In the spring of 2021, the U.S. Food and Drug Administration (FDA) announced the Closer to Zero initiative aimed at reducing exposures to elements such as lead, arsenic, cadmium, and mercury via children’s food. The FDA noted that they did not want to threaten the accessibility and affordability of nutritionally beneficial food (FDA, 2021). As part of the original initiative, the FDA stated that it would propose action levels for lead by April 2022, arsenic by April 2024, and cadmium and mercury sometime after April 2024.

The following fall, attorneys general from 23 states filed a petition urging the FDA to speed up this timeline, implement more stringent product testing, and tighten one of its existing limits for rice cereal (National Law Review, 2021). Just three months ago, in November 2021, Michael Hansen, PhD, senior scientist with the Consumer Reports advocacy group, provided testimony positing that there was enough data on heavy metal toxicity to warrant the FDA setting immediate standards on baby foods (Hansen, 2021). The FDA has until April 2022 to respond to this petition, and “[i]f the FDA denies the petition, the group of attorneys general could file a lawsuit” (Loria, 2021). 

How Can Paustenbach and Associates Help?

This petition comes on the heels of numerous class action lawsuits filed over the past year. While we wait for a response from the FDA, pressure is mounting on agencies and manufacturers to act at the behest of various consumer groups. Interestingly, Dr. Hansen, in his testimony, failed to discuss the importance of dose when claiming that there was ample information on metals in the literature to support accelerating the process. This is inconsistent with best scientific practices.

The lay press has often misunderstood why metals are present in children’s foods and the accompanying risks. The average individual probably asks why manufacturers don’t simply remove the metals from the food.

Consumers may assume that any metals that are present in the food are a sign that companies are careless and that their manufacturing practices increase the concentrations of these metals. However, metals and metalloids such as lead, arsenic, cadmium, and mercury are naturally present in soil and are absorbed by plants. It is not possible to grow these vegetables and fruits without some concentration of these metals being present. We, of course, agree that companies who make baby foods need to be fully aware of the sources of the metals and the hazard posed (if any). Like everything else, dose should drive the decision making.

Manufacturers need to understand doses which warrant concern, and they need to be sure that they consider the aggregate dose not only from their products but other sources of these metals to which children may be exposed (e.g., water, pica). 

Needless to say, for a firm to know what actions to take, they need to have a good understanding of toxicology, epidemiology, exposure science, and risk assessment. Risk communication and proper dialogue with regulatory agencies is necessary to ensure that stakeholders understand that there are safe doses of these metals and that it is impossible to remove all metals from foods like rice, beets, carrots, and virtually all vegetables.

Our firm has conducted dozens of analyses and risk assessments of heavy metals and metalloids, including lead, arsenic, and cadmium, and have published multiple papers on this topic (Keenan et al., 2010; Monnot et al., 2016; Paustenbach et al., 2016). Some of our staff have up to 25+ years of experience providing litigation support, characterizing hazards, and offering a range of possible solutions. Please contact us for more information regarding our capabilities. 

References

Closer to Zero: Action Plan for Baby Foods [Internet]. U.S. Food and Drug Administration; 2021; October 08, 2021. Available from: https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods

Keenan JJ, Le MH, Paustenbach DJ, Gaffney SH. Lead testing wipes contain measurable background levels of lead. Bull Environ Contam Toxicol. 2010;84(3):269-73. Epub 2010/01/21. doi: 10.1007/s00128-009-9926-y. PubMed PMID: 20087726.

Loria K. State Officials File Action for FDA to Get Heavy Metals out of Baby Food ASAP. 2021. Available from: https://www.consumerreports.org/baby-food/states-action-for-fda-to-get-heavy-metals-out-of-baby-food-a7632949407/.

Monnot AD, Tvermoes BE, Gerads R, Gürleyük H, Paustenbach DJ. Risks associated with arsenic exposure resulting from the consumption of California wines sold in the United States. Food Chemistry. 2016;211:107-13. doi: 10.1016/j.foodchem.2016.05.013.

National Law Review. AGs Petition FDA on Baby Food Heavy Metal Limits. 2021; XI.

Paustenbach DJ, Insley AL, Maskrey JR, Bare JL, Unice KM, Conrad VB, et al. Analysis of Total Arsenic Content in California Wines and Comparison to Various Health Risk Criteria. American Journal of Enology and Viticulture. 2016;67(2):179. doi: 10.5344/ajev.2015.15041.

Testimony of Michael Hansen, PhD, Senior Scientist (dated November 18, 2021): Hearing before the FDA Public Meeting: Closer To Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages for Babies and Young Children (December 20, 2021).