Labelling & Claims Documents

Your Global Label Cannot Enter India Unchanged

Of all the sections in the NSF dossier, Labelling and Claims -is the one where foreign   consistently underestimate the work required. The assumption is that once the product approval is secured, the labelling is a routine adaptation exercise. In practice, the India label must be built from scratch against FSSAI’s regulatory framework — not adapted from the global label.

The reason is structural. FSSAI’s claims framework is significantly more conservative than the FDA’s dietary supplement regime or the EU’s health claims register. Claims that are standard in global supplement marketing — anti-aging, cellular repair, longevity, NAD+ boosting – have no regulatory basis in Indian food law and cannot appear on a product label in India.

Submitting a draft label with impermissible claims as part of your NSF dossier generates Panel queries before the scientific review has even begun. It signals to the Panel that the applicant has not engaged seriously with India’s regulatory framework — and it starts the relationship on the wrong footing.

Global Claims vs FSSAI India — The Reality Check

Claim Type	Global Usage	FSSAI India Status
Anti-aging	Widely used in US / EU supplements	NOT PERMITTED — not a recognised food category or claim
Promotes longevity	Standard in longevity supplement marketing	NOT PERMITTED — no regulatory basis in FSS Regulations
Cellular repair / regeneration	Common in NMN / NR product marketing	NOT PERMITTED — physiological mechanism claim without substantiation and approval. Also product approval is required for such products.
Boosts NAD+ levels	Central to NMN / NR global marketing	NOT PERMITTED as a standalone claim — mechanism of action claims require substantiation & FSSAI does not currently recognise these claims. Also, product approval is required for such products.
Supports healthy aging	Standard wellness claims globally	NOT PERMITTED — as covers broad array of wellness & it cannot be defined by any one ingredient without lifestyle management.
Clinically proven / clinically validated	Widely used in premium supplement marketing	REQUIRES SUBSTANTIATION — specific clinical evidence meeting FSSAI standards on product, not just published studies, along with claim approval from FSSAI.
Boosts immunity	Common Nutraceutical claim	RESTRICTED — very conservatively reviewed; generally not permitted as general claim
Contains [X] mg of [nutrient]	Nutrient content claim	PERMITTED — under FSS (Labelling & Display) Regs 2020 with correct format
Source of [vitamin/mineral]	Nutrient content claim	PERMITTED — if product meets minimum content threshold per FSSAI schedule
High in / rich in [nutrient]	Nutrient content claim	PERMITTED — if product meets higher content threshold per FSSAI schedule

Table 1

The Three Documents in Labelling and Claims

G1 — The Draft India-Compliant Label

The draft label submitted must comply with the Food Safety and Standards (Labelling and Display) Regulations, 2020. These regulations specify the mandatory label panels, the format for ingredient lists, the nutritional information table, allergen declarations, and the physical requirements for font size and label placement.

For NSF products — which by definition have no existing FSSAI product standard — the label must also declare the product category in a manner consistent with the approval being sought. For Nutraceuticals and health supplements, this means compliance with the specific labelling provisions of the FSS (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purposes, Functional Foods and Novel Foods) Regulations, 2022.

Mandatory label elements for NSF products include but is not limited to: product name, ingredient list in descending order of weight, nutritional information table per 100g/ml and per serving, net quantity, manufacturer/importer details, country of origin, batch number, manufacturing and expiry date, storage conditions, and the FSSAI license number. For Nutraceuticals and health supplements: recommended daily intake, directions for use, and any applicable advisory statements.

G2 — Claims Substantiation Document

If you propose any claim on the India label — including nutrient content claims — you must submit a claims substantiation document. This document maps each proposed claim to the specific FSSAI regulatory provision that permits it and the scientific evidence that supports it.

For nutrient content claims — ‘contains X mg of Vitamin D per serving’ — substantiation is straightforward: the CoA confirms the nutrient content, and the FSSAI schedule defines the permitted claim format. For anything beyond basic nutrient content claims, the substantiation burden increases significantly. Health claims require pre-approval from FSSAI — they cannot simply be included on the label because they are permitted in other country’s jurisdictions.

G3 — Country of Origin Label and Current Global Label

The current approved label from the country of manufacture is submitted for Panel reference — to show how the product is positioned in its home market and to allow comparison with the India-specific label. This document is informational for the Panel, not a compliance submission. However, significant discrepancies between the global label (with its full suite of health and functional claims) and the India label (stripped back to FSSAI-permissible content) should be acknowledged in the executive summary rather than left for the Panel to discover.

Building the India Label — A Practical Framework

Step 1: Start With a Clean Document

Do not open your global label and start deleting claims. Open a blank document and build the India label from FSSAI requirements upward. This is not just good regulatory practice — it is the mental discipline needed to produce a label that is genuinely compliant rather than one that retains global claims with minor modifications.

Step 2: Map Every Claim Intention to FSSAI Permissions

For every marketing message you want to convey about your product, ask: is there a way to communicate this within FSSAI’s permitted claims framework? In many cases, the answer is yes — but the permitted language is different from global marketing copy. ‘Contributes to normal energy metabolism’ is very different from ‘boosts cellular energy’ — but if your product contains specific B vitamins at appropriate levels, the former may be an approved nutrient function claim that communicates a similar benefit in association to those ingredients.

Step 3: Build the Nutritional Information Table for Indian Serving Sizes

Indian consumers and FSSAI inspectors reference nutritional information per 100g/ml and per serving. Ensure your serving size is appropriate for the Indian market — not simply the global serving size converted to metric. If your product’s global serving size generates a daily intake that differs from your proposed Indian conditions of use, the discrepancy needs to be reconciled before filing.

A Note on the FSS (Advertisement and Claims) Regulations, 2018

Labelling compliance does not exist in isolation from advertising compliance. The FSS (Advertisement and Claims) Regulations, 2018 govern all marketing communications for food products in India — not just the physical label. Any digital marketing, social media content, or promotional material that accompanies your India launch must also comply with these regulations.

The consistency requirement is strict: claims made in advertising must not exceed claims permitted on the label. If the label carries only nutrient content claims, your advertising cannot imply disease prevention, functional benefits, or clinical validation beyond what the label states. Building your India marketing strategy in parallel with your India label — with both reviewed against FSSAI’s advertising regulations — prevents enforcement exposure after launch.