94 STAT. 1192 Exemptions.
Nutrient contents.
PUBLIC LAW 96-359—SEPT. 26, 1980
"(f)(1) Any infant formula which is represented and labeled for use by an infant— "(A) who has an inborn error of metabolism or a low birth weight, or "(B) who otherwise has an unusual medical or dietary problem, is exempt from the requirements of subsections (a) and (b). The manufacturer of an infant formula exempt under this paragraph shall, in the case of the exempt formula, be required to provide the notice required by subsection (c)(1) only with respect to adulteration or misbranding described in subsection (c)(1)(B), and to comply with the regulations prescribed by the Secretary under paragraph (2). "(2) The Secretary may by regulation establish terms and conditions for the exemption of an infant formula from the requirements of subsections (a) and (b). An exemption of an infant formula under paragraph (1) may be withdrawn by the Secretary if such formula is not in compliance with applicable terms and conditions prescribed under this paragraph. "(g) An infant formula shall contain nutrients in accordance with the table set out in this subsection or, if revised by the Secretary under subsection (a)(2), as so revised: "NUTRIENTS
Protein (gm) 1.8" 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: 750.0 (225 ug).' A (lU) 250.0 (75 ixg)' D (lU) 40.0 100.0. K(ug) 4.0 E (lU) 0.7 (with 0.7 lU/gm linoleic acid). C (ascorbic acid) (mg) 8.0 B, (thiamine) (jug) 40.0 Bj (riboflavin) (fxg) 60.0 Be (pyridoxine) (fxg) 35.0 (with 15 ixg/gm of protein in formula). B,2 i^ig)
Niacin (jug) Folic acid ifxg) Pantothenic acid (/a,g) Biotin {^lg} Choline (mg) Inositol (mg) Minerals: Calcium (mg) Phosphorus (mg) Magnesium (mg) Iron (mg) Iodine (ju,g) Zinc(mg) Copper (;xg) Manganese (fig) Sodium (mg) Potassium (mg) Chloride (mg)
0.15
250.0 4.0 300.0 1.5* 7.0" 4.0 50.0* 25.0* 6.0 0.15 5.0 0.5 60.0 5.0 20.0 80.0 55.0
60.0. 200.0. 150.0.
"Stated per 100 kilocalories. "The source of protein shall be at least nutritionally equivalent to casein. ' Retinol equivalents. " Required to be included in this amount only in formulas which are not milk-based. 'Calcium to phosphorus ratio must be no less than 11 nor more than 2.0."
�
