In the modern consumer landscape, health claims are among the most powerful marketing tools used by food businesses. Phrases such as “boosts immunity,” “supports heart health,” or “improves digestion” often influence purchasing decisions. However, these claims must stand on a strong foundation of scientific validation and regulatory compliance. In India, such claims are governed by the Food Safety and Standards (Advertising and Claims) Regulations framed under the Food Safety and Standards Act, 2006 (FSSA, 2006).
This article delves into health claims — what they are, the regulatory requirements, the scientific evidence needed, and how businesses can ensure full compliance while maintaining consumer trust.
What Are Health Claims?
A health claim is a statement on food labels, advertisements, or promotional materials that suggests a relationship between the consumption of a food or one of its constituents (like nutrients or bioactive substances) and health benefits.
Health claims typically refer to:
Legal Mandate: What FSSAI Requires
Under the Food Safety and Standards (Advertising and Claims) Regulations, FSSAI mandates that any health claim must be clear, scientifically substantiated, and not misleading. Regulation 7 of these rules outlines specific conditions that food businesses must meet before making a health claim.
1. Structure of a Health Claim
Dual Components of a Valid Claim
Every health claim must consist of two parts:
(i) Physiological Role of the Nutrient or Food Substance
This part of the claim explains how the nutrient or food component functions in the human body.
Example: “Calcium helps in the normal development of bones.”
(ii) Product Composition Details
It should specify that the food contains a sufficient amount of the nutrient related to the claimed function. If the claim relates to an entire food (not just a nutrient), then this part may be exempt if the benefit is supported by whole-food-based research.
2. Recommended Dietary Allowance (RDA) Compliance
If the claimed benefit is linked to a specific nutrient for which RDA values exist, the following applies:
Example: A product claiming “low sodium for heart health” must have sodium levels below the defined threshold in Schedule I.
3. Mandatory Label Declarations
Health claims must be accompanied by:
This ensures informed decision-making by consumers and promotes responsible use.
4. Scientific Substantiation of Claims – Function Claims & Evidence
Nutrient function claims and other health-related function claims must be:
Food businesses must maintain a scientific dossier containing:
References from peer-reviewed journals
5. Claims for Edible Vegetable Oils
FSSAI allows nutrient function claims for edible vegetable oils as per Schedule IIA. This includes statements like:
However, these claims must still meet the dual-part structure and be scientifically verifiable.
6. Disease Risk Reduction Claims
Perhaps the most sensitive category of health claims, disease risk reduction claims can only be made:
Such claims must be non-diagnostic, i.e., they can’t say a food treats or cures a disease but may claim to reduce the risk of one.
Permissible example: “Plant sterols may help reduce cholesterol, a risk factor for heart disease.”
Prohibited example: “This food prevents heart attack.”
7. Fortified Foods and Health Claims
Foods fortified as per the Food Safety and Standards (Fortification of Foods) Regulations, 2018 may use health claims listed in Schedule IV.
FSSAI also allows flexibility in wording, provided the meaning remains unchanged. This accommodates regional language variations and creative marketing, as long as scientific integrity is maintained.
8. Product-Level Claims: High Scientific Threshold
When the health benefit is attributed not to a nutrient but the entire product, the bar is even higher.
Such claims must be backed by:
This ensures that product-level health claims are credible, reproducible, and scientifically sound.
Common Pitfalls to Avoid
Food businesses must exercise caution. Some of the most common violations in health claims include:
Penalty for Non-Compliance
Under Section 53 of the Food Safety and Standards Act, 2006:
Misleading advertisements or false claims may attract a penalty of up to ₹10 lakhs.
Other consequences may include:
Irreparable brand damage
Best Practices for Food Businesses
To ensure regulatory compliance and consumer confidence:
Conclusion
Health claims offer a powerful way to communicate a product’s benefits — but with great power comes great responsibility. The Food Safety and Standards Authority of India ensures that these claims are not only truthful but also based on scientific rigor and public health considerations.
For food businesses, aligning with these regulations is not just about avoiding penalties — it’s about building trust, ensuring transparency, and contributing to the well-being of consumers. For regulators, the structured framework ensures that India’s evolving food market grows responsibly. And for consumers, it offers confidence that the health claims on labels are more than just words — they are promises grounded in science.
Read more about this Regulation: Food Safety and Standards (Advertising and Claims) Regulations, 2018
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