FDA Issues Final Guidance on Action Levels for Lead in Processed Food Intended for Babies, Young Children

The U.S. Food and Drug Administration (FDA) issued guidance for industry on the action levels for lead in processed food intended for babies and young children. The action levels reflect the levels of lead at which the FDA may regard the food as adulterated under the Federal Food, Drug, and Cosmetic Act.

The guidance, titled “Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry,” supports FDA’s Closer to Zero initiative to reduce dietary exposure to contaminants, including lead, in foods to as low as possible over time, while maintaining access to nutritious foods. 

The action levels for processed foods described in the guidance are as follows:

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

Contaminants such as lead occur naturally and as environmental pollutants in air, water and soil. Contaminants may enter the food supply when plants and animals take them up similarly to how they take up nutrients, making the food both a source of essential nutrients for child growth and development but also a source of exposure to contaminants. Because the very young are more vulnerable to adverse health effects associated with exposure to contaminants, FDA said it prioritized reducing exposure from foods commonly consumed by young children.  

The final guidance covers packaged processed foods that are represented or purported to be for babies and young children less than two years of age. This includes foods in jars, pouches, tubs or boxes and may include ready-to-eat foods such as purees, as well as semi-prepared foods such as dry infant cereals. Action levels for lead in juices are addressed in a separate draft guidance. The guidance does not cover infant formula, beverages or snack foods like puffs and teething biscuits. FDA is continuing to collect additional data on grain-based snacks to determine whether an action level would be appropriate for these products as part of its approach to reducing childhood dietary exposure to lead through Closer to Zero.  

The guidance is not intended to direct consumers in making food choices. Parents and caregivers should not throw out processed or packaged baby foods or stop feeding certain foods to babies and young children. Good nutrition — like meeting the recommendations in the Dietary Guidelines for Americans — can help protect against the health effects from exposure to lead, said FDA. Eating a variety of healthy foods can make it less likely for an individual to be exposed to the same contaminant from the same food many times and helps to provide the range of nutrients needed for health and, for children, healthy development, according to the agency. Having adequate nutrients stored in the body also can help to prevent lead from having harmful effects, FDA said. To get adequate food variety, FDA recommends that parents and caregivers feed their children many different foods from the five food groups — vegetables, fruits, grains, dairy and protein foods  — and alternate how often they provide the same food.

FDA’s Closer to Zero initiative focuses on a variety of actions that can be taken to reduce levels of lead and other contaminants in food products for babies and young children to as low as possible. To identify action levels, FDA undertakes a thorough process to understand the potential for health risks from dietary exposure to the contaminant, the levels of the contaminant in the food supply and the levels of the contaminant that are feasible for industry to achieve. Although not binding, the FDA would consider action levels, in addition to other information, when considering whether to bring enforcement action in a particular case. It is not possible to remove lead entirely from the environment or the food supply. Setting action levels like those in the guidance can help lower levels of contaminants in foods when a certain level of a contaminant is unavoidable, said FDA. However, FDA does not need an action level or guidance to take action with respect to a food product that is in violation of the law.