H.R. 7867 — Infant Formula Safety Modernization Act of 2026

This section amends Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) to enhance infant formula safety. Specifically, it (1) directs the Secretary of Health and Human Services, by regulation, to update good manufacturing practices (GMPs) to require pathogen and microorganism testing—including for Clostridium botulinum and others designated by the Food and Drug Administration (FDA)—of infant formula manufacturing facilities (including specified frequencies in Zones 2 and 3, i.e., areas adjacent to or within the processing environment where contamination risks exist) and finished products, with requirements for manufacturers to notify FDA of positive results in infant formula within one business day (even if undistributed), retain related records for inspections, and apply uniform FDA inspection and compliance standards to all products regardless of origin; (2) requires FDA to issue final regulations under these GMP updates within 90 days of enactment; (3) requires FDA to notify specified congressional committees (i.e., Appropriations and Energy and Commerce in the House; Appropriations and Health, Education, Labor, and Pensions in the Senate) within one business day of receiving manufacturer positive test notifications or issuing an "official action indicated" (or equivalent) classification after a facility inspection; and (4) makes a conforming amendment to reference the new GMP provision. (As background, current GMPs and quality control procedures for infant formula—which deem nonconforming products adulterated—require nutrient batch testing, shelf-life sampling, in-process controls, and audits to ensure nutritional adequacy and prevent contamination for this critical food source for infants.)