Limits on Baby Food Lead Levels Established by FDA Due to Health Risks for Infants, Young Children

The new guidelines determine what the FDA considers to be an adulterated product, but are not legally enforceable against manufacturers.

Federal food regulators have introduced new standards aimed at preventing babies and young children from being exposed to high levels of lead in processed foods.

The U.S. Food and Drug Administration (FDA) issued a press release on January 6, announcing the finalization of new guidelines for lead in baby food. While the guidance is not legally enforceable, the FDA emphasized that it marks just one step in its broader efforts to combat childhood lead exposure. This initiative is part of the agency’s “Closer to Zero” program, a science-based strategy to minimize toxic elements in food.

Lead is a toxic heavy metal that can cause permanent brain damage, nervous system injuries, cognitive impairment, physical disabilities or other long-term health consequences. Children are particularly vulnerable to lead exposure, as they are still developing and do not usually show exposure signs or symptoms.

While short-term exposure can cause headaches, abdominal pain, vomiting or other minor symptoms, longer exposure may result in more severe symptoms, including lethargy, muscular weakness, confusion or tremors.

According to pediatricians, there is no safe lead exposure level for children, and any exposure may increase the risk of developing serious or permanent injuries, or even death.

The new FDA guidance establishes action levels for lead in processed baby foods and foods for young children. It sets a limit of 10 parts per billion (ppb) for fruits, vegetables, mixtures, yogurts, custards, puddings and single-ingredient meats, while single-ingredient root vegetables and dry infant cereals are capped at 20 ppb.

Although these action levels serve as a benchmark for determining whether a product may be considered adulterated, the guidance does not impose legally enforceable limits.

“In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” the press release states. “The use of the word ‘should’ in FDA guidances means that something is suggested or recommended, but not required.”

FDA officials indicate that they believe the new guidance could reduce lead exposure from baby food by as much as 29%.

Lead and Heavy Metals in Baby Food

Concerns over elevated levels of lead and other heavy metals in childrens food products were first raised in April 2021, after a Congressional report on baby food heavy metal contamination found that some food manufacturers sold products that contained more than 177 times the allowable levels of lead in bottled water, as well as 91 times the maximum level of arsenic, 69 times the limits on cadmium and five times the levels of allowable mercury.

Despite calls from health experts and regulators for manufacturers to entirely remove the contaminants from their products, subsequent testing has found that toxic heavy metals in baby food remain a pervasive problem, with a report published last year finding that popular brands sold by Gerber, Plum Organics, Sprout, Walmart and others still have potentially dangerous levels.

The report has led to dozens of families throughout the U.S. pursuing toxic baby food lawsuits against Gerber, Nurture, Beech-Nut and manufacturers of other popular baby food brands, which have been found to contain high levels of lead, arsenic, cadmium and mercury, alleging that children developed life-long disabilities after consuming the toxic metals.

January 2025 Toxic Baby Food Lawsuits Update

Given common questions of fact and law raised in complaints brought throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a toxic baby food lawsuit MDL in April 2024, centralizing claims before U.S. District Judge Jacqueline Scott Corley in the Northern District of California for coordinated discovery and pretrial proceedings.

Judge Corley is currently working to resolve issues of general causation, which requires proving that toxic baby food products can scientifically cause the types of injuries parents are reporting.

After general causation issues are resolved, if the Court determines that plaintiffs have sufficient evidence establishing that toxic metals in the baby food can cause autism or ADHD, it is expected that Judge Corley will schedule a series of “bellwether” trials in the MDL, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims.

In addition to the federal litigation, there are also a number of toxic baby food lawsuits pending in California state court, where it is expected that the first trial may begin sometime in 2025. While the outcome of that trial will not have any binding impact on other claims, it will be closely watched as any jury payout awarded may influence how much the manufacturers need to pay in autism or ADHD settlements to resolve the litigation.

The next case management conference in the toxic baby food lawsuits is currently set for January 23, and the parties have been directed to submit an updated statement by at least January 21.