FDA’s (In)Action Plan Still Allows Baby Foods with Toxic Heavy Metals on Store Shelves

On February 4, 2021, the public results of a congressional report on heavy metals in baby food sparked outrage in parents of infants and toddlers. The investigation focused on four major baby food manufacturers: Beech-Nut Nutrition Company, Gerber, Hain Celestial Group, and Nurture. While seven baby food companies were initially asked to participate in the investigation, Walmart, Sprout Foods Organic, and Campbell outright refused to collaborate.  

The refusal of the three baby food manufacturers to share their internal documents concerning heavy metal testing was perceived as suspicious. According to the findings of the Subcommittee on Economic and Consumer Policy, it was. Sprout Foods Organic was blasted for requiring that the ingredients it uses to be tested for heavy metals just once per year, a practice the investigators called “the most reckless testing practice among manufacturers on the market.” Furthermore, after the congressional results were released, Beech-Nut decided to issue a voluntary recall on one of their rice products. It had a concentration of arsenic above the safe limit and ceased manufacturing that kind of baby food altogether. 

According to the subcommittee, Plum Organics, a brand of baby food belonging to Campbell, sells products “tainted with high levels of toxic metals” based on testing data of the company. Every Plum Super Puffs rice product tested contained over 200 ppb of arsenic when the safe limit is only 10 ppb. There are no official safe limits for heavy metals in baby food now, except for arsenic in infant rice cereal. Even so, the limit, which is 100 parts per billion (ppb), is dangerously high, according to most health agencies. 

The Congressional Report’s Shocking and Unexpected Findings

While the safe limit for lead is 5 ppb, Beech-Nut used as much as 886 ppb lead, and some ingredients of Hain Celestial Group contained over 200 ppb lead. Arsenic was present in the ingredients used by the former baby food company in a concentration of 309 ppb. Moreover, Beech-Nut used ingredients testing as high as 913 ppb arsenic in baby food. Baby food companies are aware of heavy metals in their ingredients and finished products yet choose profit over children’s health. 

Some ingredients allowed in infant and toddler food by Hain Celestial Group had up to 260 ppb cadmium, while the safe limit is 5 ppb. Beech-Nut also has a severe arsenic problem, as some ingredients contain over 340 ppb cadmium. As for mercury, while it is true that it ends up in baby food more rarely and in lower concentrations, manufacturers must test for it as well. Nonetheless, most of the companies that partook in the investigation were not conducted testing for mercury. 

“My Subcommittee’s investigation has pulled back the curtain on the baby foods industry, and each revelation has been more damning than the last,” said Chairman Raja Krishnamoorthi. “Companies not only under-report the high levels of toxic content in their baby food but also knowingly keep toxic products on the market,” he added. As for what the best course of action would be concerning the contaminated products, “removing these products from the market would be the most effective approach to address this issue and provide assurances to parents and caregivers,” Brian Ronholm, director of food policy at Consumer Reports, said.

The presence of heavy metals in infant and toddler food, even in trace amounts, poses a real danger to children’s health, as once inside the body, arsenic, cadmium, lead, and mercury act as neurotoxins, taking a heavy toll on the nervous system and brain. Children are considerably more susceptible to experiencing the negative health impact of heavy metal exposure, which, in their cases, occurs via ingestion. Since they have a higher uptake rate by their gastrointestinal tract and undeveloped detoxification systems, they are more likely to develop learning disabilities, autism, and cognitive damage due to early life exposure to heavy metals.

What Measures Has the FDA Taken to Minimize the Amount of Heavy Metals in Baby Food?

Although the Food and Drug Administration came up with a strategy to establish safe limits for arsenic, cadmium, lead, and mercury in baby food, known as the Closer to Zero plan, the agency has been receiving harsh criticism for the ineffectiveness of this strategy. More specifically, the Closer to Zero plan would officially implement limits for heavy metals in baby food in 2024 or later. The FDA claims that the goal of this strategy is to “identify actions the agency will take to reduce exposure to toxic elements from foods eaten by babies and young children – to as low as possible.” Following a four-stage iterative approach that includes research, regulatory, and outreach efforts, the Closer to Zero plan of the FDA involves four steps, so it should come as no surprise that it is expected to take so long until it reaches its goal. 

The first two steps of the FDA’s strategy are unnecessary. They would waste a lot of unnecessary time, during which the nation’s children would continue to consume baby food tainted with toxic metals. To be more precise, these two steps of the Closer to Zero plan involve evaluating the scientific basis for action levels and subsequently proposing action levels. These steps are redundant because we already know what the safe limit is for each of the four problematic heavy metals by virtue of the plethora of medical studies and reliable information from worldwide health agencies. Consulting with stakeholders on proposed action levels would be the FDA’s next step, including the achievability and feasibility of action levels. This is a good step, as it would help the agency figure out how to implement the safe limits practically. 

Lastly, the final step of the Closer to Zero plan is finalizing action levels, which means using the information from stakeholders, updated scientific research, and routine monitoring of data to make any necessary adjustments and enforce the safe limits for heavy metals in baby food officially. Consequently, the strategy of the FDA can be boiled down to only two steps instead of four, and this process would not take two or more years to come to fruition. Furthermore, if the Closer to Zero plan is followed as the agency has initially established, the health of infants and toddlers across the country would be at risk, as the vast majority of store baby food found on the shelves of supermarkets contains at least one toxic heavy metal. The greater the number of heavy metals inside a child’s body, the more prone to developing lifelong, debilitating neurological disorders. 

“The FDA has been absent without leave on this issue,” Chairman Krishnamoorthi said. “We have been working closely with FDA on regulations, and the report highlights the need for the agency to accelerate its proposed timeline for publishing them. The FDA needs to get on the ball and needs to make sure that we do what science requires, as opposed to what, potentially industry is asking for”, he added.

Now, there are zero regulations for heavy metals in baby food by the FDA, which is alarming, to say the least, except for arsenic in infant rice cereal. For this baby food, the limit is 100 ppb, which poses a danger to the child’s health, as it is 10 times greater than most health agencies recommend. There are no safe limits in baby food for the other three heavy metals of concern. This, unfortunately, gives leverage to major companies to skip testing, which costs between $50 and $100 per sample, and thereby save money, placing financial profit over the health and wellbeing of infants and toddlers. 

A Coalition of Attorneys General Petitioned the FDA, Urging the Agency to Take More Aggressive Measures

Because the Closer to Zero plan is a strategy so unnecessarily complex and lengthy, a coalition of 24 Attorneys General petitioned the FDA in October of last year, urging it to take more aggressive measures. While they found the agency’s initiative laudable, they believed that it was a poor management plan considering the severity of the situation at hand. The Attorney’s General petition criticized the FDA because its Closer to Zero plan meant to minimize the concentration of heavy metals in baby food does not include sufficiently aggressive timelines for lowering the concentrations of cadmium, arsenic, lead, and mercury in these products. 

“Every day and across the country, baby food companies are selling products containing dangerous levels of lead and other toxic metals, and urgent action is needed to stop it. There are common-sense, science-based actions that can drive down the levels of heavy metals in baby foods, which is why we are calling on the FDA to take these actions as soon as possible”, said Attorney General James. Indeed, many medical studies show the safe limit for each of the four heavy metals of concern, and health agencies worldwide agree on these safe limits. Therefore, the FDA could implement official interim reference levels for cadmium, arsenic, lead, and mercury within a short time, without wasting precious time and exposing developing children to harmful substances. 

The Baby Food Safety Act, a Potential Savior for the Baby Food Contamination Crisis 

Shortly after the subcommittee found out the results of the congressional study, Congressman Raja Krishnamoorthi proposed the Baby Food Safety Act of 2021. This bill would immediately set official limits for heavy metals in baby food, defined as products manufactured for children up to 36 months old. “For too long, the industry has been allowed to self-regulate baby food safety, and the results have been appalling and extremely harmful to our kids. We will not stand for that any longer,” said Chairman Krishnamoorthi. Hopefully, the bill will eventually become law so that parents nationwide will no longer have to worry about the presence of toxic metals in the products they feed their children.

If the Baby Food Safety Act of 2021 became effective, the safe limit for arsenic would be 10 ppb, cadmium, 5 ppb, lead, 5 ppb, and mercury, 2 ppb. These are very low concentrations that should not harm the health of a growing and developing child, especially if their parents alternate between store baby food with homemade baby food. Furthermore, the bill would also require the FDA to establish limits on other toxic agents upon reviewing relevant health data. Moreover, facilities that handle infant and toddler food in any way must have specific controls and plans to ensure that their products comply with the maximum limits on heavy metals set by this bill. Lastly, the Centers for Disease Control will have to carry out public awareness campaigns about the risks of toxic agents in baby food.

Meanwhile, Baby Food Manufacturers Should Ensure Their Products Are Safe

Heavy metals occur naturally in water and soil and crops inevitably absorb them. For instance, rice crops absorb up to 20 times more arsenic than other crops, making it so dangerous if eaten frequently and if not adequately prepared. Therefore, it is the responsibility of baby food manufacturers to ensure their products have a level of heavy metals below the maximum safe limit.

Baby food companies can use some effective, relatively inexpensive, practices to control the level of toxic metals in their ingredients and finished products, such as:

  • source cereals, fruits, and vegetables from fields with lower arsenic concentrations
  • grow crops with natural soil additives that lower heavy metal uptake
  • use strains of food that are less susceptible to absorbing heavy metals
  • alter irrigation practices 

Additionally, to prevent unethical conduct infiltrating baby food, such as allowing high concentrations of heavy metals in the products that will go on the market, there are some measures to take, the essential being:

  • hiring trustworthy people, which is perhaps the most critical step to take to ensure no foul play will occur
  • sourcing ingredients from ethical suppliers, such as local farmers, as they generally use transparent business practices
  • ensuring facilities are kept clean 24/7 by hiring the right people to take care of this not-so-easy job
  • periodically testing products for heavy metals to make sure the baby food allowed on the market do not contain dangerous concentrations of neurotoxins
  • have clear labels, even if the added ingredients are not so healthy
  • voluntarily recalling a line of products right when the products have been testing positive for one or multiple heavy metals

About the Author

Jonathan Sharp is Director of Claims and Chief Financial Officer at Environmental Litigation Group, P.C. The law firm, headquartered in Birmingham, Alabama, specializes in toxic exposure.