Proposed action levels for lead in baby food

The U.S. Food and Drug Administration (FDA) has announced draft guidelines for the industry on action levels for lead in processed baby foods to help reduce the risk of health effects from dietary exposure to lead. The proposed action levels may significantly reduce the exposure of lead from food and ensure the availability of nutritious foods. The action is part of Closer to Zero, a science-based FDA approach to continually reduce exposure to lead, arsenic, cadmium and mercury in foods eaten by babies and young children.

FDA Commissioner Robert M Califf said the FDA has been working towards this goal for more than 30 years and it has led to a large decline in lead exposure from foods. The FDA estimates the proposed action levels could result in a 24–27% reduction in exposure to lead from baby foods.

The draft guidance, Action Levels for Lead in Food Intended for Babies and Young Children, will cover processed foods such as food packaged in jars, pouches, tubs and boxes that are intended for babies and children under two years old. It contains the following action levels:

• 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yoghurts, custards/puddings and single-ingredient meats.
• 20 ppb for root vegetables (single ingredient).
• 20 ppb for dry cereals.

The FDA considers these action levels to be achievable when the appropriate measures are taken to minimise the presence of lead — something which it expects the industry to strive towards. The foods have differing action levels to account for variances in consumption levels and environmental factors. Action levels are a regulatory tool used by the FDA to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable. To identify the action levels for categories of foods, the agency considered the level of lead that could be in food without dietary exposure exceeding the FDA’s Interim Reference Level, a measure of the contribution of lead in food to blood lead levels.

Many crops such as fruits, vegetables and grains readily absorb both vital nutrients and contaminants such as lead from the environment. The presence of a contaminant does not make the food unsafe to eat and it is not possible to eliminate them entirely from the food supply. The FDA evaluates the level of the contaminant and the risk of exposure from consumption to determine if the food is a health risk. The agency expects that manufacturers will implement agricultural and processing measures to lower lead levels in their products according to the recommended action levels. Although not binding, the FDA would consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.

“The action levels in today’s draft guidance are not intended to direct consumers in making food choices. To support child growth and development, we recommend parents and caregivers feed children a varied and nutrient-dense diet across and within the main food groups of vegetables, fruits, grains, dairy and protein foods,” said Susan Mayne, Director of the FDA’s Center for Food Safety and Applied Nutrition. “This approach helps your children get important nutrients and may reduce potential harmful effects from exposure to contaminants from foods that take up contaminants from the environment.”

The FDA is committed to continually assessing if action levels should be lowered even further, based on evolving science and research. The agency will continue to gather data and collaborate with federal partners to establish the scientific basis for establishing Interim Reference Levels for arsenic, cadmium and mercury. Additionally, the FDA is considering the comments it received in November 2021 during the ‘Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages for Babies and Young Children’ public meeting to inform its strategy moving forward for future planned action on contaminants.

Image caption: iStock.com/SergeyKirsanov