This article was co-written by Madeleine Clavier, Associate Attorney and Elisa Detloff, Director of Litigation Management 

On January 6, 2025, the Food and Drug Administration released final details on the maximum amount of lead processed baby foods can contain, a move that would reduce early exposure to the heavy metal and set parameters for potential enforcement actions against manufacturers that sell baby food with excess lead levels. The guidance is part of the FDA's Closer to Zero initiative, which aims to lower children's exposure to heavy metals and other harmful chemicals in their food.

The FDA uses "action levels" to help reduce harmful chemicals in foods when it's not possible to completely avoid them. Action levels reflect a “level at which [FDA] may regard the food as adulterated.” The action levels set for lead in processed baby food were set at 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats; and 20 ppb for root vegetables (single ingredient) and dry infant cereals. The new rules do not apply to infant formula, drinks, or snacks.

In adopting its action level for lead, FDA highlighted the ways baby food manufacturers can act to lower the lead levels in baby food including selectively sourcing ingredients with low or nondetectable lead levels, washing and peeling raw agricultural ingredients used in baby food products, ensuring that manufacturing and processing facilities are not contributing to lead contamination, and testing for lead in baby foods. Additionally, FDA stated, “Even low lead exposure can harm children's health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavioral difficulties, and lowered IQ…Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

The FDA's new action levels come after years of concern about heavy metals in baby food. In 2021, the Subcommittee on Economic and Consumer Policy, which is part of the U.S. House of Representatives' Committee on Oversight and Reform, released two reports after investigating heavy metals in baby and children's food. The reports included test results and internal documents from seven major baby food companies. The Subcommittee found lead in some products at levels as high as 641 parts per billion (ppb), which is over 60 times higher than the amount allowed in the new FDA guidelines. Other dangerous neurotoxins found in baby food products made by major baby food brands included arsenic, cadmium, and mercury.

These new action levels also come as dozens of lawsuits have been brought against baby food manufacturers for alleged harms caused by lead in their products. Baby food manufacturers Gerber Products Co., Hain Celestial Group Inc., Beech-Nut Nutrition Co., Sprout Foods, Inc., Plum PBC, Nurture, Inc., and Walmart face consolidated litigation in the Northern District of California before the Honorable Jacqueline Scott Corley alleging that their products caused autism and/or ADHD because of the high levels of heavy metals, including lead that their products contain. Wagstaff Law Firm partner Aimee Wagstaff is co-lead of the consolidated litigation. Wagstaff Law Firm associate Madeleine Clavier serves on the Plaintiffs' Steering Committee. Additionally, in the last year, two states, California and Maryland, have adopted laws that require baby food manufacturers to test for lead and other heavy metal levels in their baby food products and make the results of those tests available to the public. The new action levels are meant to encourage companies to gradually lower the amount of heavy metals in baby and young children's food products. The FDA has stated that these action levels are achievable when manufacturers take steps to minimize the presence of lead in baby food.

If you have any questions about the lawsuits about heavy metals in baby food, or if your child has been diagnosed with Autism Spectrum Disorder (ASD) after consuming these products, reach out to Wagstaff Law Firm at 303-376-6360 for a confidential and free consultation.