21 U.S.C. § 350a: Protecting infants and improving formula supply

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 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; how many of such submissions received requests from the Secretary for additional information; how long after receiving such submissions the Secretary sent such requests for additional information; what additional information the Secretary requested of the persons submitting such submissions; and the date each new infant formula described in subparagraph (A) 1 was first marketed, if available. 1 So in original. There is no subparagraph (A). 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. 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 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. 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. infant formula marketed in the United States; any challenges in supply, or market competition with respect to such infant formula; and any differences between infant formula marketed in the United States and infant formula marketed in the European Union, including with respect to nutritional content and applicable labeling and other regulatory requirements; and include recommendations, including for infant formula manufacturers, on measures to address supply and market competition in the United States. The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after December 29, 2022 , complete such study and submit a report on the results of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Not later than 1 year after December 29, 2022 , the Secretary shall issue guidance regarding information sponsors may consider including in submissions required under section 412(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(d) ), including considerations for meeting each of the requirements of paragraphs (1), (2), and (3) of subsection (d). 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. to identify and address any cause of, and contributing factor in, known or suspected adulteration or known or suspected misbranding; and if appropriate, to restore operation of the impacted facilities. In the case that a recall of the manufacturer’s infant formula products, and subsequent actions to respond to such recall, impacts over 10 percent of the production of the infant formula intended for sale in the United States, a plan to backfill the supply of the manufacturer’s infant formula supply if the current domestic supply of such infant formula has fallen, or is expected to fall, below the expected demand for the formula. 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. a breakdown of the specific types of formula involved; and an estimate of how long current supplies will last. actions to work with the impacted manufacturer or other manufacturers to increase production; and any additional authorities needed regarding production or importation to fill a supply gap; and any supplemental funding necessary to address the shortage. This subsection shall cease to have force or effect on September 30, 2026 . address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and safely restart production at the facility. 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 December 29, 2022 , and not less than once per calendar year thereafter, the Secretary shall conduct inspections, including unannounced inspections, of the facilities (including foreign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(c)(1)(A) ), in accordance with a risk-based approach and ensure timely and effective internal coordination and alignment among the Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition. In meeting the inspection requirements under this subsection, the Secretary may rely on inspections conducted by foreign regulatory authorities, under arrangements or agreements, and conducted by State agencies under contract, memoranda of understanding, or any other obligation. 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 December 29, 2022 , a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and information they need. assessing causes of any supply disruption or shortage of infant formula in existence as of December 29, 2022 , and potential causes of future supply disruptions and shortages; assessing and addressing immediate infant formula needs associated with the shortage; and developing a plan to increase infant formula supply, including through increased competition; and where and how to find infant formula; comparable infant formulas on the market; what to do if a specialty infant formula is unavailable; safe practices for handling infant formula; and other topics, as appropriate. outlining methods to improve information-sharing between the Federal Government and State and local governments, and other entities as appropriate, regarding shortages; recommending measures for protecting the integrity of the infant formula supply and preventing contamination; outlining methods to incentivize new infant formula manufacturers to increase supply and mitigate future shortages; and recommending other necessary authorities to gain insight into the supply chain and risk for shortages, and to incentivize new infant formula manufacturers. Canada; any country in the European Union; or any other country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.). is exclusively for personal use and will not be commercialized or promoted; and does not present an unreasonable risk to human health. 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. infant formula imported pursuant to paragraph (1) may not have been manufactured in a facility that has been inspected by the Food and Drug Administration; the labeling of such infant formula may not meet the standards and other requirements applicable with respect to infant formula under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.); and the nutritional content of infant formula imported pursuant to paragraph (1) may vary from that of infant formula meeting such standards and other requirements. It is the sense of Congress that persons considering the personal importation of infant formula should consult with their pediatrician about such importation.