On January 24, FDA unveiled a draft guidance for manufacturers to reduce lead levels in processed foods intended for children younger than 2 years of age. The move was made as part of FDA’s Closer to Zero program, which was created to help reduce young children’s exposure to lead, arsenic, cadmium, and mercury to the lowest levels possible.
“For more than 30 years, the FDA has been working to reduce exposure to lead, and other environmental contaminants, from foods,” Robert M. Califf, FDA’s Commissioner, said in 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 “For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24% to 27% reduction in exposure to lead from these foods.”
Known as Action Levels for Lead in Food Intended for Babies and Young Children, the draft guidance calls for manufacturers to set new action levels of 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats; 20 ppb for root vegetables; and 20 ppb for dry cereals.
Although not binding under law, FDA could take these action levels into account when considering whether to bring enforcement action in a particular case.
Vineet Dubey, an environmental attorney based in Los Angeles, has been fighting to reduce lead levels in baby food for several years, pushing for the federal government to set levels for heavy metals in baby food, whether it be through the Closer To Zero effort or the Baby Food Safety Act. He does not believe the new draft guidance will affect much change, as the levels set forth by the proposal are not a mandate and there are no strict penalties for noncompliance. “The FDA’s own words point out that these proposed lead limits are not ‘legally enforceable responsibilities.’ In other words, consumers should continue to trust baby food makers to do the right thing, which is how we got here in the first place,” he says. “The FDA and Congress need to stop paying lip service about limiting baby and toddler exposure to excessive amounts of lead that’s in the processed food most American parents feed their kids.”
It should be noted that the timeline for FDA to release a draft guidance document is far less than the typical rule-making procedures requiring a notice and comment period, allowing FDA to alert industry more quickly for significant concerns.
Dubey also argues that a maximum allowable lead limit, per serving, needs to be mandated and must come with strict penalties for exceeding set levels. Further, he says that FDA needs to be funded in a way that allows for regular testing and monitoring of baby foods, especially those known to often carry lead, such as sweet potatoes, yams, spinach, and rice. “This guidance is long overdue in even starting to address the problem of lead found in baby food, so hopefully awareness will increase among parents and, possibly, cause some companies to start taking more seriously the danger of lead found in their products,” Dubey adds.
FDA is holding a webinar on this draft guidance for members of industry and the public on March 2. Visit the registration page for more information.