Healthy Babies Bright Futures’ 2019 study brought about a Congressional inquiry into the safety of baby food in the United States. In 2021, the U.S. House of Representatives Committee on Oversight and Reform published a report aligning with the 2019 study, finding that there are dangerous levels of heavy metals present in several popular baby food brands.
As is often the case, the Congressional report pressured the FDA to take action. Shortly after the Congressional report was published, the FDA announced the Closer to Zero initiative, which aims to “reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods.” However, after years of evaluating the underlying science and consulting with industry stakeholders, the Closer to Zero initiative has not yet resulted in final guidance for food manufacturers to follow.
Guidance from the FDA
The FDA, however, did issue draft guidance for lead levels in January 2023. This draft guidance set the following proposed action levels for lead in processed food intended for babies and young children:
- 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 (single ingredient).
- 20 ppb for dry infant cereals.
This draft guidance, while not binding or enforceable, provides context for industry stakeholders as the FDA works on the final guidance, which is expected to be announced in December 2024.
The FDA has not yet issued draft guidance for arsenic, cadmium or mercury levels. It expects to issue draft guidance for arsenic and cadmium levels in December2024. It remains unclear whether the FDA will issue any additional guidance regarding mercury levels, because mercury is unique in that the primary dietary source of this heavy metal is the bioaccumulation of the toxin in seafood.
The FDA and Environmental Protection Agency have previously issued Advice About Eating Fish to encourage consumers, including young children, to be mindful about the types of fish and shellfish they consume, and in particular, to choose options that are relatively low in mercury. At this stage, the FDA remains unclear as to whether or not it will revise these standards, or if it will issue any additional guidance for mercury levels.
A flurry of putative class actions relating to the presence of heavy metals in baby foods were filed in the wake of the Congressional report and the FDA’s Closer to Zero initiative. Some courts dismissed these cases in their early stages precisely because the FDA has not yet issued final guidance setting standards on what levels of heavy metals, if any, may be present in baby food before rendering it unsafe for consumption. Others, however, are continuing to work their way through the court system. The upcoming guidance from the FDA will provide a crucial guidepost for litigants involved in these lawsuits as well as the industry as a whole.
Courtney A. Hunter is an attorney at Bass, Berry & Sims PLC in its Nashville, Tenn., office. She represents clients in a wide variety of complex commercial litigation, including product liability and toxic tort claims as well as large-scale business disputes involving fraud, breach of contract, trade secrets and restrictive covenants. Courtney can be reached at [email protected].
