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CFSAN/Office of Nutrition, Labeling, and Dietary Supplements
April 2008
| Free | Low | Reduced/Less | Comments |
|---|---|---|---|
| Synonyms for "Free": "Zero", "No", "Without", "Trivial Source of", "Negligible Source of", "Dietarily Insignificant Source of"
Definitions for "Free" for meals and main dishes are the stated values per labeled serving |
Synonyms for "Low": "Little", ("Few" for Calories), "Contains a Small Amount of", "Low Source of" | Synonyms for "Reduced/Less": "Lower" ("Fewer" for Calories)
"Modified" may be used in statement of identity Definitions for meals and main dishes are same as for individual foods on a per 100 g basis |
For "Free", "Very Low", or "Low", must indicate if food meets a definition without benefit of special processing, alteration, formulation or reformulation; e.g., "broccoli, a fat-free food" or "celery, a low calorie food" |
| Nutrient | Free | Low | Reduced/Less | Comments |
|---|---|---|---|---|
| Calories 21 CFR 101.60(b) |
Less than 5 cal per RACC and per labeled serving | 40 cal or less per RACC (and per 50 g if RACC is small)
Meals and main dishes: 120 cal or less per 100 g |
At least 25% fewer calories per RACC than an appropriate reference food
(or for meals and main dishes, at least 25% fewer calories per 100g) Reference food may not be "Low Calorie" Uses term "Fewer" rather than "Less" |
"Light" or "Lite": if 50% or more of the calories are from fat, fat must be reduced by at least 50% per RACC. If less than 50%
of calories are from fat, fat must be reduced at least 50% or calories reduced at least 1/3 per RACC
"Light" or "Lite" meal or main dish product meets definition for "Low Calorie" or "Low Fat" meal and is labeled to indicate which definition is met For dietary supplements: Calorie claims can only be made when the reference product is greater than 40 calories per serving |
| Total Fat 21 CFR 101.62(b) |
Less than 0.5 g 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 fat or understood to contain fat, except noted below (*). |
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 100g)
Reference food may not be "Low Fat" |
"__% Fat Free": may be used if food meets the requirements for "Low Fat"
100% Fat Free: food must be "Fat Free" "Light"--see previous Calorie comments For dietary supplements: total fat claims cannot be made for products that are 40 calories or less per serving |
| Saturated Fat 21 CFR 101.62(c) |
Less than 0.5 g saturated fat and less than 0.5 g trans fatty acids per RACC and per labeled serving (or for meals and main
dishes, less than 0.5 g saturated fat and less than 0.5 g trans fatty acids per labeled serving)
Contains no ingredient that is understood to contain saturated fat except as noted below (*) |
1 g or less per RACC and 15% or less of calories from saturated fat
Meals and main dishes: 1 g or less per 100 g 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 100g)
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 3 g 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)
For dietary supplements: saturated fat claims cannot be made for products that are 40 calories or less per serving |
| Cholesterol 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 except as noted below (*) |
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 100g)
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 26 g for meal products For dietary supplements: cholesterol claims cannot be made for products that are 40 calories or less per serving |
| Sodium 21 CFR 101.61 |
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 except as noted below (*) "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 50g if RACC is small). For meals and main dishes: 35mg or less per 100g |
At least 25% less sodium per RACC than an appropriate reference food (or for meals and main dishes, at least 25% less sodium per 100g)
Reference food may not be "Low Sodium" |
"Light" (for sodium reduced 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 |
| Sugars 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 except as noted below (*) Disclose calorie profile (e.g., "Low Calorie") |
Not Defined. | 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 Does not include sugar alcohols |
Notes: * Except if the ingredient listed in the ingredient statement has an asterisk that refers to footnote (e.g., "* adds a trivial amount of fat").
