S. No.

Compliance Requirement

Key Compliance / Action Point

1

Physiological Benefit

Ensure the nutraceutical provides a physiological benefit and helps maintain good health.

2

Source of Nutraceutical

Nutraceuticals may be extracted, isolated or purified from food or non-food sources.

3

Amino Acids & Derivatives

Amino acids and their derivatives may be prepared through bacterial fermentation under controlled conditions.

4

Permitted Food Formats

Nutraceuticals may be prepared/sold as granules, powder, tablet, capsule, liquid, jelly/gel, semi-solids or other permitted food formats.

5

Packaging Formats

Products may be packed in sachets, ampoules, bottles or other formats containing measured unit quantities.

6

Parenteral Administration

Products intended for parenteral administration shall not be marketed as nutraceuticals under these provisions.

7

Permitted Ingredients

Use only ingredients specified in Schedule I, II, IV, VI, VII or VIII, as applicable.

8

Modification of Nutrients

Modifications to specified nutrients may be made where necessary for the intended use of the product.

9

Maximum Nutrient Level

Nutrients added shall not exceed the applicable Recommended Daily Allowance (RDA) specified by ICMR; where unavailable, applicable Codex standards shall apply.

10

Unlisted Nutraceuticals – Prior Approval

A nutraceutical not covered by the Regulations may be manufactured/sold in India only after obtaining prior approval from the Food Authority, where its safety has been established in India or another country.

11

Evidence of History of Usage

Application for approval of an unlisted nutraceutical shall be supported by documented history of usage of at least 15 years in India or 30 years in the country of origin.

12

Scientific Evaluation

Comply with any approval/specification of nutraceuticals issued by the Food Authority following scientific evaluation.

13

Schedule VI Ingredients

Do not use ingredients other than those specified in Schedule VI as nutraceuticals where standardisation to specified marker compounds and daily usage levels is prescribed.

14

Marker Compound Standardisation

Where marker-compound standardisation is prescribed, ensure the ingredient complies with the specified standardisation requirements.

15

Quality & Purity Requirements

Where marker-compound standardisation is not specified, comply with manufacturer specifications, quality requirements and purity criteria under Regulation 3.

16

Usage Level – Scientific Basis

Where minimum/maximum daily usage levels are not specified, determine usage levels based on relevant scientific data and retain documentary evidence.

17

Submission of Scientific Data

Submit the documented scientific data to the Food Authority whenever called for.

18

Extracts of Ingredients

Do not use an ingredient extract as a nutraceutical unless the extract is specified in Schedule IV.

19

Plant/Botanical Ingredients

Plant or botanical ingredients specified in Schedule IV/VI may be used in the specified form or as extracts, subject to applicable extractive ratios in relation to daily usage values.

20

Disease Claims Prohibited

Labelling, presentation and advertising shall not claim or imply that the nutraceutical prevents, treats or cures a human disease.

21

Structure/Function Claims

Statements concerning structure, function or general well-being may be made where permitted by the Food Authority and supported by generally accepted scientific data.

22

Declaration – Product Category

Every package containing a nutraceutical shall bear the word “NUTRACEUTICAL” on the label.

23

Common Name

Declare the common name of the nutraceutical on the label.

24

Quantity of Nutraceutical Ingredient

Declare the amount of each nutraceutical ingredient having nutritional or physiological effect.

25

RDA Declaration

Where applicable, express nutrient quantity as a percentage of the relevant ICMR RDA, including where the nutrient is present as an adjunct to the nutraceutical.

26

Recommended Daily Usage Warning

Carry the advisory warning: “not to exceed the stated recommended daily usage”, where applicable.

27

Recommended Usage

Provide an advisory warning/statement specifying the recommended usage.

28

Medicinal-Use Warning

Prominently display “NOT FOR MEDICINAL USE”.

29

Excess Consumption Warning

Provide an advisory warning wherever a danger may arise from excessive consumption.

30

Precautions & Side Effects

Declare applicable precautions, known side effects, contraindications and product-drug interactions.

31

Storage Warning

State that the product should be stored out of reach of children.

32

Supporting Documentation

Maintain scientific, technical and safety documentation supporting ingredient selection, dosage, claims, quality and applicable usage levels.