An infant formula, including an infant formula powder, shall be deemed to be adulterated if-
In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained individuals who do not have any direct responsibility for the manufacture or production of infant formula.
For purposes of this paragraph, the term "major change" has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.
the manufacturer shall promptly notify the Secretary of such knowledge. If the Secretary determines that the infant formula presents a risk to human health, the manufacturer shall immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary.
is exempt from the requirements of subsections (a), (b), and (c). 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 (e)(1) only with respect to adulteration or misbranding described in subsection (e)(1)(B) and to comply with the regulations prescribed by the Secretary under paragraph (2).
NUTRIENTS | |||
Nutrient | Minimuma | Maximuma | |
Protein (gm) | 1.8b | 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) | 1.5d | ||
Choline (mg) | 7.0d | ||
Inositol (mg) | 4.0d | ||
Minerals: | |||
Calcium (mg) | 50.0e | ||
Phosphorus (mg) | 25.0e | ||
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. |
aStated per 100 kilocalories.
bThe source of protein shall be at least nutritionally equivalent to casein.
cRetinol equivalents.
dRequired to be included in this amount only in formulas which are not milk-based.
eCalcium to phosphorus ratio must be no less than 1.1 nor more than 2.0.
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).
21 U.S.C. § 350a
EDITORIAL NOTES
AMENDMENTS2022-Subsec. (c)(1)(B). Pub. L. 117-328, §3401(g)(6), substituted "subsection (d)(1)" for "subsection (c)(1)".Subsec. (d)(4). Pub. L. 117-328, §3401(g)(3), added par. (4).Subsec. (i)(1). Pub. L. 117-328, §3401(g)(4), substituted ",which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table" for "or, if revised by the Secretary under paragraph (2), as so revised".Subsec. (j). Pub. L. 117-328, §3401(c), added subsec. (j).Subsec. (k). Pub. L. 117-328, §3401(g)(1), added subsec. (k).Subsec. (l). Pub. L. 117-328, §3401(g)(2), added subsec. (l).Subsec. (m). Pub. L. 117-328, §3401(l), added subsec. (m). 1993-Subsec. (h)(1). Pub. L. 103-80 substituted "(e)(1)(B)" for "(c)(1)(B)," in concluding provisions. 1986-Subsecs. (a) to (d). Pub. L. 99-570, §4014(a)(7), added subsecs. (a) to (d) and struck out former subsecs. (a) relating to adulteration and regulatory oversight, (b) relating to notice to the Secretary by a manufacturer and requirements and scope of that notice, (c) relating to additional notice requirements for the manufacturer, and (d) relating to procedures applicable to recalls by a manufacturer. Subsecs. (e), (f). Pub. L. 99-570, §4014(a)(1), (7), added subsecs. (e) and (f) and redesignated former subsecs. (e) and (f) as (g) and (h), respectively.Subsec. (g). Pub. L. 99-570, §4014(a)(1), (2), redesignated subsec. (e) as (g) and substituted "Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula" for "No manufacturer shall be required under this subsection to retain any record respecting the distribution of an infant formula for a period of longer than 2 years from the date the record was made". Former subsec. (g) redesignated (i).Subsec. (h). Pub. L. 99-570, §4014(a)(1), redesignated subsec. (f) as (h). Subsec. (h)(1). Pub. L. 99-570, §4014(a)(3), (4), substituted "(a), (b), and (c)" for "(a) and (b)" and "(e)(1)" for "(c)(1)". Pub. L. 99-570, §4014(a)(5), which directed that "(d)(1)(B)" be substituted for "(e)(1)(B)" in second sentence could not be executed because "(e)(1)(B)" did not appear. See 1993 Amendment note above. Subsec. (h)(2). Pub. L. 99-570, §4014(a)(6), substituted "(a), (b), and (c)" for "(a) and (b)".Subsec. (i). Pub. L. 99-570, §4014(a)(1), (b) (1), redesignated subsec. (g) as (i), designated existing provisions as par. (1), substituted "paragraph (2)" for "subsection (a)(2) of this section", substituted a period for the colon after "as so revised", and added par. (2).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 1980 AMENDMENTPub. L. 96-359, §6, Sept. 26, 1980, 94 Stat. 1193, provided that: "Section 412 of the Federal Food, Drug, and Cosmetic Act (added by section 2) [this section] shall apply with respect to infant formulas manufactured on or after the 90th day after the date of the enactment of this Act [Sept. 26, 1980]."