Appendix B
FDA Regulatory Requirements for Nutrient Content Claims1
FREE |
|
Calories |
|
Total fat |
|
Saturated fat |
|
Cholesterol |
|
Sodium |
|
Sugars |
|
LOW |
|
Calories |
|
Total fat |
|
Saturated fat |
|
Cholesterol |
|
Sodium |
|
Sugars |
|
REDUCED/LESS |
|
To bear a relative claim about the level or 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 |
|
Total fat |
|
Saturated fat |
|
Cholesterol |
|
Sodium |
|
Sugars |
|
HEALTHY |
|
Individual Food |
|
Seafood/Game Meat |
|
Meal or Main Dish |
|
LIGHT |
|
|
|
OTHER NUTRIENT CONTENT CLAIMS |
|
High |
|
Good Source |
|
More |
|
Lean |
|
Extra Lean |
|
High Potency |
|
Modified |
|
Fiber Source |
|
Antioxidants |
|
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]). |