Joint Coalition Letter: AB 2302 Infant Formula Sign-on Letter

Final.AB2302. Infant Formula Sign-on Letter+Signatures.pdf

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Support Dear Chair Bonta,  

On behalf of our members and supporters, the undersigned organizations write today to  enthusiastically support AB 2302 (C. Rodriguez), Food Safety: Infant Formula. With our  collective expertise in children’s health, environmental health, and consumer safety, we urge the  California Legislature to take this critical step in protecting babies from heavy metal  contaminants in the infant formula they rely on to thrive.  

Background and Context 

For many babies, infant formula is an important food that sustains their healthy growth. Four in  10 California infants are exclusively fed formula by the age of 6 months. Even among California  infants who are primarily breast-fed, nearly 1 in 5 also received formula in the first two days of  their lives.¹ Babies in households with lower incomes are more likely to be fed formula than  babies in households with incomes above 200% of the poverty line.² 

Federal Regulation of Infant Formula 

Infant formula is regulated by the United States Food and Drug Administration (FDA) and the  United States Department of Health and Human Services (HHS). Existing federal regulations  and requirements for manufacturing practice, quality control procedures, and quality factors for  infant formula are more focused on the prevention of contaminants such as microbes, glass,  and sanitizing agents, rather than on the presence of heavy metals.³ The FDA has not set  safety levels for heavy metals in infant formula.⁴ This is particularly concerning given that  experts at the American Academy of Pediatrics state that there is no safe level of lead exposure  in children, and that even low levels of exposure have been shown to impair cognition and  neurodevelopment.⁵ Arsenic exposure is also linked to harmful effects on neurodevelopment  and increased risk of cancer, and early life exposures are especially dangerous for children.⁶ 

¹ U.S. Centers for Disease Control 2022 Breastfeeding Report Card. https://www.cdc.gov/breastfeeding data/media/pdfs/2024/06/2022-Breastfeeding-Report-Card-508.pdf 

² California Department of Public Health Perinatal/Infant Data Dashboards.  

https://www.cdph.ca.gov/Programs/CFH/DMCAH/surveillance/Pages/Breastfeeding-Intention-and-Duration.aspx ³ U.S. Food and Drug Administration Compliance Program Manual--Program 7321.006--Infant Formula--Inspection, Sample,  Collection and Examination. https://www.fda.gov/media/71695/download?attachment 

⁴ Food and Drug Administration Expert Panel on Infant Formula: Regulatory and Safety (June 2025.  https://advances.nutrition.org/article/S2161-8313(25)00222-4/fulltext 

⁵ American Academy of Pediatrics—Lead Exposure in Children. https://www.aap.org/en/patient-care/lead-exposure/lead-exposure in-children/ 

⁶ American Academy of Pediatrics—Arsenic Exposure. https://www.aap.org/en/patient-care/environmental-health/promoting healthy-environments-for-children/arsenic/

Prevalence of Heavy Metals in Infant Formula 

In March 2025, Consumer Reports published a report after testing 41 types of powdered infant  formula for toxic chemicals, including heavy metals. At least half of the samples tested  contained potentially harmful levels of at least one contaminant. For example, more than 20% of  the formulas tested contained levels of arsenic close to or above the identified hazard quotient  limit. The highest level of arsenic detected was almost double the FDA’s limit for arsenic in  bottled water.⁷ 

The findings from Consumer Reports are very concerning; however, they also show that many  formula manufacturers are successfully producing safer alternatives with no or low levels of the  identified contaminants. The largest manufacturers—constituting nearly 80% of the national  market—all had formula products in both the “best choices” (no or low levels of contaminants)  and “worst choices” (levels of contaminants over daily limits) categories, demonstrating that they  are currently capable of producing formulas without concerning levels of harmful contaminants.⁸ 

California as a Leader in Keeping Babies Safe 

California has already set a precedent for raising standards for regulation of heavy metals in  infant formula. In 2022, the California Attorney General’s office reached a settlement with  formula manufacturer Perrigo to improve the safety of the company’s infant formula products,  after levels of lead exceeding the Proposition 65 warning threshold were detected in the  company’s products.⁹ The settlement requires Perrigo to conduct annual testing of  representative production lots of infant formula to confirm that the maximum lead level outlined  in the settlement is not exceeded. In 2024, the Attorney General’s office reached a similar  settlement with Mead Johnson.¹⁰ This bill would build on those efforts by providing an industry wide solution. 

We urge you to support AB 2302 to protect California babies from harmful heavy metals in the  formula they rely upon to grow and thrive. This will empower parents and caregivers to make  informed choices about the formula that they feed to their babies. It will also provide  pediatricians with valuable data to inform their recommendations to patients. 

Sincerely, 

Below-signed organizations  ( See Attachment)

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