This will compare and demystify basis for health claims on food products as prescribed by the United States Code of Federal Regulations (CFR) Title 21 Section 101.14 and the equivalent Indian regulation, ‘Food Safety and Standards (Claims and Advertisement) Regulations, 2018’. Part I focused on the basis for health claims and concluded with food-health relationships – calcium and vitamin D with osteoporosis.

1. MANAGE
ARTWORKS
FDA vs. FSSAI
Health Claims - Part 2

2. Summary: Following the blog series on nutrition claims, this series will compare and
demystify basis for health claims on food products as prescribed by the United States Code
of Federal Regulations (CFR) Title 21 Section 101.14 and the equivalent Indian regulation,
‘Food Safety and Standards (Claims and Advertisement) Regulations, 2018’. Part I focused on
the basis for health claims and concluded with food-health relationships – calcium and
vitamin D with osteoporosis.
This post explores the food-health relationship between:
• Fat and Cancer
• Sodium and Hypertension
• Saturated Fat, Cholesterol and Heart Disease
To recap, according to 21 CFR 101.14(a)(5) the model health claim statement will have the
following structure:
Substance (nutrient, food component) + May reduce risk of + Name of disease or condition +
Reference to total dietary patterns + Does not imply degree of risk reduction
As per Food Safety and Standards (Claims and Advertisement) Regulations, 2018, health
claims must consist of two parts:
• Information on the physiological role of the nutrient or substance or an acceptable
diet-health relationship followed by
• Information on the composition of the product relevant to the physiological role of
the nutrient or substance or the accepted diet-health relationship
Health Claims

3. Health Claims
BusinessValue
• For a given nutrient/food-health relationship, let us look at the model statements
prescribed by FDA as well as the Indian Regulation.

4. Health Claims
BusinessValue
Next up in this series, we will be comparing the health claim requirements for:
• Potassium, blood pressure and stroke
• Unique nutrient-health relationships specified in the FDA regulation that are not
covered by the equivalent Indian Regulation
o Fiber-containing grain products, fruits, vegetables and cancer
o Fruits, vegetables and grain products that contain fiber and heart disease
o Fruits, vegetables and cancer
o Folate and neural tube defects

5. THANK YOU