A Food Labeling Guide: Appendix A - Definitions of Nutrient Content Claims ΓΈ Calorie Counter
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A Food Labeling Guide: Appendix A - Definitions of Nutrient Content Claims

A Food Labeling Guide

Definitions of Nutrient Content Claims


Nutrient 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"
Calories
21 CFR 101.60(b)
Less than 5 cal per reference amount and per labeled serving

Not defined for meals or main dishes
40 cal or less per reference amount (and per 50 g if reference amount is small)

Meals and main dishes: 120 cal or less per 100 g
At least 25% fewer calories per reference amount than an appropriate reference food

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 reference amount. If less than 50% of calories are from fat, fat must be reduced at least 50% or calories reduced at least 1/3 per reference amount

"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 reference amount and per labeled serving (or for meals and main dishes, less than 0.5 g per labeled serving)

No ingredient that is fat or understood to contain fat, except noted below. (*)
3 g or less per reference amount (and per 50 g if reference amount 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 reference amount than an appropriate reference food

Reference food may not be "Low Fat"
"__% Fat Free": OK if meets the requirements for "Low Fat"

100% Fat Free: food must be "Fat Free"

"Light" - see above

For dietary supplements: calorie 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 reference amount 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)

No ingredient that is understood to contain saturated fat except as noted below(*)
1 g or less per reference amount 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 reference amount than an appropriate reference food

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 reference amount; and the amount of total fat if more than 3 g per reference amount (or 0.5 g or more of total fat for "Saturated Fat Free")

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

No ingredient that contains cholesterol except as noted below(*)

If less than 2 mg per reference amount by special processing and total fat exceeds 13 g per reference amount and labeled serving, the amount of cholesterol must be "Substantially Less" (25%) than in a reference food with significant market share (5% of market)
20 mg or less per reference amount (and per 50 g of food if reference amount is small)

If qualifies by special processing and total fat exceeds 13 g per reference and labeled serving, the amount of cholesterol must be "Substantially Less" (25%) than in a reference food with significant market share (5% of market)

Meals and main dishes: 20 mg or less per 100 g
At least 25% less cholesterol per reference amount than an appropriate reference food

Reference food may not be "Low Cholesterol"
Cholesterol claims only allowed when food contains 2 g or less saturated fat per reference amount; 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 reference amount and labeled serving (or per 50 g of food if reference amount 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 reference amount and per labeled serving (or for meals and main dishes, less than 5 mg per labeled serving

No ingredient that is sodium chloride or generally understood to contain sodium except as noted below(*)
140 mg or less per reference amount (and per 50 g if reference amount is small)

Meals and main dishes: 140 mg or less per 100g
At least 25% less sodium per reference amount than an appropriate reference food

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 reference amount. Entire term "Light in Sodium" must be used in same type, size, color & prominence. Light in Sodium for meals = "Low in Sodium"

"Very Low Sodium": 35 mg or less per reference amount (and per 50 g if reference amount is small). For meals and main dishes: 35 mg or less per 100 g

"Salt Free" must meet criterion for "Sodium Free"

"No Salt Added" and "Unsalted" must conditions of use and 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 reference amount and per labeled serving (or for meals and main dishes, less than 0.5 g per labeled serving)

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. No basis for recommended intake At least 25% less sugars per reference amount than an appropriate reference food

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

Claims about reducing dental caries are implied health claims

Does not include sugar alcohols

Notes:

  • "Reference Amount" = reference amount customarily consumed.
  • "Small Reference Amount" = reference amount of 30 g or less or 2 tablespoons or less (for dehydrated foods that are typically consumed when rehydrated with water or a diluent containing an insignificant amount, as defined in 21 CFR 101.9(f)(1), of all nutrients per reference amount, the per 50 g criterion refers to the prepared form of the food).
  • When levels exceed: 13 g Fat, 4 g Saturated Fat, 60 mg Cholesterol, and 480 mg Sodium per reference amount, per labeled serving or, for foods with small reference amounts, per 50 g, a disclosure statement is required as part of claim (e.g., "See nutrition information for___content" with the blank filled in with nutrient(s) that exceed the prescribed levels).
* Except if the ingredient listed in the ingredient statement has an asterisk that refers to footnote (e.g., "* adds a trivial amount of fat").

A Food Labeling Guide



Food and Drug Administration Center for Food Safety and Applied Nutrition
A Food Labeling Guide, September 1994 (Editorial revisions June, 1999)

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