Guidance for Industry

A Food Labeling Guide

X. Appendix B: Additional Requirements for Nutrient Content Claims

Contains Nonbinding Recommendations

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Relative Claims

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)

Other Nutrient Content Claims

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: an RDI must be established for each of the nutrients that are the subject 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.

Implied Claims

• Claims about a food or ingredient that suggests that the nutrient or ingredient are absent or present in a certain amount or claims about a food that suggests a food may be useful in maintaining healthy dietary practices and which are made with an explicit claim (e.g. "healthy, contains 3 grams of fat") are implied claims.
• Claims that a food contains or is made with an ingredient that is known to contain a particular nutrient may be made if product is "Low" in or a "Good Source" of the nutrient associated with the claim (e.g. "good source of oat bran").
• Equivalence claims: "contains as much [nutrient] as a [food]" may be made if both reference food and labeled food are a "Good Source" of a nutrient on a per serving basis. (e.g. "Contains as much vitamin C as an 8 ounce glass of orange juice").
• The following label statements are generally not considered implied claims unless they are made in a nutrition context: 1) avoidance claims for religious, food intolerance, or other non-nutrition related reasons (e.g. "100% milk free"); 2) statements about non-nutritive substances (e.g. "no artificial colors"); 3) added value statements (e.g. "made with real butter"); 4) statements of identity (e.g. "corn oil" or "corn oil margarine"); and 5) special dietary statements made in compliance with a specific Part 105 provision.
• The term "healthy" and related terms ("health," "healthful," "healthfully," "healthfulness," "healthier," "healthiest," "healthily" and "healthiness") may be used if the food meets the following requirements:

Conditions for the Use of "Healthy"

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

Claims on Foods for Infants and Children Less than 2 Years of Age

Nutrient content claims are not permitted on foods intended specifically for infants and children less than 2 years of age except:

1. Claims describing the percentage of vitamins and minerals in a food in relation to a daily value.
2. Claims on infant formulas provided for in Part 107.
3. The terms "Unsweetened" and "Unsalted" as taste claims.
4. Sugar Free" and "No Added Sugar" claims on dietary supplements only.