Genesis R&D Manual

U.S. 2016 Nutrient Content Claims


Nutrient Content Claims are per reference amount customarily consumed (RACC)  (This document does not consider Meal Products or Main Dish Products as defined in 101.13l and 101.13m)

True for all Nutrient Content Claims:

If Fat > 13 g, and/or SatFat > 4 g, and/or Cholesterol > 60 mg, and/or Sodium > 480 mg

Then a disclosure statement is required as part of the claim (eg: “See nutrition information for ___ content” with the blank filled in with the nutrient(s) that exceed the prescribed levels.)

101.13h1

If multiple content claims apply per nutrient:
Responses are listed in order of preference.

Nutrient

Claim

Other Claim Names

Citations

Qualifying Conditions

Additional Information

Calories

Free

Free of

Free

Zero

No

Without

Trivial Source of

Negligible source of

Dietarily Insignificant Source of

21 CFR 101.60(b)1

21 CFR 101.60(b)(1)ii

The food contains less than 5 Calories per RACC and per labeled serving. (Genesis reports per user entered reference amount.) 21 CFR 101.60(b)1

If the food meets this condition without the benefit of special processing, alteration, formulation, or reformulation, it is labeled to disclose that calories are not usually present in the food (e.g., “cider vinegar, a calorie free food”). 21 CFR 101.60(b)(1)ii

Calories

Low

Low

Few

Contains a Small Amount of

Low Source of

Low in

21 CFR 101.60(b)2

21 CFR 101.60(b)(2)ii


The food contains less than 40 calories per RACC. 21 CFR 101.60(b)2

If a food meets this condition without the benefit of special processing, alteration, formulation, or reformulation to vary the caloric content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (e.g., “celery, a low calorie food”). 21 CFR 101.60(b)(2)ii

Calories

Reduced

Reduced

Reduced in

Calorie reduced

Fewer

Lower

Lower in

21 CFR 101.60(b)4

21 CFR 101.60(b)(4)iii
21 CFR 101.13(j)2


The food contains at least 25 percent fewer calories per RACC than an appropriate reference food. 21 CFR 101.60(b)4
The reference food may not be “low calorie”. 21 CFR 101.60(b)(4)iii


The label must state the identity of the reference food and the percentage (or fraction) of the amount of the nutrient in the reference food by which the labeled food differs (e.g., “50 percent less fat than (reference food)” or “1/3 fewer calories than “reference food)”).

Quantitative information comparing the amount of calories in the product per labeled serving with that in the reference food must be declared. 21 CFR 101.13(j)2

Calories

Light

Light

Lite

21 CFR 101.56(b)1
21 CFR 101.56(b)2
21 CFR 101.56(b)4
21 CFR 101.13(j)(2)i
21 CFR 101.56(b)(3)ii




If the food derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per RACC compared to an appropriate reference food. 21 CFR 101.56(b)1

If the food derives less than 50 percent of its calories from fat, its calorie content is reduced by at least one-third (33-1/3 percent) per RACC compared to an appropriate reference food; or its fat content is reduced by 50 percent or more per RACC compared to an appropriate reference food. 21 CFR 101.56(b)2

Reference food cannot be “low fat” and “low calorie”. 21 CFR 101.56(b)4

The label must state the identity of the reference food and the percent that the calories and fat were reduced. 21 CFR 101.13(j)(2)i

If the labeled food contains less than 40 calories or less than 3 g of fat, the percentage reduction does not need to be declared. 21 CFR 101.56(b)(3)ii

Total Fat

Free

Free

Free of

Zero

No

Without

Negligible source of

Dietarily Insignificant Source of

Skim

100% fat free

21 CFR 101.62(b)(1)i
21 CFR 101.62(b)(1)ii
21 CFR 101.62(b)(1)iii


The food contains less than 0.5 g fat per RACC and per labeled serving. (Genesis reports per user entered reference amount.)  21 CFR 101.62(b)(1)i


Any food ingredients that contain fat must be footnoted in the ingredient statement. The listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients which states, “adds a trivial amount of fat”, “adds a negligible amount of fat”, or “add a dietarily insignificant amount of fat”. 21 CFR 101.62(b)(1)ii

The food meets these conditions without special processing, alteration, or formulation. 21 CFR 101.62(b)(1)iii

Total Fat

Low

Low

Low in

Little

Contains a Small Amount of

Low Source of

__percent fat free

21 CFR 101.62(b)(2)(i)A
21 CFR 101.62(b)(2)ii


The food contains 3 g fat or less per RACC.
If the RACC is less than 30 g (or 2 T), the food contains 3 g fat or less per 50 g. 21 CFR 101.62(b)(2)(i)A


The food meets this condition without special processing, alteration or formulation. 21 CFR 101.62(b)(2)ii

Total Fat

Reduced

Reduced

Reduced in

Fat reduced

Less

Lower

Lower in

21 CFR 101.62(b)(4)i
21 CFR 101.62(b)(4)iii
21 CFR 101.13(j)2


The food contains at least 25 percent less fat per RACC than an appropriate reference food. 21 CFR 101.62(b)(4)i


Reference food may not be “Low Fat”. 21 CFR 101.62(b)(4)iii


The label must state the identity of the reference food and the percent that the fat was reduced. Quantitative information comparing the level of fat in the product per labeled serving with that of the reference food that it replaces (e.g., “Fat content has been reduced from 8 g to 4 g per serving.”) is declared. 21 CFR 101.13(j)2

Total Fat

Light

Light

Lite

21 CFR 101.56(b)1
21 CFR 101.56(b)2
21 CFR 101.56(b)4
21 CFR 101.13(j)(2)i
21 CFR 101.56(b)(3)ii


If the food derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per RACC compared to an appropriate reference food. 21 CFR 101.56(b)1

If the food derives less than 50 percent of its calories from fat, its calorie content is reduced by at least one-third (33-1/3 percent) per RACC compared to an appropriate reference food; or its fat content is reduced by 50 percent or more per RACC compared to an appropriate reference food. 21 CFR 101.56(b)2

Reference food cannot be “low fat” and “low calorie”. 21 CFR 101.56(b)4

The label must state the identity of the reference food and the percent that the calories and fat were reduced. 21 CFR 101.13(j)(2)i

If the labeled food contains less than 40 calories or less than 3 g of fat, the percentage reduction does not need to be declared. 21 CFR 101.56(b)(3)ii

Sat Fat

Free

Free of

Saturated fat free

Zero

No

Without

Trivial Source of

Negligible source of

Dietarily Insignificant Source of

21 CFR 101.62(c)(1)i
21 CFR 101.62(c)(1)ii
21 CFR 101.62c
21 CFR 101.62(c)(1)iii


The food contains less than 0.5 g of saturated fat and less than 0.5 g trans fat per RACC. 21 CFR 101.62(c)(1)i


Any food ingredients that contain saturated fat must be foot-noted in the ingredient statement. The listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients which states, “adds a trivial amount of saturated fat”, “adds a negligible amount of saturated fat”, or “add a dietarily insignificant amount of saturated fat”. 21 CFR 101.62(c)(1)ii


The cholesterol amount must be declared if it is greater than or equal to 2 mg. 21 CFR 101.62c


The fat amount must be declared if it is greater than or equal to 0.5 g. 21 CFR 101.62c


The food meets these conditions without special processing, alteration, or formulation. 21 CFR 101.62(c)(1)iii

Sat Fat

Low

Free of

Saturated fat free

Zero

No

Without

Trivial Source of

Negligible source of

Dietarily Insignificant Source of

21 CFR 101.62(c)(2)i
21 CFR 101.62c
21 CFR 101.62(b)(2)ii



The food contains 1 g or less of saturated fat per RACC and not more than 15 percent of calories from saturated fat. 21 CFR 101.62(c)(2)i

The cholesterol amount must be declared if it is greater than or equal to 2 mg. 21 CFR 101.62c


The fat amount must be declared if it is greater than 3 g. 21 CFR 101.62c


The food meets these conditions without special processing, alteration or formulation. 21 CFR 101.62(b)(2)ii

Sat Fat

Reduced

Reduced

Reduced in

Saturated fat reduced

Less

Lower

Lower in

21 CFR 101.62(c)(4)i
21 CFR 101.62(c)(4)iii
21 CFR 101.62c
21 CFR 101.13(j)(2)i


The food contains at least 25 percent less fat per RACC than an appropriate reference food. 21 CFR 101.62(c)(4)i


Reference food may not be “Low Saturated Fat”. 21 CFR 101.62(c)(4)iii

The cholesterol amount must be declared if it is greater than or equal to 2 mg. 21 CFR 101.62c


The fat amount must be declared if is greater than 3 g. 21 CFR 101.62c


The label must state the identity of the reference food and the percent that the saturated fat has been reduced. Quantitative information comparing the amount of saturated fat in the product per labeled serving with that in the reference food must be declared. 21 CFR 101.13(j)(2)i

Cholesterol

Free

Free

Free of

Zero

No

Without

Trivial Source of

Negligible source of

Dietarily Insignificant Source of

21 CFR 101.62(d)(1)(i)A
CFR 101.62(d)(1)(i)C
21 CFR 101.62(d)(1)(i)B
21 CFR 101.13(e)2
21 CFR 101.62(d)(ii)F



The food contains less than 2 mg of cholesterol per RACC and per labeled serving. (Genesis reports per user entered reference amount.) 21 CFR 101.62(d)(1)(i)A

The food contains 2 g or less of saturated fat per RACC. 21 CFR 101.62(d)(1)(i)C


Any food ingredients that contain cholesterol must be foot-noted in the ingredient statement. The listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients which states, “adds a trivial amount of cholesterol”, “adds a negligible amount of cholesterol”, or “adds a dietarily insignificant amount of cholesterol” 21 CFR 101.62(d)(1)(i)B

If the food meets this condition without the benefit of special processing, alteration, formulation, or reformulation, it is labeled to disclose that cholesterol is not usually present in the food. 21 CFR 101.13(e)2

If the food meets the condition as a result of special processing, the identity of the reference food and percent that cholesterol is reduced are declared. Quantitative information comparing the cholesterol in the product and the reference food is also declared. 21 CFR 101.62(d)(ii)F

cholesterol

Low

Low

Low in

Little

Contains a Small Amount of

Low Source of

21 CFR 101.62(d)(2)(i)A
21 CFR 101.62(d)(2)(i)B
21 CFR 101.13(e)2


The food contains 20 mg or less of cholesterol per RACC. 21 CFR 101.62(d)(2)(i)A

The food contains 2 g or less of saturated fat per RACC. 21 CFR 101.62(d)(2)(i)B

If the food meets these conditions without the benefit of special processing, alteration, formulation or reformulation to lower cholesterol content, it is labeled to clearly refer to all foods of that type and not merely to that particular brand to which the label attaches (e.g., “low fat cottage cheese, a low cholesterol food.”). 21 CFR 101.13(e)2

Cholesterol

Reduced

Reduced

Reduced in

Cholesterol reduced

Less

Lower

Lower in

21 CFR 101.62(d)(4)(i)A
21 CFR 101.62(d)(4)(i)B
21 CFR 101.62(d)(4)iii
21 CFR 101.62(d)(4)(ii)C
21 CFR 101.13(j)(2)i

The food derives 25 percent or less cholesterol per RACC compared to an appropriate reference food. 21 CFR 101.62(d)(4)(i)A

The food contains 2 g or less of saturated fat per RACC. 21 CFR 101.62(d)(4)(i)B

The reference food may not be “low cholesterol”. 21 CFR 101.62(d)(4)iii


The total fat amount must be declared if the total fat amount is greater than 13 g. 21 CFR 101.62(d)(4)(ii)C

The label must state the identity of the reference food and the percent or fraction that the cholesterol has been reduced. Quantitative information comparing the amount of cholesterol in the product per labeled serving with that in the reference food is declared. 21 CFR 101.13(j)(2)i

Sodium

Free

Free

Free of

Zero

No

Without

Trivial Source of

Negligible source of

Dietarily Insignificant Source of

Salt free

21 CFR 101.61(b)(1)i
21 CFR 101.61(b)(1)ii
21 CFR 101.13(e)2

The food contains less than 5 mg of sodium per RACC and per labeled serving size. (Genesis reports per user entered reference amount.)  21 CFR 101.61(b)(1)i


The food contains no ingredient that is sodium chloride or is generally understood by consumers to contain sodium, unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sodium,” “adds a negligible amount of sodium” or “adds a dietarily insignificant amount of sodium.” 21 CFR 101.61(b)(1)ii

If the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to disclose that sodium is not usually present in the food (e.g., “leaf lettuce, a sodium free food”). 21 CFR 101.13(e)2

Sodium

Very Low

Very Low

Very low in

21 CFR 101.61(b)(2)i
21 CFR 101.61(b)(2)ii

The food contains 35 mg or less sodium per RACC. 21 CFR 101.61(b)(2)i

If the RACC is less than 30 g (or 2 T), the food contains 35 mg sodium or less per 50 g. 21 CFR 101.61(b)(2)i

If the food meets these conditions without the benefit of special processing, alteration, formulation or reformulation to vary the sodium content, it is labeled to clearly refer to all foods in its type and not merely to the particular brand to which the label attached (e.g., “potatoes, a very low-sodium food”). 21 CFR 101.61(b)(2)ii

Sodium

Low

Low

Low in

Little

Contains a Small Amount of

Low Source of

101.61b4

21 CFR 101.61(b)4
21 CFR 101.61(b)(4)ii



The food contains 140 mg or less sodium per RACC. 21 CFR 101.61(b)4

If the RACC is less than 30 g (2 T), the food contains 140 mg sodium or less per 50 g. 21 CFR 101.61(b)4


If the food meets these conditions without the benefit of special processing, alteration, formulation or reformulation to vary the sodium content, it is labeled to clearly refer to all foods in its type and not merely to the particular brand to which the label attached (e.g., “fresh spinach, a low sodium food”). 21 CFR 101.61(b)(4)ii

Sodium

Reduced

Reduced

Reduced in

Sodium reduced

Less

Lower

Lower in

21 CFR 101.61(b)6
21 CFR 101.61(b)(6)i
21 CFR 101.56(c)(1)A

21 CFR 101.13(j)2


The food contains at least 25 percent less sodium per RACC than an appropriate reference food. 21 CFR 101.61(b)(6)i

Reference food may not be “Low Sodium”. 21 CFR 101.61(b)6


The label must state the identity of the reference food and the percent that the sodium has been reduced. 21 CFR 101.56(c)(1)A

Quantitative information comparing the level of sodium in the product per specified weight with that of the reference food that it replaces (e.g., “Sodium content has been reduced from 300 mg to 150 mg per serving.”) is declared on the label. 21 CFR 101.13(j)2

Sodium

Light

Light

Lite
Light in

21 CFR 101.56(c)(1)i
21 CFR 101.56(c)(2)iii
21 CFR 101.13(j)(2)i

The food contains 40 calories or less and 3 g fat or less per RACC and is reduced by 50 percent or more in sodium content compared to the reference food. 21 CFR 101.56(c)(1)i

The reference food may not be “Low in Sodium”. 21 CFR 101.56(c)(2)iii


The label must state the identity of the reference food and the percent that the sodium was reduced. Quantitative information comparing the amount of sodium in the product per labeled serving with that in the reference food is declared 21 CFR 101.13(j)(2)i

Sodium

Lightly Salted

--

21 CFR 101.56(g)
21 CFR 101.13(j)(2)i

A product to which has been added 50 percent less sodium than is normally added to the reference food. 21 CFR 101.56g

The label must state the identity of the reference food and the percent that the sodium was reduced. Quantitative information comparing the amount of sodium in the product per labeled serving with that in the reference food is declared 21 CFR 101.13(j)(2)i

If the product is not “low in sodium” the statement “not a low sodium food” must be present. 21 CFR 101.56g

Sodium

No Added Salt

No Salt Added

Without added salt

Unsalted

21 CFR 101.61(c)(2)i
21 CFR 101.61(c)(2)ii
21 CFR 101.61(c)(2)iii

No salt is added during processing. 21 CFR 101.61(c)(2)i

The food that it resembles and for which it substitutes is normally processed with salt. 21 CFR 101.61(c)(2)ii

If the food is not sodium free, the statement, “not a sodium free food” or “not for control of sodium in the diet” appears adjacent to the label. 21 CFR 101.61(c)(2)iii

Sugar

Free

Free

Free of

Zero

No

Without

Trivial Source of

Negligible source of

Dietarily Insignificant Source of

Sugarless

21 CFR 101.60(c)1
21 CFR 101.9(c)(6)iv
21 CFR 101.60(c)(1)ii
21 CFR 101.60(c)(1)(iii)A

The food contains less than 0.5 g of sugars per RACC and per labeled serving. (Genesis reports per user entered reference amount.) 21 CFR 101.60(c)1

Sugar alcohol must be declared on the label when it is present in the food and a claim is made about sugar alcohol, total sugars or added sugars. 21 CFR 101.9(c)(6)iv

Any food ingredients that contain sugar must be foot-noted in the ingredient statement. The listing of the ingredient statement is followed by as asterisk that refers to the statement below the list of ingredients which states, “adds a trivial amount of sugar”, “adds a negligible amount of sugar”, or “adds a dietarily insignificant amount of sugar”. 21 CFR 101.60(c)(1)ii

If the food is “Low Calorie” or “Reduced Calorie” the label must state “low calorie” or “reduced calorie” or other claims associated with that claim group. If the food is not “Low Calorie” or not “Reduced Calorie” then the label must state “not a low calorie food” or “not a reduced calorie food” or “not for weight control”. 21 CFR 101.60(c)(1)(iii)A

Sugar

Reduced

Reduced

Reduced in

Sugar reduced

Less

Lower

Lower in

21 CFR 101.60(c)(5)i
21 CFR 101.9(c)(6)iv
21 CFR 101.13(j)(2)i
21 CFR 101.60(c)(5)(ii)B

The food contains at least 25 percent less sugar per RACC than an appropriate reference food. 21 CFR 101.60(c)(5)i

Sugar alcohol must be declared on the label when it is present in the food and a claim is made about sugar alcohol, total sugars or added sugars. 21 CFR 101.9(c)(6)iv

The label must state the identity of the reference food and the percent or fraction that the sugar has been reduced. 21 CFR 101.13(j)(2)i

Quantitative information comparing the level of the sugar in the product per labeled serving with that of the reference food that it replaces (e.g., “Sugar content has been lowered from 8 g to 6 g per serving.”) is declared. 21 CFR 101.60(c)(5)(ii)B

Sugar

No added sugars

No Added Sugars

Without Added Sugars

21 CFR 101.60(c)(2)i
21 CFR 101.60(c)(2)ii
21 CFR 101.60(c)(1)(iii)A

No sugar is added during processing. 21 CFR 101.60(c)(2)i

No ingredient containing added sugars is added to the food. 21 CFR 101.60(c)(2)ii

If the food is “Low Calorie” or “Reduced Calorie” the label must state “low calorie” or “reduced calorie” or other claims associated with that claim group. If the food is not “Low Calorie” or not “Reduced Calorie” then the label must state “not a low calorie food” or “not a reduced calorie food” or “not for weight control”. 21 CFR 101.60(c)(1)(iii)A

Sugar

Unsweetened

No Added Sweeteners

21 CFR 101.60(c)3

The terms “Unsweetened” and “No Added Sweeteners” remain as factual statements for foods, including food intended specifically for infants and children less than 2 years of age, that are unsweetened or contain no added sweeteners in the case of a food that contains apparent substantial inherent sugar content (e.g., juices). 21 CFR 101.60(c)3

--

Fiber

High

High

Rich in

Excellent source of

101.54b1

21 CFR 101.54(b)1
21 CFR 101.54(d)

The food contains 20 percent or more of the Daily Value per RACC. 21 CFR 101.54(b)1



If the food is not “low” in total fat, then the dietary fiber claim shall be accompanied by a disclosure statement of total fat per serving. (e.g., “contains [x amount] of total fat per serving. See nutrition information for fat content.”) 21 CFR 101.54(d)

Fiber

Good

Good Source of

Contains

Provides

21 CFR 101.54(c)
21 CFR 101.54(d)

The food contains 10-19 percent of the Daily value per RACC. 21 CFR 101.54c

If the food is not “low” in total fat, then the dietary fiber claim shall be accompanied by a disclosure statement of total fat per serving. (e.g., “contains [x amount] of total fat per serving. See nutrition information for fat content.”) 21 CFR 101.54(d)

Fiber

More

More

Fortified

Enriched

Added

Extra

Plus

21 CFR 101.54(e)(1)i
21 CFR 101.13(j)2
21 CFR 101.13(j)1
21 CFR 101.54(d)

The food contains at least 10 percent more of the Daily Value per RACC than an appropriate reference food. 21 CFR 101.54(e)(1)i



Must be compared to the amount of nutrient in an appropriate reference food. 21 CFR 101.13(j)2

More may be used with a dissimilar reference food (e.g., potato chips as reference for pretzels, orange juice as a reference for vitamin C tablets).  Fortified, enriched, added, extra, and plus must be compared to a similar reference food (e.g., potato chips as a reference for potato chips, one brand of multivitamin for another brand of multivitamin). 21 CFR 101.13(j)1

If the food is not “low” in total fat, then the dietary fiber claim shall be accompanied by a disclosure statement of total fat per serving. (e.g., “contains [x amount] of total fat per serving. See nutrition information for fat content.”) 21 CFR 101.54(d)

Vits/Mins + Protein

High

High

Rich in

Excellent source of

21 CFR 101.54(b)1

The food contains 20 percent or more of the Daily Value per RACC. 21 CFR 101.54(b)1

--

Vits/Mins + Protein

Good

Good Source of

Contains

Provides

21 CFR 101.54(c)

The food contains 10-19 percent of the Daily value per RACC. 21 CFR 101.54c

--

Vits/Mins + Protein

More

More

Fortified

Enriched

Added

Extra

Plus

21 CFR 101.54(e)(1)i
21 CFR 101.13(j)2
21 CFR 101.13(j)1

The food contains at least 10 percent more of the Daily Value per RACC than an appropriate reference food. 21 CFR 101.54(e)(1)i

Must be compared to the amount of nutrient in an appropriate reference food.  21 CFR 101.13(j)2

More may be used with a dissimilar reference food (e.g., potato chips as reference for pretzels, orange juice as a reference for vitamin C tablets).  Fortified, enriched, added, extra, and plus must be compared to a similar reference food (e.g., potato chips as a reference for potato chips, one brand of multivitamin for another brand of multivitamin). 21 CFR 101.13(j)1