H.R. 9788: Formula Oversight, Regulation, and Manufacturing Uniformity for Life-sustaining Assurance Act of 2026

This bill would require the Secretary of Health and Human Services to set official limits on certain contaminants in infant formula. It would add a new federal standard saying that infant formula is considered adulterated if it does not meet those contaminant limits.

In practical terms, the bill would:

• Direct HHS to create regulations setting maximum allowable levels for contaminants in infant formula.
• Require those limits to be set as close as feasible to the lowest possible level, using the best available technology and other available methods, while taking cost into account.
• Require HHS to consider several factors when setting the limits, including:
  • the effects of low-level exposure on infant brain development,
  • how common the contaminant is in soil and water used in manufacturing, and
  • whether the contaminant builds up in the human body over time.
• Require infant formula manufacturers to test their products for compliance with the limits.
• Require manufacturers to keep testing records for at least two years after the formula’s shelf life ends, and to provide those records to HHS if requested.
• Define “contaminant” broadly to include man-made or human-introduced physical, chemical, biological, or radiological substances, including heavy metals, PFAS, phthalates, microplastics, synthetic pesticides, and certain biological toxins such as cyanotoxins from harmful algal blooms.
• Require HHS to include in its annual report to Congress a list of manufacturers found in violation, the contaminant levels found in routine testing, and an assessment of progress toward lower contaminant levels in the domestic supply chain.
• Require HHS to issue the implementing regulations within 180 days after enactment, and apply them to infant formula made starting 180 days after the regulations are issued.

Relevant Companies

• WMT - Walmart sells infant formula and could be affected by changes in formula availability, labeling, and supply compliance requirements.
• TGT - Target sells infant formula and could be affected by supply-chain or compliance changes affecting formula products.
• COST - Costco sells infant formula and could be affected if manufacturing or supply costs change.
• ABT - Abbott manufactures infant formula and would likely face direct compliance, testing, and reporting obligations.
• ENR - The parent of infant formula brands including Enfamil could be directly affected by new contaminant testing and manufacturing requirements.
• NSRGY - Nestlé markets infant formula products and could be directly affected by new federal contaminant standards and testing rules.