FDA Proposes New Baby Food Lead Limits Amid Continuing Concerns About Autism, ADHD and Other Risks from Metals in Baby Food

Nearly two years after a Congressional report identified four different types of toxic metals in baby food products sold by a number of different companies, which have been blamed for causing autism and ADHD in a number of children, federal health officials have announced new draft guidance about the allowable levels of lead in food products intended for children under the age of two.

The U.S. Food and Drug Administration (FDA) announced new action levels for lead in baby food on January 24, further advancing goals set forth in the agency’s Closer to Zero program, which seeks to eliminate toxic levels of metal in baby food.

The guidance comes as a number of families are pursuing baby food lawsuits against Gerber, Beech-Nut and other well-known manufacturers, alleging that their children developed ADHD or autism from lead, arsenic, cadmium and mercury metals that have been found in baby food products, claiming that the companies have failed to properly source and screen ingredients in baby food for harmful levels of heavy metals.

FDA Sets Action Levels for Lead in Baby Food

In what is being seen as the first substantial step toward making baby food safer under the FDA’s 2021 “Closer to Zero” plan, officials have issued the draft guidance for the baby food industry on action levels for lead in processed foods intended for babies and children under two years of age.

If finalized, the draft guidance will set lead limits in baby food at:

• 10 parts per billion (ppb) for fruits, vegetables, mixtures, yogurts, custards, puddings and single-ingredient meats.
• 20 ppb for root vegetables
• 20 ppb for dry cereals

“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods”, said FDA Commissioner Robert M. Califf.

In April 2022, the FDA issued a draft guidance for the actionable levels of lead in juice, which if finalized would replace the outdated 2004 limit of 50 ppb to;

• 10 ppb of lead for apple juice on a single-strength (ready-to-drink) basis
• 20 ppb of lead for other single-strength juice types, including juice blends that contain apple juice

The announcement states the agency continues to work towards reducing the levels of all heavy metals in children’s products, and will be shifting its focus to create science-backed action levels for arsenic, cadmium and mercury in baby food products next.

While some critics claim the FDA is not being strict enough on the industry, since the action levels are not binding, the agency has maintained that providing action levels gives them opportunity to bring enforcement action against manufacturers exceeding pre-assigned limits.

January 2023 Toxic Baby Food Lawsuits Update

Concerns over toxic heavy metals were first publicly raised in February 2021, following the release of Congressional report that found many baby food products manufactured and sold by Gerber, Beech-Nut Nutrition, Plum, Hain, Campbell, Walmart, Sprout and others contained one or more heavy metals including arsenic, lead, cadmium and mercury, which may increase the risk of autism or ADHD in children.

Since early 2021, a series of baby food autism lawsuits and baby food ADHD lawsuits have been filed by parents claiming manufacturers marketed baby foods containing toxic substances as safe for infants and children without disclosing known metal contamination risks.

While a series of plaintiff’s sought to consolidate the growing number of baby food lawsuits being filed in various U.S. District Courts in to single multi-district litigation, the U.S. Judicial Panel on Multidistrict Litigation (JPML) denied the request, stating the cases would be better handled individually, since allegations raised in the lawsuits are specific to the levels of different metals in baby food products offered by different manufacturers.

Since the ruling, families are continuing to file lawsuits against baby food manufacturers in their own jurisdiction, Product liability lawyers are pursuing toxic baby food lawsuits for families of children currently under the age of 15, who were fed the contaminated brands for at least one year, and developed any of the following injuries:

• Autism diagnosed between ages of 2 and 14
• Severe ADHD diagnosed between ages of 8 and 14