Today, the U.S. Food and Drug Administration is announcing draft guidelines for industry on working levels of lead in foods that are processed and intended for infants and children under two years of age, to help reduce the potential health effects of this vulnerable population from dietary exposure to lead. . The proposed action levels will lead to significant reductions in lead exposure from food while ensuring the availability of nutritious foods. Today’s action is part of Closer to Zero, which outlines the FDA’s science-based approach to continually reducing exposure to lead, arsenic, cadmium, and mercury to the lowest levels possible in foods eaten by infants and young children.
For more than 30 years, the U.S. Food and Drug Administration has worked to reduce exposure to lead and other environmental contaminants from foods. This work has led to significant reductions in lead exposure from foods since the mid-1980s, and the levels of proposed action announced today, along with our ongoing work with our state and federal partners, and with industry and farmers to identify mitigation strategies, will lead to significant reductions in lead exposure from foods since the mid-1980s. FDA Commissioner Robert M. Califf, MD, said, “For infants and young children who eat foods covered by the current draft guidance, the FDA estimates that these measures could result in a 24-27% reduction in lead exposure levels from these foods.”
The foods covered by the draft guidance, Working Levels for Lead in Foods for Babies and Young Children, are those foods that are processed, such as foods packed in jars, bags, tubs, and boxes intended for infants and toddlers under two years of age. The mentoring project contains the following levels of work:
10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixes (including cereals and meat mixtures), and yogurt. Custard/pudding and single-ingredient meats.
20 ppb for root vegetables (1 ingredient).
20 ppb for dry grain.
The Food and Drug Administration considers these levels of action achievable when measures are taken to reduce the presence of lead and expects that industry will strive to continually reduce this contaminant. Baby foods have different levels of action, to account for differences in consumption levels of different food products and because some foods take in higher amounts of lead from the environment. Action levels are one of the regulatory tools used by the Food and Drug Administration to help lower levels of chemical contaminants in foods when a certain level of contaminants is unavoidable, for example due to environmental factors. To determine action levels for food categories, the agency considered, among other factors, what level of lead could be in a food without food exposure that exceeded the FDA’s provisional reference level, which is a measure of the contribution of lead in food to blood lead levels.
Just as fruits, vegetables, and grain crops readily absorb vital nutrients from the environment, these foods also absorb pollutants, such as lead, that can be harmful to health. However, the presence of a contaminant does not mean that the food is unsafe to eat. The US Food and Drug Administration (FDA) evaluates the level of contaminants in food and exposure based on consumption to determine if the food presents a potential health risk. Although it is not possible to completely eliminate these elements from the food supply, we would expect that recommended action levels will lead to manufacturers implementing agricultural and processing measures to reduce lead levels in their food products below suggested action levels, thereby minimizing potential harm. Effects associated with dietary exposure to lead. Although the FDA is not obligated, it will consider these levels of action, as well as other factors, when considering enforcement action in a particular case.
“The levels of action in today’s draft guidance are not intended to guide consumers in making food choices. To support child growth and development, we recommend that parents and caregivers feed children a varied, nutrient-dense diet across and within the major food groups of vegetables, fruits, grains, dairy and protein foods,” said Susan. Maine, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition. “This approach helps your children get important nutrients and may reduce potentially harmful effects from exposure to contaminants from foods that absorb contaminants from the environment.”
As part of our approach, as laid out in 2021 when the FDA issued Closer to Zero, the agency is committed to evaluating whether action levels should be reduced even further, based on cutting-edge science on health effects, mitigation techniques, and input from industry on Realizability. We expect the draft working levels announced today, along with the draft working levels for lead in juice announced in 2022, to result in lower levels of lead in the US food supply. Going forward, the agency will continue to collect data and collaborate with federal partners to establish the scientific basis for establishing interim reference levels for arsenic, cadmium, and mercury. In addition, the Food and Drug Administration (FDA) is examining more than 1,100 comments it received in November 2021 during a public meeting titled “Closer to Zero Action Plan: Effects of Toxic Exposure and Nutrition on Various Developmental Stages Critical to Toddlers and Young Children” to inform its strategy move. Forward to future planned action on pollutants and to promote participation, education and exchange of public data and information.
The FDA will host a webinar to provide an overview of the draft guidance and answer stakeholder questions. More details about the webinar will be announced soon.
The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, and nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.