Commercially produced baby foods are often the primary, if not the sole, source of nutrition for infants as they are weaned off formula or breast milk. As such, parents place a great deal of trust in the quality and safety of these foods. That trust is now under question with the early February Congressional Report: “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury, and the lack of any major reassurance provided by the FDA Response to Questions About Levels of Toxic Elements in Baby Food. What do the report and response say, and what should the industry take-away from that? The Congressional Report contains a great deal of data showing how certain baby food-production companies are exceeding certain regulatory levels – and even some of their own – thresholds for heavy metals, including arsenic, lead, cadmium, and mercury.  The report points out that some of the levels found exceed the standards of drinking water and EPA standards.  The report makes the point that this is even more critical with babies being a high-risk population.  “Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children [and] endanger infant neurological development and long-term brain function.” The report came down hard on the Trump Administration for ignoring an August 2019 “secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods.” It is now posing the challenge the new administration to do something about the critical issue, recommending the following five points for FDA to address: The Subcommittee recommends the following:

1. Mandatory Testing: Only one of the companies reviewed by the Subcommittee routinely tests its finished baby foods, even though the industry is aware that toxic heavy metals levels are higher after food processing. FDA should require baby food manufacturers to test finished products, not just ingredients, for toxic heavy metals.
2. Labeling: FDA should require manufacturers to report levels of toxic heavy metals on food labels.
3. Voluntary Phase-Out of Toxic Ingredients: Manufacturers should voluntarily find substitutes for ingredients that are high in toxic heavy metals or phase out products that have high amounts of ingredients that frequently test high in toxic heavy metals, such as rice.
4. FDA Standards: FDA should set maximum levels of inorganic arsenic, lead, cadmium, and mercury permitted in baby foods. One level for each metal should apply across all baby foods and be set to protect babies against neurological effects.
5. Parental Vigilance: Parents should avoid baby food products that contain ingredients testing high in heavy metals, such as rice products. The implementation of recommendations one through four will give parents the information they need to make informed decisions to protect their babies.

The report is clearly pushing FDA to make significant changes. However, FDA is in a tough spot. The report does not consider the overall cumulative impacts of the levels found, nor does it take into account the food matrix and the impact of the food on the absorption of heavy metals.  Fundamentally the report is focused on the actual levels, then leaps to assume it poses a significant health risk – but does not actually connect the dots. As noted, the report puts FDA in a tough spot because the Agency cannot simply ignore the report, nor can it create fear or panic in consumers about the risk.  Heavy metals are very complex to manage since they are present in soils and as such very difficult, if not impossible, to control. On February 16, FDA responded to the report, not really responding to the five requests but more kicking the can down the road, as it did not speak to the fundamental issue or address any of the five points directly. Rather, stating that toxic elements, such as arsenic and lead occur in the environment, “currently they cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals made by companies or by consumers who make their own foods.” In my opinion, FDA is correct in this statement – the key question is whether the levels found actually pose a risk that requires a different regulatory strategy. While true that they cannot be completely avoided, the levels can be contained and regulated to safe levels, particularly in foods for vulnerable populations. So FDA’s statement that it has, for example, been sampling infant rice cereal since 2011 with manufacturers showing “significant progress in reducing arsenic” does little to reassurance parents when arsenic levels were found to significantly exceed the FDA threshold of 100 ppb, which itself is “far too high to protect against the neurological effects on children.” So far, this report has not generated a massive media focus – but it may in time.  FDA’s statement that it “takes exposure to toxic elements in the food supply extremely seriously” also rings a little hollow when it passes the buck stating that it is the manufacturers’ and retailers’ “legal responsibility” to ensure product safety. And its reassurance that FDA scientists routinely monitor levels of toxic elements in baby foods, and the agency reviews company information and acts on a case-by-case basis simply raise the question and doubt when the actual levels of toxic elements are revealed. The most direct response FDA gives is that it has communicated advice about the importance of feeding infants a variety of grain-based infant cereals so that rice cereals are not the only source. However, this still does not address the recommendation to give parents the information they need to make informed decisions to protect their babies. Just as the 2011 findings of elevated levels of arsenic in apple juice brought this to the forefront with public pressure from consumer groups eventually leading to new FDA regulations, so, too, has this Congressional Report put heavy metals very squarely back on the radar screen – and we don’t expect to see it blipping off the screen without further action. In my opinion, one of the most important strategies for the food industry to consider is an in-depth risk analysis of the impact of these findings on public health. Likely this has been done or is being done.  If there is a risk, the food industry will have to act. If there is no risk, then there needs to be better communication and education of the public. We can only agree with the closing paragraph of the Report’s Executive Summary: “Baby food manufacturers hold a special position of public trust. Consumers believe that they would not sell products that are unsafe. Consumers also believe that the federal government would not knowingly permit the sale of unsafe baby food..” While the report puts the onus on FDA, FDA’s flipping of that responsibility to manufacturers should not go unnoticed. And its lack of direct response is likely to be challenged and lead to an increased focus on heavy metals as a whole. So whether you produce baby food or any other food product, it is critical to not only keep an eye on the radar screen but take a new look at your own heavy metal testing and results – of both ingredients and finished product, whether required or not because there is a real risk that concerns around heavy metals will spill over into other food types with a broader consumer focus as it has in the past.