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FDA proposes limits on lead in baby foods

January 24, 2023

The Food and Drug Administration (FDA) has issued draft guidance for manufacturers intended to lower the amount of lead in processed baby foods.

While lead can’t be removed entirely from the food supply, the FDA estimates its new action levels could result in about a 25% reduction in exposure.

Lead exposure has been associated with health, learning and behavior problems, and there is no known safe level.

“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 M. Califf, M.D., said in a statement.

The draft guidance calls for action levels of 10 parts per billion (ppb) for lead in processed fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures) and yogurts. The proposed action level would be 20 ppb for dry cereals and single-ingredient root vegetables. Even if finalized, however, the action levels are not binding for manufacturers.

A report last year from Healthy Babies Bright Futures found 94% of commercial baby food and 94% of homemade purees and family brands tested had detectable levels of heavy metals.

The AAP has long been calling for swift, comprehensive federal regulation of heavy metals in foods babies eat. It has implored the FDA to ensure its approach is science-driven and takes into account potential unintended impacts on parents’ ability to purchase safe, nutritious foods.

The FDA’s proposed lead limits are part of its Closer to Zero initiative, which aims to lower the levels of arsenic, lead, cadmium and mercury in baby foods. The proposal comes on the heels of limits set in 2020 on inorganic arsenic in infant rice cereal and proposed lower lead levels for juice released in 2022.

The AAP and FDA stress the importance of infants eating a variety of healthy foods. AAP experts recommend reducing exposure to heavy metals by washing fruits and vegetables and peeling those that can be peeled. Arsenic in rice can be reduced by draining some of the water instead of cooking rice until all the water is absorbed. Breastfeeding, avoiding fruit juice, making healthy fish choices, addressing lead hazards in the home and not smoking or vaping also can reduce heavy metal exposures, according to

The FDA is accepting comments on the proposed guidance on lead in baby food until March 27. Comments can be submitted at referencing docket number FDA-2022-D-0278.




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