WASHINGTON — The US Food and Drug Administration on Jan. 24 issued draft guidance proposing maximum levels for lead in processed foods intended for babies and children under age 2.
The level is 10 parts per billion for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings and single ingredient meats. The level is 20 ppb for root vegetables (single ingredient) and dry infant cereals.
“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,” said Robert M. Califf, MD, FDA commissioner. “For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24%-to-27% reduction in exposure to lead from these foods.”
The FDA plans to host a webinar and provide an overview of the draft guidance.
“We’re encouraged that the FDA has proposed these new standards, but clearly more needs to be done to limit exposure to toxic lead and protect babies and young children,” said Brian Ronholm, director of food policy for Consumers Reports. “The FDA should set strict limits on so-called baby junk food — grain-based snacks such as puffs, rusks and wafers — since those foods typically contain the highest levels of lead.”
Lead is especially harmful to vulnerable populations, including infants, young children, women who are pregnant and their fetuses, and those with chronic health conditions, according to the FDA. Lead exposure may harm children’s health and development, specifically the brain and nervous system.
Lead is present in the environment due to both its natural occurrence and to human activities. While recognizing it is not possible to remove the elements entirely form the food supply, the FDA said it expects the recommended action levels will cause manufacturers to implement agricultural and processing measures to lower lead levels in food products.
The FDA from 2014 to 2020 collected and analyzed 686 samples of processed foods intended for babies and young children. All food categories had mean lead concentrations below 10 ppb except for root vegetables, which had a mean concentration of 11.6 ppb.Electronic comments on the draft guidance may be given atwww.regulations.gov. Written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2022-D-0278.