H.R. 8429 — Baby Food Safety Act of 2026

This section defines the term “infant or toddler food” under the Federal Food, Drug, and Cosmetic Act to mean food that purports to be, or is represented as being, for infants or children up to the age of 24 months. Such term does not include infant formula.

This section requires the Secretary of Health and Human Services (FDA), by administrative order, to establish limits on lead, cadmium, mercury, and arsenic in infant or toddler food and food predominantly composed of fruit or vegetable puree or juice, with proposed orders due by December 31, 2026, for lead and arsenic; April 30, 2027, for cadmium; and April 30, 2029, for mercury; and final orders 18 months after each proposed order. Such limits must reflect levels that may render food injurious to health, accounting for unavoidability via alternative ingredients, best manufacturing and agricultural practices, and nutrition labeling compliance under section 418 of the Federal Food, Drug, and Cosmetic Act; food exceeding limits is adulterated under section 402(j); the FDA may set additional contaminant limits if warranted, must review all limits every four years, and may revise them using a proposed order with 45-day public comment period (bypassing full APA rulemaking). (Thus, exceeding limits subjects products to FDA enforcement actions such as seizure or injunction.) This section further requires owners or operators of facilities manufacturing or processing such foods for U.S. consumption to implement, beginning 180 days after enactment, (1) control programs for these contaminants, (2) representative sampling of final products, and (3) testing per a written sampling and testing plan specifying units, sizes, and criteria for detecting levels.

This section directs the Secretary of Health and Human Services, acting through the FDA Commissioner in coordination with the FDA Human Foods Program and Center for Food Safety and Applied Nutrition, to finalize by January 20, 2027, an implementation plan for FDA compliance with the Food and Drug Administration rule titled “Requirements for Additional Traceability Records for Certain Foods” (87 Fed. Reg. 70910 (Nov. 21, 2022)) (or successor rule). The plan must describe (1) FDA resource needs, (2) strategies to facilitate compliance, and (3) detailed communication and education plans for regulated entities, non-Federal partners, and FDA staff. The section further requires the Secretary to conduct a study determining the annual number of facility inspections sufficient to ensure imported foods meet domestic safety standards—including consistency with targets in FDA's most recent annual food report under section 1003(h) of the Federal Food, Drug, and Cosmetic Act—and to submit a report to Congress on findings within one year of enactment, including any barriers to meeting inspection goals and a plan to achieve them within two years. In addition, the section amends FDA's annual food report under section 1003(h)(1) of the Federal Food, Drug, and Cosmetic Act by adding a new subparagraph (G) requiring information on the nature of domestic and foreign facility inspections, aggregate inspection findings, and foreign food importers' compliance rate with certification standards.

This section requires persons owning, operating, or serving as agents in charge of establishments engaged in manufacturing, processing, sampling, testing, packing, transporting, distributing, receiving, holding, or importing food—or in distributing/using animal feed bearing veterinary feed directive drugs or issuing such directives—to provide specified records to the FDA Secretary upon request, in advance of, at the time of, or in lieu of an in-person inspection (including when unsafe), within a reasonable timeframe/manner/limits and in electronic/physical form, at the person's expense. It further specifies that section 703 of the Federal Food, Drug, and Cosmetic Act—which generally governs examination of certain food shipment records—does not apply to records or information obtained under this authority.

This section expands FDA's mandatory recall authority under section 423(a) of the Federal Food, Drug, and Cosmetic Act to include any article of food adulterated under section 402(a)(1) (i.e., bearing or containing any poisonous or deleterious substance that may render it injurious to health) or 402(j) (i.e., prepared, packed, or held under insanitary conditions). (Thus, such adulterated foods are now subject to mandatory recall even if there is no reasonable probability of serious adverse health consequences or death to humans or animals.)