This series compares and demystifies 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. Part II discussed the relationships between Fat and Cancer, Sodium and Hypertension and Saturated Fat, Cholesterol and Heart Disease.

1. MANAGE
ARTWORKS
FDA vs. FSSAI
Health Claims - Part 3

2. • Summary: Following the blog series on nutrition claims, this series compares and
demystifies 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. Part II
discussed the relationships between Fat and Cancer, Sodium and Hypertension and
Saturated Fat, Cholesterol and Heart Disease.
In this post we will analyze 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
• Fiber-containing grain products, fruits, vegetables and cancer
• Fruits, vegetables and grain products that contain fiber and heart disease
• Fruits, vegetables and cancer
• Folate and neural tube defects
Health Claims

3. Health Claims
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FDA has stipulated authoritative statement in addition to regular health claim for the above
mentioned food-health relationship as follows:
• …risk of stroke-related deaths is inversely related to potassium intake over the entire range
of blood pressures and the relationship appears to be dose dependent.
• A diet containing approximately 75 mEq [~3.5 g] potassium daily may contribute to reduced
risk of stroke – NAS Diet and Health Report (1989)

4. Health Claims
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5. Health Claims
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