NCHR Comments on FDA Guidance for Lead Levels in Food for Babies and Young Children

March 27, 2023

We are writing to express our views on the Food and Drug Administration (FDA) Draft Guidance regarding Action Levels for Lead in Food Intended for Babies and Young Children.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Improved standards for lead in food labeled for babies and young children are essential. They should be implemented as soon as possible, and should be enforced. The pediatric population is more vulnerable to lead and other toxic elements due to children’s greater intestinal absorption capabilities and higher food intake relative to body weight.1 In fact, children consume approximately three times as much food as adults compared to their body mass.2 The toxicity of heavy metals in children depends on the exposure frequency to a specific metal. Therefore, their risk of accumulating toxic elements from their diet is at least triple that of adults.3 A recent study evaluating the presence of lead and other heavy metals found lead in 100% of grain samples, 88% of root vegetable samples, 33% of fruit samples, and 22% of leguminous vegetable samples.4

Exposure to lead may delay puberty, stunt postnatal growth, and harm the central nervous system (for example, decreased IQ, poor academic achievement, and increased attention-related and problem behaviors).5 Since nearly 80% of brain development occurs within the first 1,000 days of life, exposure to excess lead at this time may be especially harmful.

FDA must do more to protect babies and young children from the significant risks associated with lead exposure as soon as possible and the levels should be lower than those proposed in this new draft. The FDA Closer to Zero initiative, launched in 2021, identifies actions to reduce exposure to toxic elements, including lead, from foods eaten by babies and young children to as low as possible. Unfortunately, this initiative has made little progress. The action levels proposed in the new FDA draft are a step toward this goal but do not go far enough, since they still allow substantial levels of lead and other toxic materials in these products. The levels should be lower.  Moreover, even if implemented as drafted, this proposal will likely not impact lead consumption for several years, allowing millions of babies to continue ingesting heavy metals from baby foods.

Therefore, in addition to lowering the levels of lead, the FDA should set a more aggressive timeline to achieve new action levels. We know manufacturers can do this based on what the E.U. did in 2021. The EU government imposed new limits for toxic metals in baby foods that are lower than those proposed here and required compliance within a month.6,7 Some larger, international corporations sell baby food in both the U.S. and the E.U. If they can meet lower limits in one region, we shouldn’t let them off the hook in the U.S.

Currently, infant food manufacturers set their own internal standards for toxic heavy metal content for most ingredients and products. However, many companies allow dangerously high levels and continue to use ingredients and sell products that exceed their own limits. For example, one company, Nurture, uses internal standards that “are not used to make product disposition decisions and are not a precondition to product release.”8 In fact, internal documents revealed that they sold all products tested, regardless of how much toxic heavy metal the baby food contained. According to company policy, Nurture’s toxic heavy metal testing is not intended for consumer safety. This example, and others, were detailed in a 2021 House Oversight and Reform Committee report related to seven of the largest manufacturers of baby food in the United States.8 Other examples included Hain (Earth’s Best Organic), which set internal standards for lead at 200 ppb but exceeded its policy selling products containing over 350 ppb. Internal company standards are set too high and can be disregarded anyways; too often safety does not appear to be a company’s highest priority.8

We encourage the FDA to also establish limits for other dangerous heavy metals commonly found in foods for babies and children. For example, arsenic, mercury, and cadmium are dangerous heavy metals commonly found in baby food. The Agency for Toxic Substances and Disease Registry lists arsenic on top of its list of substances that pose a threat to human health.9 Lead and mercury follow as numbers two and three, respectively. Arsenic affects multiple organ systems, with its most severe impact on cognitive development in children.10 However, the FDA only sets a standard for arsenic in bottled water and baby rice cereal. We urge the FDA to prioritize eliminating all of these dangerous elements in all baby foods.

In its Summary of FY 2024 Legislative Proposals, the FDA seeks to expand its authority so it may establish and enforce binding limits on toxic elements in foods.11 We strongly agree that the agency should have the power to hold manufacturers accountable if their products exceed limits set by the FDA. As outlined in the introduced Baby Food Safety Act of 2021, the FDA should require facilities involved in making infant and toddler foods to have controls and plans to ensure their food products comply with limits on toxic substances. The bill also allows the FDA to recall contaminated foods that exceed limits on hazardous elements. The ability to enforce standards is critical to keeping baby foods safe.

We strongly support the reintroduction of the Baby Food Safety Act in the 118th Congress to lower the levels of heavy metals in foods consumed by babies and young children. But rather than wait for Congress to act, FDA should move expeditiously as we have recommended above.


1. Lima de. Paiva, E., Morgano, M., Arisseto-Bragotto, A. (2019). Occurrence and determination of inorganic contaminants in baby food and infant formula. Curr Opin Food Sci. 30:60–6. doi: 10.1016/j.cofs.2019.05.006

2. Signes-Pastor, A., Woodside J., McMullan, P., et al. (2017). Levels of infants’ urinary arsenic metabolites related to formula feeding and weaning with rice products exceeding the EU inorganic arsenic standard. PLoS ONE. 12:e0176923. doi: 10.1371/journal.pone.0176923

3. Bair, E. (2022). A Narrative Review of Toxic Heavy Metal Content of Infant and Toddler Foods and Evaluation of United States Policy. Front. Nutr.

4.  Parker, G., Gillie, C., Miller, J., Badger, D., Kreider, M. (2022). Human health risk assessment of arsenic, cadmium, lead, and mercury ingestion from baby foods. Toxicol Rep. 9:238–49. doi: 10.1016/j.toxrep.2022.02.001

5. Dubey, V. (2022). Guest Commentary: What Happened to the Baby Food Safety Act? The Davis Vanguard.

6. Commission Regulation (EC) No 1881/2006 of 19 December 2006 Setting Maximum Levels for Certain Contaminants in Foodstuffs (Text with EEA Relevance)Text with EEA Relevance.; 2023. Accessed March 21, 2023.

7. Guest Commentary: What Happened to the Baby Food Safety Act? | Davis Vanguard. Accessed March 21, 2023.

8. U.S. House of Representatives. (2021) Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury.

9. Substance Priority List | ATSDR. Published March 17, 2023. Accessed March 21, 2023.

10. Bair EC. A Narrative Review of Toxic Heavy Metal Content of Infant and Toddler Foods and Evaluation of United States Policy. Frontiers in Nutrition. 2022;9. Accessed March 21, 2023.

11. Food and Drug Administration. (2023). Summary of FY 2024 Legislative Proposals.