In response to a February 2021 report released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy, FDA has issued a letter to baby and toddler food manufacturers reminding them of their obligations under the FSMA Preventive Controls for Human Food Rule to consider chemical hazards in foods when engaged in their required hazard analysis of food products.
FDA says it will also seek “impactful solutions for reducing toxic elements in foods commonly consumed by babies and young children.” The agency also committed to engaging in a process to set standards and limits for the presence of heavy metals in baby foods.
The new actions include issuing guidance to manufacturers for “key foods,” planning to finalize its action level for inorganic arsenic in infant rice cereal, which it started working on in 2016; and working to finalize its draft guidance for an inorganic arsenic action level in apple juice and release a draft guidance for lead action levels in juices.
“The U.S. Food and Drug Administration takes exposure to toxic elements, such as arsenic, mercury, cadmium and lead, in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population,” said Janet Woodcock, FDA’s acting commissioner of food and drugs, in its statement.
Laurie Beyranevand, director of the Center for Agriculture and Food Systems at Vermont Law School, notes that while this is an important first step and signals a stronger commitment to address the issue of heavy metals in baby foods than we’ve seen from FDA over the past few years, these actions are not enough.
“A few years ago, FDA convened a Toxic Elements Working Group to reduce exposure to toxic elements across FDA’s regulated product categories,” she tells Food Quality & Safety. “The working group prioritized lead, arsenic, cadmium, and mercury, as these metals present the highest public health risk when individuals are exposed at high levels. However, to date, FDA has only issued voluntary guidance to address inorganic arsenic in rice cereal, meaning it contains nonbinding recommendations that can’t be enforced by the agency in the same way a binding regulation can.”
Janilyn Hutchings with StateFoodSafety, a food safety education organization, says that, in addition to taking the new actions it just announced, FDA could also work on drafting action levels for inorganic arsenic and lead in other baby foods. “It could also consider appropriate action levels for cadmium and mercury,” she says. “As more testing and studies are available and more widely used, the FDA will likely implement more changes to ensure the safety of babies and children.”
In Beyranevand’s opinion, FDA should be developing binding standards with set limits that address the amount of heavy metals that can safely be present in infant, baby, and toddler foods, rather than developing nonbinding guidance. “This will require manufacturers to ensure their products are within those limits and enable FDA to enforce the limits against companies that fail to comply,” she says. “Given the vulnerability of this population and the fact that heavy metals are present in many of their first foods, this issue is of paramount importance for public health and safety.”