FDA Issues Guidance for Industry on Action Levels for Lead in Baby Foods.
Learn more about the FDA’s proposed action levels for lead in processed baby foods and how to submit public comments.
Register for the FDA and NIH 2-Day Virtual workshop.
Learn more about and register for “Bridging the Biological and Communication Sciences on Nutrients and Environmental Contaminants in Foods to Support Child Development” workshop scheduled for Thursday 02/09/2023 and Friday 02/10/2023 from 10:30 am – 4:30 pm.
Register for FDA Webinar on the Draft Guidance for Industry on Action Levels for Lead in Food Intended for Babies and Young Children
Learn more about and register for the “FDA Stakeholder Webinar on the Draft Guidance for Industry on Action Levels for Lead in Food Intended for Babies and Young Children” scheduled for Thursday 03/02/2023 at 1:00 pm (EST).
Why are arsenic, lead, cadmium, and mercury in some foods?
These contaminants may occur in the environment naturally (as elements in the earth’s crust) and from human activities. Levels in the air, water, and soil used to grow crops, process foods, and raise animals can vary depending on natural geographical differences and proximity to past or current pollution.
The amount of arsenic, lead, cadmium, or mercury in certain foods depends on the amount in the environment and how much the plant or animal ‘takes up’ from the environment.
The FDA’s goal is to reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods. The agency’s work to date has resulted in significant progress in reducing exposure to environmental contaminants from foods and Closer to Zero builds on this progress. We have prioritized foods commonly eaten by babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants. To meet the goals of Closer to Zero, we have focused our efforts on:
Research and Analysis:
- developing new and improved testing methods to measure lower levels of contaminants in food;
- conducting surveys on foods commonly eaten by infants and young children to understand variability in concentrations of arsenic, lead, cadmium, and mercury in these foods;
- working with federal partners to identify strategies to reduce contaminant levels in food products;
- evaluating consumption patterns for different populations;
- measuring dietary exposures to these contaminants;
- identifying reference levels for these contaminants to determine levels of concern; and
- understanding how nutrients can help protect against the health effects associated with contaminants.
- establishing action levels;
- increasing targeted compliance and enforcement activities; and
- monitoring levels over time to determine potential adjustments to proposed action levels.
- encouraging adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products.
Reducing levels of contaminants in foods is complicated and multifaceted. It is crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.
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.
Closer to Zero uses a science-based, iterative approach for achieving continual improvements over time.
What are action levels?
Action levels are one regulatory tool the FDA uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable.
Action levels are a level of contamination at which a food may be regarded as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. Action levels do not establish a permissible level of contamination.
The FDA considers action levels, in addition to other factors and scientific evidence, when considering whether to bring enforcement action in a particular case.
The Four Stages of the FDA’s Approach:
Evaluate the scientific basis for action levels. The cycle of continual improvement starts with the FDA evaluating existing data from routine testing of the food supply, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information. Through a process that may include engagement with stakeholders, advisory committees, public workshops, and consultation with scientific experts, federal agency partners and other stakeholders, the agency will establish interim reference levels (IRLs) as appropriate. An IRL is a measure of exposure to a contaminant from food that the FDA may use to determine if the amount of exposure to the contaminant across foods could result in a specific health impact.
Propose action levels. The IRLs may be among the key factors that inform the development of the FDA’s proposed action levels for arsenic, lead, cadmium, and mercury in categories of baby foods (e.g., cereals, pureed fruits and vegetables) and other foods commonly eaten by babies and young children. After the FDA identifies action levels, the agency submits our draft guidance on action levels for review by other federal agencies, including The White House.
Consult with stakeholders on proposed action levels, including the achievability of action levels. For each individual element in every identified category of food, the FDA will gather data and other information through a process of consultation which could include workshops, scientific meetings, and collaboration with federal partners to assess, among other things, the achievability and feasibility of the proposed action levels and the timeframes for reaching them.
Finalize action levels. The FDA will use the information gathered from stakeholders, updated scientific research, and routine monitoring of data to make any needed adjustments and finalize action levels.
The FDA's Approach in Action
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.
The availability of data and additional research needs for arsenic, lead, cadmium, and mercury are different. Therefore, because of currently available data, we will start with proposing action levels for lead while we evaluate data for arsenic, cadmium, and mercury. We will then progress through the cycle for each element as we gather more data and information across various categories of food eaten by babies and young children.
As action levels are finalized, we will continue the cycle of continual improvement, addressing arsenic, lead, cadmium, and mercury to evaluate whether downward adjustments of interim reference levels should be made; proposing new action levels, as appropriate; consulting with stakeholders on feasibility, achievability, and other issues; and adjusting (as needed) and finalizing action levels.
While action levels are a useful tool to drive down levels of contaminants in foods, the agency does not need an action level for a contaminant 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 contaminant 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.
Planned Action Items
Gather data and collaborate with federal partners.
Propose Draft Action Levels
Propose action levels for specific contaminants for foods or food groups in draft guidance to industry and open for public comment.
Consult with Stakeholders
Engage with stakeholders to assess, among other things, feasibility and best practices.
Review new scientific data, assess progress on reducing environmental contaminants in products and feasibility of attaining even lower levels.
|Lead in Juices||February 2020: Interim Reference Level for lead identified||April 2022: Issued draft guidance||
June 2022: Stakeholder webinar
|Lead in Foods Intended for Babies and Young Children||August 2022: Interim Reference Level for lead updated||April 2022: Developed action levels and submitted draft guidance for interagency review
January 2023: Issued Draft Guidance
|March 2023: Stakeholder webinar||No update|
|Arsenic in Foods Intended for Babies and Young Children||2022-2023: Continue evaluating, together with federal partners, the science for arsenic and other work related to establishing interim reference levels.||2024: Develop action levels and submit draft guidance for interagency review||No update||No update|
|Cadmium in Foods Intended for Babies and Young Children||2022-2023: Continue evaluating the foundational science for cadmium to establish interim reference levels||2024: Develop action levels and submit draft guidance for interagency review||No update||No update|
|Mercury in Foods Intended for Babies and Young Children||2022-2023: FDA and federal partner’s sponsor study on the role of seafood consumption in child growth and development||January 2023: NASEM webcast||No update||No update|
Research, Monitoring, and Compliance
|Research: Cadmium - toxicology||2022: Completed systematic review of adverse health effects from oral cadmium exposure; review of adverse health effects of cadmium in infants and children, modeling of low bone mass and osteoporosis in US adults; and modeling of cadmium dose response.|
|Research: Lead - toxicology||
2020: Identified Interim Reference Level for lead to calculate maximum daily intake from food.
2022: Completed updating the Interim Reference Level for lead to align with CDC’s 2021 updated blood lead reference value (CDC’s BLRV of 3.5 µg/dL).
|Research: Arsenic - toxicology||Ongoing: evaluating data and other information on the dose response of arsenic.|
Research: Mercury – toxicology
|2022-2023: Contracted NASEM for an independent consensus study on the role of seafood in child growth and developing, including mercury.|
|Research: Predictive toxicology||2022: Applying predictive toxicology to assess toxicity of arsenic, lead, cadmium, and mercury using predictive toxicology. FDA assessed developmental toxicity of arsenic and mercury in a non-vertebrate, alternative model using C. elegans and developmental toxicity and neurotoxicity of arsenic in a vertebrate alternative model using zebrafish.|
|Research: Methods development||Ongoing: Developing and validating analytical methods for toxic elements in foods.|
|Research, Monitoring, and Compliance: Testing foods commonly consumed by babies and young children, for arsenic, lead, cadmium and mercury.|
|Issue guidance chapter on chemical hazards in the Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food||Target 2024|
|Research: Consumer studies to inform educational content for target audiences||
Ongoing: In-depth interviews with health educators and additional focus groups with parents and caregivers are under development.
Ongoing: Focus groups conducted with parents and caregivers.
Ongoing: FDA and USDA collaboration to gather informational needs for consumer and health professional education.
Public Meetings, Workshops, and Webinars*
|Stakeholder Webinar on Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry March 2023||Event Page|
|Partnership for Food Safety Education 2023 Consumer Food Safety Education Conference, Pre-conference Workshop: FDA’s Closer to Zero Action Plan – What’s the Food Safety Message? March 2023||Event Page|
|NIH-FDA Joint Scientific Workshop “Bridging the Biological and Communication Sciences on Nutrients and Environmental Contaminants in Foods to Support Child Development” February 9-10, 2023|
|National Academies of Sciences, Engineering, and Medicine Committee Review of The Role of Seafood in Child Growth and Development Information Gathering Session, January 19, 2023|
|Science Board to the Food and Drug Administration Advisory Committee – Cadmium, December 8, 2022||Event Page|
|FDA Stakeholder Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice, June 14, 2022|
|JIFSAN-CFS3 Advisory Council Virtual Annual Symposium: Understanding of the Impact of Arsenic, Cadmium, and Lead Across the Food Supply, May 25-26, 2022|
|USDA-FDA Joint Public Meeting - Closer to Zero: Impacts of Toxic Element Exposure and Nutrition in the Food System, April 27, 2022||USDA Closer to Zero Page|
|USDA NIFA Workshop on Toxic Elements in Food: Identification of Critical Knowledge Gaps to Ensure a Safe Food Supply, April 4-5, 2022|
|FDA Grand Rounds on Closer to Zero, December 9, 2021|
|FDA-Society of Toxicology Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety - Arsenic and Children’s Health, December 1, 2021||Event page|
|FDA Public Meeting: Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages, on Closer to Zero, November 18, 2021||Event page|
Ongoing Work to Support Closer to Zero
To help us reach the Closer to Zero goals and build on the significant progress that has already been made in reducing contaminants in the food supply, we will also continue:
- Developing and validating analytical methods.
- Continuing toxicological research on impacts of arsenic, lead, cadmium, and on development in children.
- Developing new dose-response models to consider the probability of other adverse health effects in different sub-populations, including infants and young children.
- Collaborating with the U.S. Department of Agriculture on research on agronomic techniques that may mitigate uptake of these elements in agricultural commodities
- Collaborating with the National Institutes of Health and the Centers for Disease Control and Prevention to better understand impacts of these elements on development and the role of nutrition for mitigating those impacts.
- Evaluating potential impact of new technologies, interventions, or mitigation controls to reduce exposure and resulting risk to consumer health.
- Reevaluating risk assessments based on declining levels of toxic elements in foods.
The FDA’s regulatory actions, along with research and collaboration with all of our stakeholders – industry, advocacy, policy makers, academia, and consumers – will result in significant reductions in exposures to arsenic, lead, mercury, and cadmium, among children and the general population and have lasting public health impact.
- FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Food Intended for Babies and Young Children (January 26, 2023)
- FDA Issues Guidance for Industry on Action Levels for Lead in Baby Foods (January 24, 2023)
- Registration Open for Scientific Workshop Exploring Research on Nutrients and Environmental Contaminants in Foods and Child Development (January 12, 2023)
- Update on Study of the Role of Seafood Consumption in Child Growth and Development (January 12, 2023)
- FDA and Federal Partners Launch Study on the Role of Seafood Consumption in Child Growth and Development (October 11, 2022)
- FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice (June 20, 2022)
- FDA Issues Draft Guidance to Industry on Action Levels for Lead in Juice (April 27, 2022)
- FDA Announces First Closer to Zero Action Plan Public Meeting (October 8, 2021)
- FDA Statement: FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children (April 8, 2021)
- FDA Shares Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies and Young Children (April 8, 2021)
- FDA Letter to Industry on Chemical Hazards, including Toxic Elements, in Food and Update on FDA Efforts to Increase the Safety of Foods for Babies and Young Children (March 5, 2021)
- FDA Statement: FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies, Young Children (March 5, 2021)
- FDA Response to Questions About Levels of Toxic Elements in Baby Food, Following Congressional Report (February 16, 2021)