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FDA Rolls Out Proposed Limits on Lead in Processed Baby Foods


The FDA on Tuesday unveiled recommended limits on lead levels in processed baby foods including fruits and vegetables, dry cereals, and yogurts, among others, with the potential for adverse neurodevelopmental effects cited as a particular concern.

In draft guidance for manufacturers of processed foods consumed by kids under 2 years of age, the agency stated that the action levels are intended to reduce the potential health effects from dietary exposures to the metal. Babies and young children are “more sensitive than adults to the neurodevelopmental effects of lead exposure,” the FDA said.

The draft guidance includes action levels of:

  • 10 parts per billion (ppb) for fruits and vegetables (excluding single-ingredient root vegetables)
  • 10 ppb for yogurts, custards, puddings, and “mixtures” (including grain- and meat-based products)
  • 10 ppb for single-ingredient meats
  • 20 ppb for single-ingredient root vegetables
  • 20 ppb for dry cereals

Although not binding for manufacturers, the agency said it “would consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case,” according to the statement.

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 “For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods.”

The newly released draft guidance is part of the agency’s “Closer to Zero” initiative, which outlines FDA’s approach to reducing exposure to lead, arsenic, cadmium, and mercury to the lowest levels possible when it comes to foods consumed by babies and young children.

In 2020, the FDA set a limit of 100 ppb for inorganic arsenic levels in infant rice cereals, for example, and in 2021 the agency said it was planning to limit other metals found in processed baby foods — the move followed a House of Representatives panel’s report of contamination of commercial baby foods with toxic heavy metals.

Action levels are one regulatory tool the agency has to help lower levels of chemical contaminants in food when a certain level is unavoidable, potentially as a result of environmental factors, the FDA stated. To identify proposed action levels for different categories of food, the agency considered factors including the level of lead that could be in a food without dietary exposure exceeding its interim reference level, which is a measure of the contribution of lead in food-to-blood lead levels.

It is not possible to entirely remove chemical elements from the food supply, the FDA said, given that foods take up contaminants from the environment as they do vital nutrients. However, the agency said that it expects the proposed action levels to spur manufacturers’ implementation of agricultural and processing measures that are aimed at lowering lead levels.

Susan Mayne, PhD, director of the FDA Center for Food Safety and Applied Nutrition, said in a statement that the proposed action levels are “not intended to direct consumers in making food choices.”

“To support child growth and development, we recommend parents and caregivers 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. “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.”

  • Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.



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