. "Appendix C: FDA Regulatory Requirements for Nutrient Content Claims." Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices. Washington, DC: The National Academies Press, 2011.
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Front-of-Package Nutrition Rating Systems and Symbols
1 This Appendix contains material excerpted from: IOM. 2010. Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report. Washington, DC: The National Academies Press.
2 Federal Food, Drug, and Cosmetic Act, Sec. 411(c)(3) (21 U.S.C. Part 350).
REGULATORY REQUIREMENTS FOR NUTRIENT CONTENT CLAIMS1
FREE
Calories
• Less than 5 calories per RACC and per labeled serving.
Total fat
• Less than 0.5 g per RACC and per labeled serving (or, for meals and main dishes, less than 0.5 gper labeled serving).
• Contains no ingredient that is fat or understood to contain fat, except as noted below.*
• “__% Fat Free” may be used if food meets the requirements for “low fat” and the % declared is insame type size as “fat free.”
• 100% Fat Free: Food must be “fat free” and contain less than 0.5 g fat per 100 g.
Saturated fat
• 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 perlabeled serving).
• Contains no ingredient that is understood to contain saturated fat except as noted below.*
• Must declare the amount of cholesterol if 2 mg or more per RACC, and the amount of total fat if 0.5 g or more per RACC (or for meals and main dishes the amount of cholesterol, if 2 mg or more per labeled serving and the amount of total fat if 0.5 g or more per labeling serving).
Cholesterol
• Less than 2 mg per RACC and per labeled serving (or, for meals and main dishes, less than 2 mgper labeled serving).
• Contains no ingredient that contains cholesterol except as noted below.*
• Cholesterol claims only allowed when food contains 2 g or less saturated fat per RACC, or, formeals and main dish products, 2 g or less saturated fat per labeled serving size.
• Must declare the amount of total fat per serving next to claim when fat exceeds 13 g per RACC andper labeled serving (or per 50 g if RACC is small), or when fat exceeds 19.5 g per labeled servingfor main dishes or 26 g for meal products.
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole. Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 135
Front-of-Package Nutrition Rating Systems and Symbols
1 This Appendix contains material excerpted from: IOM. 2010. Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report. Washington, DC: The National Academies Press.
2 Federal Food, Drug, and Cosmetic Act, Sec. 411(c)(3) (21 U.S.C. Part 350).
3 6 FR 5921.
4 31 FR 8521.
5 37 FR 6493.
6 Federal Food, Drug, and Cosmetic Act, Sec. 201(n).
7 38 FR 6493.
8 56 FR 60302 at 60303.
9 43 FR 25296.
10 44 FR 75990.
11 Federal Food, Drug, and Cosmetic Act, Sec. 403.
12 38 FR 6950 at 6961, paragraph (i) and (i)(1).
13 52 FR 28843.
14 55 FR 5176.
15 43 FR 43248 and 43261.
16 45 FR 6314.
17 47 FR 26580 and 49 FR 15510.
18 51 FR 42584.
19 69 FR 15236.
20 54 FR 32610.
21 55 FR29487.
22 54 FR 32610.
23 54 FR 38806.
24 55 FR 29487.
25 55 FR 29478.
26 55 FR 29517.
27 55 FR 29487.
28 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353.
29 Federal Food, Drug, and Cosmetic Act, sec. 403(q) and (r).
30 56 FR 60366.
31 56 FR 60394.
32 56 FR 60421 and 60478.
33 56 FR 60537.
34 57 FR 32058.
35 56 FR 13564.
36 56 FR 60302.
37 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(b).
38 58 FR 2079 (FDA) and 58 FR 632 (USDA).
39 64 FR 62746.
40 68 FR 41434.
41 A Guide to Federal Food Labeling Requirements for Meat and Poultry Products. Available online: http://www.fsis.usda.gov/pdf/labeling_ requirements_guide.pdf (accessed September 19, 2010).
42 55 FR 29476 and 56 FR 60366.
43 Dietary Supplement Act of 1992, Public Law 102-571.
44 58 FR 2206.
45 60 FR 67164.
46 72 FR 62149.
47 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(b)(1)(A).
48 58 FR 2206.
49 54 FR 32610.
50 54 FR 38806.
51 56 FR 23072.
52 56 FR 29963.
53 57 FR 11277.
54 57 FR 32058.
55 58 FR 2079.
56 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(a)(q)(1)(A)(i).
57 58 FR 2229.
58 58 FR 2229.
59 58 FR 2229.
60 70 FR 17010.
61 70 FR 17008.
62 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 3(a)(r)(1).
63 Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 3(b)(1)(A)(iii).
64 58 FR 2302 (FDA) and 58 FR 632 (USDA).
65 59 FR 24232 (FDA) and 59 FR 24220 (USDA).
66 58 FR 2302.
67 58 FR 2302.
68 58 FR 2302.
69 58 FR 2302.
70 58 FR 2302.
71 58 FR 2302.
72 56 FR 60421.
73 56 FR 60421.
74 56 FR 60421.
75 58 FR 2944 (FDA) and 58 FR 688 (USDA).
76 59 FR 24232 (FDA) and 59 FR 24220 (USDA).
77 59 FR 24232.
78 62 FR 15390 (FDA) and 63 FR 7279 (USDA).
79 70 FR 56828 (FDA) and 71 FR 1683 (USDA).
80 70 FR 17008.
81 70 FR 17101.
82 72 FR 62149.
Appendix C
FDA Regulatory Requirements for Nutrient Content Claims
REGULATORY REQUIREMENTS FOR NUTRIENT CONTENT CLAIMS1
FREE
Calories
• Less than 5 calories per RACC and per labeled serving.
Total fat
• Less than 0.5 g per RACC and per labeled serving (or, for meals and main dishes, less than 0.5 gper labeled serving).
• Contains no ingredient that is fat or understood to contain fat, except as noted below.*
• “__% Fat Free” may be used if food meets the requirements for “low fat” and the % declared is insame type size as “fat free.”
• 100% Fat Free: Food must be “fat free” and contain less than 0.5 g fat per 100 g.
Saturated fat
• 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 perlabeled serving).
• Contains no ingredient that is understood to contain saturated fat except as noted below.*
• Must declare the amount of cholesterol if 2 mg or more per RACC, and the amount of total fat if 0.5 g or more per RACC (or for meals and main dishes the amount of cholesterol, if 2 mg or more per labeled serving and the amount of total fat if 0.5 g or more per labeling serving).
Cholesterol
• Less than 2 mg per RACC and per labeled serving (or, for meals and main dishes, less than 2 mgper labeled serving).
• Contains no ingredient that contains cholesterol except as noted below.*
• Cholesterol claims only allowed when food contains 2 g or less saturated fat per RACC, or, formeals and main dish products, 2 g or less saturated fat per labeled serving size.
• Must declare the amount of total fat per serving next to claim when fat exceeds 13 g per RACC andper labeled serving (or per 50 g if RACC is small), or when fat exceeds 19.5 g per labeled servingfor main dishes or 26 g for meal products.
OCR for page 136
Front-of-Package Nutrition Rating Systems and Symbols
Sodium
• Less than 5 mg per RACC and per labeled serving (or, for meals and main dishes, less than 5 mgper labeled serving).
• Contains no ingredient that is sodium chloride or generally understood to contain sodium except asnoted below.*
• “Salt Free” must meet criterion for “sodium free.”
• “No Salt Added” and “Unsalted” are allowed if no salt is added during processing. Must declare“This is not a sodium-free food” on information panel if food is not “sodium free.”
Sugars
• “Sugar Free”: Less than 0.5 g sugars per RACC and per labeled serving (or, for meals and maindishes, less than 0.5 g per labeled serving).
• Contains no ingredient that is a sugar or generally understood to contain sugars except as notedbelow.*
• Disclose calorie profile (e.g., “low calorie” or “not a low calorie food”).
• “No added sugars” and “Without added sugars” are allowed if no sugar or sugar containingingredient such as jam, jelly, or concentrated fruit juice is added during processing. Must state iffood is not “low” or “reduced calorie.”
LOW
Calories
• 40 calories or less per RACC (and per 50 g if RACC is small).
• Meals and main dishes: 120 calories or less per 100 g.
Total fat
• 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.
Saturated fat
• 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.
• Must declare the amount of cholesterol if 2 mg or more per RACC, and the amount of total fat ifmore than 3 g per RACC (or for meals and main dishes, the amount of cholesterol if 2 mg or more per labeled serving, and the amount of total fat if more than 3 g per 100 g or more than 30% ofcalories from fat).
Cholesterol
• 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.
• Cholesterol claims only allowed when food contains 2 g or less saturated fat per RACC, or formeals and main dish products, per 100 g.
• Must declare the amount of total fat next to claim when fat exceeds 13 g per RACC and per labeledserving (or per 50 g if RACC is small), or when fat exceeds 19.5 g per labeled serving for maindishes or 26 g for meal products.
Sodium
• 140 mg or less per RACC (and per 50 g if RACC is small).
• Meals and main dishes: 140 mg or less per 100 g.
• “Very Low Sodium”: 35 mg or less per RACC (and per 50 g if RACC is small); for meals and maindishes: 35 mg or less per 100 g.
Sugars
• Not defined.
REDUCED/LESS
To bear a relative claim about the level of a nutrient, the amount of that nutrient must be compared to an amount in an appropriate reference food. For “reduced” claims, the reference food must be (1) an established regular product or average representative product or (2) a similar food. For “less” claims, it must be either of the above or a dissimilar food in the same product category, which may generally be substituted for the labeled food (e.g., potato chips for pretzels).
Calories
• At least 25% fewer calories per RACC than appropriate reference food (or, for meals and main dishes, at least 25% fewer calories per 100 g).
• Reference food may not be “low calorie.”
• Uses term “fewer” rather than “less.”
OCR for page 137
Front-of-Package Nutrition Rating Systems and Symbols
Total 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 100 g).
• Reference food may not be “low fat.”
Saturated fat
• At least 25% less saturated fat per RACC than an appropriate reference food (or, for meals andmain dishes, at least 25% less saturated fat per 100 g).
• Reference food may not be “low saturated fat.”
• Must declare the amount of cholesterol if 2 mg or more per RACC and the amount of total fat ifmore than 3 g per RACC (or, for meals and main dishes the amount of cholesterol if 2 mg or more per labeled serving and the amount of fat if more than 3 g per 100 g or more than 30% of calories from fat).
Cholesterol
• At least 25% less cholesterol per RACC than an appropriate reference food (or, for meals and maindishes, at least 25% less cholesterol per 100 g).
• Reference food may not be “low cholesterol.”
• Cholesterol claims only allowed when food contains 2 g or less saturated fat per RACC, or, formeals and main dishes, per 100 g.
• Must declare the amount of total fat next to cholesterol claim when fat exceeds 13 g per RACC andlabeled 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.
Sodium
• At least 25% less sodium per RACC than an appropriate reference food (or, for meals and maindishes, at least 25% less sodium per 100 g).
• Reference food may not be “low sodium.”
Sugars
• At least 25% less sugars per RACC than an appropriate reference food (or, for meals and maindishes, at least 25% less sugars per 100 g).
HEALTHY
Individual food
• Low fat (e.g., 3 g or less fat per RACC).
• Low saturated fat (e.g., 1 g or less per RACC and 15% or less of calories from saturated fat).
• Sodium: 480 mg or less per RACC and 480 mg or less per labeled serving, except foods with aRACC less than or equal to 30 g or 2 Tbsp. Must contain 480 mg or less per 50 g.
• Cholesterol: 60 mg or less per RACC and 60 mg or less per labeled serving, except foods with aRACC less than or equal to 30 g or 2 Tbsp. Must contain 60 mg or less per 50 g.
• Beneficial nutrients: At least 10% of Daily Value for vitamin A, vitamin C, calcium, iron, protein,or fiber per RACC, except for raw fruits and vegetables, single ingredient or a mixture of canned or frozen fruits and vegetables, or enriched cereal grain products that conform to a standard of identity.
• Fortification in accordance with Fortification Policy in 21 CFR 104.20.
OCR for page 138
Front-of-Package Nutrition Rating Systems and Symbols
Seafood/Game meat
• Total fat: Less than 5 g fat per RACC and per 100 g.
• Saturated fat: Less than 2 g per RACC and per 100 g.
• Sodium: Same as for individual food.
• Cholesterol: Less than 95 mg per RACC and per 100 g.
• Beneficial nutrients: At least 10% of Daily Value for vitamin A, vitamin C, calcium, iron, protein, orfiber per RACC.
• Fortification in accordance with Fortification Policy in 21 CFR 104.20.
Meal or main dish
• Low fat (e.g., 3 g or less per 100 g and not more than 30% of calories from fat).
• Low saturated fat (e.g., 1 g or less per 100 g and less than 10% of calories from saturated fat).
• Sodium: 600 mg or less per labeled serving.
• Cholesterol: 90 mg or less per labeled serving.
• Beneficial nutrients: At least 10% of Daily Value per labeled serving of two of the followingnutrients for a main dish and three of the nutrients for a meal: vitamin A, vitamin C, calcium, iron, protein, or fiber per labeled serving.
• Fortification in accordance with Fortification Policy in 21 CFR 104.20.
LIGHT
• If 50% or more of the calories are from fat, fat must be reduced by at least 50% per RACC. If lessthan 50% of calories are from fat, fat must be reduced at least 50% or calories reduced at least 1/3 per RACC. Reference food may not be “low calorie” and “low fat.”
• For sodium reduced products, if sodium is reduced by 50% or more and the food does not meet thedefinition of “low calorie” or “low fat,” claim must say “light in sodium.” If sodium is reduced by 50% or more and the food meets the definition of “low calories” and “low fat,” the claim “light” may be used without further qualification.
• Meals or main dishes must meet the definition for “low calorie” or “low fat” meal and be labeled toindicate which definition is met.
• “Light in sodium”: sodium is reduced by at least 50% per RACC and, except for meals and main dishes, the reference food may not meet the definition of “low in sodium.” For meals and maindishes, “light in sodium” must meet definition for “low in sodium.”
• “Lightly salted”: 50% less sodium than normally added to reference food and if food does not meetdefinition for “low sodium,” it must state that on the information panel, i.e., “not a low sodiumfood.”
• The reference food must be representative of the type of food bearing the claim (e.g., average valueof top three brands or representative value from valid data base), or a similar food (e.g., potato chips for potato chips).
OTHER NUTRIENT CONTENT CLAIMS
High
• Contains 20% or more of the DV per RACC.
• May be used on main dishes to indicate that the product contains a food that meets the definitionand the food that is the subject of the claim is clearly identified (e.g., the serving of broccoli in this product is high in vitamin C).
Good source
• Contains 10-19% of the DV per RACC.
• May be used on main dishes to indicate that the product contains a food that meets the definition and the food that is the subject of the claim is clearly identified.
More
• Contains at least 10% more of the DV per RACC than appropriate reference food.
• May only be used for vitamins, minerals, protein, dietary fiber, and potassium.
Lean
• On seafood or game meat products: less than 10 g total fat, 4.5 g or less saturated fat, and less than 95 mg cholesterol per RACC and per 100 g (for meals and main dishes, meets criteria per 100 g and per labeled serving).
• On mixed dishes not measurable with a cup (as defined in 21 CFR 101.12(b) in Table 2): less than 8g total fat, 3.5 g or less saturated fat, and less than 80 mg cholesterol per RACC.
Extra lean
• On seafood or game meat products: less than 5 g total fat, less than 2 g saturated fat, and less than 95mg cholesterol per RACC and per 100 g (for meals and main dishes, meets criteria per 100 g and per labeled serving).
High potency
• On foods to describe individual vitamins or minerals that are present at 100% or more of the RDI per RACC or on a multi-ingredient food product that contains 100% or more of the RDI for at least 2/3 of the vitamins and minerals with RDIs and that are present in the product at 2% or more of the RDI (e.g., “High-potency multivitamin, multi-mineral dietary supplement tablets”).
Modified
• May be used in statement of identity of a food that bears a relative claim (e.g., “Modified fatcheesecake, contains 35% less fat than our regular cheesecake”).
Fiber source
• If a fiber claim is made and the food is not low in total fat, then the label must disclose the level oftotal fat per labeled serving.
OCR for page 139
Front-of-Package Nutrition Rating Systems and Symbols
Antioxidants§
• An RDI must be established for each of the nutrients that are the subject of the claim.
• The name of the nutrients that are the subject of the claim are included as part of the claim.
• Each nutrient must have existing scientific evidence of antioxidant activity.
• The level of each nutrient must be sufficient to meet the definition for “high,” “good source,” or“more.”
• Beta-carotene may be the subject of an antioxidant claim when the level of vitamin A present as beta-carotene in the food is sufficient to qualify for the claim.
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”). § Must name the antioxidant as a criteria for an antioxidant claim.
DV = Daily Value
RACC = Reference Amounts Customarily Consumed
RDI = Reference Daily Intake
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 a claim is made on a food that contains more than 13 g total fat, 4 g saturated fat, 60 mg cholesterol, or 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 (i.e., “See nutrition information _____ for content” with the blank filled in with nutrient(s) that exceed the prescribed levels). The disclosure statement is required on meal products that exceed 26 g total fat, 8 g saturated fat, 120 mg cholesterol, or 960 mg sodium, and on main dish products that exceed 19.5 g total fat, 6 g saturated fat, 90 mg cholesterol, or 720 mg sodium per labeled serving.
For “free,” “very low,” or “low” claims, 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.”
SOURCE: 21 CFR Part 101. Food Labeling Guide: Guidance for Industry. September 1994; revised April 2008. Food and Drug Administration See Appendixes A and B. Available online: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm (accessed September 11, 2010).
OCR for page 140
Front-of-Package Nutrition Rating Systems and Symbols
This page is blank
