The report - released Feb 4 by the House Oversight Committee’s subcommittee on economic and consumer policy - alleged 'dangerously high' levels of heavy metals in leading baby food brands, prompting a torrent of lawsuits and the introduction of The Baby Food Safety Act in Congress, spearheaded by Rep. Krishnamoorthi.
Rep Krishnamoorthi (D-IL, chairman of the subcommittee) told us that the Baby Food Safety Act - which sets ultra-low thresholds for lead, mercury, cadmium, and inorganic arsenic in baby food – has significant support in Congress.
“I feel very good about the Act [which was introduced to Congress in March]. Speaker Pelosi endorsed it a couple months ago, and it has a lot of support in both the House and the Senate. Obviously, we have some other items that are coming up in September that are going to occupy a lot of bandwidth. But I expect that my office is going to make a big push on this once some of that other legislation gets addressed.”
‘We're going to need some changes in the law’
Separately, Krishnamoorthi has also filed a request for the upcoming reconciliation bill to include $50m to research ‘agricultural methods of reducing toxic heavy metals in crops that are used to make baby food,’ he said.
“I think this [the $50m funding request – which is also part of the Baby Food Safety Act] can be pushed separately and I think there's a chance that we may be able to get that done as part of the appropriations process, maybe through the agriculture appropriations process.
“But I think that with regard to the other issues [setting thresholds, requiring testing of finished foods, creating a public awareness campaign etc], we're going to need some changes in the law and I think that there's a lot of support for that.”
The Baby Food Safety Act
Under the Baby Food Safety Act, manufacturers of infant formula and baby foods for kids up to 36 months would be required to adhere to maximum levels of four heavy metals within a year of the act coming into effect:
- Inorganic arsenic (10 ppb, 15 ppb for cereal)
- lead (5 ppb, 10 ppb for cereal)
- cadmium (5 ppb, 10 ppb for cereal)
- mercury (2 ppb)
Given that the FDA hasn’t yet set action levels in baby food for any of these metals with the exception of 2020 guidance on inorganic arsenic in infant rice cereal (100ppb), and is currently working on a likely years-long process to determine action levels for other metals in foods for babies, how did the authors of the Baby Food Safety Act come up with the above thresholds? And how feasible are they?
According to Rep Krishnamoorthi, “We came up with those thresholds in part in consultation with experts, scientists, and also what the FDA has set for, for instance, bottled water, which they regulate pretty thoroughly. But in contrast, they don't [yet have thresholds] for what a lot of parents consider one of the most urgent priorities, which is baby food."
‘FDA needs to get on the ball and needs to make sure that we do what the science requires, as opposed to, what, potentially industry is asking for…’
“In addition,” he said, “I would just respectfully mention that the 100 parts per billion for inorganic arsenic for babies’ cereal [set by the FDA last year] seems to be a random number; it doesn't have any basis in science, or what is required to keep babies safe. And even then, industry routinely fails to meet that standard.
“And so, I think, at this point, FDA needs to get on the ball and needs to make sure that we do what the science requires, as opposed to, what, potentially industry is asking for. Parents are demanding it right now.”
Feasibility should not be a guiding factor when setting thresholds, meanwhile, he claimed, noting that if the targets in the Baby Food Safety Act are not achievable with existing recipes, baby food brands should simply reformulate their products.
“If it is not possible, or it is exceedingly costly, to source ingredients like rice that achieve a safe level, then baby food manufacturers should find substitutes for those ingredients.”
Are thresholds for water relevant to baby food?
Asked about the fact that toxicologists say thresholds for drinking water, for example, are not immediately relevant to thresholds for other food categories, and that describing the levels of heavy metals found in some baby foods as ‘astonishingly high’ is speculative given the absence of established thresholds for these metals in infant foods, he said:
“This sounds like industry scientists to me saying this. I think that the truth of the matter is that a lot of folks would be mystified as to why we would allow only two parts per billion of lead, for instance, in bottled water [editor’s note: to date, the FDA has set maximum allowable levels in bottled water at 5ppb lead, 5ppb cadmium, 2ppb mercury, and 10 ppb inorganic arsenic, while the EPA has capped the maximum contaminant level of contaminants in drinking water at 15ppb for lead, 10ppb for arsenic, 2ppb for mercury and 5ppb for cadmium] but we would allow for hundreds if not, you know 1,000 parts per billion of lead in baby food.
“So if these scientists and others believe that two parts per billion of lead is not the right threshold for baby food, then they should tell us exactly what the threshold is [the FDA says it is working on this and can’t come up with thresholds before it has completed its work, with Dr Conrad Choiniere, director of the Office of Analytics and Outreach at FDA’s Center for Food Safety and Applied Nutrition noting in July that thresholds must be "science-based, not arbitrary, not capricious"].
‘Industry has done a very poor job of regulating itself’
Rep Krishnamoorthi added: “I think the FDA has been absent without leave on this issue, and a lot of parents are just shocked that FDA has not regulated this area much more closely.
“Now, I’m definitely encouraged that acting [FDA] commissioner [Janet] Woodcock announced the ‘Closer to Zero’ campaign in reaction to my report and has shown some greater sense of urgency on this issue and is working with our office in part to try to get more resources to FDA to start to regulate this field a little more closely, even as we're pushing legislation.
“However, I have to say that industry has done a very poor job of regulating itself, and I think people to put it mildly were surprised to learn of the levels of arsenic, cadmium, lead and mercury in baby food.
“FDA must hustle at this point, because the problem is plain to see, and as I said before, people across the ideological spectrum - namely parents - are very concerned that they have little guidance as to what to do. And most importantly, they don't know if the food that they're buying off the shelves is safe for their infants.”
The takeaway for parents?
So what did Rep Krishnamoorthi hope that parents would take away from his report, which Dr Choiniere told delegates at a virtual event over the summer had “shocked and confused parents,” and left some with the impression that the problem was processed baby food from large food companies (when in fact this is an industry-wide issue), and that the solution was buying organic (not the case), or making their own baby food from the produce section of the store (which would not address the issue).
“I think parents should take away a couple things [from the Feb 4 report],” he said. “One, they must vocalize their concerns and hold officials accountable, including FDA, the Biden administration, members of Congress and others to make sure that we address this problem, that's the first thing.
“The second is, we know that, for instance, inorganic arsenic is present in high levels, with regard to rice cereals and rice products, just as an example, so whatever, parents can do to moderate the usage of that particular product, and start to use others in feeding their children and their babies, the sooner the better.”
He added: “My wife and I have three kids, we were a profit center for baby food companies for many years, and we know it's really tough and we were shocked to learn about the results of this investigation.
“But I think that now we have information, it’s time to really diversify babies’ diets, and to make sure FDA and industry come up with foods that are safe for their children.”
Farming and processing: ‘We have to go one step back’
Asked how companies should respond to this issue, he said: “The toxic heavy metals, unfortunately, are present in the crops, and the method of farming, and, you know, even fertilization, plus the additives that industry incorporates into the process, cause the presence of these toxic heavy metals to intensify and concentrate [his office explained that Rep. Krishnamoorthi was "referring to how the final products sometimes have higher levels of the toxic heavy metals than the raw ingredients, which is why measuring the final products instead of raw component ingredients is important"].
He added: “We have to go back to step one and try to figure out how to grow the crops in a way that reduces the presence of these types of heavy metals, avoid additives that introduce even greater amounts of these metals into the process, test the products including the finished products to make sure we're going in the right direction, and then head to zero, over time.
"We must also give parents enough information that they can make the right choices, and that's why we're calling for an educational campaign in that regard [the Baby Food Safety Act would establish a public awareness campaign through the CDC to highlight the risks posed by toxic heavy metals in baby food].”
Tsunami of lawsuits: ‘That's usually what happens when the truth gets out’
To those arguing that a more constructive approach would have been to work with FDA and industry to fast-track work already in progress rather than publishing a report that prompted a wave of lawsuits and scared parents, he said: “I think the companies anticipated that [they would be sued] once the truth got out, and that's in part why there was a mystery surrounding so much of this information for so long.
“That's usually what happens when the truth gets out, people then want to hold industry accountable, and that's why there has to be more transparency, there has to be more information given to the public and to parents, who are petrified right now.
“When companies and industries are left to self-regulate, the results are very bad.”
‘When Congress asks for information, industry knows they need to cooperate’
Asked whether singling out a handful of large companies in the report was helpful to parents given that many cash-strapped smaller companies they might turn to instead are likely doing far less than many of the companies named in the Subcommittee report, he said: “I think all of them [baby food companies] have some explaining to do.
“In fact, after four of the seven companies initially responded, we started receiving information from the others including Walmart, Campbells’s and Sprout Organic Foods, and I think the reason is plain, which is when Congress asks for information, industry knows they need to cooperate.
“Now here's the rub, which is that for all the other companies that may not have been the subject of the investigation, they're going to have to follow the standards that come out of this investigatory process.”
Attorney: Report seemed ‘blatantly alarmist, while at the same time being devoid of context’
So what do food safety and legal experts make of Rep Krishnamoorthi’s comments?
While his report “may have realigned FDA priorities and dedication of resources,” and provided a kick up the metaphorical backside to industry and regulators, the tone was unhelpful given that this is an issue that the industry has been working on for some time with the FDA, said Bob Durkin, formerly deputy director at the office of dietary supplement programs at the FDA, and now of counsel at Arnall Golden Gregory.
“It seemed blatantly alarmist, while at the same time being devoid of context parents, healthcare providers, and regulators require to make informed decisions."
An 'uninformed statement’
To suggest, meanwhile, that the 100ppb threshold set by the FDA in 2020 for inorganic arsenic in infant rice cereal is a “random number” that “doesn't have any basis in science,” is “an uninformed statement,” he claimed.
“When FDA looks at setting a limit for a specific toxic element in a specific food, such as a heavy metal in baby food, it’s going to consider - in the case of baby food, for example - the physiology of babies, the consumption habits of babies, and the exposure to babies [of the toxic element] and so on as well as what mitigations are achievable by regulated industry, to lower the amount of any toxic element, without making a single jar of baby food cost $15.”
Asked whether action levels set by the FDA or other regulatory agencies for other food & beverage categories such as drinking water or bottled water were relevant to a discussion on action levels for baby foods (action levels for bottled water are frequently cited in lawsuits as a reference point, for example), he said:
“It’s a different product, a different demographic, and a different consumption rate, and there are different technologies available for mitigating or preventing toxic elements in water relative to baby food.”
FDA adopting a 'collaborative, science-based, iterative approach'
The FDA told FoodNavigator-USA that its approach is "focused on optimizing public health by reducing exposure through a collaborative, science-based, iterative approach."
A spokesperson added that using the FDA’s 100ppb action level for inorganic arsenic as a guide and through good manufacturing practices, such as selective sourcing and testing of rice and rice-derived ingredients such as rice flour, manufacturers are making good progress.
"Results from sampling in 2018 show that 76% of samples were at or below the 100 ppb action level, compared to 47% of samples tested in 2014 and 36% of samples tested between 2011-2013. Both white rice and brown rice cereals showed improvement in meeting the 100 ppb level, but the improvement was greatest for white rice cereals, which tend to have lower levels of inorganic arsenic overall."
As for the Closer to Zero plan, the spokesperson said: "For each of the four contaminants, we will evaluate the current science to develop a reference level; use that reference level and other important information to develop an action level for specific categories of foods. During this process we will work closely with stakeholders to help assess achievability of the proposed action levels; monitor progress in reducing levels in foods; and review the emerging science, to determine if further adjustments to the action levels are needed, gradually moving levels closer to zero each time."
FDA official: 'We have faced a great deal of criticism and we do hear some very strong viewpoints, some of which we don't necessarily agree with'
Speaking at the virtual Institute of Food Technologists annual meeting & Expo this summer, Conrad Choiniere, Ph.D., director of the Office of Analytics and Outreach at FDA’s Center for Food Safety and Applied Nutrition, said solutions must be “science-based, not arbitrary, not capricious, and legal,” and that takes time.
"By 2024, we should have action levels for most of the toxic elements for the various foods [commonly consumed by babies and young children]," he predicted. "Some will be drafts and some will be final.”
Dr Choiniere did not say whether the FDA considered the thresholds set in the Baby Food Safety Act to be arbitrary or capricious, but noted that, “We don't want to move too quickly or too aggressively and create some really expensive foods, or take foods off the market because manufacturers are not able to meet zero.
He added: “Oftentimes people aren't happy with us, but we're not trying to make people happy, we're just trying to find the right solution… We have faced a great deal of criticism and we do hear some very strong viewpoints, some of which we don't necessarily agree with...”