A 2019 study found heavy metal contamination in 95% of baby food tested, with 73% showing the presence of arsenic, 94% lead, 75% had cadmium, and another 32% contained mercury. There are no current federally enforceable limits. These four heavy metals all have a unique significance: All are developmental neurotoxins. All four have been linked to IQ loss, ADHD, and autism spectrum disorder, with evidence spanning decades and at least twenty-three studies published in the past decade.

In 2016 the FDA’s Toxic Elements working Group proposed setting limits or issuing guidance on the maximum amount of inorganic arsenic that could be present in infant rice baby cereal. Further, the FDA proposed limiting the amount of inorganic arsenic in apple sauce in 2013 at 10ppb and limiting lead in fruit juice in 2004 to 50ppb (which is 3.3x higher than the regulation for drinking water and 10x that of bottled water) but has failed to set specific limits for metals in any other type of baby food.

The US House of Representatives Committee on Oversight and Reform issued a report in February 2021 titled, “Baby Foods are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury.” The American Academy of Pediatrics notes that, “toxic metal exposure can be harmful to the developing brain. It’s been linked with problems with learning, cognition, and behavior.” At the same time, the World Health Organization listed the heavy metals on their World Health Organization’s top 10 chemicals of concern for infants and children.

FDA Guidlines

In January 2023 the FDA announced draft guidance for reduction in levels of lead in food processed for baby under the age of 2 as part of the Closer to Zero initiative. These guidelines were finalized in January 2025 at 10ppb of lead.

MDL

MDL #3101: Northern District of California, Judge Jacqueline Scott Corley

Litigation Updates

A September 2024 CMO required defendants to disclose the results of heavy metals test performed between 2012-2021. In January 2025 Maryland joined California via ‘Rudy’s Law’ requiring manufacturers test their products for heavy metals starting in January 2026. The first state court trial is set for July 2025 in California state court.

Important Links

1. https://hbbf.org/sites/default/files/2022-12/BabyFoodReport_ENGLISH_R6_0.pdf
2. https://health.clevelandclinic.org/should-parents-be-worried-about-toxic-heavy-metals-in-baby-food
3. https://www.cnn.com/2022/08/11/health/homemade-baby-food-toxic-metals-wellness/index.html
4. https://www.health.harvard.edu/blog/heavy-metals-in-baby-food-what-parents-should-know-and-do-2021030522088
5. https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2021-02-04%20ECP%20Baby%20Food%20Staff%20Report.pdf
6. https://www.cnn.com/2025/01/06/health/lead-baby-food-fda-wellness/index.html
7. https://www.fda.gov/news-events/press-announcements/fda-announces-action-levels-lead-categories-processed-baby-foods
8. https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods
9. https://www.consumerreports.org/babies-kids/baby-food/fda-proposes-new-limits-for-lead-in-baby-foods-a2167994237/#:~:text=The%20Food%20and%20Drug%20Administration%20on%20Tuesday%20proposed%20new%20guidelines,on%20babies%20and%20developing%20children

MDL Link

1. https://cand.uscourts.gov/in-re-baby-food-products-liability-litigation/

Case Management Orders

• JPML Transfer Order
• Pretrial Order 1
• Pretrial Order 2
• Pretrial Order 3
• Pretrial Order 4
• Pretrial Order 5
• Pretrial Order 6
• Pretrial Order 7
• Pretrial Order 8
• Pretrial Order 9
• Pretrial Order 10