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FDA vs. FSSAI – Nutrient Claims – III


In our previous blog, we had an overview of regulations pertaining to Total Fat and Cholesterol declarations. In this blog, we shall look at how regulations stand for Sodium and Sugar declarations.

NutrientsRegulationFreeLowReduced/LessComments
SodiumFDA

21 CFR101.61

Less than 5 mg per RACC and per labeled serving (or for meals and main dishes, less than 5 mg per labeled serving)

Contains no ingredient that is sodium chloride or generally understood to contain sodium.

“Salt Free” must meet criterion for “Sodium Free”

140 mg or less per RACC (and per 50 g if RACC is small)

Meals and main dishes: 140 mg or less per 100g

“Very Low Sodium”: 35 mg or less per RACC (and per 50 g if RACC is small). For meals and main dishes: 35 mg or less per 100 g

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

Reference food may not be “Low Sodium”

“Light” (for sodium reduced 21 CFR products): if food is “Low Calorie” and “Low Fat” and sodium is reduced by at least 50%.

“Light in Sodium”: if sodium is reduced by at least 50% per RACC

For meals and main dishes, “Light in Sodium” meets definition for “Low in Sodium”

“No Salt Added” and “Unsalted” must declare “This is Not a Sodium Free Food” on information panel if food is not “Sodium Free”

“Lightly Salted”: 50% less sodium than normally added to reference food and if not “Low Sodium”, so labeled on information panel

Sodium/SaltFSSRProduct contains no more than

0.005g of sodium, or 0.0125 g of salt, per 100g

Very Low: Product contains no more than 0.04 g of sodium, or 0.10 g salt, per 100 g or per 100 ml. This claim shall not be used for natural mineral waters and other waters.  
Low: Product contains no more than 0.12 g of sodium, or 0.3 g salt (NaCl) per 100 g or per 100 ml.
SugarFDA

21 CFR 101.60 (c)

“Sugar Free”: Less than 0.5 g sugars per RACC and per labeled serving (or for meals and main dishes, less than 0.5 g per labeled serving)

Contains no ingredient that is a sugar or generally understood to contain sugars

Disclose calorie profile (e.g., “Low Calorie”)

Not Defined.

May not be used

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

May not use this claim on dietary supplements of vitamins and minerals

“No Added Sugars” and “Without Added Sugars” are allowed if no sugar or sugar containing ingredient is added during processing. State if food is not “Low” or “Reduced Calorie”

The terms “Unsweetened” and “No Added Sweeteners” remain as factual statements

The claim does not refer to sugar alcohols, which may be present.

For dietary supplements: “Sugar Free” and “No Added Sugar” may be used for vitamins and minerals intended to be used by infants and children less than 2 years of age.

FSSRThe product contains no more than 0.5 g of sugars per 100 g or 100 ml.The product contains no more than 5 g of sugar per 100 g for solids or 2.5 g of sugar per 100 ml for liquids. With no added sugar or without

added sugar: Product does not contain any added mono-or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear on the label: ‘CONTAINS NATURALLY OCCURRING SUGARS’.

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).

Courtesy: Aravind Ravi, Technical Documentation Manager at ManageArtworks.

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