Sec. 3401. Protecting infants and improving formula supply
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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) ). Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended by adding at the end the following: The term critical food means a food that is— an infant formula; or a medical food, as defined in section 5(b)(3) of the Orphan Drug Act. . 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, as added by subsection (a)(2). Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ) is amended by adding at the end the following: 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— for 90 days beginning on the date that the Secretary distributes information under section 424(a)(2) with respect to a shortage of infant formula; or such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula. . Not later than one year after the date of enactment of this Act, 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— 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)was first marketed, if available. 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. The Secretary— 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 the date of enactment of this Act, 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. The report developed pursuant to the agreement under subparagraph
(A)shall— assess and evaluate— 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 the date of enactment of this Act, 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. Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ), as amended by subsection (c), is further amended by adding at the end the following: 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: If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health. If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded. Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall. An initial estimate of the disruption in domestic production that may result from the recall. . Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ), as amended by paragraph (1), is further amended by adding at the end 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 number of submissions received by the Secretary under subsection (d). The number of such submissions that included any new ingredients that were not included in any infant formula already on the market. The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b). The time between any inspection referred to in subparagraph
(C)and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b). A breakdown of the information described in subparagraphs
(A)through
(D)between foreign and domestic manufacturers and facilities. 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, United States Code, or section 1905 of title 18, United States Code. . Section 412(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(d) ) is amended by adding at the end the following: The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission. . Section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(i) ) is amended by striking or, if revised by the Secretary under paragraph (2), as so revised and inserting the following: , 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 . Not later than 1 year after the date of enactment of this Act, 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). Section 412(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a(c)(1)(B) ) is amended by striking subsection (c)(1) and inserting subsection (d)(1) . 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. A submission under subparagraph
(A)shall include the following: A plan (including an estimated timeline, as applicable) of actions the manufacturer will take, suited to the individual circumstances of the particular recall, including— 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 report under subparagraph
(A)shall include the following: Information concerning the current domestic supply of infant formula, including— a breakdown of the specific types of formula involved; and an estimate of how long current supplies will last. If a submission or submissions under paragraph
(1)show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of infant formula intended for sale in the United States— actions to work with the impacted manufacturer or other manufacturers to increase production; and specification of— 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. Upon completing an inspection of an infant formula manufacturing facility impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide the manufacturer involved a list of any actions necessary to— 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 the date of enactment of this Act, 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 the date of enactment of this Act, 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. The national strategy under paragraph
(1)shall include efforts— to increase the resiliency of the infant formula supply chain in the short-term by— assessing causes of any supply disruption or shortage of infant formula in existence as of the date of enactment of this Act 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 to ensure the development and updating of education and communication materials for parents and caregivers that cover— 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. Not later than 90 days after the submission of the report described in subsection (f)(2), the Secretary shall update the national strategy under paragraph
(1)to include efforts to improve preparedness against infant formula shortages in the long-term by— 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. Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. ) is amended by adding at the end the following: A manufacturer of a critical food (as defined in section 201(ss)) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption. Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage. Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. In this subsection, the term meaningful disruption — means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection— may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment; may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 704. If a person fails to submit information required under, and in accordance with, subsection (a)— the Secretary shall issue a letter to such person informing such person of such failure; and not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)— the letter issued under subparagraph (A); and at the request of such person, any response to such letter such person submitted to the Secretary. If the Secretary determines that the letter under paragraph
(1)was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (a), the requirements of paragraph (1)(B) shall not apply. . Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ), as amended by subsection (f)(2), is further amended by adding at the end the following: The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this Act applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to— the importation of specialty infant formula from any 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 this Act; or the distribution and sale of such imported specialty infant formula. 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 Act 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). . Notwithstanding any provision of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ), during the 90-day period beginning on the date of enactment of this Act, an individual may, without prior notice to the Food and Drug Administration, import up to a 3-month supply of infant formula for personal use from— 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. ). Infant formula may be imported pursuant to paragraph
(1)only if the infant formula— 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. The Secretary, acting through the Commissioner of Food and Drugs, shall post on the public website of the Food and Drug Administration notice that— 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.
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Sec. 3401
Protecting infants and improving formula supply
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