I 117th CONGRESS 2d Session H. R. 8038 IN THE HOUSE OF REPRESENTATIVES June 13, 2022 Mr. Johnson of South Dakota (for himself, Ms. Spanberger , Mrs. Bice of Oklahoma , and Ms. Schrier ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To authorize the Food and Drug Administration to require manufacturers of infant formula to warn about a discontinuance or interruption in the production of infant formula, and for other purposes.

1. Short title This Act may be cited as the Formula Shortage Reporting Act of 2022 . 2. Requirement to warn about discontinuance or interruption in the production of infant formula (a) In general Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ) is amended by adding at the end the following: (j) (1) A manufacturer of infant formula shall notify the Secretary, in accordance with paragraph (2), of a permanent discontinuance in the manufacture of the infant formula or an interruption of the manufacture of the infant formula that is likely to lead to a meaningful disruption in the supply of that infant formula in the United States, or a permanent discontinuance in the manufacture of an infant formula component or an interruption in the manufacture of an infant formula component that is likely to lead to a meaningful disruption in the supply of the infant formula component, and the reasons for such discontinuance or interruption. Notification under this subsection shall include disclosure of— (A) reasons for the discontinuance or interruption; (B) if an infant formula component is a reason for, or a risk factor in, such discontinuance or interruption, the source of the infant formula component and any alternative sources for the infant formula component known by the manufacturer; (C) whether any associated device used for preparation or administration included in the infant formula is a reason for, or a risk factor in, such discontinuance or interruption; (D) in the case of an interruption, the expected duration of the interruption; and (E) such other information as the Secretary may require. (2) A notice required under paragraph (1) shall be submitted to the Secretary— (A) at least 72 hours prior to the date of the discontinuance or interruption; or (B) if compliance with subparagraph (A) is not possible, as soon as practicable. (3) If a manufacturer of infant formula determines that compliance with paragraph (2)(A) is not possible, the manufacturer shall submit such determination in writing to the Secretary and the justification for such determination. (4) To the maximum extent practicable, the Secretary shall distribute to health care providers who treat pregnant women and children under the age of 2, and make publicly available on the website of the Food and Drug Administration, information on the discontinuance or interruption of the manufacture of the infant formula described in paragraph (1). (5) Nothing in this subsection shall be construed as authorizing 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. (6) The Secretary shall find a manufacturer of infant formula to be in violation of this section if— (A) the Secretary determines that— (i) the manufacturer has failed to submit the notice required by paragraph (2) and the determination and justification required by paragraph (3); or (ii) the determination and justification submitted by the manufacturer are insufficient; (B) the Secretary issues a letter to such manufacturer— (i) informing such manufacturer of such failure or insufficiency; and (ii) giving such manufacturer a period of not more than 30 calendar days to correct such failure or insufficiency; and (C) the Secretary determines such manufacturer has failed to correct such failure or insufficiency by the end of such period. (7) For purposes of this subsection— (A) the term infant formula component means a raw or in-process material, ingredient, container, or closure used in the manufacturing or processing of infant formula; (B) the term infant formula shortage or shortage , with respect to an infant formula, means a period of time when the demand or projected demand for the infant formula within the United States exceeds the supply of the infant formula; and (C) the term meaningful disruption — (i) means a change in production that is reasonably likely to lead to a reduction in the supply of an infant formula by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product; and (ii) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. . (b) Prohibited act Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (fff) The failure by a manufacturer of infant formula, with respect to a notice of discontinuance or interruption, to make a correction as required by section 412(j)(6)(C). .