H.R. 8010 — Introduced in House

I 117th CONGRESS 2d Session H. R. 8010 IN THE HOUSE OF REPRESENTATIVES June 9, 2022Mr. Guthrie (for himself, Mr. Griffith, Mr. McKinley, Mr. Armstrong, Mr. Joyce of Pennsylvania, Mr. Bucshon, Mr. Dunn, Mr. Carter of Georgia, and Mr. Bilirakis) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to act upon pending submissions for new infant formula, to increase regulatory flexibility in the event of an infant formula shortage, and for other purposes. 1. Short title This Act may be cited as the More Options for Infants and Parents Act of 2022. 2. Pending submissions for new infant formula Not later than 14 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall act upon any pending submissions from domestic manufacturers for new infant formula under section 412(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)). 3. Regulatory flexibility in the event of an infant formula shortage 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) Regulatory flexibility in the event of a shortage (1) List of products for substitution during a shortage The Secretary shall publish and keep up-to-date a list on the internet website of the Food and Drug Administration detailing which infant formula products may be appropriate substitutes for infant formula products— (A) which the Secretary has determined to be in shortage or at risk of being in shortage; and (B) that are relied upon by infants and individuals with amino-acid and metabolic conditions. (2) Flexibilities The Secretary— (A) shall consider whether any infant formula products may be substituted for those in shortage; and (B) may waive any applicable requirements under section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) regarding labeling and nutrient content to facilitate such substitutions. .