S. No.

Compliance Requirement

Key Compliance / Action Point

1

Eligible consumers

Ensure the health supplement is intended for persons above 5 years of age and is used to supplement the normal diet.

2

Permitted ingredients

Ensure the product contains one or more permitted concentrated sources such as amino acids, enzymes, minerals, proteins, vitamins, dietary substances, plants/botanicals, prebiotics, probiotics or substances of animal origin having an established nutritional/physiological benefit.

3

Non-drug status

Ensure the product is not represented or formulated as a drug under the Drugs and Cosmetics Act, 1940.

4

Permitted dosage/presentation

Market the product in appropriate single-use packaging or in permitted dosage forms such as capsules, tablets, pills, sachets, jelly/gel, semi-solids, liquids or powders designed for measured quantities.

5

Exclusion of specifically regulated foods

Ensure the product does not fall within a food category for which specific standards are prescribed elsewhere under the Regulations.

6

Permitted ingredients from Schedules

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

7

Necessary modifications

Any permitted ingredient may be modified, where necessary, having regard to the intended use of the product and the relevant nutrient requirements

8

Nutrient limits

Ensure the quantity of nutrients added does not exceed the applicable Recommended Daily Allowance (RDA) prescribed by ICMR; where unavailable, applicable Codex Alimentarius standards shall apply.

9

New nutrients/substances

Obtain approval from the Food Authority before using any new nutrient or substance having a nutritional/physiological function where it has no history of use in India, or where supporting evidence of the claimed nutritional/physiological benefit is required.

10

Scientific evaluation

Use only those new nutrients/substances that are approved by the Food Authority following scientific evaluation.

11

No disease claims

Do not claim or imply that the health supplement prevents, treats or cures any human disease.

12

Structure/function claims

Ensure any statement relating to the structure, function or general well-being of the body is supported by generally accepted scientific data and is permissible under the applicable requirements.

13

Mandatory label declaration product category

Every package shall prominently bear the words “HEALTH SUPPLEMENT”.

14

Product identification

Declare the common name or sufficiently descriptive name indicating the true nature of the product, including the common names of the nutrient/substance categories characterising it.

15

Nutrient/substance declaration

Declare the quantity of nutrients or substances having nutritional or physiological effects present in the product.

16

Medicinal-use warning

Prominently display “NOT FOR MEDICINAL USE”.

17

RDA declaration and usage warning

Where applicable, express nutrient quantities as a percentage of the relevant ICMR RDA and carry the warning “Not to exceed the recommended daily usage”.

18

Dietary-substitution statement

State that the health supplement is not to be used as a substitute for a varied diet.

19

Warnings/precautions

Declare applicable warnings, precautions, known side effects, contraindications and published product/drug interactions.

20

Child-safety statement

State that the product is required to be stored out of reach of children.

21

Permitted additives

Use only those additives permitted for health supplement formulations under Schedule VA, VE or VF.