• 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).