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CFSAN/Office of Nutrition, Labeling, and Dietary Supplements
April 2008
To bear a relative claim about the level of a nutrient, the amount of that nutrient in the food must be compared to an amount of nutrient in an appropriate reference food as specified below (21 CFR 101.13(j)(1)):
"Light" | (1) A food representative of the type of food bearing the claim (e.g., average value of top three brands or representative value from valid data base), (2) Similar food (e.g., potato chips for potato chips) |
"Reduced" and "Added" (or "Extra," "Plus," "Fortified," and "Enriched") | (1) An established regular product or average representative product, and (2) Similar food. |
"More" and "Less" (or "Fewer") | (1) An established regular product or average representative product, and (2) A dissimilar food in the same product category which may be generally substituted for the labeled food (e.g., potato chips for pretzels) or a similar food. |
For all relative claims, the percent (or fraction) of change and identity of reference food must be declared immediately adjacent to the most prominent claim. 21 CFR 101.13(j)(2)(i) and 21 CFR 101.13(j)(2)(ii)
Quantitative comparison of the amount of the nutrient in the product per labeled serving with that in the reference food must be declared on information panel. 21 CFR 101.13(j)(2)(iv)(A)
A relative claim for decreased levels of a nutrient may not be made if the nutrient content of the reference food meets the requirement for a "low" claim for that nutrient (e.g., 3 g fat or less). 21 CFR 101.13(j)(3)
Claim | Requirements |
---|---|
"High," "Rich In," or "Excellent Source Of" | Contains 20% or more of the DV per RACC. May be used on meals or main dishes to indicate that the product contains a food that meets the definition. |
"Good Source," "Contains," or "Provides" | 10%-19% of the DV per RACC. These terms may be used on meals or main dishes to indicate that the product contains a food that meets the definition. |
"More," "Fortified," "Enriched," "Added," "Extra," or "Plus" | 10% or more of the DV per RACC. May only be used for vitamins, minerals, protein, dietary fiber, and potassium. |
"Lean" | On seafood or game meat products that contain less than 10g total fat, 4.5g or less saturated fat, and less than 95mg cholesterol per RACC and per 100g (for meals & main dishes, meets criteria per 100g and per labeled serving). On mixed dishes not measurable with a cup (as defined in 21 CFR 101.12(b) in table 2) that contain less than 8g total fat, 3.5g or less saturated fat and less than 80 mg cholesterol per RACC. |
"Extra Lean" | On seafood or game meat products that contains less than 5g total fat, less than 2g saturated fat and less than 95mg cholesterol per RACC and per 100g (for meals and main dishes, meets criteria per 100g and per labeled serving). |
"High Potency" | May be used 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, multimineral dietary supplement tablets"). |
"Modified" | May be used in statement of identity of a food that bears a relative claim (e.g., "Modified fat cheesecake, contains 35% less fat than our regular cheesecake.") |
"Fiber" Claims | If a fiber claim is made and the food is not low in total fat, then the label must disclose the level of total fat per labeled serving. 21 CFR 101.54(d)(1) |
Claims using the term "antioxidant" | For claims characterizing the
level of antioxidant nutrients in a food:
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Individual Food | Seafood/Game Meat | Meal/Main Dish |
---|---|---|
low fat | TOTAL FAT < 5 g fat /RACC & /100g |
low fat |
low sat fat | SATURATED FAT < 2 g sat fat /RACC & /100g |
low sat fat |
≤ 480 mg /RACC and /l.s.; or /50 g, if RACC is small | SODIUM ≤ 480 mg /RACC and /l.s.; or /50 g, if RACC is small |
≤ 600 mg /l.s. |
≤ disclosure level | CHOLESTEROL < 95 mg /RA & /100 g |
≤ 90 mg /l.s. |
Contains at least 10% of DV /RACC for vitamins A, C, calcium, iron, protein, or fiber except: raw fruits and vegs.; frozen or canned single ingredient fruits and vegs. (may include ingredients whose addition does not change the nutrient profile of the fruit or veg.); enriched cereal-grain products that conform to a standard of identity in 21 CFR 136, 137, or 139. | BENEFICIAL NUTRIENTS Contains at least 10% of DV /RACC for vitamins A, C, calcium, iron, protein, or fiber |
Contains at least 10% of the DV /l.s. of two nutrients (for a main dish product) or of three nutrients (for a meal product) of vit. A, vit. C, calcium, iron, protein, or fiber. |
Per 21 CFR 104.20 | FORTIFICATION Per 21 CFR 104.20 |
Per 21 CFR 104.20 |
NOTE: l.s. = labeled serving; RACC = Reference Amount Customarily Consumed per Eating Occasion; small RACC = 30 g or less, or 2 tablespoons or less |
Nutrient content claims are not permitted on foods intended specifically for infants and children less than 2 years of age except: