• Enfamil® ProSobee® - Soy-based infant formula for the first 12 months
  • Enfamil® ProSobee® - 12.9 oz Powder Can
  • Enfamil® ProSobee® - Ready-to-Use - 8 fl oz Plastic Bottle
  • Enfamil® ProSobee® - 6 fl oz Plastic Nursette® Bottle
  • Enfamil® ProSobee® - 13 fl oz Concentrated Liquid Can

Enfamil® ProSobee®

Soy for Sensitive Tummy.

Soy-based infant formula for the first 12 months.

Last Updated: Thursday, January 15, 2015

ProSobee was shown to help infants in just 24 hours
  • Indication
    • For babies with sensitive tummies, when a soy formula is preferred.

      Enfamil ProSobee is a soy protein isolate formula and is relied on for the routine feeding of some infants with feeding problems resulting from sensitivity to milk-based formula. Enfamil ProSobee includes docosahexaenoic acid (DHA) and arachidonic acid (ARA), nutrients also found in breast milk, that promote brain and eye development. Enfamil ProSobee is suitable for someone with lactose intolerance.

      Breast milk is the standard for infant nutrition and the American Academy of Pediatrics (AAP) recommends breastfeeding for most infants1.

      Long-Term Usage

      Enfamil ProSobee is designed to provide a sole source of nutrition for infants up to age 6 months, and provide a major source of nutrition through 12 months of age when indicated.

  • Product Features
      • A Neuro Complete blend of nutrients that are also found in breast milk
      • Has a DHA and ARA blend shown* to foster a child’s learning ability up to age 51
      • A soy formula specifically designed for infants with fussiness, gas and crying due to sensitivity to milk-based formula
      • Clinical results showing improvements in fussiness and gas in 24 hours2†
      • Plant-sourced protein
      • Soy-based, suitable for someone with lactose intolerance
      • Has choline, a brain nutrient found in breast milk
      • DHA level similar to worldwide breast milk average3‡
      • Has our blend of DHA and ARA, nutrients also found in breast milk, that promotes brain and eye development4-11

      DHA and ARA Fatty Acid Nutrients§

      • DHA – 17 mg
      • ARA – 34 mg

      * Shown in Enfamil® Infant with DHA and ARA.

      † vs the same infants at the beginning of the study.

      ‡ Average level of DHA in worldwide breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women.

      § Per 100 Calories.

  • Nutrients||
    • (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 grams Powder (500 Cal)
      Protein, g 2.5 12.7
      Fat, g 5.3 27
      Linoleic acid, mg 800 (Pwd)
      860 (Liq)
      4100
      Carbohydrate, g 10.6 54
      Water, g 133 (Pwd; 2, 6 & 32 fl oz RTU)
      134 (8 & 13 fl oz Conc; 8 fl oz RTU)
      2.6
      (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 grams Powder (500 Cal)
      Vitamins/Other Nutrients
      Vitamin A, IU 300 1530
      Vitamin D, IU 60 310
      Vitamin E, IU 2 10.2
      Vitamin K, mcg 8 (32 fl oz RTU)
      9 (Pwd; 8 & 13 fl oz Conc; 2, 6 & 8 fl oz RTU)
      46
      Thiamin (Vitamin B1), mcg 80 410
      Riboflavin (Vitamin B2), mcg 90 460
      Vitamin B6, mcg 60 310
      Vitamin B12, mcg 0.3 1.53
      Niacin, mcg 1000 5100
      Folic acid (Folacin), mcg 16 81
      Pantothenic acid, mug 500 2500
      Biotin, mcg 3 15.3
      Vitamin C (Ascorbic acid), mg 12 61
      Choline, mg 24 122
      Inositol, mg 6 31
      (Normal Dilution) Per 100 Calories (5 fl oz) Per 100 grams Powder (500 Cal)
      Minerals
      Calcium, mg 105 530
      Phosphorus, mg 69 350
      Magnesium, mg 11 (32 fl oz RTU)
      8 (Pwd; 8 & 13 fl oz Conc; 2, 6 & 8 fl oz RTU)
      41
      Iron, mg 1.8 9.2
      Zinc, mg 1.2 6.1
      Manganese, mcg 25 127
      Copper, mcg 75 380
      Iodine, mcg 15 76
      Selenium, mcg 2.8 14.2
      Sodium, mg 36 183
      Potassium, mg 120 610
      Chloride, mg 80 410

      || Product nutrient values and ingredients are subject to change. Please see product label for current information.

  • Nutrient Facts
    • Nutrient Density 20 Calories/fl oz
      Protein (% calories) 10
      Fat (& calories) 48
      Carbohydrate (% calories) 42
      Potential Renal Solute Load (mOsm/100 Calories)12 23
      Potential Renal Solute Load (mOsm/100 mL)12 15.6 (Pwd, 8, 13 fl oz Conc; 2, 6, 8, 32 fl oz RTU)
      Osmolality (mOsm/kg water) 170 (8, 13 fl oz Conc; 6, 8, 32 fl oz RTU)
      178 (Pwd)
      200 (2 fl oz RTU)
      Osmolarity (mOsm/L) 153 (6, 32 fl oz RTU)
      155 (8, 13 fl oz Conc;
      8 fl oz RTU)
      160 (Pwd)180 (2 fl oz RTU)
      Lactose-Free Suitable for someone with lactose intolerance
      Galactose-Free Yes

      ¶ Some metabolic clinicians recommend liquid formulas even though questions have been raised about the availability of galactose bound in the carrageenan in liquid formulas.

  • Product Forms
    • Enfamil® ProSobee® is available in powder, ready-to-use liquid, and concentrate.

    • Item #: 149901
      Description: Concentrate
      Unit Size: 8 fl oz bottle
      Cal./Unit: 320
      Prod. Yield / Unit (fl oz): 16
      Case: 24 bottles per case
      Reimbursement Code: 00087-510252

    • Item #: 119501
      Description: Concentrate
      Unit Size: 13 fl oz can
      Cal./Unit: 520
      Prod. Yield / Unit (fl oz): 26
      Case: 12 cans per case
      Reimbursement Code: 00087-119541

    • Item #: 121401
      Description: Powder
      Unit Size: 12.9 oz can
      Cal./Unit: 1840
      Prod. Yield / Unit (fl oz): 93
      Case: 6 cans per case
      Reimbursement Code: 00087-121441

    • Item #: 121460
      Description: Powder
      Unit Size: 22 oz can
      Cal./Unit: 3180
      Prod. Yield / Unit (fl oz): 159
      Case: 4 cans per case
      Reimbursement Code: 00087-121442

    • Item #: 144901
      Description: RTU
      Unit Size: 2 fl oz bottle
      Cal./Unit: 40
      Prod. Yield / Unit (fl oz): 2
      Case: 48 bottles per case
      Reimbursement Code: 00087-144941

    • Item #: 026106
      Description: RTU
      Unit Size: 6 fl oz bottle
      Cal./Unit: 120
      Prod. Yield / Unit (fl oz): 6
      Case: 24 bottles per case
      Reimbursement Code: 00087-026124

    • Item #: 149801
      Description: RTU
      Unit Size: 8 fl oz bottle
      Cal./Unit: 160
      Prod. Yield / Unit (fl oz): 8
      Case: 24 bottles per case
      Reimbursement Code: 00087-510250

    • Item #: 030934
      Description: RTU
      Unit Size: 32 fl oz can
      Cal./Unit: 640
      Prod. Yield / Unit (fl oz): 32
      Case: 6 cans per case
      Reimbursement Code: 00087-030974

      HCPCS Code

  • Composition
    • Ingredients: Powder: Corn syrup solids (54%), vegetable oil (26%) (palm olein, coconut, soy and high oleic sunflower oils), soy protein isolate (14%) and less than 2%: calcium phosphate, potassium chloride, sodium citrate, calcium carbonate, magnesium chloride, magnesium phosphate, potassium citrate, ferrous sulfate, zinc sulfate, cupric sulfate, potassium iodide, sodium selenite, Mortierella alpina oil#, Crypthecodinium cohnii oil**, L-methionine, choline chloride, ascorbic acid, niacinamide, calcium pantothenate, vitamin D3, riboflavin, thiamin hydrochloride, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, vitamin B12, inositol, taurine, vitamin E acetate, L-carnitine, vitamin A palmitate.

      Ingredients: Ready To Use: Water (87%), corn syrup solids (7%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (3%), soy protein isolate (2%) and less than 1%: Mortierella alpina oil#, Crypthecodinium cohnii oil**, mono- and diglycerides, soy lecithin, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, sodium ascorbate, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium chloride, magnesium phosphate, ferrous sulfate, zinc sulfate, cupric sulfate, potassium iodide, sodium selenite, sodium chloride, potassium citrate, potassium chloride, L-methionine, taurine, L-carnitine.

      Ingredients: Ready To Use (2 fl oz Nursette® bottle): Water (87%), corn syrup solids (7%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (3%), soy protein isolate (2%) and less than 1%: Mortierella alpina oil#, Crypthecodinium cohnii oil**, calcium phosphate, potassium citrate, calcium carbonate, sodium chloride, magnesium chloride, magnesium phosphate, potassium chloride, ferrous sulfate, zinc sulfate, cupric sulfate, potassium iodide, sodium selenite, soy lecithin, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, vitamin B12, vitamin D3, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, mono- and diglycerides, L-methionine, choline chloride, carrageenan, inositol, taurine, L-carnitine.

      Ingredients: Ready to Use (6 fl oz Nursette bottle, 8 fl oz bottle): Water (87%), corn syrup solids (7%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (3%), soy protein isolate (2%) and less than 1%: Mortierella alpina oil#, Crypthecodinium cohnii oil**, calcium phosphate, potassium citrate, sodium chloride, calcium carbonate, potassium chloride, magnesium phosphate, magnesium chloride, ferrous sulfate, zinc sulfate, cupric sulfate, potassium iodide, sodium selenite, soy lecithin, mono- and diglycerides, L-methionine, carrageenan, choline chloride, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, inositol, vitamin B12, vitamin D3, taurine, L-carnitine.

      Ingredients: Concentrated Liquid (13 fl oz can): Water (75%), corn syrup solids (14%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (6%), soy protein isolate (4%) and less than 1%: Mortierella alpina oil#, Crypthecodinium cohnii oil**, mono- and diglycerides, soy lecithin, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium chloride, magnesium phosphate, ferrous sulfate, zinc sulfate, cupric sulfate, potassium iodide, sodium selenite, sodium chloride, potassium citrate, potassium chloride, L-methionine, taurine, L-carnitine.

      Ingredients: Concentrated Liquid (8 fl oz bottle): Water (75%), corn syrup solids (14%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (7%), soy protein isolate (4%) and less than 2%: Mortierella alpina oil#, Crypthecodinium cohnii oil**, calcium phosphate, potassium citrate, sodium chloride, calcium carbonate, magnesium phosphate, magnesium chloride, potassium chloride, ferrous sulfate, zinc sulfate, cupric sulfate, potassium iodide, sodium selenite, soy lecithin, mono- and diglycerides, L-methionine, choline chloride, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, inositol, carrageenan, vitamin B12, vitamin D3, taurine, L-carnitine.

      # A source of arachidonic acid (ARA).

      ** A source of docosahexaenoic acid (DHA).

  • Potential Allergens
    • Enfamil® ProSobee® contains soy.

  • Preparation of Feedings
    • The baby’s health depends on carefully following these instructions. Proper hygiene, preparation, dilution, use, and storage are important when preparing infant formula. Powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems, unless directed and supervised by a doctor.

      Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles, and nipples in water before use.

      Select a specific form:

      Powder

      1. Wash hands thoroughly with soap and water before preparing formula.
      2. Pour desired amount of water into bottle. Add powder.
      3. Cap bottle and SHAKE WELL.

      Use the following chart for correct amounts of water and powder. Use scoop in can to measure powder. Store DRY scoop in its original can.

      To Make‡‡ Water Powder Weight
      2 fl oz 2 fl oz 1 unpacked level scoop 8.8 g
      4 fl oz 4 fl oz 2 unpacked level scoop 17.6 g
      6 fl oz 6 fl oz 3 unpacked level scoop 26.4 g
      8 fl oz 8 fl oz 4 unpacked level scoop 35.2 g
      1 quart 28.5 fl oz 1 1/4 unpacked level household measuring cups 126 g

      ‡‡ Each scoop adds about 0.2 fl oz to the amount of prepared formula.

      Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either feed immediately or cover and store in the refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use prepared formula if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use within 1 hour or discard.

      Powder Storage (cans)

      Store cans at room temperature. After opening can, keep tightly covered, store in dry area, and use contents within 1 month. Do not freeze powder and avoid excessive heat. Use by date on bottom of can.

      CAUTION

      Use product by date on container. Nutritional powders are not sterile.

      Ready To Use

      1. Wash hands thoroughly with soap and water before preparing bottle for feeding.
      2. Clean can lid, SHAKE CAN WELL, and open; or SHAKE BOTTLE WELL and remove cap and foil seal.
      3. Pour into bottle(s).

      Failure to follow these instructions could result in severe harm. Opened cans and prepared bottles can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened can and/or prepared bottle if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared bottle. After feeding begins, use within 1 hour or discard.

      Ready To Use Storage

      Store unopened cans at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can or on bottle.

      Nursette® Bottles

      1. Inspect each bottle for signs of damage.
      2. Wash hands thoroughly with soap and water before preparing bottle for feeding.
      3. SHAKE BOTTLE WELL and remove cap.
      4. Attach nipple unit (not included).

      Failure to follow these instructions could result in severe harm. Opened bottles can spoil quickly. Either feed immediately or replace cap and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened bottle if it is unrefrigerated for more than a total of 2 hours. Do not freeze. After feeding begins, use within 1 hour or discard.

      Nursette Bottle Storage

      Store unopened bottles at room temperature. Avoid excessive heat and prolonged exposure to light. Do not freeze. Use by date on carton and bottle label.

      Concentrate

      1. Wash hands thoroughly with soap and water before preparing formula.
      2. Clean can lid, SHAKE CAN WELL, and open; or SHAKE BOTTLE WELL and remove cap and foil seal.
      3. Pour desired amount of water into the bottle. Add an equal amount of concentrated liquid. SHAKE OR STIR WELL.

      Failure to follow these instructions could result in severe harm. Opened cans and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened can and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use within 1 hour or discard.

      Concentrate Storage

      Store unopened cans at room temperature. Avoid excessive heat. Do not freeze. Use by date on top of can or on bottle.

      WARNING:

      Do not use a microwave oven to prepare or warm formula. Serious burns may result.

  • Product Characteristics
    • Fat

      The fat content in Enfamil ProSobee is 48% of total Calories. The fat blend consists of approximately:

      • 44% palm olein oil
      • 19.5% soy oil
      • 19.5% coconut oil
      • 14.5% high oleic sunflower oil
      • 2.5% single-cell oil blend rich in docosahexaenoic acid (DHA) and arachidonic acid (ARA)

      The levels of total fat and saturated, monounsaturated, and polyunsaturated fatty acids in Enfamil ProSobee are patterned after levels found in mature U.S. breast milk13. Human milk contains, on average, between 20% and 24% of the fatty acids as palmitic acid13. Using palm olein oil in the fat blend results in Enfamil ProSobee having palmitic acid levels similar to breast milk13. Linoleic acid provides about 17% of the total fatty acids in Enfamil ProSobee, which is within the range of means found in average, mature U.S. breast milk (14%-19%)13.

      DHA and ARA

      Enfamil ProSobee was the first soy-based infant formula in the United States to include DHA and ARA, two nutrients also found in breast milk that are important building blocks for a baby's brain and eyes4-11. The levels of DHA and ARA in Enfamil ProSobee are similar to those found in average worldwide breast milk13-16, §§ as well as levels specified by expert groups17-20.

      Enfamil ProSobee DHA level withing recommended levels

      §§ Middle of worldwide breast milk averages (25th-75th percentile range of 0.20% to 0.40% of total fatty acids), assuming about 50% of calories from fat.

      Protein

      Protein provides 10% of total Calories, is of excellent quality, and promotes good growth and development. Soy protein isolate supplemented with L-methionine is the source of protein in Enfamil ProSobee. Taurine, an amino acid also found in human milk and that serves other functions in the body, is also added to Enfamil ProSobee.

      Carbohydrate

      The carbohydrate content in Enfamil ProSobee is 42% of total Calories. Enfamil ProSobee is the only major soy formula in the U.S. that is sucrose-free and suitable for someone with lactose intolerance. Corn syrup solids, the carbohydrate in Enfamil ProSobee, are readily digested and well tolerated by infants whose ability to digest other carbohydrates, such as lactose and sucrose, is impaired21. In contrast to lactose and sucrose, corn syrup solids provide a mixture of glucose saccharides of various sizes (glucose polymers). The enzymes that digest corn syrup solids typically remain available even when lactase and sucrase are not. Figure 1 illustrates digestion of corn syrup solids.

      Carbohydrate chart for ProSobee

      In addition, corn syrup solids have a sweetness level similar to lactose, the carbohydrate found in breast milk (Figure 2).

      Figure 2 Relative Sweetness of Carbohydrates22

      Relative Sweetness of Carbohydrates

      The production of corn syrup solids includes filtration and purification procedures that remove protein, the allergenic component of corn; therefore, corn syrup solids are considered hypoallergenic23.

      Vitamins and Minerals

      Enfamil ProSobee meets U.S. Food and Drug Administration requirements for vitamins and minerals as mandated by the U.S. Infant Formula Act and the associated Code of Federal Regulations 21 C.F.R. part 10724.

      Calcium and Phosphorus

      Enfamil ProSobee contains 105 mg calcium/100 Calories and 69 mg phosphorus/100 Calories. The calcium:phosphorus ratio is about 1.5:1 which is the range specified by the Infant Formula Act24.

      Iron

      Enfamil ProSobee provides 12.2 mg iron/L. The AAP states that infants who are not breastfed should receive iron-fortified formula25.

      Electrolytes—Sodium, Potassium, and Chloride

      The electrolyte levels in Enfamil ProSobee are within the ranges specified by U.S. Food and Drug Administration regulations as mandated by the Infant Formula Act24. The sodium, potassium, and chloride levels are 36 mg/100 Calories, 120 mg/100 Calories, and 80 mg/100 Calories, respectively.

      Carnitine

      Carnitine is a nutrient found in human milk that is involved in oxidation of long-chain fatty acids in the mitochondria25. Plant foods such as soy provide little naturally occurring carnitine; therefore, carnitine is added to Enfamil ProSobee.

  • Clinical Experience
    • Growth

      A multi-center, double-blind, randomized, controlled 120-day growth study was conducted in the U.S. One hundred eighty-two infants completed the study. Infants in the experimental group were fed Enfamil ProSobee with DHA at the levels similar to those found in average worldwide breast milk13-16||||. The control group received an unsupplemented soy-based formula. Assessments of weight, length, and head circumference were made at 14, 30, 60, 90, and 120 days of age. All infants grew normally regardless of group assignment27.

      |||| Middle of worldwide breast milk averages (25th-75th percentile range of 0.20% to 0.40% of total fatty acids), assuming about 50% of calories from fat.

      Safety and Tolerance

      Enfamil ProSobee is well tolerated. In the study described above, tolerance information was obtained from a 24-hour recall survey completed by the parents/caregivers at each study visit after the enrollment visit. Adverse events were monitored throughout the study. There were no increased incidence of adverse events in the group of term infants fed Enfamil ProSobee27.

      The sources of DHA and ARA in Enfamil ProSobee are also well tolerated. In clinical studies comparing infants fed formulas including LIPIL with infants fed formulas without LIPIL, there were no clinically significant differences in tolerance, and the addition of LIPIL had no effect on the incidence of adverse events28-30. The sources of DHA and ARA in Enfamil ProSobee are Generally Recognized as Safe (GRAS) for use in infant formulas by the U.S. Food and Drug Administration31,32.

  • References
    • 1. Colombo J, Carlson SE, Cheatham CL, et al. Long-term effects of LCPUFA supplementation on childhood cognitive outcomes. Am J Clin Nutr. 2013;98:403-412.

      2. Berseth CL, Johnston WH, Stolz SI, et al. Clinical response to 2 commonly used switch formulas occurs within 1 day. Clin Pediatr (Phila). 2009;48:58-65.

      3. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr. 2007;85:1457-1464.

      4. Birch EE, Hoffman DR, Uauy RD, et al. Visual acuity and the essentiality of docosahexaenoic acid and arachidonic acid in the diet of term infants. Pediatr Res. 1998;44:201-209.

      5. Birch EE, Garfield S, Hoffman DR, et al. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42:174-181.

      6. Birch EE, Hoffman DR, Castañeda YS, et al. A randomized controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr. 2002;75:570-580.

      7. Hoffman DR, Birch EE, Castañeda YS, et al. Maturation of visual and mental function in 18-month old infants receiving dietary long-chain polyunsaturated fatty acids (LCPUFAs) [abstract]. FASEB J. 2003;17:A727-A728. Abstract 445.1.

      8. Hoffman DR, Birch EE, Castañeda YS, et al. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003;142:669-677.

      9. Hoffman DR, Birch EE, Birch DG, et al. Impact of early dietary intake and blood lipid composition of long-chain polyunsaturated fatty acids on later visual development. J Pediatr Gastroenterol Nutr. 2000;31:540-553.

      10. Birch EE, Castañeda YS, Wheaton DH, et al. Visual maturation of term infants fed long-chain polyunsaturated fatty acid-supplemented or control formula for 12 mo. Am J Clin Nutr. 2005;81:871-879.

      11. Morale SE, Hoffman DR, Castañeda, YS, et al. Duration of long-chain polyunsaturated fatty acids availability in the diet and visual acuity. Early Hum Dev. 2005;81:197-203.

      12. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.

      13. Innis SM. Human milk and formula fatty acids. J Pediatr. 1992;120(supple):S56-S61.

      14. Data on file, Mead Johnson Nutritionals, September 2002.

      15. Koletzko B, Thiel I, Abiodun PO. The fatty acid composition of human milk in Europe and Africa. J Pediatr. 1992;120(supple):S62-S70.

      16. Jensen RG. Lipids in human milk. Lipids. 1999;34:1243-1271.

      17. The British Nutrition Foundation. Recommendations for intakes of unsaturated fatty acids. In: Unsaturated Fatty Acids: Nutritional and physiological significance: The Report of the British Nutrition Foundation's Task Force. London: Chapman & Hall; 1992:152-163.

      18. FAO/WHO Joint Expert Consultation. Lipids in early development. In: Fats and oils in human nutrition. Report of a joint expert consultation. Food and Agriculture Organization of the United Nations and the World Health Organization. FAO Food and Nutr Pap. 1994;57:49-55.

      19. Simopoulos AP, Leaf A, Salem N Jr. Workshop on the essentiality of and recommended dietary intakes for omega-6 and omega-3 fatty acids. J Am Coll Nutr. 1999;18:487-489.

      20. Koletzko B, Agostoni C, Carlson SE, et al. Long-chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.

      21. Ziegler EE, Fomon SJ. Methods in infant nutrition research: balance and growth studies. Acta Paediatr. Scand. Suppl. 1982;299:90-96.

      22. Data on file, Mead Johnson Nutritionals, April 2007.

      23. Richardson GG, Leary L, Halsey JF. Allergenicity of corn-derived carbohydrate ingredients for use in infant formulas [abstract]. Presentation at American College of Allergists 5th International Food Allergy Symposium. October 15-18,1984.

      24. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100. April 1, 2006.

      25. American Academy of Pediatrics, Committee on Nutrition. Iron fortification of infant formulas. Pediatrics. 1999;104:119-123.

      26. American Academy of Pediatrics, Committee on Nutrition. Soy protein-based formulas: recommendations for use in infant feeding. Pediatrics. 1998;101:148-153.

      27. Data on file, Mead Johnson Nutritionals, June 2004.

      28. Wheaton DH, Castañeda YS, Hoffman DR,et al. Biosafety of docosahexaenoic acid (DHA)/arachidonic acid (ARA) enriched infant formula fed for 9 months [abstract]. J Am Coll Nutr. 2003;22:469. Abstract 56.

      29. Carlson SE, Mehra S, Kagey WJ, et al. Growth and development of term infants fed formulas with docosahexaenoic acid (DHA) from algal oil or fish oil and arachidonic acid (ARA) from fungal oil [abstract]. Pediatr Res. 1999;45:278A. Abstract 1639.

      30. Clandinin MT, Van Aerde JE, Merkel KL, et al. Growth and development of preterm infants fed infant formulas containing docosahexaenoic acid and arachidonic acid. J Pediatr. 2005;146:461-468.

      31. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000041. Available at: http://www.cfsan.fda.gov/~rdb/opa-g041.html. Accessed April 19, 2007.

      32. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000080. Available at: http://www.cfsan.fda.gov/~rdb/opa-g080.html. Accessed April 19, 2007.

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