FDA vs. FSSAI – Health Claims Part II |

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

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

Nutrient/Food – Health Relationship	Model Statement		Criteria for Claim
Nutrient/Food – Health Relationship	FDA	2018 Food Safety and Standards Regl., India	FDA	2018 Food Safety and Standards Regl., India
Fat and Cancer 21 CFR 101.73	Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.	*In this regulation, there are no specific model statements for any food/nutrient-cancer relationship. However the following statement is found, ‘Claims regarding cancer may be deferred.’	Low Fat Includes term ‘total fat’ or ‘fat’ Does not mention specific fatty acids Refers to “some types of cancers” States that cancer is multifactorial State that diets low in fat “may” or “might” reduce the risk of some cancers.	*No equivalent condition in Indian Regulation for food/nutrient-cancer relationship
Sodium and Hypertension 21 CFR 101.74	Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.	Diets low in sodium may reduce the risk of high blood pressure; a disease associated with many factors.	Low sodium Includes term ‘sodium’ Identify disease as “high blood pressure” May include ‘salt’ States that high blood pressure is multifactorial Includes physician statement if claim defines high or normal blood pressure	A food which is · low in sodium (0.12g sodium/100g) · A statement that the beneficial effect is obtained with a low sodium diet
Saturated fat, cholesterol and heart disease 21 CFR 101.75	Development of heart disease depends upon many factors, but its risk may be reduced by diets low in saturated fat and cholesterol and healthy lifestyles.	While many factors affect heart disease, diets low in fat, saturated fat and cholesterol may reduce the risk of heart disease	Low Fat Low Saturated Fat Low Cholesterol Includes terms ‘saturated fat’ and ‘cholesterol’ Uses ‘heart disease’ or ‘coronary heart disease’ States that heart disease is multifactorial	· Low saturated fat and cholesterol per serving · A statement that the beneficial effect is obtained with a diet low in fat, saturated fat and cholesterol and physical activity

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
- - 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