21 U.S.C. § 350a-1 Protecting Infants and Improving Formula Supply

• Library: United States Statutes
• Edition: 2023 Edition
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)

(a) Definitions

(1) In general

In this section, the term "infant formula" has the meaning given such term in section 201(z) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(z) ).

(2) Omitted

(b) Office of Critical Foods

(1) In general

The Secretary shall establish within the Center for Food Safety and Applied Nutrition an office to be known as the Office of Critical Foods. The Secretary shall appoint a Director to lead such Office.

(2) Duties

The Office of Critical Foods shall be responsible for oversight, coordination, and facilitation of activities related to critical foods, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 321(ss) ], as added by subsection (a)(2).

(c) Omitted

(d) Report

Not later than one year after December 29, 2022, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes-

(1) the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(d) ) each year since 2012;

(2) how many of such submissions received requests from the Secretary for additional information;

(3) how long after receiving such submissions the Secretary sent such requests for additional information;

(4) what additional information the Secretary requested of the persons submitting such submissions; and

(5) the date each new infant formula described in subparagraph (A) ¹ was first marketed, if available.

(e) Infant formula flexibilities

The Secretary shall publish a list on the website of the Department of Health and Human Services providing information on how to identify appropriate substitutes for infant formula products in shortage that are relied upon by infants and other individuals with inborn errors of metabolism or other serious health conditions.

(f) International harmonization of infant formula requirements

(1) In general

The Secretary-

(A) shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for infant formula, including with respect to inspections, labeling, and nutritional requirements; and

(B) may enter into arrangements or agreements regarding such requirements with other countries, as appropriate, including arrangements or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that manufacture infant formula for export to the United States.

(2) Study on infant formula

(A) In general

Not later than 60 days after December 29, 2022, the Secretary shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph as the "National Academies") to examine and report on challenges in supply, market competition, and regulation of infant formula in the United States.

(B) Contents of the report