Genesis R&D Manual
U.S. 2016 Nutrient Content Claims
- Nate Edwards
- Jill Hohnstein (Unlicensed)
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 | The food contains at least 25 percent fewer calories per RACC than an appropriate reference food. 21 CFR 101.60(b)4 | 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 | 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 | 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 |
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 | The food contains 3 g fat or less per RACC. | 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 | 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 | 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 | 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
|
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 | 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
|
Sat Fat | Reduced | Reduced Reduced in Saturated fat reduced Less Lower Lower in | 21 CFR 101.62(c)(4)i | The food contains at least 25 percent less fat per RACC than an appropriate reference food. 21 CFR 101.62(c)(4)i
| The cholesterol amount must be declared if it is greater than or equal to 2 mg. 21 CFR 101.62c
|
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 | 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 | 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 | The food contains 20 mg or less of cholesterol per RACC. 21 CFR 101.62(d)(2)(i)A | 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 | 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 total fat amount must be declared if the total fat amount is greater than 13 g. 21 CFR 101.62(d)(4)(ii)C |
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 | 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 | The food contains 35 mg or less sodium per RACC. 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 | The food contains 140 mg or less sodium per RACC. 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 101.13(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 | 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 | 21 CFR 101.56(c)(1)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 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) | 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 |
Sodium | No Added Salt | No Salt Added Without added salt Unsalted | 21 CFR 101.61(c)(2)i | No salt is added during processing. 21 CFR 101.61(c)(2)i | 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 | 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 |
Sugar | Reduced | Reduced Reduced in Sugar reduced Less Lower Lower in | 21 CFR 101.60(c)(5)i | 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 | No sugar is added during processing. 21 CFR 101.60(c)(2)i | 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 | 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) | 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 | 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 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 | 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 |