Heavy Metals Were Found in Baby Food – What Is the FDA Doing About It?

In 2012, the Consumer Products Safety Commission issued a report warning about high levels of arsenic in rice products in the US – a problem all too familiar to independent heavy metals expert and consultant Robert Thomas.

“The problem with rice that’s grown in the US is that it’s prone to absorbing arsenic from the soil,” Thomas told Technology Networks. “Arsenic is prevalent in all soil in the US but predominantly in areas where there’s been a lot of apples grown – apple orchards – because it’s a pesticide.”

“It’s the one crop that’s used to make a lot of different baby foods; whether it’s made with fruit or vegetables, they all contain rice as the bulk ingredient.”

This toddler food connection was so troubling that the FDA began studying the contamination risk of infant rice cereals right away – or to be more exact, after a haranguing from the US Congress.

“Congress got involved,” Thomas recalled. “And they wrapped the knuckles of the FDA; they reprimanded them severely. The FDA did not have a mandatory test for baby food! It relied on manufacturers or consumer advocacy groups to take up the mantle and decide to test it or decide to look at it.”

“They [Congress] told the FDA to get their act together,” Thomas continued. “It took the FDA another year to come out with an internal investigation. And they came out with what was called Closer to Zero.”

First announced in April 2021, the agency’s Closer to Zero plan committed the FDA to proposing action levels for toxic metals in various baby foods, including for lead by April 2022, inorganic arsenic by April 2024 and cadmium and mercury after April 2024. These deadlines have since disappeared from the agency’s website.

So, how is the program progressing? We asked the FDA to find out. 

The FDA’s response

“The FDA’s Closer to Zero Initiative is our strategic, long-term, iterative approach to reducing childhood dietary exposure to lead, arsenic, cadmium and mercury,” an FDA spokesperson told Technology Networks. “The FDA’s goal is to reduce dietary exposure to environmental contaminants to as low as possible, while maintaining access to nutritious foods.”

“We believe this initiative is vital in moving babies and children closer to zero exposure to heavy metals from foods. But it is crucial to ensure that our measures to reduce contaminants do not have unintended consequences, like limiting access to foods that have significant nutritional benefits or reducing the presence of one contaminant while increasing another.”

“Fruits, vegetables and grains can take up heavy metals in the environment from water, soil and air, creating limits to how low the levels can be reduced. As we work with industry to take into consideration issues related to feasibility and achievability, the FDA can help ensure the availability of safe and nutritious foods for all babies and young children.”

As for the project timeline, the spokesperson said guidance announcements would be made by the end of the year.

“The agency intends to issue final guidance for lead in foods intended for babies and young children, and draft guidance for arsenic and cadmium in foods intended for babies and young children by the end of this year. Guidance documents are provided to industry to describe the FDA’s interpretation of our policy on a regulatory issue. It is important to underscore that the FDA does not need an action level or guidance to take action against a food (or manufacturer) that is in violation of the law.”

The FDA spokesperson reiterated the draft guidance the agency published in January 2023 and the rigor it purports to apply to such standards.

“In January 2023, the FDA published draft action levels for lead in foods intended for babies and young children; the FDA has also published draft action levels for lead in juices and final action levels for arsenic in apple juice and in infant rice cereal. As described in the draft guidance, action levels represent the level at which the FDA may regard the food as adulterated because it may be injurious to health. Thus, when the FDA is developing action levels, the FDA considers whether the level of the contaminant in the food may be injurious to health.”

Congress responds, cinnamon apple sauce gets tainted

In parallel to the Closer to Zero program, a few US senators have put heavy metal contamination in infant food on Congress’s agenda, too.

In May, senators Amy Klobuchar (Democrat for Minnesota) and Tammy Duckworth (Democrat for Illinois) introduced legislation to limit the levels of heavy metals allowed in commercial food for infants and toddlers. The Baby Food Safety Act of 2024 would allow the FDA to enforce its planned heavy metal limits in commercial infant and toddler food. The bill would also increase standards for food manufacturer sampling and testing for contaminants in imported and domestic processed food and bring greater transparency to the rate of food facility inspections by the FDA in the US and abroad.

“Parents want what’s best for their children, and they deserve peace of mind knowing the food they purchase for their babies and toddlers is safe,” Klobuchar said in a statement published on May 9. “This legislation will boost food safety standards and require more complete testing by manufacturers to prevent heavy metals from poisoning our kids.”

As of July 2024, the bill has yet to be passed by the House of Representatives.

Action may be demanded sooner rather than later, however, given another recent heavy metal contamination scandal in the US.

Last year, family doctors across the US began noticing some alarming blood results affecting toddlers. Infants from multiple states were testing positive for high levels of lead – in some cases, four times the level that would initially raise concern.

While the exact number of affected children remains unclear, by November 2023, the Centers for Disease Control and Prevention (CDC) had reported at least 205 confirmed cases from 33 states. Using a different reporting method, the FDA counted 69 babies and toddlers sickened in 28 states as of December 14, 2023.

What was the common culprit behind this spate of poisonings? Cinnamon apple puree.

“The FDA came up with a report on a particular type of baby food which was imported from South America,” Thomas recalled. “It was cinnamon applesauce pouches. And they were finding that people were complaining that they had a bad taste to them.”

“They [the FDA] did their initial study and found out the cinnamon was the problem, not the applesauce. And they found the cinnamon was being manufactured by someone else.”

“[Cinnamon] is the bark of a plant, [which] is stripped and dried,” Thomas explained. “The cinnamon looks like little curls; it’s ground into a powder and then used. But this unscrupulous manufacturer was adding lead chromate to the cinnamon as a way of enhancing the color because, like chromium, cinnamon is pale orange. The applesauce manufacturer was oblivious to what was going on. They exported them all over the world; it was getting consumed by young children, two months old or maybe a year old.”

In the meantime

This recent spate of contamination underlines the importance of the kind of regulations currently mulled by the FDA and Congress. The pressure is certainly on to deliver some kind of legislative progress before more infants fall ill from tainted food.

In the meantime, the FDA spokesperson told Technology Networks that, with or without the Closer to Zero program, consumers can be reassured that food manufacturers do still have legal obligations to prevent contamination.

“Regardless of the FDA’s work determining draft action levels as part of the Closer to Zero initiative, industry, baby and toddler food manufacturers and processors have a legal obligation under the FD&C Act to follow the preventive control provisions of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Foods rule,” the spokesperson said. “The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards requiring a control, which may include arsenic, cadmium, lead and mercury.”

The regulator also stressed that it continuously monitors the US’s food supply for any signs of contamination.

“The FDA’s proposed action levels on lead have been shared with our stakeholders and through our continued collaboration with state and federal partners, industry and growers as they identify mitigation strategies for lead. Through this collaboration, we have been hearing from manufacturers about what it will take to achieve the proposed action levels and the timeframes to reach them. While we work to finalize the guidance on lead in foods intended for babies and young children, the FDA continues active surveillance of the US food supply, as well as exploring additional prevention and compliance activities, to reduce childhood dietary exposure to heavy metals in foods.”

About the interviewee:

Robert Thomas is the principal of Scientific Solutions, a consulting company that has helped educate countless professionals in the food and legal cannabis testing communities on heavy metal analysis. He is also an editor and frequent contributor of the Atomic Perspectives column in Spectroscopy magazine and has authored five textbooks on the principles and applications of mass spectrometry. Rob has an advanced degree in analytical chemistry from the University of Wales and is a fellow of the Royal Society of Chemistry and a chartered chemist.