NUTRIENTS |
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---|---|---|---|
Nutrient |
|
Minimum a |
Maximum a |
b The source of protein shall be at least nutritionally equivalent to casein. |
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d Required to be included in this amount only in formulas which are not milk-based. |
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e Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0. |
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Protein (gm) |
1.8 b |
4.5. |
|
Fat: |
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gm |
3.3 |
6.0. |
|
percent cal |
30.0 |
54.0. |
|
Essential fatty acids (linoleate): |
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percent cal |
2.7 |
|
|
mg |
300.0 |
|
|
Vitamins: |
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A (IU) |
250.0 |
(75 μg)c |
750.0 (225 μg).c |
D (IU) |
40.0 |
100.0. |
|
K (μg) |
4.0 |
|
|
E (IU) |
0.7 |
(with 0.7 IU/gm linoleic acid) |
|
C (ascorbic acid) (mg) |
8.0 |
|
|
B1 (thiamine) (μg) |
40.0 |
|
|
B2 (riboflavin) (μg) |
60.0 |
|
|
B6 (pyridoxine) (μg) |
35.0 |
(with 15 μg/gm of protein in formula) |
|
B12 (μg) |
0.15 |
|
|
Niacin (μg) |
250.0 |
|
|
Folic acid (μg) |
4.0 |
|
|
Pantothenic acid (μg) |
300.0 |
|
|
Biotin (μg) |
1.5 d |
|
|
Choline (mg) |
7.0 d |
|
|
Inositol (mg) |
4.0 d |
|
|
Minerals: |
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Calcium (mg) |
50.0 e |
|
|
Phosphorus (mg) |
25.0 e |
|
|
Magnesium (mg) |
6.0 |
|
|
Iron (mg) |
0.15 |
|
|
Iodine (μg) |
5.0 |
|
|
Zinc (mg) |
0.5 |
|
|
Copper (μg) |
60.0 |
|
|
Manganese (μg) |
5.0 |
|
|
Sodium (mg) |
20.0 |
60.0. |
|
Potassium (mg) |
80.0 |
200.0. |
|
Chloride (mg) |
55.0 |
150.0. |
The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula.
Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a notification of such recall.
The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.
Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and requirements under this chapter with respect to, specialty infant formula that is subject to a waiver under paragraph (1).
In this subsection, the term “specialty infant formula” means infant formula described in subsection (h)(1).