FDA Nutrition Labeling Revisions Federal Register, May 27, 2016
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1 FDA Nutrition Labeling Revisions Federal Register, May 27, 2016 Required Nutrients, Applicable Daily Values, and Nutrient and Daily Total Calories < 5 cal = 0 cal 5-50 cal: nearest 5 cal > 50 cal: nearest 10 cal 101.9(c)(1) Change in calorie factors for non-digestible carbs and sugar alcohols Total Fat DV=78g < 5 cal: insignificant amt 101.9(c)(2) DV increased from 65g Calories from fat eliminated Saturated fat DV=20g 101.9(c)(2)(i) trans fat No DV 101.9(c)(2)(ii) Cholesterol DV=300mg < 2mg = 0mg 2-5mg: < 5mg > 5mg: 5mg increment 101.9(c)(3) < 2mg: insignificant amt Page 1
2 Nutrient and Daily Sodium DV=2,300mg < 5mg = 0mg 5-140mg: 5mg increment > 140mg: 10mg increment 101.9(c)(4) DV decreased from 2,400mg Total Carbohydrate DV=275g < 5mg: insignificant amt 101.9(c)(6) DV decreased from 300g Dietary Fiber DV=28g Total Sugars No DV 101.9(c)(6)(i) 101.9(c)(6)(ii) DV increased from 25g Definition of what is fiber has changed May need to keep records Changed from Sugars Added Sugars DV=50g 101.9(c)(6)(iii) May need to keep records Protein DV=50g 101.9(c)(7) Page 2
3 Nutrient and Daily Vitamin D DV=20 mcg >50% DV: nearest 10% Calcium DV=1,300mg >50% DV: nearest 10% Units have changed from IU to mcg %D DV has increased Iron DV=18mg >50% DV nearest 10% Potassium DV=4,700mg >50% DV nearest 10% Voluntary Macronutrients: Calories from saturated fats Polyunsaturated Fat Monounsaturated Fat Fluoride Soluble Fiber Insoluble Fiber Sugar Alcohol DV has increased Voluntary Micronutrients: Vitamins A, B6, B12, C, E, K Thiamine, Riboflavin, Niacin, Folate/Folic Acid, Biotin, Pantothenic Acid, Cholate/Choline, Phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride 1 The revised regulations now include Daily Values for 4 distinct populations: Adults and children 4 years, Infants through 12 months, Children 1 through 3 years, and Pregnant women and Lactating women. The values included here are for Adults and children 4 years. DVs for the populations are at 21 CFR 101.9(c)(8)(iv) and. Page 3
4 Amounts Customarily Consumed per Eating Occasion (21 CFR (b)) Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes Product category Label statement amount Bacon substitutes, canned anchovies, 10 anchovy pastes, caviar 15 g _piece(s) (_g) for discrete pieces; _tbsp(s) (_g) for others Dried, e.g., jerky 30 g _piece(s) (_g) Entrees with sauce, e.g., fish with cream sauce, shrimp with lobster sauce Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake Fish, shellfish, or game meat 9, canned 10 Smoked or pickled fish, 10 shellfish, or game meat; fish or shellfish spread 140 g cooked _cup(s) (_g); 5 oz (140 g/visual unit of measure) if not measurable by cup 85 g cooked; 110 g uncooked g (NOTE: RACC has increased from 55 g) _piece(s) (_g) for discrete pieces; _cup(s) (_g); _oz (_g/visual unit of measure) if not measurable by cup 12 _piece(s) (_g) for discrete pieces; _cup(s) (_g); 3 oz (85 g/_cup) for products that are difficult to measure the g weight of cup measure (e.g., tuna); 3 oz (85 g/_pieces) for products that naturally vary in size (e.g., sardines) 55 g _piece(s) (_g) for distinct pieces (e.g., slices, links) or _cup(s) (_g); 2 oz (56 g/visual unit of measure) for nondiscrete bulk product 10 If packed or canned in liquid, the reference amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed (e.g., canned chopped clam in juice). 11 The reference amount for the uncooked form does not apply to raw fish in or to singleingredient products that consist of fish or game meat as provided for in 101.9(j)(11). 12 For raw fruit, vegetables, and fish, manufacturers should follow the label statement for the serving size specified in Appendices C and D to part 101 (21 CFR part 101) Code of Federal Regulations. Page 4
5 Determining Serving Size, Servings per Container, and Dual Column Labeling Type of Product Package with Discrete Individual Units 101.9(b)(2)(i)(A), (B), (C), (D) Products naturally varying in size (e.g., shellfish, whole fish, and fillets) 101.9(b)(2)(i)(F) Determining Single Serving Container 101.9(b)(6) and (b)(12)(i) Number of Servings and/or Dual Column 50% of RACC: number of units closest to RACC >50% and <67% of RACC: 1 or 2 units 67% and <200% of RACC: 1 unit 200% to 300% of RACC: dual column format with one column for determined serving size and one column for individual unit (exemptions in (b)(12)(i)(a), (B), and (C)) may be the amount in ounces that most closely approximates the RACC. Follow 101.9(b)(5)(vi) <200% of RACC: 1 serving >150 to < 200% of RACC: 1 serving or Optional Dual Column format with one column for determined serving size and one column for entire package. 200% to 300% of RACC: Dual column format with one column for determined serving size and one column for entire package. (exemptions in (b)(12)(i)(a), (B), and (C)) Page 5
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