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U.S. Department of Health and Human Services

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Guidance for Industry: A Food Labeling Guide (9. Appendix A: Definitions of Nutrient Content Claims)

January 2013

This document also available en Español (Spanish) , العربية  (Arabic PDF, 1.29MB), हिंदी (Hindi PDF, 1.46 MB), 简化中国 (Simplified Chinese PDF, 2.85MB), 日本人 (Japanese PDF, 1.23MB)

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The document below is available in several foreign language(s). FDA offers these translations as a service to a broad international audience. We hope that you find these translations useful. While the agency has attempted to obtain translations that are as faithful as possible to the English version, we recognize that the translated versions may not be as precise, clear, or complete as the English version. The official version of this document is the English version.


Content Claims
("Free," "Low," "Reduced/Less")
FreeLowReduced/LessComments

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 but are not defined for calories

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"

Definitions of Nutrient Content Claims
NutrientFreeLowReduced/LessComments
Calories
21 CFR 101.60(b)
Less than 5 cal per RACC and per labeled serving (b)(1)

40 cal or less per RACC (and per 50 g if RACC is small) (b)(2)

Meals and main dishes: 120 cal or less per 100 g (b)(3)

At least 25% fewer calories per RACC than an appropriate reference food (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" (b)(4) & (5)

"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 21 CFR 101.56(b)

"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 21 CFR 101.56(d)

For dietary supplements: Calorie claims can only be made when the reference product is greater than 40 calories per serving 21 CFR 101.60(a)(4)

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) (b)(1)

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) (b)(2)

Meals and main dishes: 3 g or less per 100 g and not more than 30% of calories from fat (b)(3)

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) (b)(4) & (5)

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)

"Light"--see previous Calorie comments

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)

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) (c)(1)

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 (c)(2)

Meals and main dishes: 1 g or less per 100 g and less than 10% of calories from saturated fat (c)(3)

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) (c)(4) & (5)

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) 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)

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 (*) (d)(1)

20 mg or less per RACC (and per 50 g of food if RACC is small) (d)(2)

Meals and main dishes: 20 mg or less per 100 g (d)(3)

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) (d)(4) & (5)

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) (b)(1)

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" (c)(1)

140 mg or less per RACC (and per 50 g if RACC is small) (b)(4)

Meals and main dishes: 140 mg or less per 100g (b)(5)

"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 (b)(2) & (3)

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" (b)(6) & (7)

"Light" (for sodium reduced 21 CFR products): if food is "Low Calorie" and "Low Fat" and sodium is reduced by at least 50%. 21 CFR 101.56(c)(1)

"Light in Sodium": if sodium is reduced by at least 50% per RACC. 21 CFR 101.56(c)(2)

For meals and main dishes, "Light in Sodium" meets definition for "Low in Sodium" 21 CFR 101.56(d)(2)

"No Salt Added" and "Unsalted" must declare "This is Not A Sodium Free Food" either adjacent to the claim or on the information panel. if food is not "Sodium Free" 21 CFR 101.61(c)(2)

"Lightly Salted": 50% less sodium than normally added to reference food and if not "Low Sodium", so labeled on information panel 21 CFR 101.56(g)

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) (c)(1)

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.

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 (c)(5) & (6)

"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" (c)(2)

The terms "Unsweetened" and "No Added Sweeteners" remain as factual statements (c)(3)

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. (c)(4)

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").

  • RACC = Reference Amounts Customarily Consumed.
  • Small RACC = Reference Amounts Customarily Consumed 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 RACC, the per 50 g criterion refers to the prepared form of the food).
  • When levels exceed: 13 g Total Fat, 4 g Saturated Fat, 60 mg Cholesterol, and 480 mg Sodium per RACC, per labeled serving or, for foods with small RACC, 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).
  • The term "light" may be used to describe a physical or organoleptic attribute of the food if it clearly conveys the nature of the product, e.g., "light in color," "light intexture." 21 CFR 101.56(e)
  • If there has been a long history of use of the term "light" associated with a product it may continue to be used, e.g., "light corn syrup," "light brown sugar." 21 CFR 101.56(f)

For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2371.