H.R. 2472 — INFANTS Act of 2025

This section establishes a definition of “infant and toddler food” under the Federal Food, Drug, and Cosmetic Act as food that purports to be or is represented as food for children up to 24 months of age, including infant formula.

This section establishes sampling, testing, recordkeeping, and records-access requirements for contaminants in food manufactured or processed in final product form by food facilities for sale to consumers. Specifically, it requires such facilities to (1) collect representative samples and test them at least quarterly for lead, cadmium, mercury, arsenic, and other toxic elements specified by FDA regulation, per a written sampling plan (with FDA guidance due within 18 months of enactment); (2) apply these requirements to infant and toddler foods in final package form and other foods specified by FDA regulation; (3) maintain detailed records for at least two years or the food's shelf life (whichever is longer), regardless of test results; (4) use internationally accredited laboratories (exempt from requirements in section 422 of the Federal Food, Drug, and Cosmetic Act); and (5) provide records to FDA upon request, including in lieu of inspection. The requirements apply beginning 180 days after FDA publishes the required guidance.

This section establishes a new basis for deeming food adulterated if it is manufactured or processed at a food facility whose owner, operator, or agent in charge is subject to and fails to comply with the requirements of section 425 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). (As background, section 425—enacted under the FDA Food Safety Modernization Act—requires registered food facilities to implement a hazard analysis and risk-based preventive controls plan, including sanitation controls and supply-chain programs, to minimize food safety hazards.) (Thus, such non-compliance deems the food adulterated regardless of whether it is actually injurious to health.)

This section amends FDA inspection authorities by requiring persons owning or operating establishments engaged in (1) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing food or (2) distributing or using animal feed bearing or containing a veterinary feed directive drug (i.e., certain animal drugs requiring veterinary authorization) or issuing such directives to provide specified records to the Secretary, upon request, in advance of or in lieu of an inspection, within a reasonable timeframe, in electronic or physical form, and at their expense. The section further provides that confidentiality protections of section 703 do not apply to such requests. (Thus, FDA may conduct remote record reviews for these facilities without physical entry.)

This section expands FDA mandatory recall authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include infant and toddler foods (other than infant formula) determined through any means to bear or contain a contaminant rendering them adulterated under FD&C Act section 402(a)(1) (i.e., poisonous or deleterious substances that may be injurious to health). (Previously, the Secretary was required to offer voluntary recall only for other articles of food (other than infant formula) with a reasonable probability of causing serious adverse health consequences or death due to adulteration under section 342 or misbranding under section 343(w).)

This section revises manufacturer notification requirements to the Secretary for potentially adulterated infant formula under subsection (e) as follows: (1) requires notification within 24 hours of acquiring knowledge that an infant formula may be adulterated and has left the manufacturer's control (from promptly); (2) requires, for confirmed positive analytical results for any environmental pathogen (as defined in 21 CFR 117.3 or successor regulation) from in-process or finished product testing of infant formula, notification within 24 hours regardless of whether the product has left the manufacturer's control, consultation with the Secretary on proper disposal and disposal of the affected product, and provision to the Secretary of results and isolates from the positive sample; and (3) directs the Secretary to confirm, not later than 90 days after receiving a notification under paragraph (1) or (2), via documentation provided during inspection or upon request, that the manufacturer performed or is performing appropriate corrective action. (Thus, these changes expedite and expand FDA notifications for infant formula contamination risks, including pathogens such as Listeria or Salmonella that pose severe threats to infants.)

This section establishes requirements under the Federal Food, Drug, and Cosmetic Act for manufacturers of powdered infant formula to implement a written environmental monitoring program to verify the effectiveness of sanitation and hygiene controls against potential exposure to Cronobacter spp. or Salmonella, including adequate procedures for sampling locations, number of samples, timing, and frequency of collection and testing. The section further requires manufacturers to maintain related records for at least two years or the shelf life of the formula (whichever is longer), make them available to the Secretary of Health and Human Services promptly upon request (including in advance of inspections, electronically or physically, at the manufacturer's expense, with Secretary confirmation of receipt), and clarifies that these requirements do not limit the Secretary's other inspection authorities or exempt compliance with existing infant formula standards. The requirements apply beginning 180 days after enactment.