The U.S. Food and Drug Administration Children: Draft Guidance for Industry.” As the agency outlined in Closer to Zero, it expects over time for this guidance, together with other activities, to result in industry progressively reducing levels of lead in foods to as low as possible. The FDA says that the draft guidance supports its goal of reducing dietary exposure to lead, arsenic, cadmium and mercury, and the associated health effects, while maintaining access to nutritious foods.
Foods covered by this draft guidance are those processed foods, such as food packaged in jars, pouches, tubs and boxes, that are represented or purported to be specifically for babies and young children less than two years of age. Lead may be present in these foods because agricultural commodities they are made from—fruits, vegetables, grains and animals—take up contaminants in the environment in much the same way they take up nutrients. In this way, these foods can provide nutrients essential for child growth and development, but they may also be a source of exposure to contaminants.
While it is not possible to remove lead entirely from the environment or the food supply, it is possible to lower lead levels in foods. 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 not intended to set the lowest levels for industry to achieve. The agency’s commitment under Closer to Zero is to take a variety of actions to reduce levels of lead in products for babies and young children to as low as possible and our expectation is for industry to strive for continual reductions over time. Although not binding, the FDA would consider these action levels, in addition to other information, when considering whether to bring enforcement action in a particular case. For all foods, with or without action levels, when the agency finds that the level of lead causes the food to be unsafe, it takes 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.
This draft guidance is not intended to direct consumers in making food choices. The FDA advises that parents and caregivers feed their children a variety of age-appropriate nutrient-dense foods across and within the main food groups of vegetables, fruits, grains, dairy and protein foods, including foods addressed in this draft guidance. Caregivers do not need to throw out processed or packaged baby foods or stop feeding certain foods to babies and children. Eliminating entire food groups from a child’s diet may result in nutrient deficiencies and poor health outcomes.
To identify the action levels for categories of foods, the agency considered among other factors, the level of lead that could be in a food without dietary exposure exceeding FDA’s Interim Reference Level of 2.2 ug/day. For babies and young children that eat the foods covered in this draft guidance, the FDA estimates that these action levels could result in as much as 24-27% reduction in exposure to lead from these foods.
The FDA says it will monitor industry’s progress in reducing the levels of lead in the foods identified in this draft guidance, while ensuring that manufacturers are putting in place any needed preventive controls to reduce or eliminate the presence of lead in their products. In addition, the agency says it will continue to evaluate scientific advances in reducing the levels of lead in foods and the role nutrition plays in reducing the health impact of lead exposure. Before finalizing the action levels, the FDA will assess stakeholder comments and other information and data, to determine if further adjustments are needed.