FDA vs. FSSAI – Nutrient Claims

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

Nutrient/Food – Health Relationship

Model Statement

Criteria for Claim

FDA

2018 Food Safety and Standards Regl., India

FDA

2018 Food Safety and Standards Regl., India

Potassium, blood pressure and stroke

Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of blood pressure and stroke.

Diets containing good sources of potassium and low in sodium, fat, saturated fat and cholesterol may reduce the risk of high blood pressure.

· Good Source of potassium

· Low sodium

· Low fat

· Low saturated fat

· Low cholesterol

The food contains a good source or high in potassium and is:

· Low in sodium per serving

· Low in total fat, saturated fat and cholesterol

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)

Unique Nutrient-Health Relationships specified in the FDA:

Nutrient/Food – Health Relationship	Model Statement	Criteria for Claim
Nutrient/Food – Health Relationship	FDA	FDA
Fiber-containing grain products, fruits, vegetables and cancer 21 CFR 101.76	Low-fat diets rich in fiber-containing grain products, fruits and vegetables may reduce the risk of some types of cancer, a disease with many risk factors.	· Good source of dietary fiber (without fortification) · Low fat · Must contain grain, fruit or vegetable that contains dietary fiber · Must use terms “fiber” “dietary fiber” or “total fiber” and “some cancers” or “certain types of cancer” · States that cancer depends upon many factors · Does not specify types of dietary fiber that may be related to risk of cancer
Fruits, vegetables and grain products that contain fiber and heart disease 21 CFR 101.77	Diets low in saturated fat and cholesterol and rich in fruits, vegetables and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many risk factors.	· Low fat, low saturated fat and low cholesterol · >=0.6 g soluble fiber per RACC, without fortification · Soluble fiber must be listed in Nutrition Facts panel · Limited to fruits, vegetables and grains that contain fiber · Includes terms: “fiber”, “dietary fiber”, or “some types of fiber”, “saturated fat”, “cholesterol”, and “heart disease” or “coronary heart disease” · States that heart disease is multifactorial
Fruits, vegetables and cancer 21 CFR 101.78	Low-fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamin A and C and it is a good source of dietary fiber.	· Low Fat · Good source of dietary fiber, vitamin A or vitamin C without fortification · Includes term “total fat” or “fat” · Does not identify specific fatty acids · Uses terms “fiber”, “dietary fiber”, or “total dietary fiber” · Does not specify type of dietary fiber · States “some cancers” or “certain types of cancer” · States that cancer is multifactorial
Folate and neural tube defects 21 CFR 101.79	Adequate folate in healthful diets may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.	· Good source of folate (>=40 µg folate per serving) · Include folate and %DV on Nutrition Facts panel · If folate exceeds 100%DV, claim must state that that daily folate intake should not exceed 250%DV · Cannot be made on foods that contain more than 100%DV for vitamin A · Uses “folate”, “folic acid”, “folacin” or other allowed terms · Uses term “neural tube defects”, “birth defects spina bifida or anencephaly”, “birth defects of the spinal cord” · States that neural tube defects are multifactorial