FSSAI Labelling Requirements 2023: What Nutraceutical Brands Must Know

Labelling is where most nutraceutical brands first run into FSSAI. A formulation can be perfectly compliant and still be held up — or recalled — because a declaration is missing, a claim is unsubstantiated, or the mandatory format is wrong. The Food Safety and Standards (Labelling & Display) Regulations, 2020 consolidated and tightened these rules, and the amendments that have followed continue to raise the bar for health supplements and nutraceuticals.

This guide covers the label elements FSSAI expects on a nutraceutical product sold in India, and the mistakes we most often correct during pre-launch review.

Mandatory declarations on every label

Regardless of category, a packaged nutraceutical label must carry a defined set of declarations. Getting any one of these wrong is enough to make the label non-compliant.

• Name of the food and, where applicable, the category (e.g. "Health Supplement" or "Nutraceutical") as defined under the 2016 nutraceutical regulations.
• FSSAI logo and the 14-digit licence number of the manufacturer/marketer.
• Complete list of ingredients in descending order of composition, including additives with their class and INS number.
• Nutritional information, typically declared per 100 g / 100 ml and per serving, with % contribution to RDA where a nutrient claim is made.
• Net quantity, batch/lot number, date of manufacture and "best before"/expiry.
• Name and complete address of the manufacturer, marketer or importer.
• The green (vegetarian) or brown (non-vegetarian) symbol.
• Declaration of allergens and any mandatory warning/advisory statements for the category.

Health supplements and nutraceuticals carry extra obligations

Products sold under the health supplement or nutraceutical route carry category-specific labelling duties on top of the general rules. These commonly include an advisory that the product is "not for medicinal use", a statement that it is not to exceed the recommended daily usage, a "keep out of reach of children" line where relevant, and the recommended serving and duration of use. The permitted ingredients and their limits are governed by the nutraceutical schedules, and the label must stay inside those limits.

Claims are the highest-risk area

Nutrient claims, nutrient function claims, and health claims are each governed by their own conditions and thresholds. A claim is only permitted if the product meets the qualifying criteria and the claim is substantiated by accepted scientific evidence. "Immunity", "detox", and similar marketing language attract particular scrutiny. Every claim on the pack should be mapped to its regulatory basis and evidence file before the artwork is finalised.

Get the label reviewed before the print run

Label corrections after printing are expensive, and label non-compliance discovered in the market can trigger enforcement. A structured pre-launch label review — checking mandatory declarations, category-specific statements, claim substantiation, and format against the current regulations — is the cheapest insurance a nutraceutical brand can buy.

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