FDA vs. FSSAI – Nutrient Claims

In our previous blog, we had an overview of US packaged food market sourced from India along with NCC definitions for Calories. In this blog, we shall discuss regulations pertaining to Total Fat and Cholesterol declarations.

Nutrients	Regulation	Free	Low	Reduced/Less	Comments
Total Fat	FDA 21 CFR 101.62 (b)	Less than 0.5 g RACC and per labeled serving (or for meals and main dishes, less than 0.5 g per labeled serving) Contains no ingredient that is fat or understood to contain fat	3 g or less per RACC (and per 50 g if RACC is small) Meals and main dishes: 3 g or less per 100 g and not more than 30% of calories from fat	At least 25% less fat per RACC than an appropriate reference food (or for meals and main dishes, at least 25% less fat per 100 g) Reference food may not be “Low Fat”	“__% Fat Free”: may be used if food meets the requirements for “Low Fat” 21 CFR 101.62(b)(6) 100% Fat Free: food must be “Fat Free” (b)(6)(iii) For dietary supplements: total fat claims cannot be made for products that are 40 calories or less per serving 21 CFR 101.62(a)(4)
Total Fat	FSSR	Not more than 0.5 g of fat per 100 g (solids) or 100 ml (liquids).	Not more than 3 g of fat per 100 g for solids or 1.5 g of fat per 100ml for liquids.
Saturated Fat	FDA 21 CFR101.62 (c)	Less than 0.5 g saturated fat and less than 0.5 g trans fatty acids per RACC and main dishes, less than 0.5 g saturated fat and trans fatty acids per labeled serving) Contains no ingredient that is understood to contain saturated fat	1 g or less per RACC and 15% or less of calories from saturated fat Meals and main dishes: 1 g or less per 100g and less than 10% of calories from saturated fat	At least 25% less saturated fat per RACC than an appropriate reference food (or for meals and main dishes, at least 25% less saturated fat per 100 g) Reference food may not be “Low Saturated Fat”	Next to all saturated fat claims, must declare the amount of cholesterol if 2 mg or more per RACC; and the amount of total fat if more than 3g per RACC (or 0.5 g or more of total fat per RACC for “Saturated Fat Free”) (or for meals and main dishes, per labeled serving) 21 CFR 101.62(c) For dietary supplements: saturated fat claims cannot be made for products that are 40 calories or less per serving 21 CFR 101.62(a)(4)
Saturated Fat	FSSR	Saturated fatty acids do not exceed 0.1 gm per 100 g or 100 ml of food.	*The sum of saturated fatty acids and trans fatty acids does not exceed 1.5 g per 100 g for solids or 0.75 g per 100 ml for liquids and in either case the sum of saturated fatty acids and trans-fatty acids must provide no more than 10% of energy

Nutrients	Regulation	Free	Low	Reduced/Less	Comments
Cholesterol	FDA 21 CFR 101.62(d)	Less than 2 mg per RACC and per labeled serving (or for meals and main dishes, less than 2 mg per labeled serving) Contains no ingredient that contains cholesterol	20 mg or less per RACC (and per 50 g of food if RACC is small) Meals and main dishes: 20 mg or less per 100 g	At least 25% less cholesterol per RACC than an appropriate reference food (or for meals and main dishes, at least 25% less cholesterol per 100 g) Reference food may not be “Low Cholesterol”	Cholesterol claims only allowed when food contains 2 g or less saturated fat per RACC; or for meals and main dish products, per labeled serving size for “Free” claims or per 100 g for “Low” and “Reduced/Less” claims Must declare the amount of total fat next to cholesterol claim when fat exceeds 13 g per RACC and labeled serving (or per 50 g of food if RACC is small), or when the fat exceeds 19.5 g per labeled serving for main dishes or 26g for meal products For dietary supplements: cholesterol claims cannot be made for products that are 40 calories or less per serving
FSSR	*Not more than 1.5 mg cholesterol per 100g for solids or 100 ml for liquids. Additionally, the food shall contain no more than 1.5 g saturated fat per 100 g for solids or 0.75 g of saturated fat per 100 ml for liquids and in either case must provide no more than 10% of energy.	Not more than 20 mg cholesterol per 100 g and 1.5 g saturated fat per 100 g for solids or 10 mg per 100 ml and 0.75 g of saturated fat per 100 ml for liquids and in either case must provide no more than 10% of energy.

Nutrients

Regulation

Free

Low

Reduced/Less

Comments

Cholesterol

FDA

21 CFR 101.62(d)

Less than 2 mg per RACC and per labeled serving (or for meals and main dishes, less than 2 mg per labeled serving)

Contains no ingredient that contains cholesterol

20 mg or less per RACC (and per 50 g of food if RACC is small)

Meals and main dishes: 20 mg or less per 100 g

At least 25% less cholesterol per RACC than an appropriate reference food (or for meals and main dishes, at least 25% less cholesterol per 100 g)

Reference food may not be “Low Cholesterol”

Cholesterol claims only allowed when food contains 2 g or less saturated fat per RACC; or for meals and main dish products, per labeled serving size for “Free” claims or per 100 g for “Low” and “Reduced/Less” claims

Must declare the amount of total fat next to cholesterol claim when fat exceeds 13 g per RACC and labeled serving (or per 50 g of food if RACC is small), or when the fat exceeds 19.5 g per labeled serving for main dishes or 26g for meal products

For dietary supplements: cholesterol claims cannot be made for products that are 40 calories or less per serving

FSSR

*Not more than

1.5 mg cholesterol per 100g for solids or 100 ml for liquids.

Additionally, the food shall contain no more than

1.5 g saturated fat per 100 g for solids or

0.75 g of saturated fat per 100 ml for liquids

and in either case must provide no more than 10% of energy.

Not more than

20 mg cholesterol per 100 g and 1.5 g saturated fat per 100 g for solids or

10 mg per 100 ml and 0.75 g of saturated fat per 100 ml for liquids

and in either case must provide no more than 10% of energy.

FSSR Footnotes:

# 1 kcal = 4.2 kJ

* To make these claims the specific nutrient in the food must provide the minimum amount of energy specified.

% energy from the nutrient = 100 X [(Grams of nutrient per 100 g of product X Conversion Factor for nutrient)/ (Total energy per 100 g of product)]

There are details pertaining to Nutrient Relative Claims, Other Nutrient Content Claims and Implied Claims (21 CFR 101.65) in the Food Labeling Guide prepared by FDA.

The draft notification for Food Safety and Standards (Claims and Advertisement) Regulations, 2018 also has more information on Dietary Fiber, Protein, Vitamins and/or Minerals, Relative Claims (Increased/Enhanced and Reduced), Prebiotic Fiber, Probiotics and Glycemic index (GI).

In our next blog, we will look at how the regulations stand for Sodium and Sugar declarations

Courtesy: Aravind Ravi, Technical Documentation Manager at ManageArtworks.