After a 2019 study brought to light the excessive amounts of heavy metals in infant nutritional products, a congressional investigation was launched by the Subcommittee on Economic and Consumer Policy to evaluate the true extent of the issue.

The ensuing congressional report published in February 2021 not only confirmed that a host of baby food products were contaminated with neurotoxic mercury, lead, cadmium, and arsenic, it also highlighted the lacking industry standards that allowed it to proliferate. Although the FDA vowed to address the issue in April 2021, very little progress has been achieved since, with the agency failing to accomplish any of its initial goals.

Lacking Standards Contribute to High Metal Counts

During the investigation, the Subcommittee requested internal data from seven major US baby food manufacturers. While Beech-Nut, Gerber, Nurture, and Hain Celestial provided the relevant information, three companies chose to withhold it: Sprout Foods, Walmart, and Campbell.

Despite working with limited information, the Subcommittee found lacking safety standards and practices that contributed to heavy metal contamination. Most manufacturers didn’t test for mercury, didn’t conduct final product testing and only evaluated ingredients, some used harmful additives, and some knowingly sold contaminated products. Compared to applicable safety limits for other products regulated by the FDA, baby foods had 5 times more mercury, 69 times more cadmium, arsenic counts were 91 times over the limit, and lead topped out at 177 times than what is deemed safe.

Dietary exposure to heavy metals is especially concerning for toddlers and infants due to their increased intestinal uptake of nutrients and less developed filtering systems that can’t adequately eliminate harmful contaminants. As they progressively accumulate in the body, these metals act as neurotoxins impacting the brain and nervous system, leading to issues such as decreased IQs, behavior abnormalities, and neurodevelopmental conditions like ADHD and autism.

FDA’s Inefficient Plan to Tackle the Ongoing Crisis

In April 2021, the FDA announced its four-step “Closer to Zero” action plan, which seeks to gradually establish safety limits for heavy metals in baby foods by 2024 or potentially longer. Although commendable in its intentions, the FDA’s plan has been criticized for its laxed timeline and structural redundancies.

Notably, the plan’s initial steps, which aim to elaborate and propose actionable levels for heavy metals, are widely seen as unnecessary given the vast volume of available data on the matter from reputable sources. As such, foregoing these steps and emphasizing the final two, which focus on implementation, would allow the FDA to achieve its proposed goals earlier than the current 2024 target.

The lack of adequate regulations consequently enables baby food manufacturers to largely self-regulate and set their own standards, with the FDA only recommending (not enforcing) that arsenic in infant rice cereals be limited to a disputed 100 parts per billion (ppb). One year removed from its launch, the Closer to Zero plan failed to achieve its first milestone of proposing actionable levels for lead in infant nutrition products.

The Baby Food Safety Act of 2021

Even before the FDA set its plan in motion, Senator Raja Krishnamoorthi (D-IL), who is also head of the Subcommittee, proposed the Baby Food Safety Act for the House’s consideration in March 2021. The bill would require baby food companies to present final-product testing results twice a year, increase the FDA’s regulatory involvement, and set interim safety levels which would be further reduced:

• Mercury – 2 ppb
• Cadmium and Lead – 5 ppb
• Arsenic – 10 ppb

Even though the bill was received with widespread support, its progress has been stagnant since it was submitted. In September 2021, the Subcommittee issued an updated report with information from the previously uncooperative companies, noting even higher levels of contamination than initially believed and highlighting the urgent need for regulation to protect exposed consumers.

Attorneys General Confront the FDA

Considering the Subcommittee’s new findings, the bill’s lack of progress and the FDA’s ineffective action plan garnered a strong reaction from 23 Attorneys General, including Oregon’s Ellen Rosenblum. The coalition led by Letitia James (NY) petitioned the FDA in October 2021 to accelerate its “Closer to Zero” plan’s timeline and adopt the interim safety levels proposed by the Baby Food Safety Act no later than April 2022.

The petition was denied by the FDA in May 2022 due to alleged issues stemming from the proposed methodology, which were contested by the authors one month later. On June 26, 2022, the coalition addressed a letter to the FDA and USDA, reiterating the need for “bold and timely action” in setting interim safety levels to protect vulnerable infants, who would otherwise be exposed to toxic metals for several more years under the current status quo. Significantly, the USDA manages the federal Women, Infants, and Children (WIC) program, which provides nutritional support to 53% of US newborns, yet still includes arsenic-ridden rice cereals among its available options.

Until the FDA adopts more efficient measures that ensure baby food safety, individual states can limit exposure by excluding questionable items from federal programs. In Oregon, the WIC program doesn’t offer problematic rice cerealsfor enrolled families anymore, similar to Washington, Hawaii, and Alaska, with Colorado and California also considering similar measures.

About the Author

Jonathan Sharp is the CFO of Environmental Litigation Group PC, a law firm based in Birmingham, Alabama, that specializes in toxic exposure cases and helps families whose children were affected by harmful contaminants in baby food.