S. No.

Compliance Requirement

Key Requirement / Condition

1

Permissibility of Claims

FBO may make nutritional or health claims in respect of an article of food, subject to the applicable regulatory requirements.

2

Nutritional Claims

Nutritional claims shall relate to the ingredient/nutrient/nutritional content of the food and comply with the requirements specified in the applicable Schedules.

3

Health Claims – Definition

A health claim shall state, suggest or imply a relationship between a constituent/nutrient/nutritional component and health or a specific disease condition.

4

Essential Components of Health Claim

Health claims shall contain: (i) nutrient/nutritional ingredient; and (ii) health-related benefit.

5

Permitted Types of Health Claims

May include ingredient/nutrient function claims, enhanced function claims, disease risk reduction claims, health maintenance claims, immunity claims (excluding vaccines), and anti-ageing claims.

6

Other Claims

Claims other than drug claims may be made subject to prior approval of the Food Authority.

7

Supporting Documentation

FBO shall maintain adequate documentation and valid scientific proof supporting health claims and make the same available for review by the Food Authority when required.

8

Scientific Basis – Enhanced Function/Disease Risk Reduction

Claims shall be supported by relevant scientific literature, traditional texts, post-market data, consumer/cohort studies, epidemiological data and other well-documented evidence, as applicable.

9

Efficacy and Safety Evidence

Evidence should establish the health-promoting or disease-risk-reduction effect as well as the efficacy and safety of the relevant nutrient/ingredient.

10

Human Data / Clinical Evidence

Human intervention studies, clinical trials and relevant nutraepidemiological data should be considered for substantiating efficacy and safety.

11

Structure–Function Claims

Structure–function claims relating to a specific organ or function shall be appropriately qualified and comprehensible to consumers.

12

No Drug-like Claims

Claims shall not imply that the food cures, prevents or treats a disease or possesses drug-like efficacy.

13

Prohibition on Implied Cure Claims

Disease-cure claims shall not be implied through the product name, pictures, vignettes, symbols or similar representations.

14

Specific Consumer Information

For structure–function claims, consumer information shall be provided on a case-to-case basis, particularly for specific age groups, genders or vulnerable populations, where applicable.

15

Product-led Claims – Human Studies

Product-led claims based on human studies shall be supported by valid data and appropriate statistical design, including human intervention studies where applicable.

16

Ingredient and Product Compatibility

The ingredient/nutrient and its compatibility with the product shall support the proposed health benefit, with appropriate qualifiers where necessary.

17

Use of “Shown”

The term “shown” may be used where a single human intervention study demonstrates a significant benefit, subject to the prescribed conditions.

18

Use of “Proven”

The term “proven” may be used where more than one human intervention study or epidemiological evidence from the Indian population with concurrent validity supports the claim.

19

Novel Ingredient / Lack of Scientific Support

Where adequate scientific support for a health claim does not exist or a novel ingredient is proposed, prior approval of the Food Authority is required based on adequate scientific evidence.

20

Notification of Product-led Claims

Where a health claim is product-led, the FBO shall notify the Food Authority before placing the product on the market.

21

Documents for Notification

The notification shall be accompanied by the relevant supporting documents and a copy of the product label.