• A Push for Food Safety

  • FDA’s Baby Steps

  • Closer to Zero

A Push for Food Safety

Arsenic, lead, and other heavy metals are ubiquitous in the environment and essentially unavoidable in certain foods, but the presence of heavy metals in baby food can threaten the neurological development of children. Recently, a government report sounded the alarm about elevated levels of heavy metals in food intended for babies and young children.  Addressing the public health concerns, federal legislation was introduced this year to establish limits for heavy metals in food, and the U.S. Food and Drug Administration (FDA) unveiled a strategic plan for reducing exposure to heavy metals from food.

A Congressional subcommittee report released earlier this year suggested some of the leading brands of retail baby foods contain “dangerously high levels” of arsenic, lead, cadmium, and mercury.  Initially, the report provided an opportunity for the FDA to remind companies of the preventive controls rule and the importance of considering chemical hazards when conducting a hazard analysis.  Later, the public outcry from the report encouraged the agency to release its Closer to Zero Action Plan (April 8) for reducing exposure to heavy metals.  The strategic action plan outlines goals for evaluating the levels of heavy metals in food and setting action levels for certain elements in food intended for babies and young children (e.g., cereals, infant formula, pureed fruits, and vegetables).  

FDA’s Baby Steps

Canada, Australia, and the European Union have enforced limits for heavy metals in foods for several years. The Food, Drug, and Cosmetic Act (FDCA) and the Food Safety Modernization Act (FSMA) mandate the absence of chemical hazards in food. Since the 1970s, the FDA has been developing action levels for mercury in fish, mercury in wheat, lead in candy to be consumed by small children, lead in juice, and arsenic in bottled water. In 2013, the FDA issued draft guidance setting a 10 ppb action level for inorganic arsenic in apple juice.  In 2020, the FDA finalized an action level of 100 parts per billion (ppb) for infant rice cereal, which is the first federal limit finalized for arsenic in food for children. 

In recent years, several consumer and environmental advocacy groups have expressed concerns about heavy metals in the U.S. food supply.  A 2019 study by the consumer group Healthy Babies Bright Future (HBBF) reported an independent study found heavy metals in 95% of baby foods tested by the group. In 2013, a study by Consumer Reports found elevated arsenic levels in the juice commonly consumed by children, which led to the FDA draft guidance for an action level for apple juice. 

The Baby Food Safety Act of 2021 was introduced to the U.S. House in March in an effort to mandate maximum levels for heavy metals in infant formula and food for children up to 36 months. The legislation suggested limits for the following metals: 

  • Inorganic Arsenic: 10 ppb for infant and toddler food (except cereal) and 15 ppb for infant and toddler food that is cereal
  • Cadmium: 5 ppb for infant and toddler food (except cereal) and 10 ppb for cereal food.
  • Lead: 5 ppb for infant and toddler food (except cereal) and 10 ppb for cereal food.
  • Mercury: 2 ppb

The Congressional subcommittee report (2021) included recommendations for mandatory testing of finished products and ingredients for heavy metals, and labeling to alert consumers to the presence of heavy metals in a food product. Additionally, the report advised the FDA to establish maximum levels of heavy metals permitted in baby foods.

Closer to Zero

The FDA’s Closer to Zero Action Plan was developed as a four-stage program for reducing the exposure of babies and young children to lead, mercury, cadmium, and arsenic in foods to the lowest possible level.  Here is a synopsis of the FDA’s action plan:

  • Stage 1: Evaluate the scientific basis for action levels and establish interim reference levels (IRLs) for toxic elements in food.
  • Stage 2: Propose action levels for heavy metals in specific categories of food intended for babies and young children, including infant formula, cereals, pureed fruits, and vegetables.
  • Stage 3: Conduct scientific meetings and workshops with industry to determine the “feasibility” of the proposed action levels and timelines.
  • Stage 4: Finalize action levels.

During the first phase (April 2021 – April 2022) of the action plan, the FDA will propose draft action levels for lead in foods consumed by babies and young children. Between April 2022 and April 2024, the agency intends to draft action levels for arsenic in food consumed by babies and young children, and finalize the action levels for lead. Also, the FDA plans to issue guidance on chemical hazards in its Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls in Food during this period.


Are heavy metals in your product? The determination of toxic heavy metals in ingredients and finished foods is important for any food company but particularly vital for manufacturers and processors responsible for food intended for babies and young children. Mérieux NutriSciences in North America offers testing of heavy metals in food and food ingredients using the ICP-MS instrument.   

Do you know your limits? Mérieux NutriSciences recently launched Limit Detector as an online tool for determining the maximum limits as defined by food regulations for a specific substance and/or product in a market. Our Food Compliance Solutions unit designed the Limit Detector tool with a clean interface for searching the regulatory limits of chemical (e.g. heavy metals, mycotoxins, natural toxins, others) and biological contaminants in specific food products. Contact us to request a demo of Limit Detector and a 10-day free trial.


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