The FORMULA Act of 2026 aims to enhance the safety of infant formula by amending the Federal Food, Drug, and Cosmetic Act. It mandates the Secretary of Health and Human Services to establish maximum permissible levels for contaminants in infant formula through regulation. This includes a broad range of substances such as heavy metals, per- and polyfluoroalkyl substances (PFAS), phthalates, microplastics, synthetic pesticides, and biological toxins. The bill specifies that these contaminant levels must be set as close to the maximum contaminant level goal as feasible, utilizing the best available technology while considering cost. When determining these levels, the Secretary must consider the cumulative health impacts on infant neurodevelopment , the prevalence of contaminants in agricultural soil and manufacturing source-water, and their bioaccumulative nature in the human body. Furthermore, the legislation requires infant formula manufacturers to conduct rigorous testing to ensure compliance with these new standards and to maintain detailed records for at least two years beyond the product's shelf life. Any infant formula that does not meet the established maximum permissible levels will be deemed adulterated . The Secretary is also directed to provide an annual report to Congress, detailing violations, specific contaminant concentrations found during surveillance, and progress toward achieving the lowest feasible contaminant levels in the domestic supply chain. Regulations to implement these provisions must be issued within 180 days of the Act's enactment, applying to infant formula manufactured 180 days after their issuance.
Referred to the House Committee on Energy and Commerce.
Health
FORMULA Act of 2026
USA119th CongressHR-9788| House
| Updated: 7/20/2026
The FORMULA Act of 2026 aims to enhance the safety of infant formula by amending the Federal Food, Drug, and Cosmetic Act. It mandates the Secretary of Health and Human Services to establish maximum permissible levels for contaminants in infant formula through regulation. This includes a broad range of substances such as heavy metals, per- and polyfluoroalkyl substances (PFAS), phthalates, microplastics, synthetic pesticides, and biological toxins. The bill specifies that these contaminant levels must be set as close to the maximum contaminant level goal as feasible, utilizing the best available technology while considering cost. When determining these levels, the Secretary must consider the cumulative health impacts on infant neurodevelopment , the prevalence of contaminants in agricultural soil and manufacturing source-water, and their bioaccumulative nature in the human body. Furthermore, the legislation requires infant formula manufacturers to conduct rigorous testing to ensure compliance with these new standards and to maintain detailed records for at least two years beyond the product's shelf life. Any infant formula that does not meet the established maximum permissible levels will be deemed adulterated . The Secretary is also directed to provide an annual report to Congress, detailing violations, specific contaminant concentrations found during surveillance, and progress toward achieving the lowest feasible contaminant levels in the domestic supply chain. Regulations to implement these provisions must be issued within 180 days of the Act's enactment, applying to infant formula manufactured 180 days after their issuance.