FORMULA Act of 2026

Key Points

• The bill requires HHS to set legal maximum limits on contaminants like heavy metals, PFAS, microplastics, pesticides, and algae toxins in infant formula, and formula that exceeds those limits would be considered adulterated under federal law.
• Formula manufacturers would be required to regularly test their products for these contaminants and keep testing records for at least two years after the product's shelf life ends, making them available to regulators on request.
• HHS must publish an annual report naming manufacturers found in violation and listing the specific contaminant levels, including microplastics and cyanotoxins, found during routine testing, giving parents public visibility into formula safety.
• When setting the limits, regulators must weigh how contaminants build up in a baby's body over time and affect brain development, as well as how common these substances are in farm soil and manufacturing water sources.
• If enacted, HHS has 180 days to issue the new rules, and manufacturers get another 180 days after that before the limits actually apply to newly made formula, putting full compliance roughly a year after the bill becomes law.