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  1. Environmental Contaminants in Food

Closer to Zero: Reducing Childhood Exposure to Heavy Metals from Foods

Closer to Zero - Reducing Children's Exposure to Metals from Food

About | The Closer to Zero Process | Setting Action Levels  
Understanding the FDA’s Approach | FDA Action Levels | FAQs, References, & Announcements
 

For Parents and Caregivers

Naturally, you might have questions about heavy metals in foods. FDA has answers. Check out the resources below for more information. 

About Closer to Zero

Baby foods can provide essential nutrients that support growth and development of babies and toddlers. Foods such as pureed and packaged fruits and vegetables, along with whole grains, dairy, and proteins, deliver vitamins and other nutrients that are essential for brain development, immune function and bone strength. Because foods get their nutrients from the environments where they are grown and raised, they can also absorb trace amounts of heavy metals present in those environments, such as arsenic, cadmium, lead and mercury.

Through the Closer to Zero initiative, the FDA is working with the food industry to make baby food even safer than they already are by further reducing low levels of heavy metals. This page describes the FDA’s ongoing process to progressively drive down levels of heavy metals to ensure food intended for babies and young children is as safe as it can be.   

The Closer to Zero Process

To meet the goals of Closer to Zero, the FDA focuses on:

Research and Analysis:

  • Developing new and improved testing methods to measure lower levels of heavy metals in food;
  • Conducting surveys on foods commonly eaten by infants and young children, specifically processed foods for infants and children, to understand variability in concentrations of arsenic, lead, cadmium, and mercury in these foods;
  • Developing and updating dose-response models to better characterize dose-response relationships for different adverse health effects and different sub-populations, including infants and young children, as data become available;
  • Evaluating consumption patterns for different populations and measuring dietary exposures to these heavy metals;
  • Characterizing health effects from exposure to these heavy metals and identifying benchmark levels;
  • Understanding how and whether nutrients can help protect against the health effects associated with heavy metals;
  • Evaluating potential impact of new technologies, interventions, or mitigation controls to reduce heavy metals exposure and resulting risk to consumer health; and
  • Reevaluating risk assessments based on updated levels of heavy metals in foods.

Regulation:

  • Establishing action levels and revising action levels;
  • Providing guidance on control and mitigation; and
  • Increasing targeted compliance and enforcement activities, as warranted.

Collaboration:

  • Working with federal partners to identify strategies to reduce heavy metal levels in food products, including:
    • Collaborating with the U.S. Department of Agriculture on research on agronomic techniques that may mitigate uptake of heavy metals in agricultural commodities
    • Collaborating with the National Institutes of Health and the Centers for Disease Control and Prevention to better understand impacts of heavy metals on development and the role of nutrition for mitigating those impacts.
  • Encouraging adoption of agricultural and processing best practices by industry to lower levels of heavy metals in agricultural products.

The FDA is committed to a science-driven, transparent, and inclusive process that will include active stakeholder engagement and public sharing of data and information. We will update our action items and timelines as new data, information, and resources become available.

Find more information, including links to FDA guidance and data tables, on the FDA’s arsenic, cadmium, lead, mercury, and testing results webpages.

The FDA is also committed to lowering contaminant levels in infant formula. Find more information on that effort on the FDA’s Operation Stork Speed webpage.

Setting Action Levels

What are the four stages FDA generally follows for setting action levels?

Evaluate the scientific basis for action levels. We evaluate analytical data and other scientific information, including toxicological data. If needed, we gather more data and develop benchmark levels (for example, Interim Reference Levels (IRLs) and toxicological reference values (TRVs)) to identify safe exposures.

What are Benchmark Levels?

The FDA may use a benchmark level in considering whether the amount of exposure to a heavy metals in food is a potential health concern. The FDA may use a benchmark level based on various factors. For instance, the agency has calculated the benchmark level for lead, an IRL, using the CDC’s blood reference level, which is the level at which the CDC recommends clinical monitoring of lead exposure in children. For cadmium, the FDA has derived a TRV that assesses the relationship between dietary exposure to cadmium and adverse health effects. The FDA may reassess benchmark levels if more information becomes available on dietary exposure and/or a heavy metal’s effect on human health.

Propose action levels.  We propose action levels based on toxicological data and what is achievable by manufacturers. We issue our draft action levels in a draft guidance document, consulting with other federal agencies and the White House.

Consult with stakeholders. We consult with stakeholders through the normal comment process and through workshops, scientific meetings, and collaboration with federal partners, as appropriate. We welcome input on achievability and timeframes.

Finalize action levels. The FDA will use most up-to-date information, which may include the information gathered from stakeholders, updated scientific research, and routine monitoring of data, to make any needed adjustments and finalize action levels.
 

Understanding the FDA’s Approach

Cycle of Continual Improvement: Decreasing Exposure to Toxic Elements from Foods for Babies and Young Children

Once the FDA has published final action levels, the agency will establish a timeframe for assessing industry’s progress toward meeting the action levels and resume the cycle to determine if the scientific data support efforts to further adjust the action levels. This could include evaluating the benchmark level, stakeholder engagements, and proposing and finalizing action levels, as appropriate. The FDA will continue this cycle of review, consultation, and improvement as needed to protect public health. 

While action levels are useful tools to drive down levels of heavy metals in foods, the agency does not need an action level for a heavy metal to take enforcement action on a food product that violates safety laws. By law, food manufacturers and processors have a responsibility to implement preventive controls as needed to significantly minimize or prevent exposure to chemical hazards—including lead, arsenic, cadmium, and mercury. If the agency finds that the level of a heavy metal in a food causes the food to be unsafe, we take action, which may include working with the manufacturer to resolve the issue and taking steps to prevent the product from entering, or remaining in, the U.S. market.

FDA Action Levels 

Heavy metal and Commodity PairStatus
Lead in Juices Draft guidance was issued in April 2022. The FDA is targeting 2027 to release the final guidance. 
Lead in Processed Food Intended for Babies and Young ChildrenThe FDA issued draft guidance in 2023, and final guidance in January 2025. 
Cadmium in Processed Food Intended for Babies and Young ChildrenThe FDA published draft guidance in October 2026.
Inorganic arsenic in Processed Food Intended for Babies and Young ChildrenThe FDA is targeting 2027 to release draft guidance. 

 ** Mercury. Our Closer to Zero initiative covers all heavy metals, but our research under Closer to Zero shows that mercury is not a concern in processed foods for babies and young children. The FDA has collected mercury data through its Toxic Elements compliance program (FY2009-2024, 195 samples) and two surveys of processed foods intended for babies and young children (FY2020-2022, 414 samples) and (FY2023-2024, 386 samples). Of these 995 samples collected, only 4 samples had total mercury levels above the level of quantitation of the FDA method and no samples were a concern based on a human health assessment. Therefore, the FDA is not prioritizing development of action levels for mercury in foods intended for babies and young children at this time. For more information on action levels for mercury in infant formula, see the FDA’s Operation Stork Speed webpage. For more information on our work on mercury in seafood, see Mercury in Food | FDA. 

Closer to Zero FAQs

1. What is an action level? 

An action level is a level at which FDA may regard a food as unsafe. The FDA sets action levels and uses them to clarify the level at which we may consider a product to be adulterated with a specific metal. 

2. How does the FDA determine action levels? 

To establish these action levels, the FDA goes through a thorough process to understand the potential for health risks from dietary exposure, the amount of the food consumed, the levels of heavy metals in the food supply, and what levels are feasible for industry to achieve.   

3. Does the need for an action level mean a food is unsafe?

Not necessarily. Just because a heavy metal is present doesn’t mean a product is unsafe, but we also want to make sure we are limiting exposure. The action levels are meant to provide guidance, which may help industry in producing safer food. The FDA will take action to remove a product from the market if FDA finds the food to have unsafe levels of heavy metals or any contaminant. 

4. Do the action levels set under Closer to Zero apply to fresh fruits and vegetables?

No, the action levels issued apply to processed food intended for babies and young children, like purees in jars or pouches, or dry infant cereal.

5. How do heavy metals get into foods? 

Heavy metals like arsenic, cadmium, lead and mercury (also called toxic elements) may occur in the environment naturally (as elements in the earth’s crust) and from human activities. These heavy metals can be present in the environment where food is grown, raised or processed.

6. Do homemade foods have safer levels of heavy metals?

No. There is no reason to believe that homemade foods would contain fewer heavy metals. These elements are present in the environment where food is grown, raised or processed. This is true for the ingredients that go into processed food or the ingredients you purchase to make your own food. The important thing is to eat a variety of foods that contain different nutrients. 

7. Is organic baby food safer from heavy metals?

Not necessarily. Organic crops absorb heavy metals from the earth just like conventional crops do. 

8. What can consumers do to protect their children from diet-related exposures to heavy metals?

A balanced, nutritious diet that includes a wide range of vegetables, fruits, grains, protein foods, and dairy, like that recommended in the Dietary Guidelines for Americans, can help protect against adverse health effects from exposure to heavy metals. Variety ensures that children aren’t repeatedly exposed to a food that contains a contaminant. Additionally, nutrients like iron, zinc, and calcium are essential for child development and can help prevent the harmful effects of heavy metals.

Additional information:

9. What can industry do to protect against heavy metals in the foods they process?

Under the FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule manufacturers and processors are responsible for considering risks from chemical hazards. Manufacturers of baby food are expected to have a food safety plan in place that includes a hazard analysis to identify any hazards and requiring a preventive control. If there are such hazards, the manufacturers would be required to have a preventive control, such as a plan to check or confirm the safety of incoming ingredients. The FDA released a new draft guidance, Chapter 12 of the preventive controls for human food draft guidance, that provides more details.

FDA Closer to Zero Tools 

Closer to Zero Research 

Closer to Zero Testing Results 

Announcements, Public Meetings, Workshops, and Webinars 

* Events listed include public events that are hosted, co-hosted, and/or funded/sponsored by FDA.

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