The Food and Drug Administration has issued final industry guidance setting the levels of lead in some processed foods that would trigger recalls and other actions.
The action levels apply to foods intended for babies and young children like fruit puree pouches and dry infant cereals. This guidance grew out of the agency’s Closer to Zero initiative to lower exposure to contaminants like lead in foods.
The initiative was launched in 2021, but calls to address lead in some products ramped up following the discovery of high lead levels in some cinnamon-apple pouches in 2023.
In 2023 WanaBana LLC voluntarily recalled all its apple cinnamon fruit puree pouches after a North Carolina state lab linked them to elevated blood lead levels in children. Other brands also recalled products due to lead levels.
Some products contained lead levels around 3,000 parts per billion. An investigation later tied these levels to the cinnamon grinder in Ecuador as the likely source of lead.
The FDA’s final guidance sets action levels at 10 parts per billion for packaged, processed foods with fruit, vegetables (excluding single-ingredient root vegetables), mixtures including grain and meat-based mixes, yogurts, custards and single ingredient meats.
The guidance also sets an action limit of 20 parts per billion for single-ingredient root vegetables and dry infant cereals.
FDA is continuing to collect data on grain-based snacks to determine an appropriate action level. Therefore the guidance does not cover infant formula, beverages, or snack foods like puffs and teething biscuits.
Lead and other contaminants can naturally enter foods the same way plants and animals take up nutrients. These can also enter the supply through environmental pollutants in air, water and soil.
Still, even a small amount of lead over time can pose a health risk as it accumulates in the body. The risks are most pressing among babies and young children, which is why FDA prioritized action levels for foods designated to these age groups.
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