FDA Issues Draft Guidance Regarding Lead Levels in Processed Baby Food

On January 24, 2024, the FDA issued a new draft guidance regarding lead levels in processed baby food meant for children under two as part of its Closer to Zero initiative. The Closer to Zero initiative is focused on researching, analyzing, regulating, and consulting contaminant levels in food, with its primary goal of reducing childhood exposure to contaminants, namely, arsenic, lead, cadmium, and mercury.

The guidance, titled Action Levels for Lead in Food Intended for Babies and Young Children, focuses on processed food, specifically those in jars, pouches, tubs, and boxes. The guidance sets maximum levels of lead in multiple types of food, including 10 parts per billion (ppb) for fruit and vegetables, mixtures, yogurts and puddings, and single-ingredient meats. The only exception to the levels mentioned earlier is single-ingredient root vegetables, which can have up to 20 ppb. Additionally, dry cereals may also have up to 20 ppb of lead. The organization found these were achievable standards, noting 88–96% achievability for each guideline.

In the press release, the FDA acknowledges that fruits, vegetables, and other crops absorb contaminants from the environment just as they absorb nutrients. Despite the uptake of contaminants, the organization clarifies that it does not necessarily deem the food unfit for consumption. Instead, the FDA’s strategy is to analyze food contaminants’ levels and determine whether it is a potential health risk.

The FDA also implied that removing the elements from food is impossible; however, the organization feels its action levels will help guide food production and facilitate lower lead levels in baby food overall.

“The action levels in today’s draft guidance are not intended to direct consumers in making food choices.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, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, in the press release. “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.”