OTHER NUTRIENT CONTENT CLAIMS

High

  • 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 10–19% 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.

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 8 g 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 95 mg 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, 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 Source

  • 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.

Antioxidants

  • 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.

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”).

RACC = Reference Amounts Customarily Consumed.

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. (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm [accessed September 11, 2010]).



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