Late last month, the FDA announced a draft guidance in an attempt to reduce lead levels in processed foods for children 2 years old and younger. This announcement comes nearly two years after a Congressional report called on federal regulators to enforce stricter standards on baby food manufacturers.
Titled Action Levels for Lead in Food Intended for Babies and Young Children, the draft guidances urges manufacturers to set new action levels of 10 parts per billion (ppb) for fruits, vegetables, mixtures (including grain and meat-based), yogurts, custards/puddings and single-ingredient meats. For root vegetables and dry cereals, the proposed action level is 20 ppb.
This move is part of the FDA’s Closer to Zero program, which was launched in April 2021. The program’s mission is to reduce exposure to lead, arsenic, cadmium and mercury for babies and young children.
For the past decade, firm co-founder and environmental attorney Vineet Dubey has been fighting to keep lead and other toxic heavy metals out of baby foods. In 2021, he filed two lawsuits on behalf of Ecological Alliance LLC against Nurture Inc. and Gerber for selling baby food products containing toxic levels of lead. After the FDA’s announcement of the draft guidance in late-January, Vineet told Food Quality & Safety that he does not believe this will affect much change.
According to the draft guidance, these action levels are not legally enforceable. They can, however, consider these action levels when assessing whether to bring enforcement action in a specific case.
“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,” Vineet said.
He continued, “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.”
Vineet also stated that there needs to be a mandated maximum allowable lead limit per serving, and strict penalties must be enforced for exceeding those limits. In March 2021, Congress introduced the Baby Food Safety Act which would immediately impose limits on lead, cadmium, arsenic and mercury, but it has not been discussed since 2021. Vineet’s July 2022 column for the Davis Vanguard highlights this issue and calls for Congress to move forward with the stagnant bill.
“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,” Vineet told Food Quality & Safety.
On March 2, the FDA is holding a webinar for the public and members of the industry to provide an overview of this draft guidance and answer stakeholder questions. To register, fill out this form.
Comments are also being received on the draft guidance until March 27. Submit comments electronically on Regulations.gov to docket number FDA-2022-D-0278.
Scrambling to purchase a last-minute Valentine’s Day gift for your partner? Make sure to take a look at last week’s newsletter to make sure you’re not purchasing a toxic present!