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Baby Food Makers Get FDA’s Proposed Lead Limits After Delay (1)

Jan. 24, 2023, 2:37 PMUpdated: Jan. 24, 2023, 5:57 PM

Fruits, vegetables, and some other foods for babies and young children shouldn’t contain lead in amounts higher than 10 parts per billion, under a limit proposed by the FDA Tuesday.

The Food and Drug Administration will use the proposed levels, once finalized, to determine whether or not to take enforcement action against baby food companies with products containing lead over that amount. The FDA initially planned to issue the draft action levels by April 2022, but did not send proposed levels to the White House’s Office of Management and Budget until that month. OMB didn’t complete its review of the draft guidance until Jan. 18.

The proposed levels come just weeks after Bloomberg Law published findings from a months-long investigation into the presence of toxic heavy metals in baby foods sold in the US. Out of 33 baby food products tested by an accredited laboratory, all but one contained at least two of three heavy metals: lead, arsenic, and cadmium.

“The proposed action levels announced today, along with our continued work with our state and federal partners, and with industry and growers to identify mitigation strategies, will result in long-term, meaningful and sustainable reductions in the exposure to this contaminant from foods,” FDA Commissioner Robert Califf said in a statement.

Read the Bloomberg Law investigation: Baby Foods With Toxic Metals Stay on US Market While FDA Dithers

Studies have shown that early childhood exposure to lead and other heavy metals can lead to lower IQ, slow development, and create other serious health issues.

A baby’s body treats lead like calcium, an element vital to neurological and bone development. When lead takes calcium’s place in a child’s brain, it can disrupt the communication between neurons and ultimately kill brain cells.

The FDA, as well as Congress and manufacturers, has long known about the dangers of heavy metals. Critics say the FDA isn’t moving fast enough to set guidance for baby food manufacturers.

But Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, has said the agency is moving “as fast as the speed of science.”

The draft guidance is “not intended to direct consumers in making food choices,” and parents and caregivers should “feed children a varied and nutrient-dense diet across and within the main food groups of vegetables, fruits, grains, dairy and protein foods,” Mayne said in a statement Tuesday.

“This approach helps your children get important nutrients and may reduce potential harmful effects from exposure to contaminants from foods that take up contaminants from the environment,” she added.

Lowering Lead

The draft action level of 10 ppb woud also apply to mixtures, including grain and meat-based mixtures, as well as yogurts, custards/puddings, and single-ingredient meats, according to the draft guidance.

For single-ingredient root vegetables and drug infant cereals, the FDA is proposing a lead draft action level of 20 ppb.

The FDA estimates that the proposals will result in lead exposure reductions for 90% of babies and young children by 26% in fruits, mixtures, and yogurts. The estimated reduction for children eating root vegetables is 27%, and dry infant cereals 24%, according to the FDA.

Action levels for grain-based snacks like puffs and teething biscuits weren’t included in the draft guidance. Multiple brands of teether crackers, puffs, and other baby food snacks tested by Bloomberg Law included levels of lead higher than 10 ppb.

The FDA said in its draft guidance that the agency analyzed grain-based snacks, but “is seeking additional information on this category of foods to inform whether an action level would be appropriate.”

Tom Neltner, the Environmental Defense Fund’s senior director for safer chemicals, said the proposed lead limits are “an important step forward,” and noted they go further than the European Union’s lead standard of 20 ppb in cereal-based baby foods. But he argued that more is needed to limit heavy metal exposure in all foods that young children may eat.

“These only apply to those things that are intended for babies and young children, but that doesn’t apply to the ingredients in the produce aisle,” Neltner said.

Scott Faber, senior vice president of government affairs at the Environmental Working Group, said the FDA’s proposal “sends an important signal to farmers and baby food companies to get to work.” He added, “more progress must be made, including changes in where and how we grow rice, potatoes, carrots and other ingredients in baby foods.”

Closer to Zero

The draft guidance is part of FDA’s Closer to Zero action plan, which the agency announced amid Congress’ probe into heavy metals in baby food in 2021. The only other guidelines issued under this action plan so far have been for lead in juices.

Before the agency launched Closer to Zero, it set the guidance for inorganic arsenic in infant rice cereal at 100 ppb in August 2020. Mayne said in an interview that the FDA “identified that as a priority based upon risk and based upon that particular exposure and started working with the industry moving towards establishing action levels.”

The FDA is proposing action levels in the form of guidance rather than regulations. Guidance, which consist of nonbinding recommendations, make enforcement by the agency optional.

FDA officials explained in 2020 guidance for manufacturers on inorganic arsenic in rice cereals that they set action levels instead of regulatory limits when technological or other changes might require adjustment of the amount of a substance allowed in the near future.

Next on the FDA’s agenda are draft action levels for arsenic in baby foods, beyond just infant rice cereal. The agency plans to propose these by April 2024. By that time or later, the FDA said it will issue draft levels for cadmium and mercury.

(Includes updated reporting throughout.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Cheryl Saenz at csaenz@bloombergindustry.com; Brent Bierman at bbierman@bloomberglaw.com; Gary Harki at gharki@bloombergindustry.com