The report released Thursday by the Subcommittee on Economic and Consumer Policy in the House of Representatives, contains the results of an investigation launched in the wake of an October 2019 report (‘Healthy Babies Bright Futures’) raising alarm bells about heavy metals in baby foods.
What does ‘dangerously high’ mean?
As to whether the trace levels of metals cited in the report are indeed “dangerously high” as the authors allege, some industry sources claim language like this misleads consumers by raising alarm bells over microscopic levels of substances, noting that ‘the dose is the poison,’ while others argue that there is no safe level of lead in baby food, and that even ultra low-level exposure could hinder infant neurological development.
The report acknowledges that the FDA has not set thresholds for most metals in baby food, but notes the agency sets maximum allowable levels in bottled water at 10 ppb inorganic arsenic, 5 ppb lead, and 5 ppb cadmium, while the EPA has capped the allowable level of mercury in drinking water at 2 ppb.
The test results of baby foods and their ingredients “eclipse those levels: including results up to 91 times the arsenic level, up to 177 times the lead level, up to 69 times the cadmium level, and up to 5 times the mercury level,” notes the report.
'There is no safe level of lead for children'
While the FDA recently finalized a 100 ppb threshold for inorganic arsenic for infant rice cereals, it has not set thresholds for lead, mercury, or cadmium in infant foods, so when baby food brands tell reporters that they adhere to all FDA regulations, it is not clear what that means when it comes to metals aside from arsenic.
But that doesn't mean that firms have nothing to go on, observed Jackie Bowen, executive director at nonprofit The Clean Label Project, which tests foods for everything from pesticide residues to acrylamide.
Manufacturers should establish supplier assurance programs that screen for heavy metals, especially for high-risk products, she said: "While there may not be established federal tolerances, California's Proposition 65 has established limits for arsenic, cadmium, lead, and mercury and is arguably the most consumer protective regulation in the US when it comes to heavy metals.
"As to the old adage that the dose is the poison, contaminants like lead are the exception that prove the rule: The EPA, FDA, WHO, the CDC, the American Medical Association and the American Academy of Pediatrics have all independently stated there is no safe level of lead for children. In this case, the poison is the poison."
Asked whether testing for heavy metals is required under food safety laws, she said: "HARPC (Hazard and Risk-Based Prevention Controls) requires virtually every food manufacturer, processer, packer, and storage facility to: identify food safety and adulteration hazards associated with their foods and processes, implement controls to minimize the hazards, verify that the controls are working, and design and implement corrective actions to address any deviations from the controls that might arise in a food safety plan.
"Heavy metal contamination in the baby food supply chain and production process should be a preventative control that is accounted for within a FSMA compliant quality program."
Attorney: ‘I would be shocked if there was not litigation filed’
Asked whether the report might prompt civil litigation, Kevin Bell, partner at law firm Arnall Golden Gregory LLP, told FoodNavigator-USA that he “would be shocked if there was not litigation filed,” although the “question is whether they will be the frivolous litigations we have become accustomed to seeing from the plaintiff’s bar, or will there be more substantive allegations resulting from this report.”
He added: “Based on my experience, the named companies and their counsel have been in ongoing communications with members of the subcommittee and their staff throughout this process… This is baby food. Schadenfreude should not be the response.”
'I find it hard to believe that FDA was aware of the problem and didn’t take action'
Bob Durkin, formerly deputy director at the office of dietary supplement programs at the FDA, and now of counsel at Arnall Golden Gregory, added: "It is true that the FDA does not set specific limits for heavy metals in all types of food, but that does not mean that a food cannot be deemed adulterated if its heavy metal content renders it injurious to someone’s health.
"Some of the data reported is very concerning – the target population for the product is also one that is very at risk from the perils of heavy metal poisoning. I find it hard to believe that FDA was aware of the problem and didn’t take action. They could have purchased the products from retail sellers and conducted their own tests to determine if there was an issue. Either FDA was not actually aware of the situation, didn’t undertake their own testing, or they did test the products in question and the results wouldn’t support an adulteration charge."
FDA: ‘There is more work to be done’
So how has the FDA responded?
An official acknowledged that “there is more work to be done,” but told this publication that sampling showed manufacturers “had made significant progress in reducing arsenic in infant rice cereal products” since 2016. The agency did not say whether it is planning to set action levels for lead, mercury or cadmium in infant foods.
The FDA has been “providing consumers with actionable advice to limit exposure” to “toxic elements,” said the official: “For example, the FDA has communicated advice about the importance of feeding infants a variety of grain-based infant cereals. Rice cereal fortified with iron is a good source of nutrients for infants, but it shouldn’t be the only source and does not need to be the first one.”
'Providing consumers with actionable advice to limit exposure'
The official added: “Our scientists conduct research designed to help us better understand the problem and identify solutions. This includes estimating young children’s exposure to cadmium and lead using Total Diet Study data; improving existing methods to detect toxic elements in even more foods; assessing whether rinsing and cooking rice lowers arsenic levels and identifying new methods that will help us determine how simultaneous exposure to multiple metals may affect health.
“The toxicity of specific metals, the amount of intake, and a person’s age and developmental stage are all key factors that help determine how exposure to metals and other contaminants may affect individual health.”
The report calls for:
- Mandatory testing for toxic heavy metals in finished products, not just ingredients
- Labeling of levels of toxic heavy metals on pack
- Maximum levels of toxic heavy metals permitted in baby foods to be set by the FDA
How have the brands responded?
According to the report, Nurture Inc (HappyBaby), Beech-Nut, Hain Celestial (Earth’s Best), and Gerber responded to the subcommittee requests, while Walmart (Parent’s Choice), Campbell Soup (Plum Organics), and Sprout Foods did not cooperate, prompting “concern 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."
FoodNavigator-USA has contacted all of the brands referenced in the report for comment.
Plum Organics: 'Campbell has conducted testing on every Plum Organics product on the market'
Responding to allegations in the report that, “Campbell provided a spreadsheet self-declaring that every one of its products meets criteria’ but declined to state what those criteria are," a Campbell Soup spokeswoman said:
"Given the lack of specific FDA guidance on baby food, Campbell used standards from California’s Proposition 65, the EU and the WHO, along with general guidance from the FDA on lead not specific to baby foods—to develop a testing protocol for evaluating whether heavy metals in Plum Organics’ products exceeded levels that independent authorities had determined to be acceptable.”
Asked whether Plum Organics routinely tests its raw materials or finished products for the heavy metals in question, she added: "Campbell has conducted testing on every Plum Organics product on the market to ensure none exceed acceptable levels of arsenic, lead, cadmium, or mercury."
As to procurement strategies for high-risk ingredients, she said: "This issue has been and continues to be on the radar of our procurement team. We also share our quality requirements and guidelines for heavy metals with our external partners, including our contract manufacturers."
Walmart: ‘We comply with all applicable laws and regulations’
A Walmart spokesman told FoodNavigator-USA that the 2019 Healthy Babies Bright Futures report that prompted the congressional probe “tested 7 Walmart private label products and… the metals tested were within FDA guidance levels [although it is not clear what this means given that the FDA has not set guidance levels for metals with the exception of inorganic arsenic].”
Walmart had “provided information to the subcommittee nearly a year ago and invited more dialogue on this important issue but never received any additional inquiries,” he claimed.
Walmart’s private label suppliers must “comply with all applicable laws and regulations” and with “internal finished goods specifications, which for baby and toddler food means the levels must meet or fall below the limits established by the FDA,” he added.
Given that the FDA hasn’t set limits for lead, cadmium, and mercury, it is not clear what this means. He did not say whether Walmart has set internal guidelines for private label suppliers for these metals.
Gerber: ‘Where government standards don’t currently exist, we develop our own rigorous standards’
Gerber, which claimed that its safety and quality standards “are among the strictest in not just the US, but the world,” said that “where government standards don’t currently exist, we develop our own rigorous standards.”
To minimize the presence of metals in crops that naturally accumulate contaminants from soil, said a spokesperson, “We take multiple steps including prioritizing growing locations based on climate and soil composition; approving fields before crops are planted based on soil testing; rotating crops according to best available science; and testing of produce, water, and other ingredients.”
Gerber is also a founding member of the Baby Food Council, a group comprising baby food companies (Beech-Nut, Hain/Earth’s Best, Gerber, Danone/Happy Family Organics), academics, government, and NGO partners and advisors on a mission to reduce heavy metals in baby foods using best-in-class management practices, noted the spokesperson.
Hain Celestial: Report ‘inaccurately characterized our meeting with the FDA’
A Hain Celestial spokesperson said the company was “disappointed that the Subcommittee report examined outdated data and does not reflect our current practices.” The report – which claimed the “FDA received a secret slide presentation from Hain,” also “inaccurately characterized a meeting with the FDA,” said the company.
“Like any food producer, we meet with regulatory and oversight agencies to refine and update our policies and procedures to ensure the safety of our products. As science evolves, so too should our standards and practices, which is why we met with the FDA last year to discuss how to better refine those standards and practices.
“Following the meeting, we took several steps to reduce the levels of heavy metals in our finished products – including no longer using brown rice in our products that are primarily rice based, changing other ingredients and conducting additional testing of finished product before shipping.”
Happy Family Organics: 'We are disappointed at the many inaccuracies, select data usage and tone bias in this report'
Happy Family Organics said the test results referenced in the report were "not representative generally of our entire range of products at-shelf today," adding that it was "disappointed at the many inaccuracies, select data usage and tone bias in this report."
The report also failed to spell out that many everyday foods contain trace amounts of these elements, which are found in soil and water, whether they are prepared at home or sold as packaged food, added the company.
"We can say with the utmost confidence that all Happy Family Organics products are safe for babies and toddlers to enjoy, and we are proud to have best-in-class testing protocols in our industry... We are committed to progress and welcome additional guidelines from the FDA.
"Additionally, we are partnering with industry leaders in the creation of a Baby Food Standard with the shared goal of reducing the levels of heavy metals to as low as reasonably achievable."
Beech-Nut Nutrition: Our products are safe
Beech-Nut Nutrition said: "We want to reassure parents that Beech-Nut products are safe and nutritious. We are currently reviewing the subcommittee report. We look forward to continuing to work with the FDA, in partnership with the Baby Food Council, on science-based standards that food suppliers can implement across our industry."
How should parents respond?
Parents alarmed by headlines about 'toxins' in baby food are right to be concerned, but should think before throwing out their packaged infant foods, said Durkin at Arnall Golden Gregory.
"It would likely be a mistake for parents to suddenly begin to feed their children other food that may be dangerous and present other types of hazards. For example, homemade baby food could end up with a similar level of heavy metals, or worse, because parents would likely be making it from a lot of the same ingredients in the commercial versions."
Homemade baby food can also introduce microbiological risks if you are not careful, he added: "I would advise parents to let more details come out about the situation before they make any drastic changes."