EDF Health

A closer look at FDA’s “Closer to Zero” plan to reduce for heavy metals in children’s food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 21, 2021

Tom Neltner, J.D. is the Chemicals Policy Director.

This month, the Food and Drug Administration (FDA) released its “Closer to Zero” action plan to reduce exposure to heavy metals in foods for babies and young children. The plan, released in response to a recent House of Representatives Committee on Oversight and Reform report and the introduction of the Baby Food Safety Act in both the House and the Senate, is a step forward since it commits the agency to specific actions and general deadlines for the first time. However, there is room for improvement, specifically the agency should:

  1. Explicitly consider the cumulative effect of heavy metals on neurodevelopment when setting limits.
  2. Move up deadlines for draft action levels for arsenic and cadmium;
  3. Be consistent in messaging that there is no safe level of lead in children’s blood;
  4. Define what “as low as possible” and “children’s food” means as soon as possible;
  5. Be transparent by posting testing data quickly; and
  6. Add milestones for compliance verification with action levels and preventive controls.

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House Oversight Committee draws renewed attention to heavy metals in baby food and calls for FDA to act

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 11, 2021

Tom Neltner, J.D. is the Chemicals Policy Director.

Last week, the House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy released an important report summarizing baby food testing data submitted by four companies (Beech-Nut, Gerber, Happy Family, and Earth’s Best), finding that “baby foods are tainted with dangerous levels of arsenic, lead, cadmium and mercury.” These heavy metals are widely recognized as harming children’s brain development.

The report found that three of the four companies (all but Gerber) used ingredients that had exceeded limits set in their internal standards. Additionally, the committee cited “grave concerns” that three other companies (Walmart, Plum, and Sprout) did not provide their internal standards and testing results in response to the legitimate request by the House Committee. Their lack of transparency undermines credibility and trust.

Due to the alarming nature of these findings about a food marketed as safe and healthy for infants and toddlers, the report garnered significant attention and has prompted calls for the Food and Drug Administration (FDA) and food manufacturers to do more on this issue.

Importantly, the report provides new insights into industry decision-making processes, highlights the need for greater oversight, and adds urgency to EDF’s ongoing efforts to reduce heavy metals in food.

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When it comes to testing heavy metals in food, the result is only as good as the lab.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 23, 2020

Tom Neltner, J.D., Chemicals Policy Director and Boma Brown-West, Senior Manager.

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“Even though the levels of a metal in any particular food is low, our overall
exposure adds up because many of the foods we eat contain them in small amounts.”

 

Dr. Conrad Choiniere, leader of FDA’s Toxic Elements Workgroup on April 20, 2018

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Heavy metals such as arsenic, cadmium, and lead are present in most foods, whether conventional or organic, usually as the result of environmental contamination. Because heavy metals pose significant threats even at low levels, the Food and Drug Administration (FDA) has made reducing cumulative exposure a priority. The Baby Food Council – consisting of Beech-Nut Nutrition Company, Happy Family Organics, Earth’s Best, and Gerber Products Company and supported by Healthy Babies Bright Futures (HBBF), Cornell University and EDF – shares this goal and seeks to reduce heavy metals in the companies’ products to as low as reasonably achievable using best-in-class management practices.

Through the Council, EDF is coordinating a proficiency testing program to enable retailers, food manufacturers, ingredient suppliers, and others to identify laboratories that are capable of measuring arsenic, cadmium, and lead at levels in the low parts per billion (ppb). The Council has arranged for FAPAS, a leading proficiency testing provider for the food and water testing industries, to manage the testing program.

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For children’s food, heavy metals require more attention and better standards

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 12, 2018

Tom Neltner is Chemicals Policy Director and Michelle Harvey and Maricel Maffini are consultants

In June 2017, EDF released Lead in Food: A Hidden Health Threat. The report examined a decade’s worth of data from the Food and Drug Administration (FDA) and found lead detected in 20% of baby food samples compared to 14% for other foods. Eight types of baby foods, including fruit juices, root vegetables, and teething biscuits, had detectable lead in more than 40% of the samples. We closed the report with the following recommendation:

In the meantime, parents should consult with their pediatrician to learn about how to reduce lead exposure. They should also check with their favorite brands and ask whether the company regularly tests their products for lead, and ensures that, especially for baby food, there is less than 1 ppb of lead in the food and juices they sell.

As described below, we have reason to believe it will take more focused effort on the part of both FDA and food companies to ensure consistently low levels of heavy metals – lead, arsenic, and cadmium in particular – in infant’s and toddler’s diets.

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FDA details its new push on heavy metals in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 25, 2018

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant

In May 2017, the US Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) announced it had “established a Toxic Elements Working Group whose mission in part is to develop a strategy for prioritizing and modernizing the Center’s activities with respect to food/toxic element combinations using a risk-based approach.” FDA set a goal of limiting lead “to the greatest extent feasible.”

In April 2018, FDA released an interview with the Working Group’s chair, Conrad Choiniere, providing an update on its activities. An overarching point expressed by Choiniere during the interview is that “these metals [lead, arsenic, cadmium and mercury] can have effects on children’s neurological development.” This affirmation of scientific evidence is a welcome sign from the agency. FDA’s key statements are:

  • Initial scope: Children’s exposure to “metals like lead, arsenic, cadmium, and mercury in foods, cosmetics, and dietary supplements.”
  • Approach: “Looking at all the metals across all foods rather than one contaminant, one food at a time.”
  • Initial findings: “Even though the level of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”
  • Next steps:
    • “Finalizing the draft guidance that sets an action-level for the presence of inorganic arsenic in infant rice cereals and apple juice.”
    • “Begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 6, 2018

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant.

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Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

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In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

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