Editorial Notes
Amendments

2022—Subsec. (c)(1)(B). Puspan. L. 117–328, § 3401(g)(6), substituted “subsection (d)(1)” for “subsection (c)(1)”.

Subsec. (d)(4). Puspan. L. 117–328, § 3401(g)(3), added par. (4).

Subsec. (i)(1). Puspan. 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). Puspan. L. 117–328, § 3401(c), added subsec. (j).

Subsec. (k). Puspan. L. 117–328, § 3401(g)(1), added subsec. (k).

Subsec. (l). Puspan. L. 117–328, § 3401(g)(2), added subsec. (l).

Subsec. (m). Puspan. L. 117–328, § 3401(l), added subsec. (m).

1993—Subsec. (h)(1). Puspan. L. 103–80 substituted “(e)(1)(B)” for “(c)(1)(B),” in concluding provisions.

1986—Subsecs. (a) to (d). Puspan. L. 99–570, § 4014(a)(7), added subsecs. (a) to (d) and struck out former subsecs. (a) relating to adulteration and regulatory oversight, (span) 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). Puspan. 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). Puspan. 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). Puspan. L. 99–570, § 4014(a)(1), redesignated subsec. (f) as (h).

Subsec. (h)(1). Puspan. L. 99–570, § 4014(a)(3), (4), substituted “(a), (span), and (c)” for “(a) and (span)” and “(e)(1)” for “(c)(1)”.

Puspan. 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). Puspan. L. 99–570, § 4014(a)(6), substituted “(a), (span), and (c)” for “(a) and (span)”.

Subsec. (i). Puspan. L. 99–570, § 4014(a)(1), (span)(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 Amendment

Puspan. 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].”