'Consider chemical hazards' in the baby foods you sell, FDA warns manufacturers - CNN

"We appreciate your attention to your obligation to consider potential chemical hazards, including toxic elements, when conducting a hazard analysis," wrote Susan Mayne, director of the FDA Center for Food Safety and Applied Nutrition, and Dr. Janet Woodcock, the FDA's acting commissioner of food and drugs, in a letter addressed to all baby and toddler food manufacturers and processors.

The FDA action came one month after a congressional investigation found several baby food manufacturers knowingly sold baby food that contained high levels of toxic heavy metals.

"We presented evidence of a pervasive problem of toxic heavy metals in baby foods, and when we asked the Biden Administration's FDA for help in addressing it, they were very concerned and responsive," said Democratic Rep. Raja Krishnamoorthi of Illinois, chair of the House Subcommittee on Economic and Consumer Policy, which conducted the investigation, signed by the Democratic members.

"This represents a welcome change at FDA," Krishnamoorthi said. "However, we are disappointed that FDA failed to commit to establishing concrete rules to remove toxic heavy metals from all baby foods. It highlights the need for Congress to pass legislation with strict standards and timelines.

"Babies don't have time to wait for FDA to fill in details. Parents: I encourage you to keep pushing for progress with us," he said.

In the announcement, the FDA put manufacturers on notice that exposure to toxic elements in the food supply would be taken "extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population."

The agency went on to say that "when the levels of toxic elements or other chemicals in foods do pose a health risk, FDA takes steps to remove those foods from the market," pointing to a January federal court decree that forced "a U.S. company to stop distributing adulterated juice products containing potentially harmful levels of inorganic arsenic" until the company met FDA standards.

Reaction from advocacy groups to the FDA action was lukewarm.

"I think it's a positive -- but limited -- step. I'm disappointed that there is no timeline for action," said Tom Neltner, the chemicals policy director for health at the Environmental Defense Fund.

"In the absence of enforceable standards and deadlines, this is hardly what any of us would call progress," said Scott Faber, senior vice president of government affairs for EWG, or Environmental Working Group.

Food companies are already required by law to look for hazards, "including metals in baby foods, and to adopt changes in how they make food and source ingredients to reduce or eliminate those hazards," Faber said.

"The law is pretty clear, but we doubt baby food companies are following this provision. We also doubt that FDA has been enforcing it. So, today's announcement may indicate that FDA will actually look at food safety plans to assess what they are doing," he said.

"The devil is in the details," said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies' exposures to neurotoxic chemicals.

"While the update and letter are vague, FDA is signaling its intent to take a series of actions to reduce children's exposures to toxic heavy metals," she said.

"For meaningful, significant exposure reductions, FDA must set enforceable health-based limits for toxic heavy metals in the foods that account for the greatest exposures, including rice-based foods and snacks, juices, infant cereals, and root vegetables," Houlihan said.

Internal documents showed 'dangerous' levels

The congressional investigation examined internal documents provided by four leading baby food manufacturers: Gerber; Beech-Nut Nutrition Company; Nurture, Inc., which sells Happy Baby products; and Hain Celestial Group, Inc., which sells Earth's Best Organic baby food.

Internal testing done by the four companies showed levels of heavy metals far above limits set for bottled water by the FDA and the US Environmental Protection Agency, the congressional investigators found.

"Dangerous levels of toxic metals like arsenic, lead, cadmium and mercury exist in baby foods at levels that exceed what experts and governing bodies say are permissible," Rep. Krishnamoorthi told CNN when the report was released.

Whether the baby food was organic or not did not matter, the subcommittee found -- levels of toxic metals were still high.

Krishnamoorthi said the spreadsheets provided by manufacturers were "shocking," because they showed evidence that some baby foods contain hundreds of parts per billion of dangerous metals.

"Yet we know that in a lot of cases, we should not have anything more than single-digit parts per billion of any of these metals in any of our foods," he told CNN.

At the time, Gerber, Beech-Nut, Nurture and Hain all told CNN that they do implement strict testing and quality standards for the products they sell.

Not fully cooperative

Three additional baby food companies did not fully cooperate with the subcommittee's investigation, according to the report: Sprout Organic Foods; Walmart, which sells Parent's Choice baby food; and Campbell Soup Company, which sells the Plum Organics brand of baby products.

"The Subcommittee 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," the report stated.

At the time, a Campbell spokesperson told CNN the company had complied, a statement which the subcommittee contradicted in the report:

"Instead of producing any substantive information, Campbell provided a spreadsheet self-declaring that every one of its products 'meets criteria,'" the subcommittee wrote in its investigation.

Following the report's publication, Walmart also told CNN it had complied with the subcommittee investigation, which a subcommittee spokesperson said was false at the time of the report. Sprout Organic Foods did not respond to CNN's request for comment.

A subcommittee spokesperson told CNN Friday that Walmart and Campbell have now provided internal documents on levels of toxic metals to the subcommittee. Those documents are currently being analyzed. Sprout Organic Foods asked for an extension, which was granted.

Chemicals of concern for children

Arsenic, lead, cadmium and mercury are in the World Health Organization's top 10 chemicals of concern for infants and children.

As natural elements, they are in the soil in which crops are grown and thus can't be avoided. Some crop fields and regions, however, contain more toxic levels than others, partly due to the overuse of metal-containing pesticides and ongoing industrial pollution.

"There was a time where we used metals as the predominant pesticide for many years, assuming it was safe," said Dr. Leonardo Trasande, chief of environmental pediatrics at NYU Langone.

All of these heavy metals have been linked to cancer, chronic disease and neurotoxic effects, but it's the devastating damage that can be done to a developing baby's brain that makes baby food toxicity so critical.

The US Food and Drug Administration has not yet set minimum levels for heavy metals in most infant food. The agency did set a standard of 100 parts per billion inorganic arsenic for infant rice cereal, but even that level is considered much too high for baby's safety, critics say, especially since the FDA has already set a much lower standard of 10 parts per billion of inorganic arsenic for bottled water.

From the time of conception through the age of 2, babies have an extremely high sensitivity to neurotoxic chemicals, said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures.

"Their brain is forming rapidly, and so when they're exposed to metals that can interrupt those natural processes, the impacts range from behavioral problems to aggression to IQ loss and all kinds of cognitive and behavioral deficits that can persist throughout life," Houlihan said.

"Pound for pound, babies get the highest dose of these heavy metals compared to other parts of the population," she said. "So the consequences are serious."

Healthy Babies Bright Futures published a report in 2019 that found toxic metals in 95% of the baby foods randomly pulled off supermarket shelves and tested -- that exposé was the "inspiration" for the subcommittee's work, Krishnamoorthi told CNN.

Legislation may still be needed

The congressional investigation suggested a number of regulatory actions that could be taken by the FDA.

Instead of setting limits for one food at a time, the FDA should standardize maximum levels for each toxic metal that can damage a baby's developing brain and apply them to all foods, the report said.

There should be mandatory testing of any baby food product before it hits the shelves, the subcommittee recommended. Manufacturers should no longer be allowed to simply test ingredients.

Substitutes should be found for any ingredients over recommended limits, and if that cannot happen, then the food or ingredient should not be used in baby food, the subcommittee said. Take rice, for example, which is a primary source of inorganic arsenic exposure for babies.

"Every maker of baby food ... is on notice that we in Congress are not going to sit back and accept the status quo anymore," Krishnamoorthi told CNN last month.

On Thursday, Krishnamoorthi, Democratic Sen. Amy Klobuchar of Minnesota, Democratic Sen. Tammy Duckworth of Illinois, and Democratic Rep. Tony Cárdenas of California announced they had drafted a bill which they had sent to the FDA.

They asked the agency to respond with "technical guidance to strengthen the effectiveness of the legislation."

"It's unacceptable that despite parents' best efforts to keep their children safe, some leading baby food manufacturers have put products on the market that expose children to dangerous toxins," Klobuchar said in a press release.

"This legislation will protect children and ensure they get a healthy start by holding manufacturers accountable for removing toxins out of infant and toddler foods. I'll keep fighting to give parents the peace of mind they deserve," she said.

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