Lead poisoning is one of the most frequent, but rarely spoken about, public health concerns for babies and young children. It is estimated that as many as 500,000 children (approximately 2.5% of the population under the age of six) in the United States have blood lead levels (BLL) greater than or equal to five micrograms per deciliter. The Centers for Disease Control and Prevention note that this is considered an elevated BLL and recommend that children with a BLL of 3.5 micrograms per deciliter or higher receive routine medical assessments. Lead poisoning or elevated BLLs have been linked to developmental delays, cognitive impairments, abdominal pain, neurologic changes, and irritability; at high levels, lead poisoning can be fatal. There is particular concern regarding lead poisoning in babies due to their developing brain and neurological system.
Lead exposure often comes from inhalation of dust from lead paint, ingestion of water that previously passed through lead pipes, and as recent studies have shown – lead-tainted food. The concern of lead-tainted baby foods became mainstream in 2019 when a study found that 95% of baby foods contained heavy metal contamination. In 2021, the Food and Drug Administration announced its “Closer to Zero” project with the goal of reducing exposure to contaminants in food eaten by babies and young children. The “Closer to Zero” initiative is still on ongoing, and on January 6, 2025, the FDA issued guidance on lead levels at which the FDA may regard the processed foods intended for babies and young children as adulterated under the Federal Food, Drug, and Cosmetic Act. The Federal Food, Drug, and Cosmetic Act notes that food shall be deemed adulterated for numerous reasons, and in the current guidance for baby food, would likely be due to it “contain[ing] any poisonous or deleterious substance which may render it injurious to health.” The FDA set its lead levels for various types of baby food as follows: no more than ten 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; 20 ppb for single-ingredient root vegetables; and 20 ppb for dry infant cereals.
This guidance is important for producers of processed foods intended for babies and young children, both for their manufacturing standards and their potential legal liability. These newly implemented standards will help protect the health and development of babies and young children but could also provide litigants with a clear standard to target food producers in toxic tort lawsuits stemming from injuries associated with lead poisoning or elevated blood lead levels. As the guidance has only recently been released by the FDA, there has not been sufficient time to study its effects on the potential uprising of lead-based toxic tort lawsuits, however, it is recommended that food manufacturers ensure they are compliant with the FDA’s provided lead levels to avoid entanglement in any potential waves of litigation.
Sources:
https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim
https://health.clevelandclinic.org/should-parents-be-worried-about-toxic-heavy-metals-in-baby-food
https://pmc.ncbi.nlm.nih.gov/articles/PMC5645046/
https://www.yalemedicine.org/conditions/lead-poisoning-in-children