Infant formulas

An infant formula, including an infant formula powder, shall be deemed to be adulterated if— The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for— During the manufacturing process or at the final product stage and before distribution of an infant formula, an infant formula shall be tested for all nutrients required to be included in such formula by subsection (i) for which testing has not been conducted pursuant to subparagraph (A) or (B). Testing under this subparagraph shall be conducted to— The Secretary shall by regulation establish requirements respecting the retention of records. Such requirements shall provide for— the retention of— No person shall introduce or deliver for introduction into interstate commerce any new infant formula unless— For purposes of paragraph (1), the term “new infant formula” includes— A person shall, with respect to any infant formula subject to subsection (c), make a submission to the Secretary which shall include— If the manufacturer of an infant formula has knowledge which reasonably supports the conclusion that an infant formula which has been processed by the manufacturer and which has left an establishment subject to the control of the manufacturer— If a recall of infant formula is begun by a manufacturer, the recall shall be carried out in accordance with such requirements as the Secretary shall prescribe under paragraph (2) and— Any infant formula which is represented and labeled for use by an infant— The Secretary may by regulation— NUTRIENTS Nutrient Minimum a Maximum a a Stated per 100 kilocalories. b The source of protein shall be at least nutritionally equivalent to casein. c Retinol equivalents. d Required to be included in this amount only in formulas which are not milk-based. e Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0. Protein (gm) 1.8 b 4.5. Fat: gm 3.3 6.0. percent cal 30.0 54.0. Essential fatty acids (linoleate): percent cal 2.7 mg 300.0 Vitamins: 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: 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. The waiver authority under this subsection shall remain in effect— 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. A notification under paragraph (1) shall include the following: Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information: 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. The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this chapter applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to— 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).