Allowable levels of lead in certain baby and toddler foods should be set at 20 parts per billion or less, according to new draft guidelines released Tuesday by the US Food and Drug Administration.
“For babies and young children consuming the foods discussed in today’s draft guidance, the FDA estimates that these exposure levels could result in a reduction in exposure to lead from those foods by up to 24-27%,” said FDA Commissioner Dr . Robert Califf in a statement.
Baby food covered under the new proposal includes processed baby food sold in boxes, jars, pouches and tubs for babies and toddlers under the age of 2, the agency said.
While any action by the FDA is welcome, the proposed lead levels aren’t low enough to move the needle, said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates for reductions exposure of babies to neurotoxic chemicals.
“Almost all baby formulas on the market already conform to their recommendations,” said Houlihan, who authored a 2019 report that found dangerous levels of lead and other heavy metals in 95% of baby formulas manufactured.
That report sparked a 2021 congressional investigation that found leading baby formula manufacturers were knowingly selling products high in toxic metals.
“The FDA has not done enough to protect babies and young children from the harmful effects of lead with these proposed lead limits. There is no known safe level of lead exposure, and children are particularly at risk,” Houlihan said.
Consumers Reports’ director of food policy, Brian Ronholm, also expressed concerns. In 2018, Consumer Reports analyzed 50 baby formulas and found “concerning” levels of lead and other heavy metals. In fact, “15 of them would pose a risk to a child eating one serving or less per day,” according to Consumer Reports.
“The FDA should encourage the industry to work harder to reduce hazardous lead and other heavy metals in baby formula because young children are vulnerable to toxic exposures,” Ronholm said in a statement.
Lead, arsenic, cadmium and mercury are among the World Health Organization’s top 10 chemicals of concern for infants and children.
As natural elements, they are found in the soil where crops are grown and therefore cannot be avoided. However, some fields and regions contain more toxic levels than others, due in part to overuse of metal-based pesticides and ongoing industrial pollution.
The new FDA guideline suggests that manufactured baby foods puddings, fruits, food mixes — including grain- and meat-based mixes — puddings, vegetables, yogurts, and single-ingredient meats and vegetables contain no more than 10 parts per billion lead.
The exception to the above applies to single-ingredient root vegetables like carrots and sweet potatoes, which the new guidance should contain no more than 20 parts per billion.
Dry cereals marketed to babies and young children should also contain no more than 20 parts per billion lead, the new FDA guideline says.
However, the FDA hasn’t proposed a lead limit for granola puffs and teething cookies, Houlihan said, even though the products account for “7 of the 10 highest lead levels we found in over 1,000 baby food tests we evaluated.”
The limit set for root vegetables will help, Houlihan added. Because root vegetables grow underground, they can easily pick up heavy metals. For example, sweet potatoes often exceed the FDA’s proposed 20 parts per billion limit, she said.
Prior to this announcement, the FDA had only set limits for heavy metals in one baby formula — infant rice porridge, Houlihan said. In 2021, the agency set a 100 parts per billion limit for arsenic, which has been linked to adverse pregnancy outcomes and neurodevelopmental toxicity.
“The FDA needs to establish a boundary that protects children’s neurodevelopment,” Houlihan added.
“There are already so many solutions to reduce heavy metal levels in baby food. Businesses can require suppliers and producers to test and select ingredients with lower levels. Growers can use soil amendments, different farming methods and crop varieties that are known to reduce lead in their products,” she said.