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Infant Formula: Evaluating the Safety of New Ingredients (2004)

Chapter: B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States

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Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×

B
Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States

Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×

TABLE B-1 Composition of Selected Formulas Marketed for Feeding to Term Infants in the United States

 

Milk-Based

 

Component

Lactose Free

Whey Predominant

Contain DHA and ARAa

Protein equivalent (g)

14

14–16

14

Fat (g)

31–37

36–37

36–37

Fatty acids

DHA (%)

NAb

NA

0.15

ARA (%)

NA

NA

0.40

Polyunsaturated (%)

22

Saturated (%)

45

Monounsaturated (%)

33–38

Linoleic (mg)

8,784

3,360–6,205

5,810–6,757

Carbohydrate (g)

72–74

71–81

73–74

Minerals

Calcium (mg)

550–568

423–527

527

Phosphorus (mg)

370–378

263–358

284–358

Magnesium (mg)

41–540

47–54

41–54

Iron (mg)

12

11–12

12

Zinc (mg)

5–7

4–7

5–7

Manganese (µg)

34–101

51–101

34–101

Copper (µg)

510–608

470–584

527–608

Iodine (µg)

61–101

11–68

41–68

Selenium (µg)

15–19

14–19

12–19

Sodium (mg)

200–203

148–182

162–182

Potassium (mg)

723–740

558–730

709–730

Chloride (mg)

439–450

376–431

426–439

Vitamins

Vitamin A (IU)

2,000–2027

2,016–2,190

2,027

Vitamin D (IU)

405–410

403–438

228–405

Vitamin E (IU)

14–20

9–15

10–13

Vitamin K (µg)

54

54–60

54

Thiamin (µg)

540–676

438–672

541–676

Riboflavin (µg)

950–1,014

946–1,008

946–1,014

Niacin (µg)

6,800–7,095

5,475–6,757

6,757–7,095

Vitamin B6 (µg)

405–410

405–548

405

Folic Acid (µg)

101–108

50–110

101–108

Vitamin B12 (µg)

2

1.3–2

2

Pantothenic acid (µg)

3,041–3,400

2,117–3,378

3,040–3,378

Biotin (µg)

20–30

15–35

20–30

Vitamin C (mg)

61–81

57–81

61–81

Other nutrients

Choline (mg)

81–108

81–101

81–108

Inositol (mg)

29–115

28–131

32–41

Nucleotides (mg)

28–34

Potential renal solute load (mOsm/L)

132–180

99–132

270

NOTE: Nutrient unit/L, unless otherwise noted.

aDHA = docosahexaenoic acid, ARA = arachidonic acid.

bNA = not applicable.

c—= not available.

SOURCE: Melanie Fairchild-Dzanis, personal communication, Nestle (August 26, 2002); IOM (1997, 1998, 2000, 2001, 2002, 2004); Mead Johnson Nutritionals (1999); Ross Products Division (2001), Anna Skulimowski, personal communication, Wyeth Nutrition (August 26, 2002, and December 11, 2002).

Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×

 

Human Milk

Adequate Intake (per day)

Isolated Soy-Protein Based

0–6 Months

7–12 Months

0–6 Months

7–12 Months

17–20

11.7

12.1

9.1

9.9

33–37

40

40

31

31

NA

1.58

1.58

0.5 g

0.5 g

NA

c

24

15.6

15.6

4.9 g

5.1 g

43

33

3,360–6,757

560

560

440

460

68–74

74

74

60

95

605–710

264

210

210

270

409–560

124

124

100

275

50–74

34

34

30

75

12

0.35

0.35

0.27

4–8

2.5

0.85

2.0

169–228

3.5

3.5

3

600

470–804

250

200

200

220

60–101

146

146

110

130

14–19

18

18

15

20

202–297

160

130

120

370

706–810

500

500

400

700

376–540

180

570

2,000–2,077

1,616

1,616

1,333

1,666

402–410

15.9 ± 8.6

15.9 ± 8.6

200

200

9–20

7.3

7.3

6

7.5

52–74

250

250

2

2.5

402–672

21 ± 0.04

21 ± 0.04

20

30

608–1,008

35

35

30

40

5,040–9,122

180

180

200

400

402–420

13

13

10

30

50–108

65

65

65

80

2–3

0.4

0.4

0.4

0.5

3,024–5,068

220

220

170

180

20–52

6

6

5

6

56–107

50

50

40

50

54–87

160

160

125

150

28–121

130–180

Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×

REFERENCES

IOM (Institute of Medicine). 1997. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington, DC: National Academy Press.

IOM. 1998. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academy Press.

IOM. 2000. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. Washington, DC: National Academy Press.

IOM. 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: National Academy Press.

IOM. 2002. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: National Academy Press.

IOM. 2004. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington, DC: The National Academies Press.


Mead Johnson Nutritionals. 1999. Pediatric Products Handbook. Evansville, IN: Mead Johnson.


Ross Products Division. 2001. Pediatric Nutritionals Product Guide. Columbus, OH: Ross Products Division/ Abbott Laboratories.

Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×
Page 179
Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×
Page 180
Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×
Page 181
Suggested Citation:"B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States." Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. doi: 10.17226/10935.
×
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Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants.

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