Speaking on a packed zoom call at the virtual Institute of Food Technologists annual meeting & Expo (IFT FIRST) on Tuesday, Conrad Choiniere, Ph.D., director of the Office of Analytics and Outreach at FDA’s Center for Food Safety and Applied Nutrition, said the report was “highly critical of manufacturers as well as the FDA, citing us for a lack of action.”
But he added that the report also “shocked and confused parents of young children… many of them tossed out the jars of baby food they had in their pantry, believing that these products were being recalled. They were not being recalled.”
Buying organic does not solve the problem
While the report did acknowledge that arsenic, lead, cadmium and mercury are present in soil and water and can be sucked up by plants, this was lost on many parents, who assumed that ditching ‘processed’ baby food and instead buying organic foods, or making their own baby food by shopping the produce aisle or buying canned vegetables or fruits was the solution, which is not the case, he stressed.
“The crops that are used to produce baby foods are also the crops that are used to fill the produce aisle [in the supermarket] or the crops that are used in canned goods in stores, so you're going to find contamination with lead and arsenic and the others across all of those types of foods, including organically grown foods.”
"By 2024, we should have action levels for most of the toxic elements for the various foods [commonly consumed by babies and young children]. Some will be drafts and some will be final.”
Baby Food Safety Act: ‘We don’t comment on pending legislation’
Asked by FoodNavigator-USA if lawmakers had jumped the gun by setting (very low) action levels for heavy metals in the Baby Food Safety Act (introduced to Congress in late March) when the FDA had not yet determined what levels might be appropriate based on the available science, he said: “We don't comment on pending legislation.”
Asked whether the FDA had been consulted by lawmakers drafting the Bill, he said: “As a matter of course, for many pieces of legislation, we may get asked for some technical input, not necessarily what levels should be or things like that, but they might just write something and give it to us and ask us to comment, and sometimes our comments are taken [up] and sometimes they are not.”
Solutions must be ‘science-based, not arbitrary, not capricious…'
While fixed thresholds can help manufacturers testing their wares for heavy metals know if they are in the right ballpark and potentially defend themselves against litigation (brands named in the report are currently facing 86+ lawsuits), solutions must be “science-based, not arbitrary, not capricious, and legal,” and that takes time, he said, noting that the FDA expects to have draft guidance out for comment for action levels on lead across various foods commonly consumed by babies and young children by April 2022.
“By 2024, we would finalize that action level, but it can take up to anywhere from two to three years for a process to establish these levels, and we have staggered them, so arsenic would be at least a year after lead, and cadmium and mercury will be staggered a year or so after… there's more science that's needed for us to understand the effects of mercury, which generally speaking, is not found in many foods, with the exception of seafood.”
Overly aggressive targets could be counterproductive
Dr Choiniere did not say whether the FDA considered the thresholds set in the Baby Food Safety Act to be arbitrary, capricious or unrealistic, 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.
“And so we believe the best way… is to take gradual steps to reduce contaminants over time, giving industry time and giving growers time to implement best practices that will reduce the uptake of those contaminants, as well as providing guidance to consumers about how best to provide their children with nutritious foods.”
While some commentators feel that the FDA has been caught on the back foot, he noted that the agency is constantly talking to other regulatory bodies around the world about heavy metals and has been looking at the issue for some time.
“We have taken a look at the EU standards and their regulations and they have some established levels for foods where we do not [lead and cadmium levels are set for infant formula in the EU, for example], but generally speaking, there’s not that much of a difference in terms of the foods that are covered by EU standards as well as the level that they have selected. So for instance, they also use 100ppb [threshold for inorganic arsenic] for rice foods intended for infants."
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...”
That said, the report and the fallout had prompted a change in the agency’s communications strategy, he said: “We have often in the past been in a reactive mode where we react to stories that are in the press about contaminants in food supply after parents have already been frightened, so we are shifting to a more proactive approach.”
Congressman Raja Krishnamoorthi – who chairs the Subcommittee on Economic and Consumer Policy which released the recent baby food report – says feasibility shouldn't be a guiding factor in setting action levels for heavy metals in baby food.
If the challenging targets in the Baby Food Safety Act are not achievable with existing recipes, he said, baby food brands should 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.”
(Picture courtesy of Rep. Krishnamoorthi's office.)
Is the action level for one category relevant to other categories?
Asked whether action levels set by the FDA or other regulatory agencies for other food & beverage categories such as drinking 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 not the level that's in the food [that matters per se]. It's the amount of exposure from that food… how much of that food is being consumed? Water is consumed on a much higher level than rice for instance, so you would expect a lower level [of heavy metals] in water. So we don't believe there's a one size fits all approach or one level you can establish across all groups.”
Refined white rice has lower inorganic arsenic than brown rice
Delving into rice, a particularly problematic crop when it comes to heavy metals, which some baby food brands avoid altogether, he said more work is needed to determine why rice from certain places might present greater risks than others, noting that different varietals may also have a bearing on heavy metal uptake.
Dr Jing Zhao from California State University of Los Angeles also noted that arsenic tends to be concentrated in the fibrous bran (outer layer) and protein-rich germ (very inner layer) of rice grains, such that refined white rice – which is basically just the starchy endosperm – is therefore a safer bet when it comes to heavy metals.
Potential benefits here, of course, must in turn be weighed against the negative impact of removing the parts of the grain that contain healthy fibers, vitamins and minerals.
Dr Choiniere added: “Brown rice may have a higher level of nutrients that are beneficial for development, in addition to perhaps higher levels of arsenic, but I do know that manufacturers have switched to using more white rice in their infant rice products and there has been a resulting reduction in arsenic exposure.”
Closer to Zero
Unveiled in early April, FDA’s Closer to Zero action plan set forth its approach to reducing exposure to toxic elements in foods commonly eaten by babies and young children.
The move followed a torrent of lawsuits filed against baby food brands named in the Feb 4 Congressional SubCommitee report and follows the introduction of The Baby Food Safety Act in Congress, which proposed action levels for four heavy metals in baby foods, although the FDA has yet to evaluate the scientific basis for such thresholds.
While the ultimate goal is to get levels of arsenic, lead, cadmium and mercury down as close to zero as possible in baby foods, the FDA says it is “sensitive to the fact that requiring levels that are not currently feasible could result in significant reductions in the availability of nutritious, affordable foods that many families rely on for their children."
It added: "Through this plan, we’ll also take measures to ensure that limiting exposure to toxic elements in foods does not have unintended consequences—like limiting access to foods that have significant nutritional benefits by making them unavailable or unaffordable for many families, or unintentionally increasing the presence of one toxic element when foods are reformulated to reduce the presence of another.
FMI: The Food Industry Association welcomed the plan, adding that “federal standards regarding these elements in baby food should be evaluated by FDA and guided by science,” while Consumer Reports, which is backing The Baby Food Safety Act (currently sitting with the House Committee on Energy and Commerce) said Congress "should not wait for the FDA to act.”