The U.S. Food and Drug Administration (FDA) recently released a new action plan designed to further reduce exposure to toxic elements, including heavy metals, from foods for infants and young children. This represents the latest development concerning the widespread focus on the levels of heavy metals in baby food. The action plan, titled “Closer to Zero” highlights four steps that the FDA will take over the next three years to reduce exposure to toxic elements “to as low as possible.”

First, the FDA will evaluate existing data from a variety of sources, including routine testing of the food supply to develop interim reference levels (IRLs) for certain toxic elements. FDA plans to develop the IRLs in conjunction with stakeholders and based on relevant scientific information. The FDA will then use the IRLs to develop proposed action levels for toxic elements in certain categories of food commonly eaten by babies and young children. This proposed action would likely developed through a public rulemaking process.

Action levels are significant because they represent the level of contamination at which a food can be considered as adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act. This classification also opens the door for FDA to use its mandatory recall authority should a food company not cooperate with FDA’s request to recall a product. In order to issue a mandatory recall, FDA must first determine that there is a reasonable probability the food is adulterated under section 402. If FDA concludes the food is adulterated, it then makes a determination to issue a recall depending on whether there is a reasonable probability that exposure to the food will cause serious adverse health consequences. Currently, FDA has only one action level for heavy metals in baby food: 100 ppb inorganic arsenic standard for infant rice cereal so this step of the action plan and the potential proliferation of action levels for metals in baby foods could have widespread implications.

Following the drafting of action levels, FDA plans to consult with stakeholders on the proposed action levels. FDA seems particularly interested on receiving input on the achievability and feasibility of action levels. This is an important component considering heavy metals are naturally present in the environment and enter food through soil, water, or air meaning food manufacturers often have a limited ability to reduce the presence of these metals in foods. Finally, FDA plans to finalize the action levels based on the above steps. FDA plans to begin this process for lead first due to available data and then repeat the process for other heavy metals as the data become available. After being finalized, FDA will establish a timeframe for assessing progress towards meeting the action levels and make adjustments as necessary.

While protecting vulnerable populations such as young children and babies from exposure to toxins is necessary it is important to remember that heavy metals are naturally occurring, and that FDA’s testing shows that children are not at an immediate health risk from exposure. Food manufacturers should familiarize themselves with FDA’s action plan and be prepared to engage with FDA in the stakeholder opportunities to ensure the final standards are both safe and achievable.

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Husch Blackwell has experience working with food retailers and the food service industry to assist with meeting FDA’s food safety requirements.  Contact Seth MailhotEmily Lyons, or your Husch Blackwell attorney for more information.