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Jul 09, 2023

Chemicals of Concern: The Social and Regulatory Evolution of the Baby Food Category

Image credit: wundervisuals/iStock / Getty Images Plus via Getty Images The U.S. baby food industry has seen its fair share of advocacy and regulatory headlines in recent years. From the congressional

Image credit: wundervisuals/iStock / Getty Images Plus via Getty Images

The U.S. baby food industry has seen its fair share of advocacy and regulatory headlines in recent years. From the congressional investigation1 into levels of heavy metals in top-selling baby foods, to the infant formula recall,2 shortage,3 and the subsequent Operation Fly Formula,4 the media attention has been in full force—and not necessarily in a good way. When it comes to heavy metals, however, changes in regulatory policy and guidance are on the horizon that will hopefully begin to address some of these challenges.

Those not working in the baby food and infant formula category may be surprised to learn that the issue of heavy metals contamination has been percolating in regulatory and consumer advocacy circles for several years. If the attention by baby food consumer advocates, regulatory calls to action, and subsequent rulemaking are any indication of things to come, there are lessons to be learned by the broader food industry.

In 2017, the Environmental Protection Agency (EPA) issued its "Proposed Modeling Approaches for a Health-Based Benchmark for Lead in Drinking Water." EPA developed potential scientific modeling approaches to define the relationship between lead levels in drinking water and blood lead levels, particularly for sensitive life stages such as formula-fed infants and children up to age seven. This report also mentioned the potential of dietary lead exposure in its evaluation.

Later that year, the Environmental Defense Fund (EDF) released a study5 that examined a decade's worth of U.S. Food and Drug Administration (FDA) data and found lead in 20 percent of baby food samples. EDF recommended that FDA update its standards, encourage manufacturers to reduce lead levels in food, and take enforcement action when limits are exceeded.

National nonprofit Clean Label Project was next to draw attention to the issue of heavy metals in baby food in 2018. Its initial whitepaper, followed by a peer-reviewed academic publication6 in partnership with the University of Miami, highlighted the extent of the contamination of lead and cadmium, and how U.S. baby foods and infant formula performed relative to California Proposition 65 compliance and the World Health Organization Provisional Tolerable Monthly Intake (PTMI). The study emphasized that products containing rice were higher in both lead and cadmium concentrations and that further research is needed to understand the long-term health effects of this chronic daily low-level heavy metal exposure in babies.

Later that year, Consumer Reports published a report7 that analyzed 50 nationally distributed packaged foods made for babies and toddlers, checking for cadmium, lead, mercury, and inorganic arsenic. The report also included the results of a survey of parents which suggested that parents are often unaware of the potential risks of heavy metals in their children's food. The survey results also suggested that parents believed that children's foods are subject to stricter regulation and safety testing procedures than other packaged foods.

In 2019, Healthy Babies Bright Futures8 conducted a study that revealed that 95 percent of baby foods tested were contaminated with toxic heavy metals. This study reinvigorated the national conversation about the need for urgent FDA action.

On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the Subcommittee on Economic and Consumer Policy requested internal documents and test results from seven of the largest manufacturers of baby food in the U.S., including both makers of organic and conventional products. Following its review, the report's1 recommendations included:

The investigation garnered significant media attention and consumer response, which prompted action by Congress.

The Baby Food Safety Act of 20219 was put forward by Congress and promised to set limits on the amount of lead, mercury, arsenic, and cadmium contained in baby food by imposing strict requirements on manufacturers to regularly test and verify that their baby foods are under these new, lowered limits for these substances. Under the Act, within a year of coming into effect, manufacturers of baby food and infant formula would be required to adhere to the following maximum levels of heavy metals contamination:

While perceived to be intended to serve as a short-term fix until FDA could formalize industry policy, now nearly two years later, this Act has not yet passed.

Following the Congressional investigation and the Baby Food Safety Act, FDA released its Closer to Zero10 plan. FDA's goal is to reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods. While the process (Figure 1) embraces continuous improvement, it has faced its fair share of criticism including the long timeline to implementation and the structural redundancies that prevent more expedient solutions.

Recent accomplishments of the Closer to Zero program include:

Also, in June 2023, FDA released final guidance for industry setting the action level for inorganic arsenic in apple juice at 10 ppb, which is consistent with the action level laid out in draft guidance in 2013.

The EPA's Chemicals of Concern list includes chemical substances found to be harmful or toxic to human health and the environment. This list was published in accordance with a 2016 amendment to the Toxic Substances Control Act (TSCA), which requires that EPA evaluate and address the potential risks of chemical substances. While current federal efforts are focused on heavy metals, many other chemicals of concern could face the same level of consumer and regulatory scrutiny (but have not yet), including formaldehyde, asbestos, glyphosate, hazardous air pollutants, per- and polyfluoroalkyl substances (PFAS), pesticide chemicals, and polychlorinated biphenyls (PCBs).

Whether in the baby food/infant formula category or not, when it comes to the issue of heavy metal contamination, there are a few realities that are important for regulators, industry, and consumers to understand:

Outlined below are some tips for addressing heavy metals in your supply chain:

When it comes to food safety, it does not have to take an act of Congress to voluntarily think about food safety differently. Recognize the changes in regulatory policy and the consumer and societal shifts in food safety and quality expectations, and align your quality systems accordingly.

Jaclyn Bowen, M.P.H., M.Sc., is Executive Director of the Clean Label Project. Before coming to the Clean Label Project, Jackie held numerous technical, standards development, and leadership roles within the World Health Organization Collaborating Centers and NSF International. Most recently, she served as the General Manager of Quality Assurance International, the Director of NSF International’s Consumer Values Verified division, and the Director of NSF Agriculture. Jackie earned a B.S. degree in Environmental Biology from Michigan State University, an M.P.H. degree in Management and Policy from the University of Michigan, an M.S. degree in Quality Engineering from Eastern Michigan University, and a Post-Graduate Certificate in Innovation and Business Strategy from the Massachusetts Institute of Technology.

Jaclyn Bowen, M.P.H., M.Sc., Executive Director, Clean Label Project