FDA Issues Guidance for Industry on Action Levels for Lead in Baby Foods

What's New

April 6, 2023

The FDA has reopened the comment period on the proposed guidance “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.” Submit either electronic or written comments on the draft guidance by May 8, 2023, to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. For more information, see the Federal Register Notice announcing the reopening of the comment period.

March 28, 2023

The U.S. Food and Drug Administration (FDA) will reopen the comment period for 30 days for the proposed guidance “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry” announced in the Federal Register on January 25, 2023. The Federal Register Notice is forthcoming. We are taking this action in response to a request from stakeholders for additional time to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-D-0278.

Original Constituent Update

January 24, 2023

Today the U.S. Food and Drug Administration issued for public comment “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.” As the agency outlined in Closer to Zero, we expect 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 The draft guidance announced today supports the FDA’s goal of reducing dietary exposure to lead, arsenic, cadmium and mercury, and the associated health effects, while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Foods covered by this draft guidance are those processed foods, such as food packaged in jars, pouches, tubs and boxes, that are represented or purported to be specifically for babies and young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. Our 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, we take 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 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, we 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, we will assess stakeholder comments and other information and data, to determine if further adjustments are needed. The FDA will host a webinar to provide an overview of the draft guidance and answer stakeholder questions. More details on the webinar will be announced shortly.

To ensure comments regarding “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry" are considered before the FDA begins work on the final guidance, please submit written or electronic comments by March 27, 2023.

Submit comments electronically on Regulations.gov to docket number FDA-2022-D-0278.

Submit written/paper submissions to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All submissions received must include the Docket No. FDA-2022-D-0278 for “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry."

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