The FDA’s Closer to Zero Plan Is Ineffective, Lengthy, and Causing an Imminent Health Crisis

Opinion By: Jonathan Sharp

On February 4, 2021, the Subcommittee on Economic and Consumer Policy made public the results of a report concerning the presence of heavy metals in infant and toddler food. What prompted the investigation was a previous study conducted by the non-profit organization Healthy Babies Bright Futures, whose results showed that up to 95% of the baby food on the market contains at least one heavy metal of the four problematic ones, namely arsenic, cadmium,lead, and mercury. The findings of the congressional report sparked outrage in parents, and for good reason.

Seven major baby food manufacturers were asked to participate in the investigation by making available the results of their internal studies on the levels of heavy metals in their ingredients and finished products. However, only four agreed to collaborate with the investigators, more specifically Beech-Nut Nutrition Company, Gerber, Hain Celestial Group, and Nurture, whereas Campbell, Sprout Organic Foods, and Walmart refused to share their internal documents.
Because there were baby food companies that did not want to be part of the investigation, the Subcommittee stated that it is “greatly concerned that their lack of cooperation might be obscuring the presence of even higher levels of toxic heavy metals in their baby food products than their competitors’ products.”
Parents are highly alarmed concerning the content of heavy metals in baby food because exposure to arsenic, cadmium, lead, and mercury has been linked to autism, among many other neurological disorders. Once these toxic metals enter the body, they act as neurotoxins, attacking the nervous system and brain of the person. Children are especially susceptible to experience the adverse health effects of heavy metal exposure because they are still developing and have undeveloped detoxification systems. Roughly 2% of children live with autism at the moment in the United States, and 1 out of 54 babies born after 2008 eventually develop the disorder.
Perhaps the most disturbing thing about this situation is that the U.S. Food and Drug Administration (FDA) has no regulations for heavy metals in baby food except for arsenic in infant rice cereal. Even so, the safe limit the agency set for this toxic metal is 100 ppb (parts per billion), which is considered very high by most health agencies. Attempting to solve the issue of heavy metals in baby food, the FDA came up with the Closer to Zero plan, which would set limits for all four heavy metals only in 2024 or even later. For this reason, the strategy proposed by the agency has been heavily criticized for being loose and ineffective, as well as for not entailing aggressive enough timelines.
Nevertheless, a glimpse of hope for parents of infants and toddlers would be the Baby Food Safety Act of 2021, which, if it becomes effective, would immediately set maximum allowable limits for heavy metals in baby food. It would also involve the FDA to a greater degree in making decisions on the safest toxic metals limits. It would make it mandatory for facilities that handle baby food in any way to be more transparent about their internal practices.
The Congressional Report’s Findings: Appalling and Unexpected Before exposing some of the most shocking findings of the Congressional Reports’ investigation, it is paramount to be aware of the safe limits of each of the four problematic heavy metals in baby food to comprehend how serious the issue is. Accordingly, the limit is 10 ppb for arsenic, cadmium 5 ppb, lead 5 ppb, and mercury 2 ppb.
Over 100 ppb arsenic was found in 25% of the products Nurture allowed to go on the market, whereas Hain Celestial Group used ingredients with a concentration of arsenic as high as 309 ppb. As for Beech-Nut, the company was the most negligent concerning arsenic, as the heavy metal exceeded 900 ppb in some of the ingredients the manufacturer used.

While Beech-Nut included in its baby food ingredients with more than 880 ppb lead, Hain Celestial Group used ingredients with up to 352 ppb lead. Still, Nurture is the company whose internal test results were the most concerning regarding lead, as the investigators found that some of its products contained over 640 ppb lead.

When it comes to cadmium, some ingredients Beech-Nut used had a concentration of more than 340 ppb, and Hain Celestial Group included some ingredients testing up to 260 ppb cadmium in its baby food.
 Furthermore, some carrots Gerber used to make baby foodcontained 87 ppb cadmium. Lastly, most companies admitted to rarely testing for mercury, if at all.

“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.

Brian Ronholm, director of food policy at Consumer Reports, believes that “removing these products from the market would be the most effective approach to address this issue and provide assurances to parents and caregivers.” So far, only two baby food companies have voluntarily recalled products from the shelves. In April 2021, Maple Island Inc. recalled three lots of Walmart’s Parent’s Choice Rice Baby Cereal, while in June, Beech-Nut recalled one lot of Beech-Nut Stage 1, Single Grain Rice Cereal. Both recalls were issued because the products had too much arsenic.
The FDA’s Closer to Zero Plan Is Loose, Ineffective, and Dangerously Slow to Take Effect. The FDA promises to implement a “science-based, iterative approach for decreasing exposure to toxic elements from food,” known as the Closer to Zero plan. Although this is a laudable initiative, the agency has thought that this strategy is far from effective and rapid. Because the issue of heavy metals in baby food is extremely severe, immediate measures to mitigate the risk of children ingesting harmful substances must be taken. The Closer to Zero plan has four steps, two of which are unnecessary, as they refer to determining the interim reference levels for the four heavy metals. These steps are redundant because there are plentiful national and international health agencies that have already discovered the maximum level for each toxic metal in baby food.
It is only the third step of the Closer to Zero plan that entails something useful, namely assessing the achievability and feasibility of the action levels, as the FDA has to make sure every baby food manufacturer can keep the content of heavy metals in their products within the safe limit by using practices such as sourcing rice from crops where the soil has a low concentration of this toxic metal. The fourth step of the FDA’s strategy involves finalizing the action levels, which, once again, is unnecessary, as it can be completed before the third. Moreover, the Closer to Zero plan of the FDA has additional shortcomings, such as failing to consider the cumulative effect of toxic metals on neurodevelopmental when establishing limits, to move up the deadlines for draft action levels for arsenic and cadmium, and to define what “as low as possible” and “children’s food” mean.
In the Closer to Zero plan, the FDA’s deadline to propose draft action levels for arsenic is April 2024, and there are no deadlines for cadmium and mercury. Consequently, those timelines need to be accelerated. This is what made a coalition of 24 Attorneys General from 23 states petition the FDA on October 21, 2021, urging the agency to set interim proposed action levels right away and prioritize children’s safety, health, and wellbeing of children.
“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 Letitia James the leader of the coalition.

The Baby Food Safety Act Could Solve the Baby Food Contamination Crisis. A bill known as the Baby Food Act of 2021 was introduced in the House by Congressman Raja Krishnamoorthi on March 26, 2021. Should it pass the Senate and become law, it would immediately set maximum limits for arsenic, cadmium, lead, and mercury in baby food, defined as products for 36 months or younger children. “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.

The Baby Food Safety Act of 2021 would also require the FDA to set limits on other toxic agents upon reviewing the most recent health data. Additionally, facilities that handle infant and toddler food in any way would have to have certain controls and strategies to ensure that their products comply with the safety limits on heavy metals set by the bill. Finally, the Centers for Disease Control would have to carry out public awareness campaigns about the risks of toxic agents in baby food.
Hopefully, the Baby Food Safety Act of 2021 will enter law as soon as possible. It is a considerably more feasible alternative to the Closer to Zero plan. It would spare infants and toddlers the constant worry about the harmful substances that might lurk in their children’s food.
Jonathon Sharp has been part of the legal team of Environmental Litigation Group, P.C., for over
20 years. The law firm specializing in toxic exposure is headquartered in Birmingham, Alabama.
His primary responsibilities are client relations, collecting and distributing the funds, financial
analysis, and managing firm assets.