Regulations, 2020, the minimum height of letters and numerals on the principal display panel is 1 mm up to 200 cm², 2 mm above 200 and up to 500 cm², 3 mm above 500 and up to 2500 cm², and 6 mm above 2500 cm², with larger minimums for blown, moulded or perforated containers. Net quantity, MRP, dates and consumer-care details follow Legal Metrology sizes, so keep high contrast and confirm the final artwork against current rules.

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Written by Uma, Senior Sales Executive

Uma is a senior sales executive at Sai Impression and helps brands and exporters choose label materials and place orders. Sai Impression has printed labels and packaging in Chennai, India since 2010 for more than 1000 brands, in India and across 25+ export markets, on flexo, flatbed and digital presses. About us

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