United States Code
USC most recently checked for updates: Mar 01, 2024
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)).
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.
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).
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.
Not later than 60 days after
The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after
Not later than 1 year after
Promptly after the initiation of a recall of infant formula, the manufacturer of the recalled infant formula shall submit information to the Secretary regarding such recall.
Promptly after a submission under paragraph (1) is received, the Secretary shall provide such submission, together with the information specified in subparagraph (B), in 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.
This subsection shall cease to have force or effect on
Not later than 7 days after receiving a written communication from a manufacturer of infant formula containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufacturing of an infant formula impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide a substantive response to such communication concerning the sufficiency of the proposed corrective actions.
The Secretary shall ensure timely communication with a manufacturer of infant formula following an inspection of a facility engaged in the manufacturing of infant formula for consumption in the United States. If a reinspection of a manufacturer of an infant formula is required to ensure that such manufacturer completed any remediation actions or addressed any deficiencies, the Secretary shall reinspect such facility in a timely manner. The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an infant formula.
Not later than 6 months after
The Secretary, in consultation with the Secretary of Agriculture and other heads of relevant departments and agencies, shall develop and issue, not later than 90 days after
If a health care provider becomes aware of any adverse event which the health care provider reasonably suspects to be associated with infant formula imported pursuant to paragraph (1), the health care provider shall report such adverse event to the Commissioner of Food and Drugs.
It is the sense of Congress that persons considering the personal importation of infant formula should consult with their pediatrician about such importation.