The Important Factors of FSSAI Advertisement & Claims Approval For Food Supplements & Nutraceuticals.

Before FSSAI approval gets advertisements and claims that appear on food supplements and nutraceuticals, there are many important considerations.

FSSAI is very careful about the regulation of claims to ensure that they appear in the light of scientific fact, are not misleading, and are healthy for public interest. The following are key considerations:

Compliance with FSSAI Regulations

Under this, advertisements or claims pertaining to food products, which include supplements and nutraceuticals, are regulated by Food Safety and Standards (Advertising and Claims) Regulations, 2018.

Claims shall comply with definitions and guidelines adopted under regulations of FSSAI for categories including 3.1.1 Nutrient Function claims; 3.1.2 Health claims; and 3.1.3 Risk reduction claims.

  • The product and its claims should be in accordance with the  Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods, and Novel Foods) Regulations, 2016.

Truthfulness and Non-Deceptiveness

   - All the claims associated with advertisements need to be  true,  clear, and  non-misleading.

- All health or nutritional claims are supported by scientific evidence and do not create false expectations about what the benefits of the product might be and to what extent it may impact health.

   - It should not exploit consumers' unawareness on such matters, and there must not be any transmission of unfounded information.

Scientific Support for Claims

   Any health benefit claims for a product are scientifically substantiated.

- Manufacturers need to have scientific evidence for clinical data, research studies, or published scientific evidence for the claims. FSSAI has a claim justification dossier that has the scientific basis for each and every claim that is being derived on the product or in the advertising material.

   Unsubstantiated or exaggerated claims, especially those claiming to treat, prevent, or cure diseases, fall under drugs are not allowed.

Claims that cure, treat, or prevent a given disease cannot be made for foods supplements and nutraceuticals. Such statements can be used only for drugs and would be violative of FSSAI guidelines as false or misleading

   Claims that are superior in comparison but about which there is no substantial evidence over comparable products cannot be permitted.

- Those undermining a balanced diet or overconsumption of the product are not acceptable either.


hitesh gupta

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