This month has seen two important legal developments for the baby food and infant formula industries. On March 6, California Attorney General Rob Bonta issued an enforcement advisory to manufacturers and retailers of baby food sold in California.
Then, on March 11, Congresswoman Rosa DeLauro (D-CT3) introduced the Infant Formula Safety Modernization Act, which she said would "modernize federal oversight of the nation's infant formula supply and close longstanding gaps in testing, transparency, and regulatory enforcement."
We provide additional information on each below.
California enforcement advisory on compliance with baby food law
California law requires manufacturers of baby food that is sold or distributed in the state to comply with specific testing and consumer disclosure requirements for arsenic, cadmium, lead, and mercury. Additionally, if the manufacturer does not comply with the testing or disclosure requirements, the law prohibits any person or entity from delivering, holding, or offering the product for sale in California. The testing requirements have been in effect since January 2024, and the disclosure requirements have been in effect since January 2025. For context, the requirements are similar to those Illinois recently enacted, which we wrote about here.
This month, Attorney General Bonta issued an enforcement advisory to manufacturers and retailers of baby food sold in California. The advisory notes that the attorney general "may seek civil penalties, restitution, and injunctive relief, or pursue criminal liability" for noncompliance. The attorney general "urge[s] companies to assess their testing and disclosure practices for baby food products" to ensure compliance. The advisory is worth reviewing in full, as it provides a good overview of the testing and disclosure requirements.
Infant formula legislation introduced in Congress
Congresswoman DeLauro recently introduced the Infant Formula Safety Modernization Act. If enacted, the bill would, among other things:
- Direct FDA to develop a comprehensive list of pathogens and microorganisms that infant formula manufacturers must test for
- Mandate regular environmental testing inside infant formula facilities
- Require infant formula manufacturers to notify FDA of any positive pathogen test regardless of whether the formula has left the facility
The bill has received little media attention, and we have not seen evidence that it is likely to pass. However, infant formula safety is a bipartisan issue. We are closely monitoring for any signs that the bill might gain traction.
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Have any questions about current requirements for baby food or infant formula, or pending legislation? Venable's Food & Drug Law Group is ready to assist.